SYSTEMS AND METHODS FOR REPAIRING SOFT TISSUES

Abstract

A wicking component is integrated into an arthroscopically deployable bone anchor, and is intended to improve soft tissue-to-bone repair. Once deployed, the fibrous wick component extends from within the bone tunnel, out of the hole, and to the bone-tendon interface on the bone surface. The tissue is approximated against the bone, sandwiching the wick material between the bone and tissue. The wick component is ideally a polymeric fibrous or tissue-based scaffold that provides a pathway for cells (autologous bone marrow constituents and blood) to travel from within the bone to the soft tissue-bone interface, accelerating and promoting the healing response. The system provides a biomimetic structure that stimulates the extracellular matrix to encourage cell attachment and potentially improve the healing response. The wick component does not need to be integrated into a suture anchor and installed when the suture anchor is deployed. For example, the wick component could be placed above or near a traditional suture anchor after it has been deployed.

Claims

1.-20. (canceled)

21. An anchoring system for securing soft tissue to bone, comprising: a delivery shaft with a distal end insertable into a tunnel formed in a bone; a single unitary piece of fiber material including an elongated distal portion and a proximal head portion, the single unitary piece of fiber material carried upon the delivery shaft for delivering the single unitary piece of fiber material to the bone, wherein the single unitary piece of fiber material being so carried includes a first section of the elongated distal portion extending longitudinally along a first side of the delivery shaft and a second section of the elongated distal portion extending longitudinally back along a second side of the delivery shaft opposite the first side, the elongated distal portion having a first width permitting the elongated distal portion to be received in the tunnel, the proximal head portion to reside outside the tunnel sandwiched between the soft tissue and the bone in the form of a sheet for promoting a healing response between the soft tissue and the bone when the elongated distal portion is received in the tunnel, the proximal head portion having a second width that is wider than said first width; and a suture anchor received on the delivery shaft for delivering the suture anchor into the tunnel, the suture anchor formed unconnected to the single unitary piece of fiber material.

22. The anchoring system of claim 21 further comprising a floating suture coupled to the suture anchor for extending back out of the tunnel through an opening in an outer surface of the bone when the suture anchor is received in the tunnel.

23. The anchoring system of claim 21, wherein the suture anchor is a screw-in anchor.

24. The anchoring system of claim 21, wherein the suture anchor is an all-suture anchor pullable a distance back through the tunnel following delivery for expanding the all-suture anchor in the tunnel to secure the all-suture anchor in the tunnel, the all-suture anchor pullable via a floating suture coupled to the all-suture anchor for extending back out of the tunnel through an opening in an outer surface of the bone when the all-suture anchor is received in the tunnel.

25. The anchoring system of claim 21, wherein the elongated distal portion includes a folded section folded around the distal end of the delivery shaft.

26. The anchoring system of claim 25, wherein the folded section is positioned distally of the suture anchor along the delivery shaft.

27. The anchoring system of claim 21, wherein the elongated distal portion includes a first hole therein that is located between the first section and the second section, the delivery shaft extending through the first hole.

28. The anchoring system of claim 27, wherein a leading portion of the suture anchor is positioned distally of the first hole along the delivery shaft.

29. The anchoring system of claim 28 further comprising a floating suture coupled to the suture anchor, the floating suture extending from the suture anchor back through the first hole.

30. The anchoring system of claim 27 further comprising a distal anchor element received on the delivery shaft for delivering the distal anchor element into the tunnel, the distal anchor element having a second hole formed therein, the delivery shaft extending through the second hole to position the second hole distally of the first hole along the delivery shaft.

31. The anchoring system of claim 30 further comprising a proximal anchor element received on the delivery shaft, the proximal anchor element having a third hole formed therein, the delivery shaft extending through the third hole to position the first hole between the second hole and the third hole along the delivery shaft.

32. An anchoring system for securing soft tissue to bone, comprising: a delivery shaft with a distal end insertable into a tunnel formed in a bone; a single unitary piece of fiber material including an elongated distal portion and a proximal head portion, the single unitary piece of fiber material carried upon the delivery shaft for delivering the single unitary piece of fiber material to the bone, the elongated distal portion having a first width permitting the elongated distal portion to be received in the tunnel, the proximal head portion to reside outside the tunnel sandwiched between the soft tissue and the bone in the form of a sheet for promoting a healing response between the soft tissue and the bone when the elongated distal portion is received in the tunnel, the proximal head portion having a second width that is wider than said first width; an all-suture anchor received on the delivery shaft for delivering the all-suture anchor into the tunnel, the all-suture anchor formed unconnected to the single unitary piece of fiber material; and a floating suture coupled to the all-suture anchor for extending back out of the tunnel through an opening in an outer surface of the bone when the all-suture anchor is received in the tunnel, the floating suture usable to pull the all-suture anchor a distance back through the tunnel following delivery for expanding the all-suture anchor in the tunnel to secure the all-suture anchor in the tunnel.

33. The anchoring system of claim 32, wherein the elongated distal portion includes a first section extending longitudinally along a first side of the delivery shaft and a second section extending longitudinally back along a second side of the delivery shaft opposite the first side.

34. The anchoring system of claim 33, wherein the elongated distal portion includes a folded section folded around the distal end of the delivery shaft.

35. The anchoring system of claim 34, wherein the folded section is positioned distally of the all-suture anchor along the delivery shaft.

36. The anchoring system of claim 32, wherein the elongated distal portion includes a first hole therein that is located between the first section and the second section, the delivery shaft extending through the first hole.

37. The anchoring system of claim 36, wherein a leading portion of the all-suture anchor is positioned distally of the first hole along the delivery shaft.

38. The anchoring system of claim 37, wherein the floating suture extends from the all-suture anchor back through the first hole.

39. The anchoring system of claim 36 further comprising a distal anchor element received on the delivery shaft for delivering the distal anchor element into the tunnel, the distal anchor element having a second hole formed therein, the delivery shaft extending through the second hole to position the second hole distally of the first hole along the delivery shaft.

40. The anchoring system of claim 32, wherein the single unitary piece of fiber material provides a pathway for cell travel from bone marrow within the tunnel to an area between the soft tissue and the bone.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] FIG. 1 is a schematic drawing of a first prior art approach for repairing a rotator cuff;

[0032] FIG. 2 is a schematic drawing of a second prior art approach for repairing a rotator cuff;

[0033] FIG. 3 is a schematic drawing of a third prior art approach for repairing a rotator cuff;

[0034] FIG. 4 is an isometric view of a sheath wick construct in accordance with the principles of the present invention;

[0035] FIG. 5 is a view illustrating the flat pattern of the wick component of FIG. 4;

[0036] FIG. 6 is an isometric view of the sheath of FIG. 4;

[0037] FIG. 7 is a cross-sectional view of the sheath wick anchor embodiment shown in FIG. 4 adjacent to a bone tunnel prior to insertion thereof;

[0038] FIG. 8 is a cross-sectional view similar to FIG. 7, after the sheath wick anchor has been inserted into the bone tunnel;

[0039] FIG. 9 is a cross-sectional view of the sheath wick anchor of FIG. 4 in a deployed configuration;

[0040] FIG. 10 is an isometric view of the deployed sheath wick construct of FIGS. 4-9;

[0041] FIG. 11 is an isometric view of an alternative embodiment of the invention, comprising an all suture PEEK hybrid anchor construct;

[0042] FIG. 12 is a view illustrating the flat pattern of the wick component of FIG. 11;

[0043] FIG. 13 is a cross-sectional view of the hybrid anchor construct of FIG. 11, disposed adjacent to a bone tunnel prior to insertion;

[0044] FIG. 14 is a cross-sectional view similar to FIG. 13, after the hybrid anchor has been inserted into the bone tunnel;

[0045] FIG. 15 is a cross-sectional view of the hybrid anchor in a deployed configuration;

[0046] FIG. 16 is an isometric view of the deployed hybrid anchor construction of FIGS. 11-15;

[0047] FIG. 17 is an isometric view of an add-on wick assembly constructed in accordance with the principles of the present invention; and

[0048] FIG. 18 is an isometric view of the add-on wick assembly of FIG. 17 in a deployed configuration.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0049] Referring now more particularly to the drawings, it is noted that the embodiments shown and described herein comprise a wick component integrated into a suture anchor that is deployed using current arthroscopic methods. In particular, the described embodiments are usable with and build upon the SURELOCK™ all-suture anchor, currently marketed by the assignee of the present application, Cayenne Medical, Inc., of Scottsdale, Ariz. The SURELOCK suture anchor is disclosed, for example, in commonly assigned U.S. patent application Ser. No. 14/639,943, entitled All-Suture Suture Anchor Systems and Methods, filed on Mar. 5, 2015 and presently pending. An all-suture suture anchor is also disclosed in commonly assigned U.S. patent application Ser. No. 14/589,960, entitled All-Suture Suture Anchor Systems and Methods, filed on Jan. 5, 2015, and also presently pending. Both of these prior applications are herein expressly incorporated by reference, in their entirety. Of course, other types of suture anchors could be used in connection with the invention, as those of ordinary skill in the art will discern.

[0050] The all-suture anchor provides the structural support for the floating sutures that secure the tissue against the bone in the present invention. The PEEK (Polyether ether ketone) and wick components provide the wick pathway from the cancellous bone marrow to the bone tissue interface.

[0051] A sheath wick construct 6 is illustrated in FIGS. 4-10. This embodiment adds three primary elements to the aforementioned SURELOCK all-suture anchor 8 and inserter. One of these three elements is a wick component 10. Also present are a sheath 12 for protecting the wick 10 during insertion and deployment of the all-suture anchor 8, as well as an outer sleeve or deployment tube sleeve 14 to house the construct and provide a depth limiter. FIG. 4 illustrates the sleeve 14 in a fully retracted orientation, with the wick 10 in a deployed orientation.

[0052] The wick component 10 in this embodiment may be made from an 85/15 L lactide/glycolide polymer, electrospun into a thin scaffold sheet. Both sides of the sheet comprise aligned microfibers 16 of material (FIG. 5), aligned in the direction shown, lengthwise along a longitudinal axis of the wick. As illustrated, the wick 10 comprises a paddle portion 18, which is adapted to be oriented substantially orthogonally relative to a longitudinal axis of the device 6 and is planar in configuration, and an elongated portion 20, which is adapted to be disposed longitudinally relative to the device 6, and in engagement with a corresponding elongated portion 22 of the sheath 12, as shown in FIG. 4. When deployed, the fibers 16 are aligned with the direction of travel of the cells from the bone marrow to the surface, as well as with the linearly oriented fibers of the soft tissue. The term “microfiber” is intended to include nanofibers, as well as other small diameter fibers up to and including approximately 1×10.sup.−4 m, and more preferably in the range of approximately 0.1-20 μm.

[0053] The sheet material is cut into a shape similar to that shown in FIG. 5. The long, narrow elongated portion 20 is wrapped around the tip of the all suture anchor 8 prior to deployment, and the paddle portion 18 is wrapped around inserter shaft 24, inside the deployment tube sleeve 14. After the anchor is deployed, the elongated portion 20 runs from the bottom of the bone tunnel, alongside the all-suture anchor 8, up to the bone surface. The paddle portion 18 lies on the bone surface, underneath the soft tissue being repaired.

[0054] The sheath 12, in one embodiment, is made from a thin sheet of PEEK or other suitable material, which is cut into the illustrated shape, and runs along the length of the anchor on top of the wick 10, wrapping around the tip of the inserter. The function of the sheath 12 is to protect the fragile wick 10 as the anchor is inserted into the bone tunnel and during deployment of the all-suture anchor 8. The sheath 12 may have holes or slots 26 cut into it, as shown in FIG. 6, to improve fluid communication between the bone marrow and the wick 10 or to improve the pull-out force of the anchor.

[0055] The components are held in place by the deployment tube sleeve 14 prior to deployment, as shown in FIG. 7. The tip of the inserter (with the anchor 8) is placed into a bone tunnel 28. The end of the deployment tube sleeve 14 bottoms out against the bone surface 30. As the anchor is malleted into the bone tunnel 28, the deployment tube sleeve 14 slides with respect to the inserter shaft 24 and stays stationary against the bone surface 30 (FIG. 8). The deployment tube sleeve bottoms out against the inserter handle 32, to act as a depth stop for the anchor construct 6. Once the anchor is inserted to the proper depth, the all-suture anchor 8 is deployed by turning the knob 32 on the inserter. The anchor is pulled upwardly by floating sutures 34 and expands to compress against the walls of the bone tunnel 28, securing it within the bone. Once it is fully deployed, the inserter is removed by pulling it away from the bone surface 30. The paddle portion 18 of the wick 10 is pulled out of the deployment tube sleeve 14 and can be folded down to sit on the surface of the bone 30, as shown in FIGS. 9 and 10. The wick 10 provides a pathway to move bone marrow constituents from the bone tunnel 28 up to the interface between the bone surface (below the paddle portion 18) and the soft tissue 36 (above the paddle portion 18).

[0056] The repair is completed by passing the floating sutures 34 through the soft tissue 36, and knots are tied to secure the soft tissue 36 against the bone 30, sandwiching the wick material 10 between the bone and tissue.

[0057] FIGS. 11-16 illustrate another embodiment of the present invention, namely a PEEK anchor hybrid construct 38. When describing this embodiment, those elements which correspond to elements described in connection with the embodiment of FIGS. 1-10 are denoted by corresponding reference numerals in the drawings. As noted above in connection with construct 6, the construct 38 also adds three primary components to the existing SURELOCK all-suture anchor, or to other all-suture anchors which might be utilized in connection with the invention. In particular, the embodiment 38 includes a wick component 10, a two-piece PEEK barbed anchor 40, and a deployment tube sleeve 14. The two-piece barbed anchor protects the wick 10 during insertion into the bone tunnel 28 and secures it after deployment. In FIG. 11, the deployment tube sleeve 14 is shown in its fully retracted configuration.

[0058] The wick component 10 is preferably made from 85/15 L lactide/glycolide polymer, or other suitable material, electrospun into a thin scaffold sheet. Both sides of the sheet comprise aligned micro fibers of material 16, aligned in the illustrated direction along a longitudinal axis of the wick. When deployed, the fibers are aligned with the direction of travel of the cell from the bone marrow to the surface, as well as with the linearly oriented fibers of the soft tissue.

[0059] The sheet material for the wick 10 may be cut into a shape similar to that shown in FIG. 12. The narrow elongated end 20 is wrapped between the two PEEK anchor pieces 42 and 44, and the inserter shaft tip and floating sutures 34 run through the hole. The paddle portion 18 is wrapped around the inserter shaft 24, inside the deployment tube sleeve 14. After the anchor is deployed, the narrow elongated end 20 runs from the bone surface 30, down into the bone tunnel 28 alongside the PEEK anchor 40, and back up to the bone surface. The larger paddle portion 18 lies on the bone surface 30, underneath the soft tissue 36 being repaired.

[0060] The function of the PEEK barbed anchor pieces, including the distal piece 42 and the proximal piece 44 are to protect the fragile wick material 10 as the anchor is inserted into the bone tunnel 28. The distal anchor piece 42 enlarges the hole 28 as it is inserted to make room for the narrow strip 20 of wick material. Once the anchor is in place, the wick 10 is captured between the distal and proximal anchor pieces 42, 44, respectively, to secure it in place in the bone tunnel. The PEEK anchor pieces also compress against the sides of the bone tunnel 28 and add to the pull-out strength of the all-suture anchor alone, especially in soft bone.

[0061] The components are held in place by a deployment tube sleeve 14 prior to deployment, as shown in FIG. 13. The tip of the inserter (with the anchor) is placed into the bone tunnel 28, as shown in FIG. 14. The end 46 of the deployment tube sleeve 14 bottoms out against the bone surface 30. As the anchor is malleted into the bone tunnel 28, the deployment tube sleeve 14 slides with respect to the inserter shaft 24 and stays stationary against the bone surface 30, as also shown in FIG. 14. The deployment tube sleeve 14 bottoms out against the inserter handle 32 to act as a depth stop for the anchor construct 40. Once the anchor is inserted to the proper depth, the all-suture anchor 8 is deployed by turning the knob 32 on the inserter. The anchor is pulled upwardly by the floating sutures 34 and expands to compress against the walls of the bone tunnel, securing it within the bone. Once it is fully deployed, the inserter is removed by pulling it axially away from the bone surface. The paddle end 18 of the wick 10 is pulled out of the deployment tube sleeve 14 and can be folded down to sit on the surface of the bone, as shown in FIG. 15. The wick 10 provides a pathway to move bone marrow constituents from the bone tunnel up to the interface between the bone surface (beneath the paddle portion 18) and the soft tissue 36 (above the paddle 18).

[0062] As shown in FIG. 16, the repair is completed by passing the floating sutures 34 through soft tissue 36, and knots are tied to secure the soft tissue against the bone 30, sandwiching the wick material 10 between the bone 30 and tissue 36.

[0063] A logical extension of the all-suture PEEK hybrid anchor concept disclosed above is a separate system that only comprises the two-part PEEK anchor and wick components, as shown in FIG. 17. This assembly 48 may be loaded into an inserter that allows the practitioner to deploy the assembly on top of any traditional pre-loaded suture anchor, after that anchor has been implanted and deployed. Examples of such anchors, by no means limiting, include the suture anchors sold by the assignee, Cayenne Medical, Inc., under the trademarks QUATTRO X or SURELOCK, but other competitor's pre-loaded suture anchors may be employed as well.

[0064] Now with reference particularly to FIG. 18, as well as FIG. 17, a procedure for implanting the assembly 48 will be described. This procedure comprises first deploying a pre-loaded suture anchor 8 into the desired procedural site, which may comprise the footprint of the rotator cuff, as discussed in connection with the preceding embodiments, and includes a bone tunnel 28 and a bone surface 30. The pre-loaded suture anchor 8 may include an all-suture suture anchor, or one of the screw-in or push-in type, for example. The floating sutures 34 from the suture anchor are snared through the tip of the inserter, through the center of the anchor wick assembly, and out through a window 50 in the inserter shaft. The inserter tip travels down the floating sutures 34 to the suture anchor 8. The proximal end of the inserter is malleted lightly to drive the two-piece PEEK and wick anchor into the tunnel 28, above the suture anchor. The inserter is removed and the wick 10 is flattened against the bone surface. The floating sutures 34 are passed through the rotator cuff tissue. Knots are tied over the top of the tissue, securing the soft tissue against the bone and sandwiching the wick between the bone and tissue, as in the prior embodiments.

[0065] While the foregoing particular embodiments and methods have been shown and described, particularly in connection with the repair of a rotator cuff, one skilled in the art will recognize other suitable applications for the disclosed system and methods. The system is applicable in any situation wherein suture anchors are appropriately used, to assist in promoting the healing process, by the use of a suture anchor with a built-in aligned monophasic nanofiber or microfiber scaffold placed as an interpositional material between a repaired soft tissue member and the underlying bone insertion site, for improvement of the speed of soft tissue healing, strength of the healed soft tissue, cellular patterns at the insertion site, and no requirement for modification to accepted arthroscopic standard-of-care technique. Examples include, but are not limited to, the repair of biceps tenodesis, repair of osteo condral defects, glenoid repair, meniscal repair, tendon repair, or the repair of an ACL (anterior cruciate ligament), in conjunction with the usage of the APERFIX system, manufactured and sold by the assignee, Cayenne Medical, Inc.

[0066] Accordingly, although an exemplary embodiment of the invention has been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.