US20050020884A1 - Surgical access system - Google Patents
Surgical access system Download PDFInfo
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- US20050020884A1 US20050020884A1 US10/927,551 US92755104A US2005020884A1 US 20050020884 A1 US20050020884 A1 US 20050020884A1 US 92755104 A US92755104 A US 92755104A US 2005020884 A1 US2005020884 A1 US 2005020884A1
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- Prior art keywords
- ring
- hand
- seal
- sheath
- access system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0293—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with ring member to support retractor elements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00265—Hand assisted surgery, i.e. minimally invasive surgery with at least part of an assisting hand inside the body
Abstract
The invention is directed to a hand access system that provides hand access to a surgical area while maintaining pneumoperitoneum during laparoscopic surgery. The hand access system comprises a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor includes a first ring being adapted for disposition interiorly of the wound, a second ring being adapted for disposition exteriorly of the wound, and a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound. The hand access system further comprises a detachable hand seal adapted to be removable from the second ring of the sheath retractor. The sheath retractor may be formed of an elastomeric material, and the hand seal may be formed of a gel material and includes a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of the instrument or hand. In another aspect, there is disclosed a surgical access device adapted for disposition relative to an incision in a patient comprising a valve including a plurality of overlapping sheets defining an access channel, and a ring having an inner diameter for holding the valve by fixing each of the overlapping sheets along a portion of the perimeter, the access channel extends into communication with the incision in the patient. Each of the overlapping sheets includes a portion of the perimeter that is not fixed to the inner diameter of the ring, which provide open edges defining the access channel. The open edges slightly overlap at the center of the ring. The open edges may have different shapes including at least one of a straight edge, concave, convex and a cross-configuration. The hand access device may further comprise a septum seal formed at the proximal and distal ends of the ring.
Description
- This is a continuation application claiming the priority of (1) PCT application Serial No. PCT/US2004/005484, entitled “Sealed Surgical Access Device,” filed on Feb. 25, 2004, (2) PCT application Serial No. PCT/US2004/0054-87, entitled “Wound Retractor for Use in Hand-Assisted Laparoscopic Surgery,” filed on Feb. 25, 2004, and (3) PCT application Serial No. PCT/US2004/005361, entitled “Apparatus and Method for Illuminating a Peritoneal Cavity During Laparoscopic Surgery,” filed on Feb. 24, 2004, all of which claim priority to (4) provisional application Ser. No. 60/449,857, filed on Feb. 25, 2003, entitled “Hand-Assisted Laparoscopy Apparatus and Method,” all of which are fully incorporated herein by reference in their entireties.
- 1. Field of the Invention
- This invention generally relates to surgical access systems that facilitate sealed access across a body wall and into a body cavity during a laparoscopic surgical procedure.
- 2. Discussion of the Relevant Art
- During laparoscopic surgery, it is desirable to inflate the abdominal cavity in order to increase the volume of the working space. This is accomplished with an insufflation gas which must be maintained at a pressure sufficient to inflate the abdomen. Maintaining the pressure of the insulation gas is difficult when it is also desirable to insert instrumentation through the abdominal wall. If a surgeon is interested in inserting his or her hand in a hand-assisted laparoscopic procedure, the maintenance of insulation pressure is even more difficult. Currently, several devices exist that accomplish this surgical need although they suffer from drawbacks such as difficult placement and cumbersome use. For example, these hand-assisted devices require elaborate mechanisms such as inflatable cuffs and adhesives to seal around a surgeon's wrist or forearm to maintain the insulation gases. As such, there is a need for a special seal formed around the wrist or forearm of a surgeon to prevent the escape of insulation gases. Moreover, it is desirable that the wound be retracted, protected and fixed while maintaining the insufflation seal.
- The invention is directed to a hand access system that provides hand access to a surgical area while maintaining pneumoperitoneum during laparoscopic surgery. The hand access system comprises a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor includes a first ring being adapted for disposition interiorly of the wound, a second ring being adapted for disposition exteriorly of the wound, and a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound. The hand access system further comprises a detachable hand seal adapted to be attached and detached from the second ring of the sheath retractor. In particular, the hand seal can be detached from the sheath retractor to convert the hand access system from laparoscopic surgery to open surgery. In one aspect, the first ring, second ring and sheath are formed from an elastomeric material, and the hand seal is formed of a gel material and includes a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of the instrument or hand. The gel material includes, for example, a thermoplastic base such as Kraton® and an oil. The resulting elastomer has excellent tear strength, elongation greater than 1,000 percent, a very low durometer or hardness, and biocompatibility. It is appreciated that the first ring has a first diameter and the second ring has a second diameter, and the first and second diameters are greater than the desired diameter of the wound.
- In another aspect, the sheath retractor further comprises a third ring disposed circumferentially of the sheath and moveable between a plurality of positions between the first ring and the second ring, each of the positions being associated with a different retraction force, the third ring being adapted for disposition exteriorly of the wound. The sheath retractor may further comprise means for retaining the third ring at one of the plurality of positions in order to provide the desired radial retraction force associated with that position. The retaining means may comprise a fourth ring adapted to interlock with the third ring to fix the sheath at the desired position. The retaining means may include a wedge disposed between the third ring and the fourth ring.
- In yet another aspect of the invention, the hand access system may further comprise an adapter having a first adapter cavity for releasably attaching to a ring of the retractor sheath and a second adapter cavity for releasably attaching to the hand seal. The first adapter cavity has a first diameter and the second adapter cavity has a second diameter.
- In other aspects of the invention, the hand seal may include a cavity to receive the second ring of the sheath retractor, the hand seal may further comprise a latch on an inner diameter for latching the third ring, and the third ring may comprise at least a hook to latch the hand seal as the hand seal is attached to the sheath retractor. To facilitate sealing of the peritoneum, a conformable gasket may be provided that may be attached to the first ring or to the sheath of the sheath retractor, or the conformable gasket may float unattached to the sheath and interiorly of the wound.
- In another aspect of the invention, the hand access system may comprise a detachable iris seal in place of the hand seal that is adapted to be attached and detached from the sheath retractor. The iris seal comprises a first iris ring, a second iris ring coaxially attached to the first iris ring, and a cylindrical elastic member connected to the first and second iris rings and having an opening. With this aspect, the first and second iris rings operate to rotate relative to one another in either direction to open or close the opening of the cylindrical elastic member. More specifically, the first and second iris rings may be rotated in opposite directions to create an airtight constriction in the middle of the elastic member. After rotation, at least one of the first and second iris rings may be de-rotated to loosen or enlarge the constriction of the elastic member.
- Each of the iris rings may comprise a plurality of tracks to allow the iris rings to be relatively rotated at predetermined angles. In yet another aspect, the iris seal may further comprise a spring connecting the first and second iris rings to further facilitate a complete opening, a partial constriction or an airtight constriction of the opening of the elastic member. The spring operates to automatically pull and rotate the iris rings after de-rotation. In particular, as an object is withdrawn from the iris seal, the spring contracts and causes the sheath constriction to tighten automatically. The spring may be formed from an elastomeric material. It is appreciated that the amount the spring stretches and contracts is determined by the length of the spring. Each of the iris springs may comprise a hollow frame and a plurality of interlocking tracks. The interlocking tracks operate to encase the spring to prevent the spring from crossing into an instrument or hand passage area within the iris rings. The interlocking tracks also operate to open and close the seal at predetermined angles.
- In another aspect of the invention, there is disclosed a surgical access device adapted for disposition relative to an incision in a patient comprising a valve including a plurality of overlapping sheets defining an access channel, and a ring having an inner diameter for holding the valve by fixing each of the overlapping sheets along a portion of the perimeter, the access channel extends into communication with the incision in the patient. With this aspect, each of the overlapping sheets includes a portion of the perimeter that is not fixed to the inner diameter of the ring. It is appreciated that the non-fixed portions provide open edges defining the access channel. In one aspect, the open edges slightly overlap for about 0.25″ at the center of the ring. The hand access device may further comprise a septum seal formed at the proximal end and at the distal end of the ring, the septum seal having a hole formed at the center of the seal. It is further appreciated that the open edges of the non-fixed portions may have different shapes including at least one of a straight edge, concave, convex and a cross-configuration.
- In yet another aspect of the invention, there is disclosed a surgical access device adapted for disposition relative to an incision in a patient comprising a plurality of septum layers each having a hole at the center of the septum layer and a first diameter, a ball sandwiched between the septum layers and having a second diameter greater than the first diameter, and a ring having an inner diameter for affixing the plurality of septum layers along the perimeter. In another aspect, a surgical access device facilitating a sealing relationship with an instrument or an arm of a surgeon extending through the device and into an incision in a patient is disclosed, the access device comprising a valve structure including a plurality of overlapping sheets defining an access channel, the valve in a first state forming a zero seal in the absence of the instrument or the arm of the surgeon extending through the valve structure, the valve in a second state forming an instrument seal in the presence of the instrument or the arm of the surgeon extending through the valve structure, and the access channel extends into communication with the incision in the patient.
- These and other features of the invention will become more apparent with a discussion of the various embodiments in reference to the associated drawings.
- The accompanying drawings, which are included in and constitute a part of this specification, illustrate the embodiments of the invention and, together with the description, explain the features and principles of the invention. In the drawings:
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FIG. 1 is a perspective view showing a patient prone on an operating table with his abdomen insufflated and with instrument access provided by trocar and the access device of the present invention; -
FIGS. 2A and 2B illustrate a perspective view and a cross-sectional view, respectively, of a hand access system in accordance with a first embodiment of the invention; -
FIGS. 3A-3E illustrate axial perspective views and cross-sectional views of a hand access system in accordance with another embodiment of the invention including a one-way mechanism; -
FIGS. 4A and 4B illustrate cross-sectional views of a hand access system in accordance with another embodiment of the invention including an adapter; -
FIGS. 5A-5C illustrate an axial perspective view and cross-sectional views of a hand access system in accordance with another embodiment of the invention including a conformable gasket; -
FIG. 6 illustrates a cross-sectional view of a hand access system in accordance with another embodiment of the invention including an iris seal; -
FIGS. 7A-7E illustrate the rotation of the iris seal rings of the invention to create an airtight constriction in the middle of the sheath; -
FIGS. 8A-8C illustrate side views of another embodiment of the iris seal including a spring connecting the two rings; -
FIG. 9 illustrates a top view ofFIG. 8B ; -
FIGS. 10 and 11 illustrate perspective and top views of rings of an iris seal having interlocking tracks in accordance with another embodiment of the invention; -
FIG. 12 illustrates a perspective view of a hand-assisted laparoscopic seal formed by overlapping sheets of elastomeric material in accordance with another embodiment of the invention; -
FIG. 13 illustrates a perspective view of a hand-assisted laparoscopic seal formed by differently shaped overlapping sheets of elastomeric material in accordance with another embodiment of the invention; -
FIGS. 14 and 15 illustrate perspective views of a hand-assisted laparoscopic seal formed by overlapping sheets of elastomeric material having concave and convex configurations; -
FIG. 16 illustrates a perspective view of a hand-assisted laparoscopic seal formed by overlapping sheets of elastomeric material including a central patch supported by spokes in accordance with another embodiment of the invention; and -
FIG. 17 illustrates a perspective view of a hand-assisted laparoscopic seal formed by two septum layers sandwiching a ball in accordance with another embodiment of the invention. - Referring to
FIG. 1 , there is shown a typical abdominal surgery on a patient 10 in a prone position on an operating table 12.FIG. 1 further illustrates a surgeon having an arm 16 and ahand 17 performing the surgery. In the illustrated example, the operative procedure is performed within anabdominal cavity 18 with instrument access provided through anabdominal wall 21. In this type of operation, commonly referred to as laparoscopic surgery,trocars 23 and 25 are commonly used to provide minimally invasive access through theabdominal wall 21 for instruments such as agrasper 27 and anendoscope 30. In addition, it is desirable that the surgeon be able to insert his/herhand 17 through theabdominal wall 21 and into theabdominal cavity 18. The insertion of thehand 17 provides the surgeon with direct access to various elements of the anatomy. - In order to accommodate the
hand 17 and arm 16 of the surgeon, asmall incision 32 is typically created in theabdominal wall 21. Anaccess device 34 of the present invention can be provided to further facilitate this access by thehand 17 of the surgeon. Particularly in the case of laparoscopic surgery, it is advantageous to insufflate theabdominal cavity 18 with a gas, such as carbon dioxide, in order to elevate theabdominal wall 21 and thereby increase the volume of the working space within thecavity 18. Maintenance of this insufflation pressure, commonly referred to as pneumoperitoneum, is particularly difficult where access is desired across theabdominal wall 21, for example, through thetrocars 23, 25, as well as theaccess device 34. For this reason, a substantial effort has been directed to providing such access devices with sealing characteristics both in the presence of instruments and in the absence of instruments, such as thegrasper 27,scope 30 andhand 17. - Were it not for the desire to maintain the pneumoperitoneum, there would be no need for the
trocars 23, 25 or theaccess device 34. That is, one would merely cut an incision in theabdominal wall 21 and insert the instrument directly through the incision. However, without appropriate valves or seals, the insufflation gases would merely escape through theincision 32. This would be particularly detrimental in the case of theincision 32 which must be sufficiently large to accept thehand 17 of the surgeon. Thus, theaccess device 34 operates to form with theincision 32 to provide an access or working channel, and to provide a valve or other sealing structure across the working channel in order to maintain the pneumoperitoneum. - Referring to
FIGS. 2A and 2B , there are shown a perspective view and a cross-sectional view, respectively, of ahand access system 100 of the invention. Thehand access system 100 provides hand access to a surgical area such as theabdominal cavity 18 while maintaining pneumoperitoneum during laparoscopic surgery. Thehand access system 100 comprises asheath retractor 110 including aperitoneal ring 112, aproximal ring 114, and a sheath 116 extending along anaxis 117 connecting theperitoneal ring 112 and theproximal ring 114. The sheath 116 has a generally cylindrical configuration that may be retracted to protect an incision within a body cavity such as theabdominal wall 21. Theperitoneal ring 112 andproximal ring 114 are disposed in respective planes which extend radially of theaxis 117. Thehand access system 100 further comprises adetachable hand seal 120 that is operably attachable and detachable to theproximal ring 114 of thesheath retractor 110 as illustrated inFIG. 2B to permit insufflation. It is appreciated that thehand seal 120 can be separated from thesheath retractor 110 to allow removal of large organs or to provide open access to theabdominal cavity 18. Stated another way, thehand seal 120 can be removed at any time to allow conversion from laparoscopic surgery to open surgery. - It is further appreciated that wound retraction in accordance with the present invention allows a surgeon to easily locate the
sheath retractor 110 and to provide a base for thehand seal 120. Thesheath retractor 110 operates to remove the tissue pressure from the wrist during hand-assisted laparoscopic surgery. Thesheath retractor 110 further protects tissue at the wound site, for example, from abrasion, bacteria or other contaminated organs, such as donor kidneys to be removed with minimal risk or damage. Thesheath retractor 110 also opens the wound providing greater access to the operative site for instruments, such as the hand of the surgeon. In particular, thesheath protector 110 includes the sheath 116 having elastomeric properties that separate the tworings peritoneal ring 112 is placed interiorly of theabdominal wall 21 and theproximal ring 114 is placed exteriorly of theabdominal wall 21 and is then stretched beyond its natural state. The diameters of therings rings rings - Referring to
FIGS. 3A and 3B , there are shown perspective views of a hand access system 100 b where elements of structure similar to those previously described are designated by the same reference numeral followed by the lower case letter “b” in accordance with another embodiment of the invention. The sheath retractor 110 b comprises a peritoneal ring 112 b, a proximal ring 114 b, a sheath 116 b extending along an axis 117 b connecting the peritoneal ring 112 b and the proximal ring 114 b, and a one-way mechanism 118 b (a cylindrical plug) that is placed to extend above the incision. More specifically, the one-way mechanism 118 b is placed between the peritoneal ring 112 b and the proximal ring 114 b. The hand access system 100 b further comprises a “plug” hand seal 120 b that is operably attached to the proximal ring 114 b of the sheath retractor 110 b. The hand seal 120 b can be made of a soft gel material including a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of an instrument or hand. The gel material includes, for example, a thermoplastic base such as Kraton® and an oil. The resulting elastomer has excellent tear strength, elongation greater than 1,000 percent, a very low durometer or hardness, and biocompatibility. - Referring to
FIGS. 3C-3E , there are shown axial perspective views of an exemplary embodiment of the one-way mechanism 118 b of the invention. Specifically, the one-way mechanism 118 b comprises two complimentary interlocking rings 83 and 90. The proximal ring 114 b can be disposed outwardly of the sheath 116 b and the lockingring 90 can be disposed inwardly of the sheath 116 b. These tworings 114 b and 90 function to clamp the sheath 116 b so that thering 83 is maintained in a fixed position by the lockingring 90. The interlocking rings 83, 90 ofFIG. 3C provide for simple operation of the sheath retractor 110 b. These interlocking rings 83, 90 can be pushed down so that they rest on the outer surface of theabdominal wall 21. As the sheath 116 b is drawn upwardly to achieve the proper degree of tension, it is easily moved between the interlocking rings 83, 90. However, any tendency of this sheath 116 b to move back into the wound site will tighten the interlocking relationship of therings ring 90 from thering 83. - The one-way characteristics of the interlocking rings 83, 90 are further illustrated in the progressive views of
FIGS. 3D and 3E . With reference to these figures, it can be seen that retraction is maintained by preventing the sheath 116 b from pulling back into the wound by means of the one-way operation of the interlocking rings 83, 90. The sheath 116 b slides easily through the interlocking rings 83, 90 in the upper direction, but is prevented from sliding through therings rings ring 83 to be removed from the sheath 116 b in order to remove the retractor 116 b from the wound site. - In another aspect of the invention,
FIGS. 4A and 4B illustrate axial perspective views of a hand access system 100 c comprising a sheath retractor 110 c, anadapter 140 and a detachable hand seal 120 c. The sheath retractor 110 c includes a peritoneal ring 112 c, a proximal ring 114 c, and a sheath 116 c extending along an axis 117 c connecting the peritoneal ring 112 c and the proximal ring 114 c. Theadapter 140 comprises a first orlower ring 142 for attaching to the proximal ring 114 c of the sheath retractor 110 c, and a second orupper ring 144 for attaching to the detachable hand seal 120 c.FIG. 4B illustrates the hand access system 100 c with the sheath retractor 110 c, theadapter 140 and the hand seal 120 c installed. More specifically, theadapter 140 is first attached to the proximal ring 114 c of the sheath retractor 110 c. In turn, the hand seal 120 c may be attached and detached from theupper ring 144 of theadapter 140 as needed. - It is appreciated that the proximal ring 114 c may further include a movable ring, which together with the proximal ring 114 c, may be used to press down on the
adapter 140 against the abdomen, for example, to secure it and form an airtight connection. It is further appreciated that theupper ring 144 may have a diameter that is greater than, equal to or less than the diameter of thelower ring 142. In another aspect of the invention, theadapter 140 may further comprise grooves to snap in a self-closing iris seal to gain pneumoperitoneum. -
FIGS. 5A-5C illustrate perspective and cross-sectional views of ahand access system 100 d in accordance with yet another embodiment of the invention where elements of structure similar to those previously described are designated by the same reference numeral followed by the lower case letter “d”. Thehand access system 100 d comprises asheath retractor 110 d and ahand seal 120 d operably attached to thesheath retractor 110 d. Thesheath retractor 110 d includes aperitoneal ring 112 d, aproximal ring 114 d, a sheath (not shown) connecting theperitoneal ring 112 d and theproximal ring 114 d, and a one-way mechanism 118 d comprising a plurality of interlocking rings 83 d, 90 d. Thehand seal 120 d operably attaches to theproximal ring 114 d of thesheath retractor 110 d. Thehand seal 120 d may be formed of a soft gel material and includes a small slit to allow passage of a hand or a surgical instrument during surgery. Referring toFIG. 5B , there is shown a cross-sectional view of thehand seal 120 d having acavity 125 d inside the gel to receive theproximal ring 114 d of thesheath retractor 110 d. Referring toFIG. 5C , thehand seal 120 d may further comprise alatch 121 d on an inner diameter for latching the one-way mechanism 118 d. The access sheath material may be placed inside or outside of thehand seal 120 d after attachment of thehand seal 120 d and theseal retractor 110 d. - In another aspect, the one-way mechanism 118 d may include hooks to latch the
hand seal 120 d as theseal 120 d is pressed down on the open end of the sheath. As explained above, thehand seal 120 d includes a small slit in the gel that will not allow air to pass with the absence of an instrument or hand, but the slit will stretch and the gel will compress to allow objects to pass through with little loss of pneumoperitoneum. Compression of the gel onto theproximal ring 114 d of thesheath retractor 110 d creates an airtight connection. Thesheath retractor 110 d, as illustrated inFIG. 5A , may further include a conformable gasket 123 d to facilitate sealing of the peritoneum. The conformable gasket 123 d on the peritoneum ensures an airtight seal inside the incision as opposed to outside the incision. The gasket 123 d can be attached to theperitoneal ring 112 d or the sheath 116 d, or it can float unattached to the sheath. The floating gasket 123 d is less likely to crease or bunch (a path for air leaks) as theabdominal wall 21, sheath 116 d andperitoneal ring 112 d distort as the sheath 116 d is pulled up into the incision. Without the need for sealing externally on the skin surface, the conformable gasket 123 d is not susceptible to air leaks from irregularities on the skin, such as scars or folds. Furthermore, the conformable gasket 123 d protects theabdominal wall 21 from potential traumatic pressure or abrasion by theperitoneal ring 112 d. - In all of the above embodiments of the invention, the ability to attach and detach the hand seal from the sheath retractor allows larger objects to pass unfettered through the incision. In addition, the invention is easy to use, it provides increased comfort for the surgeon, and is less traumatic to tissue being passed through the incision. For example, the latching or interlocking feature of the hand seal and the adapter with the sheath retractor makes it fast and simple to use compared to other methods that may involve inflatable cuffs or adhesives. Adhesives often require time to cure and inflation with pumps also creates delay.
- In another aspect of the invention, the hand access system may comprise a sheath retractor and an iris seal directly connected to the sheath retractor to form a continuous, seamless sheath. Referring to
FIG. 6 , there is shown a hand access system in accordance with another embodiment of the invention including aniris seal 200. Theiris seal 200 comprises afirst ring 202, asecond ring 204 coaxially attachable to thefirst ring 202, and a cylindricalelastic member 206 connected to the first andsecond rings second rings elastic member 206. In particular, theseal 200 operates like the iris aperture of a camera, except that theiris seal 200 is made of a thin film sheath orelastic member 206. Aring elastic sheath 206. Referring toFIGS. 7A-7C , therings elastic member 206. The constriction is maintained as long as the rotation is not undone (termed de-rotation). The sheath orelastic member 206 can be made of an elastic material, which allows objects small in diameter relative to therings FIG. 7D . Once an object is withdrawn, therings FIG. 7E . In another aspect, therings tracks 207 such that they may be relatively rotated to open or close the opening at predetermined angles as further discussed below and illustrated inFIG. 10 . More specifically, the sectional area of the opening changes in response to the predetermined angle rotation of the rings. - Referring back to
FIG. 6 , theiris seal 200 may be attached to asheath retractor 110 f having a peritoneal ring 112 f, a proximal ring 114 f, a sheath 116 f connecting the peritoneal ring 112 f and the proximal ring 114 f, and a one-way mechanism 118 f (comprising a plurality of interlocking rings 83 f, 90 f). A feature of theiris seal 200 is its constriction can be dilated as wide as the retracted incision and, as such, it may not be necessary for it to be detached from thesheath retractor 110 f. In this case, theiris seal 200 can be made a permanent part of one of the interlocking rings of the one-way mechanism 118 f. Thus, the self-closingiris seal 200 andsheath retractor 110 f combination allows pneumoperitoneum to be regained more quickly without having to detach and reattach a seal as with previous methods. In another aspect, an iris seal can be easily removed when constructed as part of a two-ring design in the form of a wedge clamp similar to that shown inFIGS. 3C-3E . Pulling up on a sheath pushes or un-wedges the seal out of the sheath retractor. - It is appreciated that other hand seals can be used and interchanged as contemplated by the concept of the invention. For example, the iris seal of the invention may further include a
spring 208 connecting the first andsecond rings elastic member 206. More particularly, one ormore springs 208 may be used to connect the first andsecond rings FIGS. 8A-8C , there are shown perspective views of the iris seal 200 c of the invention further comprising thespring 208 connecting the first andsecond rings 202 c, 204 c.FIG. 9 is a top view of the iris seal 200 c ofFIG. 8B . - As illustrated in
FIGS. 8 and 9 , as therings 202 c, 204 c are rotated relative to one another, thespring 208 expands and contracts causing opening and constriction of the seal. More specifically, thespring 208 can be used to pull and rotate therings 202 c, 204 c automatically after de-rotation, for example. The ends of thespring 208 are connected to therings 202 c, 204 c in a manner such that de-rotation causes thespring 208 to stretch as illustrated inFIGS. 8A and 8B . Afterwards, thespring 208 contracts and causes the sheath constriction to tighten automatically as large objects are withdrawn (FIG. 8C ). The amount thespring 208 stretches and contracts is determined by the length of thespring 208—typically larger objects require longer springs. Longer springs, however, may crossover the area within therings 202 c, 204 c and interfere with the passage of objects as illustrated inFIG. 9 . To limit interference and to accommodate large objects, longer springs can be housed partially within a series of interlockingtracks 207 of hollow frame rings 202 d, 204 d as illustrated inFIGS. 10 and 11 . In particular, the interlockingtracks 207 on the rings can encase longer springs so they do not cross into the passage area. The interlocking tracks 207 also operate to open and close the seal at predetermined angles.FIG. 11A illustrates an axial cross-sectional view of the seal with the springs contracted and the iris closed, andFIG. 11B illustrates an axial cross-sectional view of the seal with the springs expanded and the iris opened. - An advantage of rotational adjustment, versus fixed rings, is that a wider range of object sizes can easily pass through the iris seal. A self-closing mechanism of the invention has the advantage of hands-free adjustment. In comparison to other self-closing methods that involve gears and springs that are connected to stationary components external to the iris seal, the spring(s) of the present invention are connected to and contained within the rings, which are integral to the iris seal. With the self-closing mechanism built in, the iris seal is portable and can be more easily adapted to a wide range of access ports, wound retractors and the like.
- In another aspect of the invention, a hand-assisted
laparoscopy seal 300 is formed by overlappingseveral sheets FIG. 12 . Each of thesesheets portion 302 a, 304 a, 306 a, 308 a, 310 a, 312 a of its perimeter fixed to the ring and aportion 302 b, 304 b, 306 b, 308 b, 310 b, 312 b not fixed to the ring. These non-fixed portions 302 b-312 b provide open edges within the area of the ring. The sheets 302-312 are laid on top of one another and are rotated so that open edges extend along different planes. These open edges slightly overlap, such as approximately one-quarter inch, at the center of the ring to prevent leakage of the insufflation gas. During operation, an instrument or hand of the surgeon is introduced through the center of the ring forcing the open edges to part, but also causing the open edges to form a sealing structure around the forearm or wrist. - It is appreciated that in the above aspect, the overlapping
sheets FIG. 13 , there is shown another aspect of the invention where the open edges 404 b, 406 b, 408 b, 410 b have different shapes, which when laid on top of one another, tend to form overlapping sections of a circle. It is appreciated that the concept of the invention contemplates any number of overlapping sheets of any material and of any shape. In one simple embodiment, for example, the invention contemplates two semi-circular sheets having slightly straight overlapping edges. - In another aspect,
FIGS. 14 and 15 show how the open edges can be provided with concave or convex configurations. The sheets or layers having convexopen edges 506, 510, 608, 610 tend to flex more while the sheets or layers havingconcave edges FIG. 16 where one of the layers includes acentral patch 704 supported byspokes central patch 704 is large enough to cover the hole 702 a in theseptum layer 702. In the embodiment ofFIG. 17 , two septum layers 802, 806 sandwich a ball 804 which is movable within the confines of the ring. The ball 804 has a diameter greater than the holes 802 a, 806 a in the septum layers 802, 806, respectively. - It will be understood that many other modifications can be made to the various disclosed embodiments without departing from the spirit and scope of the invention. For these reasons, the above description should not be construed as limiting the invention, but should be interpreted as merely exemplary of the disclosed embodiments.
Claims (57)
1. A hand access system, comprising:
a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor comprising
a first ring being adapted for disposition interiorly of the wound;
a second ring being adapted for disposition exteriorly of the wound; and
a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound; and
a detachable hand seal adapted to be attached and detached from the second ring of the sheath retractor.
2. The hand access system of claim 1 , wherein the hand seal can be detached from the sheath retractor to convert the hand access system from laparoscopic surgery to open surgery.
3. The hand access system of claim 1 , wherein at least one of the first ring, the second ring and the sheath is formed from an elastomeric material.
4. The hand access system of claim 1 , wherein the hand seal is formed of a gel material and includes a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of an instrument or hand.
5. The hand access system of claim 1 , wherein the first ring has a first diameter and the second ring has a second diameter, and the first and second diameters are greater than the desired diameter of the wound.
6. The hand access system of claim 1 , wherein the sheath retractor further comprises a third ring disposed circumferentially of the sheath and moveable between a plurality of positions between the first ring and the second ring, each of the positions being associated with a different retraction force, the third ring being adapted for disposition exteriorly of the wound.
7. The hand access system of claim 6 , wherein the sheath retractor further comprises means for retaining the third ring at one of the plurality of positions in order to provide the desired radial retraction force associated with that position.
8. The hand access system of claim 7 , wherein the retaining means comprises a fourth ring adapted to interlock with the third ring to fix the sheath at the desired position.
9. The hand access system of claim 8 , wherein the retaining means further comprises a wedge disposed between the third ring and the fourth ring.
10. The hand access system of claim 1 , further comprising an adapter having a first adapter cavity for releasably attaching to the ring of the retractor sheath and a second adapter cavity for releasably attaching to the hand seal.
11. The hand access system of claim 10 , wherein the first adapter cavity has a first diameter and the second adapter cavity has a second diameter less than or equal to the first diameter.
12. The hand access system of claim 1 , wherein the hand seal includes a cavity to receive the second ring of the sheath retractor after installation of the hand seal.
13. The hand access system of claim 6 , wherein the hand seal further comprises a latch on an inner diameter for latching the third ring.
14. The hand access system of claim 13 , wherein the access sheath may be placed inside or outside of the hand seal after attachment of the hand seal and the seal retractor.
15. The hand access system of claim 6 , wherein the third ring comprises at least one hook to latch the hand seal as the hand seal is attached to the sheath retractor.
16. The hand access system of claim 1 , further comprising a conformable gasket to facilitate sealing of the peritoneum.
17. The hand access system of claim 16 , wherein the conformable gasket is attached to the first ring or to the sheath of the sheath retractor.
18. The hand access system of claim 16 , wherein the conformable gasket floats unattached to the sheath and interiorly of the wound.
19. A hand access system, comprising:
a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor comprising
a first ring being adapted for disposition interiorly of the wound;
a second ring being adapted for disposition exteriorly of the wound; and
a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound; and
an iris seal adapted to be attached and detached from the sheath retractor.
20. The hand access system in claim 19 , wherein the iris seal comprises:
a first iris ring;
a second iris ring coaxially attached to the first iris ring; and
a cylindrical elastic member connected to the first and second iris rings and having an opening,
wherein the first and second iris rings operate to rotate relative to one another in either direction to open or close the opening of the cylindrical elastic member.
21. The hand access system in claim 20 , wherein the first and second iris rings are rotated in opposite directions to create an airtight constriction in the middle of the elastic member.
22. The hand access system in claim 21 , wherein at least one of the first and second iris rings is de-rotated to loosen or enlarge the constriction of the elastic member.
23. The hand access system in claim 21 , wherein each of the iris rings comprises a plurality of tracks to allow the iris rings to be relatively rotated at predetermined angles.
24. The hand access system in claim 20 , wherein the sheath retractor further comprises a third ring disposed circumferentially of the sheath and moveable between a plurality of positions between the first ring and the second ring, each of the positions being associated with a different retraction force, the third ring being adapted for disposition exteriorly of the wound.
25. The hand access system in claim 24 , wherein the sheath retractor further comprises means for retaining the third ring at one of the plurality of positions in order to provide the desired radial retraction force associated with that position.
26. The hand access system in claim 25 , wherein the retaining means comprises a fourth ring adapted to interlock with the third ring to fix the sheath at the desired position.
27. The hand access system in claim 26 , wherein the retaining means further comprises a wedge disposed between the third ring and the fourth ring.
28. The hand access system in claim 24 , wherein the third ring comprises at least one hook to latch the hand seal as the hand seal is attached to the sheath retractor.
29. The hand access system in claim 20 , further comprising a spring connecting the first and second iris rings to further facilitate a complete opening, a partial constriction or an airtight constriction of the opening of the elastic member.
30. The hand access system in claim 29 , wherein the spring automatically pulls and rotates the iris rings after de-rotation.
31. The hand access system in claim 29 , wherein the spring is formed from an elastomeric material.
32. The hand access system in claim 29 , wherein as an object is withdrawn from the iris seal, the spring contracts and causes the sheath constriction to tighten automatically.
33. The hand access system in claim 29 , wherein the amount the spring stretches and contracts is determined by the length of the spring.
34. The hand access system in claim 29 , wherein each of the iris springs comprises a hollow frame and a plurality of interlocking tracks.
35. The hand access system in claim 34 , wherein the interlocking tracks operate to encase the spring to prevent the spring from crossing into an instrument or hand passage area within the iris rings.
36. The hand access system in claim 35 , wherein the interlocking tracks operate to open and close the seal at predetermined angles.
37. A surgical access device adapted for disposition relative to an incision in a patient, comprising:
a valve including a plurality of overlapping sheets defining an access channel; and
a ring having an inner diameter for holding the valve by fixing each of the overlapping sheets along a portion of the perimeter,
wherein the access channel extends into communication with the incision in the patient.
38. The hand access device in claim 37 , wherein each of the overlapping sheets includes a portion of the perimeter that is not fixed to the inner diameter of the ring.
39. The hand access device in claim 38 , wherein the non-fixed portions provide open edges defining the access channel.
40. The hand access device in claim 39 , wherein the open edges slightly overlap at the center of the ring.
41. The hand access device in claim 40 , wherein the overlap is about 0.25″.
42. The hand access device in claim 37 , further comprising a septum seal formed at the proximal end of the ring and having a hole at the center of the seal.
43. The hand access device in claim 42 , further comprising a second septum seal formed at the distal end of the ring and having a hole at the center of the second septum seal.
44. The hand access device in claim 39 , wherein the open edges of the non-fixed portions may have different shapes including at least one of a straight edge, concave, convex, and a cross-configuration.
45. A surgical access device adapted for disposition relative to an incision in a patient, comprising:
a plurality of septum layers each having a hole at the center of the septum layer and a first diameter;
a ball sandwiched between the septum layers and having a second diameter greater than the first diameter; and
a ring having an inner diameter for affixing the plurality of septum layers along the perimeter.
46. A surgical access device facilitating a sealing relationship with an instrument or an arm of a surgeon extending through the device and into an incision in a patient, the access device comprising:
a valve structure including a plurality of overlapping sheets defining an access channel,
the valve in a first state forming a zero seal in the absence of the instrument or the arm of the surgeon extending through the valve structure,
the valve in a second state forming an instrument seal in the presence of the instrument or the arm of the surgeon extending through the valve structure, and
the access channel extends into communication with the incision in the patient.
47. The hand access device in claim 46 , further comprising a rigid or semi-rigid ring having an inner diameter for holding the valve structure by fixing each of the overlapping sheets along a portion of the perimeter.
48. The hand access device in claim 46 , wherein the zero seal and the instrument seal have properties for inhibiting the escape of liquids and gases through the valve structure.
49. The hand access device in claim 46 , wherein each of the overlapping sheets includes a portion the perimeter that is not fixed to the inner diameter of the ring.
50. The hand access device in claim 49 , wherein the non-fixed portions provide open edges defining the access channel.
51. The hand access device in claim 50 , wherein the open edges slightly overlap at the center of the ring.
52. The hand access device in claim 47 , further comprising a septum seal formed at the proximal end of the ring and having a hole at the center of the seal.
53. The hand access device in claim 52 , further comprising a second septum seal formed at the distal end of the ring and having a hole at the center of the second septum seal.
54. The hand access device in claim 50 , wherein the open edges of the non-fixed portions may have different shapes including at least one of a straight edge, concave, convex, and a cross-configuration.
55. A surgical access system facilitating a sealing relationship with a robotic device or an arm of surgeon extending through the access system and into an incision in a patient, comprising:
a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor comprising
a first ring being adapted for disposition interiorly of the wound;
a second ring being adapted for disposition exteriorly of the wound; and
a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound; and
a detachable instrument seal adapted to be attached and detached from the second ring of the sheath retractor.
56. The surgical access system of claim 55 , wherein at least one of the first ring, the second ring and the sheath is formed from an elastomeric material.
57. The surgical access system of claim 55 , wherein the instrument seal is formed of a gel material and includes a slit providing an instrument seal in the presence of the robotic device or hand and a zero seal in the absence of the robotic device or hand.
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US13/105,179 US8932214B2 (en) | 2003-02-25 | 2011-05-11 | Surgical access system |
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PCT/US2004/005361 WO2004075930A2 (en) | 2003-02-25 | 2004-02-24 | Apparatus and method for illuminating a peritoneal cavity during laparoscopic surgery |
PCT/US2004/005487 WO2004075741A2 (en) | 2003-02-25 | 2004-02-25 | Wound retractor for use in hand assisted laparoscopic surgery |
PCT/US2004/005484 WO2004075730A2 (en) | 2003-02-25 | 2004-02-25 | Sealed surgical access device |
US10/927,551 US20050020884A1 (en) | 2003-02-25 | 2004-08-25 | Surgical access system |
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Also Published As
Publication number | Publication date |
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US8932214B2 (en) | 2015-01-13 |
US20110282157A1 (en) | 2011-11-17 |
US7951076B2 (en) | 2011-05-31 |
US20060084842A1 (en) | 2006-04-20 |
US20150173736A1 (en) | 2015-06-25 |
US9295459B2 (en) | 2016-03-29 |
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