US20050049636A1

US20050049636A1 - Device and method for tacking a prosthetic screen

Info

Publication number: US20050049636A1
Application number: US10/841,929
Authority: US
Inventors: Arnold Leiboff
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-08-07
Filing date: 2004-05-07
Publication date: 2005-03-03
Also published as: US20050049635A1; US20060116718A1; WO2005016176A2; US7021316B2; WO2005016176A3; EP1673017A2

Abstract

A prosthetic screen tacking device includes a barbed filament with a perpendicular foot at one end and a swaged needle at the other. The barbs are situated near the foot and angulated in such a manner that they permit movement of the device through tissue in one direction (toward the needle), but prevent movement in the opposite direction (toward the foot). Methods of using the device and an improved barb are also disclosed.

Description

This application is a continuation-in-part of co-pending application Ser. No. 10/636,841, filed Aug. 7, 2003, the complete disclosure of which is hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention
The invention relates to a device and method which simplifies the attachment of a prosthetic screen to the abdominal wall during the repair of abdominal wall hernias.
2. Brief Description of the Prior Art
The layer or layers of fascia which lie in the abdominal wall and surround the peritoneal cavity are the strong structures which maintain the integrity of the peritoneal cavity. If there is a defect in the fascia, abdominal contents may penetrate weaker layers of the abdominal wall (comprised of muscle or fat) and push ahead the abdominal cavity's thin lining (peritoneum) so that abdominal contents, such as omentum or bowel, within their envelope of peritoneum, become situated in a subcutaneous position, often causing a visible bulge.
Viscera being squeezed through a facial defect can cause pain. When a visceral structure becomes trapped outside the fascial plane, it is said to be incarcerated. Incarcerated viscera can be strangulated by a narrow facial defect, producing ischemic necrosis. This may lead to infection and death if not surgically repaired. Hernias are therefore usually repaired electively, before they become incarcerated or strangulated.
Historically, hernias of the abdominal wall were repaired by closing the fascial defect with sutures. Large hernias tend to recur if closed in this way. Prosthetic screens, made of plastic mesh or sheets, are now frequently used to cover large fascial defects. One way to implant the prosthetic screen is to attach the prosthesis to the fascia of the abdominal wall with sutures. This is relatively easy to do, but the repair has a high rate of failure because the sutured prosthesis often pulls away from the fascial edge.
Other ways to secure prosthetic screens include overlapping the prosthesis over the edge of the fascia. These methods are less likely to fail. Increased intra-abdominal pressure tends to force the periphery of the prosthesis against the abdominal wall rather than pull the prosthesis away from the fascia. A gap where both prosthesis and fascia are absent is less likely to develop.
If the prosthetic screen is allowed to overlap the edges of the fascial defect, there are a number of ways it can be secured in place. The sutures can secure the fascia to the prosthesis inward from the edge of the prosthesis. This is technically easy when the surgery is done in the conventional approach. However, materials such as Gortex™ or polypropylene mesh used for prosthetic screens are soft and may buckle and deform outside the suture line, so that the structural advantage of the overlap with fascia is not realized.
A better method is to secure the prosthesis to the abdominal wall fascia with sutures as close to the edge of the prosthesis as possible, while maintaining generous overlap between prosthesis and intact fascia. However, it can be difficult to secure an overlapping intraperitoneal prosthesis at its periphery when performing surgery using a conventional approach. Access to the inside surface of the abdominal wall overlying the periphery of the prosthesis is limited. The more the overlap, the more difficult the access.
In order to achieve generous overlap the surgeon may bring the sutures through the abdominal wall. The midpoint of a suture may be tied to the edge of the prosthesis, and the two ends brought out directly through the abdominal wall near one another, through a single small separate incision in the skin. Both ends of this transmural suture are then tied together, placing the knot beneath the skin in the subcutaneous tissue. The skin incision is closed separately with skin sutures or staples. This process is completed around the periphery of the prosthesis.
If surgery is done by a minimally invasive technique (e.g. laparoscopic surgery), the surgeon's view is from within the abdominal cavity looking up at the anterior abdominal wall. The periphery of the prosthesis can be fixed to the abdominal wall by direct suture (using a laparoscopic suture technique), or by using one of several fixation devices, such as staples or helical tacks. Alternatively, sutures can be fixed to the prosthesis before it is introduced through a port site into the peritoneal cavity. Once the prosthesis is correctly positioned, both ends of these sutures can be pulled through the abdominal wall and the same small skin incision and the ends tied together, placing the knot subcutaneously. A combination of techniques, using a few transmural sutures, at equidistant points along the periphery of the prosthesis, with staples or helical tacks in between, is also useful.
Despite the many advances made in laparoscopic suturing techniques as well as in open hernia repair, there are still many problems to be overcome. One problem is that in order to secure the prosthesis to the abdominal wall at a single point with a transmural suture, each suture end must be pulled separately through the abdominal wall. This is time consuming. Another problem is that after placement of both ends of each suture through the abdominal wall, they must be clamped together above the body wall while other transmural sutures are placed, because it is much easier to place transmural sutures before the prosthesis is cinched up against the abdominal wall. Clamping insures that suture ends do not inadvertently pull out of the abdominal wall during this process. A large number of clamps clutters the operative field and the sutures and clamps tend to entangle one another. Furthermore, multiple short skin incisions must be made to set the knot of each tied pair subcutaneously. This process is somewhat time consuming and the multiple skin incisions produces a poor cosmetic result. Moreover, when two strands of suture are tied subcutaneously to secure a prosthetic screen, tissues of the abdominal wall are captured and partially strangulated within the ligature. This often produces postoperative pain and cosmetically undesirable dimpling of the skin at the ligature sites.
The previously incorporated parent application discloses a prosthetic screen tacking device which includes a barbed filament with a perpendicular foot at one end and a loop at the other. The foot may be a linear form, so that end of the device forms a T. The barbs are situated near the foot and angulated in such a manner that they permit movement of the device through tissue in one direction (toward the loop), but prevent movement in the opposite direction (toward the foot).
Using the open method of hernia repair, several tacking devices are pulled through the prosthetic screen equidistantly along the periphery (circumference) of the prosthesis. The assembly is then positioned within the open abdominal cavity, over the viscera. A suture passer (a needle-like implement with the ability to grasp sutures, e.g., a Reverdin needle) is then used to penetrate the abdominal wall at a point opposing the location where one tacking device penetrates the prosthesis, a point substantially beyond the edge of the fascial defect. The suture passer grasps the loop of the tacking device, and draws it back through the abdominal wall, so that the loop lies external to the body. The loop is then disengaged from the suture passer. The tacking device remains in place because the loop impedes accidental withdrawal from the abdominal wall. The same action is repeated until the loops of all devices are passed through the abdominal wall. Each device is then pulled further through the abdominal wall by grabbing the loop and pulling upward. The devices are pulled as far as possible using appropriate force to draw the prosthesis against the abdominal wall. This action draws the barbs into the abdominal wall and through at least one fascial layer. Each device is then pulled by its loop under tension. The skin, where penetrated by the device, is simultaneously pressed downward, further compressing the abdominal wall, and the filament is severed at skin level. Pressure is released, the abdominal wall expands and the severed end of the filament recedes beneath the skin. The barbs on the remaining portion of the filament prevent dislodgement of the device which prevents the prosthesis from pulling away from the abdominal wall. The abdominal wound above the prosthesis is closed as completely as possible by standard technique, and the operation is concluded.
The tacking device can be similarly utilized in a laparoscopic procedure. Here the devices are loaded onto the periphery of the prosthesis, the assembly is introduced through a port site into the peritoneal cavity. The assembly is unfurled and oriented within the abdomen so that the loops are upward towards the abdominal wall. A suture passer is then used to penetrate the abdominal wall at a point corresponding to the preferred point of fixation of a particular device and the procedure proceeds substantially the same as described above.
Since the filing of the parent application, I have made additional improvements to the tacking device for use in open surgery.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall.
It is another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall which is particularly applicable to open surgery.
It is still another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall which requires penetrating the abdominal wall only once for each point of fixation.
It is a further object of the invention to provide a device which impedes accidental withdrawal once it is passed through the abdominal wall.
It is also an object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall which does not require the tying of sutures.
It is another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall which does not require a skin incision to obtain subcutaneous fixation.
It is still another object of the invention to provide a device and method to fix a prosthetic screen to the abdominal wall which does not strangulate tissues of the abdominal wall.
In accord with these objects which will be discussed in detail below, the prosthetic screen tacking device according to the invention includes a barbed filament with a perpendicular foot at one end and a swaged needle at the other. The foot may be a linear form, so that end of the device forms a T. The barbs are situated near the foot and angulated in such a manner that they permit movement of the device through tissue in one direction (toward the loop), but prevent movement in the opposite direction (toward the foot).
Using the open method of hernia repair, several tacking devices are pulled through the prosthetic screen equidistantly along the periphery (circumference) of the prosthesis. The assembly is then positioned within the open abdominal cavity, over the viscera. The swaged needles are individually passed through the abdominal wall at a point opposing the location where one tacking device penetrates the prosthesis, a point substantially beyond the edge of the fascial defect. The needles are separated from the filaments and the filaments are held in place with clamps. Each device is then pulled further through the abdominal wall by grabbing the filament and pulling upward. The devices are pulled as far as possible using appropriate force to draw the prosthesis against the abdominal wall. This action draws the barbs into the abdominal wall and through at least one fascial layer. The skin, where penetrated by the device, is simultaneously pressed downward, further compressing the abdominal wall, and the filament is severed at skin level. Pressure is released, the abdominal wall expands and the severed end of the filament recedes beneath the skin. The barbs on the remaining portion of the filament prevent dislodgement of the device which prevents the prosthesis from pulling away from the abdominal wall. The abdominal wound above the prosthesis is closed as completely as possible by standard technique, and the operation is concluded.
A second embodiment of a tacking device according to the invention includes a loop located between the barbs and the swaged needle. The loop obviates the need for a clamp to hold the device in place while the other devices are installed. The loop is also useful in pulling the filament up through the skin to secure the barbs.
Another improvement of the present invention is a new barb design which passes through the skin easier when being installed and provides greater holding strength when installed.
One advantage of the tacking device of the invention over the conventional transmural suture is that it requires one filament rather than two suture ends to be drawn through the abdominal wall to secure the prosthesis at any point on its periphery. Thus, half the work is required.
Another advantage is that a suture passer is not needed since the device includes a swaged needle.
An advantage of the second embodiment is that the loop of the device provides an excellent handle which can be used to secure the barbs.
Another advantage of the second embodiment is that once pulled through the abdominal wall the device will not be inadvertently withdrawn, since the loop will prevent withdrawal.
An advantage of both embodiments is that no knot is required.
Another advantage of both embodiments is that no skin incision is required to place a knot subcutaneously.
Another advantage of both embodiments is that, unlike a transmural suture, this tacking device will not strangulate tissue of the abdominal wall and therefore will not produce as much postoperative pain.
Another advantage of both embodiments is that, unlike a transmural suture, this device will not produce cosmetically undesirable dimpling of the skin.
Furthermore, a knot below a skin incision is more likely to become infected than is the single filament of the tacking device of the invention, which retracts into the abdominal wall well below a small skin puncture site. Infectious agents are then less likely to travel down to infect the prosthetic screen. Use of the tacking device of the invention will result in fewer prosthetic screen infections, which are a major cause of morbidity, re-operation and recurrent hernia. Infected prosthetic screens must often be removed to control infection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of a prosthetic screen tacking device according to a first embodiment of the invention;
FIGS. 2 and 3 schematically illustrate how the first embodiment of the prosthetic screen tacking device is used in conventional open surgery;
FIG. 4 is a side elevational view of a prosthetic screen tacking device according to a second embodiment of the invention;
FIGS. 5 and 6 schematically illustrate how the second embodiment of the prosthetic screen tacking device is used in conventional open surgery;
FIG. 7 is a broken side elevational view of a filament with a barb according to the invention; and
FIG. 8 is a view similar to FIG. 7 rotated 90 degrees about the axis of the filament.

DETAILED DESCRIPTION OF THE PREFERRED AND ILLUSTRATED EMBODIMENTS

Turning now to FIG. 1, a prosthetic screen tacking device 10 includes a filament 12 with a perpendicular foot 14 at one end and a swaged needle 15 at the other end. A plurality of barbs 18 are provided adjacent to the foot 14. The foot 14 may be a linear form, so that end of the device forms a T or may have other configurations as described in more detail in the previously incorporated parent application. The barbs 18 are angulated in such a manner that they permit movement of the device through tissue in one direction (toward the needle 15), but prevent movement in the opposite direction (toward the foot 14).
FIGS. 2 and 3 schematically illustrate how the tacking device 10 is used in the open method of hernia repair. Several devices 10 are pulled through the prosthetic screen 1 equidistantly along the periphery (circumference) of the prosthesis 1. The assembly is then positioned within the open peritoneal cavity, over the viscera (FIG. 2). The swaged needle 15 is then used to penetrate the abdominal wall at a point opposing the location where one device penetrates the prosthesis, a point substantially beyond the edge of the fascial defect. The device is drawn back through all layers of the abdominal wall 2, including the peritoneum 2 d, fascia 2 c, muscle if present (not shown), subcutaneous tissue 2 b and skin 2 a, so that the needle 15 lies external to the body (rt. side of FIG. 2). The needle 15 is then disengaged or cut-off from the filament 10 (FIG. 3) and the filament 12 is held in place with a clamp (not shown). The same action is repeated until all devices are pulled through the abdominal wall.
Each device 10 is then pulled further through the abdominal wall so that the barbs 18 engage the abdominal wall as shown in FIG. 3. The devices are pulled as far as possible using appropriate force to draw the prosthesis 1 against the abdominal wall 2 with the aid of foot 14. When all devices have been pulled in this fashion, the prosthesis is secured against the abdominal wall circumferentially.
Each device 10 is then pulled under tension. The skin 2 a, where penetrated by the device, is simultaneously pressed downward as shown and described in the previously incorporated parent application, further compressing the abdominal wall, and the filament 12 is severed at skin level. Pressure is released, the abdominal wall re-expands and the severed end of filament 12 recedes beneath the skin. The barbs 18 on the remaining portion of filament 12 prevent dislodgement of device 10, which prevents prosthesis 1 from pulling away from abdominal wall 2. The abdominal wound above prosthesis 1 is closed as completely as possible by standard or conventional techniques, and the operation is concluded.
The devices 10 may be color coded so that they may be more easily identified for handling in the proper sequence. The filament and barbs may be made of a biodegradable and absorbable material (e.g., polydioxanone, polyglycolide, etc.) so that they disintegrate and disappear after the prosthetic screen is naturally integrated into the abdominal wall and is no longer able to dislodge.
The geometry of the foot can vary. Three examples are shown and described in the previously incorporated parent application. The configuration of the barbs 18 may also vary. Several examples are shown and described in the previously incorporated parent application and a new configuration is described herein below with reference to FIGS. 7 and 8 The tacking device may also be used in conjunction with a button as shown and described in the previously incorporated parent application.
Turning now to FIG. 4, a second embodiment of a prosthetic screen tacking device 110 includes a filament 12 with a perpendicular foot 14 at one end and a swaged needle 15 at the other end. A plurality of barbs 18 are provided adjacent to foot 14. Foot 14 may be a linear form, so that end of the device forms a T or may have other configurations as described in more detail in the previously incorporated parent application. Barbs 18 are angulated in such a manner that they permit movement of the device through tissue in one direction (toward needle 15), but prevent movement in the opposite direction (toward foot 14). According to this embodiment, a loop 16 is formed in the filament at a location between barbs 18 and needle 15. The loop performs the same functions as described in the previously incorporated parent application.
FIGS. 5 and 6 schematically illustrate how the tacking device 110 is used in the open method of hernia repair. Several devices 110 are pulled through the prosthetic screen 1 equidistantly along the periphery (e.g., circumference) of the prosthesis 1. The assembly is then positioned within the open peritoneal cavity, over the viscera (FIG. 5). The needle 15 is then used to penetrate the abdominal wall at a point opposing the location where one device penetrates the prosthesis, a point substantially beyond the edge of the fascial defect. Needle 15 draws the filament through all layers of the abdominal wall 2, including the peritoneum 2 d, fascia 2 c, muscle if present (not shown), subcutaneous tissue 2 b and skin 2 a, so that loop 16 lies external to the body (rt. side of FIG. 5). The needle is then disengaged or cut-off from filament 12. The tacking device will remain in place, because substantial force is necessary to withdraw loop 16 even before the barbs engage the abdominal wall. The same action is repeated until the loops of all devices are pulled through the abdominal wall and needles 15 are removed.
Each device 110 is then pulled further through the abdominal wall by grabbing loop 16 and pulling upward so that the barbs 18 engage the abdominal wall as shown in FIG. 6. The devices are pulled as far as possible using appropriate force to draw the prosthesis 1 against the abdominal wall 2 with the aid of foot 14. When all devices have been pulled in this fashion, the prosthesis 1 is secured against the abdominal wall circumferentially.
Each device 110 is then pulled by its loop 16 under tension. The skin 2 a, where penetrated by the device, is simultaneously pressed downward as shown and described in the previously incorporated parent application, further compressing the abdominal wall, and filament 12 is severed at skin level. Pressure is released, the abdominal wall re-expands and the severed end of filament 12 recedes beneath the skin. The barbs 18 on the remaining portion of the filament prevent dislodgement of the device, which prevents the prosthesis 1 from pulling away from the abdominal wall 2. The abdominal wound above the prosthesis 1 is closed as completely as possible by standard or conventual techniques, and the operation is concluded.
As mentioned above, the present invention includes a new barb 118 which is illustrated in FIGS. 7 and 8. Barb 118 has an upper end 118 a and a lower end 118 b. The barb 118 is flared in two directions from the upper end 118 a to the lower end 118 b. As shown in FIGS. 7 and 8, the two directions are mutually orthogonal. This results in a wedge-shaped barb having a generally triangular cross-sectional profile (see FIG. 8) with a relatively large lower end 118 b as compared to the upper end 118 a. This barb penetrates tissue more easily and provides greater holding strength.
There have been described and illustrated herein a device and method for affixing a prosthesis to the abdominal wall. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. For example, although the tacking device is preferably made of plastic material, it could be made, at least in part by other materials such as metal. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as so claimed.

Claims

1. A surgical tacking device suitable for the fixation of a prosthetic screen, said device comprising:

a filament having a first end and a second end;

a plurality of barbs arranged on said filament between said first and second ends, said barbs being configured to allow said filament to pass through body tissue when said first end is pulled but to prevent said filament from passing through body tissue when said second end is pulled;

a swaged needle on said first end of said filament; and

a foot on said second end of said filament, said foot arranged to prevent said second end of said filament from passing through a prosthetic screen.

2. The surgical tacking device according to claim 1, wherein said barbs are arranged in side by side pairs.

3. The surgical tacking device according to claim 1, wherein said barbs are arranged in an alternating configuration.

4. The surgical tacking device according to claim 1, wherein said barbs are arranged in a random configuration.

5. The surgical tacking device according to claim 1, wherein said barbs are substantially conical.

6. The surgical tacking device according to claim 1, wherein said barbs are tapered and have a relative wide lower end and relatively narrow upper end.

7. The surgical tacking device according to claim 6, wherein said barbs are wedge-shaped and having a generally triangular cross-sectional profile.

8. The surgical tacking device according to claim 1, wherein:

said foot is substantially planar.

9. The surgical tacking device according to claim 8, wherein said foot is substantially circular.

10. The surgical tacking device according to claim 8, wherein said foot is substantially elliptical.

11. The surgical tacking device according to claim 1, further comprising a button arranged to slide over said barbs when moved over said filament from said first end toward said second end but unable to slide over said barbs when moved from said second end toward said first end.

12. The surgical tacking device according to claim 1, further comprising a button configured to slide over said barbs when rotated to a first position but unable to slide over said barbs when rotated to a second position.

13. The surgical tacking device according to claim 1, wherein said device is made of a non-biodegradable material.

14. The surgical tacking device according to claim 1, wherein said device is made of a biodegradable material.

15. A method for affixing a prosthetic screen to the wall of the abdomen, said method comprising:

passing a plurality of surgical tacking devices through the screen, the tacking devices including a filament having a first end and a second end with a swaged needle at said first end, a foot at said second end, and a plurality of barbs between said first and second ends;

delivering the screen with attached tacking devices to the peritoneal cavity;

passing the surgical tacking devices through the abdominal wall from inside to outside; and

pulling the filament of each tacking device through the abdominal wall so that the barbs of the device lodge in the abdominal wall and affix the prosthesis to the abdominal wall.

16. The method according to claim 15, further comprising:

cutting said tacking devices at a point between said first and second ends so that the needle is removed and no part of the tacking device is exposed on the skin of the patient.

17. A surgical tacking device suitable for the fixation of a prosthetic screen, said device comprising:

a filament having a first end and a second end;

a swaged needle on said first end of said filament;

a foot on said second end of said filament, said foot arranged to prevent said second e nd of said filament from passing through a prosthetic screen; and

a loop between said barbs and said first end.

18. The surgical tacking device according to claim 17, wherein said barbs are arranged in side by side pairs.

19. The surgical tacking device according to claim 17, wherein said barbs are arranged in an alternating configuration.

20. The surgical tacking device according to claim 17, wherein said barbs are arranged in a random configuration.

21. The surgical tacking device according to claim 17, wherein said barbs are substantially conical.

22. The surgical tacking device according to claim 17, wherein said barbs are tapered and have a relatively wide lower end and relatively narrow upper end.

23. The surgical tacking device according to claim 22, wherein said barbs are wedge-shaped and having a generally triangular cross-sectional profile.

24. The surgical tacking device according to claim 17, wherein:

said foot is substantially planar.

25. The surgical tacking device according to claim 23, wherein said foot is substantially circular.

26. The surgical tacking device according to claim 23, wherein said foot is substantially elliptical.

27. The surgical tacking device according to claim 17, further comprising a button arranged to slide over said barbs when moved over said filament from said first end toward said second end but unable to slide over said barbs when moved from said second end toward said first end.

28. The surgical tacking device according to claim 17, further comprising a button configured to slide over said barbs when rotated to a first position but unable to slide over said barbs when rotated to a second position.

29. The surgical tacking device according to claim 17, wherein said device is made of a non-biodegradable material.

30. The surgical tacking device according to claim 17, wherein said device is made of a biodegradable material.

31. A method for affixing a prosthetic screen to the wall of the abdomen, said method comprising:

passing a plurality of surgical tacking devices through the screen, the tacking devices including a filament having a first end and a second end with a swaged needle at said first end, a foot at said second end, a plurality of barbs between said first and second ends, and a loop between said barbs and said first end;

delivering the screen with attached tacking devices to the peritoneal cavity of the abdomen;

passing the needle and loop of the surgical tacking devices through the abdominal wall from inside to outside;

separating the needles from the filaments; and

pulling the loop of each tacking device to bring the filament through the abdominal wall so that the foot of the device draws the prosthesis against the abdominal wall and barbs of the device lodge in the abdominal wall and affix the prosthesis to the abdominal wall.

32. The method according to claim 30, further comprising:

cutting said tacking devices at a point between said first and second ends so that the loop is removed and no part of the tacking device is exposed on the skin of the patient.