Patent Grant
11583384
The present invention relates generally to soft tissue repair sites. More particularly, the present invention relates to devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone.
One of the most common needs in orthopedic surgery is the fixation of soft tissue, such as ligament or tendon, to bone. Typically, fixating soft tissue to bone is implemented with a bone anchor and suture material with suture coupled between the soft tissue and the bone anchor such that the soft tissue is cinched in against the bone. However, coupling suture to soft tissue is time consuming and often requires complex suture patterns for effective fixation, often requiring specialized surgeons. While this can provide a good initial repair, the strength and quality of the repair may quickly degrade with subsequent loading and mobilization, depending on the activity level of the patient, which often results. As such, it would be advantageous to eliminate the complexity and the time consuming nature of this type of surgery while also increasing the long term effectiveness of the procedure.
Embodiments of the present invention are directed to various devices, systems and methods for repairing soft tissue at a soft tissue repair site. For example, in one embodiment, a repair device for fixating to soft tissue at a soft tissue repair site is provided. The repair device includes an anchor member, a capture member, and one or more flexible members. The anchor member includes a base with at least four legs extending integrally from the base, the at least four legs configured to be moveable from a straight first position to a formed second position. The capture member is configured to be coupled to the anchor member such that the at least four legs of the anchor member move around structural portions of the capture member with the at least four legs of the anchor member in the formed second position. The one or more flexible members are coupled to the base of the anchor member, the one or more flexible members extending at least partially along the base of the anchor member.
In another embodiment, the base includes multiple recesses defined therein, the recesses sized and configured to receive the one or more flexible members for coupling the one or more flexible members to the base. In another embodiment, the at least four legs each extend from the base with a length, a width, and a depth, the length being longer than the width and the depth, the width extending with a first taper and a second taper along the length of the at least four legs, the first and second tapers of the at least four legs sized and configured to facilitate the at least four legs to be moveable to the formed second position. In still another embodiment, the at least four legs extend from an outer periphery of the base with a curvature to extend downward relative to an underside surface of the base of the anchor member.
In another embodiment, the one or more flexible members includes one or more filaments sized and configured to wrap around portions of the base. In still another embodiment, the one or more flexible members include a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member. In yet another embodiment, the one or more flexible members are configured to be coupled to a bone anchor.
In another embodiment, the capture member extends with multiple apertures defined therein, each one of the multiple apertures sized and configured to correspond with one of the at least four legs of the anchor member. In still another embodiment, the capture member extends with a generally flat configuration.
In accordance with another embodiment of the present invention, a repair device system for fixating soft tissue to bone is provided. The repair device system includes a bone anchor with an elongated structure, a soft tissue anchor member, and one or more flexible members. The soft tissue anchor member includes a base with multiple legs integrally extending from the base, the legs configured to be moveable from a straight first position to a formed second position, the soft tissue anchor configured to be coupled to soft tissue with the legs in the formed second position. With this arrangement, the soft tissue anchor is coupled to the bone anchor with the one or more flexible members.
In another embodiment, the repair device system further includes a capture member configured to be coupled to the anchor member such that the legs of anchor member curl around structural portions of the capture member with the legs in the formed second position. In another embodiment, the capture member extends with a generally flat configuration. In still another embodiment, the capture member includes tines configured to extend upward toward the base of the anchor member.
In another embodiment, the multiple legs extend from an outer periphery of the base with a curvature to extend downward relative to an underside surface of the base of the anchor member. In another embodiment, the multiple legs each extend from the base with a length, a width, and a depth, the length being longer than the width and the depth, the width extending with a first taper and a second taper along the length of the legs, the first and second tapers of the legs sized and configured to facilitate the legs to be moveable to the formed second position. In another embodiment, the one or more flexible members include a first flexible member and a second flexible member, the first flexible member coupled to the base of the soft tissue anchor member and the second flexible member directly coupled to the first flexible member and coupled to the bone anchor.
In accordance with another embodiment of the present invention, a method for fixating to soft tissue at a soft tissue repair site is provided. The method including the steps of: providing a delivery device coupled to an anvil with an anvil surface having anvil buckets defined therein, the delivery device configured to hold an anchor member with a base and at least four legs integrally extending from the base, the anchor member including one or more flexible members coupled to the base; positioning soft tissue over the anvil surface of the anvil; and forcing the at least four legs of the anchor member with the delivery device through the soft tissue to then compress the at least four legs into the anvil buckets so that the at least four legs of the anchor member are formed to couple to the soft tissue.
In another embodiment, the method step of providing includes providing a capture member over the anvil surface so that, upon forcing the at least four legs, the at least four legs wrap around structural portions of the capture member so that the soft tissue is captured between the base of the anchor member and the capture member. In another embodiment, the method further includes the step of coupling the one or more flexible members to a bone anchor. In still another embodiment, the method step of forcing includes forcing the one or more flexible members through the soft tissue with a needle structure.
In accordance with another embodiment of the present invention, a repair device system for fixating soft tissue to bone with a bone anchor is provided. The repair device system including a delivery device and an anchor member. The delivery device includes an anvil surface, the anvil surface defining anvil buckets therein. The anchor member includes a base with at least four legs extending from the base. Further, the base includes one or more flexible members coupled thereto. With this arrangement, the at least four legs are configured to be compressed against the anvil buckets to move the at least four legs to a formed configuration for fixation to the soft tissue and the one or more flexible members are configured to be coupled to the bone anchor.
In another embodiment, the repair device system further includes a capture member, the capture member configured to be positioned over the anvil surface and configured to be captured by the at least four legs of the anchor member upon the at least four legs being moved to the formed configuration. In another embodiment, the one or more flexible members are configured to be coupled to a bone anchor. In still another embodiment, the one or more flexible members includes a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member. In another embodiment, the delivery device includes a needle structure sized and configured to deliver the one or more flexible members through the soft tissue.
In accordance with another embodiment of the present invention, a repair device for fixating to soft tissue at a soft tissue repair site is provided. The repair device includes an anchor member and one or more flexible members. The anchor member includes a base with at least four legs integrally extending from the base, the at least four legs sized and configured to move from a straight first position to a formed second position. The one or more flexible members are coupled to the base of the anchor member, the one or more flexible members extending adjacent a periphery of the base.
In another embodiment, the one or more flexible members are coupled to the anchor member by wrapping the one or more flexible members around portions of the base. In another embodiment, the one or more flexible members are configured to be coupled to a bone anchor. In still another embodiment, the one or more flexible members include a first flexible member and a second flexible member, the second flexible member configured to couple to the first flexible member. In still another embodiment, the base includes recesses defined therein, the recesses sized and configured to facilitate coupling the flexible member to the base. In yet another embodiment, the formed second position of the at least four legs of the anchor member exhibit a curled configuration.
The foregoing and other advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which:
Various embodiments are disclosed herein of a soft tissue repair device and system. Such repair device and system may be sized and configured to approximate and fuse, for example, soft tissue to bone. The various embodiments may provide structure that maintains the soft tissue against bone in an abutting relationship, without gapping. In this manner, the repair device and system of the present invention may provide the proper healing required for fusing the soft tissue to bone.
Now with reference to
With respect to
In one embodiment, the base 18 may include coupling structure 29 for coupling the one or more flexible members 16 to the base 18. Such coupling structure 29 may include recesses, notches, protrusions, and/or openings formed in the base 18. The coupling structure 29 of the anchor member 12 may also include a portion of the legs 20, such as the curved portion 21 of the legs 20 or leg portions adjacent the base 18. In this manner, the legs 20 may be employed, at least in part, as the coupling structure 29. For example, the coupling structure 29 formed in the base 18 may include multiple recesses 30 defined in the base, the recesses 30 sized and configured to facilitate wrapping the first flexible member 17 to the base 18 of the anchor member 12. Such recesses 30 may be defined in the outer periphery 22 of the base 18 and may extend between the upper surface 26 and the lower surface 28 of the base 18. The inner periphery 24 of the base 18 may extend with bumps 32 or protrusions that correspond with the recesses 30 defined in the base 18.
The one or more flexible members 16 may be formed from one or more filaments or fibers. The filaments or fibers may be formed from a polymeric material or a natural fiber. In one embodiment, the filaments or fibers may be a polyethylene material, such as ultra-high-molecular-weight polyethylene (“UHMWPE”), a polyester material, a polypropylene material, or the like. In another embodiment, the one or more flexible members 16 may be formed of suture material and/or extend as a suture. In another embodiment, the polymeric filament or fiber may be a bioresorbable material, such as polylactide (“PLA”), polycaprolactone (“PCL”), polydioxanone (“PDX”), or the like, or any other suitable bioresorbable material as known to one of ordinary skill in the art. In another embodiment, the filaments or fibers may be formed in a woven or braided configuration or may extend with strands wound in a side-by-side configuration, or may extend with strands wound side-by-side and in a twisted configuration or any other suitable configuration to form a flexible member. In another embodiment, the one or more flexible members 16 may be a continuous loop. In another embodiment, the continuous loop may include a woven or braided structure. In another embodiment, the one or more flexible members 16 may extend with at least two free ends.
The anchor member 12 may be laser cut from sheet material or cut from the sheet material with any other suitable process. As such, the anchor member 12 may be a monolithic structure or a seamless unitary structure. The base 18 may include an outer diameter and an inner diameter, the outer diameter defined by the outer periphery 22 and the inner diameter defined by the inner periphery 24. The inner periphery 24 of the base 18 may define a central opening 25 of the base 18. In one embodiment, the tissue anchor axis 27 may be centrally located so that the tissue anchor axis 27 extends axially through the central opening 25. The base 18 may also define a thickness 34 similar to the thickness of the sheet material. As such, the base 18 may extend with a substantially flat structure or configuration with the upper surface 26 and the lower surface 28 being substantially planar. The outer periphery 22 and inner periphery 24 of the base 18 may extend radially relative to the tissue anchor axis 27 (or about the axis 27) along a majority of the outer and inner peripheries 22, 24 such that the outer and inner peripheries exhibit a generally circular profile (as viewed from the top or bottom of the anchor member 12). Further, the legs 20 may include a length 36, a width 38, and a depth 40, the depth being similar to the thickness of the base 18, which also may correspond with the thickness of the sheet material. The width 38 may include multiple tapers along the longitudinal length 36 of the legs 20. For example, the width 38 may include a first taper 42 and a second taper 44, each of which may be sized and configured to manipulate a direction and orientation for the legs 20 to curl and/or wrap upon being compressed against an anvil (not shown), discussed further herein. The first taper 42 may extend from adjacent to the curved portion 21 of the legs along a majority of the length 36 of the legs 20. The second taper 44 may extend from an end of the first taper to a free end 43 of the legs 20 such that the second taper 44 is shorter than the first taper 42.
With reference to
Further, the capture member 14 may include an upper surface 48 and a lower surface 50 such that the apertures 46 extend through and between the upper and lower surfaces 48, 50 of the capture member 14. The capture member 14 may also define an outer periphery 52 and an inner periphery 54 such that the inner periphery 54 may define a central opening of the capture member 14. The upper surface 48 and the lower surface 50 of the capture member may extend to the outer and inner peripheries 52, 54 of the capture member 14. The capture member 14 may also include tines 56 extending upward above the upper surface 48. The tines 56 may extend from the inner periphery 54 and may be sized and configured to engage with soft tissue. Further, the tines 56 may extend in an inward canted manner or may extend substantially perpendicular relative to the upper surface 48 of the capture member 14. Such capture member 14, similar to the anchor member 12, may be formed as a monolithic, seamless structure from sheet material. As such, but for the tines 56, the capture member may be a substantially flat structure or configuration. Further, the upper surface 48 and lower surface 50 may extend in a planar manner. Further, the structure of the capture member 14 may define a capture member axis 57 that may extend centrally and axially relative to the structure of the capture member 14 such that the capture member axis 57 may extend substantially perpendicular relative to the upper and lower surfaces 48, 50 of the capture member 14.
In one embodiment, the sheet material for forming the anchor member 12 and the capture member 14 may be formed from a metallic material, such as stainless steel, titanium, or Nitinol, or any other suitable medical grade material or combinations of materials. As previously set forth, such anchor member 12 and capture member 14 may be laser cut from the sheet material or cut using any suitable technique known in the art. In another embodiment, the anchor member 12 may be formed from a polymeric material or a bioresorbable material, formed and manufactured as known by one of ordinary skill in the art. Upon being cut from the sheet material, the legs 20 of the anchor member 12 may be bent to position the legs downward or moved to orient the legs to extend away from a single side or underside of the anchor member 12. Similarly, the tines 56 of the capture member 14 may be bent upward, such as at a canted orientation or substantially perpendicular relative to the upper surface 48 of the capture member 14. Once the legs 20 or tines 56 have been appropriately oriented and bent into position, the anchor member 12 and capture member 14 may undergo an electro polishing or chemical polishing process, as known to one of ordinary skill in the art. In another embodiment, the anchor member 12 and/or the capture member 14 may be formed from a medical grade polymeric material, as known to one of ordinary skill in the art. In another embodiment, the anchor member 12 and/or the capture member may be formed from a bioresorbable material, as known to one of ordinary skill in the art.
Now with reference to
In one embodiment, as depicted in
In one embodiment, the second flexible member 60 may extend with two free ends. In another embodiment, the second flexible member 60 may extend as a continuous loop. Such free ends or an end portion of a continuous loop may be configured to be coupled to a bone anchor (not shown), discussed further herein. In this manner, along such lengths 62 or portions of the first flexible member 17 being the coupling structure, the second flexible member 60 may be wrapped and coupled to the first flexible member 17. With this arrangement, the coupling between the second flexible member 60 and the first flexible member 17 may be more resistant to fatigue, fraying and/or deterioration since the coupling is between flexible members, without rigid edges between the coupling thereof. Further, such coupling may be advantageous because the first flexible member 17 may act somewhat resiliently to any force placed on the second flexible member 60. Further, upon a force being placed upon the second flexible member 60, such as from being coupled to a bone anchor, the coupling of the second flexible member 60 to the first flexible member 17, such as at each length 62 or expanse, may distribute the force along the base 18 of the anchor member 12. In this manner, the one or more flexible members 16 may act to distribute the force along the tissue adjacent the repair device 10 as well as minimize the stress being placed upon the soft tissue and the one or more flexible members 16 to, thereby, maintain the repair device 10 intact with the soft tissue.
Now with reference to
Once the capture member 14 may be positioned over the anvil upper surface 74, the soft tissue may then be positioned over the capture member 14. The anvil 70 may also include a neck portion 80 extending laterally from the anvil upper surface 74 with an upward extension 82 spaced from the anvil upper surface 74. The upward extension 82 of the neck portion 80 may be coupled to the guide portion 72. With this neck portion 80, there is additional space for positioning the soft tissue over the anvil upper surface 74 of the anvil 70. Upon positioning the soft tissue 5 over the anvil 70 (see
With reference to
The implant delivery member 65 may include a cradle 90, a cartridge 92 and a pusher member 94, each of which may be sized and configured to cooperate with the repair device 10. The cartridge 92 may be linearly slidable along and coupled to the guide portion 72 with a c-arm or channel or the like extending along an underside of the cartridge 92. The guide portion 72 may be fixedly coupled to an elongated extension 82 of the cradle 90. The cartridge 92 may be hollow or define a hollow portion so as to define an opening 96 that may extend through opposite sides of the cartridge 92. The pusher member 94 may be positionable within a proximal side of the hollow portion or opening 96 of the cartridge 92. The proximal side of the opening 96 may be covered by a cap 98. Adjacent a distal side of the opening 96 or hollow portion, the anchor member 12 may be positioned distally adjacent the pusher member 94 within the cartridge 92. Further, the cartridge 92 may define internal grooves 104 in structure along the distal side of the hollow portion or opening 96, the internal grooves 104 sized and configured to hold the legs 20 of the anchor member 12 such that legs 20 of the anchor member 12 may be pushed through the cartridge 92 and along the internal grooves 104.
In one embodiment, the elongated extension 82 extending from the neck portion 80 of the cradle 90 may be fixedly coupled to a tongue portion 100. Such tongue portion 100 may be coupled to an underside of the elongated extension 82, the tongue portion 100 and elongated extension 82 may act and be referenced as a base or base portion of the implant delivery member 65. Further, the tongue portion 100 may include threads 102 along a portion thereof, such as along an upper side of the tongue portion 100, the threads 102 sized and configured to engage threads within the delivery device 11 (
Now with reference to
The thumb wheel 126 of the delivery device 11 may be manually rotatable to cooperate with the worm drive 120. As such, the physician may position the tongue 100 within an end opening 128 or within a bore of the barrel housing 116 and, for example, position the tongue 100 within a space below the push rod 122. Once positioned, the physician may rotate the thumb wheel 126 so that the worm drive 120 may engage the threads 102 of the tongue 100 and linearly move and pull the tongue 100 within the barrel housing 116. Upon engaging the tongue 100, the physician may continue to rotate the thumb wheel 126 so that the tongue 100 continues proximally so that the push rod 122 moves and slides the cartridge 92 distally until the cartridge 92 abuts and stops against the anvil 70 of the cradle 90. The push rod 122 may include a recess 130 at a distal end portion of the push rod 122. Upon the cartridge 92 being moved to a distal stop against the anvil 70 or cradle, further movement of the thumb wheel 126 may move the push rod 122 over a lip 132 adjacent a proximal side of the cartridge 92 so that the recess 130 in the push rod 122 engages and may be captured by the lip 132. The physician may hear, for example, a click as an assurance that the cartridge 92 is engaged with the push rod 122.
At this juncture, the push rod 122 may be engaged with the cartridge 92 such that reverse movement of the thumb wheel 126 may move the push rod 122 and the cartridge 92 proximally with linear movement. The physician may then move the cartridge 92 proximally a desired distance to then position soft tissue 5 over the anvil surface 74 and neck portion 80 (see
If it is desired to implant a second repair device in the soft tissue, the user may then continue to rotate the thumb wheel 126 to continue to move the implant delivery member 65 distally until the worm drive 120 is disengaged from the threads 102 of the tongue 100 of the implant delivery member 65. At this stage, the physician may take a second one of the implant delivery member 65 and position it within the barrel housing 116 for engaging with the delivery device 11 as described above to then position a second repair device in the soft tissue, if desired. In this manner, the implant delivery member 65 is removable and replaceable relative to the delivery device 11 so that the delivery device 11 may be repeatably employed with multiple implant delivery members 65.
The components of the delivery device 11 and implant delivery member 65 may be formed and made with medical grade materials, such as stainless steel, titanium, Nitinol, and/or alloys thereof or any other suitable metallic material or polymeric materials, such as liquid crystal polymers or acrylonitrile butadiene styrene (“ABS”) or any other suitable polymeric materials known to one of ordinary skill in the art. Such components of the delivery device 11 may be formed by employing molding and/or machining techniques, or any other suitable techniques and processes known to one of ordinary skill in the art.
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In this embodiment, the capture member 234 may include a base 248 with spokes 250, such as five spokes, extending from a central portion 252. The central portion 252 defines a central hole 254 configured to correspond with the central opening 244 of the anchor 232. The spokes 250 may extend radially from the central portion 252. Further, each spoke 250 may include structure 256 defining an aperture 258 at an outer end thereof. Further, the structure 256 defining the aperture 258 may include a tine 259 or spike extending therefrom sized and configured to engage and grab soft tissue. With this arrangement, the capture member 234 may be positioned on a cradle so that the legs 246 of the anchor 232 may be aligned with the apertures 258 of the capture member 234 such that, upon the anchor 232 being deployed from the cartridge, the legs 246 extend through the apertures 258 to then engage anvil buckets to curl around the structure 256 defining the apertures 258. In this manner, the anchor 232 and the capture member 234 may be coupled to soft tissue, similar to previous embodiments, which may be coupled to bone with one or more flexible members coupled to an embedded bone anchor, similar to that depicted in
With reference to
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The soft tissue anchor portion 354 of the repair device 350 may include an anchor 360 and a capture member 362. The anchor 360 may include multiple legs 364 extending from a proximal side 366 or surface of the bone anchor portion 352. Such legs 364 may be embedded within the bone anchor portion 352 during, for example, a molding process of forming the bone anchor portion 352. The legs 364 may be moved from a first position to a second position, the first position being a linear elongated position (
The various repair device embodiments or other embodiments disclosed herein may be applied to any one of various soft tissue to soft tissue repairs as well as soft tissue to bone repairs. For example, the various repair device embodiments may be employed for flexor tendon repairs, patellar tendon repairs, Achilles tendon repairs, quadriceps tendon repairs, and/or bicep tendon repairs, or any other tendon, ligament, and tendon/ligament to bone repairs, such as kidner procedures or insertional Achilles repairs, or any other tendon/ligament to bone repairs. As such, the repair device may be appropriately sized for proper fixation to the different sized or types of soft tissue.
While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. Further, the structural features of any one embodiment disclosed herein may be combined or replaced by any one of the structural features of another embodiment set forth herein. As such, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention includes employing any portion of one embodiment with another embodiment, all modifications, equivalents, and alternatives, falling within the spirit and scope of the invention as defined by the following appended claims.
The present application claims the benefit of U.S. Provisional Application No. 62/464,300, filed Feb. 27, 2017, U.S. Provisional Application No. 62/608,533, filed Dec. 20, 2017, and U.S. Provisional Application No. 62/633,000, filed Feb. 20, 2018, the disclosures of each are hereby incorporated by reference in their entirety. The present application also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 15/870,447, filed Jan. 12, 2018, which claims the benefit of U.S. Provisional Application No. 62/581,031, filed Nov. 2, 2017, U.S. Provisional Application No. 62/464,300, filed Feb. 27, 2017, and U.S. Provisional Application No. 62/445,596, filed Jan. 12, 2017, the disclosures of each are hereby incorporated by reference herein in their entirety. Further, U.S. patent application Ser. No. 15/870,447 also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 15/719,346, filed Sep. 28, 2017, which claims the benefit of U.S. Provisional Application No. 62/401,042, filed Sep. 28, 2016, the disclosures of which are hereby incorporated by reference herein in their entirety. Further, U.S. patent application Ser. No. 15/719,346 also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 14/885,959, filed Oct. 16, 2015, now U.S. Pat. No. 10,219,804, which claims the benefit of U.S. Provisional Application No. 62/215,739, filed Sep. 9, 2015, U.S. Provisional Application No. 62/129,742, filed Mar. 6, 2015, U.S. Provisional Application No. 62/094,032, filed Dec. 18, 2014, and U.S. Provisional Application No. 62/064,533, filed Oct. 16, 2014, the disclosures of each are hereby incorporated by reference herein in their entirety. Further, U.S. patent application Ser. No. 14/885,959 also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 14/645,924, filed Mar. 12, 2015, now U.S. Pat. No. 9,629,632, which claims the benefit of U.S. Provisional Patent Application No. 62/053,056, filed Sep. 19, 2014, U.S. Provisional Patent Application No. 62/040,451, filed Aug. 22, 2014, U.S. Provisional Patent Application No. 62/007,783, filed Jun. 4, 2014, and U.S. Provisional Patent Application No. 61/952,114, filed Mar. 12, 2014, the disclosures of each are hereby incorporated by reference herein in their entirety. Further, the present application also claims the benefit, and is a continuation-in-part of, U.S. patent application Ser. No. 14/885,956, filed Oct. 16, 2015, now U.S. Pat. No. 10,390,935, which claims the benefit of U.S. Provisional Patent Application No. 62/064,533, filed Oct. 16, 2014, the disclosures of each are hereby incorporated by reference herein in their entirety.
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