BACKGROUND
1. Field of Technology
The present disclosure relates generally to soft tissue repair, and more specifically, devices and methods used for such repair.
2. Related Art
Current devices available for arthroscopic soft tissue repair include suture anchors, metal post and washer screws, and interference screws. These devices provide immediate fixation of the tissue to the bone with little postoperative activity modification. However, the tissue must be delivered out of the body, stitched, and then re-inserted into a previously drilled bone hole. This reinsertion can be done through a portal, but is very technically demanding, precluding some patients from being a candidate for this procedure. Additionally, these devices don't prevent the tissue from sliding past the device as the device is inserted into the bone hole and/or when repetitive loads are applied to the soft tissue after fixation. Slippage of the tissue past the device may lead to decreased or failed fixation of the tissue to the bone and therefore an unsuccessful repair.
Therefore, a procedure is needed that is simple, reproducible, and that would allow both beginner and experienced surgeons to perform the procedure. Similarly, the devices used in the procedure would be simple to use, cost effective, and marketable to arthroscopic and open surgery surgeons alike and configured to prevent the tissue from sliding past the devices.
SUMMARY
In one aspect, the present disclosure relates to a tissue repair assembly. The assembly includes an interference device and a fixation device coupled to the interference device, wherein the fixation device includes a coupling portion and a capturing portion. In an embodiment, the interference device includes threads on an outer surface of the interference device. In another embodiment, the capturing portion includes a semi-circular shape. In yet another embodiment, the capturing portion includes a first end having a hole and a second end having a hole. In a further embodiment, the interference device includes a cannulation. In yet a further embodiment, the capturing portion is a loop and includes a through hole. In an embodiment, the capturing portion includes a top surface, a bottom surface, and at least two grooves. In another embodiment, the capturing portion includes a through hole having a first opening on the top surface and a second opening on the bottom surface. In yet another embodiment, the capturing portion includes an opening and the interference device includes a tip, the tip extending through the opening. In a further embodiment, the first opening includes a rim surrounding the first opening. In yet a further embodiment, the capturing portion includes four grooves.
In an embodiment, the interference device is configured for engagement with soft tissue. In another embodiment, the fixation device is configured for engagement with soft tissue. In yet another embodiment, the fixation device is configured for engagement with the bone. In a further embodiment, the capturing device is open-ended. In yet a further embodiment, the capturing device is closed-ended. In an embodiment, the fixation device includes a shape memory material. In another embodiment, the coupling portion includes at least two legs. In yet another embodiment, each leg includes two ends, wherein one end is coupled to the capturing portion and the other end is coupled to the interference device. In a further embodiment, the coupling portion is coupled to the interference device via a snap-fit connection.
In another aspect, the present disclosure relates to a tissue repair assembly. The assembly includes an interference device and a fixation device coupled to the interference device, wherein the fixation device includes a proximal end and a pointed distal end. In an embodiment, the fixation device includes a channel extending a partial length of the fixation device. In another embodiment, the interference device includes a cannulation, wherein the fixation device is partially housed within the cannulation. In yet another embodiment, the fixation device is coupled to the interference device via engagement between surface features on the fixation device and surface features on the interference device. In a further embodiment, the fixation device includes a collar. In yet a further embodiment, the fixation device includes multiple pointed distal ends.
In yet another aspect, the present disclosure relates to a fixation device. The fixation device includes a base portion having a first leg, a second leg, and a groove located between the first and second legs; and a top portion extending from the base portion. In an embodiment, the device is cannulated. In another embodiment, both the first leg and the second leg include a pointed end portion.
In a further aspect, the present disclosure relates to a tissue repair assembly. In an embodiment, the assembly includes a fixation device having a base portion including a first leg, a second leg, and a groove located between the first and second legs, and a top portion extending from the base portion and an interference device coupled to the fixation device. In an embodiment, the fixation device is cannulated. In another embodiment, the interference device is cannulated. In yet another embodiment, the interference device is coupled to the top portion of the fixation device. In yet another embodiment, the interference device includes threads on an outer surface of the interference device. In a further embodiment, the interference device is configured for rotary advancement into a target tissue.
In yet a further aspect, the present disclosure relates to a method of tissue repair. The method includes preparing a hole in a bone; inserting soft tissue into the hole via the use of a fixation device; and inserting an interference device into the hole.
In an embodiment, the fixation device includes a base portion having a first leg, a second leg, and a groove located between the legs, and a top portion extending from the base portion. In another embodiment, the soft tissue is located within the groove of the fixation device when the soft tissue is advanced into the hole. In yet another embodiment, the method further includes applying tension to the soft tissue prior to inserting the interference device into the hole. In a further embodiment, inserting the interference device into the hole fixates the soft tissue to the bone. In yet a further embodiment, the interference device includes threads on an outer surface of the interference device. In an embodiment, the interference device is configured for rotary advancement into the hole. In another embodiment, insertion of the interference device into the hole occurs via rotary advancement of the interference device into the hole.
In yet another embodiment, the soft tissue includes a sleeve of woven or braided material. In a further embodiment, the fixation device engages the sleeve. In yet a further embodiment, the fixation device engages the sleeve and the soft tissue. In an embodiment, the fixation device engages the sleeve, the soft tissue, and the bone. In another embodiment, the fixation device engages the soft tissue and the bone. In yet another embodiment, the interference device includes a cannulation and the interference device is inserted into the hole such that the interference device is housed within the cannulation. In a further embodiment, the fixation device is coupled to the interference device via engagement between surface features on the fixation device and surface features on the interference device. In yet a further embodiment, the fixation device is coupled to the interference device via engagement between surface features on the fixation device and surface features on the interference device. In an embodiment, the sleeve is coupled to the soft tissue via use of a suture.
In an aspect, the present disclosure relates to a method of tissue repair. The method includes preparing a hole in a bone; inserting a soft tissue into the hole; inserting an interference device into the hole, the interference device including a cannulation; and inserting the fixation device into the hole such that the fixation device is housed within the cannulation. In an embodiment, upon insertion of the fixation device into the hole, the fixation device engages the soft tissue. In another embodiment, the fixation device engages both the soft tissue and the bone.
Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the disclosure, arc intended for purposes of illustration only and are not intended to limit the scope of the disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present disclosure and together with the written description serve to explain the principles, characteristics, and features of the disclosure. In the drawings:
FIG. 1 shows a perspective view of a first tissue repair assembly of the present disclosure.
FIG. 2 shows a perspective view of the tissue repair assembly of FIG. 1 during soft tissue repair.
FIG. 3 shows a perspective view of a second tissue repair assembly of the present disclosure.
FIG. 4 shows a perspective view of the tissue repair assembly of FIG. 3 during soft tissue repair.
FIG. 5 shows a perspective view a third tissue repair assembly of the present disclosure.
FIG. 6 shows a perspective view of the tissue repair assembly of FIG. 5 during soft tissue repair.
FIG. 7 shows a cross-sectional view of a fourth tissue repair assembly of the present disclosure.
FIG. 8 shows a perspective view of the tissue repair assembly of FIG. 7 during soft tissue repair.
FIG. 9A shows a perspective view a fifth tissue repair assembly of the present disclosure.
FIG. 9B shows a perspective view of the fixation device of the tissue repair assembly of FIG. 9A.
FIG. 10 shows a perspective view of the tissue repair assembly of 9A during soft tissue repair.
FIG. 11 shows a perspective view of the fourth tissue repair assembly during soft tissue repair wherein the soft tissue includes a sleeve.
FIG. 12 shows a perspective view of the fourth tissue repair assembly during soft tissue repair wherein the soft tissue strands include a sleeve.
FIG. 13A shows a perspective view of a sixth tissue repair assembly of the present disclosure.
FIG. 13B shows a perspective view of an alternative fixation device for use in the sixth tissue repair assembly of FIG. 13A.
FIG. 14 shows a perspective view of a seventh tissue repair assembly of the present disclosure.
FIG. 15 shows a perspective view of an eighth tissue repair assembly of the present disclosure.
DETAILED DESCRIPTION OF THE EMBODIMENTS
The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses.
FIG. 1 shows a first tissue repair assembly 10 of the present disclosure. The assembly 10 includes an interference device 11 having a tapered body 11a and a cannulation 11b. The body 11a includes a first portion 11c and a second portion 11d having threads 11e. The assembly 10 also includes a fixation device 12 coupled to the interference device 11. The fixation device 12 includes a coupling portion 12a and a capturing portion 12b. The coupling portion 12a includes a shaft 12c and a coupler 12d. The coupler 12d includes an open-ended shape, such as a semi-circular shape, and is configured to provide a snap-fit connection to the body 11a of the interference device 11. The capturing portion 12b also includes a semi-circular shape and has a first end 12e and a second end 12f. The first end 12e includes a first opening 12g and the second end 12f includes a second opening 12h. The first opening 12g is aligned with the cannulation and is configured to house a guide wire, as will be further discussed below, and the second opening 12h is configured to house a suture, as will be further described below.
FIG. 2 shows the assembly 10 disposed on a guide wire 13. The guide wire 1.3 is advanced into a bone tunnel 21, such as a tibial tunnel of a knee joint, and the assembly 10 is disposed on the guide wire 13, such that the guide wire 13 is passed through the first opening 12g and the cannulation 11b. A soft tissue graft 30 rests on the capturing portion 12b with each end 30a,30b of the graft 30 draped over the interference device 11. A suture 14 may be used to further capture the graft 30 on the capturing portion 12b by placing ends of the suture 14 through openings 12g,12h, such that the suture 14 is placed over the tissue 30, and then tying the ends of the suture 14. The assembly 10 and graft 30 are advanced into the bone tunnel 21, via a delivery device (not shown). The threads 11e allow for compression of the graft 30 against the walls of the bone tunnel 21.
FIG. 3 shows a second tissue repair assembly 40 of the present disclosure. The assembly 40 includes an interference device 41 having a tapered body 41a and a cannulation 41b. The body 41a includes a first portion 41c and a second portion 41d having threads 41e. The assembly 40 also includes a fixation device 42 coupled to the interference device 41. The fixation device 42 includes a coupling portion 42a and a capturing portion 42b. The coupling portion 42a includes a shaft 42c and a coupler 42d. The coupler 42d includes a semi-circular shape and is configured to provide a snap-fit connection to the body 41a of the interference device 41. The capturing portion 42b is in a closed-ended shape, such as a loop, and includes a through hole 42e configured for disposal of a soft tissue graft.
FIG. 4 shows the assembly 40 located on a guide wire 50. The guide wire 50 is advanced into a bone tunnel 61, such as a tibial tunnel of a knee joint, and the assembly 40 is disposed on the guide wire 50, such that the guide wire 50 is passed through the cannulation 41b. A soft tissue graft 70 is disposed through the hole 42e of the catering portion 42b with each end 70a,70b of the graft 70 draped over the interference device 41. The assembly 40 and graft 70 are advanced into the bone tunnel 61, via a delivery device (not shown). The threads 41e allow for compression of the graft 70 against the walls of the bone tunnel 61.
FIG. 5 shows a third tissue repair assembly 80 of the present disclosure. The assembly 80 includes an interference device 81 having a tapered body 81a having threads 81e and a cannulation 81b. The assembly 80 also includes a fixation device 82 coupled to the interference device 81. The fixation device 82 includes a coupling portion 82a and a capturing portion 82b. The capturing portion 82b includes a top surface 82e, a bottom surface 82f, and a through hole 82g. The through hole 82g includes a first opening 82h located on the top surface 82e and a second opening (not shown) located on the bottom surface 82f. A rim 82j surrounds the first opening 82h and serves as the coupling portion 82a to couple the fixation device 82 to the interference device 81. The rim 82j includes a diameter equal to an inner diameter of the interference device 81. For the purposes of this disclosure, the capturing portion 82b includes four grooves 82k1-82k4. However, the capturing portion 82b may have less than four grooves, such as the two grooves 82k1,82k3 for housing of end portions of a soft tissue graft, as will be further described below. In addition, it is also within the scope of this disclosure for the rim 82j to have a diameter less than or greater than an inner diameter of the interference device 81.
FIG. 6 shows the assembly 80 located on a guide wire 90. The guide wire 90 is advanced into a bone tunnel 101, such as a tibial tunnel of a knee joint, and the assembly 80 is disposed on the guide wire 90, such that the guide wire 90 is passed through the cannulation 81b and the through hole 82g of the capturing portion 82b. A soft tissue graft 200 rests on the bottom surface 82f of the capturing portion 82b with each end 200a,200b of the graft 200 draped over the interference device 81 and housed in grooves 82k1, 82k3. The assembly 80 and graft 200 are advanced into the bone tunnel 101, via a delivery device (not shown). The threads 81e allow for compression of the graft 200 against the walls of the hone tunnel 101.
For the purposes of FIGS. 5 and 6, it is within the scope of this disclosure for the capturing portion to not have grooves. Rather the sides of the capturing portion may be straight such that the portion is in the shape of a square. Other shapes are also within the scope of this disclosure.
FIG. 7 shows a fourth tissue repair assembly 300 of the present disclosure. The assembly 300 includes an interference device 301 having a tapered body 301a with threads 301e and a cannulation 301b. The assembly 300 also includes a fixation device 302 disposed within the cannulation 301b of the interference device 301. The fixation device 302 includes a proximal end 302a, a pointed distal end 302b, and a channel 302c extending a partial length of the fixation device 302.
FIG. 8 shows the assembly 300 being advanced into a bone tunnel 401, such as a tibial tunnel of a knee joint. A delivery device (not shown) is inserted into the channel 302c and the delivery device (not shown) is used to insert a soft tissue graft 500 into the bone tunnel 401. The soft tissue graft 500 rests on the pointed distal end 302b with each end 500a,500b of the graft 500 draped over the interference device 301. The assembly 300 and graft 500 are advanced into the bone tunnel 401, via the delivery device (not shown) and the pointed distal end 302b extends through the graft 500 and into bone 402. The threads 301e allow for compression of the graft 500 against the walls of the bone tunnel 401.
Alternatively, the graft 500 is inserted into the tunnel 401, the fixation device 302 is inserted into the tunnel 401 such that the pointed distal end 302b engages the graft, possibly being inserted through the graft 500 and into the bone 402, and then the interference device 301 is inserted into the tunnel 401 such that the fixation device 302 is housed within the cannulation 301b and the ends 500a,500b of the graft 500 are draped over the device 301. Insertion of the interference device 301 into the tunnel 401 directly after inserting the tissue 500 into the tunnel 401 and subsequently inserting the fixation device 302 into the cannulation 301b such that the pointed end 302b is inserted through the grail 500 and possibly into the hone 402, is also within the scope of the disclosure. The fixation device 302 may be of a variety of lengths and may include surface features that mate with surface features located within the cannulation 301b to further couple the fixation device 302 to the interference device 301. The surface features may include threads, barbs, ribs, or other surface features known to one of skill in the art and that have the ability to further facilitate coupling between the fixation device 302 and the interference device 301. It is also within the scope of this disclosure for the fixation device 302 and/or the interference device 301 to be made out of a material, such as a shape memory material, that expands or otherwise allows for further coupling between the devices 301,302 in response to body temperature or an external energy source.
FIG. 9A shows a fifth tissue repair assembly 600 of the present disclosure. The assembly 600 includes an interference device 601 having a tapered body 601a with threads 601e and a cannulation 601b. The assembly 600 also includes a fixation device 602 disposed within the cannulation 601b of the interference device 601. As shown in FIG. 9B, the fixation device 602 includes a first leg 602a, a second leg 602b, and a groove 602c located between the legs 602a,602b. The device 602 also includes a top portion 604 extending from the base portion 603. As can he seen in FIG. 9A, the top portion 604 has a smaller diameter than the cannulation 601b so as to allow the top portion 604 to be disposed within the cannulation 601b. In addition, the device 602 is cannulated to allow passage of a guide wire 610 through both the interference device 601 and the fixation device 602. As will be further described below, the legs 602a,602b and the groove 602c cooperate to house soft tissue within the groove and fixate the tissue within a bone tunnel. For the purposes of FIGS. 9A and 9B, the fixation device 902 is U-shaped. However, the device may be V-shaped or have any other shape known to one of skill in the art.
FIG. 10 shows the assembly 600 located on the guide wire 610. The guide wire 610 is advanced into a bone tunnel 701, such as a tibial tunnel of a knee joint, and the assembly 600 is disposed on the guide wire 610, such that the guide wire 610 is passed through both the interference device 601 and the fixation device 602. A soft tissue graft 800 rests between the legs 602a,602b with each end 800a,800b of the graft 800 draped over the interference device 601. The assembly 600 and graft 800 are advanced into the bone tunnel 701 together, via a delivery device (not shown). The threads 601e allow for compression of the graft 800 against the walls of the bone tunnel 701. Alternatively, the assembly 600 may be advanced into the tunnel 701 such that the fixation device 602 is advanced into the tunnel 701 followed by advancement of the interference device 601. In this manner, tension may be applied to the soft tissue 800 prior to inserting the interference device 601 into the tunnel 701.
FIGS. 11 and 12 show tissue repair assemblies 900 that are similar to the fourth tissue repair assembly 300 and method shown in FIGS. 7 and 8, albeit including a sleeve of braided or woven material 1100 on the tissue 1000. As shown in FIGS. 11 and 12, one strand or multiple strands of tissue 1000 may he fixated within the tunnel 1200. While the sleeve 1100 is located between the ends 1000a,1000b, it is within the scope of this disclosure for the sleeve 1100 to be located anywhere along the lengths) of the strand(s) 1000 or over the entire strand(s) 1000 prior to placing the tissue(s) 1000 within the bone tunnel 1200. Having the sleeve 1100 on the tissue(s), such as in FIGS. 11 and 12, allows for maintaining the soft tissue(s) 1000 at the tapered end 902 of the interference device 901 via insertion of the fixation device 903 through at least a portion of the sleeve 1100, thereby alleviating the need for the fixation device 903 to be inserted through the soft tissue 1000. However, as shown in FIGS. 11 and 12, it is also within the scope of this disclosure for the fixation device 903 to be inserted through the soft tissue 1000 and the sleeve 1100 or the soft tissue 1000, the sleeve 1100, and the hone 1201. Additionally, rather than using one sleeve 1100 for all of the strands of tissue 1000, as shown in FIG. 12, it is also within the scope of this disclosure to have a sleeve 1100 located on each strand of tissue 1000. A flexible member, such as a suture, may be used to couple the sleeve 1100 to the tissue 1000.
FIG. 13A shows a sixth tissue repair assembly 1300 of the present disclosure that is similar to the fourth tissue repair assembly 300 of FIG. 7. However, assembly 1300 includes a collar 1303 located on the fixation device 1302. When the assembly 1300 is used to fixate soft tissue to bone via a method similar to the method of FIG. 8, the collar 1303 further facilitates maintenance of the location of the soft tissue in front of, or at the tapered end of the interference device 1301.
FIG. 13B shows an alternative fixation device 1302 for use with repair assembly 1300. Rather than having one pointed distal end 1302b, the device may have multiple pointed distal ends 1302b. This would allow the device 1300 to capture more of the tissue and therefore provide for increased fixation of the tissue to bone. For the purposes of FIG. 13B, the device 1300 includes only two pointed distal ends 1302b. However, it is within the scope of this disclosure for the device 1300 to include more than two pointed distal ends 1302b.
FIG. 14 shows a seventh tissue repair assembly 1400 of the present disclosure that is similar to the tissue repair assembly 10 of FIG. 1. However, instead of shaft 12c, the fixation device 1600 includes a coupling portion 1600a having at least two legs 1600b. Each leg 1600b has one end 1600c coupled to the capturing portion 1600d and another end 1600e coupled to a thread 1501 of the interference device 1500. For the purposes of this disclosure, each end 1600e includes a foot 1600f that allows for snap lock coupling of the foot 1600f to the thread 1501 and therefore coupling of the fixation device 1600 to the interference device 1500. The legs 1600b are tapered to accommodate the tapered end portion 1502 of the device 1500. It is within the scope of this disclosure for the legs 1600b to be of different lengths such that one foot 1600f is coupled to one thread 1501 and the other foot 1600f is coupled to a different thread 1501. It is also within the scope of this disclosure for the coupling portion 1600a to have more than two legs 1600b. The capturing portion 1600d is of a semi-circular shape so as to capture soft tissue in a manner similar to how the capturing portion 12b of the assembly 10 of FIGS. 1 and 2 capture tissue. However, the capturing portion 1600d may be of any other shape that would allow capturing of the tissue and maintenance of it in front of or at the tapered end 1502 of the interference device 1500 during and after repair. The ends 1600c,1600e may be coupled to the capturing portion 1600d and the interference device 1500 in any manner known to one of skill in the art.
FIG. 15 shows an eighth tissue repair assembly 1700 of the present disclosure. The assembly 1700 is similar to assembly 80 of FIG. 5. However, the interference device 1701 of assembly 1700 includes a tip 1703 that extends beyond the tapered end 1702 of the device 1701. The fixation device 1704 is coupled to the interference device 1701 such that the tip 1703 extends through a center opening 1705 of the device 1704. During repair, soft tissue is disposed on the fixation device 1704 in a manner similar to how soft tissue is disposed on the fixation device 82 of assembly 80 and shown in FIG. 6.
The assemblies 10, 40, 80, 300, 600, 900, 1300, 1400, 1700 of the present disclosure, and especially the fixation devices 12, 42, 82, 302, 602, 903, 1302, 1600, 1704 maintain the location of the soft tissue in front of, or at the tapered end of the interference device 11, 41, 81, 301, 601, 901, 1301, 1500, 1701 thereby preventing slippage of the tissue past the device 11, 41, 81, 301, 601, 901, 1301, 1500, 1701 during and after repair. This substantially reduces the possibility of a failed fixation of the tissue to the bone, thereby leading to an unsuccessful repair.
For the purposes of this disclosure, the fixation devices and the interference devices are made from a resorbable polymer material. However, a metal material and other non-metal materials, either resorbable or non-resorbable, arc also within the scope of this disclosure. In addition, the devices may he made via a molding process or other process known to one of skill in the art. The cannulations and channel may be formed during the molding process or after the molding process by drilling. Furthermore, rather than containing threads, the outer surface of the interference device may include other surface features that would allow engagement of the interference device with the hone tunnel and soft tissue. The threads allow for rotary advancement of the assembly and the soft tissue graft into the tunnel. However, these other surface features may allow for other advancement, such as axial advancement, into the tunnel. Also, the number of surface features may vary.
In addition, the fixation devices may be coupled to the interference devices in manners other than those described above. For the purposes of this disclosure, the method and devices, described above, are used in arthroscopic knee repair. However, the method and devices may be used in the repair of other soft tissue. The fixation devices may be of a variety of lengths and may include surface features that mate with surface features located within the cannulations to further couple the fixation devices to the interference devices. The surface features may include threads, barbs, ribs, or other surface features known to one of skill in the art and that have the ability to further facilitate coupling between the fixation devices and the interference devices. It is also within the scope of this disclosure for the fixation devices and/or the interference devices to be made out of a material, such as a shape memory material, that expands or otherwise allows for further coupling between the devices in response to body temperature or an external energy source.
Furthermore, it is within the scope of FIGS. 1, 3, and 14 for the fixation devices 12,42,1600 to be coupled to the interference devices 11,41,1500 via the use of a hole on the fixation devices 12,42,1600 that at least the tapered ends 11d,41d,1502 are disposed within, rather than using the shafts 12e,42c, couplers 12d,42d, and legs 11600b. Additionally, it is within the scope of FIGS. 1, 3, 5, and 14 for the fixation devices 12, 42, 82, 1600 to be coupled to the interference devices 11, 41, 81, 1500 via the use of a shaft that would extend from the coupling portions 12a, 42a, 82a, 1600a to be housed within the cannulations 11b, 41b, 81b of the interference devices 11, 41, 81, 1500.
Additionally, it is within the scope of this disclosure for the top portion 604 of fixation device 602 and fixation devices 903,1302 to have a length that extends either an entire length or a partial length of the interference devices 301,601,901,1301.
As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the disclosure, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.
Patent Application
20100145395
