Patent Publication Number: US-2022218464-A1

Title: Direct soft tissue fixation implantable device and method of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefits of U.S. Provisional Application No. 62/856,593, filed on Jun. 3, 2019, the disclosure of which is hereby incorporated by reference in its entirety including all figures, tables, and drawings. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable 
     THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
     Not applicable. 
     REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISC APPENDIX 
     Not applicable. 
     BACKGROUND OF THE INVENTION 
     The present invention relates to surgical fixation devices and methods of surgical soft tissue fixation. More specifically, the device disclosed herein is an implantable device to secure soft tissue to bone or soft tissue to soft tissue, which is accomplished by direct contact between the device and tissue to be secured or fixated without the use of sutures or other fixation components. Also disclosed are methods of using the herein described device. 
     There are many devices and methods disclosed in the art to achieve soft tissue fixation to bone, or other soft tissue. For example, various embodiments of a “button” fixation device have been described for fixating soft tissue to bone. See U.S. Ser. No. 10/070,874; Buchholz et al.,  Biomechanical Comparison of Intramedullary Cortical Button Fixation and Interference Screw Technique for Subpectoral Biceps Tenodesis . Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol. 29, No. 5 (May 2013). However, all embodiments of “button” fixation devices require a suture connection from the device to the soft tissue to be fixated. Soft tissue-suture-device connections require a high degree of skill for a surgeon to perform. Furthermore, tissue quality can significantly affect the strength of the soft tissue-suture-device connection. Patients with poor tissue quality exhibit higher instances of loss of fixation and surgical failure. Similarly, the delicate soft tissue to suture connection associated with such devices requires a prolonged protective phase post-surgery to allow for sufficient physiologic healing and fixation stability prior to initiating rehabilitation of the repaired tissue. It is well described in the literature that early rehabilitation after surgery generally improves surgical outcomes. 
     Another device and technique utilized for soft tissue fixation is the use of an interference screw. An interference screw requires a suture to screw connection between the tissue to be fixated and the interference screw. Fixation is accomplished by engaging the threads of the interference screw in a bony tunnel, thus creating the anchor point for the soft tissue-suture-screw connection. Similar to the cortical “button” described above, interference screws require a suture connection between the device and soft tissue to be fixated. See Buchholz et al. supra. Furthermore, interference screws require purchase of threads into bone, which can potentially damage bone and is susceptible to loosening. 
     Similarly, U.S. Pat. No. 5,571,104 describes a surgical anchor and method of use where the device consists of a body with a plurality of barbs, which engage a bony tunnel to secure soft tissue to bone. The 104&#39; device includes an opening to receive a loop of tendon, a loop of suture, or a bone block or plug. As such, the device requires enough free tendon or ligament to create a loop back onto itself for fixation to the device, a bone block or plug, or a suture to fix the device to the soft tissue. 
     U.S. Pat. No. 9,101,462 describes various devices and a method for preventing retraction of biological tissue during resection. The engaging element of the 462&#39; patent includes at least two cooperating parts for trapping the first biological soft tissue and an anchor to interact with the second biological tissue. As such, the system described in the 462&#39; patent requires surgical placement of two components and a mechanism or suture to connect the two components. 
     Various other crimping, clamping, and anchoring devices exist in the art, but suffer from the same shortcomings as the devices described previously. See U.S. Pat. No. 8,900,302 (tendon crimp requires suture); U.S. Pat. No. 5,968,044 (bone fastener requires suture or knot for tissue-device connection); U.S. Pat. No. 5,108,431 (clamp sleeve for artificial ligament utilizes internal saw tooth segments to engage ligament); WO 2008/017834 (Aglet compressed onto soft tissue, but requires suture to fixate); and U.S. Pat. No. 6,106,556 (splice consisting of reinforcing member and plurality of pins). 
     One common orthopaedic surgical procedure involves treating disease of the long head of the biceps and/or tearing at its proximal origin. Releasing the tendon (tenotomy) is an acceptable treatment option but has some potential side effects and occasionally results in a cosmetic deformity. The present preferred treatment is to subsequently reattach the long tendon of the biceps to the proximal humerus after tenotomy in the shoulder joint. There are a number of commercially available implants to accomplish this goal, some of which have been described above. 
     Because of the above described problems evident in the prior art, a need remains for an implantable device to secure tendon to bone or tendon to tendon, which is accomplished by direct contact between the tissue to device and tissue to be secured. The present device presents a novel approach to achieve this goal with relative ease and speed, both desirable attributes during surgery. There are also other advantages compared to current devices (interference screws, expandable anchors, metal implants attached via sutures) including use of a smaller cortical socket thereby reducing risk of subsequent bone fracture, minimizing inventory, circumferential tendon to bone healing, avoidance of graft disruption upon implant deployment, and avoiding suture creep or knot failure. 
     BRIEF SUMMARY OF THE INVENTION 
     Provided is the description of a novel implantable device with direct attachment to the soft tissue or tendon in question via a novel crimping method using a novel crimping device. The implantable device is comprised of material, which surrounds the diameter of soft tissue or tendon, and is affixed directly to the soft tissue or tendon by crimping the device with the tendon/tissue passed through the device, thereby providing secure fixation of the device to the tendon/tissue without the use of suturing. Once affixed to the tendon/tissue, the implant can be inserted into the medullary canal of a bone, such as the proximal humerus, through a unicortical socket sized to precisely match the tendon/tissue diameter. The socket is made with widely available techniques and instruments. Matching tendon diameter to the unicortical socket provides for circumferential healing of the tendon/tissue-bone connection, increased stability of the fixation, and less healing time of the repair. Typically, other fixation devices described above must utilize a considerably larger socket than the tendon/tissue diameter to accommodate the implant, which risks subsequent fracture due to the larger socket size, decreased stability, and potentially inadequate healing and/or longer healing durations. Once inserted beyond the cortex, the device is rotated 90 degrees so that the crimped device ends are held against the fixation surface, or medullary wall by the resting tension of the fixated soft tissue. Once inserted, the device will no longer fit back through the socket, effectively fixing the tendon inside the bone. 
     A preferred embodiment of the device is utilized for reattachment of soft tissue to bone. The typical steps include: (1) releasing the soft tissue from its insertion or origin point; (2) making a small incision and dissection to approach the fixation point for site preparation; (3) Measuring the diameter of the soft tissue to be fixated at or just distal to the musculotendinous junction; (4) drilling a corresponding unicortical socket to match the measured soft tissue diameter; (5) applying the implantable device to the soft tissue at the appropriate location; (6) crimping said implantable device with crimping pliers to appropriate force; (7) resecting the remainder of the proximal or distal soft tissue; and (8) inserting the crimp/soft tissue construct into the unicortical socket by rotating the crimp/soft tissue construct 90 deg. to clear the cortical wall of the unicortical socket and de-rotating the crimp/tendon construct to abut against the inner medullary wall. Another preferred embodiment of the method if using the device is further comprised of the step of doubling back of the tissue onto itself and reinserting the resected end of said tissue back through the device, which provides for increased tissue thickness for the device to crimp onto. 
     Another preferred embodiment of the implantable device is comprised of an oval ring with a lengthwise opening of approximately 8 mm and a width opening of approximately 6 mm. Said device is approximately 2 mm wide and is preferably made of any acceptable material suitable for implantation and structurally capable of resisting deformation once crimped. Titanium, or surgical stainless are the preferred materials; however, any implantable material capable of the herein described specifications could be used. Furthermore, said device could be sized or shaped to accommodate any morphology of tissue, where application of the device would be appropriate. For example, another preferred embodiment of the device is comprised of a circular-ring, sized to accommodate the tissue to be fixated. 
     Another preferred embodiment of the implantable device is comprised of a multiple opening device, which would allow for the tendon/tissue to be fixated to be inserted through a first opening and then doubled back and passed back through the a second opening of the device to achieve multiple crimps of the device on the tendon/tissue to increase fixation strength. 
     Another preferred embodiment is comprised of a crimping pliers device designed to accept the described implantable device. Each opposing jaw of said crimping pliers will have a longitudinal recessed groove to accept the implantable crimp device. The pliers will have a preset endpoint determined by tissue diameter to provide sufficient force to crimp the implantable device securely to the soft tissue but prevent excessive force and tissue damage. 
     While specific embodiments are provided herein, one skilled in the art would appreciate that the described device could be used for virtually any procedure requiring soft tissue fixation to bone. Furthermore, the described device could comprise any shape or size to accommodate different soft tissue morphology. 
     Due to the problems identified in the prior art regarding soft tissue-bone fixation devices and methods, it is an object of the present invention to provide a direct soft tissue-bone fixation device. It is another object of the present invention to provide a fixation device where the unicortical socket utilized with the device is the same diameter as the soft tissue to be fixated. It is another object of the present invention to provide a soft tissue-bone fixation device and method that reduces the risk of fixation site fracture, graft disruption upon implant deployment, and avoids suture creep or knot failure. It is another object of the present invention to provide a fixation device that minimizes prolonged post-surgical protection prior to initiating rehabilitation. It is a further object of the present invention to provide a direct soft tissue-soft tissue connection. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1  is an anatomical representation of the anterior shoulder, proximal humerus, and long head of the bicep tendon. 
         FIG. 2  is an anatomical representation of a resected long head of biceps tendon. 
         FIG. 3  illustrates drilling of a unicortical socket during a preferred method. 
         FIG. 4  illustrates application of a preferred device around the resected tendon. 
         FIG. 5  shows device placed around the resected tendon, prior to crimping. 
         FIG. 6  demonstrates crimping of the device to resected tendon to create the crimp/tendon construct. 
         FIG. 7  demonstrates trimming of resected portion of tendon proximal to crimped device. 
         FIG. 8  demonstrates installation of the crimp/tendon construct by rotating device 90 degrees to insert device into unicortical socket. 
         FIG. 9  demonstrates installed crimp/tendon construct where device is de-rotated 90 degrees to abut against the medullary wall. 
         FIG. 10  illustrates application of another preferred implantable device with multiple openings prior to application to a resected tendon. 
         FIG. 11  shows the multi-opening embodiment of the implantable device placed around the resected tendon, prior to crimping. Tendon through first opening and back through second opening. 
         FIG. 12  demonstrates crimping of the multi-opening implantable device to resected tendon to create the crimp/tendon construct. Two crimps of doubled back tendon achieves greater device retention and fixation strength. 
         FIG. 13  demonstrates installation of the multi-opening implantable device crimp/tendon construct by rotating device 90 degrees to insert device into unicortical socket. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Embodiments of the present invention will now be described more fully with reference to the accompanying drawings. As shown in  FIGS. 4-9 , the implantable device is comprised of a material structurally capable of resisting deformation once crimped. Said device is sized and shaped in a manner to insert a resected tendon or other tissue end through an interior opening of said device. Said interior opening is defined by an interior border of the material of said device. The device is also comprised of an exterior border, which is accepted by a specialized crimping tool, which crimps said device to said tendon/tissue. The implantable device can be sized and shaped in any manner to accommodate different sizes and morphologies of tissues. Furthermore, said interior and exterior borders can be further comprised of features to enhance purchase of the implantable device on the tissue/tendon once crimped. 
     One preferred embodiment of the implantable device is comprised of an oval ring  10 . Said oval ring can be a complete contiguous oval, or an incomplete oval comprised of a gap  11  to aid in affixing the device to the tissue/tendon at issue. One familiar with the art would recognize that the implantable device could be comprised of various shapes to accommodate tissues of any shape or size. Said oval ring  10  is comprised of an interior opening  12 , which accommodates the tendon to be fixated. Said interior opening is defined by an interior border  13 , which can be compete or incomplete as shown in  FIG. 4 . Said device is further defined by an exterior border  14 , which is accepted by a specialized crimping pliers for crimping. Said exterior border  14  can be complete or incomplete as shown in  FIG. 4 . 
     The implantable device is preferably made of any acceptable material suitable for implantation and structurally capable of resisting deformation once crimped. Titanium, or surgical stainless are the preferred materials; however, any implantable material capable of the herein described specifications could be used. One of the preferred embodiments of said implantable device oval ring  10  is comprised of an interior opening  12  length of approximately 8 mm and a width of approximately 6 mm as shown on  FIG. 4 . The material portion of said device is approximately 2 mm in diameter. However, the device could be sized for application to any tendon/tissue size and/or morphology. For example, another preferred embodiment of the device is comprised of a circular ring, sized to accommodate the diameter of tissue to be fixated. The interior border  13  of said implantable device oval ring opening  12  can be further comprised of texturing, studs, barbs, or similar means to increase purchase of the implantable device on the tissue/tendon once crimped. The exterior border  14  of said implantable device can be further comprised of features to enhance purchase of said device to a fixating structure or surface. For example, said exterior border could be comprised of barbs, hooks, wings, or texturing to enhance purchase of the device to a fixation surface such as bone once implanted. 
     A preferred embodiment of the implantable device oval ring  10  is utilized for reattachment of the long head of the biceps tendon  100  to the proximal humerus  101  after tenotomy  FIG. 2  in the shoulder joint. The typical steps include: (1) releasing the long head biceps  100  from the labrum arthroscopically (for tearing of the biceps, SLAP tear, subscapularis repair, or any other conditions treated with biceps tenodesis); (2) making a small incision and dissection to approach the intertubercular portion  102  of the humerus at the inferior margin of the pectoralis major; (3) Measuring the diameter  103  of the long head of the biceps tendon  100  at or just distal to the musculotendinous junction (anatomic studies suggest restoration of correct length by tenodesing the tendon near the musculotendinous junction at a location immediately proximal to the inferior border of the pectoralis major); (4) drilling  104  a corresponding unicortical socket  105  to match the tendon diameter  103  ( FIG. 3 ); (5) applying the implantable oval ring  10  to the long head of the biceps tendon  100  at the appropriate location ( FIG. 5 ) by inserting said tendon into said opening  12 ; (6) crimping said implantable oval ring  10  with crimping pliers  20  to appropriate force ( FIG. 6 ); (7) resecting  106  the remainder of the proximal tendon  107  ( FIG. 7 ); and (8) inserting the crimp/tendon construct  15  into the unicortical socket  105  by rotating the crimp/tendon construct  15  90 deg. ( FIG. 8 ) to clear the cortical wall  108  of the unicortical socket  105  and de-rotating the crimp/tendon construct  14  to abut against the fixation surface of the inner medullary wall  109  ( FIG. 9 ). Once inserted, the crimped implantable oval ring  10  ends  16  are held against the fixation surface such as a medullary wall  109  by the resting tension of the fixated soft tissue. 
     Another preferred embodiment of the implantable device is shown in  FIGS. 10-13 . In this embodiment the implantable device is comprised of multiple openings, which allow for a tendon/tissue to be passed through a first opening  31  and doubled back through at least a second opening  32 . In this embodiment said device material is comprised of multiple interior borders  13  which define multiple interior openings. The multiple interior borders, which define the multiple openings can be connected via a common central connection  33  as shown in  FIG. 10 . This embodiment can be comprised of the shape of multiple oval rings connected via said common central connection  33 . In this embodiment the implantable multi-opening device  30  can also be utilized for reattachment of the long head of the biceps tendon  100  to the proximal humerus  101  after tenotomy  FIG. 2  in the shoulder joint. The typical steps include: (1) releasing the long head biceps  100  from the labrum arthroscopically (for tearing of the biceps, SLAP tear, subscapularis repair, or any other conditions treated with biceps tenodesis); (2) making a small incision and dissection to approach the intertubercular portion  102  of the humerus at the inferior margin of the pectoralis major; (3) Measuring the diameter  103  of the long head of the biceps tendon  100  at or just distal to the musculotendinous junction (anatomic studies suggest restoration of correct length by tenodesing the tendon near the musculotendinous junction at a location immediately proximal to the inferior border of the pectoralis major); (4) drilling  104  a corresponding unicortical socket  105  to match the tendon diameter  103  ( FIGS. 3 and 10 ); (5) applying the implantable multi-opening device  30  to the long head of the biceps tendon  100  at the appropriate location by inserting said tendon through said first opening  31  and doubling said tendon back through said second opening  32  ( FIG. 11 ); (6) crimping said implantable multi-opening device  30  with crimping pliers  20  to appropriate force ( FIG. 12 ); (7) resecting  106  the remainder of the proximal tendon  107  ( FIG. 7 ); and (8) inserting the multi-opening device  30  crimp/tendon construct  33  into the unicortical socket  105  by rotating the multi-opening device  30  crimp/tendon construct  33  90 deg. ( FIG. 8 ) to clear the cortical wall  108  of the unicortical socket  105  and de-rotating the multi-opening device  30  crimp/tendon construct  33  to abut against the inner medullary wall  109  fixation surface ( FIG. 9 ). Once inserted, the crimped multi-opening device  30  ends  34  are held against the fixation surface such as a medullary wall  109  by the resting tension of the fixated soft tissue. 
     While specific embodiments are provided herein, one skilled in the art would appreciate that the described device could be used for virtually any procedure requiring soft tissue fixation to bone or other soft tissue. Furthermore, one skilled in the art would appreciate that the described device could comprise any shape or size to accommodate different soft tissue morphology. 
     Another preferred embodiment is comprised of a crimping pliers  20  device designed to accept the described implantable device. Each opposing jaw surface  21  of said crimping pliers  20  is further comprised of a longitudinal recessed groove to accept the implantable device for crimping. In another embodiment, the longitudinal recessed groove will be sized to match the material diameter and length of the implantable device oval ring  10  or multi-opening device. The crimping pliers are comprised of a preset endpoint determined by implant device material composition, soft tissue diameter, and optimal compression force to provide sufficient force to crimp the implantable device securely to the soft tissue but prevent excessive force and tissue damage. 
     It is understood that the foregoing examples are merely illustrative of the present invention. Certain modifications of the articles and/or methods may be made and still achieve the objectives of the invention. Such modifications are contemplated as within the scope of the claimed invention.