ANCHORING DEVICE FOR SOFT TISSUE REPAIR

Abstract

Disclosed is a surgical device for soft tissue repair, including: a flexible anchor consisting of a textile braid forming a first arm and a second arm extending distally away from a vertex area; and at least one suture thread having a median portion placed near the vertex area and two strands passing through the braid transversely at several sites. The first strand passes through the braid alternately at two sites adjacent to the first arm and at two sites adjacent to the second arm, the sites passed through in sequence on the same arm moving away from the vertex zone. The second strand passes through the braid at least at two sites of the second arm, the sites passed through in sequence moving away from the vertex zone. The device is inserted into a hole made in a bone and assumes a compressed configuration after insertion.

Claims

1. A surgical device for the repair of soft tissues which is capable of being inserted into a hole produced in a bone in an initial deployed configuration and of adopting a final compressed configuration after insertion, wherein in the initial configuration, the surgical device comprises: a flexible anchor constituted by a braid of textile fibers, which is curved into a hoop to form a first and a second arm extending distally from an apex zone, and at least one suture filament, a median portion of which separating a first and a second long strand each having a free end, the median portion of the suture filament being placed between the first and the second arm in the vicinity of the apex zone of the anchor, and the two strands of the suture filament passing transversely through the braid from one side to the other at a plurality of sites, the first strand passing through the braid alternately at two adjacent sites of the first arm and at two adjacent sites of the second arm, the sites passed through in sequence on the same arm being increasingly distant from the apex zone, and the second strand passing through the braid at at least two sites of the second arm, the sites passed through in sequence being increasingly distant from the apex zone.

2. The device as claimed in claim 1, wherein the first strand passes through the braid in 2n+1 pairs of adjacent sites, alternately of the first arm and of the second arm, with n being equal to 1 or 2.

3. The device as claimed in claim 1, wherein the first strand passes through the braid at two adjacent sites of the first arm, at two adjacent sites of the second arm, and at two adjacent sites of the first arm, in sequence and in this order, two sites which are passed through in sequence on said first arm and said second arm being at a substantially identical distance from the apex zone.

4. The device as claimed in claim 1, wherein the second strand of the suture filament passes through the braid at two sites of the second arm, one in the vicinity of the apex zone and the other in the vicinity of the distal portion of said second arm.

5. The device as claimed in claim 4, wherein the sites of the second arm through which the first strand passes are located between the two sites of said second arm through which the second strand passes.

6. The device as claimed in claim 1, wherein the free end of the first strand and the free end of the second strand each open out from a site located at the distal portion of one of the arms of the anchor in the space comprised between the two arms in a manner such that the distal ends of the first and second arms form fins spontaneously adopting a diverging orientation with respect to the axis of the anchor.

7. The device according to claim 6, wherein the distal ends of the first and second arms forming the fins are stiffened by thermosetting.

8. The device as claimed in claim 1, further comprising a second suture filament, a median portion of which separates a first and a second long strand, each having a free end, said strands passing through the braid transversely from one side to the other at two sites of the apex zone which are adjacent to each other, in a manner such that said median portion covers said apex zone and such that said first and second strands extend between the arms of the anchor.

9. The device as claimed in claim 8, wherein the strands of the second suture filament are interlaced with the portions of the first suture filament passing transversely between the sites of the first and of the second arm.

10. The device as claimed in claim 1, wherein the anchor is constituted by a braided tubular sheath, taken in a flattened configuration along its longitudinal axis.

11. The device as claimed in claim 10, wherein the sheath is flattened while hot before cutting to a selected length comprised between 2 cm and 5 cm.

12. The device as claimed in claim 10, wherein the sheath is formed from 4 to 6 textile fibers with a count of between 20 dtex and 200 dtex which are braided together.

13. The device as claimed in claim 1, wherein the device comprises resorbable or non-resorbable polymer material which is identical to or different from the anchor, for said at least one suture filament.

14. The device as claimed in claim 13, wherein said polymeric material is selected from polyethylenes, polyethylene terephthalates and polylactic acids.

15. A surgical device for the repair of soft tissues as claimed in claim 1, wherein the device is configured to be capable of: an initial deployed configuration in which the arms of the anchor are extended and the braid is extended along its axis, the configuration having a first length and a first width allowing the device to be inserted into a hole in a human or animal bone, and a final compressed configuration obtained by pulling the strands of said at least one suture filament, and the strands of the second suture filament if it is present, in which the arms of the anchor are folded and the braid is compacted along its axis, the configuration having a second length which is less than the first length and a second width which is greater than the first width, providing the device with its anchoring configuration in the hole.

16. The device as claimed in claim 8, wherein the device comprises resorbable or non-resorbable polymer material which is identical to or different from the anchor, for said at least one suture filament and for the second suture filament.

17. The device as claimed in claim 2, wherein the first strand passes through the braid at two adjacent sites of the first arm, at two adjacent sites of the second arm, and at two adjacent sites of the first arm, in sequence and in this order, two sites which are passed through in sequence on said first arm and said second arm being at a substantially identical distance from the apex zone.

18. The device as claimed in claim 2, wherein the second strand of the suture filament passes through the braid at two sites of the second arm, one in the vicinity of the apex zone and the other in the vicinity of the distal portion of said second arm.

19. The device as claimed in claim 3, wherein the second strand of the suture filament passes through the braid at two sites of the second arm, one in the vicinity of the apex zone and the other in the vicinity of the distal portion of said second arm.

20. The device as claimed in claim 2, wherein the free end of the first strand and the free end of the second strand each open out from a site located at the distal portion of one of the arms of the anchor in the space comprised between the two arms in a manner such that the distal ends of the first and second arms form fins spontaneously adopting a diverging orientation with respect to the axis of the anchor.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The present invention will be better understood and its details will become more apparent from the description below of different embodiments, made with reference to the accompanying figures, in which:

[0047] FIG. 1 shows a device in accordance with the invention, in which an anchor and a suture filament are assembled in accordance with a first embodiment.

[0048] FIG. 2 shows a device in accordance with the invention, in which an anchor and a suture filament are assembled in accordance with a second embodiment.

[0049] FIG. 3 shows a device in accordance with the invention, in which an anchor and a suture filament are assembled in accordance with a third embodiment.

[0050] FIG. 4 shows a device in accordance with the invention, in which an anchor and a suture filament are assembled in accordance with a fourth embodiment.

[0051] FIG. 5 shows a device in accordance with the invention in which an anchor and two suture filaments are assembled.

[0052] FIG. 6 shows the same device after positioning on an insertion tool for its implantation in a receiving bone.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Example 1

[0053] FIGS. 1 to 4 show a surgical device in a first variational embodiment in the deployed configuration (i.e. extended configuration, before installation), which comprises an anchor 1 assembled with a suture filament 20. The anchor 1 is constituted by a braid 2 curved into a hoop. The hoop comprises an apex zone 3, or tip, from which a first arm 11 and a second arm 12 extend in the distal direction, which define an interior space and an exterior space of the hoop which can be identified visually. The braid 2 is a tubular sheath, produced with the aid of synthetic fibres, produced here from very high molecular weight polyethylene. The tubular braid 2, initially with a round cross-section, is flattened by hot pressing, for example at a temperature of 150° C. for 15 s to 30 s, in a manner such that it comprises a double thickness of interlaced fibres, forming two layers which are perfectly superimposed and integral. A braid with six fibres with a count of 50 dtex, with approximately eight motifs per cm, makes it possible to obtain a suitable rigidity of the anchor 1 and a spacing of the meshes allowing the passage of a splicing needle for assembly with the suture filament 20. The ends of the braid 2 may be thermally fixed, for example by means of cutting to the desired length using a heated knife.

[0054] The suture filament 20 is associated with this anchor by passing the braid 2 transversely from one side to the other at a plurality of sites 50. Here, a suture filament of the standard type, produced from UHMWPE polyethylene with a diameter of USP 2 (0.500 mm-0.599 mm), was used. It was threaded through the meshes of the braid 2 which move slightly apart when a tool such as a splicing needle passes through it, without it being necessary to pierce any perforations. The suture filament 20 is first stitched into the braid at two sites 50, one on the first arm 11, the other on the second arm 12, in the proximity of the apex zone 3, for example 5 mm from the extreme tip of the hoop. It is passed from the interior towards the exterior of the hoop in a manner such that a portion of the suture filament 20 is placed between the first and second arms in the vicinity of the apex zone 3 of the anchor. This portion, known as the median portion 23, separates a first strand 21 and a second strand 22 of the suture filament 20. Each strand passes through the braid 2 transversely from one side to the other at a plurality of sites 50, then terminates in a free end 211 and 221, with a length of several tens of cm (for example from 20 cm to 70 cm), allowing ligation of the soft tissues in a convenient manner. These lengths and positions are given for a device in the state in which the surgeon receives it, but they may be modified during its handling, in particular by sliding or gliding the suture filament 20 relative to the braid 2.

[0055] The arrangement of the suture filament 20 relative to the anchor 1 satisfies several criteria, with common points and possible variations relating to each of the two strands 21, 22. They have in common that they each pass through the braid 2 an even number of times, progressing from the vicinity of the apex zone towards the distal portion of the arms 11, 12. Since they begin their passage over the braid by passing through it towards the exterior of the hoop, they always end it by opening towards the interior of the hoop. The free strands 211, 221 of the suture filament 20 are therefore situated between the distal ends of the two arms 11, 12. These distal ends spontaneously adopt a diverging orientation relative to the axis of the anchor 1, forming two fins 112, 122 about 5 mm long, for example. These fins tend to move away from the axis of the anchor, even more so as the strands 21, 22 are placed under tension. They therefore fulfil a function of attachment to the cortical wall of the receiving bone of the implant, allowing better stabilization in situ and increasing the tear strength. They may undergo a treatment with a view to hardening them further (by hot pressing, impregnation with a polymer, coating with adhesive, etc.).

[0056] Each strand 21, 22 advances on the braid along a different path. The first strand 21 penetrates the braid 2 at two sites 50 adjacent to each other, located on one arm, then penetrates the braid 2 at two sites 50 adjacent to each other, located on the other arm, several times. More precisely, it initially passes through two adjacent sites 51, 52 of the first arm 11, then through two adjacent sites 53, 54 of the second arm 12, then back to two adjacent sites 51, 52 of the first arm 11, and so on, always towards the exterior and then towards the interior of the hoop and progressing from the vicinity of the apex zone towards the end of the arms 11, 12, up to the distal portion 111 of the first arm 11. In accordance with an alternative embodiment shown in FIG. 1, the first strand 21 passes through the braid 2 in three pairs of adjacent sites, alternately from the first arm 11 (two pairs of sites 51, 52) and from the second arm 12 (one pair of sites 53, 54). The same applies in the variation shown in FIG. 4. In accordance with alternative embodiments shown in FIGS. 2 and 3, the first strand 21 passes through the braid 2 in five pairs of adjacent sites, alternately from the first arm 11 (three pairs of sites 51, 52) and from the second arm 12 (two pairs of sites 53, 54). Preferably, the sites 50 of the same arm are substantially equidistant. The distance separating two adjacent sites 51, 52 or 53, 54 corresponds to the progressive advance of the strand from the apex zone 3 towards the distal portion of each arm. In contrast, as illustrated in FIGS. 1, 2 and 4, two sites 50 passed through in sequence on the first arm 11 and the second arm 12 (and conversely on the second arm 12 and the first arm 11) are at a substantially identical distance from the apex zone 3. As shown in FIG. 3, this distance may be greater. Whatever the case, the path of the first strand 21 ends at the distal portion of the first arm 11, towards the interior of the hoop.

[0057] The second strand 22 of the suture filament 20 for its part penetrates the braid 2 several times at two sites 60 situated on the second arm 12. More precisely, it passes through two sites 60 of the second arm 12, two or four times, always towards the exterior and then towards the interior of the hoop and progressing from the vicinity of the apex zone towards the distal portion of the second arm 12. In accordance with an alternative embodiment shown in FIG. 1, the second strand 22 passes through the braid 2 at two sites of the second arm 12, namely a site 61 in the vicinity of the apex zone 3 and the other site 62 in the vicinity of the distal portion 121 of said second arm. The same applies to the variation shown in FIG. 2. In these cases, it is preferable for the two sites 61, 62 to surround the sites 53, 54 of the second arm 12 through which the first strand 21 passes, i.e. for the sites 53, 54 through which the first strand 21 passes to be located between the two sites 61, 62 through which the second strand 22 passes. In accordance with alternative embodiments shown in FIGS. 3 and 4, the second strand 22 passes through the braid 2 at four sites 60, which may or may not be interposed between the pairs of sites 53, 54 through which the first strand 21 passes.

Example 2

[0058] The surgical device in a second variation embodiment may comprise an anchor 1 assembled with two suture filaments 20, 30. The anchor 1 consists of a braid 2 curved into a hoop, and the first suture filament 20 is associated with this anchor by passing the braid 2 transversely from one side to the other at a plurality of sites 50, as described in Example 1 above. FIG. 5 illustrates a device in a deployed configuration, in which a second suture 30 is associated with the assembly shown in FIG. 1. This device may also be associated with the other assemblies presented in Example 1.

[0059] The second suture 30 is associated with the anchor 1 by passing the braid 2 transversely from one side to the other at two mutually adjacent sites 71, 72 situated on the apex zone 3 of the anchor 1. A standard type suture filament produced from UHMWPE polyethylene, with a diameter of USP 2, with a colour which makes it easy to distinguish it from the first suture, has been used here. It is threaded through the meshes of the braid 2 which move slightly apart when a tool such as a splicing needle passes through it, without it being necessary to make any perforations. The second filament 30 passes from the exterior towards the interior of the hoop in a manner such that a portion of the suture filament 30 is placed above the apex zone 3, and against the apex zone when the second suture filament is extended. This portion, known as the median portion 33, separates a first strand 31 and a second strand 32 of the suture 30. Each strand passes through the braid 2 transversely from one side to the other at the sites 71, 72, which extends between the arms 11, 12 of the anchor 1, and then terminates in a free end 311 and 321, with a length of several tens of cms (for example from 20 cm to 70 cm), allowing the soft tissues to be ligatured in a convenient manner. These lengths and positions are given for a device in the state in which the surgeon receives it, but they may be modified during its handling, in particular by sliding or gliding the suture filament 30 relative to the braid 2. As illustrated in FIG. 5, the strands 31, 32 of the second suture filament 30 may be interlaced with the portions of the first suture filament 20 circulating transversely between the sites 50 of the first and second arms 11, 12, passing alternately above and below. The routing of the strands 31, 32 of the second suture filament 30 is advantageously simultaneous, so as to create a passage and to provide guidance for an insert 100 as far as the apex zone 3, as illustrated in FIG. 6.

[0060] Tests carried out on the anchoring device in accordance with the invention have exhibited excellent results as regards the mechanical properties of tensile strength during their installation. Their properties from the point of view of their expansion in volume and expansion have been tested successfully with regard to the risk of tearing. In addition, the function of sliding before and after implantation, essential for the production of surgical knots, is ensured. Their size is satisfactory, no excess material having been observed. Finally, mounting on the inserter does not give rise to any difficulties.