WO2009121081A1

WO2009121081A1 - Device having a band for annularly surrounding part of a gastrointestinal tract

Info

Publication number: WO2009121081A1
Application number: PCT/AT2009/000074
Authority: WO
Inventors: Walter Egle
Original assignee: A.M.I. Agency For Medical Innovations Gmbh
Priority date: 2008-03-31
Filing date: 2009-02-25
Publication date: 2009-10-08
Also published as: AT506631A1; AT506631B1

Abstract

A device having a band (1) for annularly surrounding part (14) of a gastrointestinal tract, wherein the band (1) has a contact surface (2), which in the usage position faces the part (14) of the gastrointestinal tract to be surrounded, and wherein on the band (1) a first, particularly prefabricated, holding element (3) is disposed and at a distance from the first holding element (3) a second, particularly prefabricated holding element (4) is disposed, and wherein the band (1) has an appendage (7) longitudinally extending in a longitudinal extension direction (10), said appendage in a stretched position of the band (1) protruding beyond the second holding element (4) in a direction that faces away from the first holding element (3) and comprising a partial region of the contact surface (2) of the band (1), wherein in the annular usage position the band (1) is disposed in an overlapping manner in the region of the appendage (7), wherein the holding elements (3, 4) in the annular usage position of the band (1) are disposed at a distance from each other in the longitudinal extension direction (10) of the appendage (7) and can be tensioned relative to each other by means of a thread (5).

Description

Device with a strap for annularly enclosing a part of a gastro-

Intestinal tract

The present invention relates to a device with a band for annularly encompassing a part of a gastrointestinal tract, wherein the band has a contact surface, which in the operating position faces the part of the gastrointestinal tract which is too extensive, and on the band a first, in particular prefabricated, holding element and spaced from the first holding element, a second, in particular prefabricated, holding element is arranged and the strip has a longitudinally extended in a longitudinal direction extension, which in an extended position of the band in a direction away from the first holding element on the direction second holding element protrudes and has a portion of the abutment surface of the band, wherein in the annular operating position, the band is arranged overlapping in the region of the extension.

Generic facilities are z. B. known as gastric bands, they serve to support the stomach, the small intestine or the colon or other parts of the gastrointestinal tract and / or constrict. Accordingly, they are usually initially wrapped in a ring around the part of the gastrointestinal tract that is too extensive and then closed. From US 5,074,868 z. For example, a corresponding gastric band is known in which the ends of the band are sewn together. In order subsequently to be able to set the desired inner diameter of the annularly closed gastric band in this form, it has balloon-like hollow chambers into which fluid can be pressed in, which leads to a narrowing of the diameter of the annularly enclosed opening of the generic device. A problem with such devices is that sooner or later they may leak in the course of their use, so that their function is no longer possible. As a result, operative removal and replacement of the ligament is required, which is associated with a corresponding burden on the patient. Such leaks occur in practice, in particular in the band which delimits the band towards the passage opening. The leaks may occur, for example, as a result of material fatigue during use or overfilling of the belt. For so-called early leaks, which occur until about a year after the onset of the tape, are usually responsible for injuries in the operative, especially laporoskopischen placement of the tape by a surgical instrument are made. In order to remedy this problem, it is already known from AT 413 477 B to provide a piston-cylinder arrangement in a generic device in which the cylinder engages at one end of the band and the piston at the opposite end of the band, whereby Moving the piston in the cylinder, the distance between the two ends of the band and thus the diameter of the annularly-shaped opening of the band can be adjusted. To move the piston in the cylinder, an injection port is provided which is in fluid communication with the cylinder. Liquid can be injected via the injection port or liquid can be sucked off in order to adjust the piston in the cylinder. Although this device reduces the problem of leaking balloon-like cavities. Due to the need for a Injektionsportes, the cylinder and the interposed fluid lines but relatively voluminous and expensive components of the device in the body of the patient to be arranged. In addition, there is still the risk of leaks in said fluid system.

The object of the invention is to propose a possibility which makes it possible to set the desired diameter of the annular opening enclosed by the band in the case of a generic device with measures which are as simple as possible but reliable.

This is inventively achieved by the holding elements in the annular operating position of the strip in the longitudinal extension direction of the extension spaced from each other and can be clamped together by means of a thread.

A basic idea of the present invention is thus to lay a thread around the two holding elements arranged at a distance from one another. By tension of the thread, the distance of the holding elements can then be changed, wherein the overlap in the region of the extension of the band increases or decreases. By this measure, a simple way has been created to set the desired diameter of the annular band-bound opening for the over-extensive part of the gastro-intestinal tract, without the need for a fluid injection system and the like are used in the body of the person to be treated got to. In addition, it is also permanently ensured by the embodiment according to the invention that the once set opening width of the band no longer changes, ie the band remains in the once set annular operating position. For the sake of completeness it should be pointed out that ring-shaped in the sense of the invention is to be understood essentially as circumferentially closed. The term annular means in this context in no way that the ends of the band must end in shock to each other. Rather, as already stated in the description of the generic properties, a spirally overlapping arrangement of the band is also to be regarded as ring-shaped, since in this case too, a peripherally closed enclosure of the part of the gastrointestinal tract is possible.

The retaining elements are conveniently prefabricated on the tape. This means that they are already provided in the production of the device on the tape and are thus already available at delivery. The thread is preferably part of the device and is conveniently shipped with this. But it is also possible to use other threads.

The device according to the invention can in principle be used in all known forms of use of generic devices for encompassing and, if necessary, narrowing of hollow organs. However, devices according to the invention can particularly preferably be applied in the course of a gastroplasty, ie in the course of a surgical reshaping of the stomach as a stabilizing device around the reshaped stomach, so that the surgically formed connection of the small intestine, ie the anastomosis, does not expand. A particularly preferred application is in Gastrojejustonomie, ie in so-called gastric bypass surgery.

It is particularly preferably provided that the holding elements with the thread in different annular operating positions, preferably continuously, at different distances from each other are clamped with each other. By changing the distances between the holding elements during the tensioning of the thread, the overlap in the region of the extension of the band changes accordingly, as a rule.

In order to be able to tension the thread well, it is advantageously provided that at least one of the holding elements has at least one rounded contact surface for the thread. Conveniently, all contact surfaces of the holding elements on which the thread is applied, rounded. The rounded contact surfaces prevent the thread from being pulled over edges or the like during clamping. On the one hand, the rounded contact surfaces ensure that the thread can be sufficiently tensioned, since there is no fear that the thread will hang on the edges during clamping remains, which could usually lead to a loosening of the thread subsequently after the tensioning.

Particularly preferred and readily tensionable embodiments provide that the thread braces the holding elements in the operating position in the form of a self-contained loop with each other. B. be closed by means of at least one node. Particular preference is given to known sliding knots are used. These make it possible to narrow the loop by moving the knot on the thread and thus to clamp the holding elements together. Once the desired annular operating position of the band or the desired tension state of the thread has been reached, the sliding node permanently holds the thread in the once set length and position, without requiring further measures to be taken for this purpose. To move the Schiebeknotens on the thread forked shaped instruments are known in the art. If a normal knot is used, it can be attached during the introduction of the band in the body, ie intracorporeally, or also outside the body, ie extracorporeally, and then be tightened accordingly. In order to be able to set the widest possible range of different diameters of the device which is annularly enclosed in the operating position with a device according to the invention, the overlap in the region of the extension should be variable as far as possible. For this it is favorable if the longitudinal extent of the extension amounts to at least 20%, preferably at least 30%, of the longitudinal extension of the band. By a corresponding longitudinal extent of the extension is achieved that the extension opposite end portion of the tape can be moved over a correspondingly long distance on the extension, so as to set the desired overlap.

In order to avoid pinching of the part of the gastrointestinal tract which is to be covered with the device according to the invention, it is particularly favorable if the, preferably the entire, contact surface is designed to be stepless or smooth. If steps or edges are present in the abutment surface, the danger always arises that tissue will be pinched or pinched during or after the band has been applied between the steps and edges. In this sense, it is also advantageous if all the holding elements outside the abutment surface, preferably on the opposite surface of the abutment surface of the belt are arranged and / or if the thread, preferably exclusively, outside of the abutment surface, preferably on the Ange- geoberfläche opposite side of the Band, since this prevents dert is that tissue of the over-extensive part of the gastro-intestinal tract between the holding elements or in the thread jammed.

In order to be able to guide the band as simply as possible around this part when applying it to the part of the gastrointestinal tract that is too extensive, it is favorable if the band is elastically deformable. It is particularly preferred that the band is biased in an unloaded state in a C-shape or spiral shape. The latter makes it possible to guide the band around the part of the gastrointestinal tract which is too extensive with a rotating movement. The term prestressing is to be understood in this context as meaning that the band is elastically deformable, but in the unloaded state always finds its way back into the C-shape or spiral shape given by the pretension.

Preferred embodiments provide that the first holding element and / or the second holding element is (are) designed as a closed eyelet or as a hook or as a mushroom-shaped knob. It is also advantageous if the second holding element is arranged on a projection of the band, wherein the supernatant is at least partially disposed on the side facing away from the contact surface side of the extension and spaced from the extension. It is also preferred that the thread, preferably exclusively, is arranged outside the contact surface, preferably on the side of the band opposite the contact surface. In order to avoid impairment of the thread, it is advantageously provided that at least one of, preferably all, retaining elements has (have) at least one rounded contact surface for the thread.

Further details and features of preferred embodiments of the invention will become apparent from the following description of the figures. Show it:

1 to 4 a first embodiment of the invention,

5 to 7, a second embodiment of the invention, Fig. 8 to 10, a third embodiment according to the invention and

11 to 13, a fourth inventive embodiment.

Fig. 1 shows first a device according to the invention, in which the band 1 is shown in an extended position. In this embodiment, the first holding member 3 is formed in the shape of a mushroom-shaped head. As in particular in the partially sectioned illustration acc. 4, has the holding element 3 thus formed between the head 16 and the band 1 on a region 17 with a smaller diameter. This is formed with rounded contact surfaces and thus serves as an incised channel in which the thread 5 is guided. Unintentional slipping is avoided by the head 16.

The first holding element 3 is arranged at the end region 8 of the band 1 opposite the extension 7. The second holding element 4 is spaced in the extended position of the band 1 both from the first holding element 3 and thus from the end region 8 opposite end of the band 1. Between the second holding member 4 and the end portion 8 opposite end 18 of the band 1 extends of the

Extension 7. The direction 10 of the longitudinal extent 11 of the extension 7 can be seen particularly well in FIGS. 1 and 4. It is measured between the end region 8 opposite end 18 of the band 1 and the respective center of the second holding element 4.

It extends over the entire length of the belt 1, ie from the end region 8 to the opposite end 18 of the extension 7. As already mentioned, the Investment surface 2 as completely as possible continuously and smooth. At the, the end region 8 opposite end of the band 1, the extension of the tapered, ie z. B. wedge-shaped end 18, as can be seen particularly well in Fig. 4. This tapered end 18 also ensures that no tissue is trapped in the annularly rolled-up operating position of the band 1.

The second holding element 4 is gem. 1 to 4 formed as an eyelet. This also has rounded contact surfaces 15, so that the thread 5 can be well tensioned. In the exemplary embodiment shown, the second retaining element 4 is arranged on a projection 13 of the band 1. The projection 13, in turn, is arranged at least partially on the side of the extension 7 facing away from the contact surface 2 and at a distance from the extension 7. In the embodiment shown, as can be seen particularly well in Fig. 4, the supernatant 13 extends a little way parallel to the extension 7. Between the extension 7 and the supernatant 13, a slot-like recess is arranged. Through this, the thread 5 is passed.

The extension 7 of the band 1 is used so that the band 1 with its opposite end portion 8 on the extension 7 in the annular or spirally rolled together Operating position acc. Fig. 3 rests. In order to prevent lateral slippage of resting on the extension 7 end portion 8 of the belt 1, at least one guide element is advantageously provided, which protrudes on the side facing away from the contact surface 2 of the extension 7 of this. In the embodiment shown, two such guide elements in the form of the side walls 9 and 9 ^' realized. These are arranged on opposite sides of the extension 7 and stand on the side facing away from the contact surface 2 of the extension 7 of this. By facing away from the contact surface 2 surface of the extension 7 and the two side walls 9 and 9 ', a channel-like guide is formed in which, in accordance with, in the annular operating position. Fig. 3, the end portion 8 of the belt 1 in the direction 10 of the longitudinal extension 11 of the extension 7 is guided. A lateral slipping is prevented. It should be noted in this connection that the guide element (s) can of course not only be designed in the form of side walls 9 and 9 ^' . For example, it is just as possible for a pin or wall-type guide element to engage in a slot-like recess in the end region 8 of the band 1 in order to secure the end region 8 against lateral slippage. Regardless of the embodiment of the guide elements or the side walls 9 and 9 ^' , it makes sense in the sense of a secure guidance, if the or the guide element (s) to at least 20%, preferably at least 50%, of the longitudinal extension 11 of the extension 7 at this extends.

Fig. 2 shows the device according to the invention in the unloaded state, in which the band 1 is spirally biased. In this state, the thread 5 is not yet wrapped around the first holding element 3, but depends exclusively on the second holding element 4th

Fig. 3 shows the annular operating position of the band 1, shown in dashed lines is the part 14 of the gastrointestinal tract, which is annularly encompassed by the band 1. In this operating state, the end region 8 overlaps the extension 7 and is guided between its side walls 9 and 9 ', or secured against lateral slipping. The thread 5 is tensioned by pulling the sliding knot 6 between the first holding element 3 and the second holding element 4. These are arranged spaced apart in the longitudinal direction 10 of the extension 7. If the thread 5 is tensioned, it prevents the end region 8 from sliding away from the second retaining element 4 on the extension 7. By the thread 5 is thus ensured that the once set diameter of the inner, encompassed by the band 1 opening remains constant. By different fixed clamping of the thread 5 different inner diameter or opening widths can be adjusted, which in turn the predetermined by the band 1 outer diameter of, from the band. 1 Part 14 of the gastrointestinal tract is discontinued. Depending on the distance between the two holding elements 3 and 4, the degree of overlap between the extension 7 and the end portion 8 of the band 1 changes. For completeness, it should be noted that by rolling or stretching the band 1, of course, nothing in the longitudinal direction of extension 10th of the extension 7 changes.

FIGS. 5 to 7 now show a second embodiment. Fig. 5 again shows the stretched condition of the band 1, Fig. 6 shows the unloaded condition in which the band 1 is helically biased. Fig. 7 shows the operating position in which the band 1 is wrapped around the annular to the comprehensive part 14 of the gastrointestinal tract and the holding elements 3 and 4 are clamped together by means of the thread 5. The second exemplary embodiment, like the further exemplary embodiments described below, is similar to the first exemplary embodiment according to FIGS. 1 to 4, so that in the following only the differences will be discussed. The essential difference between the first and the second exemplary embodiment is that, in the second embodiment, both holding elements 3 and 4 are designed in the form of eyelets. These, in turn, for the reasons already stated rounded contact surfaces 15th In the third embodiment. Fig. 8 to 10, a hook is provided at the first holding element 3 in place of an eyelet. This also has rounded contact surfaces 15. Otherwise, this embodiment is similar to the previously described embodiments.

In the fourth embodiment acc. 11 to 13 are both holding elements 3 and 4 in the form of mushroom-shaped buttons. These same the mushroom-shaped knob of the first holding element 3 of the first embodiment.

The holding elements 3 and 4 are favorably arranged fixed and prefabricated on the band 1 in all embodiments. They can be made of metal or as metal inserts. This applies both to the embodiment as a mushroom button, as eyelet and as a hook. The band itself is conveniently made of a soft long-term implant suitable plastic. Silicone or polyurethane are particularly preferred here. As is known per se, the band can, in particular on the side remote from the contact surface 2, carry a reinforcing fabric or another reinforcement which can absorb the tensile forces occurring in the band 1. Of course, this reinforcement or reinforcing fabric can also be cast into the band 1. A favorable embodiment provides that devices according to the invention not only, as in the Figures shown with a single thread, but with two, three or more threads are delivered. These sutures form a reserve that allows the surgeon to rapidly use a second suture thread to tighten the band if a first suture has been torn or contracted too far. So that the threads provided by the provisions do not interfere with the other operation, they can be guided into tubes or the like, the respective threads being released by pulling off the tube and laid over the holding element (s) 3 and / or 4 can be.

The devices according to the invention make it possible to tension the band in the desired shape without the need for inflating a balloon-like hollow body. For the sake of completeness, however, it should be pointed out that, if deemed necessary, devices according to the invention can additionally be equipped with such expandable, balloon-like hollow bodies known per se from the prior art.

L e g e to the reference numbers

1 band

2 contact surface

3 first holding element

4 second holding element

5 threads

6 knots

7 extension

8 opposite end region

9, 9 'side wall

10 direction of longitudinal extension

11 longitudinal extension

12 longitudinal extension

13 supernatant

14 part of the gastrointestinal tract

15 rounded contact surface

16 head

17 area

18 end

Claims

claims

1. Device with a band (1) for annularly enclosing a part (14) of a

Gastrointestinal tract, wherein the band (1) has a contact surface (2), which faces in the operating position to the comprehensive part (14) of the gastrointestinal tract, and the band (1) a first, in particular prefabricated , Holding element (3) and a second, in particular prefabricated, holding element (4) is arranged at a distance from the first holding element (3) and the strip (1) has an extension (7) elongated in a longitudinal direction (10), which extends in one longitudinal direction stretched position of the band (1) in a direction away from the first holding element (3) over the second holding element (4) protrudes and a portion of the abutment surface (2) of the strip (1), wherein in the annular operating position the band ( 1) in the region of the extension (7) is arranged overlapping, characterized in that the holding elements (3, 4) in the annular operating position of the band (1) in the longitudinal extension direction (10) of the extension (7) v spaced apart and by means of a thread (5) are clamped together.

2. Device according to claim 1, characterized in that the holding elements (3, 4) with the thread (5) in different annular operating positions, preferably continuously, in mutually different distances are braced with each other.

3. Device according to claim 1 or 2, characterized in that, preferably the entire, abutment surface (2) is formed continuously or smoothly.

4. Device according to one of claims 1 to 3, characterized in that the thread (5) the holding elements (3, 4) braced together in the operating position in the form of a self-contained loop.

5. Device according to claim 4, characterized in that the loop by means of at least one node (6), preferably by means of at least one Schiebekno- least, closable or closed.

6. Device according to one of claims 1 to 5, characterized in that the band (1) is elastically deformable.

7. Device according to claim 6, characterized in that the band (1) is biased in an unloaded state in a C-shape or spiral shape.

8. Device according to one of claims 1 to 7, characterized in that the longitudinal extent (11) of the extension (7) is at least 20%, preferably at least 30%, of the longitudinal extent (12) of the band.

9. Device according to one of claims 1 to 8, characterized in that all holding elements (3, 4) outside the abutment surface (2), preferably on the abutment surface (2) opposite side of the belt (1) are arranged.

10. Device according to one of claims 1 to 9, characterized in that it comprises at least one guide element which on the, from the contact surface (2) applied side of the extension (7) protrudes from this (protrude).

11. A device according to claim 10, characterized in that it as ment element (e) at least one side wall (9), preferably two on opposite sides of the extension (7) arranged side walls (9, 9 '), which on the , of the contact surface (2) applied side of the extension (7) protrudes from this (stand out).

12. Device according to claim 10 or 11, characterized in that the or the guide element (s) to at least 20%, preferably at least 50%, a longitudinal extent (11) of the extension (7) extends (extend).

13. Device according to one of claims 1 to 12, characterized in that the band (1) has an extension (7) opposite end portion (8), with which it the extension (7) in the annular operating position on the abutment surface ( 2) overlapped opposite side.

14. Device according to one of claims 10 to 12 and claim 13, character- ized in that the opposite end region (8) of the band (1) in the annular operating position of the (the) guide element (s) in Längserstre- ckungsrichtung (10) of the extension (7) is guided.

15. Device according to one of claims 1 to 14, characterized in that the extension (7) has a tapered end.