US20100331862A1

US20100331862A1 - Tissue compression using surgical clips

Info

Publication number: US20100331862A1
Application number: US12/521,597
Authority: US
Inventors: Leonid Monassevitch; Boaz Shenhav; Boaz Harari; Amir Perle; Michael Arad; Shahar Millis; Kobby Greenberg; Shlomo Lelcuk; Doron Kopelman; Amol Bapaye; Dror Rosner
Original assignee: Niti Surgical Solutions Ltd
Current assignee: Novogi Ltd
Priority date: 2006-03-09
Filing date: 2007-12-27
Publication date: 2010-12-30
Also published as: EP1993451A2; WO2007102152A2; ATE525964T1; EP1993451B1; US20070213747A1; EP1993451A4; US7892244B2; US20110112559A1; WO2007102152A3

Abstract

A compression clip system where compression is used to close a tissue opening, reduce the volume of an organ, ligate dilated blood vessels or compress tissue adjacent to various other types of lesions to induce healing. Compression prevents bleeding and the leakage of body fluids into a body cavity. The opening may be surgery induced as in gastrectomies or formed naturally such as peptic ulcers and hemorrhoids. The system may include a compression clip, a suitable clip applier, a grasper assembly and an endoscope all brought to the compression site via a multi-lumen sleeve.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority rights from “Tissue Compression Using Surgical Clips”, U.S. Provisional Application 60/897,842, filed Jan. 29, 2007; “Endoscopic Full Thickness Resection Using Surgical Compression Clips”, U.S. patent application Ser. No. 11/647,912, filed Dec. 29, 2006; and “Surgical Compression Clips”, U.S. patent application Ser. No. 11/647,913, filed Dec. 29, 2006. The present invention is a continuation-in-part of U.S. patent application Ser. No. 11/647,912, filed Dec. 29, 2006.

FIELD OF THE INVENTION

The present invention relates to the field of tissue compression employing surgical clips.

BACKGROUND OF THE INVENTION

Several methods are known in the art for joining tissue portions requiring tissue closure, particularly in the gastrointestinal (GI) tract. Methods for joining severed tissue or tissue deficiencies as a result of excisions are known. These include threads for manual suturing, staplers for mechanical suturing, tissue adhesives and compression rings and clips.
While manual suturing is a time tested, universally known and relatively inexpensive technique, the degree of success depends considerably on the skill of the surgeon. Another disadvantage of this technique is that post-operative complications are common Further, suturing an organ results in lack of smoothness of the sutured tissue. When the sutured organ is part of the gastrointestinal tract, the sutural scar tissue hampers peristalsis in the sutured area. Suturing involves a foreign body reaction while the tissue is healing which may also affect recurrence rates in cancer patients. Finally, suturing is both labor and time consuming and, when performed endoscopically, is also technically complicated.
Increasingly, stapling is being used for suturing. Staples for mechanical suturing ensure a reliable joining of tissue and reduce the time needed for surgery compared with manual suturing. However, after healing, metal staples remain in place along the perimeter of the suture, which reduces elasticity of the junction and adversely affects peristalsis when the sutured organ is part of the gastrointestinal tract. These complications often lead to strictures and inflammatory reactions to the foreign bodies left behind. Staples also often lead to undesired leakage of blood and other body liquids into the region of resected tissue which leads to a local inflammatory process and may result in severe infection. Additionally, stapling mechanisms generally are relatively large and fairly rigid, limiting the maneuverability of an endoscope used in conjunction with the stapling mechanism. This lack of maneuverability restricts an endoscopic approach to many locations within the body.
Junctions using compression devices, such as rings (or loops) and clips, ensure the best seal and allow for ideal post-operative function of organs. The compression force exerted by compression rings and clips is applied at the junction and decreases as the tissue is crushed and its thickness is reduced. Their design is cheap and they are small in size. Moreover, when used in the GI tract they are often self-evacuated.
A major disadvantage of known clips is that they permit compression of only approximately 80-85% of the junction perimeter, thus requiring additional manual sutures. This reduces the integrity of the seal of the junction during the healing period and its elasticity during the post-operative period. Furthermore, additional suturing is problematic inasmuch as it has to be carried out across a joint which includes a portion of the clip, thereby rendering difficult sealing and anastomosis of the organ portions.
The compressive force exerted by clips generally is not equal at both ends of the clip because of the clip's typically asymmetric construction. This can lead to the clip disengaging from the closure site before hemostasis is complete and before scar tissue is mature.
Typically, clips do not necessarily have a securing mechanism against slipping off the tissue. In clips that do have a securing mechanism, the compression line is collinear with the securing line, the latter formed by, and positioned between, the securing elements holding the tissue to be compressed. This can lead to compromised tissue healing and, in cases where securing elements penetrate the tissue, to leakage or bleeding. Clips, as currently designed, may also affect the maneuverability of an endoscope.
Perforations in organs may be caused by ulcers, neoplasms, infection, trauma and other pathological processes and may be iatrogenic in nature. These may occur in various systems such as the gastrointestinal tract, the urinary tract, the vaginal cavity, the peritoneal cavity and others. Surgical treatment of perforations or repair of incisions and fistulas in these systems, whether as a result of a pathology or as a result of an iatrogenic procedure, often requires the closure of large openings or excisions.
Additionally, natural orifice transluminal endoscopic surgery (NOTES) which obviates the need for cutting through the abdominal wall, is a new and promising surgical technique. In NOTES, an incision is made from within a natural orifice, for example the GI tract or other body lumen, to reach the peritoneal cavity or other organs. While methods for joining tissue portions or repairing of tissue perforations are known, they suffer from many of the drawbacks noted above. Likewise, solutions for joining tissue portions adjacent to tissue excised in a NOTES procedure that are superior to solutions currently available will be required.
Closing perforations and openings after iatrogenic procedures including NOTES or as a result of pathological processes all require wound closing instruments, systems and methods to prevent leakage into the peritoneal cavity or other body organs. In a recent meeting of a group of surgeons from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and gastroenterologists from the American Society of Gastrointestinal Endoscopists (ASGE), a framework for the initial safe application of NOTES procedures was discussed and worked out. It was agreed that further expansion of the use of NOTES procedures depends inter alia on an effective collaboration with industry. Development of effective instruments allowing traction/countertraction and stable optical platforms, as well as the means to control hemostasis, securely close the visceral wall, and perform suturing functions and gastrointestinal anastomoses were deemed critical.
Hemorrhoids, when surgically removed by procedures other than heat, laser or infrared instruments, employ suturing, stapling and rubber ligation bands. Challenges outlined above for suturing and stapling also apply to suturing and/or stapling in hemorrhoidectomies. Additionally, rubber ligation bands purse tissue which often leads to bleeding and/or rugged scar formation. In addition, in most cases band ligation does not deal with the root cause of the hemorrhoid, i.e. the feeding blood vessel.
A new compression clip and a system and method for its use would therefore answer long standing problems in several surgical areas where compression is the best way to accelerate wound healing.

DEFINITIONS

“Proximal” relates to the side of a clip or device closest to the user, while “distal” refers to the side of a clip or device furthest from the user.
“Lesion” may be used in place of the word “polyp” “perforation”, hemorrhoids, tissue adjacent to a resected site, or openings within tissue generated by any surgical procedure or occurring naturally, without any intent at differentiating between these different types of lesions, except where specifically indicated or otherwise obvious from the context of the relevant discussion in the text. Ulcerous lesions may also be subsumed under the term “lesion” discussed herein when the context of the discussion admits of that possibility.
“Gastrointestinal tract” or its equivalents are used in the specification and claims without any intent at being limiting. Other organ systems, and lesions found therein, are also contemplated as being treatable with the compression clips, devices and methods described in the present specification.
“Hinge spring” is one type of a “force applier” and this latter term may be used herein interchangeably with hinge spring without any intent at differentiating between these terms, except where specifically indicated. Accordingly, the latch described herein, as well as elements having other shapes, may also be considered force appliers if they are used for, and their operation is based on, their being formed from and possessing the force applying properties of shape-memory materials. Hinge springs may be described herein as “hinge members”, “force means” and “force members”, again, without any attempt at differentiating between these terms except where specifically indicated.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved surgical compression clip, as well as a system and method for its use, having force appliers/force means formed of a shape memory alloy material. These clips may be used for joining tissue portions at the site of a tissue opening or excision, as well as in a method for closing various other types of organ perforations. These clips may be used inter alia in gastrectomies, polypectomies, surgical treatment of intestinal and gastric perforations, natural orifice transmural endoscopic surgery (NOTES) procedures, and gastroplastic procedures. The systems and methods here may even be applied to surgeries that generally are not thought of in purely tissue closure terms, such as hemorrhoidectomies. In general, they can be used in all cases where compression is needed.
It is an object of the present invention to provide a surgical compression clip which exerts a constant compressive force irrespective of the thickness of the tissue being compressed, and its changes in thickness during the wound healing process. Such a clip thereby reduces the chances of liquid leakage during compression and ensures necrosis in an aseptic environment, and faster healing and closure of the tissue around an opening or other type of lesion.
It is a further object to provide a clip which is not left within the body after tissue closure is complete.
Another object of the present invention is to provide a non-unitary surgical clip which exerts a substantially slowly changing compressive force along a line between its linear compressing elements which provides a compressive force over large elongations. Since the compression is effected along a continuous line, undesired post-surgery fluid leakage and bleeding is prevented. Such a continuous line is difficult to attain when using surgical staples.
Another object of the present invention is to use compression clips for compressing that exert pressure along a compression line that is closer to the base of the lesion than is the clip's securing line. This assists in reducing leakage of bodily fluids.
It is a further object of the present invention to provide a surgical compression clip, and a system for applying the clip, that reduces the risk of tissue perforation by a clip.
The surgical clips described herein may find particular use in various types of resections of a suspect lesion, such lesion arising in, for example, but without intending to be limiting, the bowel, rectum, appendix, gallbladder, uterus, stomach esophagus, etc.
In one aspect of the present invention there is provided a system for use with a surgical compression clip for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue adjacent to the compression site. The clip comprises a pair of compression elements and one or more force applier element formed of a shape memory material, the clip having an open position and a closed position and configured to receive tissue to be compressed therethrough when in its open position. The force applier element is operative for providing a force to the compressing elements, and the compressing elements are operative to apply a compression force to the tissue to be compressed when the clip is closed thereabout, so as to cause first tissue necrosis, closure and then healing of the tissue around the compression site. The system includes: an endoscope having an insertion shaft having one or more channel; a multi-lumen sleeve having a primary lumen encasing the endoscope insertion shaft, and one or more secondary lumen; a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be compressed, wherein the working conduit is a preselected one of (i) the one or more channel of the insertion shaft and (ii) the one or more secondary lumen of the multi-lumen sleeve; and a grasper assembly selectably extendible through the working conduit, for engaging and pulling the tissue to be compressed through the clip when the clip is in its open position.
In one embodiment of the system the clip applier includes: two arm elements selectably engageable with the compression clip, each arm element having a slot and a pin hole; a position controlling element in mechanical communication with the arm elements, the position controlling element including a first and second pin, where the first pin passes through the position controlling element and the pin hole on each of the two arm elements and the second pin passes through the position controlling element and the slot on each of the arm elements; and an activating element in mechanical communication with and operable to move the pins in the position controlling element, thereby to produce substantially scissor-like motion of the arm elements bringing them from their closed adjacent position to their open spaced apart position and vice versa; and thereby to cause the compression clip to move from its open position to its closed position and vice versa in tandem with the motion of the arm elements of the clip applier.
In another embodiment of the system of the present invention the compression clip includes a threaded bolt inside a compression element, the threaded bolt having a receiving aperture, and the clip applier includes: a head element mateably insertable into the receiving aperture on the threaded bolt inside the compression element of the compression clip; and an activator for rotating the head element, thereby to cause the threaded bolt to rotate and the clip to move from its open position to its closed position and vice versa depending on the direction of rotation.
In still another embodiment of the system, the at least one force applier element is two force applier elements and the compression clip includes a compression element and one or more connector elements on each of the two force applier elements, and wherein the clip applier includes: two wires each connected to a connector element on a different one of the two force applier elements; and a pin passing through an anchor positioned in the compression element, one of the wires being wound around the pin, whereby the compression clip moves from its closed position to its open position when the wires are pulled and moves to its closed position from its open position when the wires are released.
In another embodiment of the system the grasper assembly is comprised of: a grasper having a closed and an open position, the grasper comprised of: forceps arms for grasping and pulling the portion of the tissue to be compressed; and a wire in mechanical connection with and for controlling and maneuvering the forceps arms and for bringing the forcep arms from their closed position to their open position and vice versa; and a grasper transporting element for transporting the grasper in its closed position to a location near the portion of the tissue to be compressed whereat the grasper is ejected from the transporting element allowing the forcep arms to open to their open position. In some instances of this embodiment the one or more of the wire and the forceps arms includes a bend, the bend facilitating grasping and pulling the tissue to be compressed through the clip. In some instances of this embodiment the one or more of the wire and the forceps arms is formed at least partially of a shape memory material.
In another embodiment of the system the grasper assembly includes: a flexible resilient vacuum cup having a closed and an open position; a suction source for generating negative pressure; a conduit joining the vacuum cup to the suction source; a grasper transporting element for transporting the vacuum cup in its closed position to a location near the site of the tissue to be compressed where the vacuum cup is ejected from the transporting element allowing the vacuum cup to open to its open position; and articulation means for bringing the vacuum cup to the site of the tissue to be compressed for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.
In another aspect of the present invention there is provided a system for compressing tissue to induce necrosis and subsequent healing of the tissue around the compression site. The system comprising: an endoscope having an insertion shaft having one or more channel; a multi-lumen sleeve having a primary lumen encasing the endoscope insertion shaft, and one or more secondary lumen; a compression clip having an open position and a closed position, the clip configured to receive tissue to be compressed therethrough when in its open position, and operative to apply a compression force thereto when closed thereabout; a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be compressed, wherein the working conduit is a preselected one of (i) the one or more channel of the insertion shaft and (ii) the one or more secondary lumen of the multi-lumen sleeve; and a grasper assembly selectably extendible through the working conduit, for engaging and pulling the tissue to be compressed, the engaged tissue being positioned in the clip when the clip is in its open position, wherein the compression clip is operable to compress the tissue extending therethrough, thereby inducing necrosis and subsequent healing of the tissue around the compression site.
In one embodiment in this second system of the present embodiment, the compression clip further includes a pair of generally elongated compressing elements for compressing the tissue to be compressed, the compressing elements formed and configured for being disengageably joined to the clip applier. In some instances of this embodiment, the compression clip includes one or more shape memory force applier elements formed of shape memory material, the one or more force applier element operative for providing a force to the pair of compressing elements for compressing tissue held therebetween. In some embodiments the compressing elements and the one or more shape memory force applier element form a planar configuration in both the clip's open and closed positions and the compressing elements of the surgical clip apply a compressive force to the tissue to be compressed, the compressive force acting in the plane of the clip and in a line between the compressing elements. In some instances of this embodiment, the system further includes a pair of generally elongated securing elements and wherein the one or more shape memory force applier element is positioned between, and in mechanical connection with, the operatively associated securing and compressing elements, and wherein the one or more shape memory force applier element and the pairs of securing and compressing elements all lie in substantially the same plane in both the first open and second closed positions of the clip and wherein an axis of securing for holding the tissue to be compressed is formed by, and is tangential to, the securing elements and an axis of compression for compressing tissue to be compressed is formed by, and tangent to, the compression elements, the lines of securing and of compression not being collinear lines. In some of this cases of this last embodiment the securing and compressing elements are substantially linear elements.
In another embodiment of the second system, the clip further includes a pair of generally elongated securing elements each having formed thereon a pair of mutually opposing gripping portions adapted to secure therebetween the tissue to be compressed, the securing elements operationally associated with the compressing elements, the securing elements formed and configured for being disengageably joined to the clip applier. In some instances of this embodiment, the gripping portions of the securing elements include toothed first edges which are in proximity to each other when the clip is in its closed position and wherein the toothed first edges of the securing elements are spaced apart from each other when the clip is in its open position. In some instances of the last embodiment of the system the securing and compressing elements are substantially linear elements.
In yet another embodiment of the herein above mentioned second system of the present invention, the grasper assembly includes a grasper having a closed and an open position, the grasper including: forceps arms for grasping and pulling the tissue to be compressed; and a wire in mechanical connection with and for controlling and maneuvering the forceps arms and for bringing the forceps arms from their closed position to their open position and vice versa; and a grasper transporting element for transporting the grasper in its closed position to a location near the tissue to be compressed whereat the grasper is ejected from the transporting element allowing the forceps arms to open to their open position. In some instances of this embodiment the one or more of the wires and the forceps arms includes a bend, the bend facilitating grasping and pulling the tissue to be compressed through the clip. In some instances of this embodiment the one or more of the wires and the forceps arms is formed at least partially of a shape memory material.
In yet anther embodiment of the second system of the present invention, the grasper assembly includes: a flexible resilient vacuum cup having a closed and an open position; a suction source for generating negative pressure; a conduit joining the vacuum cup to the suction source; a grasper transporting element for transporting the vacuum cup in its closed position to a location near the tissue to be compressed where the vacuum cup is ejected from the transporting element allowing the vacuum cup to open to its open position; and articulation means for bringing the vacuum cup, when in its open position, to the tissue to be compressed for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.
In a further embodiment of the system the clip further includes a pair of compressing elements and at least two shape memory force applier elements formed of shape memory material where one of the force applier elements is constructed as a latch which is operable to engage with an engagement means formed on one end of one of the pair of compressing elements, the latch thereby exerting a force on the tissue to be compressed when the tissue is held between the compressing elements. In some instances of this last embodiment, the clip further includes a wire snare.
In a still further embodiment of the second system the compression clip comprises a pair of generally linear compression elements for securing tissue therebetween and for applying to the secured tissue a compression force, wherein the compression clip has an initial, open position in which the linear compression elements may be positioned about the tissue to be secured therebetween, and a final, closed position whereat the compression elements are substantially parallel to each other, thereby to apply a compressive force to the secured tissue; and force means formed from a shape memory material and disposed between the pair of compression elements and operative to transmit operational forces therebetween. In some instances of this embodiment, the force means includes one or more one active hinge members disposed between the linear compression elements.
In yet another embodiment of the system the endoscope is selected from a group of instruments consisting of a rigid instrument or a flexible instrument.
In another embodiment of the system the endoscope is selected from a group of instruments consisting of: a gastroscope, a laparoscope, a colonoscope, a rectoscope, a bronchoscope, a urethroscope, and a hysteroscope.
In still another embodiment of the system, the tissue to be compressed is selected from a group consisting of: tissue adjacent to a disease-induced perforation of an organ wall; tissue adjacent to a perforation in the stomach wall resulting from a gastrectomy procedure; tissue adjacent to a perforation in an organ wall resulting from a natural orifice transmural endoscopic surgical (NOTES) procedure; stomach tissue, the compression of which is required to reduce stomach volume in a gastroplastic procedure; gastric tissue adjacent to an ulcerous lesion; duodenal tissue adjacent to an ulcerous lesion; esophageal tissue adjacent to an ulcerous legion; other tissue adjacent to an ulcerous lesion; rectal tissue adjacent to hemorrhoids that are ligated by the clip; and other tissue compressed and ligated by the clip.
In another embodiment of the system of the present invention, when the compression clip is in its open position the clip is positioned around the tissue grasped and pulled by the grasper assembly.
In yet another embodiment of the system of the present invention the grasped and pulled tissue to be compressed is brought by the grasper assembly into the clip when the clip is in its open position.
In a further aspect of the present invention there is provided a method for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue surrounding the compression site. The method includes the steps of: placing an endoscope in a body cavity and advancing the endoscope to and positioning it near the site of the tissue to be compressed; positioning a compression clip near the site of the tissue to be compressed; and extending a grasping instrument for grasping and pulling the tissue to be compressed, the grasped tissue being positioned in the compression clip when the clip is in its open position and compressed when the clip is in its closed position thereby producing necrosis in the compressed tissue and then healing of the tissue surrounding the compression site.
In an embodiment of the method, the method further includes the step of opening the compression clip prior to the step of extending and also further including the step of closing the compression clip after the tissue to be compressed has been positioned within the open clip by the grasping instrument thereby to compress the tissue. In some instances of this embodiment the step of positioning includes positioning the clip around a perforation in the tissue to be compressed and then in the step of closing compressing the tissue around the perforation thereby causing closure of the perforation.
In yet another embodiment of the method of the present invention, the step of extending includes the step of grasping sufficient tissue to include large margins around the site of the tissue to be compressed.
In still another embodiment of the method, claim 30, the step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed through a first secondary lumen of a multi-lumen sleeve and in the step of positioning the compression clip is advanced and brought to the site of the tissue to be compressed through a second secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the second secondary lumen is the secondary lumen closest to the site of the tissue to be compressed.
In another embodiment of the method, the step of extending the grasping instrument and in the step of positioning the compression clip are both advanced and brought to the site of the tissue to be compressed through the same secondary lumen of a multi-lumen sleeve wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the site of the tissue to be compressed.
In still another embodiment of the method, in the step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed through a working channel of the endoscope and in the step of positioning the compression clip is advanced and brought to the site of the tissue to be compressed through a secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the site of the tissue to be compressed.
In another embodiment of the method of the present invention, the method further includes the step of activating a vacuum source so as to effect the action of grasping in the step of extending by a suction operated grasping instrument.
In yet another embodiment of the method, the step of extending precedes the step of positioning and in the step of positioning the clip is positioned around the grasped and pulled tissue to be compressed.
In still another embodiment of the method, the tissue to be compressed is selected from a group consisting of: tissue adjacent to a disease-induced perforation of an organ wall; tissue adjacent to a perforation in the stomach wall resulting from a gastrectomy procedure; tissue adjacent to a perforation in an organ wall resulting from a natural orifice transmural endoscopic surgical (NOTES) procedure; stomach tissue, the compression of which is required to reduce stomach volume in a gastroplastic procedure; gastric tissue adjacent to an ulcerous lesion; duodenal tissue adjacent to an ulcerous lesion; esophageal tissue adjacent to an ulcerous legion; other tissue adjacent to an ulcerous lesion; rectal tissue adjacent to hemorrhoids that are ligated by the clip; and other tissue compressed and ligated by the clip.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and its features and advantages will become apparent to those skilled in the art by reference to the ensuing description, taken in conjunction with the accompanying drawings, in which:

FIG. 1A is an overall isometric view of an endoscopic system constructed according to the present invention;

FIG. 1B is an enlarged view of the distal end of the endoscopic system shown in FIG. 1A;

FIG. 1C is an enlarged view of the proximal end of the endoscopic system shown in FIG. 1A;

FIG. 2 shows an isometric view of the compression clip constructed according to a first embodiment in its closed position;

FIGS. 3A and 3B show isometric top and bottom views of the compression clip shown in FIG. 2 in its open position;

FIGS. 4A, 4B and 4C show isometric views of different configurations of spring elements constructed according to various embodiments of the present invention;

FIG. 5 is an isometric view of a clip applier constructed according to one embodiment of the present invention, the applier in its closed position;

FIG. 6 is an isometric view of the clip applier in FIG. 5, the applier in its open position;

FIG. 7 is an isometric view of the clip applier in FIG. 5 without its base element, the applier in its open position;

FIG. 8 is an isometric view of the clip applier of FIG. 5 used to position the clip in FIG. 2, the clip being attached to the applier and in its closed position;

FIG. 9 is an isometric view of a clip applier used to position the clip in FIG. 2, the clip being attached to the applier and in its open position;

FIG. 10 is an isometric view of a clip applier constructed according to a second embodiment of the present invention, the applier in its closed position;

FIG. 11 is an isometric view of the clip applier in FIG. 10, the applier in its open position;

FIG. 12 is an isometric view of the clip applier of FIG. 10, attached to a clip constructed as in FIG. 2, the clip being attached to the applier and in its closed position;

FIG. 13 is an isometric view of the clip applier of FIG. 10, attached to a clip constructed as in FIG. 2, the clip being attached to the applier and in its open position;

FIGS. 14 and 15 show isometric views of a second embodiment of a surgical compression clip constructed according to the present invention, wherein FIG. 14 and FIG. 15 show the clip in its closed and open positions, respectively;

FIG. 16 shows an exploded view of the clip in FIGS. 14 and 15;

FIGS. 17 and 18 show isometric partially cut-away views of the compression clip shown in FIGS. 14 and 15, respectively;

FIGS. 19 and 20 show isometric views of a clip applier used with the clip shown in FIGS. 14-18, FIG. 19 showing the applier engaged to the clip and FIG. 20 disengaged from the clip;

FIG. 21 shows an isometric view of the applier in FIGS. 19 and 20;

FIG. 22 shows a partially exploded view of the applier in FIGS. 19 and 20;

FIG. 23 shows a cross-sectional view of the applier shown in FIGS. 19 and 20;

FIG. 24A shows an exploded view of a third embodiment of a compression clip constructed according to the present invention;

FIG. 24B shows an isometric partially cut-away view of the clip shown in FIG. 24A;

FIGS. 25A and 25B are an isometric top and bottom view of a clip constructed according to a fourth embodiment of the present invention, the clip being in its closed position;

FIGS. 26A and 26B are an isometric top and bottom view of a clip constructed according to the embodiment of FIGS. 25A and 25B, the clip being in its open position;

FIGS. 27A and 27B are isometric views of a clip applier constructed according to another embodiment of the present invention, the applier shown in its closed and open position, respectively;

FIGS. 27C and 27D are cross-sectional views of the clip applier shown in FIGS. 27A and 27B, the applier shown in its closed and open position, respectively;

FIGS. 28A and 28B are isometric views of the clip applier shown in FIGS. 27A and 27B constructed in its closed and open position, respectively, when attached to and operating the clip shown in FIGS. 25A-26B;

FIG. 29 is an exploded view of another embodiment of a clip applier for use with the clips in the specification herein;

FIGS. 30A and 30B are isometric views of the clip applier shown in FIG. 29 in its closed and open position, respectively;

FIG. 30C is a revealed inner view of FIG. 30B;

FIG. 31A is a cross-sectional view of a surgical compression clip constructed according to a fifth clip embodiment of the present invention, the clip being in its open position and attached to its associated applier;

FIG. 31B is an enlarged view of a portion of the distal end of the clip shown in FIG. 31A;

FIGS. 32 and 33 are different partially exploded views of the surgical compression clip and applier in FIG. 31A;

FIG. 34 shows different views of the shape-memory spring element of the clip in FIG. 31A;

FIG. 35 shows different views of the latch arm of the clip presented in FIG. 31A;

FIG. 36 shows an isometric view of the clip's spring element at the hinge region of the clip shown in FIG. 31A;

FIG. 37 shows an isometric front side view of the clip in FIG. 31A, the clip in its open position;

FIGS. 38 and 39 show different views of the clip in FIG. 31A where the wire of the clip has been drawn taut;

FIG. 40 shows an enlarged view of the clip shown in FIG. 31A including the clip's distal end and its locking process;

FIG. 41 shows an enlarged cross-sectional view of the distal end of the clip shown in FIG. 31A, the clip in its latched position;

FIGS. 42 and 43 show additional enlarged views of the distal end of the clip shown in FIG. 31A, the clip being in its closed position;

FIG. 44 shows an isometric view of the clip shown in FIG. 31A, the clip in its closed position and ready for insertion into a clip applier;

FIG. 45 is an isometric view of an endoscope body encased in a multi-lumen sleeve, the sleeve having collapsed secondary lumens;

FIGS. 46-49 show various configurations of multi-lumen sleeves with collapsed secondary lumens;

FIGS. 50-53 show several configurations of the multi-lumen sleeves in FIGS. 46-49 with their secondary lumens distended;

FIG. 54 shows a grasper assembly constructed according to one embodiment of the present invention, the assembly being in its open position;

FIG. 55 shows a grasper assembly constructed according to another embodiment and in its closed position;

FIG. 56 shows additional details of the grasper assembly in FIG. 55 in its partially opened position;

FIG. 57 shows a schematic overall view of a vacuum-based tissue grasper assembly of the present invention;

FIG. 58 shows an exploded view of the distal portion of the vacuum-based tissue grasper assembly in FIG. 57;

FIGS. 59A and 59B show a schematic view and a cut-away view, respectively, of the distal end of the vacuum-based tissue grasper assembly in FIG. 57;

FIGS. 60A and 60B show two schematic views of a vacuum cup emerging from the distal end of the vacuum-based tissue grasper assembly with FIG. 60B showing the cup being turned toward a lesion (not shown);

FIG. 60C shows a schematic view of the vacuum cup extending even further from the distal end of the vacuum-based tissue grasper assembly;

FIG. 61A shows a schematic view of the vacuum cup of the vacuum-based tissue grasper assembly shown in FIG. 57;

FIG. 61B shows a schematic view of a ribbed embodiment of the vacuum cup of the vacuum-based tissue grasper assembly shown in FIG. 57;

FIG. 61C shows a schematic view of the vacuum cup of the vacuum-based tissue grasper assembly shown in FIG. 57 supported by a stent-like structure;

FIG. 62 shows an endoscope being inserted into a multi-lumen sleeve;

FIG. 63A shows an endoscope after insertion into a multi-lumen sleeve;

FIG. 63B shows an enlarged view of the distal end of the endoscope in FIG. 63A;

FIG. 64 shows the sleeve-encased endoscope as it approaches a polyp in the gastrointestinal tract;

FIG. 65 shows a view of a surgical clip attached to an applier being advanced to the site of the polyp through a secondary lumen of a multi-lumen sleeve;

FIG. 66 shows a top view of the surgical clip attached to an applier positioned proximate to the polyp;

FIG. 67 shows a top side view of a surgical clip and applier positioned proximate to the polyp and a mechanical grasper assembly being positioned proximate to the polyp after advancing through a working channel of the endoscope;

FIG. 68 shows a top side view of the opened clip proximate to the polyp;

FIG. 69A shows a top view of the grasper of the grasper assembly beginning to pull the polyp through the opened clip shown in FIG. 68;

FIG. 69B shows a top side view of the grasper of the grasper assembly grasping the polyp;

FIG. 70 shows a top side view of the grasper continuing to pull the polyp through the opened surgical clip;

FIG. 71 shows a top side view of the grasped polyp held by a closed surgical clip, the applier still attached to the closed clip;

FIG. 72 shows a top side view of the closed surgical clip and polyp where the applier has already been withdrawn through a secondary lumen from the region of the polyp;

FIG. 73 shows a top side view of the closed surgical clip and polyp with a severing device approaching the polyp for severing;

FIG. 74A shows a top side view of the stalk of the polyp held by the clip at the resection site after resection of the polyp;

FIGS. 74B and 74C show two side views of the tissue held by the clip at the resection site;

FIG. 75 shows a top side view of a surgical clip attached to an applier being positioned proximate to a polyp in another embodiment of the method of the present invention;

FIG. 76 shows a top side view of a surgical clip and attached applier positioned proximate to the polyp and a vacuum-based tissue grasper assembly being positioned proximate to the polyp after advancing through a secondary lumen of a multi-lumen sleeve;

FIG. 77 shows a top side view of the vacuum cup of the vacuum-based tissue grasper assembly pulling the polyp through the opened clip shown in FIG. 76;

FIG. 78 shows a top side view of the surgical clip closed around the polyp, the polyp being pulled by the vacuum cup of the vacuum-based tissue grasper assembly;

FIG. 79 shows a compression clip constructed according to the present invention being positioned by a clip applier around an internal hemorrhoid

FIG. 80 shows a top side view of an open surgical clip attached to its clip applier and a vacuum based grasper assembly being positioned proximate to a gastric perforation or NOTES incision according to an embodiment of the method of the present invention;

FIG. 81 shows a top side view of the opened surgical clip positioned around the perforation of FIG. 80 and a vacuum cup of an extended vacuum-based grasper assembly beginning to pull the gastric perforation of FIG. 80 through the opened clip, the clip, the applier and the grasper assembly constructed according to embodiments of the present invention;

FIG. 82 shows a top side view of the grasper assembly grasping and pulling the tissue around the perforation through the open clip;

FIG. 83 shows the tissue surrounding the perforation as it is compressed by a compression clip constructed according to an embodiment of the present invention;

FIG. 84 shows a top side view of the compression clip, after disengagement from the clip applier, compressing the tissue surrounding the perforation; and

FIG. 85 shows a top side view of a compression clip, after disengagement from clip appliers, compressing a portion of the stomach pulled in as occurs in a gastroplastic surgical procedure.

Similar elements in the Figures are numbered with similar reference numerals.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention describes a system for the use of non-unitary surgical compression clips, in various tissue compressing surgical procedures. These procedures include full or partial excisions and partial resections or tissue closure. These situations all require good compression for tissue necrosis and healing. The compression is critical for the initiation of a necrotic process at the compression site yielding tissue closure. Healing is dependent on continuously compressing the tissue at the resection, perforation, or lesion site, and is independent of the variation of tissue thickness. Compression lessens the likelihood of internal leakage of bodily fluids, or bleeding, which often occurs when staple suturing is used.
These clips, when used with the system of the present invention, also lessen the likelihood of bleeding and assist in rapid healing in surgical procedures were there are dilated blood vessels, such as in hemorrhoidectomies and non-full thickness resections of, for example, pedunculated GI polyps. Preventing leakage is also critical in gastrectomies and gastroplastic procedures as well as surgical treatment of intestinal and gastric perforations. The system and clips used therewith may also be used to induce necrosis and subsequent healing with naturally occurring lesions such as ulcers.
The non-unitary, i.e. compound, surgical compression clip described herein, typically has one or more elements, generally two or more elements, made of a shape-memory material, such as a nickel-titanium (Ni—Ti) alloy. The clip includes two compressing elements connected operationally by at least one of the shape-memory elements. Typically, the clip also includes securing elements with which to hold the tissue being compressed. Also typically, the compressing elements are linear as are the securing elements. When tissue to be joined is held between the two compressing elements, a constant compressive force acts between the two elements, these latter being connected at both of their ends by the shape-memory elements. The slowly changing force is a result of the well-documented long plateau region of the shape-memory material's stress-strain hysteresis curve. The force is slowly changing constant irrespective of deformation in the deformation range of the plateau. This is a consequence of properties exhibited by shape-memory materials. Additionally, stress-induced strain is recoverable in these materials; in the case of Ni—Ti alloys, 6-8% of the strain can be recovered.
Discussions on the stress-strain curves and stress-induced strain of shape memory materials can be found in many publications. See for example “Shape Memory Materials”, edited by K. Otsuka and C. M. Wayman, Cambridge University Press 1998, p. 62 and H. Tobushi et al in “Deformation Behaviour of Ni—Ti Superelastic Alloy Subjected to Strain Variation” in SMST-94: The Proceeding of the International Conference on Shape Memory and Superelastic Technology, edited by A. Pelton, D. Hodson and T. Duerig, 1995, pp. 389-391.
It should also be noted that the line of compressive force produced by the compression elements of the clips of the present invention is not collinear with the line exerted by the securing elements on the tissue to be resected. These are two different lines of action, separated by a distance. Were they to be co-linear the healing of the tissue at the compression site may be compromised. Additionally, the arrangement of non-collinearity allows for more homogeneous tissue compression by the compression elements. Any penetration of the teeth for securing the tissue is compensated for by the continuous compression line more proximate to the body cavity wall.
The shape-memory elements, which act as a force applier, are typically made of nickel-titanium (Ni—Ti) alloys but other shape memory materials may also be used. The other elements of the clip, i.e. the compressing elements and the securing elements (and possibly separate toothed elements for attachment to the securing elements when there is no integrally formed toothed edge on the securing elements) may also be made of a shape-memory material such as a Ni—Ti alloy, but that is not essential. Other metals or alloys, such as stainless steel or other titanium alloys, and even certain plastic materials may also be used. The compression clips described herein are attached to an applier and brought to tissue adjacent to a resection site, or to tissue adjacent to a perforation to be joined, or to tissue having an opening requiring closure, or to any tissue requiring compression.
No foreign bodies are left behind in the body cavity after healing as the clip is typically self-evacuating.
The surgical clips described herein may be used with standard commercially available endoscopes. Dedicated or specially designed endoscopes may be used but are not required.
Current clips which are delivered to a treatment site using an endoscope or other medical instrument are typically limited in size. Accordingly, all currently contemplated solutions for NOTES are sutures-based. However, endoscopic suturing is not commonly used and is very complicated technically. It is envisioned that the larger size of the clips discussed in the present invention will allow the closure of larger tissue openings. Similarly, the clips of the present invention should be able to close tissue openings in organs with thicker tissue such as the stomach. Additionally, perforations that may require multiple smaller clips should be able to be closed with a single clip.
Additionally, grasper assemblies for bringing sufficient tissue to ensure adequate compression resulting in closure of surgically produced or naturally occurring openings or perforations in a body lumen, or compression of tissue at a resection site or compression of a lesion, e.g. hemorrhoid and ulcers, are also described. The grasper assemblies describe herein can be used to grasp many different types of lesions contemplated as treatable with the clips of the present invention. These include, but are not limited to polyps, perforations—naturally occurring and surgically induced—and hemorrhoids. These also include excisions performed by NOTES procedures or stomach volume reduction resulting from a gastroplastic procedure. In general, larger tissue openings can be closed with the grasper assemblies and the compression clips taught herein below than can be closed with prior art systems and clips.
Additionally, using the compression clips of the present invention is not limited to any particular direction or shape of resection incision; both radial and longitudinal incisions are contemplated by the present invention.
Before explaining embodiments of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
FIGS. 1A-1C, to which reference is now made, show an overall view of an endoscopic system constructed according to the present invention, an enlarged view of the system's distal end F and an enlarged view of the system's proximal end N, respectively.
FIG. 1A includes an endoscope insertion shaft 300 encased in a multi-lumen sleeve 150. At the distal end F of endoscope insertion shaft 300, working instruments constructed according to the present invention may exit. These instruments include a surgical clip 10 attached to an applier 30 and a grasper assembly 200 including a grasper transporting element 260. These instruments are inserted into a working channel 154 of endoscope insertion shaft 300 or one or more secondary lumens 158 of sleeve 150. Insertion of the instruments is effected at the proximal end N of endoscope insertion shaft 300. They are advanced in the direction of, and ultimately exit at, or adjacent to, the distal end F of endoscope insertion shaft 300. Actuators 306 and 308 may be any of many known to those skilled in the art. They can apply one or a combination of control actions or movements, such as pull and release, articulation, swivel and the like. Endoscope insertion shaft 300 is typically connected to a fiberoptic cable 304 which communicates images to a visual display 302.
Details of the instruments used, the multi-lumen sleeve and other specific aspects of the system of the present invention are further discussed below.
Reference is now made to FIGS. 2-3B where FIG. 2 presents a view of a non-unitary compression clip constructed according to a first embodiment of the present invention. In FIG. 2 the clip is shown in its closed position. FIGS. 3A and 3B present a view of the compression clip shown in FIG. 2 in its open position.
Clip 10 is constructed of two shape-memory hinge springs 12A and 12B, also herein often denoted as force appliers. Typically, but without intending to be limiting, the shape-memory material is a Ni—Ti alloy. The operation of the clip relies on shape-memory effects exhibited by these materials. Springs 12A and 12B may be made of a single wire or flattened wire or strip or it may be constructed of two or more wires, flattened wires or strips connected together at their ends. Furthermore, in some embodiments, the springs may be constructed to have a coiled shape.
Clip 10 further includes two securing elements 14A and 14B, each of which has a series of teeth 20 for grasping tissue. Each of securing elements 14A and 14B may be formed from a single piece or welded together from several pieces, typically but without intending to be limiting, of metal. Teeth 20 may be formed integrally with elements 14A and 14B or they may be joined to the elements, for example, by welding. Generally, these securing elements are made of metal and typically are welded or otherwise joined to two metal compressing elements 16A and 16B. However, the securing elements and the compressing elements may be joined together by any method known to those skilled in the art. Securing elements 14A and 14B may also be formed integrally with compressing elements 16A and 16B, respectively.
Securing elements 14A and 14B are formed with spacings 18 configured and sized to receive the pushing elements of a clip applier (not shown). Compressing elements 16A and 16B, typically, but without intending to be limiting, are cylindrically-shaped. These include holes 19 (best seen in FIG. 3B) into which connectors 17 (also best seen in FIG. 3B) of hinge springs 12A and 12B are insertable. Insertion of hinge springs 12A and 12B occurs prior to welding or otherwise joining toothed securing elements 14A and 14B to compressing elements 16A and 16B, respectively. As a result of the weld or other joining method, securing elements 14A and 14B prevent connectors 17 of hinge springs 12A and 12B from dropping out of holes 19. Securing elements 14A and 14B, and compressing elements 16A and 16B are joined together by hinge springs using any method known to those skilled in the art, particularly in the art of articulation hinges (swing joints). The natural tension of hinge springs 12A and 12B operates to keep compressing elements 16A and 16B in their closed position as in FIG. 2.
The metal used for forming securing elements 14A and 14B, compressing elements 16A and 16B and teeth 20, if these latter are made from separate pieces and welded to elements 14A and 14B, should be a rigid metal such as, but without being limiting, stainless steel.
While in the above embodiment, securing elements 14A and 14B are welded to compressing elements 16A and 16B, respectively, in other embodiments this need not be the case. The securing and compressing elements may be joined to each other by mechanical means such as by U-shaped elements positioned on securing elements 14A and 14B clippably engageable to compressing elements 16A and 16B or by press connections wherein an edge on each of securing elements 14A and 14B would be pressed to enter a slit in their respective compressing elements 16A and 16B. Alternatively, securing elements 14A and 14B and compressing elements 16A and 16B can be crimped together.
In other embodiments, securing elements 14A and 14B and compressing elements 16A and 16B may be made of a single piece of plastic, for example by ejection molding. In such embodiments, only hinge springs 12A and 12B are made of metal, specifically a shape-memory metal or alloy, typically but without intending to be limiting, a Ni—Ti alloy. In such plastic embodiments, hinge springs 12A and 12B (force appliers) would typically be snapped into place between securing elements 14A and 14B and compressing elements 16A and 16B. However, it is evident to one skilled in the art that other methods of introducing the metal hinge springs 12A and 12B could also be used.
Clip 10 in its closed position appears as shown in FIG. 2. Hinge springs 12A and 12B exert no force when the clip is fully closed, i.e. when compressing elements 16A and 16B lie proximate and tangent to each other. However, as compressing elements 16A and 16B are separated apart, hinge springs 12A and 12B exert a force which tries to bring compressing elements 16A and 16B and securing elements 14A and 14B together. When clip 10 is to be opened, pushing elements of a clip applier (not shown) may be positioned and wedged between teeth 20 of securing elements 14A and 14B or they may be positioned in a spacing or indentation 18. The applier is activated to apply a force via its pushing elements (not shown). This force opposes the force exerted by hinge springs 12A and 12B. This counter force spreads securing elements 14A and 14B and compressing elements 16A and 16B apart. It also spreads hinge springs 12A and 12B as in FIGS. 3A and 3B.
After tissue is brought to and positioned between the separated compressing elements 16A and 16B, the applier is operated to relax the applied force allowing securing elements 14A and 14B to move toward each other and to return to their original closed position (FIG. 2). Shape-memory hinge springs 12A and 12B also relax and return to their original shape. The tissue positioned between the securing and compressing elements of clip 10 prevents compressing elements 16A and 16B and springs 12A and 12B from completely returning to their original closed positions. Once the compressing elements are stopped by the tissue, continued closure of the applier's pushing elements leads to separation of the pushing elements of the applier from securing elements 14A and 14B of clip 10. This, in turn, causes the applier to disengage from clip 10.
While the shape-memory elements used to effect opening or closing of clip 10 are here described as hinge springs, these elements can more generally be classified as force appliers. Therefore, it should be understood that elements of any shape which can generate a force for either opening or closing a compression clip may be used and these elements can and will often be denoted herein as force appliers.
In other embodiments, pushing elements of a clip applier are inserted into special indentations in securing elements 14A and 14B. The spacing/indentation is best seen as element 718 in FIGS. 25A and 26A discussed below. In yet another embodiment, when pushing securing elements 14A and 14B, the pushing elements of an applier (not shown) are inserted and loosely held in holes (not shown) positioned on securing elements 14A and 14B.
Shape-memory hinge springs 12A and 12B can have distinctive connectors 17 at their ends as shown in FIGS. 4A-4C. A hinge spring having uni-directional connectors 17 is shown in FIG. 4A. However, the use of hinge springs with bi-directional connectors 17′ as shown in FIG. 4B is advantageous over the uni-directional connectors 17 shown in FIG. 4A. The hinge spring's bi-directionality allows connectors 17′ to be inserted simultaneously into holes 21 in securing elements 14A and 14B and into holes 19 in compressing elements 16A and 16B. This increases stability of the clip 10. It also reduces the chance that hinge springs 12A and 12B will be displaced during operation of the clip and interfere with closure of the clip. The positioning of hinge springs 12A and 12B with connectors 17′ can readily be seen in FIGS. 2, 3A and 3B where clip 10, in its closed and open positions, is shown. Reference to the use of hinge springs with connectors of the type of connector 717 shown in FIG. 4C will be made later in the text.
Connectors 17, 17′ and 717 shown in FIGS. 4A, 4B and 4C respectively form articulating joints when they are inserted into corresponding apertures or holes in compression elements and/or securing elements as described in the first through fourth compression clip embodiments described below. These connectors rotate or swing in their respective apertures and holes allowing for articulation.
It should be noted that as in clip 10 of FIGS. 2-3B, in some embodiments teeth 20 do not necessarily extend the entire length of securing element 14A and 14B while in others they do. Additionally, it should be noted that in some embodiments of clip 10 in FIGS. 2-3B, teeth 20 need not be distributed uniformly along securing elements 14A and 14B. Additionally, at both ends of elements 14A and 14B there is a small bend 22 welded or otherwise joined to the sides. In some embodiments, bend 22 may be integrally formed as part of elements 14A and 14B. This provides extra security against clip 10 slipping off the compressed suspect tissue during resection.
In the compression clip embodiments shown in FIGS. 2-3B and as discussed elsewhere in this specification, the securing elements and their respective compressing elements have been described as separate elements. In their operational state within the clips, these are typically a single joined element reflecting a single part and may be thought of as such. In the joined part, the securing elements attach to and grip the tissue to be resected while the compressing elements act to press the parts of the resected site together even when they are formed as separate elements and are only later joined together to operate as a single part.
Reference is now made to FIGS. 5-9 where various views of a first embodiment of a clip applier are shown. The clip applier may be used with surgical compression clip 10 shown in and described in conjunction with FIGS. 2-3B.
FIG. 5 shows clip applier 30 in its closed position. Clip applier 30 is comprised of applier arms 34A and 34B, applier base 32, and connector elements 36A and 36B. The elements of clip applier 30 are typically constructed of stainless steel but they may also be constructed of other metals, such as, but not limited to, titanium, titanium alloys or reinforced plastics.
As best seen in FIG. 6 where clip applier 30 is shown in it open position, each of applier arms 34A and 34B has, at its distal end, an insertion projection 38A and 38B, respectively. Insertion projections 38A and 38B are formed substantially transverse to applier arms 34A and 34B and are operative for insertion between teeth 20 of securing elements 14A and 14B in FIG. 2, or into indentations 718 of clip 710 in FIG. 25A, or alternatively into holes positioned in securing elements 14A and 14B and compressing elements 16A and 16B.
FIG. 7 shows open clip applier 30 without its applier base 32.
As seen in FIGS. 5 and 6, applier base 32 has a generally barrel-like shape from which emerges a pair of applier base projections 31. Each of these projections 31 has an applier base slot 45 and an applier base projection hole 37. Each of applier arms 34A and 34B has at its proximal end applier arm slots 40A and 40B and applier arm holes (not shown). Applier arm 34B is constructed with a bend 35 in it so that the distal portions of arm 34B and arm 34A can lie in the same plane. It also allows insertion projections 38A and 38B to lie in the same plane.
Each of connector elements 36A and 36B has a pair of holes 41A-41D (41C and 41D not visible), one at each end of each element.
Applier arms 34A and 34B are joined to applier base 32 by connecting pin 43 which passes through applier base projection holes 37 and applier arm holes (not shown). Pin 42 is inserted into holes (not shown) in connector elements 36A and 36B and is movable in applier base slots 45 and applier arm slots 40A and 40B. As pin 42 moves it forces applier arm slots 40A and 40B to overlap with applier base slots 45 at the point of the pin, thus creating an opening and closing effect.
The proximal ends of connector elements 36B and 36A, respectively, are attached to an operating cable (not shown) that exits the proximate end of the endoscope. The cable is activated by an actuator 306 (FIG. 1A), for example, positioned outside the proximal end N (FIG. 1A) of the endoscope.
FIG. 8 and FIG. 9 show clip applier 30 of the present embodiment attached to surgical compression clip 10 described in FIGS. 2-3B in its closed and open position, respectively.
To open clip applier 30, an operating cable (not visible) pulls connector elements 36A and 36B in the proximal direction. Concurrently, pin 42 moves to the proximal end of applier base slots 45 and the proximal ends of applier arm slots 40A and 40B. In that position, applier arms 34A and 34B move apart as in FIG. 9.
To close clip applier 30, the tension in the operating cable (not visible) is released. In doing so, the force that hinge springs 12A and 12B exert is greater than that of the operating cable. A force is thus exerted on applier arms 34A and 34B through securing elements 14A and 14B. The clip's force brings applier arms 34A and 34B together, which pushes connector elements 36A and 36B in the distal direction. Concurrently, pin 42 moves to the distal end of applier base slots 45 and the distal ends of applier arm slots 40A and 40B. In that position, applier arms 34A and 34B move together as in FIG. 8.
When applier arms 34A and 34B are pushed apart as in FIG. 9, insertion projections 38A and 38B of clip applier 30 push against the spacings between teeth 20 of securing elements 14A and 14B of clip 10 shown in FIG. 2 (or indentations 718 of clip 710 shown in and discussed below in conjunction with FIGS. 26A and 26B) so that securing elements 14A and 14B and compressing elements 16A and 16B of clip 10 move apart. When applier arms 34A and 34B are moved together as in FIG. 8, insertion projections 38A and 38B of clip applier 30 exert a reduced force on the spacings between the teeth 20 of securing elements 14A and 14B of clip 10 in FIG. 2 (or on indentions 718 of clip 710 shown in and discussed in conjunction with FIGS. 26A and 26B) so that securing elements 14A and 14B and compressing elements 16A and 16B of clip 10 move together. The counter force exerted by hinge springs 12A and 12B keeps clip applier 30 in place. Once tension generated by springs 12A and 12B is reduced sufficiently, that is as clip 10 closes on and compresses tissue, insertion projections 38A and 38B of applier 30 essentially fall away and disengage from clip 10.
FIGS. 10-13, to which reference is now made, show various views of a second embodiment of a clip applier constructed according to the present invention. The applier is intended for use with the surgical compression clip (slightly modified as discussed below) shown in and discussed in conjunction with FIGS. 2-3B. FIG. 10 shows the clip applier in its closed position, while FIG. 11 shows the applier in its open position.
Turning to FIG. 11 first, clip applier 50 includes insertion links 60A and 60B which are swing jointed by links 62A, 62B, 64A, 64B and central bar 66. An operating cable (not shown) is connected to the proximal end of central bar 66 and inserted into spring 52. The latter connection can be achieved by welding or any other connecting method or means known to those skilled in the art.
Insertion links 60A and 60B each have extensions (not shown) which are positioned on their distal end so that these extensions are insertable into cylindrical elements 58A and 58B. As shown in FIGS. 12 and 13, cylindrical elements 58A and 58B (best seen in FIGS. 10 and 11) are themselves insertable into the ends of compressing elements 16A and 16B of a surgical compression clip similar to clip 10 discussed above in conjunction with FIGS. 2-3B.
Compressing elements 16A and 16B, as shown in FIGS. 2-3B, require a slight modification to be compatible with cylindrical elements 58A and 58B of clip applier 50. To be compatible, at least one of the ends of elements 16A and 16B should be hollow and tubular so that cylindrical elements 58A and 58B of clip applier 50 can be inserted into them.
While in the embodiment shown in FIG. 10 and FIG. 11, cylindrical elements 58A and 58B are separate elements, in other embodiments they may be integrally formed at the ends of insertion links 60A and 60B.
FIGS. 10 and 11 show assembled clip applier 50 in its closed and open positions, respectively. FIGS. 12 and 13 show clip applier 50 inserted into compressing elements 16A and 16B of surgical compression clip 10 when the clip is in its closed and open positions, respectively.
Moving from the open to the closed position of clip applier 50 (or vice versa), and therefore to the open or closed position of clip 10 (or vice versa), can be effected using an operating cable (not shown) joined to, or in other ways in direct communication with, central bar 66 (FIG. 11). The cable passes through spring 52 and out of the proximal end N (FIG. 1A) of the endoscope where it is activated by a user employing an actuator (schematically shown as element 306 of FIG. 1A). The actuator may be any of several types known to those skilled in the art.
Spring 52, in addition to protecting the cable (not shown), serves as a stop sleeve for element 56 while pulling the cable thus enabling the separation of insertion links 60A and 60B. In addition, it allows for greater flexibility of the apparatus as it advances through a lumen of a multi-lumen sleeve (or an endoscopic working channel) from the proximal end of the endoscope toward the suspect lesion near the distal end of the endoscope. Alternatively, the cable can be covered and protected by a flexible tube. The tube may be formed of polytetrafluoroethylene (PTFE), but the choice of this material is exemplary only and it is not intended to be limiting.
To open clip applier 50, central bar 66 is pulled by the operating cable (not shown) in the proximal direction. When that occurs, interconnect links 62A and 62B and 64A and 64B and insertion links 60A and 60B move apart as in FIG. 11 due to the moment exerted on links 64A and 64B. When insertion links 60A and 60B are inserted into clip 10 as in FIG. 12, clip 10 also opens as shown in FIG. 13 because of the force exerted by insertion links 60A and 60B and their attached cylindrical elements 58A and 58B on compressing elements 16A and 16B.
During insertion of clip 10 into a body cavity, the clip is attached to clip applier 50 and both clip 10 and applier 50 are advanced, in their closed positions, through a secondary lumen of a multi-lumen sleeve (or through a working channel of the endoscope shaft). A tension is maintained in the operating cable (not shown) in order to keep clip 10 attached to clip applier 50 during the entire advance from the proximal end of the secondary lumen (or working channel) to its distal end. The tension in the cable or wire, acts against the force of hinge springs 12A and 12B of clip 10. This creates a force between cylindrical elements 58A and 58B of applier 50 and compressing elements 16A and 16B of clip 10 preventing detachment of clip 10 from applier 50. This force is smaller than the force required to open clip applier 50 and clip 10 attached to it.
To close clip applier 50, the tension in the wire/cable (not shown) passing through spring 52 is released. The force of hinge springs 12A and 12B is passed through compressing elements 16A and 16B to insertion links 60A and 60B. This force applies a moment on links 64A and 64B, which is opposite in direction to the moment exerted when pulling the wire/cable passing through spring 52. When that occurs interconnect links 62A and 62B and 64A and 64B and insertion links 60A and 60B move together as in FIG. 10. When they move together with clip 10 attached as in FIG. 12, compressing elements 16A and 16B also move together as shown in FIG. 12.
While completely releasing the tension in the pull wire allows for the applier to fully return to its original closed position, the tissue pulled and held within clip 10 prevents the clip from following the applier and fully returning to its original closed position. When this occurs, cylindrical elements 58A and 58B easily disengage from clip 10 since the hinge springs' 12A and 12B force is acting essentially on the tissue instead of on the applier.
A second embodiment of a compression clip 510 constructed according to the present invention is shown in FIGS. 14-18, to which reference is now made. FIGS. 14 and 15 show clip 510 in its closed and open position, respectively. FIG. 16 is an exploded view of the clip and discussion of the clip will be made in conjunction with that Figure. Most of the elements in FIGS. 14-18 are the same as those discussed in conjunction with the clip embodiments shown in FIGS. 2-3B. Elements that are essentially equivalent in structure and operation will not be discussed again. Only new elements or structural features will be described. Essentially identical or equivalent elements in the embodiments have been numbered as in clips 10 with the addition of 500 as a prefix.
In clip 510, hinge springs 512A and 512B are not symmetrical, each having legs which are of different lengths. Legs 508A and 508B are longer than legs 509A and 509B. Bi-directional connectors 517 are formed at the end of legs 509A and 509B. These connectors formed substantially transversally to the body of clip 510 are sized and configured to be inserted into holes 521 on securing element 514A and holes 519 on compressing element 516A. At the end of legs 508A and 508B are hollow cylinders 532A and 532B insertable over projections 530, more fully described below.
While compressing element 516A is configured essentially as in FIGS. 2-3B, compressing element 516B is a hollow tubular rod with two slots 538 on its surface proximal to securing element 514B. Inside compressing element 516B, a rod, formed of two connected threaded bolts 536A and 536B, is positioned. The length of each threaded bolt is less than half the length of the rod, with the bolts separated by connector means 540. Threaded bolts 536A and 536B each have different “handedness”, that is thread direction. Because the two threaded bolts have different “handedness” they separate when turned in one direction and come closer together when turned in the opposite direction.
Over the ends of threaded bolts 536A and 536B are fitted cylindrical elements 528, the latter having complementary threads on their inner surface. Threaded bolts 536A and 536B have an attachment means 534A and 534B on their ends for insertion and joining with cylindrical elements 528. Cylindrical elements 528 are each formed with a projection 530 protruding substantially transversally to the long axis of cylindrical elements 528. Projections 530 pass through slots 538 preventing fitted cylindrical elements 528 from turning as threaded bolts 536A and 536B are turned. This forces cylinders 528 to move linearly along the long axis of compression element 516B. The threaded rod with cylinders 528 are held to compressing element 516B by plugs 526. Plug 526 on one side of the rod, the proximal side, includes a recess 524, typically, but without being limiting, a square recess, which is configured to receive a screw rotation apparatus (not shown). Projections 530 on cylindrical elements 528 are configured and sized to be inserted into hollow cylinders 532A and 532B formed on the longer legs 508A and 508B of springs 512A and 512B. The placement of legs 508A and 508B of hinge springs 512A and 512B and the relationship between plugs 526, cylindrical elements 528 and threaded bolts 536A and 536B (which when joined form the threaded rod discussed above) are best seen in FIGS. 17 and 18.
Reference is now made to FIGS. 19-23 which show a clip applier 550 that can be used to operate clip 510, the latter described in conjunction with FIGS. 14-18. FIGS. 19 and 20 show clip applier 550 in its engaged and disengaged position, respectively, with clip 510.
The structure and operation of clip applier 550 can best be understood by viewing FIGS. 21-23. A cable 552 capable of being rotated is extended through a tube 554, typically a flexible plastic tube capable of advancing the clip to the distal end of an endoscope. Cable 552 ends at rotation head 558 which includes a washer element 560 and a male element 562, the latter sized and configured for insertion into recess 524 of clip 510 (FIGS. 14-18).
In some embodiments, tube 554 may be a spring having sufficient flexibility to advance a clip attached to applier 550 past the distal end of the endoscope.
Clip 510, for example, is inserted into a cup 556 of clip applier 550. Cup 556 typically is made of plastic or metal. Plug 526 with recess 524 (FIGS. 14-18) is positioned proximate to applier 550. Male element 562 is inserted into recess 524 of clip 510. Recess 524 and male element 562 are configured to be mateable. Moving clip 510 forward or backward is effected by pushing or pulling cable 552. Rotating cable 552 opens and closes the clip depending on the direction of rotation and the sequence of the bolts and the “handedness” of the threaded bolt proximate to male element 562.
Pushing forward releases clip 510 from applier 550. First, washer element 560 pushes clip 510 out of cup 556. Then, by pulling cable 552 towards the proximal end of the endoscope, male element 562 is released from recess 524 of clip 510, thereby fully releasing the clip from the applier.
A third embodiment of a compression clip constructed according to the present invention is shown in FIGS. 24A and 24B, to which reference is now made.
From FIG. 24A, which shows an exploded view of clip 610, it is readily apparent that many of the elements presented there have been encountered and described previously in conjunction with previously discussed embodiments of compression clips constructed according to the present invention. Accordingly, elements that are structurally and operationally similar to previously described elements will not be described again here. Essentially identical or equivalent elements to those found in clips 10 and 510 have been numbered as in clips 10 and 510 with the prefix 600.
Securing and compressing elements 614A, 614B and 616A, 616B, respectively, are essentially the same as in clip 510. Hinge springs 612A and 612B are unsymmetrical as in clip 510. Again, there is a bi-directional connector 617 on the shorter legs 609A and 609B of hinge springs 612A and 612B which are inserted into holes 621 in securing element 614A and holes 619 on compressing element 616A. Compressing element 616B is again a hollow tubular member with two slots 638. The longer legs 608A and 608B of hinge springs 612A and 612B include unidirectional connectors 624 at their ends which extend in the direction of compressing element 616B allowing for insertion into preformed holes 630 of cylindrical elements 628, to be discussed below.
Cylindrical elements 628, formed with holes 630, are insertable into and retained in hollow tubular compressing element 616B. Holes 630 of cylindrical elements 628 act as receiving recesses for connectors 624 of springs 612A and 612B. When connectors 624 are inserted into holes 630 they are movable in slots 638 and do so with the opening and closing of springs 612A and 612B. Tubular compressing element 616B is capped by plugs 626. The plug 626 distal to the user has a hole into which pin 634 is inserted.
Passing through tubular compressing member 616B are wires 639A and 639B. These wires have loops 640A and 640B at their ends configured to fit over connectors 624.
Upon viewing FIG. 24B, the arrangement of the various elements of clip 610 and their operation becomes evident. In FIG. 24B, clip 610 has been flipped vis-a-vis the view shown in FIG. 24A and compressing element 616B and securing element 614B are not presented. By pulling the ends E of wires 639A and 639B in the direction of the arrow shown, legs 608A and 608B of springs 612A and 612B separate as do securing elements 614A and 614B (the latter not shown) and compressing elements 616A and 616B (the latter not shown). One of the wires in the Figure, wire 639B, passes around pin 634 when pulled. When wires 639A and 639B are released, or pushed in a direction opposite to that shown by the arrow, the clip's elements—its securing elements, compressing elements, and the legs of its springs—move to a position adjacent to each other with the tissue to be resected held between the securing and compressing elements.
After severance of the suspect tissue is effected, excess wire is cut and withdrawn from the endoscope and body.
A fourth embodiment of a surgical compression clip constructed according to the present invention is shown in FIGS. 25A-26B, to which reference is now made.
This embodiment is very similar to the embodiment shown in FIGS. 2-3B and elements are numbered similarly with the inclusion of a prefix digit 7. Similar elements are constructed and operative as in the embodiment presented in FIGS. 2-3B and, accordingly, will not be discussed again.
The present embodiment is different from the embodiment of FIGS. 2-3B in that the bi-directional hinge spring connectors 717 are now joined on the inside of hinge spring arms 708 of spring elements 712A and 712B (best seen in FIG. 4C) and not at the ends of hinge spring arms 8 of hinge spring elements 12A and 12B as in FIGS. 2-3B and FIGS. 4A and 4B. Additionally, and as a direct result of the new positioning of hinge spring connectors 717, spaces 725 must be formed in lateral walls 727 of securing elements 714A and 714B. These spaces are absent in walls 27 of securing elements 14A and 14B as seen and labeled in FIG. 3B. Its necessity with the present clip embodiment is readily seen in FIGS. 25A, 25B, 26A and 26B where hinge spring arms project, at least partially, through spaces 725. It should be noted that securing elements 714A and 714B may be a single integral structure or elements made from several parts joined together by any process known to those skilled in the art, such as by welding. This is true as well for the securing elements shown in previous embodiments and discussed elsewhere herein.
The positioning of connectors 717 on the inside of arms 708 of hinge spring elements 712A and 712B effectively creates a preload that allows the clip to open wider while still applying the forces needed for the necrotic process. An alternative, or additional, technique to achieve preloading is to heat hinge spring elements 712A and 712B and shape them during manufacture.
As best seen in FIGS. 25A and 25B, top and bottom views respectively of clip 710, hinge spring elements 712A and 712B exert a force on compressing elements 716A and 716B even when clip 710 is in its closed position.
Clip 710 is effectively preloaded and a gap 711 (best seen in FIG. 25B) exists between securing elements 714A and 714B even when clip 710 is in its closed position. This gap typically, but without intending to be limiting, is in the range of 0.7 to 0.9 mm, which ensures that the force exerted by clip 710 falls to zero before it has a chance to cut through the healing tissue. It should be remembered that when the necrotic process is in an advanced stage, tissue thickness is reduced significantly.
Gap 711, can be formed in one of many ways. Without intending to be limiting, one of these ways is by forming gap forming projections 713 (best seen in FIGS. 25B, 26A and 26B) at the end of one or both ends of compressing elements 716A and 716B.
An embodiment of a clip applier 750 that can be used with clip 710 of FIGS. 25A-26B is shown in FIGS. 27A-28B. While discussed in terms of its use with the clip shown in FIGS. 25A-26B, it should readily be understood that applier 750, with little or no modification, may be used with other clip embodiments discussed above. FIGS. 27A and 27B are isometric views of clip applier 750, the applier shown in its closed and open position, respectively. FIGS. 27C and 27D are cross-sectional views of the applier in FIGS. 27A and 27B, respectively. FIGS. 28A and 28B are isometric views of the clip applier shown in FIGS. 27A-27B in its closed and open position, respectively, when attached to and operating the clip shown in FIGS. 25A-26B.
FIGS. 27A-27D, to which reference is now made, shows a wire or cable 754 encased in a sheath 752 which extends toward, and exits from, the body cavity so that it can be operated by a user. Wire (or cable) 754 is attached to a cam 756 which is positioned inside applier body 760, the later covered by applier body cover 758. Applier body 760 at its distal end includes a hole 762 on each of two opposing walls. Applier 750 includes two arms 764A and 764B each having a projection 768 at their proximal end and attachment projections 770 at their distal end. Attachment projections 770 attach to clip 710 (FIG. 25A) at its indentations 718 (FIG. 25A). Arms 764A and 764B each have an aperture (not shown) to receive a pin 766 (FIGS. 27C and 27D) which also passes through holes 762 of applier body 760. Pin 766 serves as an axis around which arms 764A and 764B rotate. Arms 764A and 764B each have a bend 772 in them which allows the positioning of projections 768 on arms 774 of cam 756.
Referring now to FIG. 27C, applier 750 is shown in its closed position. Wire or cable 754 has been pushed in the distal direction, i.e. away from the user, causing attached cam 756 to also move in the distal direction within applier body 760. Due to the force applied by open clip 710 on applier arms 764A and 764B, projections 768 of arms 764A and 764B rotate towards each other around pin 766, towards the center and into the space 759, best seen in FIG. 27D. Space 759 is formed between cam arms 774 and cam flanges 757. This results in applier arms 764A and 764B moving to a position where they are adjacent to each other. When applier arms 764A and 764B are brought together, clip 710 is brought to its closed position as best seen in FIG. 28A.
Referring now to FIG. 27D, applier 750 is shown in its open position. Wire 754 has been pulled in the proximal direction, i.e. toward the user, causing attached cam 756 to also move in the proximal direction in applier body 760. This forces projections 768 of applier arms 764A and 764B to rotate in the outward direction. This causes applier arms 764A and 764B to move to a position where they are spaced apart from each other and where projections 768 of applier arms 764A and 764B are pushed and held apart by the wider distal portion of cam arms 774. When arms 764A and 764B separate from each other as just described, clip 710 is brought to its open position as best seen in FIG. 28B.
FIG. 29 through FIG. 30C, to which reference is now made, show various views of another embodiment of a clip applier 800 which may be used with many of the surgical clips discussed herein. FIG. 29 is an exploded view of clip applier 800. FIGS. 30A and 30B are isometric views of clip applier 800 shown in FIG. 29 in its closed and open position, respectively. FIG. 30C is an inner, totally cut-away view of FIG. 30B.
In FIG. 29, there is a wire or cable 812 with a threaded end 814. Wire or cable 812 extends to and exits from the body cavity so that it can be operated by a user. Threaded end 814 of wire or cable 812 is inserted into jagged entry 820 of applier body 818. A casing (not shown) of wire or cable 812 is caught on the jagged surface of entry 820. The threaded end 814 of wire or cable 812 is threaded into a threaded bolt 822 of configuration controller 816 when controller 816 is positioned in guide slot 826A (discussed below) of applier body 818. Configuration controller 816 is formed to also include two wing elements 824 and a projection 830.
Applier body 818 includes a first and a second guide slot 826A and 826B, respectively, and configuration controller 816 is positioned so that it rides in first guide slot 826A. Wing elements 824 of configuration controller 816 move freely in first guide slot 826A. Proximal ends 828 of applier arms 802A and 802B are positioned in and move in second guide slot 826B.
Applier arms 802A and 802B each include an attachment projection 804, a hole 806 and an arm guide slot 808. Projection 804 connects to the surgical clips in a manner similar to that shown elsewhere herein. When the proximal ends 828 of applier arms 802A and 802B are inserted in second guide slot 826B, a pin 810 is inserted through hole 829 of applier body 818 and through holes 806 in applier arms 802A and 802B. This pin acts as an axis of rotation when arms 802A and 802B are brought proximate to or spaced apart from each other. When arms 802A and 802B are inserted into guide slot 826B, projection 830 of configuration controller 816 passes through arm guide slots 808 of applier arms 802A and 802B.
Now referring additionally to FIGS. 30A and 30B, when wire or cable 812 is rotated in one direction configuration controller 816 advances in the distal direction of guide slot 826A with projection 830 (FIG. 29) moving towards the distal end of arm slots 808 (FIG. 29). This causes applier arms 802A and 802B to rotate towards each other and attain their closed position. When wire or cable 812 is rotated in the other direction, configuration controller 816 moves in the proximal direction in guide slot 826A and projection 830 moves towards the proximal end of arm slots 808 causing applier arms 802A and 802B to rotate away from each other and attain their open position (FIGS. 30B and 30C). Wing elements 824 of configuration controller 816 prevent turning of controller 816 when rotated by the threaded end 814 (FIG. 29) of wire/cable 812, thereby allowing for the conversion of rotational motion into translational motion.
A fifth embodiment of a surgical compression clip constructed according to the present invention is shown in FIGS. 31A-44, to which reference is now made.
FIG. 31A presents a side cross-sectional view of a surgical compression clip 70, constructed according to a fifth embodiment of the present invention, together with its associated applier 105. FIG. 31B is an enlarged view of the distal end F of a first arm 74 of clip 70, including the clip's latch 80 mechanism.
Clip 70 is formed of a first arm 74 and a second arm 72 which are held apart from each other by a force exerted by a hinge spring 86 (force applier). Hinge spring 86 is made of a shape-memory material, typically, but without intending to be limiting, a Ni—Ti alloy. Arms 72 and 74 are formed having teeth 98 on their faces which lie opposite each other. The teeth are positioned so that they mesh when the arms are brought proximate to each other. The teeth can be formed as an integral part of arms 72 and 74. Alternatively, they can be formed as separate elements and connected to arms 72 and 74 by, for example, welding or by any one of many other techniques known to those skilled in the art.
Second arm 72 has a slant-shaped guide 85 attached to its distal end F. Guide 85 helps lift latch 80 so that it can snap into place as shown in FIG. 40 to be discussed below. Arms 72 and 74 are typically constructed of metal, e.g. stainless steel or other medical grade metals. However, without being limiting, it may also be constructed of plastic by ejection molding. Arms 72 and 74 are formed so that one end of each arm receives the ends of hinge spring 86.
Restrictor element 94 (best seen in FIGS. 37 and 38) extends from the proximal end of arm 72, and is positioned on the proximal side of the most proximal tooth 98. The function of restrictor element 94 is to prevent tissue from entering into the region occupied by hinge spring 86. This is essential to ensure that all of the tissue grasped will be compressed; tissue that is not compressed will not undergo the required necrotic process.
A latch 80 is inserted in first arm 74 of surgical clip 70. Latch 80 has a crook-shaped end 84 and includes a straight portion 71. Crook-shaped end 84 is also described herein as an engageable end. This is intended to indicate that any construction, not necessarily a crook-shaped construction, capable of engaging with a catch as described below would also be acceptable. Latch 80 is connected to an anchor element 97 which lies inside a rectangular hole 75 (best seen in FIG. 35) positioned at the latch's non-crook shaped end 99. This is best seen in FIG. 31B. Latch 80 is typically formed of a Ni—Ti alloy, but other shape memory materials may also be used. Additionally, other materials having some elasticity may also be satisfactory for use.
Shown in FIG. 31A is a wire 90 which runs from the distal end F of arm 72 to the distal end F of arm 74. One end 91 of wire 90 is ball-shaped and is attached to latch 80 through first arm 74. The second end of wire 90 extends all the way through second arm 72 reaching past proximal end N of clip applier 105, to the proximal, i.e. user, end of an endoscope (not shown). Wire 90 may also be described herein as a cable without any intent at differentiating between the two descriptions.
Attached to anchor element 97 at the non-crooked shaped end 99 of latch 80 is a cable 102 which extends through clip applier 105 past its proximal end N to the proximal end of the endoscope N (FIG. 1A) where an applier actuator (e.g. 306 or 308 in FIG. 1A) is located.
Arms 72 and 74 may be considered to consist of both compressing elements and securing elements and in this way be subsumed into the overall rubric of the other clips discussed herein. In the Figures, each arm appears as a single piece but essentially it consists of a bar, typically but without intending to be limiting, with a rounded cross section having teeth joined to it. The toothed portion (securing element) may by welded to the round bars (compressing elements) or otherwise joined or produced as an integral part of the round bars. The round elements are typically hollow and they can be considered cylindrical. The hollow arms allow insertion therein of hinge spring 86, latch 80, and wires 90 and 102 used to operate clip 70.
FIGS. 32 and 33 are partially exploded views of the elements of surgical clip 70 and clip applier 105 shown in and discussed in conjunction with FIGS. 31A and 31B. FIGS. 32 and 33 also show applier arms 83 and 89 of applier 105 to which first and second arms 72 and 74, respectively, of clip 70 are joined. Attachment is effected by applier arm projections 93; projections 93 extend substantially transversally from the ends of applier arms 83 and 89. Applier arm projections 93 are positioned in projection receptor spacings 95 on arms 72 and 74 when applier 105 is engaged to clip 70.
FIG. 34 shows several isometric and side views of a typical, but non-limiting, hinge spring 86 design.
FIG. 35 shows the details of latch 80. The straight section 71 of latch 80 includes a straight slot 77 with a round hole 79 at its distal end. The end 91 of wire 90 (FIG. 31B) is inserted and held in slot 77, the diameter of end 91 being greater than the width of slot 77. When clip 70 is completely positioned around the tissue to be resected, latch 80 is snapped into place, as discussed in greater detail below. As latch 80 snaps into place, wire 90 is then detached naturally from latch 80 and from clip 70 through hole 79 (FIGS. 35 and 43). After wire 90 is freed from latch 80, wire 90 is pulled entirely through second arm 72 toward the proximal end of the endoscope where it exits the endoscope and the body. A rectangular hole 75 at the end 99 of straight section 71 of latch 80 is used to anchor latch 80 to anchor element 97 (FIG. 31B) which is used by the user to pull latch 80.
FIG. 35 also shows that at the end of crook-shaped end 84 of latch 80 is a curved latch snout 92. Curved snout 92 is intended to catch in latch hole 182 discussed below in conjunction with FIGS. 38 and 40. This ensures that latch 80 snaps into place when clip 70 is in its closed position, thereby ensuring compression of the tissue between arms 72 and 74.
FIG. 36 shows an expanded isometric side view of the hinge spring 86 section of clip 70 and the section of clip applier 105 proximate to this section of clip 70. FIG. 37 shows an isometric front side view of clip 70, wire 90 and the distal end of applier 105. Both FIGS. 36 and 37 show clip 70 in its open position.
FIG. 36 shows hinge spring 86 as being inserted into arms 72 and 74 of clip 70. FIG. 37 shows the attachment of applier arms 83 and 89 which close clip arms 72 and 74 by exerting a force counter to the force exerted by hinge spring 86. The latter tends to force clip 70 open. Applier arms 83 and 89 are attached to arms 72 and 74, respectively, by applier arm projections 93, the latter being inserted into the clip's projection receptor spacings 95. Projections 93 and spacings 95 are also shown in FIG. 33. FIG. 36 also shows that applier arms 83 and 89 are integrally formed with pushing attachments 87 and 81, respectively. These are typically, but not necessarily, single piece elements, that is elements 89 and 81 form a single integral piece and elements 83 and 87 form another single integral piece. Alternatively, elements 83 and 87 (and 89 and 81) can be welded together from two or more separate structures.
These pieces include a bend 103 readily recognizable in FIGS. 36 and 38; bend 103 is required to ensure planarity of the pushing device.
Pushing attachments 87 and 81 each has an applier arm slot 88 in which a pushing attachment pin 107 moves when rotating pushing attachments 81 and 87 around pin 109 (FIGS. 31A and 36).
FIGS. 38-39 show different views of clip 70 and the distal end of clip applier 105 when wire 90 is pulled taut as a first step in closing applier 105. The taut wire keeps tissue (not shown) from slipping out when positioned between arms 72 and 74 as these arms move toward each other in a scissor-like or clamp-like fashion.
The wire is pulled taut after the tissue has been brought completely into clip 70 in its open position; the tissue is grasped and held between arms 72 and 74 and wire 90. Continuing to pull wire 90 brings distal end F (FIG. 31A) of arm 72 close to distal end F (FIG. 31A) of arm 74 until arm 72 is pressed against the tissue situated between arm 72 and arm 74. At this stage, latch 80 is brought to its locking position as will be described below. Wire 90 enters arm 72 through wire aperture 104. Wire section 106, best seen in FIG. 41, extends to the proximal end of the endoscope (not shown) and is pulled at that end when it is desired to bring wire 90 to its taut position between arms 72 and 74 of the clip.
FIG. 40 shows the distal end F of clip 70 and the locking action of latch 80. Between arms 72 and 74, tissue (not shown) is positioned and wire 90 is pulled taut. At that point, the distance between clip arms 72 and 74 is small. When arms 72 and 74 are in apposition, latch 80 is pulled by cable 102 (see FIGS. 31A and 37 for example) in a proximal direction indicated by the wavy double arrows. As latch 80 moves in the direction of those arrows, the rounded latch head slips (indicated by the single solid arrow) over slanted guide 85 until it contacts arm 72. It then latches when latch snout 92 (FIGS. 35 and 38) enters latch hole 182 (FIGS. 38 and 42). When in that position, latch 80, in concert with hinge spring 86 (force applier), exert a compressive force which acts in a line between arms 72 and 74. In the latched stage, arms 72 and 74 are separated somewhat, the gap between them arising from the thickness of the gripped tissue.
It should readily be understood that any other suitable catch structure can be used in place of latch hole 182. The choice of a hole here, functioning as a latch catch, should be considered as exemplary only. A protrusion with which latch 80 can engage would work equally as well. In fact, any engagement means that can engage and hold latch snout 92 of latch 80 is contemplated by the present invention.
The tissue situated between arms 72 and 74 of clip 70 prevents the clip from fully tracking clip applier 105 and returning to its completely closed position. As a result of this lack of complete tracking, applier arm projections 93 disengage from projection receptor spacings 95 by themselves and applier 105 falls away from clip 70.
As noted above, the shape-memory elements used to effect opening or closing of the compression clips described herein are typically described as hinge springs. However, these elements can more generally be classified as and called force appliers. Latch 80, because it is typically formed of shape memory materials, acts as a force applier that holds compression clip 70 closed.
FIGS. 41-43 show three different views of surgical compression clip 70 after latching as described above in conjunction with FIG. 40. FIG. 41 best shows exit hole 202 through which cable 102 is attached. Compression clip 70, by anchoring latch 80 to latch hole 182, brings anchor element 97 to exit hole 202, allowing anchor element 97 to naturally exit through hole 202. Both cable 102 and anchor element 97 are then pulled toward and through applier 105. From there they are pulled toward the proximal end of the endoscope and withdrawn from the body.
FIG. 44 shows an isometric view of a closed, but unlatched, surgical compression clip 70 constructed according to the embodiment shown in FIGS. 31A-43. FIG. 44 reflects the position of clip 70 as it is delivered to the site of a lesion by applier 105 via a working channel of an endoscope or via a secondary lumen of a multi-lumen sleeve encasing an endoscope. The use of multi-lumen sleeves is discussed below in conjunction with FIGS. 45-53.
Applier 105 is attached to clip 70 via applier arm projections 93 of applier arms 83 and 89 (see for example FIG. 33) at receptor spacings 95 on arms 72 and 74. In the closed but unlocked position of FIG. 44, the force exerted by applier arms 83 and 89 is counter to the force exerted by hinge spring 86. The force provided by applier 105 exerts a force which holds arms 72 and 74 adjacent to each other while clip 70 is being advanced within the endoscope (or sleeve lumen) to the lesion. At the site of the lesion, the force exerted by applier 105 is released and the clip opens.
Tissue is brought between the clip arms, the clip is closed, the lesion is severed and the site of the severed lesion is compressed between arms 72 and 74 of the clip 70 until necrosis and healing occurs. The entire process is discussed in greater detail below.
It should be noted that wire 90 is pushed forward once clip 70 approaches the suspect lesion. This relaxes wire 90 and enables the user to place it over, and/or around, the lesion. The relaxed, extended wire has a loop with an increased area through which the lesion can be pulled. With clip 70, the open arms 72 and 74 of the clip may be slid from the side of the pulled tissue after the polyp is positioned in the area between arms 72 and 74 and wire 90; this is unlike with clips 10 and 710 (FIGS. 2-3B and FIGS. 25A-26B), for example, where the polyp must be pulled through the arms of these latter clips using a grasper (discussed further below). Because of the use of wire 90, larger polyps may be treated.
The multi-lumen sleeve element of the present invention is shown in FIGS. 45-53, to which reference is now made.
FIG. 45 shows an isometric view of the distal end 152 of the insertion shaft of an endoscope positioned in a primary lumen 155 of a multi-lumen sleeve 150. The sleeve 150 has a primary lumen 155 and at least one secondary lumen 158. Both the distal end and the proximal ends of the sleeve may be open.
The distal end 152 of the insertion shaft of the endoscope includes a working channel 154, and at least one auxiliary element 157, such as optics, illumination, irrigation etc. In FIG. 45, three such auxiliary elements 157A-157C are present, but more or fewer auxiliary elements may be present in other embodiments.
When inserting the sleeve-encased endoscope into a patient, the secondary lumens 158 typically but without being limiting, are collapsed. Keeping the secondary lumens collapsed allows for a smaller profile as the endoscope is inserted into a body cavity, wending its way toward a lesion. One method of keeping the secondary lumens collapsed and substantially adjacent to the primary lumen 155 is by using bands 160, typically, but without intending to be limiting, bands made of silicone.
The multi-lumen sleeve 150 can be made of any of many different types of flexible plastics. Without intending to limit the choice of flexible plastics or elastomers, these may include polyethylene, polyurethane, polyvinyl chloride and almost any other medical grade plastic.
Secondary lumens 158 may be formed using any of several known methods for working sheet plastics; most typically the secondary lumens 158 are formed integrally with the primary lumen. The secondary lumens can be kept collapsed by directly extruding the multi-lumen sleeve with the secondary lumens in their collapsed positions. Secondary lumen(s) may also be attached to a primary lumen using one of many techniques known to those skilled in the art such as by using a suitable medical grade glue or solvent, by employing soldering, by heat treatment, or by using high frequency welding.
When using high frequency plastic welding, the secondary lumens, in their collapsed shape, are welded directly to the primary lumen. High frequency plastic welding, also known as floating welding, may be used to gently weld multiple single secondary lumens to the primary lumen producing sleeve shapes shown in FIGS. 46-49. The sleeve can also be welded from a single plastic sheet, after first doubling back the sleeve one or more times so that portions of the sleeve are positioned to be adjacent to each other.
FIGS. 46-53 show various configurations of multi-lumen sleeves 150 usable with the present invention. As noted above, the secondary lumens 158 may be integrally formed with the primary lumen 155 by extrusion or by any of a number of plastic sheet processing techniques, such as by hot welding or high frequency (HF) welding or solvent gluing. The attachment should be effected so that it allows expansion of the secondary lumen(s) 158 when surgical instruments pass through them. The number of secondary lumens 158 is different in each of the configurations shown and the secondary lumens 158 are shown in their collapsed state (FIGS. 46-49). FIGS. 50-53 show various configurations of integrally formed multi-lumen sleeves 150 with the number of secondary lumens 158 different in each configuration. In FIGS. 50-53 the secondary lumens 158 are distended as is the case when surgical working tools are positioned inside them.
While in the embodiments described above the primary lumen is continuous, in other embodiments it need not be. In these other embodiments, the primary lumen may include holes, be net-like, etc.
Reference is now made to FIGS. 54-56 wherein a grasper assembly 200 constructed according to the present invention is shown.
FIG. 54 shows the grasper assembly 200 in its open position. The assembly includes a grasper 250, a grasper transporting element 260, and a spring (not shown) situated within a spring cover 266. Grasper transporting element 260 has a side window 262 through which grasper 250 is ejected when grasper assembly 200 has been brought proximate to the tissue to be resected. Grasper transporting element 260 may be made of Ni—Ti alloys or other alloys; in some embodiments it may be made of plastic.
Grasper 250 is made up of forceps arms 252A and 252B joined to a cable 256, the cable passing through the spring (not shown) in spring cover 266. Forceps arms 252A and 252B have at their ends forceps tips, 254A and 254B, respectively. These tips can take different shapes, e.g. tooth-shaped, ball-shaped, etc. In FIG. 54, cable 256 has a bend 264 or curve in it. In other embodiments, the bend is situated in forceps arms 252A and 252B. See for example bend 268 in FIG. 56.
Cable 256 should be made of a torsion resistant material such as, but not limited to, Ni—Ti alloys, while forceps arms 252A and 252B may also be made of Ni—Ti alloys. A superelastic and/or shape memory material is preferred because the cable and forceps need to straighten when they are pulled into the grasper transporting element prior to insertion. Similarly, they are also needed to straighten when pulling the grasped tissue into an opened surgical compression clip and rotating it over and around grasper transporting element 260. Since cable 256 must be rotated, a torsion resistant cable, such as a Ni—Ti cable is important. Ni—Ti alloys typically provide better twist resistance since they possess significant torsional stability. Additionally, Ni—Ti alloys have high elasticity which makes it easier to straighten curves with large radii of curvature. This is the situation when keeping the bent forceps or bent cable inside grasper transporting element 260.
While the above has been discussed in terms of Ni—Ti alloys, it is readily apparent to one skilled in the art that other shape-memory materials having properties similar to Ni—Ti alloys may be used as well.
Turning to FIG. 55, grasper assembly 200 is shown in its closed position with grasper 250 and forceps arms 252A and 252B positioned and lying inside grasper transporting element 260. Grasper 250 is partially visible through window 262. Grasper 250 remains in its encased closed position while grasper assembly 200 is advanced through a working channel of the endoscope or through a secondary lumen of a multi-lumen sleeve such as those discussed previously. Spring 258 is visible in this Figure.
FIG. 56 shows an additional view of grasper assembly 200 again with bend 268 in forceps arms 252A and 252B and not in cable 256 as in FIG. 54. Bends are required because grasper 250 must move through the clip to grasp and pull a polyp. A distance must be traversed which depends inter alia on whether grasper assembly 200 has been advanced to the polyp through a working channel of the endoscope or through a secondary lumen of the multi-lumen sleeve. This secondary lumen may be the same lumen as the one through which a clip and clip applier has been advanced or a different secondary lumen. A bend in the forceps arms is more advantageous then a bend in the cable. A bend in the forceps arms is more compact; in such a case, the length of metal that needs to be pushed out of, or pulled back into, the grasper transporting element 260 is shorter than the equivalent length of metal when the bend is in the cable. In the former case, the bend exists only in the forceps arms while in the latter case both the forceps arms as well as the bend in the wire must be pushed out of, or pulled back into, the grasper transporting element 260.
Grasper assembly 200 is activated by an actuator (not shown) situated outside the proximal end of the endoscope (see for example element 308 in FIG. 1A). The actuator is in communication with grasper 250 through cable 256, the latter an operating cable. The actuator may be of any of many types known to those skilled in the art of endoscopy. The actuator typically includes a stopper to prevent forceps arms 252A and 252B which are grasping the pulled tissue from fully retracting into window 262. By fully retracting forceps arms 252A and 252B with the grasped tissue into window 262, there would be a chance that the tissue would fully disengage from forceps arms 252A and 252B and be left behind in the body cavity.
In another embodiment of grasper assembly 200, the assembly can include a plastic tube instead of a spring and spring cover 266. The tube should be flexible enough to be inserted into the GI tract through an endoscope's working channel or through one of the secondary lumens of a multi-lumen sleeve. The plastic tube needs to have relatively good resistance to torsion.
In this last embodiment, the plastic tube can be extended to include an integrally formed grasper transporting element 260 obviating the need for a separate grasper transporting element 260. A side window 262 can be formed in the plastic tube. In this embodiment, therefore, the grasper assembly includes two elements, grasper 250 and a plastic tube with a side window 262 close to its distal end.
In a previous embodiment of the tissue grasper, a mechanically operated instrument was described. Typically, at least one portion of the grasper included a shape memory material. In a second embodiment of the tissue grasper, rather than using mechanical grasping of the tissue to be resected or closed, a vacuum-based tissue grasper assembly is contemplated. Like the mechanical grasper assembly, the vacuum-based grasper assembly is also capable of grasping and pulling a large section of a, generally slippery, polyp extending from an organ wall, or other type of lesion, sufficient for resection and/or closure. Also like the mechanical grasper, the vacuum grasper can be employed in general tissue closing surgical procedures.
The vacuum-based tissue grasper assembly is shown in FIGS. 57-61C to which reference is now made.
FIG. 57 shows a schematic overview of the vacuum grasper assembly. The assembly 1000 includes an assembly body 1010 which further includes a vacuum cup advancer control 1015 and an articulation wire control 1014. A tube 1012 is joined to assembly body 1010 and to a suction source (not shown). Tube 1012 is joined to the proximal side of assembly body 1010. On the distal side of assembly body 1010 is a connector tube 1024 to which is attached an articulation wire 1026. At the most distal end of connector tube 1024 is vacuum cup cover 1018. Not shown are buttons activating the suction source, a water source if required, or any other necessary auxiliary instruments.
FIG. 58, to which reference is now made, shows an exploded view of the distal end of vacuum-based grasper assembly 1000 shown in FIG. 57. In FIG. 58, connector tube 1024, vacuum cup 1022 in its collapsed position, cup transporter 1020, and vacuum cup cover 1018 are shown. Also shown is articulation wire 1026. FIG. 59A shows a partially extended cup transporter 1020 projecting past vacuum cup cover 1018. FIG. 59B shows a cut away view of the distal portion of assembly 1000 before cup transporter 1020 is extended to allow for the emergence of collapsed vacuum cup 1022 and its transition to its non-collapsed position.
FIGS. 60A-60B show various stages of vacuum cup 1022 emerging from vacuum cup cover 1018 with cup transporter 1020 also at various stages of projecting past vacuum cup cover 1018. Articulation wire 1026 is joined to cup transporter 1020 (best seen in FIGS. 59A, 59B, 60A and 60B) and the results of its operation can best be seen in FIG. 60C.
Typically, but without intending to be limiting, vacuum cup 1022 is cup-shaped as in FIGS. 61A-61C. FIG. 61A shows an unsupported cup typically formed of a flexible plastic. FIGS. 61B and 61C show supported cups; in FIG. 61B the support are ribs 1032 either formed of resilient plastic or metal. Ribs 1032 may even be formed of the same plastic from which vacuum cup 1022 itself is formed. FIG. 61C shows the supporting structure to be a resilient stent-like structure 1030.
Typically vacuum cup 1022 is formed of a resilient plastic such as polyurethane, polyvinyl chloride, or other medical grade polymeric materials. The other parts of vacuum-based grasper assembly 1000 are formed of polymeric plastics, metals or a combination of both. Cup transporter 1020 is formed as a spring having an inner coating for reducing friction between itself and vacuum cup 1022. The spring allows for easier articulation of the vacuum cup 1022 when manipulated by articulation wire 1026. Flexible plastic tubes, specially cut metal tubes, and even tubes made from Ni—Ti alloys can be used as alternatives to a spring for allowing easier articulation. The materials noted above are exemplary only and are not intended to be limiting.
A method for effecting resection of, for example a pedunculated polyp in the GI tract, using the compression clips of the present invention is illustrated in FIGS. 62-74C, to which reference is now made.
The method of operation of the clips, their applier systems, and the grasper assemblies of the present invention in other situations, such as where only tissue closure is required or in a hemorrhoidectomy, is similar to the method shown in FIGS. 62-74C and discussion presented therewith. It should readily be understood by one skilled in the art, that clip appliers can be designed as the surgical procedure and nature of the tissue to be closed warrants. The design would generally require little or no modification to the applier shown in the Figures presented herein.
It should also be readily understood by one skilled in the art that certain features and working instruments shown in FIGS. 62-74C for polyp resection would not necessarily be required in other tissue compression procedures and/or may be replaced by commercially available instruments. For example, a severing instrument may not always be required and generally is not present in procedures solely used to effect tissue closure. Similarly, a grasper assembly as used in the Figures may not always be needed.
FIG. 62 shows an endoscope insertion shaft 300 being brought for positioning in a multi-lumen plastic sleeve 150. The endoscope insertion shaft 300 is encased in the primary lumen 155 (FIG. 65 or 69A, for example) of the multi-lumen sleeve 150 and the one or more secondary lumens 158 of sleeve 150 are typically collapsed and, if needed, held by bands 160 (FIGS. 63A and 63B). The bands 160 are expandable when working instruments are inserted into the collapsed secondary lumens 158. Insertion of these instruments occurs after the distal end 152 of the endoscope shaft 300 is positioned proximate to the suspect lesion. Bands may not be required in some embodiments, if the secondary lumens 158 remain collapsed by themselves while the encased endoscope insertion shaft 300 (FIGS. 63A and 63B) is inserted into a body organ or if not required by the physician. It is to be understood that means or methods other than bands may be used to ensure that the secondary lumens remain collapsed while the encased endoscope shaft is inserted into the body and positioned near the suspect lesion.
The encased endoscope insertion shaft 300 is advanced within the body lumen until it is near the lesion, herein taken to be a polyp P in the gastrointestinal (GI) tract (FIG. 64).
At that point, a surgical compression clip 10, and its attached applier 30, both in their closed positions, are advanced through a secondary lumen 158 of the sleeve 150 to polyp P. Clip 10 exits the secondary lumen 158 still in its closed position (FIG. 65).
Closed clip 10 is then brought to its position adjacent to polyp P (FIG. 66).
A grasper assembly is then inserted into a working channel 154 of the endoscope insertion shaft 300, advanced through the shaft, and then advanced out of the distal end 152 of endoscope insertion shaft 300 to the region adjacent to polyp P (FIG. 67).
In other embodiments, the grasper assembly, i.e. grasper and grasper transporting element 260, is introduced via a secondary lumen 158 of the multi-lumen sleeve 150 and not through a working channel 154 of the endoscope shaft. From an operational point of view, this has no significant effect on the method described.
In yet another embodiment, the grasper assembly, clip 10 and clip applier 30 may be advanced through the same secondary lumen 158 from the proximal end of the endoscope shaft to the suspect lesion.
In yet another embodiment, the grasper assembly may be inserted into and advanced through a second working channel of the endoscopic insertion shaft.
Clip 10 is then opened by applier 30. The opened clip is positioned so that the lesion can be pulled through the clip. FIG. 68 shows an isometric view of this step.
Up to this point, the grasper (not shown) remains inside its grasper transporting element 260. Now the forceps arms 252A and 252B of the grasper are ejected from grasper transporting element 260 and positioned to grasp polyp P through the open clip (FIGS. 69A and 69B).
Polyp P is then pulled by forceps arms 252A and 252B into the separated compressing and securing elements 16A, 16B and 14A, 14B, respectively, of open clip 10. This is shown in a top side view in FIG. 70. In this view, one of the forceps arms 252 of the grasper is barely visible; most of this arm and the entire second forceps arm are obscured by polyp P.
Clip applier 30 then closes clip 10 around pulled polyp P (FIG. 71). Clip applier 30 is detached from the closed clip 10 and withdrawn via the secondary lumen 158 through which it entered (FIG. 72). Alternatively, if the physician feels it will assist him during the tissue resection, clip applier 30 could be detached from clip 10 after tissue resection.
Polyp P, compressed by clip 10, is severed by a severing device 310 shown being positioned close to polyp P (FIG. 73). Severing device 310 may be advanced to the polyp through the endoscope's working channel 154 or through a secondary lumen 158 of sleeve 150. In FIG. 73, severing device 310 has been advanced to its position for severing through the secondary lumen 158 used for advancing clip 10 and its applier 30. Severing device 310 approaches polyp P and severs it from the wall of the GI tract. The actual step of severing is not shown.
After severance of polyp P, the severed polyp held by the forceps arms of the grasper, together with the remainder of the grasper assembly, the severing device 310 and the endoscope shaft, are retracted in the direction of the proximal end of the endoscope and withdrawn from the body. Withdrawal directly from the body organ is a straight-forward step, and therefore this step of the method is not presented in a separate Figure. Polyp P can then be biopsied or treated as needed by a physician.
The closed surgical compression clip 10 remains around that portion of the GI wall from which the tissue was resected (FIGS. 74A, 74B and 74C). Compression continues until necrosis is induced and healing of the resected site occurs. Clip 10 is naturally expelled from the body through the rectum or retrieved by the physician if needed.
The above described method may be operative when employing most of the clips designed according to embodiments of the present invention (FIGS. 2-44 above).
However, clip embodiment five discussed in conjunction with FIGS. 31A-44 requires some additional and/or modified steps. The element numbering below is that used in conjunction with FIGS. 31A-44 to which reference should be made.
The method for using the clip described in conjunction with FIGS. 31A-44 includes many of the same steps as those described above. However, the following additional or modified steps emphasize the novel aspects of the method associated with clip embodiment five. It does not include all of the steps required, many of which can be readily understood by reviewing the method described above.
Additional, or modified, steps when using clip embodiment five include:
Insertion of clip 70 in its closed position together with its applier 105;
Releasing the force exerted by applier 105 allowing hinge spring 86 to spread apart arms 72 and 74 of clip 70;
Pushing wire 90 forward and extending it to form a loop;
Placing the wire 90 loop over the polyp;
Pulling the polyp with a grasper through the loop created by the extended wire;
Positioning the arms 72 and 74 of clip 70 in their open position and bringing them around the side of the polyp rather than positioning the clip from the top of the polyp as with other clips discussed in the present invention;
Alternatively, the clip may be positioned in proximity to the polyp, after which the polyp is pulled between the open clip arms using a grasper;
Pulling wire 90 taut thereby preventing the polyp from escaping from between arms 72 and 74;
Closing arms 72 and 74 by continuing to pull wire 90 and/or using applier 105, and pulling cable 102 until latch 80 snaps over the second clip arm and latches therewith;
Detaching the anchor element 97 which anchors wire 90 to arm 74; and
Pressing applier 105 slightly to release the applier.
The above step of pulling the polyp with a grasper is optional since in most situations wire 90 loop by itself can be maneuvered to encompass, grasp and pull the polyp or its stalk.
Positioning the clip from the side as discussed above is a result of the polyp being encompassed by wire 90 when the latter is in its extended position. When made taut, the wire effectively pulls the polyp from a lateral position into the waiting open arms 72 and 74 of clip 70.
Generally, insertion of closed clip 70 is effected through a secondary lumen of a multi lumen sleeve, but it also may be advanced through a working channel of the endoscope. Using applier 105 to open clip 70 occurs only after clip 70 has exited the secondary lumen or working channel.
It is readily understood by one skilled in the art that resection with wide lateral areas (margins) is very difficult to achieve using conventional surgical approaches and employing conventional surgical instruments. This is particularly true of large polyps and especially large sessile polyps. Grasping and pulling a large section of a, generally slippery, polyp is very difficult especially given the limited space available in the body lumen for manipulation of the tissue. In the present method, a specially designed grasper assembly as described herein is used. The grasper assembly is used to ensure that the entire polyp plus an adequate margin is resected.
The vacuum-based grasper assembly discussed above in conjunction with FIGS. 57-61C is also capable of grasping and pulling a large section of a, generally slippery, polyp sufficient for resection with a large margin.
As can be seen in FIGS. 75-78, to which reference is now made, the method for using vacuum-based grasper assembly 1000 of FIGS. 57-61C for effecting resection of a polyp is very similar to that discussed in conjunction with FIGS. 62-74C where a mechanical tissue grasper is used. These latter Figures will again be referred to in the discussion of the method of use of the vacuum-based grasper assembly. It should be understood that in FIGS. 62-74C referred to below, the mechanical grasper assembly shown therein should be replaced by vacuum-based grasper assembly 1000 of FIGS. 57-61C mutatis mutandis.
FIG. 62 shows an endoscope insertion shaft 300 being brought for positioning in a multi-lumen plastic sleeve 150. The endoscope insertion shaft 300 is encased in the primary lumen 155 (FIG. 65 or 69A, for example) of the multi-lumen sleeve 150 and the one or more secondary lumens 158 of sleeve 150 are typically collapsed and, if needed, held by bands 160 (FIGS. 63A and 63B). The bands 160 are expandable when working instruments are inserted into the collapsed secondary lumens 158. Insertion of these instruments occurs after the distal end 152 of the endoscope shaft 300 is positioned proximate to the suspect lesion. Bands may not be required in some embodiments, if the secondary lumens 158 remain collapsed by themselves while the encased endoscope insertion shaft 300 (FIGS. 63A and 63B) is inserted into a body organ or if not required by the physician. It is to be understood that means or methods other than bands may be used to ensure that the secondary lumens remain collapsed while the encased endoscope shaft is inserted into the body and positioned near the suspect lesion.
The encased endoscope insertion shaft 300 is advanced within the body lumen until it is near the lesion, herein taken to be a polyp P in the gastrointestinal (GI) tract. (FIG. 64).
At that point, a surgical compression clip 10, and its attached applier 30, both typically in their closed positions, are advanced through a secondary lumen 158 of the sleeve 150 to polyp P. Clip 10 exits the secondary lumen 158 still in its closed position (FIG. 65).
Closed clip 10 is then brought to its final position adjacent to polyp P. (FIG. 75).
A vacuum grasper assembly, such as vacuum grasper assembly 1000 shown in FIGS. 57-61B, is then inserted into a secondary lumen 158 of the multi-lumen sleeve 150, advanced through the lumen, and then advanced out of the distal end of secondary lumen 158 to the region adjacent to polyp P (FIG. 76).
In other embodiments, the vacuum grasper assembly is introduced via a working channel 154 of the endoscope insertion shaft 300 and not through a secondary lumen 158 of sleeve 150. From an operational point of view, this has no significant effect on the method described.
In yet another embodiment, the grasper assembly, clip 10 and clip applier 30 may be advanced through the same secondary lumen 158 from the proximal end of the endoscope shaft to the suspect lesion.
Clip 10 is then opened by applier 30 (FIG. 76). The opened clip is positioned so as to be near polyp P so that the lesion can be pulled through the clip by vacuum grasper assembly 1000.
Up to this point, vacuum cup 1022 remains inside its grasper transporting element 1020. Now vacuum cup 1022 of the grasper assembly 1000 is ejected from grasper transporting element 1020 and positioned to grasp polyp P through the open clip (FIG. 77). An articulation wire allows for maneuvering vacuum cup 1022 so that it can approach and grasp polyp P. In FIGS. 76-78, the articulation wire is obscured by vacuum cup 1022 and connector tube 1024.
Until clip 10 is opened and positioned close to polyp P, the grasper remains within connector tube 1024 inside lumen 158. After clip 10 is opened, vacuum cup 1022 advances out of lumen 158 and opens. Using an articulation wire to maneuver flexible cup transporter 1020, here formed having a spring construction, vacuum cup 1022 is positioned to grasp polyp P through open clip 10 (FIG. 77).
While what is described herein above refers to an articulation wire, any element capable of causing articulation of vacuum cup 1022 may also be used.
Polyp P is then pulled by vacuum cup 1022 into the separated compressing and securing elements 16A, 16B and 14A, 14B, respectively, of open clip 10 which is then closed. This is shown in FIG. 78. The suction of the vacuum-based grasper assembly ensures that sufficient tissue is being maneuvered into clip 10 and brought near a severing device similar to severing device 310 shown in FIG. 73 to allow for resection.
Clip applier 30 then closes clip 10 around pulled polyp P (FIG. 78). Clip applier 30 is disengaged from the closed clip 10 and withdrawn via the secondary lumen 158 through which it entered (not shown). Alternatively, if the physician feels it will assist him during the tissue resection, clip applier 30 could be detached from clip 10 after tissue resection.
Polyp P, compressed by clip 10, is severed by a severing device 310 shown being positioned close to polyp P (FIG. 73). Severing device 310 may be advanced to the polyp through the endoscope's working channel 154 or through a secondary lumen 158 of sleeve 150. In FIG. 73, severing device 310 has been advanced to its position for severing through the secondary lumen 158 used for advancing clip 10 and its applier 30. Severing device 310 approaches polyp P and severs it from the wall of the GI tract. The actual step of severing is not shown.
After severance of polyp P, the severed polyp held by the vacuum cup 1022, together with the remainder of the grasper assembly, the severing device 310 and the endoscope shaft, are retracted in the direction of the proximal end of the endoscope and withdrawn from the body. Withdrawal directly from the body organ is a straight-forward step, and therefore this step of the method is not presented in a separate Figure. Polyp P can then be biopsied or treated as needed by a physician.
The closed surgical compression clip 10 remains around that portion of the GI wall from which the tissue was resected (FIGS. 74A, 74B and 74C). Polyps typically have associated with them a well-developed vascular system that needs compression to prevent bleeding. Additionally, compression continues until necrosis is induced and healing of the resected site occurs. Clip 10 is naturally expelled from the body through the rectum or retrieved by the physician if needed.
The above described method using a vacuum-based grasper assembly may be operative when employing most of the clips designed according to embodiments of the present invention. However, clip embodiment five discussed in conjunction with FIGS. 31A-44 requires some additional and/or modified steps. These steps are the same as already discussed above with regard to the use of these clips with the mechanical grasper assembly.
Reference now is made to FIG. 79 where a procedure for the treatment of internal hemorrhoids is shown. The compression clips of the present invention as described herein can be used in place of ligation bands currently in use. The present invention's compression clips can be used for compressing a blood vessel rich hemorrhoid (H) causing its necrosis and subsequent healing of the rectal/anal (A) tissue. While in FIG. 79 a clip applier similar to those discussed herein is used, such as in the method of FIG. 62-74C, it is readily understandable that other methods of applying the clips to the hemorrhoid are also possible. Instead of using a flexible endoscope, a more rigid scope can be used when applying the compression clips of the present invention in hemorrhoids applications.
In another application of the system and method of the present invention there is presented in FIGS. 80-84, a method for tissue closure of GI tract perforations. These include “natural” perforations, such as peptic or duodenal ulcers, and surgically generated perforations, such as those produced as a result of NOTES procedures, gastrectomies or gastroplastic procedures. These Figures are very similar to the Figures found in the resection method discussed in conjunction with FIGS. 62-74C above. Except for the step of severing and the requirement for a severing instrument, these Figures are mutatis mutandis very similar to those discussed previously. Accordingly, no detailed discussion is needed. It can be seen that FIG. 80 is essentially equivalent to FIGS. 68 and 76; FIG. 81 is essentially equivalent to FIGS. 69A, 69B, and 77; FIG. 82 is essentially equivalent to FIGS. 70; FIG. 83 is essentially equivalent to FIGS. 71 and 78; and FIG. 84 is essentially equivalent to FIG. 72. FIGS. 62 to 67 are essentially unchanged in the method. In FIGS. 80-84, PF indicates the perforation and T the tissue undergoing compression and necrosis. FIGS. 80-84 therefore indicate the general method for compressively closing tissue, not necessarily resected tissue. They also generically show the application of the system and method of the present invention to other types of lesions such as ulcers.
Gastroplastic surgical procedures are used to reduce the volume of the stomach in order to encourage weight loss in obese individuals. A portion of the stomach is grasped, pulled and held within a compression clip 10 as shown in FIG. 85. Alternatively, a plurality of clips may be used to achieve the desired result. The held stomach portion forms a pouch (PCH) into which food does not enter. The original stomach wall S′ has been shortened to S by clip 10. Clip 10 induces necrosis of the pouch area, and after necrosis is completed, the region around the necrotic area heals leaving an organ with an effective smaller volume. The tissue is held by a compression clip 10 constructed according to the present invention which encourages tissue closure by compression. Typically, clip 10 can be evacuated naturally through the rectum after its disengagement from the healed tissue. Alternatively, the clip may be retrieved after disengagement using a wire attached to the clip and exiting the mouth.
In the discussion in conjunction with FIGS. 62-74C, the invention has been described as being used in bowel polyp non-full thickness resections. It should be evident to one skilled in the art that other types of lesions, in other organs in other organ systems, can also be resected and/or closed using the present invention with little or no modification. Such organs include, but are not limited to, the urinary bladder and other organs of the urinary tract, the uterus, the liver, the esophagus, the gall bladder, the lungs and the rectum.
Typical lesions which may be compressively closed according to the system and method of this invention include: tissue adjacent to a disease-induced perforation of an organ wall; tissue adjacent to a perforation in the stomach wall resulting from a gastrectomy procedure; tissue adjacent to a perforation in an organ wall resulting from a natural orifice transmural endoscopic surgical (NOTES) procedure; stomach tissue, the compression of which is required to reduce stomach volume in a gastroplastic procedure; gastric tissue adjacent to an ulcerous lesion; duodenal tissue adjacent to an ulcerous lesion; esophageal tissue adjacent to an ulcerous legion; other tissue adjacent to an ulcerous lesion; rectal tissue adjacent to hemorrhoids that are ligated by the clip; and other tissue compressed and ligated by the clip. This list is not intended to be limiting.
In the above discussion, the system and method of the present invention have been described as being used in endoscopic procedures which do not require a direct incision into the body cavity. The system and method as described herein above has been described as being inserted into the body cavity through one of the body's existing orifices. However, it is readily understood by those skilled in the art that the system and method described herein above can be used in open surgical procedures with little or no modification, where the point of entry of the system is an incision into the body cavity.
“Endoscope”, as used herein, contemplates the use of the present invention with all different types of invasive instruments, flexible or rigid, having scope features. These include, but are not limited to, instruments referred to as endoscopes, gastroscopes, laparoscopes, colonoscopes, rectoscopes, bronchoscopes, urethroscopes, and hysteroscopes. Such instruments, as is readily known to those skilled in the art, are subsumed within the term endoscope. The present invention, while discussed in terms of general endoscopes can readily be adapted for use with each of these specific instruments with little or no modification. It should also be noted that the use of the term “endoscopic” is to be construed as referring to the many different types of invasive scopes subsumed under the term endoscopes. As known by those skilled in the art the term “invasive” denotes a medical procedure requiring insertion of an instrument or device into the body through the skin or a body orifice for diagnosis or treatment.
It should be readily apparent to one skilled in the art that the device and method of the present invention can be used to excise animal tissue as well as human tissue, particularly, but without being limiting, tissue of other mammalian species.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
It will be appreciated by persons skilled in the art that the present invention is not limited by the drawings and description hereinabove presented. Rather, the invention is defined solely by the claims that follow.

Claims

1-40. (canceled)

41. A system for use with a surgical compression clip for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue adjacent to the compression site, wherein the clip comprises a pair of compression elements and at least one force applier element formed of a shape memory material, the clip having an open position and a closed position and configured to receive tissue to be compressed therethrough when in its open position, the force applier element operative for providing a force to said compressing elements, and the compressing elements operative to apply a compression force to the tissue to be compressed when the clip is closed thereabout, so as to cause first tissue necrosis and then healing of the tissue around the compression site, the system comprising:

an endoscope having an insertion shaft having at least one working channel;

a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be compressed, wherein said working conduit is said at least one working channel of said insertion shaft; and

a grasper assembly selectably extendible through said working conduit, for engaging and pulling the tissue to be compressed through the clip when the clip is in its open position.

42. A system according to claim 41 further comprising a multi-lumen sleeve having a primary lumen encasing said endoscope insertion shaft, and at least one secondary lumen and where said working conduit is a preselected one of (i) said at least one working channel of said insertion shaft and (ii) said at least one secondary lumen of said multi-lumen sleeve.

43. A system according to claim 41, wherein said clip applier includes:

two arm elements selectably engageable with the compression clip, each arm element having a slot and a pin hole;

a position controlling element in mechanical communication with said arm elements, said position controlling element including a first and second pin, where said first pin passes through said position controlling element and said pin hole on each of said two arm elements and said second pin passes through said position controlling element and said slot on each of said arm elements; and

an activating element in mechanical communication with and operable to move said pins in said position controlling element,

thereby to produce substantially scissor-like motion of said arm elements bringing them from their closed adjacent position to their open spaced apart position and vice versa; and

thereby to cause the compression clip to move from its open position to its closed position and vice versa in tandem with the motion of said arm elements of said clip applier.

44. A system according to claim 41, wherein said grasper assembly is comprised of:

a grasper having a closed and an open position, said grasper comprised of:

forceps arms for grasping and pulling the portion of the tissue to be compressed; and

a wire in mechanical connection with and for controlling and maneuvering said forceps arms and for bringing said forceps arms from their closed position to their open position and vice versa; and

a grasper transporting element for transporting said grasper in its closed position to a location near the portion of the tissue to be compressed whereat said grasper is ejected from said transporting element allowing said forceps arms to open to their open position.

45. A system according to claim 44, wherein at least one of said wire and said forceps arms includes a bend, said bend facilitating grasping and pulling the tissue to be compressed through the clip.

46. A system according to claim 44, wherein at least one of said wire and said forceps arms is formed at least partially of a shape memory material.

47. A system according to claim 41, wherein said grasper assembly comprises:

a flexible resilient vacuum cup having a closed and an open position;

a suction source for generating negative pressure;

a conduit joining said vacuum cup to said suction source;

a grasper transporting element for transporting said vacuum cup in its closed position to a location near the site of the tissue to be compressed where said vacuum cup is ejected from said transporting element allowing said vacuum cup to open to its open position; and

articulation means for bringing said vacuum cup to the site of the tissue to be compressed for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.

48. A system for compressing tissue to induce necrosis and subsequent healing of the tissue around the compression site, the system comprising:

an endoscope having an insertion shaft having at least one working channel, said endoscope selected from a group of endoscopes consisting of rigid and flexible endoscopes;

a compression clip having an open position and a closed position, said clip configured to receive tissue to be compressed therethrough when in its open position, and operative to apply a compression force thereto when closed thereabout;

a clip applier for advancing said clip through a working conduit and for positioning said clip near the tissue to be compressed, wherein said working conduit is said at least one working channel of said insertion shaft; and

a grasper assembly selectably extendible through said working conduit, for engaging and pulling the tissue to be compressed, the engaged tissue being positioned in said clip when said clip is in its open position,

said compression clip further comprising a pair of generally elongated compressing elements for compressing the tissue to be compressed, said compressing elements formed and configured for being disengageably joined to said clip applier, and said compression clip is operable to compress the tissue extending therethrough, thereby inducing necrosis and subsequent healing of the tissue around the compression site.

49. A system according to claim 48, further comprising a a multi-lumen sleeve having a primary lumen encasing said endoscope insertion shaft, and at least one secondary lumen wherein said working conduit is a preselected one of (i) said at least one channel of said insertion shaft and (ii) said at least one secondary lumen of said multi-lumen sleeve.

50. A system according to claim 48, wherein said compression clip includes at least one shape memory force applier element formed of shape memory material, said at least one force applier element operative for providing a force to said pair of compressing elements for compressing tissue held therebetween.

51. A system according to claim 50, wherein said compressing elements and said at least one shape memory force applier element form a planar configuration in both the clip's open and closed positions and said compressing elements of said surgical clip apply a compressive force to the tissue to be compressed, the compressive force acting in the plane of said clip and in a line between said compressing elements.

52. A system according to claim 50, wherein said system further includes a pair of generally elongated securing elements and wherein said at least one shape memory force applier element is positioned between, and in mechanical connection with, said operatively associated securing and compressing elements, and wherein said at least one shape memory force applier element and said pairs of securing and compressing elements all lie in substantially the same plane in both the first open and second closed positions of said clip and wherein an axis of securing for holding the tissue to be compressed is formed by, and is tangential to, said securing elements and an axis of compression for compressing tissue to be compressed is formed by, and tangent to, said compression elements, the lines of securing and of compression not being collinear lines.

53. A system according to claim 48, said clip further comprising a pair of generally elongated securing elements each having formed thereon a pair of mutually opposing gripping portions adapted to secure therebetween the tissue to be compressed, said securing elements operationally associated with said compressing elements, said securing elements formed and configured for being disengageably joined to said clip applier.

54. A system according to claim 53 wherein said gripping portions of said securing elements include toothed first edges which are in proximity to each other when said clip is in its closed position and wherein said toothed first edges of said securing elements are spaced apart from each other when said clip is in its open position.

55. A system according to claim 48, wherein said grasper assembly is comprised of:

a grasper having a closed and an open position, said grasper comprised of:

forceps arms for grasping and pulling the tissue to be compressed; and

a grasper transporting element for transporting said grasper in its closed position to a location near the tissue to be compressed whereat said grasper is ejected from said transporting element allowing said forceps arms to open to their open position.

56. A system according to claim 55, wherein at least one of said wire and said forceps arms includes a bend, said bend facilitating grasping and pulling the tissue to be compressed through said clip.

57. A system according to claim 55, wherein at least one of said wire and said forceps arms is formed at least partially of a shape memory material.

58. A system according to claim 48, wherein said grasper assembly comprises:

a flexible resilient vacuum cup having a closed and an open position;

a suction source for generating negative pressure;

a conduit joining said vacuum cup to said suction source;

a grasper transporting element for transporting said vacuum cup in its closed position to a location near the tissue to be compressed where said vacuum cup is ejected from said transporting element allowing said vacuum cup to open to its open position; and

articulation means for bringing said vacuum cup, when in its open position, to the tissue to be compressed for engaging the tissue under a suction force, and for subsequently pulling the tissue through said surgical clip.

59. A system according to claim 48, wherein said clip further includes a pair of compressing elements and at least two shape memory force applier elements formed of shape memory material where one of said force applier elements is constructed as a latch which is operable to engage with an engagement means formed on one end of one of said pair of compressing elements, said latch thereby exerting a force on the tissue to be compressed when the tissue is held between said compressing elements.

60. A system according to claim 59, wherein said clip further includes a wire snare.

61. A system according to claim 48 wherein said compression clip comprises:

a pair of generally linear compression elements for securing tissue therebetween and for applying to the secured tissue a compression force, wherein said compression clip has an initial, open position in which said linear compression elements may be positioned about the tissue to be secured therebetween, and a final, closed position whereat said compression elements are substantially parallel to each other, thereby to apply a compressive force to the secured tissue; and

force means formed from a shape memory material and disposed between said pair of compression elements and operative to transmit operational forces therebetween.

62. A system according to claim 61, wherein said force means includes at least one active hinge member disposed between said linear compression elements.

63. A method for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue surrounding the compression site, said method comprising the steps of:

placing an endoscope in a body cavity and advancing the endoscope to and positioning it near the site of the tissue to be compressed; and

positioning a compression clip near the site of the tissue to be compressed; and

extending a grasping instrument for grasping and pulling the tissue to be compressed, the grasped tissue being positioned in the compression clip when the clip is in its open position and compressed when the clip is in its closed position thereby producing necrosis in the compressed tissue and then healing of the tissue surrounding the compression site,

wherein said step of extending includes the step of grasping sufficient tissue to include sufficient margins around the site of the tissue to be compressed to ensure successful compression without leakage.

64. A method according to claim 63, wherein said step of positioning includes positioning the clip around a perforation in the tissue to be compressed and then in said step of closing, compressing the tissue around the perforation thereby causing closure of the perforation.

65. A method according to claim 63, wherein said step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed through a working channel of the endoscope and in said step of positioning the compression clip is advanced and brought to the site of the tissue to be compressed through a second working channel of the endoscope.

66. A method according to claim 63, wherein said step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed through a working channel of the endoscope and in said step of positioning the compression clip is advanced and brought to the site of the tissue to be compressed through a secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the site of the tissue to be compressed.

67. A method according to claim 63, further comprising the step of activating a vacuum source so as to effect the action of grasping in said step of extending by a suction operated grasping instrument.

68. A method according to claim 63, wherein said step of extending precedes said step of positioning and in said step of positioning the clip is positioned around the grasped and pulled tissue to be compressed.