US 20050051597 A1
A improved flexible annular stapler for joining annular organs (163, 164) is disclosed. The novel stapler features greater accuracy of operation and better control by the operator, as well as additional functions, such as internal illumination (76) and viewing facility (82), and accommodation of a large number of accessories, such as fibroscopes (90) and catheters. The novel stapler features easy attachability of both stapling jaws (18, 25) and easy detachability of the head (11). The novel features of the flexible stapler, and associated methods performed thereby, are particularly useful for closed surgery.
1. A flexible annular surgical stapler for stapling together two parts of hollow organs, the stapler comprising
(a) an elongated flexible tubular body having two ends;
(b) a handle attached to a first end of said body;
(c) a first jaw having an axial jaw hole therethrough and two faces, a first of said faces being attached to the second end of said body;
(c) a flexible cable slidably disposed inside said body and through said jaw hole, said cable consisting of two portions, a first of said portions defining an end segment, at least part of which protrudes from the second of said faces of said first jaw; and
(d) a second jaw, forming a head, being attachable to said end segment;
said jaw hole having a non-circular cross-sectional shape and said end segment having a complementary cross-sectional shape such as to allow easy sliding of said end segment through said hole while keeping their mutual angular orientation about the axis of said hole fixed;
wherein one of said first and second jaws includes a hammer and the other of said first and second jaws includes an anvil.
2. The stapler of
3. The stapler of
4. The stapler of
5. The stapler of
(i) a housing attached to the second end of said body,
(ii) an elongated externally threaded member disposed inside said housing and attached to the second portion of said cable,
(iii) a turning assembly, which includes an internally threaded member that engages said externally threaded member, and a knob outside said housing, and
(iv) a lever assembly, which includes a manually pressable lever;
said turning assembly being operative, upon turning of the knob, to cause said cable to slide along said body, and
said lever assembly being operative to keep said turning assembly at a fixed axial position relative to said housing, when said lever is not being pressed, and to pull said turning assembly axially away from said body, when said lever is being pressed.
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10. A flexible annular surgical stapler for stapling together two parts of hollow organs, the stapler comprising
(a) an elongated flexible tubular body having two ends;
(b) a handle attached to a first end of said body;
(c) a flexible cable slidably disposed inside said body having two ends, a first end being inside said handle; and
(d) a head attached to the second end of said cable and including an end cap;
said cable having, over its entire length, a passageway therethrough for insertion of one or more additional tools or parts thereof.
11. The stapler of
12. The stapler of
13. The stapler of
14. The stapler of
15. The stapler of
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17. The stapler of
18. The stapler of
19. The stapler of
20. The stapler of
21. The stapler of
22. The stapler of
23. A method for joining two parts of hollow organs over an annular area defined on a plane in each of the two parts, whereby each part has an opening through the respective plane essentially inside the respective annular area, the method sequentially comprising the steps of
(a) providing a flexible annular stapler having two round jaws;
(b) inserting said jaws into a first one of the two parts and advancing said jaws to where one jaw is inside the first part and the other jaw is inside the second one of the two parts, each jaw being substantially near the respective plane;
(c) for each of the two parts, shrinking the opening so as to form an at least partially closed butt that encloses the respective one of said jaws; and
(d) operating said annular stapler so as to pull the two said butts together and essentially combine the two annular areas into a combined annular area, to staple the two organs or segments to each other over said combined annular area and to cut away portions of said butts that are central to said combined annular area.
24. The method of
25. The method of
26. The method of claim-23, wherein any of steps (b) through (d) are carried out under conditions of closed surgery.
27. The method of
28. A method for joining two parts of hollow organs over an annular area defined on a plane in each of said two organs or segments, the method comprising the steps of
(a) providing a flexible annular stapler having a flexible body, two round jaws and a flexible cable slidable through said body and through a first one of said jaws and having an end protrudable from said first jaw, said second one of said jaws being attachable to said end of said cable, said second jaw being initially detached;
(b) inserting said first one of said jaws into a first one of the two parts of hollow organs, advancing said first jaw to where it is inside the first part near the respective plane and causing said end of said cable to protrude from said first part;
(c) introducing said second jaw and attaching it to said end of said cable;
(d) having said second jaw inside the second one of the two parts of hollow organs and having each of the two parts form an at least partially closed butt at or near the respective plane, said butt enclosing the respective one of said jaws; and
(e) operating said annular stapler so as to pull said two butts together, to staple the two organs or segments to each other over the annular areas and to cut away portions of said butts that are central to the annular area.
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35. A method for joining two parts of hollow organs over an annular area defined on a plane in each of the two parts, under conditions of closed surgery performed on a patient, the method comprising the steps of
(a) providing a flexible annular stapler having a flexible body, two round jaws and a flexible cable slidable through said body and through a first one of said jaws and having an end protrudable from said first jaw, the first one of said jaws being attachable to said body and the second one of said jaws being attachable to said end of said cable, both of said jaws being initially detached;
(b) inserting said flexible body through the patient's body wall;
(c) introducing said first jaw through the patient's body wall and attaching it to said flexible body;
(d) introducing said second jaw through the patient's body wall and attaching it to said end of said cable;
(e) having said first jaw inside the first one, and said second jaw inside the second one, of the two parts of hollow organs and having each of the two parts form an at least partially closed butt at or near the respective plane, said butt enclosing the respective one of said jaws; and
(f) operating said annular stapler so as to pull said two butts together, to staple the two organs or segments to each other over an annular area and to cut away portions of said butts that are central to said annular area.
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The present invention relates to excision of a section of a hollow or tubular soft organ, such as the digestive tube, and rejoining the remaining ends and, more particularly, to methods for performing these operations under conditions of closed surgery, using a flexible annular stapling and cutting instrument. The invention also relates to an improved construction of such an instrument.
Various ailments of the digestive tube, particularly of the esophagus, the stomach, the small intestines and the colon, such as tumors, chronic inflammation or other disorders, often require excision of a portion of the tube, followed by rejoining of the remaining end segments, through anastomosis to reestablish continuity of the tube. In some cases it is necessary to thus join one organ to another; for example, the cut end of the small intestines may be joined to the colon, or the cut end of the duodenum may be joined to the stomach. In some other cases, two organs or two portions of the same organ may be joined side-to-side (rather than end-to-end or end-to-side, as in the above cases). In the discussion to follow and in the claims, the terms “parts of hollow organs” or just “parts” will be used, for brevity, to collectively denote the two parts to be joined, and the terms “part of a hollow organ” or just “part”—to denote each of the two parts to be joined, whether they are truly two different hollow organs or two segments of the same hollow organ.
It has been common practice since the end of the '50s to use, for the purpose of the anastomosis, a suitable annular stapling and cutting instrument. An example of such an instrument, to be referred to here below as stapler, is depicted in
This, conventional, type of stapler has several shortcomings:
French patent FR 9204490 to the present applicant, which is incorporated into the present disclosure by reference, discloses a novel annular stapler that differs from the one described hereabove essentially in the following (see
This novel stapler avoids the shortcomings of the conventional one, listed hereabove. In particular, it enables reaching any segment of the digestive tube—either through a natural opening (mouth or anus) or through a single, conveniently located cut. It also enables end-to-side or side-to-side joints.
Even so, the novel stapler of French patent FR 9204490 (to be referred to as the French patent) still has a few shortcomings and many as yet unrealized potentialities. One shortcoming is that in the disclosed construction there is an appreciable length of cable between the point at which the cable emerges from the anvil and the point at which it enters the head structure, even when these two components are at their closest approach. This may allow some twist in the cable and consequently some angular misalignment between the staple pins in the head and the grooves in the face of the anvil, which may cause malfunctioning of the stapling action. Likewise, because of uneven back pull of an intestinal butt, the faces of the two components may not be parallel, or may not be axially aligned prior to the stapling action, which, again, could cause malfunction. Another shortcoming of the instrument is in the operation of the handle; turning the knob may not be the optimal way to activate the stapling and cutting operation. Yet another shortcoming is the difficulty with which the head or anvil and are attachable or detachable, making such operations within the body, as would be advantageous in certain procedures, close to impossible.
The unrealized potentialities are mainly associated with a new possible mode of its employment, a mode that was not contemplated in the French patent but is the subject of the present invention, namely closed surgery. The practice and techniques of closed surgery, such as laparoscopy and thoracoscopy, have made tremendous progress over the past five years and many surgical procedures on internal organs are now carried out in this mode. Whereas in conventional, open, surgery, a relatively large incision is made in the abdominal wall or chest, closed surgery is characterized by insertion of very thin tools through otherwise intact walls—usually with the aid of small tubular ports, called trocars, which also serve to seal the openings during operation. Some of these tools serve for viewing and usually include a video system so that the entire operation is viewed and monitored on a video screen. The main advantages of closed surgery are (a) the much reduced trauma, resulting in fewer complications and much faster recuperation, which, in turn, shortens hospitalization and costs, (b) reduced risk of infection and (c) considerable reduction of scars.
Closed surgery of the digestive tube is also being practiced. However, because the only practical instrument now available for anastomosis is the rigid type described hereabove, which has to be operated under open conditions, the surgery ends up being, in part, of the open type (such as laparoscopically assisted surgery) and thus foregoes some of the advantages listed above. Basically, a flexible stapler, as described hereabove and contrary to a conventional, rigid, stapler, lends itself to completely closed surgery (such as laparospcopy and thoracoscopy)., since the instrument is insertable either through the natural openings or through a suitable opening in the intact wall and can reach almost any location. However, such use of a flexible stapler has not yet been attempted nor, to the best of the inventor's knowledge, even been suggested. Moreover, there are certain aspects of this type of surgery that render direct utilization of the instrument, as disclosed in the French patent, difficult or impractical. For example, the preliminary circular sewing of the butt ends over the instrument's head or anvil, difficult even during open surgery, is close to impossible. Under certain circumstances it is preferable to place the active part of the instrument in the affected area prior to excision; it is then difficult to sense its position within the intestines. Also, there is a need for endoscopy during the operation and it may be difficult to insert or manipulate both the endoscope and the flexible stapler simultaneously in the same tube. A similar difficulty holds for internal ultrasonic examination.
Since, as stated, use of a flexible stapler in closed surgery has not yet been attempted and since, moreover, such an instrument is not yet available, there has been no clinical experience with anastomosis in the digestive tube under conditions of closed surgery and certainly no experience using such an instrument. Thus, no suitable procedures have so far been developed, which fact keeps the clinicians and patients from benefiting from the tremendous potential advantages of the technology and also hinders potential acceptance by clinicians of the instruments when they become available.
There is thus a recognized need for, and it would be highly advantageous to have, an improved stapler for anastomosis in the digestive tube that will overcome the shortcomings of presently known instruments and will, moreover, enable such operation under conditions of closed surgery. There is, furthermore, a need for practical methods and procedures for utilizing such an instrument under conditions of closed surgery.
The present invention successfully addresses the shortcomings of the presently known configurations by providing an improved and more practical flexible annular stapler, which is applicable to a wide variety of procedures and surgical conditions, including closed surgery.
More specifically, the stapler of the present invention enables accurate alignment of the head to the anvil during stapling, more convenient activation of the stapling operation itself, possibility of introducing into the stapler, or building into it, various auxiliary tools, such as imagers and catheters, and easy attachability and detachability of the head and of the anvil, all of which are particularly advantageous for operation under conditions of closed surgery.
The present invention discloses a novel construction of a flexible annular stapler with a large number of optional features and attachments. It also discloses novel methods and procedures for using a flexible stapler, in general, and the improved stapler of the present invention in particular, for anastomosis of hollow organs, which methods contribute to more efficient and cleaner operation.
According to the present invention there is provided a flexible annular surgical stapler for stapling together two parts of hollow organs, the stapler comprising
According to further features in preferred embodiments of the invention described below, the end segment of the cable is stiffer than the rest of the cable and may be formed separately.
According to still further features in the described preferred embodiments, the handle includes
According to other features of the invention, the head is attachable to the end segment, and the anvil is attachable to the body, by a snap coupling.
According to yet other features of the invention, the cable has, over its entire length, a passageway therethrough for insertion of one or more additional tools or parts thereof or to pass air or fluid to the end cap or to a balloon attached thereto.
According to another embodiment, the stapler further comprises an ultrasonic transducer for ultrasonically probing tissue near the head, or an illuminator for illuminating tissue near the head, or imaging optics for viewing tissue near the head, the imaging optics including a coherent fibers bundle disposed inside and along a passageway through the cable, or a video camera, for viewing tissue near the head.
Also according to the present invention there is provided a method for joining two parts of hollow organs over an annular area defined on a plane in each of the two parts, whereby each part has an opening through the respective plane essentially inside the respective annular area, the method sequentially comprising the steps of
According to further features of the invention, steps (b) through (d) are carried out under conditions of closed surgery, inserting is effected through a natural opening of the patient's body and shrinking includes, with respect to each of the two parts, pressing the tissue surrounding the opening to form a pair of adjoining lips and stapling the lips together by means of a linear stapler
An alternative method according to the invention, provides for joining two parts of hollow organs over an annular area defined on a plane in each of the two parts, under conditions of closed surgery performed on a patient, the method comprising the steps of
The present invention is of methods and apparatus for performing anastomosis of the digestive tube under closed surgery conditions. Specifically, the present invention includes an improved flexible annular stapler and can be used to conveniently and quickly perform such anastomosis at any location and in conjunction with any of a large variety of surgical procedures, which may include end-to-end, end-to-side and side-to-side joints.
The principles and operation of an improved annular stapler, as well as new surgical methods utilizing it, according to the present invention may be better understood with reference to the drawings and the accompanying description.
Referring now to the drawings,
According to the invention, there is also more freedom in choosing a suitable cross-sectional shape (rather than a circle with a flat, as specified in the French patent) for the end segment, the cable and the hole, namely one that will optimize the stiffness of the end segment (or extension rod), with respect to both bending and twisting, as well as its rotational fixation within the similarly shaped hole in the anvil (and thus—of the head with respect to the anvil). The relative cross-sectional sizes of end segment 83 and hole 34, and thus the fit between them, should preferably be closely controlled, so as to maximally fix their relative angular position, on the one hand, and allow easy sliding, on the other hand. Cable 21 itself preferably has an identical shape, though its fit within the hole need not be as tight. Clearly, during operation, as the head is pulled toward the anvil, the stiff end segment slides through the matching hole in the anvil; their cooperation ensures that the opposing faces of the head and the anvil become essentially parallel and mutually aligned, both laterally and rotationally, while approaching each other. Another advantage of a stiff end segment is that it lends itself better to forming a pointed end for piercing tissue, as is required in certain procedures. It is noted that the stiff end segment (or extension rod) may be hollow, just as the rest of the cable, to form a through passageway.
It is noted that the construction according to the French patent, which serves as the preferred basis for the present invention, calls for an anvil to be part of the mechanical assembly that is attached to the end of the tubular body, while the mechanical assembly that is attached, or attachable, to the end of the cable (or the extension rod), which is referred to as the head, contains, inter alia, a circular knife, a hammer and a cartridge of stapling pins. In the context of the present invention it is equally possible, and may sometimes be preferable, that the anvil be placed in the head and the hammer and stapling pins—in the assembly attached to the body. The knife, moreover, may be independently placed in either one of the two assemblies. Therefore, for the sake of both brevity and generality, the two assemblies will sometimes, when no differentiation is necessary, be referred to as jaws. When differentiation is necessary, the jaw attached to the end of the body will be referred to as anvil and the jaw attached to the end of the cable will be refrred to as the head. The use of the term anvil is based on the examplary configuration for convenience only, with the other configuration (i.e., anvil in the head and hammer and pins in the jaw attached to the body) being understood to also come within the scope of the present invention. Sometimes the term anvil is used to denote the part itself (rather than the jaw), in which case the meaning will be understood from the context.
Referring now to
It is noted that an optional passageway along the instrument is also shown in the French patent, where it, however, serves to supply air to a dilatation balloon at the tip of the head. The passageway according to the present invention must accommodate the optical fiber and may optionally serve for both the fiber and the air supply. According to an alternative embodiment, the optical fiber is replaced by a pair of wires, which are connected inside the head to a lamp and at the handle end—to a voltage source. In another alternative embodiment, shown in
Another possible configuration is shown in
According to an alternative embodiment of the fiber-based imager, the fibers bundle terminates with an objective lens inside the head—similarly to the depiction in
Another alternative embodiment of a flexible stapler with an internal fiber-based imager is shown in
Another configuration of a flexible stapler with an internal imaging facility is shown in
Yet another configuration of the flexible stapler according to the present invention, which allows internal ultrasonic examination, is shown in
A novel configuration for attaching the head to the end of the flexible cable (alternative to the previously disclosed set screw arrangement) is a snap coupling, that is—an arrangement by which the head may be simply pushed onto the end of the cable until a flexible, or spring-loaded, member on the head engages a feature, such as a notch, on the cable and whereby the two parts thereafter remain interlocked until intentionally released. This feature is useful in certain procedures in that it enables easily attaching the head to the cable inside the patient's body, possibly inside the affected organ, and is particularly advantageous for closed surgery, as will be illustrated here below. There are many ways known in the art to realize this configuration. One embodiment, presented here by way of example, is depicted in
In order to unlock and release the cable from the head, there is provided, in the exemplary embodiment shown and as depicted in the cross-sectional view in
A snap coupling configuration is also possible for the attachment of the anvil to the body. This feature as well is useful in certain procedures, in that it enables easily attaching the anvil to the body of the stapler inside the patient's body, possibly inside the affected organ, and is particularly advantageous for closed surgery, as will be illustrated here below. Again, many ways are known in the art for realizing this configuration. One possible embodiment, presented by way of example and illustrated in
The end of the body is attachable to the anvil as follows: As illustrated in
In order to unlock and release the body from the anvil, there is provided, in the embodiment shown and as depicted in the cross-sectional view in
It is noted that the improvements in flexible staplers and the methods utilizing them, described hereabove are applicable in any form of surgery of the digestive tube but are particularly advantageous in closed surgery. However, the very use of a flexible annular stapler in performing anastomosis of the digestive tube under closed surgery in general is considered to be part of the present invention. The main advantage of such use is that the flexible stapler is insertable through the mouth or the anus or possibly also through a suitable trocar in the abdominal wall, to reach almost any location, thus eliminating the need for a wide incision through the wall—which is required for utilizing a conventional stapler. The other alternative—manual suturing or stapling—is much more difficult, particularly in closed surgery, and takes longer. Moreover, for some hard to reach locations such incisions are not possible and manual stitching is even more difficult, so that a flexible stapler is the only practical alternative. Further advantages of using a flexible stapler in general, or an improved one according to the present invention, in closed surgery of the digestive tube may be evident from the description of methods disclosed here below by way of examples.
It is noted that the last discussed example, as well as further examples to be discussed here below, concern end-to-end anastomosis. It is appreciated, though, that procedures can be similarly developed for end-to-side and side-to-side anastomoses.
Another procedure utilizing a flexible stapler, which features even greater cleanliness and maximum simplicity, is illustrated schematically in
Yet another procedure utilizing a flexible stapler and suitable for cases where the affected segment is relatively clear is illustrated schematically in
It is appreciated that the procedures described above are by way of examples only and that many variations and extensions are possible and that they can be applied also to organs other than the colon. These may be any of a number of hollow organs, including any part of the digestive tube (or alimentary tract) and organs external thereto, such as the gall bladder and the biliary tree, the urinary bladder and tree or the bronchial tree. The procedures may also be applied to joining two different ones of such organs, as well as to joining two different segments of the same organ. Furthermore, neither of the parts to be joined need to be naturally tubular near the joint (like the cut end of the intestines), but may, for example, be a wall of the respective organ. What is common to all cases is that there is conceptually defined, for each of the two parts, a plane and an annular area thereon, the two annular areas being essentially congruent; during the joining operation, the two annular areas are brought together and conceptually combined into one annular area, over which the stapling and eventually the anastomosis take place. In the case that one of the parts is tubular at the joint, as in an end-to-end or end-to-side anastomosis, (in which case that part is always cut across) the defined plane is transverse and a short distance away from the plane of cutting: in the case that one of the parts presents an outer face of a wall at the joint, as in a side-to-end or side-to-side anastomosis, the plane is essentially at that face. Furthermore, in the case of a tubular part, there is an inherent opening through it at the defined plane and interior to the annular area (which opening is, in some procedures, not always initially accessible to the stapler, or, in some other procedures, may be intentionally closed off before the stapler reaches it); on the other hand, in the case of a part being joined at its wall, there is no such initial opening and, if required by a particular procedure (e.g. for insertion of part of the stapler thereto), a suitable opening has to be cut through the wall, interior to the annular area. Of course and as the raison d'etre, after the end of the procedure there remains in all cases a clear opening through both parts.
It is further appreciated that the stapler can also be inserted through openings other than the anus, including, in particular, the mouth and artificial openings through the body wall, such as practiced in closed surgery, and obviously also the wide opening of open surgery; clearly, insertion through such an artificial opening also requires a suitable lateral cut in the affected organ, for insertion of the stapler, or of a jaw, therein.
It is further appreciated that the pointed end of the cable can pierce the wall of an organ, or an artificially closed butt thereof, so as to protrude into, or out of, the organ.
Insertion of the stapler through the body wall may be called for during closed surgery in cases where the affected area is too far from a natural opening, such as proximal portions of the small intestines, or where there are intervening obstructions or where none of the organs to be joined has a clear passageway to a natural opening. In such cases it may be possible to insert the stapler, including the head and/or the anvil, through a sufficiently wide trocar. Such a wide trocar would, however, be generally considered inappropriate or disadvantageous. Fortunately, configurations with detachable head and anvil, particularly the snap-coupling configurations for attachment of the head and the anvil, described hereabove, enable alternative procedures, exemplified by the following, as illustrated in