Tissue augmentation scaffold for use in soft tissue fixation repair

Abstract

This invention is entitled "Tissue-Reinforcing Scaffold for Use in Soft Tissue Fixation and Repair." The invention provides apparatus, systems, and methods for improving the reliability and speed of soft tissue repair surgery. The apparatus and systems include one or more tissue-reinforcing constructs comprising structures configured to increase the coverage area on the tissue by which the sutures exert force when tightened to the tissue. The tissue-reinforcing constructs can be quickly and easily associated with the repair sutures and can be used in many different tissue repair procedures disclosed in this application. The tissue-reinforcing constructs may include various blocks and scaffolds, as well as other shaped structures. Among other disclosures, this disclosure includes methods for using tissue-reinforcing scaffolds including folded scaffolds, and descriptions and methods associated with ultra-wide tissue-reinforcing blocks.

Description

[0001] Cross-references to related applications

[0002] This application is a continuation-in-part of U.S. Patent Application Serial No. 15 / 419,330, filed January 30, 2017, entitled “TISSUE AUGMENTATION CONSTRUCTS FOR USE WITH SOFT TISSUE FIXATION REPAIR SYSTEMS AND METHODS,” which claims priority to U.S. Provisional Patent Application Serial No. 62 / 289,702, filed February 1, 2016, entitled “COMPRESSION STRIPS AND SCAFFOLDS FOR USE IN SOFT TISSUE FIXATION,” U.S. Provisional Patent Application Serial No. 62 / 348,548, filed June 10, 2016, entitled “COMPRESSION CONSTRUCTS AND RELATED METHODS FOR USE IN SOFT TISSUE FIXATION,” and U.S. Provisional Patent Application Serial No. 62 / 348,548, filed September 12, 2016, entitled “TISSUE AUGMENTATION CONSTRUCTS AND RELATED METHODS FOR USE IN SOFT.” Priority is claimed in each of the U.S. Provisional Patent Application Serial No. 62 / 393,277 entitled “TISSUE FIXATION”, all of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to systems, apparatus, and methods for securing soft tissue to bone, and more specifically to systems, apparatus, and methods for increasing coverage and / or compression between sutures and tissue during procedures such as rotational sleeve repair surgery. Background Technology

[0004] Complete or partial separation of tendons, ligaments, or other soft tissues from bone is a common injury, especially in athletes and older adults. Tissue separation can occur during falls, due to excessive force, or for a variety of other reasons. Surgical intervention is usually required, particularly when tissue is completely separated from its associated bone. Currently available devices for tissue attachment include screws, staples, suture anchors, and pins. These devices may be particularly inappropriate for older patients because degenerated tissue can lead to inadequate suture-to-anchor fixation and further damage to the soft tissue.

[0005] Repair structures made of one or more surgical sutures are commonly used in soft tissue repair surgeries, such as in rotator cuff fixation, to hold the tissue in a desired position. The repair structure is typically positioned to pass through one or more sections of the tissue to be repaired, which can cause trauma to the tissue, and is usually attached to an anchor placed in bone, with the tissue close to the bone. Furthermore, in cases where soft tissue has begun to degenerate, the increased pressure applied by the sutures can cause further damage to the tissue, for example, by causing abrasions or a "cheese-wiring" effect. "Cheese-wiring" refers to the process of peeling one or more strands of tissue from the parent tissue, much like peeling a string of cheese from a block of cheese using a cheese slicer. In other words, because sutures have a small surface area and a large amount of force is applied to the soft tissue over this small surface area, the sutures may have a tendency to cut into already damaged tissue, thereby causing further damage. Current solutions to this problem involve applying a relatively large allograft or xenograft profiling (typically about 3 cm x 3 cm) to the soft tissue after repair but before tightening the soft tissue with sutures. However, the application of this profiling is often expensive, requires numerous sutures, and demands a high level of skill, and is therefore used only by a small number of surgeons. Furthermore, applying a relatively large profiling can significantly increase the surgical time, adding approximately half an hour to an hour for each allograft or xenograft profiling applied. Moreover, in some forms of repair profiling, such as those including a membrane that provides strength to the profiling, surgeons may find it difficult to ensure that the preferred sides of the profiling contact the host tissue.

[0006] Furthermore, delivering repair constructs such as the patches or stents presented herein can sometimes be cumbersome. This delivery is performed through small openings or cannulas, which often results in deformation of the construct before and / or during insertion into the surgical site. Existing repair procedures may involve delivering tissue-reinforcing patches or stents into the surgical area through small openings or cannulas. Passing a tissue-reinforcing patch through a small opening can be very difficult and often requires deformation of the tissue-reinforcing patch before or during insertion. Furthermore, methods of employing surgical repair constructs typically involve first performing a surgical repair (e.g., a rotational sleeve repair) and then inserting the surgical repair construct. In addition to other disadvantages arising from the isolation of these events, the associated techniques disrupt surgical workflows, thereby prolonging the time required to perform the procedure—disadvantages that will be apparent to those skilled in the art.

[0007] Therefore, it is desirable to provide systems, devices, and methods for use in soft tissue repair that are robust, effective, and promote healing, while minimizing the cost and time of the procedure and making it easier to deliver the surgical repair constructs (e.g., tissue-enhancing patches) provided herein to the surgical site. Summary of the Invention

[0008] Systems, devices, and methods are typically provided for performing surgical procedures involving sutures, such as rotational sleeve repairs and other suture repair procedures. More specifically, these systems, devices, and methods are designed to allow users to rapidly add one or more tissue-reinforcing constructs or matrices to sutures used for tissue repair. The use of tissue-reinforcing constructs in various configurations, including but not limited to bands, tubes, blocks, loops, pins, washers, and patches, can expand the coverage area of ​​the associated sutures. This expanded coverage area helps distribute the forces exerted by the sutures on the tissue over a larger surface area, protecting aspects of the system and / or tissue, providing body support for damaged or otherwise degenerated tissue and / or tendons, and can help promote tissue growth and repair at the surgical site.

[0009] Tissue-reinforcing constructs can be associated with sutures as needed, allowing surgeons to quickly and easily expand the coverage area of ​​sutures or similarly presented materials such as suture bands based on the needs during surgery. Various techniques can be used to associate the construct with the suture, including placing the construct on the suture and passing the suture through the construct, among others. In some exemplary embodiments, the tissue-reinforcing construct is pre-positioned on a suture threader, and the threader is operable to associate sutures used for soft tissue repair with the tissue-reinforcing construct. Surgical procedures utilizing the tissue-reinforcing constructs provided in this disclosure, as well as various manufacturing techniques and methods for forming tissue-reinforcing constructs, are also provided.

[0010] Exemplary methods for soft tissue repair, including the use of patches or scaffolds, are disclosed, as well as exemplary methods for soft tissue repair including the use of tissue-reinforcing blocks with ultra-wide configurations. Furthermore, exemplary configurations of tissue-reinforcing scaffolds, such as scaffolds with foldable features, and constructs, such as blocks with ultra-wide configurations, are also provided. Further, configurations for removing the basement membrane from tissue repair constructs are also provided.

[0011] An exemplary method of using a patch or scaffold includes passing each of a first suture branch and a second suture branch through soft tissue and attaching a scaffold to each of the first and second suture branches. This results in an increased surface area for engaging tissue associated with each of the first and second suture branches. A first end of the scaffold is advanced to a location near where the first and second suture branches pass through the soft tissue, and one or more suture tails are coupled to at least one suture anchor disposed in the bone of the attached soft tissue. In some embodiments, the one or more suture tails are part of the suture forming the first and second branches, while in other embodiments, the one or more suture tails are sutures separate from the suture forming the first and second suture branches.

[0012] Tissue-reinforcing patches can have a variety of different configurations. In one configuration, the tissue-reinforcing patch includes an opening extending through a first tissue-reinforcing patch, wherein a first suture branch is configured to pass through the opening of a first tissue-reinforcing block, such that the first tissue-reinforcing block can freely pass along the first suture branch in an unrestricted manner. In configurations where the system includes a first tissue-reinforcing patch and a second tissue-reinforcing patch, the first and second tissue-reinforcing patches can have the same or different configurations. Furthermore, in some embodiments, the first tissue-reinforcing patch may comprise at least one of the following: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, autologous graft, allogeneic graft, allogeneic, xenogeneic, or xenograft connective tissue (including human epidermal matrix, decellularized porcine epidermal matrix, decellularized bovine epidermal matrix, periosteum, pericardial tissue, and / or fascia), and combinations thereof. In some embodiments, the first tissue-reinforcing block comprises collagen. Various techniques known to those skilled in the art or additionally provided herein can be used to weave, nonwoven, knit, or manufacture the patch.

[0013] Patches can have various configurations, shapes, and sizes, and can be made of a variety of materials. In some embodiments, a patch may comprise at least one of the following: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, autologous graft, allogeneic graft, allogeneic, xenogeneic, or xenograft connective tissue (including human epidermal matrix, decellularized porcine epidermal matrix, decellularized bovine epidermal matrix, periosteum, pericardial tissue, and / or fascia), and combinations thereof. In some embodiments, the patch comprises collagen. Various techniques known to those skilled in the art or additionally provided herein can be used to weave, nonwoven, knit, or manufacture patches. Furthermore, in some embodiments, a first layer of the patch may comprise a biodegradable polymer, and a second layer of the patch may comprise an extracellular matrix. The thickness of the first layer may be greater than the thickness of the second layer. Additionally, in some embodiments, the patch may include adjustable suture loops disposed at the edge of the patch, the adjustable suture loops being configured to prevent accidental slippage of the patch relative to suture branches passing through the respective adjustable suture loops.

[0014] The patch may include a second material layer disposed above the first material layer, such that the second material layer is positioned above the tissue-facing surface of the scaffold, and the second material layer includes a second surface of the scaffold. In such embodiments, a first suture branch and a second suture branch may be disposed between the topmost surface of the first material layer opposite to the tissue-facing surface of the patch and the tissue-facing surface of the second material layer opposite to the second surface of the patch.

[0015] An exemplary method of soft tissue repair includes passing a first suture through soft tissue from a medial suture anchor disposed in bone at a surgical repair site. The medial anchor is located beneath the soft tissue. Passing the first suture through the soft tissue causes a first suture branch and a second suture branch of the first suture to extend from the soft tissue. The method also includes passing a second suture through the soft tissue from the medial suture anchor, causing a first suture branch and a second suture branch of the second suture to extend from the soft tissue. Medial stitches are applied to the second suture to secure the soft tissue to the bone. A first suture branch of the first suture is passed through a channel in a tissue-enhancing scaffold, and the tissue-enhancing scaffold is delivered to the surgical repair site. The method further includes attaching the first suture branch of the first suture to a first lateral suture anchor disposed in bone. The attachment of the first suture branch of the first suture to the first lateral suture anchor disposed in bone occurs after the tissue-enhancing scaffold has been delivered to the surgical repair site. After the tissue-enhancing scaffold has been delivered to the surgical repair site, a second suture branch of the first suture is traversed across the top surface of the tissue-enhancing scaffold. The second suture branch of the first suture is attached to a second lateral suture anchor disposed in bone at the surgical repair site.

[0016] In some embodiments, the method may include passing a first suture branch of a second suture through an inner hole extending through the thickness of the tissue-enhancing scaffold, and tying the first and second suture branches together to secure the tissue-enhancing scaffold to the soft tissue. In some such embodiments, a third suture may pass through the soft tissue from an inner anchor such that a first and second suture branch of the third suture extends from the soft tissue. A first suture branch of the third suture may pass through an inner hole extending through the thickness of the tissue-enhancing scaffold, and the first and second suture branches may be tying together to secure the tissue-enhancing scaffold to the soft tissue.

[0017] The method may further include installing a medial suture anchor in the bone, and / or installing a first lateral suture anchor in the bone, and / or installing a second lateral suture anchor in the bone. Delivering the tissue-enhancing scaffold to the surgical repair site may include tightening a first suture branch and a second suture branch of the first suture to guide the tissue-enhancing scaffold toward the soft tissue. Channels in the tissue-enhancing scaffold may extend from a first edge of the tissue-enhancing scaffold to a second edge of the tissue-enhancing scaffold.

[0018] In some embodiments, the medial suture anchor may be a first medial suture anchor, and the method may further include passing a third suture through the soft tissue from a second medial suture anchor disposed in the bone beneath the soft tissue, such that a first suture branch and a second suture branch of the third suture extend from the soft tissue. The method may include passing a fourth suture through the soft tissue from the second medial suture anchor, such that a first suture branch and a second suture branch of the second suture extend from the soft tissue. Medial stitches may be installed on the third suture to secure the soft tissue to the bone. A first suture branch of the fourth suture may pass through a second channel in the tissue-enhancing scaffold. Furthermore, after the tissue-enhancing scaffold has been delivered to the surgical repair site, a first suture branch of the fourth suture may be coupled to a second lateral suture anchor disposed in the bone. A second suture branch of the fourth suture may traverse the top surface of the tissue-enhancing scaffold. This may occur after the tissue-enhancing scaffold has been delivered to the surgical site. Additionally, a second suture branch of the fourth suture may be coupled to a first lateral suture anchor. In some such embodiments, delivering the tissue-enhancing scaffold to the surgical site may include tightening a first suture branch and a second suture branch of a first suture, as well as a first suture branch and a second suture branch of a fourth suture, to guide the tissue-enhancing scaffold toward soft tissue. Alternatively or additionally, in some such embodiments, the method may include passing a first suture branch of a second suture through a first inner hole in the tissue-enhancing scaffold, and tying the first and second branches of the second suture together to secure the tissue-enhancing scaffold to the soft tissue; and passing a first suture branch of a third suture through a second inner hole in the tissue-enhancing scaffold, and tying the first and second branches of the third suture together to secure the tissue-enhancing scaffold to the soft tissue. In embodiments including a first suture and a fourth suture, the second suture branches of the first and fourth sutures may cross each other as they traverse the top surface of the tissue-enhancing scaffold. In some embodiments, connecting the first suture branch of the first suture and the second suture branch of the fourth suture to the first outer suture anchor may include installation in a first outer row fixing manner, and connecting the second suture branch of the first suture and the first suture branch of the fourth suture to the second outer suture anchor may include installation in a second outer row fixing manner.

[0019] In some embodiments where the medial suture anchor is the first medial suture anchor, the method may further include passing a third suture through the soft tissue from the first medial suture anchor, such that a first suture branch and a second suture branch of the third suture extend from the soft tissue; passing a fourth suture through the soft tissue from the second medial suture anchor disposed in the bone beneath the soft tissue, such that a first suture branch and a second suture branch of the fourth suture extend from the soft tissue; passing a fifth suture through the soft tissue from the second medial suture anchor, such that a first suture branch and a second suture branch of the fifth suture extend from the soft tissue; and passing a sixth suture through the soft tissue from the second medial suture anchor, such that a first suture branch and a second suture branch of the sixth suture extend from the soft tissue. In some such embodiments, medial suture stitches may be attached to the fourth suture to secure the soft tissue to the bone. A first suture branch of the third suture may pass through a first medial hole in the tissue-enhancing scaffold, and the first and second suture branches of the third suture may be tied together to secure the tissue-enhancing scaffold to the soft tissue. Furthermore, a first suture branch of the fifth suture can be passed through the second inner hole in the tissue-enhancing scaffold, and the first and second branches of the fifth suture can be tied together to secure the tissue-enhancing scaffold to the soft tissue. Further, a first suture branch of the sixth suture can be passed through the second channel in the tissue-enhancing scaffold and can be attached to a second lateral suture anchor disposed in the bone. This can occur after the tissue-enhancing scaffold has been delivered to the surgical repair site. Similarly, after the tissue-enhancing scaffold has been delivered to the surgical repair site, a second suture branch of the sixth suture can be traversed across the top surface of the tissue-enhancing scaffold. The second suture branch of the sixth suture can be attached to a first lateral suture anchor disposed in the bone at the surgical repair site.

[0020] In some embodiments where the medial suture anchor is the first medial suture anchor and the tissue-reinforcing scaffold is the first tissue-reinforcing scaffold, the method may further include passing a third suture through the soft tissue from the second medial suture anchor disposed in the bone beneath the soft tissue, such that a first suture branch and a second suture branch of the third suture extend from the soft tissue; and similarly, passing a fourth suture through the soft tissue from the medial suture anchor, such that a first suture branch and a second suture branch of the second suture extend from the soft tissue. Medial stitches may be attached to the third suture to secure the soft tissue to the bone. The method may further include attaching medial stitches to the third suture to secure the soft tissue to the bone, connecting a first suture branch of the fourth suture to a second lateral suture anchor, and connecting a second suture branch of the fourth suture to a first lateral suture anchor.

[0021] Tissue-enhancing scaffolds may comprise at least one of the following: fabrics, plastics, synthetic polymers, natural polymers, collagen, collagen scaffolds, reconstructed collagen, autologous connective tissue, allogeneic connective tissue, xenograft connective tissue, human epidermal matrix, porcine epidermal matrix, bovine epidermal matrix, periosteum, pericardial tissue, and fascia. In some such embodiments, the tissue-enhancing scaffold comprises collagen.

[0022] Another exemplary method of soft tissue repair includes passing a first suture through the soft tissue from a medial suture anchor disposed in the bone at the surgical repair site. The medial anchor is located beneath the soft tissue. Passing the first suture through the soft tissue causes a first suture branch and a second suture branch of the first suture to extend from the soft tissue. The method also includes passing a second suture through the soft tissue from the medial suture anchor, causing a first suture branch and a second suture branch of the second suture to extend from the soft tissue. The first suture branches of the first and second sutures are passed through channels in a tissue reinforcement block, and the tissue reinforcement block is delivered to the surgical repair site. The method further includes attaching the first suture branches of the first and second sutures to a first lateral suture anchor disposed in the bone. Attaching the first suture branches of the first suture to the first lateral suture anchor disposed in the bone occurs after the tissue reinforcement block has been delivered to the surgical repair site. Attaching the second suture branches of the first and second sutures to a second lateral suture anchor disposed in the bone at the surgical repair site occurs after the tissue reinforcement block has been delivered to the surgical repair site.

[0023] In some embodiments, the medial suture anchor can be a first medial suture anchor, and the tissue reinforcement block can be a first tissue reinforcement block. A third suture can be passed through the soft tissue from a second medial suture anchor located in the bone beneath the soft tissue, such that a first suture branch and a second suture of the third suture extend from the soft tissue. Furthermore, a fourth suture can be passed through the soft tissue from the second medial suture anchor, such that a first suture branch and a second suture branch of the fourth suture extend from the soft tissue. The first suture branches of the third and fourth sutures can be passed through channels in the second tissue reinforcement block, and the second tissue reinforcement block can be delivered to the surgical repair site. After each of the first and second tissue reinforcement blocks has been delivered to the surgical repair site, the first suture branches of the third and fourth sutures can be connected to a second lateral suture anchor located in the bone. Furthermore, after each of the first and second tissue reinforcement blocks has been delivered to the surgical repair site, the second suture branches of the third and fourth sutures can be connected to a first lateral suture anchor located in the bone. In some such embodiments, the method may include attaching medial sutures to a first suture, a second suture, a third suture, and a fourth suture to secure soft tissue to bone.

[0024] A third tissue reinforcement block (or more) may also be used. For example, the method may further include passing one or more of a second branch of the first suture and a second branch of the second suture through a channel in the third tissue reinforcement block. The third tissue reinforcement block can be delivered in various configurations, but in some embodiments, it may be delivered to the surgical repair site such that one end of the third tissue reinforcement block is adjacent to a first end of the first tissue reinforcement block, and the opposing second end of the third tissue reinforcement block is adjacent to a second end of the second tissue reinforcement block. The first end of the first tissue reinforcement block may be adjacent to a first medial anchor, and the second end of the second tissue reinforcement block may be adjacent to a second lateral anchor. The action of connecting the second suture branches of the first and second sutures to the second lateral anchor may occur after the third tissue reinforcement block has been delivered to the surgical repair site.

[0025] The tissue-enhancing block may comprise at least one of the following: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstructed collagen, autologous connective tissue, allogeneic connective tissue, xenograft connective tissue, human epidermal matrix, porcine epidermal matrix, bovine epidermal matrix, periosteum, pericardial tissue, and fascia. In some such embodiments, the tissue-enhancing block comprises collagen. In some embodiments, the tissue-enhancing block has an ultra-wide configuration. For example, the width of the tissue-enhancing block may be at least 6 mm. In some such embodiments, the length of the tissue-enhancing block is at least 15 mm.

[0026] An exemplary embodiment of a foldable soft tissue repair system includes a tissue-reinforcing scaffold having a first material layer, a tissue-facing surface, and a second surface opposite to the tissue-facing surface. The first material layer includes one or more intrusion features forming at least one folding axis, the at least one folding axis spanning at least a portion of the length of the material (and in at least some instances, the entire length of the material). The one or more intrusion features enable the tissue-reinforcing scaffold to fold around the at least one folding axis to reduce the insertion profile of the tissue-reinforcing scaffold relative to the at least one folding axis.

[0027] In some embodiments, a tissue-facing surface defines a first intrusion feature along a first fold axis, the first intrusion feature being configured to bias a fold of material along a first direction. A second surface may define a second intrusion feature along a second fold axis. The second intrusion feature may be configured to bias a fold of material along a second direction opposite to the first direction. Each of one or more intrusion features may define a cut in the material along a respective fold axis from an inner edge to an outer edge. Alternatively or additionally, each of one or more intrusion features may define a notch channel in the material along a respective fold axis from an inner edge to an outer edge.

[0028] The scaffold may define an inner edge and an opposing outer edge. In such embodiments, a first material layer may define one or more intrusion features that form at least one folding axis spanning at least a portion from the inner edge to the outer edge. Furthermore, the one or more intrusion features enable the tissue-enhancing scaffold to fold about at least one folding axis to reduce the insertion profile of the tissue-enhancing scaffold relative to the inner and outer edges.

[0029] One or more invasive features may be spaced apart along the fold axis to define a plurality of pores penetrating the material. In some embodiments, the tissue-enhancing scaffold comprises a dermal scaffold. In some embodiments, the tissue-enhancing scaffold comprises a freeze-dried scaffold. The tissue-enhancing scaffold may comprise at least one of the following: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, autologous connective tissue, allogeneic connective tissue, xenograft connective tissue, human epidermal matrix, porcine epidermal matrix, bovine epidermal matrix, periosteum, pericardial tissue, and fascia. In some such embodiments, the tissue-enhancing block comprises collagen.

[0030] Unless otherwise specified, such as examples described herein of the advantages associated with delivering tissue-enhancing constructs to the surgical repair site prior to performing the repair, the steps of the methods provided in this disclosure may be performed in any order. Attached Figure Description

[0031] Figure 1A This is a top view of an exemplary embodiment of an organization-enhanced structure;

[0032] Figure 1B yes Figure 1A A side view of the tissue-enhanced structure;

[0033] Figure 2A This is a side perspective view of another exemplary embodiment of the organization-enhanced structure;

[0034] Figure 2BIt contains a wire threader. Figure 2A A side view of the tissue-enhanced structure;

[0035] Figure 2C yes Figure 2B A perspective view of the tissue-enhanced structure;

[0036] Figure 2D yes Figure 2A Front view of the tissue-enhanced structure;

[0037] Figure 2E This is a perspective view of another exemplary embodiment of the organization-enhanced structure;

[0038] Figure 2F This is a perspective view of yet another exemplary embodiment of an organization-enhanced structure;

[0039] Figure 2G This is a side view of another exemplary embodiment of the organization-enhanced structure;

[0040] Figure 2H This is a side view of another exemplary embodiment of the organization-enhanced structure;

[0041] Figure 2I This is a side view of yet another exemplary embodiment of the organization-enhanced structure;

[0042] Figure 3 This is a side view of an exemplary organization enhancement construct installation tool, which has a similar structure to its associated features. Figure 2A Tissue reinforcement of structures;

[0043] Figure 4 This is a perspective view of another exemplary embodiment of the organization-enhanced structure;

[0044] Figure 5 This is a perspective view of yet another exemplary embodiment of an organization-enhanced structure;

[0045] Figures 6A to 6C This is a schematic continuous diagram of an exemplary embodiment for installing tissue reinforcement structures in a double-row fixed manner;

[0046] Figures 7A to 7D This is a schematic continuous diagram of another exemplary embodiment for mounting tissue-enhancing structures in a double-row fixed manner;

[0047] Figure 8A This is a schematic diagram of yet another exemplary embodiment of a tissue reinforcement structure installed in a double-row fixed manner;

[0048] Figure 8BThis is a schematic diagram of another exemplary embodiment of installing tissue reinforcement structures in a double-row fixed manner;

[0049] Figure 9 This is a schematic diagram of yet another exemplary embodiment of a tissue reinforcement structure installed in a double-row fixed manner;

[0050] Figures 10A to 10E It is used for installation in a double-row fixed manner. Figure 2G A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0051] Figures 11A to 11C This is a schematic continuous diagram of an exemplary embodiment for installing tissue reinforcement structures in a single-row fixed manner;

[0052] Figure 11D This is a schematic diagram of another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0053] Figure 11E This is a schematic diagram of another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0054] Figure 11F This is a schematic diagram of another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0055] Figure 12 This is a schematic diagram of yet another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0056] Figure 13 This is a schematic diagram of another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0057] Figure 14 This is a schematic diagram of another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0058] Figure 15 This is a schematic diagram of another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0059] Figures 16A to 16C This is a schematic diagram of yet another exemplary embodiment of installing tissue reinforcement structures in a single-row fixed manner;

[0060] Figures 17A to 17D This is a schematic continuous diagram of an exemplary implementation of soft tissue repair;

[0061] Figures 18A to 18C This is a schematic continuous diagram of another exemplary implementation of soft tissue repair;

[0062] Figure 19 This is a schematic diagram of yet another exemplary implementation scheme for repairing soft tissue;

[0063] Figures 20A to 20C This is a schematic continuous diagram of another exemplary implementation of soft tissue repair;

[0064] Figures 20D to 20F This is a schematic continuum diagram of yet another exemplary implementation of soft tissue repair;

[0065] Figure 21A This is a schematic diagram of an exemplary embodiment of an organization-enhanced structure;

[0066] Figures 21B to 21F It is used for installation Figure 21A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0067] Figure 21G It is used for installation Figure 21A A schematic diagram of another exemplary embodiment of the tissue-enhancing structure shown;

[0068] Figure 21H yes Figure 21A A schematic diagram of an alternative exemplary embodiment of the tissue-enhancing structure shown;

[0069] Figure 21I yes Figure 21A A schematic diagram of an alternative exemplary embodiment of the tissue-enhancing structure shown;

[0070] Figures 22A to 22C It is used for manufacturing Figure 2A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0071] Figure 23A This is a front view of a plurality of tissue-enhancing structures during an exemplary embodiment of the manufacture of tissue-enhancing structures;

[0072] Figure 23B yes Figure 23A A top view of the tissue-enhanced structure;

[0073] Figure 23C yes Figure 23A A front view of one of the multiple tissue-enhancing structures;

[0074] Figure 24A This is a front view of a plurality of tissue-enhancing structures during another exemplary embodiment of the manufacture of tissue-enhancing structures;

[0075] Figure 24B yes Figure 23A A top view of the tissue-enhanced structure;

[0076] Figure 24C yes Figure 23A A front view of one of the multiple tissue-enhancing structures;

[0077] Figure 25 It is used for manufacturing Figure 2A A side view of an exemplary embodiment of the distal end of the tool for the tissue enhancement structure shown;

[0078] Figures 26A to 26C This is a schematic continuous diagram of another exemplary embodiment for manufacturing tissue-enhanced structures;

[0079] Figure 26D It is possible from Figures 26A to 26C A side view of a tissue-reinforced structure produced by the manufacturing process shown;

[0080] Figure 26E It is possible from Figures 26A to 26C A side view of an alternative tissue-reinforced structure produced by the manufacturing process shown;

[0081] Figure 26F yes Figure 26E A top view of the tissue-enhanced structure;

[0082] Figures 26G to 26I This is a schematic continuous diagram of yet another exemplary embodiment for manufacturing tissue-enhanced structures;

[0083] Figure 27A This is a schematic side view of an exemplary embodiment of a tunnel workstation used for manufacturing tissue-enhanced structures;

[0084] Figure 27B and Figure 27C yes Figure 27A A side view of the support components at the tunnel work site;

[0085] Figures 27D to 27I Is it possible to... Figure 27A Various exemplary embodiments of the distal end of the lumen-forming tool used in conjunction with the tunnel work station;

[0086] Figures 27J to 27L Is using Figure 27A A schematic continuous diagram of an exemplary embodiment of a tunnel worksite manufacturing organization reinforcement structure;

[0087] Figure 27M This is a schematic side view of another exemplary embodiment of a tunnel workstation used for manufacturing tissue-enhanced structures;

[0088] Figure 28 This is a side view of an exemplary embodiment of an organization-enhanced structure;

[0089] Figure 29A This is a perspective view of another exemplary embodiment of the organization-enhanced structure;

[0090] Figure 29B It is installed at the surgical site. Figure 29A A perspective view of the tissue-enhanced structure;

[0091] Figure 30A This is a side view of another exemplary embodiment of the organization-enhanced structure;

[0092] Figure 30B yes Figure 30A A top view of the tissue-enhanced structure;

[0093] Figures 30C to 30E It is used for manufacturing Figure 30A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0094] Figure 30F It is used for installation Figure 30A A schematic diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0095] Figures 30G to 30I It is used to install something similar to Figure 30A A schematic continuous diagram of an exemplary embodiment of an organization-enhancing structure;

[0096] Figure 30J It is a perspective view of another exemplary embodiment of a tissue-enhancing structure, wherein the tissue-enhancing structure has a collapsible collar disposed thereon;

[0097] Figure 30K yes Figure 30J A perspective view of a tissue-reinforcing structure having suture branches passing through a collapsible collar;

[0098] Figure 30L It is used for installation Figure 30J A schematic diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0099] Figures 31A to 31C This is a schematic continuous diagram of yet another exemplary embodiment for manufacturing tissue-enhanced structures;

[0100] Figure 32A This is a top view of another exemplary embodiment of the organization-enhanced structure;

[0101] Figures 32B to 32E It is used for installation Figure 32A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0102] Figures 32F to 32H It is used to install something similar to Figure 32A A schematic continuous diagram of an exemplary embodiment of an organization-enhancing structure;

[0103] Figures 32I to 32J It is used for manufacturing Figure 32A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0104] Figures 33A to 33E It is a schematic top view of various exemplary embodiments of tissue reinforcement structures and suture configurations;

[0105] Figure 34A This is a top view of another exemplary embodiment of the organization-enhanced structure;

[0106] Figure 34B yes Figure 34A A side view of the tissue-enhanced structure;

[0107] Figures 34C to 34J It is used for installation Figure 34A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0108] Figure 34K It is used for installation Figure 34A A schematic diagram of another exemplary embodiment of the tissue-enhancing structure shown;

[0109] Figure 35A This is a top view of another exemplary embodiment of the organization-enhanced structure;

[0110] Figure 35B yes Figure 35A A side view of the tissue-enhanced structure;

[0111] Figure 35C and Figure 35D It is used for installation Figure 35A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0112] Figure 36A This is a top view of another exemplary embodiment of the organization-enhanced structure;

[0113] Figure 36B yes Figure 36A A side view of the tissue-enhanced structure;

[0114] Figures 36C to 36I It is used for installation Figure 36A A schematic continuous diagram of an exemplary embodiment of the tissue-enhancing structure shown;

[0115] Figure 37This is a top view of another exemplary embodiment of an organization-enhancing structure in an installation arrangement.

[0116] Figures 38A to 38E It is used for installation Figure 37 A schematic continuous diagram of an exemplary embodiment of an organization-enhancing structure;

[0117] Figures 39A to 39D It is used for installation Figure 37 A schematic continuous diagram of another exemplary embodiment of the organization-enhancing structure;

[0118] Figures 40A to 40E This is a schematic continuous diagram of an exemplary embodiment for installing a tissue-enhancing structure;

[0119] Figure 41 This is a schematic diagram of another exemplary embodiment for installing tissue-enhancing structures;

[0120] Figure 42A It is a top view of an exemplary embodiment of a tissue-enhancing structure having one or more folded axes;

[0121] Figure 42B yes Figure 42A A side view of an organization-reinforced structure, showing an exemplary embodiment of a notch formed along one or more folding axes of the structure;

[0122] Figure 42C yes Figure 42A A side view of an organization-reinforced structure, which shows another exemplary embodiment of a notch formed along one or more folding axes of the structure;

[0123] Figure 42D yes Figure 42A A side view of an organization-enhanced structure, showing yet another exemplary embodiment of a notch formed along one or more folding axes of the structure;

[0124] Figure 42E yes Figure 42D The tissue-reinforced structure in its side view after it has been folded; and

[0125] Figure 42F This is a top view of another exemplary embodiment of a tissue-enhancing structure having one or more folded axes. Detailed Implementation

[0126] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and the scope of this disclosure is defined only by the claims. Feature structures shown or described in conjunction with one exemplary embodiment may be combined with feature structures of other embodiments. Such modifications and variations are intended to be included within the scope of this disclosure. Additionally, in this disclosure, components with similar numbers in the embodiments generally have similar features. Furthermore, the extent to which linear or circular dimensions are used in the description of the disclosed systems, devices, and methods is not intended to limit the types of shapes that may be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be readily determined for any geometry. The size and shape of systems and devices and their components may depend at least on the anatomy of the patient in whom the system and device will be used, the size and shape of the components with which the system and device will be used, and the methods and procedures in which the system and device will be used.

[0127] The accompanying drawings provided herein are not necessarily drawn to scale. Furthermore, the arrows used to describe directions of movement are exemplary and in no way limit the directions in which individual components can or should move. Those skilled in the art will recognize other ways and directions from this disclosure to obtain the desired results. Additionally, many terms may be used interchangeably in this disclosure, but those skilled in the art will understand. As a non-limiting example, the terms suture, filament, and flexible member are used interchangeably and include other materials for similar purposes, such as suture tape. Furthermore, the term “block” used to describe some of the structures and matrices provided herein is not limited to squares or rectangles, or any shape having a flat surface in this respect. Additionally, the term “threading” used to describe as associating one component with another is not limited to actually threading a filament through another material. It may also include threading it through an opening (e.g., as described below, at least relative to an opening in the body where some tissue-reinforcing blocks are formed), and thus can more generally refer to associating one component with another. When a “feature” or “step sequence” is described as “first feature” or “first step” or “second feature” or “second step”, this ordering is generally arbitrary unless otherwise explicitly indicated, and therefore such numbering can be interchanged.

[0128] Systems, devices, and methods for soft tissue repair are typically provided, including but not limited to: one or more surgical repair filaments and / or flexible members; one or more tissue-reinforcing constructs or matrices comprising strips, tubes, rods, staples, washers, and / or patches, each described in more detail below; and devices for one or more suture implants or similar constructs or uses. The terms “tissue-reinforcing construct” and “tissue-reinforcing matrix” may also be used interchangeably with the terms “suture-reinforcing construct” and “suture-reinforcing matrix,” and more generally with the terms “reinforcing construct” and “reinforcing matrix” and the terms “construct” and “matrix.” As described herein, the term “construct” refers to any implant associated with a suture branch to expand the branch coverage area, the term “block” refers to a subset of constructs comprising strips or bands, tubes, rods, washers, and other hollow bodies, and the terms “staple” or “button,” and “patch” or “support” (as well as the terms strips, bands, tubes, rods, and washers, etc.) will be described in more detail below. Surgical repair filaments or flexible components can have various configurations, including typical suture configurations and band forms, and can be used in conjunction with various types of suture implants, such as filament anchors, suture anchors, or bone anchors (including rigid and soft anchors), to attach or reattach soft tissue to bone. The repair filament can pass through the soft tissue, allowing it to be positioned in the desired location. The repair filament is secured to the anchor, which is then secured in the bone. Tissue-reinforcing constructs can be associated with surgical repair filaments to increase coverage and provide body mass for damaged or degenerated soft tissue, thereby increasing the surface area along which the suture repair filament applies compression and helping to promote tissue growth and repair. Although each of the repair filaments, tissue-reinforcing constructs, and suture implants is described as part of a system or device, any one of these components can be provided independently for use with other components or implants and devices used in surgical procedures.

[0129] While this disclosure can enhance many different reconstructive procedures, in some exemplary embodiments, the soft tissue repair apparatus and system provided herein can be used in a rotating sleeve fixation procedure. In a rotating sleeve fixation procedure, the surgeon can reattach the rotating sleeve to the bone by first passing sutures through the soft tissue, such that two suture branches extend from the tissue. The surgeon can then pass each suture through a corresponding tissue-reinforcing construct and subsequently fix the suture branch to one or more bone anchors adjacent to the tissue. The tissue-reinforcing construct increases the surface area or coverage of the system in contact with the soft tissue. This increased coverage area can distribute any loading forces across the soft tissue, and therefore taut sutures are less likely to wear down or otherwise damage the soft tissue, for example, through a “suture-cutting-cheese” effect. Furthermore, during the procedure, the tissue-reinforcing construct can be easily and quickly inserted into or otherwise associated with the suture branches, in contrast to existing systems that involve complex and time-consuming methods for associating xenografts or allogeneic graft profilings with suture branches. The resulting procedure thus allows for the addition of tissue-reinforcing constructs to the suture branches as needed. Furthermore, tissue-reinforcing constructs can be made of biocompatible materials (e.g., collagen) and other types of materials, enabling the formation of new tissue growth bands during the healing process, thereby further enhancing the effectiveness of the rotational sleeve fixation procedure. In other non-limiting exemplary embodiments disclosed herein, soft tissue repair devices and systems can be used in other soft tissue repair surgeries, such as repair of torn anterior cruciate ligaments (ACLs), unstable or glenoid surgeries, meniscus repair, superior bursa reconstruction, hip capsule closure, etc. Various methods for manufacturing tissue-reinforcing constructs, as well as various methods for associating tissue-reinforcing constructs with manipulative sutures using installation tools and / or threaders, are also described.

[0130] Tissue-reinforcing structures - tissue-reinforcing blocks with strip or band configurations

[0131] Figure 1A and Figure 1B An exemplary embodiment of a tissue-reinforcing construct, such as tissue-reinforcing block 10, is provided. In one exemplary embodiment, tissue-reinforcing block 10 is a strip or band configured to penetrate or otherwise associate with suture branch 12a. More specifically, the tissue-reinforcing strip or band 10 may have a generally rectangular shape, having a width W, a length L, and a thickness T, and including substantially flat tissue-engaging surfaces 10a and / or 10b. As shown, the length of band 10 is greater than its width, and the width is greater than its thickness. Typically, the length L is significantly greater than the width W, and the width W is significantly greater than the thickness T. Furthermore, the width W may be greater than the diameter of the filament or suture associated with the tissue-reinforcing band 10, such as suture branch 12a, thereby increasing the compression surface area of ​​the system or device used in surgical repair.

[0132] Those skilled in the art will recognize that the dimensions of the tissue-reinforcing strip 10—length L, width W, and thickness T—can depend on a variety of factors, including, but not limited to, the size of the filament associated with it, the patient's anatomy, and the type of surgery being performed. In some embodiments, the ratio of the width W of the strip 10 to the diameter of the suture branch 12a can be approximately in the range of about 2:1 to about 20:1, and more specifically, in some cases, the width W can be at least three times larger than the diameter of the filament or suture associated with the tissue-reinforcing strip 10. In embodiments where the suture branch 12a is a suture band, in some cases, the width W of the tissue-reinforcing strip 10 can be twice the diameter of the suture band associated with it. Those skilled in the art will recognize that the ratio of the width of the tissue-reinforcing strip to the diameter of the filament or associated structure using the strip can be any suitable ratio, which depends at least in part on the type of filament or associated structure used, the type of strip or other construction used, and the type of procedure being performed, and therefore the width-to-diameter ratio can be less than or greater than those ratios provided herein. Furthermore, in some embodiments, the ratio of the length L of the strip 10 to the width W of the strip 10 can be approximately in the range of about 2:1 to about 20:1, and more specifically, in some cases, the length L can be at least three times larger than the width W, in others at least five times larger, and in some cases at least ten times larger, but other LW ratios are also possible. Additionally, the strip 10 can be substantially flat and generally uniform. In some embodiments, the ratio of the width W of the strip 10 to the thickness T of the strip 10 can be approximately in the range of about 2:1 to about 20:1, and more specifically, in some cases, the width W can be at least three times larger than the thickness T, in others at least five times larger, and in some cases at least ten times larger, but other WW ratios are also possible. Various other sizes and shapes of the tissue-reinforcing strip 10, including the size ratio of the tissue-reinforcing strip to associated components (e.g., suture branch 12a), can be utilized without departing from the spirit of this disclosure.

[0133] While ratios can be used to help describe the relationship between strip 10 and filament branches 12a, and the relationship between the dimensions of strip 10, some exemplary non-limiting dimensions of the tissue-reinforcing strip can also be used to understand this disclosure. As mentioned above, these dimensions can depend on a variety of factors. In some embodiments, the length L can cover a considerable portion, covering almost the entire length of the tissue extending between the suture formed in the tissue and the bone anchor used to help fix the tissue. In some embodiments, the length L can be generally in the range of about 5 mm to about 1 cm, the width W can be generally in the range of about 1 mm to about 5 mm, and the thickness T can be generally in the range of about 0.5 mm to about 3 cm. Furthermore, although strip 10 is described as having a certain length, width, and thickness, and Figure 1A It is shown as basically flat. Figure 1B The strip 10 is shown to be relatively flexible, for example, it can be partially raised by suture branches 12 passing through it. The materials used to form the strip 10 are described in a later part of this disclosure.

[0134] Various techniques can be used to associate the tissue-enhancing strip 10 with the suture branch 12a. For example... Figure 1B As shown, suture branch 12a passes from top side 10a to bottom side 10b and returns to top side 10a of tissue-reinforcing strip 10. The process of passing suture branch 12a through tissue-reinforcing strip 10 can be repeated multiple times as needed. In some embodiments, the suture threader can pass through tissue-reinforcing strip 10 before surgery, so that surgical sutures can pass through the tissue-reinforcing strip within the body during surgery. Exemplary suture threaders are discussed below for alternative tissue-reinforcing constructs.

[0135] although Figure 1BThe tissue-reinforcing strip 10 is shown to have an exaggerated wavy profile when engaged with the suture branch 12a, effectively conforming to the geometry of the soft tissue it contacts. By including the tissue-reinforcing strip 10 on the suture branch 12a, the suture branch 12a has a wider coverage area, thus covering a larger surface area of ​​the tissue. Furthermore, the tissue-reinforcing strip 10 allows the force applied to the tissue by the suture branch 12a to be distributed over a larger surface area. This larger amount can depend on the surface area of ​​the tissue-reinforcing strip 10. Thus, in embodiments where the width of the tissue-reinforcing strip 10 is at least three times larger than the diameter of the suture branch 12a, the force exerted by the suture branch 12a on the tissue can be distributed over an area at least three times larger than in the case where no tissue-reinforcing strip 10 is associated with the suture branch 12a. The increased tissue surface area coverage and the distributed force of the tissue-reinforcing strip 10 can result in a reduction in the peak pressure on the soft tissue. In use, the surface of the engaged tissue is surface 10a or surface 10b, and this increased distribution can be permitted. In cases where soft tissue degenerates due to injury or age, reduced pressure may decrease the chance of tissue abrasion. Furthermore, greater tissue coverage can promote the healing of tissues damaged in other ways.

[0136] The suture branch 12a used in conjunction with the tissue reinforcing strip 10 can be any type of suture (e.g., braided filament, hollow filament, monofilament, suture tape, etc.) and can have sizes of approximately #5 filament (approximately 20 to approximately 21 gauge) and approximately #3-0 filament (approximately 29 to approximately 32 gauge). Those skilled in the art will recognize that various other filament types and sizes can also be used in conjunction with the reinforcing strip 10 (e.g., if suture tape is used).

[0137] Tissue-reinforced structures - tissue-reinforced structures with hollow sections

[0138] Figures 2A to 2DAnother exemplary embodiment of a tissue-reinforcing structure is provided, as shown in tissue-reinforcing block 110. Alternatively, tissue-reinforcing structures such as block 110 may generally be referred to as tissue-reinforcing structures having a hollow body. Tissue-reinforcing structures having a hollow body may include tube 110, rods 3010, 3010′, and washers 310, 410. In one exemplary embodiment of the reinforcing block, the block may be a hollow tube configured to be disposed on or otherwise associated with a suture branch 112a. More specifically, the reinforcing tube 110 may have a substantially cylindrical or oval body having a hole or lumen 114 extending therethrough from the proximal end 110p to the distal end 110d. Within the scope of the description of block 110 as a tube, such description in no way limits the construction of the tissue-reinforcing block to a tube or having a tubular construction. A tubular configuration is one of the various configurations of the block provided herein or otherwise modified. Other non-limiting embodiments of the block, as further described below, include, but are not limited to rods and washers.

[0139] Returning to the hollow nature of block 110, the hole 114 can be used, for example, to receive suture branch 112a, so that block 110 and branch 112a can be associated with each other, as described in more detail below. As shown, block 110 has a length L' greater than its diameter D, and in many cases significantly greater. Furthermore, diameter D can be greater than the diameter of the filament or suture associated with tissue-reinforcing block 110, such as suture branch 112a, thereby increasing the surface area for tissue reinforcement in systems or devices used in surgical repair.

[0140] Those skilled in the art will recognize that the dimensions of the length L' and diameter D of the tissue-enhancing strip 110, and the diameter d of the orifice 114, can depend on a variety of factors, including, but not limited to, the size of the filament associated therewith, the patient's anatomy, and the type of surgery being performed. In some embodiments, the ratio of length L' to diameter D can be approximately in the range of about 2:1 to about 20:1, and more specifically, in some cases, L' can be at least three times larger than the diameter D. Furthermore, in some embodiments, the ratio of the diameter D of the tube 110 to the diameter of the suture branch 112a can be approximately in the range of about 2:1 to about 20:1, and more specifically, in some cases, the diameter D can be at least three times larger than the diameter of the filament or suture associated with the tissue-enhancing strip 110. Various other sizes and shapes of the tissue-enhancing tube 110, including the size ratio of the tissue-enhancing block and associated components (e.g., suture branch 112a), can be utilized without departing from the spirit of this disclosure.

[0141] While ratios can be used to help describe the relationship between tube 110 and filament branch 112a, and the relationship between the dimensions of tube 110, some exemplary non-limiting dimensions of the tissue-reinforcing tube can also be used to understand this disclosure. As mentioned above, these dimensions can depend on a variety of factors. In some embodiments, the length L' can cover a considerable portion, covering almost the entire length of the tissue extending between the suture formed in the tissue and the bone anchor used to help fix the tissue. In some exemplary embodiments, the length L' can range from about 5 mm to about 2 cm, and the diameter D can range from about 1 mm to about 5 mm. The diameter d of the hole 114 can also depend on a variety of factors, including but not limited to the size of the branch to be passed through. In some embodiments, the diameter d can range from about 0.75 mm to about 3 mm.

[0142] Alternative implementation of the tissue reinforcement block 110 with a hollow portion in Figure 2E , Figure 2F , Figure 2G , Figure 2H and Figure 2I As shown in the image. Although the hollow part is... Figures 2A to 2I The blocks 110, 3010, 3110, 2810a, 2810', and 2810" provided in the document share common features, but not all tissue-reinforcing blocks have a hollow portion. Other configurations of tissue-reinforcing blocks do not have a hollow portion or a hollow portion through which suture branches pass, and therefore other configurations can be associated with branches using other techniques known to those skilled in the art.

[0143] As discussed above, such as Figure 2E and Figure 2F As shown, the tissue reinforcing rods 3010 and 3110 can have rectangular and / or square cross-sectional shapes. Other cross-sectional shapes, including, for example, triangular, quadrilateral, pentagonal, hexagonal, octagonal, etc., are also possible. Figure 2E As shown, the hollow rod 3010 is configured to be disposed on or otherwise associated with a suture branch, as described above with respect to the hollow tube 110. More specifically, the rod 3010 may have a generally rectangular body having a rectangular hole or cavity 3014 extending therethrough from the nearest end 3010p to the farthest end 3010d. For example, the hole 3014 may be used to receive a suture branch, such that the rod 3010 and the suture branch can be associated with each other, as described in more detail below. It is conceivable that the hole 3014 may be constructed using the manufacturing techniques discussed below with respect to the reinforcing block 110.

[0144] Figure 2F Alternative configurations of tissue reinforcement rods 3010 and 3110 are shown. For example... Figure 2FAs shown, the hollow rod 3110 is configured to be disposed on or otherwise associated with a suture branch, as described above with respect to hollow blocks 110, 3110. More specifically, the rod 3110 may have a generally rectangular body having a rectangular hole or cavity 3114 extending therethrough from the nearest end 3110p to the farthest end 3110d. For example, the hole 3114 may be used to receive a suture branch, such that the rod 3110 and the suture branch can be associated with each other, as described in more detail below. As shown, the rod 3110 may be composed of two parts of material 3110a, 3110b. The two parts of material 3110a, 3110b may be associated with each other by sutures 3124a, 3124b. The two parts of material 3110a, 3110b may be attached to each other, such that the cavity 3114 is formed using any of the manufacturing techniques discussed throughout this disclosure. Without departing from the spirit of this disclosure, various other sizes and shapes of rods 3010 and 3110 may be utilized, including the size ratio of the rod and associated components (e.g., suture branches).

[0145] Other optional constructions of the organization enhancement blocks 2810a, 2810' and 2810" are in Figure 2G , Figure 2H and Figure 2I The figures are shown separately. As shown in the figure, hollow blocks 2810a, 2810', and 2810" are all essentially the same as tissue reinforcement block 110, such as... Figures 2A to 2D As shown. Alternatively, hollow blocks 2810a, 2810', 2810" may have a configuration substantially similar to tissue reinforcement rods 3010, 3110. Hollow blocks 2810a, 2810', 2810" may have a significantly longer length than tissue reinforcement block 110. In some embodiments, block 2810a may have a length generally ranging from about 15.0 mm to about 25.0 mm. Advantageously, blocks 2810a, 2810', 2810" may have a length that extends inward from the lateral anchor and over the soft tissue repair to provide additional protection for the repair and additional scaffold to promote healing.

[0146] Various techniques can be used to associate tissue reinforcement blocks 110, 3010, 3110, 2810a, 2810', 2810" with suture branch 112a. For example, as Figure 2AAs shown, the suture branch 112a passes through or through the tissue-enhancing tube 110 from its nearest end 110p to its farthest end 110d without passing through (i.e., traversing) the body of the tube 110. In other words, the suture branch 112a does not enter the sidewall of the body defining the lumen 114. Thus, the tube 110 is not coupled or attached to the suture branch 112a, but can pass freely along the length of the branch 112a without obstruction or restriction. In other embodiments, the branch 112a may pass through (i.e. traverse) the body once or more to further secure the position of the tube 110 relative to the branch 112a, thereby coupling or attaching the tube 110 to the suture branch 112a. Those skilled in the art will recognize that the tube 110 may be associated or coupled to the branch 112a in a variety of other ways without departing from the spirit of this disclosure.

[0147] The tissue-enhancing tube 110 can be manually passed through the suture branch 112a at the surgical site or outside the body. Alternatively, such as Figure 2B and Figure 2C As shown, before the tissue reinforcement tube 110 is threaded onto the suture branch 112, the tissue reinforcement tube 110 may have a threader 206 for insertion through the through hole 114. The threader 206 may include a proximal handle portion 208, an intermediate elongated portion 210, and a distal suture receiving end 212. The proximal handle portion 208 may be designed to be easy for a user to grip, for example, by having a generally rectangular shape as shown. Other shapes and features for gripping may be provided. The intermediate portion may be a filamentous portion 210 that allows the tissue reinforcement structure, such as the tissue reinforcement tube 110, to be associated with it, thereby allowing the threader 206 to be flexible. The distal suture receiving end 212 may have a distal opening 212 through which a suture to be associated with the reinforcement strip, such as the suture branch 112a, can be disposed. In the illustrated embodiment, the distal opening 212 is flexible and, in some embodiments, may be made of wire, fiber, suture, cord, and / or other flexible structures or other materials with similar characteristics. Because the distal opening 212 is flexible, its shape can change before, during, and after use, and therefore, although it has a rhomboid or kite shape in the illustrated embodiment, other configurations are also possible. Furthermore, the flexible nature of the opening 212 allows it to collapse around the suture disposed therein to tighten or otherwise retain the suture during use. In some embodiments, the intermediate portion 210 may also be made of wire, fiber, suture, cord, and / or other flexible structures. The term "wire" does not mean that the structure is made of metal or has metallic features, but the intermediate portion 210 and the distal suture receiving end 212 may be made of metal.

[0148] Figures 2G to 2IAdditional configurations of suture branching associated with tissue-reinforcing structures are provided. For example... Figure 2G As shown, structure 2810a may include two threaders disposed therethrough for associating structure 2810a with at least one suture branch. Figure 2G As shown, the first threader 2809a can be disposed through the block 2810a from the top surface 2811t to the bottom surface 2811a, such that the handle 2808a is close to the top surface 2811t and the receiving end 2807b is close to the bottom surface 2811b. The first threader 2809a can be disposed through the block 2810a such that it intersects the central lumen 2870 of the block 2810a substantially perpendicularly. Alternatively, the threader 2809a can be disposed at any angle relative to the central lumen 2870. The first threader 2809a can be disposed at the proximal end 2811p or the proximal half of the block 2810a. The second threader 2809b can be disposed through the distal portion 2811d of the block 2810a. For example, the second threader 2809b may extend from the distal end 2811d of block 2810a through lumen 2870 to an inner position 2870m of lumen 2870, and exit from the bottom 2811b of block 2810a. In an exemplary embodiment, the second threader 2809b may extend through block 2810a such that the handle portion 2808b of threader 2809b is close to the distal end 2811d of block 2810a, and the receiving end 2807b of threader extends from the bottom 2811b of block 2810a. Alternatively, other suture threader configurations may be considered, as described below. Figure 2H and 2I As described.

[0149] In an alternative suture threader configuration, such as Figure 2I As shown, block 2810' may include a pre-threaded suture 2814' located in the proximal end 2811p' of the block, thus eliminating the need for a second threader. The pre-threaded suture 2814' may be integrated with... Figure 2G The second threader 2809b shown is inserted into block 2810' at a substantially similar position. The pre-threaded suture 2014' can be inserted into block 2810' before or after the block is associated with the repair suture (not shown). In yet another alternative configuration, such as... Figure 2HAs shown, 2810” may include two threaders 2809a” and 2809b”. Threaders 2809a” and 2809b” may be substantially similar to the threaders 2809a and 2809b discussed above. As shown, a second threader 2809b” may be positioned, for example, from the proximal terminal 2811p” through the central lumen 2870” to the distal terminal 2811d”. Alternatively, the second threader 2809b” may extend any length through the central lumen 2870”. The second threader 2809b” may associate suture branches (not shown) with block 2810” using techniques provided throughout this disclosure. Each of the suture branches and the repair suture branch may exit block 2810” at the distal end 2811d”, respectively, and the repair suture branch will then be anchored into the bone at a location of the laterally offset soft tissue repair.

[0150] In use, a force P1 can be applied to the handle portion 208 to move the filament portion 210 and the distal opening 212 relative to the reinforcing tube 110 in the direction of the force P1. The distal opening 212 and the corresponding associated suture branch 112a can be pulled in and through the reinforcing tube 110 by movement, thereby positioning the reinforcing tube 110 on the suture branch 112a. As the distal opening 212 enters the reinforcing tube 110, the opening 212 can collapse around the suture branch 112a, for example, compressing to a smaller width to tighten the branch 112a, thereby making it easier to pull the suture branch 112a into the body of the reinforcing tube 110. Once the reinforcing tube 110 is positioned on or otherwise associated with the suture branch 112a, the suture branch 112a can be detached from the distal opening 212, and the threader 206 can be discarded or reused because it is no longer associated with either the reinforcing tube 110 or the suture branch 112a. As described in further detail below, the combination of suture branch 112a and reinforcing tube 110 can be used in a variety of procedures. The process of placing the reinforcing tube 110 on the suture branch 112a can occur outside or inside the body, including near the surgical site.

[0151] Similar to the tissue-reinforcing strip 10, by including a tissue-reinforcing tube 110 on the suture branch 112a, the suture branch 112a has a larger coverage area, thus covering a greater area of ​​tissue surface. Furthermore, the tube 110 allows the force applied to the tissue by the suture branch 112a to be distributed over a larger surface area. This larger amount can depend on the surface area of ​​the tissue-reinforcing strip 110. Therefore, in embodiments where the diameter of the tissue-reinforcing tube 110 is at least three times larger than the diameter of the suture branch 112a, the force exerted on the tissue by the suture branch 112a can be distributed over an area at least three times larger than the area associated with the suture branch 112a without the tissue-reinforcing strip 110. The increased tissue surface area coverage and the distributed force of the tissue-reinforcing tube 110 can result in a reduction in peak pressure on the soft tissue. In cases of soft tissue degeneration due to injury or age, increased tissue surface area coverage and reduced pressure may reduce the chance of tissue abrasion. Furthermore, greater tissue coverage can promote the healing of otherwise damaged tissue and / or provide propagation for otherwise damaged or degenerated tissue and / or tendons.

[0152] Similar to threader 206, threaders can also be used in conjunction with installation tools to help associate reinforcement structures with sutures. Figure 3 A threader 206' similar to threader 206 is provided, except that the proximal handle portion 208' and the distal receiving end 212' have slightly different shapes. As shown, the proximal handle portion 208' takes the form of a gripping protrusion 208' having a diameter larger than that of the intermediate filament portion 210', thereby allowing the user to easily grip the proximal handle portion 208'. Those skilled in the art will understand that the proximal handle portion 208' can have almost any shape. Similarly, the shape of the distal receiving end 212' can also have almost any shape. In the illustrated embodiment, the distal receiving end 212' is a distal opening 212', but this opening is shown as more rounded than the distal opening 212. However, as mentioned above, since the distal opening 212' can be flexible, even the illustrated embodiment can be manipulated into other shapes.

[0153] The installation tool 200' may include a handle portion 202' and a cylindrical portion 204'. The handle portion 202' may be long, allowing the installation tool 200' to pass through a cannula and be inserted into a surgical site inside the body. Alternatively, the handle portion 202' may be of any suitable length. Figure 3As shown, the handle 202' includes a proximal portion 202p' and a distal portion 202d'. The distal portion 202d' of the handle 202' may be offset at an angle from the proximal portion 202p' to allow the tube 204' to be oriented in a favorable orientation for inserting the reinforcing tube 110' into the branch 112a'. Alternatively, the proximal portion 202p' and the distal portion 202d' may be aligned with each other.

[0154] The distal portion 202d' can be attached to the tube 204', which is sized to receive the reinforcing tube 110' to be inserted into the suture branch 112a'. The tube 204' can be cylindrical with an approximately circular cross-section. Alternatively, the tube 204' can have a triangular, rectangular, or any other shape and / or cross-section. The tube 204' can have a lumen 214' extending from the first opening 216' through it to the second opening 218'. The first opening 216' can be larger than the second opening 218'. Alternatively, the first opening 216' and the second opening 218' can be of any desired size. Figure 3 As shown, the first opening 216' may have a diameter substantially the same as that of the lumen 214', allowing the reinforcing lumen 110' to be placed through it. The second opening 218' may have a diameter sized to receive the relevant portion of the threader 206' passing through it.

[0155] like Figure 3 As shown, suture branch 112a' is inserted through opening 212', and threader 206' can be operated in a similar manner to threader 206 to place reinforcing tube 110' onto suture branch 112a'. For example, an operator can hold the handle portion 208' of threader 206' to apply force F. P Pull the opening 212' through the insertion cannula 114' of the reinforcing tube 110'. The handle 208' can be pulled until the entire threader 206' and the distal portion of the suture branch 112a' have passed through the second opening 218'. Once the suture branch 112a' has passed through the reinforcing tube 110', the suture 206' can be discarded or reused, and the installation tool can release the reinforcing tube 110' by actuating a release mechanism (not shown). Alternatively, the reinforcing tube 110' can be held in the cylinder 204' by an interference fit, eliminating the need for a release mechanism. Although referenced to the reinforcing tube 110' and suture branch 112a' as described above, the installation tool 200' can be... Figures 1A to 1B The reinforcing strip 10 and other constructions provided herein are used in the same manner. Furthermore, although the threader is discussed for use in conjunction with an installation tool, the threader itself can be considered an installation tool because the embodiments provided herein allow the threader to be used to associate sutures with the reinforcing construction without the use of installation tool 200'.

[0156] Tissue-reinforcing structures - tissue-reinforcing blocks with gasket, disc, or ring configurations.

[0157] Figure 4 Exemplary embodiments of tissue-reinforcing structures are provided, such as tissue-reinforcing block 310. Reinforcing block 310 has a configuration that can be described as a washer, disc, or ring, and in the illustrated embodiment, it is configured as a square washer disposed on or otherwise associated with a suture branch 312a. For example, washer 310 may have a substantially rectangular prism-shaped body having a hole or lumen 314 extending from its proximal end 310p through it to its distal end 310d. Hole 314 may be used, for example, to receive suture branch 312a, such that washer 310 and branch 312a can be associated with each other, as described in more detail below. As shown, washer 310 has substantially the same length L. B and width W B and less than length L B and width W B Height T B Alternatively, washer 310 may have a length L. B Width W B A larger, more elongated rectangular shape. In another alternative form, the length L B Width W B and height T B They can be approximately equal, thus forming a cubic-shaped main body. Furthermore, the diameter d of the lumen... B It can be larger than the diameter of the filament or suture associated with the washer 310, such as suture branch 312a. In other embodiments, suture branch 312a may pass through the washer 310 without a pre-formed lumen. Once the block is associated with suture branch 312a, the block can increase the compressible surface area of ​​the system or device for surgical repair due to the increased surface area of ​​the block.

[0158] Those skilled in the art will recognize that the length L of washer 310 B Width W B Thickness or height T B and diameter d B The size can depend on a variety of factors, including but not limited to the size of the associated filament, the patient's anatomy, and the type of surgery being performed. In some embodiments, the washer 310 may have a length L ranging from about 3 mm to about 6 mm. B and the width W in the range of approximately 3 mm to approximately 6 mm. B And a thickness or height T ranging from about 1 mm to about 3 mm. B Alternatively, a location of length L is selected. B Width W B And thickness or height TB All may be substantially equal in size and have dimensions ranging from approximately 2 mm to approximately 5 mm. One advantage of the smaller size of the washers 310 is that surgeons can load multiple washers 310 onto a single suture branch, as further described below, to allow for precise application of the washers to the damaged tissue area where they are needed. For example, precise application of the washers may include moving the washers along the length of the suture branch to more precisely guide the force from the suture branch, distributing it over a larger surface area. Given this disclosure, it can be clearly seen that the thickness or height of the washers 310 may be significantly smaller than the length of the suture branch on which the washers 310 are disposed. Any number of washers 310 may be disposed on a suture branch, including but not limited to up to 30. In some exemplary embodiments, the number of washers 310 disposed on a single suture branch is approximately in the range of approximately 2 to approximately 8.

[0159] Figure 5 Alternative embodiments of a tissue reinforcement structure for efficient integration with other similarly sized structures on the same suture branch are shown. As shown, the tissue reinforcement structure is a tissue reinforcement block 410 having a configuration that can be described as a washer, disc, or ring. In the illustrated embodiment, it is a ring or circular washer. For example, the tissue reinforcement washer 410 may have a hole or lumen 414 extending from its nearest side 410p through it to its farthest side 410d. The hole 414 may be used, for example, to receive a suture branch 412a, such that the washer 410 and the branch 412a can be associated with each other, or alternatively, the branch 412a may be associated with the washer 410 by passing it through the body of the ring without any pre-drilled openings or holes.

[0160] Those skilled in the art will recognize that the diameter D of washer 410 W Height H W and aperture d W This can depend on various factors, including but not limited to the size of the associated filament, the patient's anatomy, and the type of surgery being performed. In some implementations, the diameter D... W The height H can be roughly in the range of about 3 mm to about 6 mm. W It can be roughly in the range of about 1 mm to about 3 mm, and the aperture d W The thickness can be generally in the range of about 0.5 mm to about 2 mm. Similar to washer 310, it can be clearly seen from this disclosure that the thickness or height of washer 310 can be significantly smaller than the length of the suture branch on which washer 410 is disposed. Any number of washers 410 can be disposed on the suture branch, including but not limited to up to 30. In some exemplary embodiments, the number of washers 410 disposed on a single suture branch is generally in the range of about 2 washers to about 8 washers.

[0161] As further described below, one advantage of washers 310, 410 is that the surgeon can pass the anterior and posterior sutures through washers 310, 410 at the suture insertion point to prevent a "suture-cutting cheese" effect at the suture insertion point. Furthermore, washers 310, 410 can be used with any of the disclosed tissue-reinforcing constructs, including by placing one or more washers 310, 410 on the same suture branches that have been or will be placed on another tissue-reinforcing construct.

[0162] Many techniques known to those skilled in the art can be used to associate gaskets 310, 410 with corresponding suture branches 312a, 412a. Suture branches 312a, 412a can be inserted into or pass through the distal ends 310d, 410d of gaskets 310 or 410 from their nearest ends 310p, 410p, without passing through and / or through the body of gaskets 310 or 410; that is, suture branches 312a, 412a extend directly through lumens 314, 414. Therefore, like tube 110, since gaskets 310, 410 are not coupled to or attached to suture branches 312a, 412a, they can pass freely along the length of suture branches 312a, 412a without obstruction or restriction. In other embodiments, branches 312a, 412a can pass through the body once or multiple times to further ensure the position of gaskets 310, 410 relative to branches 312a, 412a. Those skilled in the art will recognize that washers 310, 410 may be associated with branches 312a, 412a in a variety of other ways without departing from the spirit of this disclosure. For example, washers 310 or 410 may be manually passed through suture branches 312a, 412a at the surgical site or outside the body. Alternatively, one or more washers 310 or 410 may have a threader (not shown) inserted into a corresponding hole 314, 414 before the washers 310 or 410 are passed through suture branches 312a, 412a. The threader may be the same as or similar to the threaders 206, 206' described above and may be used to pass washers 310 or 410 through suture branches 312a, 412a at the surgical site.

[0163] Similar to reinforcing blocks 10 and 110, by including either or both of gaskets 310 or 410 on the suture branch, the force applied to the tissue by the suture branch is distributed over a larger surface area. The larger amount depends on the surface area of ​​the reinforcing gaskets 310 or 410 and the number of gaskets used.

[0164] Materials used to form reinforcing structures

[0165] The constructs discussed above (e.g., blocks 10, 110, 3010, 3110, 310, and 410, and those further described below (including various patches or scaffolds)) may be made of one or more biocompatible, bioabsorbable materials, such that after implantation in a patient to replace or repair connective tissue, the strips gradually degrade or remodel over time. During the regeneration or healing process, the reabsorption profile of the construct may be long enough to enhance and provide structure to the tissue. Those skilled in the art can determine a suitable reabsorption profile, at least in part, based on the intended use of the construct, and the reabsorption profile can be tailored by changing the materials used to form the construct.

[0166] While many different materials (alone or in combination with other materials) can be used to form tissue-reinforcing structures, in some cases, the material is a biocompatible polymer. Exemplary embodiments of suitable biocompatible materials are synthetic polymers, natural polymers, and combinations of both. As used herein, the term "synthetic polymer" refers to a polymer that does not exist in nature, even if the polymer is made from naturally occurring biological materials. As used herein, the term "natural polymer" refers to a polymer that exists naturally. In embodiments in which the tissue-reinforcing construct comprises at least one synthetic polymer, a suitable biocompatible synthetic polymer may include polymers selected from: aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyoxoalkylene glycol esters, polyamides, tyrosine-derived polycarbonates, poly(imino carbonates), polyorthoesters, polyoxyesters, polyamino esters, amine-containing polyoxyesters, poly(anhydrides), polyphosphazenes, polyurethanes, poly(ether polyurethanes), poly(ester polyurethanes), poly(propylene glycol fumarate), poly(hydroxyalkanoates), polydioxane, poly-hydroxybutyrate-co-hydroxyvalerate, polyamide carbonates, polytrimethylene, polyoxoamides, elastic copolymers, and combinations or blends thereof. Suitable synthetic polymers for tissue-enhancing constructs may include biosynthetic polymers based on sequences found in the following substances: collagen, collagen scaffolds, powdered collagen sheets, elastin, thrombin, silk, keratin, fibronectin, starch, polyamino acids, gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, proelastin, hyaluronic acid, ribonucleic acid, deoxyribonucleic acid, polypeptides, proteins, polysaccharides, polynucleotides, and combinations thereof. Types of materials that can be used, in whole or in part, to construct tissue-enhancing constructs include non-absorbable polymers selected from the following substances: including but not limited to polyethylene, polypropylene, polyetheretherketone (PEEK), polytetrafluoroethylene, silicone, rubber, or other biocompatible non-absorbable polymers and combinations thereof. The natural polymer used to reinforce strip 10 may be selected from the following substances: including but not limited to fibrous materials, collagen materials, hyaluronic acid materials, cellulose materials, silk materials, gelatin materials, glycoprotein materials, cellulose materials, polysaccharide materials, protein materials, fibronectin materials, chitin materials, pectin materials, elastin materials, alginate materials, dextran materials, albumin materials, natural poly(amino acid) materials, decellularized tissue, purified extracellular matrix (ECM), demineralized bone matrix, and combinations thereof.

[0167] Furthermore, virtually any type of tissue can be used to form tissue-enhanced constructs, including but not limited to autologous and allogeneic tissues, as well as human allogeneic and xenogeneic tissues (including those from pigs, cattle, and horses). The tissues used can be selected from biological connective tissues, including ligament tissue, tendon tissue, model tendon, skin tissue, muscle tissue, periosteum, pericardial tissue, synovial tissue, epidermal tissue, decellularized porcine epidermal matrix, decellularized bovine epidermal matrix, fascia, small intestine tissue, embryonic tissue, amnion tissue, placental tissue, periodontal tissue, peritoneum tissue, vascular tissue, blood, and combinations thereof. The materials used to form tissue-enhanced constructs can be cross-linked or non-cross-linked, and any material provided herein can be used in combination with other materials (whether synthetic, natural, or in combination thereof). Additionally, platelet-rich plasma (PRP), bone marrow, cells, and other bone and / or tissue growth-promoting materials can be used to treat tissue-enhanced constructs and / or materials used to form them.

[0168] Various techniques can be used to fabricate and / or form materials for forming tissue-reinforced structures. These techniques include, but are not limited to, knitting and braiding them. The overall construction of the material can be described as woven, knitted, nonwoven, and / or foamed, as well as other constructions produced by techniques known to those skilled in the art. Furthermore, combinations of techniques can be used for individual structures and / or portions thereof. Forming techniques can be used in conjunction with materials (e.g., synthetic polymers and other materials provided above) and tissue.

[0169] In some implementations, tissue-reinforcing constructs can be prepared without a basement membrane. The basement membrane is a thin fibrous tissue that separates the epithelium from the underlying tissue between the epidermis and dermis, and functionally separates the epidermis and dermis. While a basement membrane can increase the strength of tissue-reinforcing constructs such as dermal constructs, including such a membrane "orients" the membrane so that only one side (the epithelial side) should be positioned in contact with the tissue. Otherwise, the integration of the dermal patch with the host tissue would be significantly slower. During surgery, surgeons may find it difficult to easily identify which side is the epithelial layer.

[0170] As an improved alternative, this disclosure contemplates actions to remove the basement membrane from the tissue-reinforcing structure. This can be accomplished, for example, by excising or splitting the basement membrane from the remainder of the tissue-reinforcing structure. Alternatively or otherwise, materials that facilitate dermal patch integration may be associated with one side of the structure that includes (or has included) the basement membrane.

[0171] Tissue Enhancement Kit

[0172] The filaments and tissue-reinforcing constructs provided herein may be included together as part of a soft tissue repair kit. Such kits may also include components such as threaders, installation tools, bone anchors, and / or bone drills. For example, an exemplary embodiment of the kit may include one or more tissue-reinforcing constructs and one or more threaders. In some cases, the tissue-reinforcing constructs may be pre-positioned on the threaders. Tissue-reinforcing constructs may include any constructs provided herein or otherwise obtained from this disclosure, including but not limited to tissue-reinforcing blocks 10, 110, 3010, 3110, 310, 410 and tissue-reinforcing patches 2210, 2310, 2410 and 2510 described below. Threaders may include threaders 206, 206' and other threaders provided herein or otherwise obtained from this disclosure. Where the tissue-reinforcing constructs are pre-positioned on the threaders, the constructs may be positioned on intermediate portions 208, 208' of threaders 206, 206'.

[0173] The kit may also include other components for use in conjunction with tissue-enhancing constructs and suture threaders, including but not limited to one or more sutures (such as sutures 12a, 112a), one or more installation tools (such as installation tool 200'), one or more implants (e.g., bone anchors), and one or more bone drills. In some exemplary embodiments, the kit may include tissue-enhancing blocks 10, 110, 3010, 3110, 310, 410 for each suture branch 12a, 112a, 312a, 412a to be anchored to soft tissue. The type and configuration of the filaments, constructs, installation tools (which may include suture threaders as stand-alone installation tools), and bone anchors can vary, thus providing the user with options for any surgical procedure. Therefore, any combination of blocks having strip or band configurations (e.g., strip 10), hollow tube configurations (e.g., tube 110), hollow rod configurations (e.g., rod 3010, rod 3110), and washer configurations (e.g., washer 310, washer 410) can be mixed and matched by the surgeon as needed, including by setting them on the same suture branch. The selection of the construct to be used can depend at least in part on a variety of factors, including but not limited to the size of the filament associated with it, the patient's anatomy, and the type of surgery being performed.

[0174] The threader and / or installation tool may be a single device for repeatedly associating tissue reinforcement constructs with branches, or multiple threaders and tools may be provided to allow for the formation of multiple strip branch combinations or to allow for different configurations preferred by different users. Without departing from the spirit of this disclosure, the threader and / or installation tool may be particularly suited for use with particular tissue reinforcement constructs, procedures, and / or surgeon preferences.

[0175] As long as the implant (such as an anchor) is provided as part of a kit or used in conjunction with any of the disclosures provided herein, the implant can be any type of implant known to those skilled in the art for various types of tissue repair surgeries. For bone anchors, the anchor can have a hard or soft construction, and in some cases they can be non-knotted anchors, meaning that the associated filament does not need to be tied by the surgeon during the surgical procedure to attach the tissue to the filament and / or the anchor. Some exemplary embodiments for use in kits or more generally for hard suture anchors of this disclosure include: Healix Ti, commercially available from DePuy Synthes. TM Anchoring components and Healix Advance TM Anchoring components, Helix Advance Knotless TM Anchoring components, Healix BR TM Anchoring components, Healix PEEK TM Anchoring components, Healix Transtend TM Anchoring components Anchoring components Anchoring components Anchoring components Anchoring components Anchoring components, Minilok TM Anchoring components Anchoring components Anchoring elements, each of which is also commercially available from DePuy Mitek, Inc. Some exemplary embodiments for use with kits or more generally with the soft stitch anchors of this disclosure include those described in Sengun’s U.S. Patent 9,345,567, the entire contents of which are incorporated herein by reference.

[0176] Regarding the inclusion of a bone drill in the kit, any type of bone drill known to those skilled in the art for forming bone holes in which anchors can be disposed may be provided.

[0177] Usage Instructions - Rotary Sleeve Repair

[0178] Exemplary methods for using systems, apparatus, and kits of the types described herein are now described in more detail. While the methods described herein generally involve attaching soft tissue to bone, and are discussed primarily in relation to rotational sleeve repairs in this segment of the disclosure, those skilled in the art will recognize that other types of procedures and repairs can be performed using the associated constructs and methods. Furthermore, with regard to the specific types of tissue-reinforcing constructs illustrated in the embodiments below, those skilled in the art will understand how other tissue-reinforcing constructs provided herein can be used without departing from the spirit of this disclosure. Similarly, any sutures or anchors provided herein or known to those skilled in the art, including non-knotted anchors, can be used. Additionally, while the lengths of sutures and branches may be substantially equal in the illustrated embodiments, any suture or branch can be of any desired length, and therefore the lengths of sutures and branches need not be equal. Likewise, with regard to the technical discussions described below having a certain number of suture branches (e.g., one, two, three, etc.) extending from or otherwise associated with a suture anchor to perform tissue repairs, those skilled in the art will understand, based on this disclosure, how to use different numbers of branches to perform the same or similar repairs. The benefit of each of the methods described herein is that tissue-enhancing constructs can be associated with sutures used in the repair in an on-demand manner, thereby allowing surgeons to quickly and easily associate one or more tissue-enhancing constructs with repair sutures to form the desired coverage area for the repair.

[0179] Rotary sleeve repair - double row application

[0180] Figures 6A to 6C The image illustrates a first exemplary method of soft tissue repair using tissue reinforcement blocks 110 (shown as blocks 110a, 110b) in conjunction with double-row application or repair. The method involves fixing a piece of soft tissue 130 (e.g., a rotating sleeve) relative to bone 150. If the tissue reinforcement blocks 110a, 110b become dry, rehydration of the tissue reinforcement blocks 110a, 110b may be necessary prior to surgery. Any of conventional open repair, arthroscopic repair, or mini-open repair can be used to form the incision for surgery. Once the surgeon has entered the surgical site and the tissue and bone are prepared according to recognized surgical techniques, the surgeon can install sutures 112 into the soft tissue 130 using medial row stitches 140. Alternatively, any known stitches can be used. Figures 6A to 6C As shown, the inner suture 140 produces two suture branches 112a and 112b that extend outward from the soft tissue.

[0181] like Figure 6BAs shown, tissue reinforcement blocks 110a and 110b are respectively disposed on suture branches 112a and 112b. The tissue reinforcement blocks 110a and 110b can be inserted into the suture branches 112a and 112b by hand using an installation tool 200' (not shown) and / or threaders 206 and 206'. (Refer to the above text.) Figure 3 As discussed, if the installation tool 200' is used, the suture branch 112a can be passed through the opening or loop 212, and then the handle portion 208 can be pulled to pull the threader 206 and the suture branch through the tissue reinforcement block 110a. Similarly, if only the threaders 206, 206' are used, force can be applied to the threaders to pull the suture branch 112a in and through the tissue reinforcement block. Once the suture branch 112a has been inserted into the tissue reinforcement block 110a, the threader 206 can be removed, and if the installation tool 200' is used, the tissue reinforcement block 110a is released from the installation tool 200'. The tissue reinforcement blocks 110a, 110b can be threaded onto the suture branches 112a, 112b at a surgical site inside the body. Alternatively, the tissue reinforcement blocks 110a, 110b can be inserted outside the body.

[0182] Once blocks 110a and 110b have been inserted onto suture branches 112a and 112b, they can be advanced in direction D1 along the respective suture branches 112a and 112b. In the illustrated embodiment, blocks 110a and 110b are positioned close to the inner suture 140 because the length of blocks 110a and 110b is similar to the length of the distance extending between the ends of the inner suture 140 and the tissue 130. However, in embodiments where the length of blocks 110a and 110b is less than this distance, blocks 110a and 110b may not necessarily be close to the inner suture 140, but may extend along certain portions of the length of the branches 112a and 112b extending between the ends of the inner suture 140 and the tissue 130. After blocks 110a and 110b have been attached to the respective suture branches 112a and 112b, the free ends of the suture branches 112a and 112b can be secured in vivo. For example, the free ends of each suture branch 112a, 112b can be connected to the corresponding anchors 160a, 160b, such as... Figure 6C As shown, these anchors may be non-knotted anchors in some exemplary embodiments. The suture branches 112a, 112b may then be tightened to secure the soft tissue 130 to the bone 150 before the anchors 160a, 160b fully secure the bone 150, thereby completing a double-row lateral fixation associated with the medial suture 140.

[0183] The procedure can be repeated multiple times as needed to optimally fix the soft tissue 130 to the bone 150. Blocks 110a and 110b provide greater coverage for branches 112a and 112b, and they offer a larger surface area to distribute the forces applied to the soft tissue 130 by the suture branches 112a and 112b. As the patient heals from the surgery, new tendonoid tissue bands can form around and enter into and surround blocks 110a and 110b, creating stronger tissue within the soft tissue and between the soft tissue and bone. For example, blocks formed from collagen scaffolds or decellularized epidermal matrix materials can be remodeled into tendonoid tissue and integrated with the natural tissue as the patient heals from the surgery. This additional coverage of tendonoid tissue on the soft tissue increases the strength of the soft tissue-bone connection and can prevent further damage.

[0184] Figures 7A to 7D Another exemplary method for soft tissue repair is provided. As shown, soft tissue 1030 is secured to bone 1050 using an alternative double-row application. Once the surgeon has entered the surgical site and the tissue, bone, and blocks 1010a-1010c are prepared according to recognized surgical techniques (including those provided herein), the surgeon can install sutures 1012 and 1016, respectively, in the tissue 1030 using medial stitches 1040 and 1042. Blocks 1010a-1010c may resemble blocks 110, 3010, 3110, or other blocks and structures provided in this disclosure. Furthermore, any known stitches may be used. Medial stitch 1040 produces two suture branches 1012a and 1012b extending outward from the soft tissue, and the second medial stitch 1042 produces two suture branches 1016a and 1016b extending outward from the soft tissue.

[0185] like Figure 7A As shown, blocks 1010a-1010c are threaded onto suture branches 1012a, 1012b, and 1016b respectively using the technique provided in this disclosure. For example, as Figure 7A As shown, block 1010a is threaded onto suture branch 1012a via threader 206. Once block 1010a has been threaded onto suture branch 1012a, as... Figure 7B As shown, it can be advanced along suture branch 1012a in direction D1' until it approaches the inner suture 1040, because the length of block 1010A is similar to the distance extending between the ends of the inner suture 1040 and the tissue 1030. Similarly, blocks 1010b and 1010c can be advanced along suture branches 1012b and 1016b until they approach the inner sutures 1040 and 1042, respectively. Block 1010a can be advanced along suture branches using an instrument like knot pusher 1080 or other instruments suitable for advancing strips along branches.

[0186] Once blocks 1010b and 1010c have been installed onto the corresponding suture branches 1012b and 1016b, such as Figure 7C As shown, the free ends of suture branches 1012b and 1016b can be fixed inside the body, for example, by attaching them to anchor 1060b in a lateral fixation manner. Similarly, once block 1010a has been installed on suture branch 1012a, it can be attached to anchor 1060a in a lateral fixation manner to fix the free ends of suture branches 1012a and 1016a inside the body. Figure 7C As shown, before installing suture branches 1012a and 1016a into anchor 1060a, suture branches 1012b and 1016b are installed into anchor 1060b, such that suture branch 1016a rests on top of block 1010b. Alternatively, suture branch 1016a can be placed below suture branch 1012b by changing the fixing order. Figure 7D As shown, the suture branches 1012a, 1012b, 1016a, and 1016b can be tightened to fix the soft tissue 1030 to the bone 1050 before the anchors 1060a and 1060b fully fix the bone 1050.

[0187] Figure 8A and Figure 8B An alternative exemplary method for soft tissue repair is shown. This method uses washers 310 (such as washers 310a, 310b, and 310c shown) instead of blocks 10, 110 to fix soft tissue 1030' to bone 1050' via double-row application. Relative to Figure 8A and Figure 8B The disclosed alternative double-row application helps reduce the additional volume that may occur when two constructs are stacked together as part of the repair design, with the suture branches crossing each other. Furthermore, the use of washers in such constructs helps reduce the likelihood of any aggregation that may occur when using block-configuration constructs. Once the surgeon has entered the surgical site and the tissue, bone, and washers 310a-310c are prepared according to recognized surgical techniques (including those described herein), the surgeon can install sutures 1012', 1016' in tissue 1030 using initial mattress suture stitches. Alternatively, any known stitches may be used. The inner row stitch 1040' in tissue 1030' produces two suture branches 1012a', 1012b' extending outward from the tissue, and the second inner row stitch 1042' produces two suture branches 1016a', 1016b' extending outward from the tissue.

[0188] Although the following discussion pertains only to suture branch 1012a', for clarity, suture branches 1012b', 1016a', and 1016b' may have washers 310 threaded thereon in substantially the same manner. Figure 8A As shown, washers 310a-310c are threaded onto suture branches 1012a'. Alternatively, any number of washers 310 can be used on any of the suture branches 1012a', 1012b', 1016a', and 1016b'. Washers 310a-310c can be threaded onto suture branches 1012a' using the techniques provided in this application by hand, installation tools, and / or threaders. Once washers 310a-310c have been threaded onto suture branches 1012a', they can be advanced along the suture branch body 1012a'. In the illustrated embodiment, washers 310a-310c are arranged such that they are equidistantly distributed along the length of branch 1012a' on tissue 1030'. After the washers 310 have been installed onto the respective suture branches 1012a', 1012b', 1016a', and 1016b', as... Figure 8A As shown, the free ends of suture branches 1012a', 1016a' and 1012b', 1016b' can be fixed in the body, for example, by attaching them to anchors 1060a' and 1060b', respectively. In the illustrated embodiment, suture branches 1012b', 1016b' are attached to anchor 1060b' before suture branches 1012a', 1016a' are attached to anchor 1060a', resulting in suture branch 1016a' resting on top of suture branch 1012b', although other configurations are possible without departing from the spirit of this disclosure. Suture branches 1012a', 1012b', 1016a', 1016b' can be tightened to fix soft tissue 1030' to bone 1050' before anchors 1060a', 1060b' are fully fixed to bone 1050'.

[0189] Figure 8B Another exemplary double-row fixation method is shown in the figure. This method for fixing soft tissue 1030” to bone 1050” is essentially the same as... Figure 8AThe method shown is the same, but it also includes the use of circular washers 410 at the location of the inner suture (not visible), as shown in washers 410a and 410b. The placement of washers 410a and 410b, as shown, provides protection for the suture located beneath washers 410a and 410b, while also increasing the coverage area of ​​the suture branches 1012a”, 1012b”, 1016a”, 1016b” and allowing the distribution of forces that will otherwise be directly applied to the tissue 1030” on the surface of washers 410a and 410b. In use, washers 410a and 410b can be inserted onto the corresponding suture branches 1012a”, 1012b”, 1016a”, 1016b” before washers 310' are inserted onto the suture branches 1012a”, 1012b”, 1016a”, 1016b”. Then, for example, according to the above document regarding… Figure 8A The described process completes the double-row fixing method. Compared to... Figure 8A and Figure 8B For both configurations shown, the greater the angle formed by the sutures extending from the anchors 1060a', 1060b' and washers 410a, 410b, the higher the stability of the repair.

[0190] Figure 9 This paper illustrates another alternative method for securing soft tissue 1030”' to bone 1050”' using a double-row fixation technique. Once the surgeon has entered the surgical site and the tissue, bone, and blocks 1010a”'-d”' are prepared according to recognized surgical techniques (including those described herein), the surgeon can install sutures 1012a”'-c”' and 1016a”'-c”' in the tissue 1030”' using initial mattress sutures 1040”', 1042”', respectively. A first inner row anchor 1060a”' can be inserted into the three sutures extending therefrom. In bone 1050”’ of branch 1012a”’-c”’, the three suture branches 1012a”’-c”’ pass through tissue 1030”’ via the first medial row stitch 1040”’. A second medial row anchor 1060b”’ can be inserted into bone 1050”’ having three suture sides 1016a”’-c”’ extending therefrom, the three suture branches 1016a”’-c”’ passing through tissue 1030”’ via the second medial row stitch 1042”’.

[0191] As shown in the figure, using the technique provided in this disclosure, a block 1010a”', which may be in the form of a strip, tube, or hollow block, or other disclosed configurations, is threaded onto one of the suture branches 1012a”' and 1016a”', and the suture branches 1012a”' and 1016a”' are tied together with a knot to fix the tissue 1030”' to the bone 1050”'. Furthermore, once the knot has been formed, the block 1010a”' can be moved to cover the knot to reduce the possibility of tissue damage from the knot. Then, using the technique provided in this disclosure, blocks 1010b”’ and 1010c”’ can be threaded onto suture branches 1012b”’ and 1012c”’ respectively, and advanced to a position near the inner suture 1040”’. Similarly, once blocks 1010d”’ and 1010e”’ have been threaded onto suture branches 1016b”’ and 1016c”’, they can be advanced to a position near the inner suture 1042”’. After blocks 1010b”’, 1010d”’ and 1010c”’, 1010e”’ have been installed onto the corresponding suture branches 1012b”’, 1016b”’ and 1012c”’, 1016c”’, the free ends of suture branches 1012b”’, 1016b”’ and 1012c”’, 1016c”’ can be fixed in vivo. For example, the free ends of each suture branch 1012b”', 1016c”' and 1012c”', 1016b”' can be connected to the corresponding anchors 1062a”' and 1062b”'. The suture branches 1012b”', 1012c”', 1016b”', 1016c”' can be tightened to secure the soft tissue 1030”' to the bone 1050”' before the anchors 1062a”', 1062b”' are fully secured to the bone 1050”'.

[0192] Figures 10A to 10E The use of Figure 2G Tissue-reinforced structure 2810a and tissue-reinforced structure 2810b with the same structure (e.g.) Figure 10E Another alternative double-row fixation method for soft tissue repair (shown) is described. The two structures do not need to be constructed identically, as they can be constructed similarly and / or may have other configurations provided herein or known to those skilled in the art. This method can be used with alternative extra-long block applications to fix the soft tissue 2830 to the bone 2850 to provide additional coverage for the repair.

[0193] Once the surgeon has entered the surgical site and the tissue, bone, and tissue reinforcement block are prepared according to recognized surgical techniques (including those described herein), the surgeon may insert a first anchor 2860a beneath the soft tissue 2830. The first anchor 2860a may have two suture branches 2812a, 2812b extending therefrom. These two suture branches 2812a, 2812b may pass through the soft tissue 2830 to begin assisting in securing the soft tissue 2830 to the bone 2850. A first mattress suture 2840a may be formed in the soft tissue 2030 inside the first anchor 2860a. The first mattress suture 2840a may produce two suture branches 2814a, 2814b extending out of the soft tissue 2830.

[0194] The block 2810a can be threaded onto the suture branches 2812a and 2814a using the techniques provided herein. For example, the suture branch 2814a can be associated with the proximal end 2811p of the first block 2810a by advancing the first threader 2809a along the first direction D1, as... Figure 10B As shown (threader 2809a is not shown, but those skilled in the art will understand, based on this disclosure, how threader 2809a can be operated to allow suture branch 2814a to pass through the proximal end 2811p of the first block 2810a). Furthermore, suture branch 2812a can be associated with the middle portion 2811i and the distal portion 2811d of the block 2810a shown by advancing the second threader 2809b along the second direction D2, as well as... Figure 10B As shown. Although the corresponding threaders 2809a and 2809b for the respective suture branches 2814a and 2812a are not shown, those skilled in the art will understand, based on this disclosure, how the threaders can be operated to pass the respective suture branches through the portions of the first block 2810a. The block 2810a can then be advanced inwards such that the proximal end 2811p of the block 2810a approaches the first mattress suture stitch 2840a, as... Figure 10C As shown. This process can be repeated for the second block 2810b and its corresponding branches 2816a and 2818b. For example, the second anchor 2862a can be installed below the soft tissue 2830, as... Figure 10E As shown, the anchor 2862b has two repair suture branches 2816a, 2816b extending therefrom. The two repair branches 2816a, 2816b can similarly pass through the soft tissue 2830 and can form a second mattress suture 2840b in the soft tissue 2030 inside the second anchor 2862a. Figure 10E(As shown in the diagram). The second mattress suture 2840b can produce two suture branches 2818a and 2818b extending into the soft tissue 2830. The resulting suture branches 2816a, 2816b, 2818a, and 2818b can be associated with block 2810b to continue tissue fixation and repair.

[0195] After blocks 2810a and 2810b have been installed onto the corresponding suture branches 2812a, 2814a and 2816a, 2818a, the free ends of the suture branches 2812a, 2812b, 2816a, 2816b can be fixed in vivo. For example, the free end of each suture branch 2812a, 2816b and 2812b, 2816a can be connected to the corresponding anchors 2860b and 2862b, as shown. Figure 10C and Figure 10E As shown. In the illustrated embodiment, suture branches 2812b and 2816b can pass through soft tissue 2830 to form an "X" configuration or shape, such that suture branch 2812b is fixed in the same anchor 2862b as suture branch 2816a, and suture branch 2816b is fixed in the same anchor 2860b as suture branch 2812a. Suture branches 2812a, 2816a can be configured to pass through the respective central lumens 2870a, 2870b of blocks 2810a, 2810b to increase the coverage area of ​​suture branches 2812a, 2816a, thus reducing the possibility of damage to soft tissue 2830 as described above. Because blocks 2810a, 2810b have sufficient length, they can be installed such that they extend inwardly over the first and second repairs 2838a, 2838b, as... Figure 10E As shown. The suture branches 2812a, 2812b, 2816a, 2816b can then be tightened to secure the soft tissue 2830 to the bone 2850 before the anchors 2860b, 2862b fully fix the bone 2850. Two branches 2814a, 2814b can be tied together with knot 2880a, and branches 2818a, 2818b can be tied together with knot 2880b to secure the proximal ends 2811p of the corresponding blocks 2810a, 2810b to the inside of the restorations 2838a, 2838b, as shown. Figure 10D and Figure 10E As shown. Based on this disclosure and the knowledge of those skilled in the art, those skilled in the art will recognize that restorations 2838a and 2838b may represent multiple restorations.

[0196] Rotary sleeve repair - single row application

[0197] Figures 11A to 11CAnother method for soft tissue repair is illustrated. This method uses a single-row application to fix the soft tissue 130' to the bone 150'. Once the surgeon has entered the surgical site and the tissue, bone, and blocks 110a', 110b' are prepared according to recognized surgical techniques (including those described herein), the surgeon can install sutures 112' in the soft tissue 130' using an initial mattress suture stitch. Alternatively, any known suture stitch can be used. The mattress suture stitch 140' produces two suture branches 112a', 112b' extending outward from the soft tissue.

[0198] like Figure 11B As shown, blocks 110a' and 110b' are threaded onto suture branches 112a' and 112b' using the technique provided in this application, respectively. Once blocks 110a' and 110b' have been threaded onto suture branches 112a' and 112b', they are advanced along the corresponding sutures in direction D1' until they approach mattress suture stitch 140'. As described above, the position of the strip relative to stitch 140' can depend at least in part on the size of blocks 110a' and 110b' and the distance between the ends of stitch 140' and tissue 130'. After blocks 110a' and 110b' have been installed onto the corresponding suture branches 112a' and 112b', they can be secured in the body, for example, by attaching the free ends of suture branches 112a' and 112b' to a single anchor 160', such as... Figure 11C As shown. Suture branches 112a', 112b' can be tightened to secure soft tissue 130' to bone 150' before anchor 160' is fully secured to bone 150', thereby completing a single-row fixation associated with medial suture 140'. In some exemplary embodiments, a second anchor with two suture branches extending therefrom (each branch having at least one tissue-reinforcing construct disposed thereon) can be implanted relative to the same tissue 130' and bone 150' in a manner similar to that of anchor 160', branches 112a', 112b', and blocks 110a', 110b' to provide a second fixation system for the tissue. As with all the various configurations provided herein, any number and combination of implants (e.g., bone anchors, sutures, and tissue-reinforcing constructs) can be used to fix soft tissue to bone.

[0199] Figures 11D to 11F Alternative single-row applications are shown. In Figure 11DIn the first alternative single-row application shown, a standard single-row repair can be accomplished using two anchors 160a” and 160b” installed in the bone 150” below the tissue 130”. Anchors 160a” and 160b” may each have two suture branches 112a”, 112b” and 116a”, 116b” extending from them respectively. Suture branches 112a” and 116a” can pass through the soft tissue 130” and are used to bring the soft tissue 130” into contact with the bone 150”. Suture branches 112b” and 116b” can similarly pass through the soft tissue 130”.

[0200] like Figure 11D As shown, the tissue reinforcement block 110” can be inserted into one of the suture branches 112b”, 116b” using the techniques provided in this disclosure, and advanced to the desired position relative to the tissue 130”. After the reinforcement block 110” has been installed into one of the suture branches, the free ends of each suture branch 112b”, 116b” can then be tied together with a knot (not shown). Furthermore, the block 110” can be moved to cover the knot to minimize any potential tissue abrasion caused by the knot and to contact the tissue 130”.

[0201] Figure 11E A second alternative single-row application is shown. Similar to... Figure 11D The procedure can be performed using two anchors 160a”’ and 160b”’ installed in the bone 150”’ below the tissue 130”’ to complete a standard single-row repair. As shown in the figure, the first suture 111”’ can be installed inside the repair through a mattress suture stitch 140a”’, so that the two suture branches 111a”’ and 111b”’ extend from the tissue 130”’, and the second suture 113”’ can be installed inside the repair through a second mattress suture stitch 140b”’, so that the two suture branches 113a”’ and 113b”’ extend from the tissue 130”’. In some cases, after two mattress sutures 140a”' and 140b”' have been installed in the tissue 130”', anchors 160a”' and 160b”' can be installed in the bone 150”' beneath the tissue 130”'. Surgical sutures 112”' and 114”' can be used to connect the tissue 130”' to the anchors 160a”' and 160b”' respectively attached thereto, according to recognized surgical techniques.

[0202] The tissue reinforcement block 110a”'-d”' can be inserted into the suture branches 111a”', 111b”', 113a”', 113b”' using the techniques provided in this disclosure, and can be advanced along the corresponding sutures to the desired position. The free ends of the suture branches 111a”', 113a”' and 111b”', 113b”' can be tied to and tightened around the surgical sutures 112”', 114”', respectively.

[0203] Figure 11F Another alternative single-row application is shown. A first suture 111”” is installed internally via a mattress suture stitch 140a””, such that two suture branches 111a””, 111b”” extend from tissue 130””. A second suture 113”” is installed via a second mattress suture stitch 140b””, such that two suture branches 113a””, 113b”” extend from tissue 130””. After the first and second sutures 111””, 113”” have been installed, a first internal anchor and a second internal anchor 160a””, 160b”” are installed in the bone 150”” beneath tissue 130””. Repair can be performed using surgical sutures 112””, 114”” connected to anchors 160a””, 160b”” respectively, according to accepted surgical methods, so that tissue 130”” contacts bone 150””. Once tissue 130”” has been repaired, blocks 110a””-d”” can be installed onto suture branches 111a””, 111b””, 113a””, 113b”” using techniques provided throughout this disclosure. For example, they can be secured in vivo by attaching the free ends of suture branches 111a””, 113a”” and 111b””, 113b”” to anchors 160c”” and 160d””. Suture branches 111a””, 111b””, 113a””, 113b””” can be tightened to further secure blocks 110a””-d”” to soft tissue 130, such that the repair formed by sutures 112””, 114”” is covered by tissue-enhancing blocks.

[0204] Figure 12Another exemplary method for soft tissue repair is illustrated. This method uses a single-row fixation to secure a piece of soft tissue 1130 (e.g., a rotating sleeve) to bone 1150. Once the surgeon has entered the surgical site and the tissue, bone, and tissue reinforcement block are prepared according to recognized surgical techniques (including those described herein), the surgeon can install sutures 1112, 1114 in the soft tissue 1130 using mattress suture stitches 1140, and sutures 1116, 1118 using mattress suture stitches 1142. Sutures 1112, 1114 and 1116, 1118 are respectively installed in anchors 1160a, 1160b beneath the tissue 1130 in bone 1150. Figure 12 As shown, each of mattress sutures 1140 and 1142 produces four suture branches 1112a, 1112b, 1114a, 1114b and suture branches 1116a, 1116b, 1118a, 1118b extending outward from the soft tissue.

[0205] At least one block 310' may be threaded onto at least one of the suture branches of each suture 1112, 1114, 1116, 1118. Block 310' may be similar to block 310, but the difference lies in that block 310' is thicker than block 310. Alternatively, block 310' may have any suitable size depending on the requirements of a given surgical procedure. In some embodiments, each of the suture branches 1112a, 1114a, 1116a, 1118a may have block 310' threaded onto it using the techniques provided in this disclosure, and then the two suture branches of each pair may be tied together. For example, suture branches 1112a, 1112b may be tied together after block 310' has been threaded onto them. After the suture branches 1112a, 1112b have been tied together, block 310' may be moved over the knot to cushion or cover the knot. The process can be repeated for each of the suture branch pairs 1114a and 1114b, 1116a and 1116b, and 1118a and 1118b.

[0206] Figure 13 Another exemplary method for soft tissue repair is shown. This method uses a single row of tear-resistant stitches to secure a piece of soft tissue 1230 (e.g., a rotating sleeve) to bone 1250. Once the surgeon has entered the surgical site and the tissue, bone, and tissue-reinforcing structures are prepared according to recognized surgical techniques (including those described herein), the surgeon can use stitch 1240 to attach sutures 1212, 1214 to anchor 1260a and use stitch 1242 to attach sutures 1216, 1218 to anchor 1260b. Any known stitches can be used. Figure 13As shown, stitch 1240 produces four suture branches 1212a, 1212b, 1214a, 1214b extending outward from the soft tissue, and stitch 1242 also produces four suture branches 1216a, 1216b, 1218a, 1218b extending outward from the soft tissue.

[0207] The tissue reinforcement block 1210 can be threaded onto one of the suture branches associated with each mattress knot 1240, 1242 using the techniques provided in this disclosure. The block 1210 in the illustrated embodiment is a construction similar to the bars 3010, 3110. In the illustrated embodiment, each suture branch 1212a and 1216a has its associated block 1210. Once each of the suture branches 1212a and 1216a has a block 1210 threaded thereon, the suture branches 1212a and 1216a can be tied together with complementary suture branches 1212b and 1216b, respectively. Furthermore, as shown, the block 1210 can slide over the knot to cushion or cover it. The suture branches 1214a and 1214b can then be tied together over the top of the block 1210 to form a tear-resistant stitch. Advantageously, once the suture branches 1214a and 1214b are tied together, they will prevent the soft tissue 1230 from being torn, as the block 1210 will act as a buffer, thereby distributing the applied load. This process can be repeated for the second mattress suture 1242.

[0208] Figure 14 Another method for soft tissue repair is illustrated. This method provides for securing a piece of soft tissue 1330 (e.g., a rotating sleeve) to bone 1350 using anterior-posterior mattress sutures extending between anchors. Once the surgeon has entered the surgical site and the tissue, bone, and tissue reinforcement block are prepared according to recognized surgical techniques (including those described herein), the surgeon can pass two branches 1312a, 1312b of the suture 1312 attached to anchor 1360a through the tissue 1330. Similarly, a second anchor 1360b may be implanted into bone 1350, having suture branches 1314a, 1314b of the suture 1314 extending from anchor 1360b through the tissue 1330. Any known suture stitch can be used.

[0209] A block 1310 can be threaded onto any suture branch 1312a, 1314a of any anchor 1360a, 1360b using the techniques provided throughout this disclosure. The block 1310 shown has a length generally ranging from about 10 mm to about 20 mm, a width generally ranging from about 2 mm to about 5 mm, and a height generally ranging from about 1 mm to about 3 mm. Once the suture branch 1312a has the block 1310 threaded onto it, the suture branch 1312a can be tied together with the suture branch 1314a. Furthermore, after the suture branches 1312a, 1314a have been tied together, the block 1310 can slide over a knot (not shown) to cushion or cover the knot. The suture branches 1312b, 1314b can then be tied together over the block 1310. Advantageously, once the suture branches 1312b and 1314b are tied together, they will prevent the soft tissue 1330 from being torn, because the block 1310 will act as a buffer between them to distribute the applied load.

[0210] Figure 15 An alternative single-row fixation method for soft tissue repair is illustrated. This method uses alternative extra-long and extra-wide blocks to fix the soft tissue 1430 to the bone 1450. Once the surgeon has entered the surgical site and the tissue, bone, and tissue reinforcement blocks are prepared according to recognized surgical techniques (including those described herein), the surgeon can fix the soft tissue 1430 to the bone 1450 to produce repairs 1438a, 1438b (shown in dashed lines). Once repairs 1438a, 1438b are completed, a first mattress suture 1440 is formed through the soft tissue 1430 inside repair 1438a, and a second mattress suture 1442 is formed inside repair 1438b to install sutures 1412 and 1414 within the soft tissue 1430. The first mattress suture 1440 produces two suture branches 1412a and 1412b extending outward from the soft tissue 1430, and the second mattress suture 1442 produces two suture branches 1414a and 1414b extending outward from the soft tissue. Alternatively, the sutures 1440 and 1442 may be formed prior to the repair 1438a and 1438b.

[0211] Blocks 1410a-1410c have configurations that can be considered larger versions of some of the other block configurations presented herein. As shown in the figure, blocks 1410a-1410c resemble... Figure 2E and Figure 2FThe hollow block configurations 3010 and 3110 have a generally rectangular shape, but are thicker. Specifically, according to this disclosure, other configurations of blocks 1410a-1410c are also possible, including but not limited to configurations more similar to one or more of the strip 10, tube 110, and washers 310, 410, or combinations thereof. In one exemplary embodiment, blocks 1410a-1410c may have a length generally ranging from about 15 mm to about 25 mm, a width generally ranging from about 4 mm to about 5 mm, and a thickness generally ranging from about 1 mm to about 3 mm.

[0212] Blocks 1410a and 1410c can be threaded onto suture branches 1412a and 1414a using the techniques provided throughout this disclosure. In the illustrated embodiment, block 1410b has two suture branches associated with it, suture branches 1412b and 1414b. Although the latter configuration can also be implemented using the techniques provided in this disclosure, in one exemplary method, a single installation tool can be used to simultaneously associate the two suture branches 1412b and 1414b with block 1410b. For example, a threader 206 (not shown) may be disposed in block 1410b, and the two branches may be passed through its distal opening 212 (not shown) before the threader is operated as described above to associate branches 1412b and 1414b with block 1410b. Alternatively, block 1410b may have two threaders disposed therethrough for threading suture branches 1412b and 1414b therethrough, respectively. In another alternative, a single threader can be passed through block 1410b to pull suture branch 1412b through block 1410b, and then the threader or a different threader can be inserted into block 1410b to allow suture branch 1414b to pass through block 1410b.

[0213] Once blocks 1410a-1410c have been inserted onto the suture branches 1412a, 1412b, 1414a, 1414b, they can be advanced along the suture branches 1412a, 1412b, 1414a, 1414b until they approach the inner sutures 1040, 1042. One advantage of blocks 1410a-1410c is that their dimensions can be designed to cover a significant portion of the surgical site, including the circumference defined by anchors 1460a, 1460b and mattress sutures 1440, 1442. Other advantages of the tissue-reinforcing constructs provided herein also apply. After blocks 1410a-1410c have been installed on the respective suture branches, the free ends of the suture branches 1412a, 1412b and 1414a, 1414b can be secured in vivo, for example, by attaching them to anchors 1460a and 1460b, respectively. The suture branches 1412a, 1412b, 1414a, and 1414b can be tightened to fix the soft tissue 1430 to the bone 1450 before the anchors 1460a and 1460b are fully fixed to the bone 1450.

[0214] The various embodiments described above can be used in combination with any of the other embodiments described above, such that some parts of the soft tissue are fixed with double-row application while other parts are fixed with single-row application. Furthermore, any number of suture branches and tissue reinforcement blocks can be used during any particular surgical procedure, including placing multiple strips on a single branch and / or using only a single branch or more than two branches.

[0215] Rotary sleeve repair - partial tear repair

[0216] Figures 16A to 16C An exemplary method for repairing partially torn soft tissue is illustrated. This method involves securing a piece of soft tissue 1530 (e.g., a rotatable sleeve) to bone 1550 in the event of a partial tear. Figure 16A As shown, soft tissue 1530 remains in contact with bone 1550 at 1530d. Length X indicates the "healthy" coverage area that should exist between tissue 1530 and bone 1550. This procedure helps to reattach soft tissue to bone to form a "healthy" coverage area. Procedures in existing fields may create depressions at the attachment point due to the necessary compression of the tissue by the sutures, resulting in weakening of the tissue and, more generally, the rotational sleeve.

[0217] Once the surgeon has entered the surgical site and the tissue, bone, and tissue-reinforcing constructs are prepared according to recognized surgical techniques (including those described herein), the surgeon can install the anchor 1560 into the bone 1550. The anchor 1560 may have a suture 1512 associated with it, the suture having two suture tails 1512a, 1512b extending therefrom and passing through soft tissue 1530. A block 1510 may be inserted onto at least one of the suture tails 1512a, 1512b. The block 1510 may be any of the configurations provided herein, including but not limited to blocks 10, 110, 3010, 3110, 310, and 410 described below, and patches 2210, 2310, 2410, and 2510. For example, the construct 1510 may be inserted onto the suture branch 1512a using techniques provided throughout this disclosure, and advanced along the suture 1512a until it approaches the tissue 1530. After the construct 1510 has been installed into one of the suture branches, the free ends of each suture branch 1512a, 1512b can be tied together with a knot (not shown) to bring the damaged tissue 1530 into contact with the bone 1550. The construct 1510 can then be moved to a position where it covers the knot and contacts the tissue 1530. Figure 16B As shown, once the structure 1510 is installed, it can increase the height of the recess to rebuild the height of the repair tissue 1530.

[0218] Instructions for Use - Repairing Non-Rotating Sleeves

[0219] This disclosure envisions that the tissue-reinforcing constructs provided herein have applications beyond being used as reinforcing constructs for rotational sleeve repairs. Some non-limiting examples of those alternative surgical procedures are provided below. These examples are by no means exhaustive. Furthermore, those skilled in the art will understand how some of the disclosures provided in this non-rotational sleeve repair segment can be applied to rotational sleeve repair surgery. Each of the embodiments described below, including those discussed after non-rotational sleeve repairs (i.e., upper lip repair or enlargement, ACL repair, Achilles tendon repair, AC joint repair, meniscus repair, and superior bursa reconstruction), is discussed in relation to the use of tissue-reinforcing constructs (which include any of the blocks and patches disclosed herein or otherwise obtained from this disclosure). Based on this disclosure, those skilled in the art will understand how various tissue-reinforcing constructs can be applied to various surgical procedures. Furthermore, in exemplary embodiments of each method described in this disclosure, for example, collagen may be used as part of or completely or almost entirely to form the construct. This allows the construct to grow in its area once the repair has healed. Other materials may also be used to form the construct, including other materials that produce results similar to collagen.

[0220] Non-rotational sleeve repair - Upper lip defect correction

[0221] Figures 17A to 17D An alternative surgical procedure is shown. This method uses a tissue-reinforcing construct 1610 or a structure to fill the gaps where the soft tissue 1630 is damaged and torn from the bone 1650. For example, as Figure 17A As shown, the upper lip 1630 may have a tear or defect 1635, exposing a portion of bone 1650. Once the surgeon has entered the surgical site and the tissue, bone, and tissue-reinforcing construct are prepared according to recognized surgical techniques (including those provided herein), the surgeon may install a first anchor 1660a into the bone at a proximal position 1635p of the tear 1635. The first anchor 1660a has a suture 1612 therein. The tissue-reinforcing construct 1610 may be inserted through the suture branch 1612 using techniques provided herein and advanced along the suture until the tissue-reinforcing construct 1610 approaches the proximal end of the tear 1635p. The construct 1610 may be advanced toward the anchor 1660a using any type of tool provided herein or known to those skilled in the art (including knot-pushing tools). At implantation, the tissue-reinforcing construct 1610 may be approximately the same length as the defect 1635 and may be pre-cut and / or cut in real time at the surgical site to ensure proper fit.

[0222] After the tissue-reinforcing construct 1610 has been attached to the suture branch 1612, the free end of the suture branch 1612 can then be anchored to the bone via a second anchor 1660b (such as a non-knotted fixation anchor). The tail of the suture 1612 can be tightened before the anchor 1660b is fully inserted into the bone. By positioning the anchors 1660a, 1660b and the construct 1610 in these locations, with the construct 1610 ending at the posterior edge of the glenoid cavity rather than on its face, the upper lip can be reconstructed using a prosthesis, not just to repair the defect, as is more typical in previous upper lip repair surgeries. In an alternative embodiment, separate sutures extending from each of the two anchors 1660a, 1660b can pass through the upper lip on either side, and the tissue-reinforcing construct 1610 can be positioned on one of the two sutures, which can be joined together, for example, using a knot. In addition, the tissue-reinforcing structure 1610 can be positioned at the point where the two sutures are tied together to protect the area where the sutures are joined.

[0223] Non-rotating sleeve repair - ACL repair

[0224] Figures 18A to 18C Another alternative surgical procedure is shown. This method uses tissue-enhancing construct 1710 or other constructs to repair the torn ACL. For example, as... Figure 18AAs shown, a bundle of ACL 1702 is torn or otherwise damaged. Once the surgeon has entered the surgical site and the tissue, bone, and tissue-reinforcing structures have been prepared according to recognized surgical techniques, the surgeon can begin partial ACL repair. First, a bone tunnel 1704 is drilled through the femur 1706 and tibia 1707 adjacent to the naturally undamaged ACL 1708. Then, a bone is prepared in the same manner as described above regarding other embodiments. Figure 18B The tissue-reinforcing structure 1710 is shown with suture branches 1712a and 1712b extending from opposite ends. The structure 1710 may have a length generally ranging from about 5 mm to about 100 mm. Figure 18C As shown, the structure 1710 can penetrate the bone tunnel 1704, allowing the structure 1710 to contact the undamaged ACL 1708. The structure 1710 can be secured within the bone tunnel using known surgical techniques, such as suture branches 1712a and 1712b.

[0225] Alternatively, the construct 1710 can be used to enhance an autologous graft. Where the autologous or allogeneic graft is too short and / or too thin and not strong enough to complete the repair, the construct 1710 can be sutured or otherwise attached to the autologous graft to produce an implant of the desired size. In another alternative, a construct having a lumen extending through it can pass through the autologous or allogeneic graft to further enhance the autologous or allogeneic graft used for ACL repair.

[0226] Non-rotational sleeve repair - supracapular reconstruction

[0227] Figure 19Another alternative surgical procedure is shown. This method may use at least one of tissue-reinforcing constructs 1810a and 1810b to help anchor the superior bursa reconstruction graft 1820 above the head of the humerus 1802. Once the surgeon has entered the surgical site and the tissue, bone, tissue-reinforcing construct, and superior bursa reconstruction graft are prepared according to recognized surgical techniques (including those described herein), the surgeon may attach one end of the graft 1820 to the glenoid rim 1804. The surgeon may attach one end of the graft 1820 to the glenoid rim 1804 by installing a first medial anchor 1860a having a suture 1812a extending therefrom. The first tissue-reinforcing structure 1810a can be threaded onto suture 1812a using techniques provided throughout this disclosure, and the structure 1810a can be tightened against the graft 1820 using techniques provided herein or known to those skilled in the art, for example by tying suture 1812a to suture 1812b (not shown), both of which extend from anchor 1860a. The pressure applied by structure 1810a to graft 1820 can hold graft 1820 in a desired position relative to glenoid rim 1804. Depending on the technique used in superior bursal reconstruction surgery, the opposite ends of graft 1820 can be anchored near humeral head 1802, and the position and / or size of graft 1820 can be adjusted such that glenoid rim 1804 contacts humeral head 1802.

[0228] Although many different techniques can be used to attach the other end of the graft 1820 to the vicinity of the humeral head 1802, in the illustrated embodiment, the first and second lateral anchors 1862a, 1862b are used in conjunction with the second tissue reinforcement structure 1810b to form a repair. More specifically, in one exemplary embodiment, at least one of the anchors 1862a, 1862b may have an associated suture 1812b, and the second tissue reinforcement structure 1810b may be disposed on at least a portion of the suture 1812b using techniques provided in this disclosure. By using any of the techniques provided herein or known to those skilled in the art, the suture 1812b may extend between the two anchors 1862a, 1862b, and the construct 1810b may be tightened downward against the graft 1820 to help maintain the position of the graft 1820 relative to the humeral head 1802, while allowing the construct 1810b to better distribute any forces applied by the suture 1812b on its surface area. Any number of tissue-reinforcing constructs may be used in the repair, and in an alternative embodiment, the tissue-reinforcing construct may be used only in conjunction with attaching the graft 1820 to only one of the glenoid rim 1804 and the humeral head 1802.

[0229] Soft tissue repair through closure of gaps – examples of rotating sleeve and non-rotating sleeve techniques

[0230] Figures 20A to 20F Two exemplary embodiments for closing gaps or voids in tissue are shown. Figures 20A to 20C The first embodiment shown involves the convergence of the rotating sleeve edges, such as Figures 20D to 20F The second embodiment shown relates to hip joint capsule closure. However, those skilled in the art will recognize that these embodiments can be applied in practice without departing from the spirit of this disclosure.

[0231] Figure 20A A rotating sleeve structure 1930 with a gap or opening 1905 is shown. First and second sutures 1912a, 1912b can be associated with the first and second structures 1910a, 1910b using techniques provided throughout this disclosure. Figure 20B As shown, the first free end of the first suture 1912b can pass through the rotating sleeve tissue 1930 on the first side of the gap 1905 and return through the rotating sleeve tissue 1930 on the opposite side of the gap 1905. The first free end can be tied to the second free end to bring the edges 1930a and 1930b of the gap 1905 together. Figure 20C As shown, the process can be repeated for the second suture 1912b to complete the repair. The tissue-reinforcing structures 1912a, 1912b provide many benefits provided herein, including but not limited to increasing the force from the sutures 1912a, 1912a through their distributed surface area, protecting the knots used to connect the free ends of the sutures 1912a, 1912b, and providing a scaffold for new tissue growth to produce a stronger repair between the edges 1930a and 1930b, wherein the scaffold essentially becomes a new tissue layer on top of the existing rotating sleeve tissue 1930.

[0232] Figure 20D A hip joint capsule tissue 1930' with a cavity or gap 1905' is shown. First and second sutures 1912a', 1912b' can be associated with the first and second structures 1910a', 1910b' using techniques provided throughout this disclosure. Figure 20E As shown, the first free end of the first suture 1912a' can pass through the hip joint capsule 1930' on the first side of the gap 1905', and return through the hip joint capsule 1930' on the opposite side of the gap 1905'. The first free end can be tied to the second free end to bring the edges 1930a' and 1930b' of the gap 1905' together. Figure 20FAs shown, the process can be repeated for the second suture 1912b' to complete the repair. Like the tissue-reinforcing structures 1912a and 1912b, the tissue-reinforcing structures 1912a' and 1912b' provide many of the benefits described herein, including the outstanding benefits provided relative to the structures 1912a and 1912b.

[0233] Tissue-enhancing structures - collagen staples / buttons

[0234] Figure 21A and Figure 21B Another exemplary embodiment of the tissue-reinforcing structure is shown. The tissue-reinforcing structure (such as pin or button 2010) has a generally cylindrical shape and is configured to be disposed on or otherwise associated with suture 2012. More specifically, the tissue-reinforcing pin 2010 may have a generally cylindrical body having a hole or lumen 2014 extending from its proximal end 2010p through it to its distal end 2010d. For example, the hole 2014 may be used to receive suture 2012 via stitch 2013, such that pin 2010 and suture 2012 can be associated with each other, as described in more detail below. In an alternative embodiment, suture 2012 may pass through pin 2010 without forming a pre-formed lumen in the body of pin 2010 and / or suture 2012 may wrap around or otherwise connect to pin 2010 without passing through it. As shown, the height H of pin 2010 is... T Smaller than diameter D T In addition, diameter D T It can be larger than the diameter of the filament or suture (e.g., suture 2012) associated with the pin 2010, thereby increasing the coverage area of ​​the suture 2012 and the surface area of ​​the tissue enhancement system or device used in surgical repair.

[0235] The suture 2012 can be any type of suture provided herein or known to those skilled in the art. In the illustrated embodiment, the suture 2012 includes a self-locking mechanism 2015 associated with the middle portion 2012i of the suture 2012, a collapsible collar 2040 extending from one side of the self-locking mechanism 2015, and retaining and tensioning tails 2012f and 2012t extending from the opposite side of the self-locking mechanism 2015. The self-locking mechanism 2015 can take various forms, and in the illustrated embodiment, it has a configuration similar to a finger catcher, which is formed by passing a portion of the second branch of the suture 2012 through the first branch of the suture 2012 before the first branch leaves the second branch to generate the retaining and tensioning tails 2012f and 2012t. The retaining tail 2012f may wrap around and / or be connected to the pin 2010, and as shown, a stitch 2013 is used to help manage the retaining tail 2012 and attach it to the pin 2010. The tensioning tail section 2012t can be used to help adjust the diameter of the collapsible collar 2040.

[0236] A collapsible collar 2040 can be coupled to an implant (e.g., a bone anchor 2060), and the diameter of the collar 2040 can be adjusted by moving the self-locking mechanism 2015 proximally away from the anchor 2060 and distally toward the anchor 2060, as shown in the illustrated embodiment, for example by applying a force to move it proximally away from the anchor 2060 to the tensioned tail 2012t. The anchor 2060 can be a thin-profile anchor, allowing it to pass more easily through the tendon. Those skilled in the art will recognize that various suitable thin-profile anchors, including some of those provided above, can be used in conjunction with this disclosure, such as... and Healix Transtend TM Anchoring components.

[0237] Many other suture configurations are possible, including some suture configurations further disclosed below and others known to those skilled in the art. Some suture configurations that can be incorporated into this design include, but are not limited to, those disclosed in U.S. Patent 8,821,544 entitled “Surgical Filament Snare Assemblies” and U.S. Patent 9,060,763 entitled “Systems, Devices, and Methods for Securing Tissue,” the entire contents of which are incorporated herein by reference.

[0238] Those skilled in the art will recognize that the tissue-enhancing thumbtack 2010 has a high H T and diameter D TThe diameter of the hole 2014 can depend on a variety of factors, including but not limited to the size of the associated filament, the patient's anatomy, and the type of surgery being performed. In some embodiments, the diameter D of the pin 2010... T The ratio of the diameter of the suture branch 2012 to the diameter of the suture can be roughly in the range of about 2:1 to about 100:1, and more specifically, in some cases, the diameter D T It can be at least three times larger than the diameter of the filament or suture associated with the tissue-reinforcing pin 2010. Various other sizes and shapes of the tissue-reinforcing pin 2010, including the size ratio of the pin and associated components (e.g., suture 2012), may be utilized without departing from the spirit of this disclosure.

[0239] While ratios can be used to help describe the relationship between the pin 2010 and the filament 2012, and the relationship between the dimensions of the pin 2010, some exemplary non-limiting dimensions of tissue-reinforced pins can also be used to understand this disclosure. As mentioned above, these dimensions can depend on a variety of factors. In some embodiments, the height H... T It can be roughly in the range of about 1 millimeter to about 1 centimeter, and the diameter D T The diameter d of the hole 2014 may range from approximately 1 mm to approximately 10 mm. The size of the diameter d may also depend on various factors, including but not limited to the size of the branch to be passed through. In some embodiments, the diameter d may range from approximately 0.5 mm to approximately 3 mm. Alternatively, the hole 2014 may be absent, and the filament 2012 may pass through the thumbtack 2010 without a hole. The thumbtack 2010 may be made of any material provided above relative to other tissue-reinforcing structures, including but not limited to collagen.

[0240] In some implementation schemes, such as Figure 21B As shown, the inserter tool 2070 can be used to install the anchor 2060 into a pre-formed hole in the bone 2050 in a transtendon manner. The inserter tool 2070 may have a releasable mechanism (not shown) at its distal end 2070d, which can releasably engage the anchor 2060 such that the inserter tool can be removed after the anchor is installed in the bone 2050. For example, the releasable mechanism may be a compression fit, a thread for engaging the anchor 2060, a ball-type locking device, or other releasable mechanisms that may be associated with the inserter tool 2070 according to this disclosure or known to those skilled in the art.

[0241] In use, the inserter tool 2070 can be used to insert the anchor 2060 through the tendon or other soft tissue 2030, such as... Figure 21CAs shown. The surgeon can then remove the inserter tool 2070 from the anchor 2060 after it has been secured to the bone 2050 beneath the tendon 2030, as... Figure 21D As shown. Once the anchor 2060 is fixed to the bone 2050, tension can be applied along direction T1 towards the tension tail, as... Figure 21E As shown. When the tension tail 2012t is pulled, the diameter of the suture loop 2040 decreases and the pin 2010 contacts the tendon 2030 to compress the tendon 2030 against the bone 2050. The self-locking mechanism 2015 holds the tension tail 2012t in position to keep the structure in a locked configuration. The tension tail can then be trimmed.

[0242] Using tissue-reinforced thumbtacks 2010 has many advantages. For example... Figure 21E As shown, the resulting configuration is one in which the pin 2010 is positioned on top of the tissue 2030 without any exposed hard parts and / or knots. This reduces the likelihood of tissue abrasion and other benefits. The same type of benefits provided by other constructions described herein also apply. For example, when the tissue-reinforcing pin 2010 is made of collagen or other types of tissue-growth-promoting materials, the repair can result in tissue remodeling, leaving no parts behind other than sutures. Furthermore, after the pin 2010 is pushed toward the anchor 2060 and secured to the tissue 2030, postoperative suture management is not really required.

[0243] Alternatively, if two tensioning pins 2010a and 2010b are used, such as Figure 21F As shown, tensioning thumbtacks 2010a and 2010b can be compared with the above-mentioned... Figures 21A to 21E The same installation method is described above. Instead of trimming the tail sections 2012t_1 and 2012t_2, the tensioned tail sections 2012t_1 and 2012t_2 can be secured to the side anchorage 2062 to provide further compression of the tissue 2030 against the bone 2050. In another alternative method, such as Figure 21G As shown, the two tensioned tails 2012t_1 and 2012t_2 can be tied together with a knot 2018. The knot 2018 can be covered by one or more additional tissue-reinforcing structures as provided herein.

[0244] As thumbtacks 2010' and 2010 respectively, in Figure 21H and Figure 21IOther non-limiting alternative embodiments of the pin 2010 are shown, which focus on other types of self-locking mechanisms associated with the corresponding sutures 2012', 2012'". The configuration of the suture 2012' includes a self-locking slip knot 2015' configured to selectively restrict the movement of the tensioned tail 2012t' relative to the pin 2010'. Those skilled in the art will recognize many different types of self-locking knots 2015' that can be used in conjunction with the pin 2010'.

[0245] Figure 21I Another alternative thumbtack 2010 is shown. Thumbtack 2010" has substantially the same dimensions as thumbtack 2010 and may be made of substantially the same material. However, tissue-reinforced thumbtack 2010" has two holes 2014a" and 2014b" extending from the nearest side surface 2010p" to the farthest side surface 2010d". Figure 21I As shown, the two holes 2014a” and 2014b” may be parallel to each other, but other alternative configurations are conceivable. In some embodiments, the holes may be absent, and instead, as provided herein or known to those skilled in the art, sutures may be passed through or otherwise associated with the pin 2010”.

[0246] The suture 2012” used in conjunction with the thumbtack 2010” may be similar to the suture 2012, but as shown, it is manipulated to have a configuration with two self-locking mechanisms 2015a” and 2015b” and two collars 2040a” and 2040b”. The self-locking mechanisms 2015a” and 2015b” may be formed as described above or as known to those skilled in the art. In the illustrated embodiment, the self-locking mechanisms 2015a” and 2015b” have a configuration similar to a finger catcher, which is formed by passing a portion of the second branch of the suture 2012” through the first branch before the first branch leaves the second branch to generate a fixed and tensioned tail 2012f_1”, 2012f_2” and 2012t_1” and 2012t_2”. As shown, the fixed tails 2012f_1” and 2012f_2” can be attached to the pin 2010” using one or more stitches 2013”, and the tensioning tails 2012t_1” and 2012t_2” can extend from the nearest side end 20120p” of the pin 2010”. As shown, the loops 2040a” and 2040b” can both be attached to the suture implant, the anchor 2060a” as shown, and as described above, the tensioning tails 2012t_1” and 2012t_2” are operable to adjust the diameter of the respective loops 2040a” and 2040b”. Although the self-locking mechanisms 2015a” and 2015b” are shown in the illustrated embodiment as having a configuration similar to a finger catcher, other types of self-locking mechanisms including slip knots can be used instead of the self-locking mechanisms 2015a” and 2015b” shown.

[0247] Methods for manufacturing tissue-enhanced structures

[0248] Many different techniques can be used to manufacture the tissue-enhancing constructs provided herein, some of which are described below. Other techniques known to those skilled in the art or developed after this disclosure (particularly according to this disclosure) can also be used to manufacture tissue-enhancing constructs of the various configurations disclosed.

[0249] Methods for manufacturing tissue-reinforced structures - Ultrasonic forming

[0250] In one exemplary embodiment of manufacturing tissue-reinforced constructs (blocks, scaffolds, etc.), freeze-dried dermis is supplied in one or more sheets or other block configurations and can be trimmed to the desired size to form a tissue-reinforced construct configured for soft tissue repair applications. Exemplary methods for trimming the sheets or other block configurations include using an ultrasound generator and a handheld device. The handheld device can use off-the-shelf or custom-made blades to cut the sheets or other block configurations to the desired size and shape. In some embodiments, custom-made blades can be used to shave small pieces from the edges of the freeze-dried dermis and / or puncture the dermis. These actions can create one or more channels in the tissue-reinforced construct, which can be used to allow sutures or other devices to pass through to hold the tissue-reinforced construct at the surgical site. Using ultrasound techniques such as ultrasound generators and handheld devices is superior to conventional manual scalpel techniques because ultrasound allows for a significant reduction in the force required to cut and shape the freeze-dried dermis into tissue-reinforced constructs. In addition, the use of ultrasonic cutting technology can reduce the deformation of freeze-dried dermis due to the cutting action, which can produce more accurate cuts and punctures, and thus produce tissue-enhancing structures with more precise dimensions.

[0251] Ultrasonic techniques, including cutting and shaping freeze-dried dermis, can be used to form some or all of the features or shapes of the tissue-enhancing structures disclosed herein.

[0252] Methods for manufacturing tissue-enhanced structures - blocks with configurations

[0253] In one exemplary embodiment of fabricating the tissue-reinforcing band or strip 10, the material used to fabricate the strip 10 can be cut into a desired shape. For example, in embodiments where the strip is fabricated using autologous, allogeneic, or xenograft tissue, if the tissue is harvested prior to surgery, the fresh tissue can be cut into a desired shape, such as, for strip 10, a generally rectangular shape having a length L, a width W, and a thickness T, as shown below. Figure 1A As shown. Regardless of whether the strip is made from harvested material, the harvesting of material to make the strip can be achieved using any technique known to those skilled in the art. According to this disclosure, the strip or band 10 can have any shape; for example, tissue can be cut into ovals, circles, triangles, etc. Furthermore, the tissue does not need to be cut with a conventional surgical scalpel or scissors. In some cases, punches, computer numerical control machine tools, laser cutters, or other known manufacturing techniques can be used to determine the dimensions.

[0254] Once the tissue has formed the desired shape, the threader can be associated with the strip 10. For example, similar to Figure 1BThe suture branch 12a shown, the central filament portion 210 of the threader 206, can be threaded through the strip 10 using a plain needle. The stitches can pass back and forth through the body of the strip 10 as needed. In an alternative embodiment, the central filament portion 210 of the threader 206 can be passed from one strip 10 to another without protruding beyond the body. After the threader 206 is installed, the strip 10 can be dried for packaging. Alternatively, the threader 206 can be inserted after the tissue has dried. Furthermore, the strip 10 does not require drying.

[0255] Methods for manufacturing tissue-reinforced structures - blocks with tubular configurations

[0256] An exemplary embodiment for fabricating the tissue-reinforcing tube 110 is shown in Figures 22A to 22C The material used to make tube 110 can be harvested or collected using techniques known to those skilled in the art. The material can then be shaped using any techniques described above with respect to strip 10, described elsewhere herein, or known to those skilled in the art. For example... Figure 22A As shown, a piece of material 120 with length L' and width W' can be harvested. The width W' can be approximately equal to D × π, where D is the diameter of the tube 110, as shown. Figure 2B As shown. Figure 22A As shown, the material part 120 may be generally rectangular and have a first end 120a and a second end 120b extending a width W' therebetween. Alternatively, the material part 120 may have any shape.

[0257] Once the material part 120 is cut, the first end and the second end 120a, 120b can approach each other and subsequently attach to each other, thereby forming a tube. For example... Figure 22B and Figure 22C As shown, the first and second ends 120a, 120b are attached together using sutures or filaments 122 to suture the ends together. Alternatively, the first and second ends 120a, 120b may be attached to each other using adhesives, collagen binders, staples, light curing, crosslinking, mechanical interlocking, dehydration, or other techniques known to those skilled in the art for attaching soft tissue to soft tissue. A threader 206 may be inserted into the tube 110 before or after attaching the two ends 120a, 120b. The tube 110 may be dried for packaging. Alternatively, the tube 110 may be kept in a hydrated form without dehydrating the block 110 (this is true for any construction discussed herein or other constructions derived therefrom). Figures 23A to 23C The document provides an alternative method for manufacturing tissue-reinforcing tubes. In this method, multiple tubes 110a-110c can be manufactured from a single material in a single process, or, as shown, from two materials, one placed on top of the other.

[0258] As shown in the figure, one of the first material 130a and the second material 130b is placed on top of the other. Similar to earlier embodiments, materials 130a and 130b can be acquired, sized, and shaped using any techniques provided herein or other techniques known to those skilled in the art. Figure 23B As shown, the first and second materials 130a, 130b may have a length L' and a width determined according to the desired number of tubes 110a-110c. Specifically, each tube 110 has a diameter or width D, as described above. Therefore, the width of the material piece may be equal to the desired number of tubes 110 multiplied by D. Alternatively, the manufacturing process can be planned to allow a selected amount of space to be formed between each strip formed. In some embodiments, a single piece of material (not shown) having a generally rectangular shape may be used, wherein the piece is folded in half to form the first and second materials as shown, one layered on top of the other.

[0259] Once the two materials 130a and 130b are cut to the desired dimensions, pins 132a-132c can be placed between them. Pins 132a-132c can be placed approximately parallel to each other and perpendicular to the long side 131 of the materials. Pins 132a-132c can be spaced apart such that there is sufficient space between each pin 132a-132c to allow for the attachment and disengagement of the individual tubes 110a-110c.

[0260] like Figures 23A to 23C As shown, suture 134 is used to attach the first and second materials 130a, 130b together to form a tube around pin 132a. Alternatively, the first and second materials 130a, 130b can be attached to each other using glue, collagen binder, staples, light curing, or other known techniques. Once all tubes 110a-110c are sewn together, individual tubes 110a-110c can be cut along lines L1 and L2. Figure 23B As shown, lines L1 and L2 are approximately parallel to pins 132a-132c. Once the individual tubes 110a-110c are cut, pins 132a-132c can be removed, as... Figure 23C As shown, a hole or lumen 114a is left. The threader 206 may be associated with the lumen 114a in a manner provided herein relative to the lumen 114 of the tube 110 to allow the suture branch to pass through the lumen.

[0261] This method of manufacturing tubular structures can also be used in a similar way to manufacture hollow structures, such as... Figure 2E and Figure 2F The rods 3010 and 3110 are shown. In this case, once the cannula is formed using pins 132a-132c, the pins can be removed, and the two material layers 130a' and 130b' can be slightly compressed, or can loosen towards each other on their own. As a result, as Figure 23C As shown, the lumen 114a' can be deformed from a tubular shape into a slit-shaped lumen 114a', as... Figure 2E and Figure 2F As shown. As described above, the overall shape of structures 3010 and 3110 can be approximately rectangular prisms. For example, in the construction of structures 3010 and 3110, the use of pins 132a'-132c' can be completely omitted. Alternatively, pins 132a'-132c' can be replaced by stab cutters (not shown), so that the shape of the lumen 114c' begins with a slit rather than a tubular shape.

[0262] exist Figures 24A to 24C Other alternative methods for manufacturing tissue-reinforcing tubes are provided herein. This method also allows multiple tubes 110a'-110c' to be fabricated at once from a single material, or from multiple pieces of material if desired. As shown, a piece of material 130' may have a length L” and a width determined based on the desired number of tubes. Specifically, each tube 110a'-110c' has a diameter or width D'. Therefore, the width of the material piece may be equal to the desired number of reinforcing blocks 110' multiplied by D'. Alternatively, this width may include an additional space X between each tube 110', which may be taken into account when forming the dimensions of the material piece 130'. As with any embodiment provided herein, the thickness of the material may vary depending on a variety of factors, including but not limited to the size and shape of other components and tissues used in the tubes, the patient's anatomy, and the type of surgery performed. In some exemplary embodiments, such as Figure 24A The thickness T' shown can be in the range of approximately 0.5 mm to approximately 10 mm.

[0263] Once the material piece 130' is cut to the desired size, pins 132a'-132c' can be inserted through the material piece 130' from the first edge 130a' to the second edge 130b'. Pins 132a'-132c' can be inserted such that they are generally parallel to each other and generally perpendicular to the first and second edges 130a', 130b' of the material 130'. Pins 132a'-132c' can be spaced apart such that there is sufficient space between each pin 132a'-132c' to allow for separation. The pins 132a'-132c' can be sized to have a diameter approximately equal to the diameter of the resulting lumen 114".

[0264] Alternative locations, such as Figure 25As shown, cannula 2802 can be used to form a lumen 114 in a piece of material. Cannulas are generally known to those skilled in the art, and therefore a detailed description of cannulas is not necessary. In fact, in the illustrated embodiment, only the distal end of cannula 2802 is shown, which includes a tip 2804 and a shaft 2806 associated (e.g., coupled) with the tip 2804. The distal end of the tip 2804 is sharp and is therefore configured to puncture tissue. The shaft 2806 of the cannula extends distally from the housing (not shown) to help guide the cannula in the material.

[0265] Cannula 2802 is unique compared to other cannulas because the shaft 2806 has a gradually increasing diameter in the proximal direction P (i.e., toward the housing). More specifically, the tip 2804 has a substantially constant diameter D ranging from about 0.10 mm to about 1 mm. P1 As shown in the figure, the diameter of the farthest end is even smaller than D. P1 Shaft 2806 has a gradually increasing diameter, said diameter starting from a first diameter D. P1 It begins and ends at the second diameter D P2 And the diameter is approximately in the range of about 0.5 mm to about 5 mm. Other sizes are of course possible, depending at least in part on the desired lumen size, the instruments equipped with the cannula to be used, and the surgeon's preference.

[0266] The gradually increasing diameter of shaft 2806 allows for more precise formation of a lumen within the tissue. Starting with a cannula whose shaft has a smaller diameter near the distal end 2804 makes it easier to position and advance the cannula 2802 into soft biological tissue. In use, the end 2804 can be positioned, for example, on a first edge of a piece of material, and advanced by applying pressure and / or twisting the cannula 2802 as the end is advanced toward a second side of the tissue to form an initial lumen. As the cannula 2802 is advanced distally toward the second side, the size of the opening it forms gradually increases from D... P1 Increase to D P2 This differs from a typical cannula, which usually has a single-dimensional axis associated with the distal end.

[0267] Go back to Figures 24A to 24C Once all pins 132a'-132c' are inserted, individual tubes 110a'-110c' can be cut along lines C1-C6. For example... Figure 24B As shown, lines C1-C6 are approximately parallel to pins 132a-132c. Once individual tubes 110a'-110c' are cut, pins 132a'-132c' can be removed, as... Figure 24C As shown, lumen 114a' is left. Threader 206 can be provided in a manner consistent with lumen 114a' for the purposes of this document.

[0268] The manufacturing method described in this article does not need to be performed in a prescribed order. For example, regarding Figures 23A to 23C and Figures 24A to 24C The method allows for the removal of pins 132a-132c and 132a'-132c' before cutting tubes 110a-110c and 110a'-110c'. Furthermore, tubes 110a-110c and 110a'-110c' can be dried at any suitable point in the manufacturing process. Additionally, this process can be used to create any number of blocks with any number of shapes or configurations, including but not limited to tubular or rectangular shapes, such as single tissue-reinforcing blocks 110a and 110a', two reinforcing blocks, or more than three reinforcing blocks. Furthermore, the manufacturing techniques provided with respect to various manufacturing embodiments can be modified according to this disclosure to manufacture other tissue-reinforcing structures. As a non-limiting example, blocks with band or strip configurations can be formed according to this disclosure, thereby allowing multiple strips to be formed from single pieces of material and / or multiple pieces of material stacked on top of each other where such additional thickness and / or additional material is required. These techniques can also be applied to forming reinforced washers, for example by forming blocks 110, 3010 or 3110 disclosed in this invention and then cutting them along their length to form washers.

[0269] Methods for manufacturing tissue-reinforced structures - Core sampling

[0270] In some embodiments of the various tissue-reinforcing structures disclosed in this invention, including blocks, strips, tubes, rods, washers, patches, and pins, one or more lumens or cannulas can be formed within the body of the structure. Some techniques for forming such lumens involving the use of pins have been provided above. Another exemplary technique for forming such lumens involves coring, as discussed regarding… Figures 26A to 26I As shown and described.

[0271] like Figure 26A As shown, a pre-cut portion of a structure 2110 having a length L1 and a width W1 can be prepared for core extraction. A tool, such as a core extraction tube 2132, can be used to extract the core from the structure 2110. The core extraction tube 2132 may have a handle 2134 at a proximal end and a hollow tube 2136 at a distal end. The hollow tube 2134 of the core extraction tube 2132 may have a distal edge 2138, which may be sharpened or serrated to produce a clean incision. The hollow tube 2134 may have a diameter d1 smaller than the W1 of the structure. The diameter d1 can be selected based on the suture size required for a given procedure.

[0272] like Figure 26BAs shown, the core tube 2132 can be advanced along direction S while simultaneously rotating along direction R. The rotation and linear translation of tool 2132 provide a sharper cut; however, the tool can only be pushed along the S direction without any rotation. Figure 26C As shown, once the distal end of the core tube 2132 is advanced along the entire length of the structure 2110, it can be removed in the opposite direction S′, thereby removing a portion of the material 2110a and leaving a circular cavity 2114. Figure 26D As shown, multiple lumens 2114a-2114c can be formed within a single structure 2110. Alternatively, Figure 26D The structures can be cut into strips extending parallel to the lumens 2114a-2114c, thereby forming multiple structures, each comprising only one lumen. In another alternative embodiment, such as Figure 26E and Figure 26F As shown, at least two holes 2114d and 2114e can be formed in the structure 2110 such that they intersect at a certain position 2120 in the structure.

[0273] In alternative core extraction implementation schemes, such as Figures 26G to 26I As shown, a curved cavity 2114' can be formed using a core sampling tube 2132'. For example... Figure 26G As shown, a generally U-shaped structure 2110′ having first and second generally curved edges 2110a′, 2110b′ and two straight edges 2110c′, 2110d′ is prepared for core extraction. Similar to... Figures 26A to 26C In one implementation, the coring tube 2132′ is used to cor the lumen 2114′ by means of a structure that enters and exits along edge 2110a′. Figure 26H In the diagram, the lumen 2114′ is shown as substantially linear. Once the lumen 2114′ is formed, the structure can be stretched or otherwise rearranged such that the edges 2110a′-d′ are all substantially straight to form a generally rectangular structure 2110′, as shown below. Figure 26I As shown.

[0274] Methods for manufacturing tissue-reinforced structures - tunnel work site

[0275] In another alternative manufacturing method, a tunnel-forming station for the structure is provided. For example... Figure 27A As shown, the structure forming tunnel station 3200 may include a platform 3220 for holding the tissue-enhancing structure, a lumen forming tool 3224 for forming a lumen in the structure, and a guide 3228 for assisting in positioning the lumen forming tool 3224 relative to the structure held by the platform 3220.

[0276] In one exemplary embodiment, a structure platform 3220 may support and guide a material component 3230 that can be formed into a structure. The structure platform 3220 may be a self-centering compression platform to hold the material component 3230 at a fixed height via the platform 3220. The self-centering of the structure platform 3220 may be accomplished according to recognized manufacturing techniques. The structure platform 3220 may include two platforms 3220a, 3220b that are movable toward and away from each other Y1, Y2 to self-center and compress the material 3230. Alternatively, only one platform 3220a, 3220b may be translated, or the platforms 3220a, 3220b may be fixed relative to each other. The first platform 3220a may have a distal side 3219a opposite the proximal side 3219b of the second platform 3220b. Each of the distal side 3219a and the proximal side 3219b may include a semi-circular relief 3221a, 3221b capable of receiving material 3230 when the lumen-forming tool 3222 is inserted, such as Figure 27B and Figure 27C As shown. The structure platform 3220 may include a mechanism (not shown) for advancing material 3230 along the Z direction to automate the manufacturing process, for example, as described below regarding Figure 27J As stated above.

[0277] The tunnel forming station 3200 may include a lumen forming tool 3224, which may include a guide 3228 and a cutting tool 3222. In the illustrated embodiment, the guide 3228 typically includes a lumen 3227 and is secured relative to the structure platform 3220 via connectors 3226a, 3226b to ensure that the relative orientation of the tool 3224 and the platform 3220 remains fixed, such that the orientation of the lumen within the structure formed by the fixture station 3200 is within acceptable manufacturing tolerances between structures. Alternatively, the guide 3228 may be secured to the platform 3220 with only one connector or more than two connectors. Furthermore, although the lumen forming tool 3224 is shown as physically connected to the structure platform 3220, alternatively, the tool 3224 and the platform 3220 may be separate pieces fixed relative to each other (e.g., attached to the same worktable) to ensure proper lumen forming alignment.

[0278] The cutting tool 3222 can be disposed within the guide 3228, including by being removably and alternatively associated with the guide 3228, such that the tool 3222 can freely rotate R and translate X within the guide 3228. In some embodiments, the tool 3222 can be as follows: Figure 27D The needle shown. Alternatively, the cutting tool can be a spear, such as... Figure 27EAs shown, for example, the Premier Edge MVR knife purchased from Oasis Medical, Glendora, California. The spear may include a proximal shank portion 3222p and a distal spear portion 3222d having a generally circular cross-sectional shape. The distal spear portion may have multiple straight, sharp edges 3223. The multiple straight, sharp edges 3223 may have a smooth transition from the proximal shank portion 3222p of the tool.

[0279] In another alternative embodiment, the cutting tool 3222 may have a variety of alternative designs. For example, such as Figure 27F The cannula shown, such as Figure 27G The drill bit shown, such as Figure 27H The coring tube shown or as Figure 27I The straight blade shown. Each of the alternative tools can be used to form a lumen within the structure 3210, based on recognized manufacturing techniques provided throughout this disclosure.

[0280] In one exemplary method of use, multiple tubes 3210a-3210d can be fabricated at once from a single length of material, or from multiple pieces of material if desired. As shown, material piece 3230 may have a length L and a width W. The width W of the material may be the length of the resulting structure, while the length L may be determined based on the desired number of structures. Specifically, each structure 3210a-3210d has a diameter or width D. Therefore, the length L of the material piece may be equal to the desired number of structures 3210 multiplied by D. Alternatively, the length L may include additional space between each structure 3210, which may be taken into account when forming the dimensions of the material piece 3230. As with any embodiment provided herein, the thickness of the material may vary depending on a variety of factors, including but not limited to the size and shape of other components and tissues of the structures used, the patient's anatomy, and the type of surgery performed.

[0281] Once the material part 3230 is pushed into the platform 3220, the lumen forming tool 3224 can be actuated, allowing the cutting tool 3222 to pass through the material part 3230 and be inserted from the first edge 3230a to the second edge 3230b. Figures 27I to 27KAs shown. Depending on the type of cutting tool 3222 used, the lumen forming tool 3224 can translate the tool 3222 in the X direction, or rotate and translate the tool 3222 into the material 3230 in both directions X and R. Actuation of the cutting tool 3222 can be performed automatically using an actuator. Alternatively, the cutting tool 3222 can be manually actuated by the user. The cutting tool 3222 can then retract, leaving lumens 3214a-3214c. The material 3230 can then be advanced a predetermined distance in the Z direction, and this process can be repeated to form additional structures. Individual structures 3210a-3210d can then be separated from the material 3230, as... Figure 27K and Figure 27L As shown. For example, individual structures 3210a-3210d can be separated by punches 3290a-3290d or other cutting mechanisms provided throughout this disclosure.

[0282] like Figure 27M As shown, an alternative structure forming the fixture station 3200 can provide parallel lumen formation. For example... Figure 27M As shown, platform 3220 can accommodate the larger length L′ of material 3230′. For example, as Figure 27M As shown, platform 3220' can accommodate the length required to form three structures. Alternatively, platform 3220' can be extended to accommodate any number of structures. Similar to the platform of fixture station 3200, platform 3220' may have a semi-circular relief and may be self-centered. Similar to... Figures 27A to 27L In one embodiment, station 3220′ may include a plurality of lumen-forming tools 3224a′, 3224b′, and 3224c′, which are aligned parallel to each other. Alternatively, the plurality of tools 3224a′, 3224b′, and 3224c′ may be oriented at any angle relative to each other. The lumen-forming tools 3224a′, 3224b′, and 3224c′ are aligned such that each of the respective cutting tools 3222a′, 3222b′, and 3222c′ translates toward the platform in a parallel direction. In the illustrated embodiment, three lumen-forming tools 3224a′, 3224b′, and 3224c′ are shown, but any number of lumen-forming tools may be provided. After each of the lumen-forming tools 3224a′, 3224b′, and 3224c′ is actuated and retracted to form lumens 3214a′, 3214b′, and 3214c′ in the material 3230′, the material 3230′ may be advanced in direction D′. Individual structures 3210a′, 3210b′, and 3210c′ may be separated according to the techniques provided herein. Alternatively, structures comprising multiple lumens may be cut from the material to form patches or supports, as further discussed below.

[0283] Methods for manufacturing tissue-reinforced structures - General methods

[0284] The above embodiments represent some specific techniques associated with manufacturing blocks having specific configurations (e.g., strips, tubes, rods, and washers). More general techniques, such as coring, are also provided. These techniques can be adapted by those skilled in the art for use in other configurations of tissue-reinforced structures according to this disclosure. Furthermore, this disclosure provides even more general techniques and methods that can be used to form the various tissue-reinforced structures disclosed herein that are available from this disclosure. The methods provided in this section can be used as standalone methods, in combination with each other, and / or in combination with other manufacturing techniques provided in this disclosure.

[0285] In some embodiments, the structure may be manufactured entirely or partially by phase separation techniques, freeze drying, knitting, weaving, electrospinning, rapid prototyping (e.g., 3D printing), or combinations thereof. To promote tissue growth, perforations may be formed in the structure using thermal, electrical, and / or mechanical means. For example, perforations may be formed by lasers or sharp objects such as needles, punches, or molds. The size of the perforations may be any suitable size, but preferably, the size of the perforations is designed to allow tissue to grow inward. More preferably, the perforation size may be in the range of approximately 50 micrometers to approximately 2000 micrometers, and even more preferably in the range of approximately 50 micrometers to approximately 1000 micrometers.

[0286] In some implementations, biological tissues, including but not limited to allogeneic or xenograft tissues, may optionally be incorporated into various tissue-enhancing constructs to form bilayered constructs. The combination of biological tissues within these tissue-enhancing constructs can provide enhanced biological and mechanical properties to the resulting constructs.

[0287] For example, such as Figure 28As shown, construct 2710 (shown as a patch or scaffold as described in more detail below) may include a reconstructed collagen matrix or biodegradable polymer 2702 or any other material described herein for tissue-enhancing constructs (e.g., autologous grafts, xenografts, pulverized collagen sheets, porcine dermis, etc.), and a biological component, such as extracellular matrix (ECM) 2704, attached to one side of matrix 2702 using techniques known to those skilled in the art. The reconstructed collagen matrix or biodegradable polymer may be a first layer or may be part of a first layer, and the biological component may be a second layer or may be part of a second layer, wherein the first layer has a larger thickness and surface area and is significantly larger than the second layer in thickness and surface area, as shown in the figure. In other embodiments, the biological component, such as ECM 2704, may be disposed on and / or coated or immersed on the opposite side of matrix 2702. Those skilled in the art will recognize that several different attachment options may be used to attach ECM 2704 to matrix 2702, including but not limited to gluing and suturing. Including ECM 2704 or other biological components can help integrate the enhanced construct with the tissue of the construct used. In one exemplary embodiment, the matrix 2702 may have a thickness T1 ranging from about 1 mm to about 4 mm, and the ECM layer may have a thickness ranging from about 80 micrometers to about 3 mm.

[0288] In some embodiments, the biological component may be coated onto or incorporated into the tissue-enhancing structure. If the biological component is coated onto the tissue-enhancing structure, the biological component is preferably associated with at least a portion of the structure. For example, the biocompatible structure may include an adhesive for anchoring a suspension of the biological component to the scaffold. The adhesive may be an anchoring agent, a crosslinking agent (i.e., a chemical or physical crosslinking agent), or a combination thereof. Suitable anchoring agents may include, for example, hyaluronic acid, fibrin glue, fibrin clots, collagen gel, alginate gel, gelatin-resorcinol-formalin adhesive, mussel-based adhesive, dihydroxyphenylalanine (DOPA)-based adhesive, chitosan, transglutaminase, poly(amino acid)-based adhesive, cellulose-based adhesive, polysaccharide-based adhesive, synthetic acrylate-based adhesive, platelet-rich plasma (PRP), platelet-poor plasma (PPP), PRP clots, PPP clots, matrix adhesive, monostearate cosuccinate (MGSA), monostearate cosuccinate / polyethylene glycol (MGSA / PEG) copolymer, laminin, elastin, proteoglycans, and combinations thereof.

[0289] Crosslinking can be achieved using physical means and chemical reagents. Examples of chemical reagents used for crosslinking may include dehydrothermal treatment (DHT), divinyl sulfone (DVS), polyethylene glycol divinyl sulfone (VS-PEG-VS), hydroxyethyl divinyl sulfone methacrylate (HEMA-DIS-HEMA), formaldehyde, glutaraldehyde, acetaldehyde, isocyanates, alkyl and aryl halides, imine esters, N-substituted maleimides, acylated compounds, carbodiimides, hexamethylene diisocyanate, 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC or EDAC), hydroxychlorides, N-hydroxysuccinimide, light (e.g., blue light and UV light), pH, temperature, and combinations thereof.

[0290] Biological components can be one or more effectors that promote the healing and / or regeneration of affected tissues at the site of injury. Biological components of a construct may include heterologous or autologous growth factors, proteins, matrix proteins, peptides, antibodies, antibiotics, anti-inflammatory agents, therapeutic agents, chemokines, antimicrobial agents, compounds that minimize or prevent adhesion formation, compounds or agents that suppress the immune system, cell attachment mediators, bioactive ligands, integrin-binding sequences, enzymes, cytokines, glycosaminoglycans, polysaccharides, viruses, viral particles, nucleic acids, analgesics, cells, platelets, platelet-rich plasma (PRP), fragmented extracellular particles, fragmented tissue debris, hydroxyapatite, tricalcium phosphate, bioactive glass, biphasic calcium phosphate, calcium sulfate, other bone and / or tissue growth promoting materials, and combinations thereof.

[0291] As described herein, in some embodiments, the tissue-reinforcing structure may have one or more through-holes or apertures extending therethrough. Through-holes may be slits or channels with different cross-sectional shapes, such as circular, elliptical, square, rectangular, etc. Through-holes can be formed using any tool capable of removing material, including mechanical, thermal, or power tools. Alternatively, a through-hole may be a slit that can be formed by any tool that causes separation of two surfaces.

[0292] In some embodiments, the structure may consist of more than one layer. The layers of the structure may be made of the same material or different materials. The layers may be bonded or fused together using sutures, mechanical, electrical, and chemical fastening techniques. Examples of bonding or fusion may include, for example, tissue welding, nails, rivets, tissue pins, darts, screws, pins, arrowheads, crosslinking, vacuum pressing, compression, compression combined with dehydration, vacuum pressing combined with dehydration, or bioadhesives, or combinations thereof. In this case, dehydration may include, for example, freeze-drying (i.e., lyophilization). Bioadhesives may include, for example, fibrin glue, fibrin clots, collagen gels, alginate gels, gelatin-resorcinol-formalin adhesives, mussel-based adhesives, dihydroxyphenylalanine (DOPA)-based adhesives, chitosan, transglutaminase, poly(amino acid)-based adhesives, cellulose-based adhesives, polysaccharide-based adhesives, synthetic acrylate-based adhesives, platelet-rich plasma (PRP), platelet-poor plasma (PPP), PPP clots, matrix adhesives, monostearate cosuccinate (MGSA), monostearate cosuccinate / polyethylene glycol (MGSA / PEG) copolymers, laminin, elastin, hyaluronic acid, proteoglycans, and combinations thereof.

[0293] In some embodiments, the structure may include a reinforcing material. The reinforcing material may be made of any absorbable or non-absorbable textile having, for example, woven, knitted, warp-knitted (i.e., lace-like), nonwoven, and braided structures. In one embodiment, the reinforcing material may have a mesh structure. The mechanical properties of the material can be altered by changing the material's density or texture, the type of knit or weave, the material's thickness, or by embedding particles within the material.

[0294] The mechanical properties of reinforcing materials can also be altered by forming sites within the structure at which the fibers are physically bonded to each other or to other agents, such as adhesives or polymers. The fibers used to prepare the reinforcing components can be, for example, monofilaments, yarns, threads, braids, or fiber bundles. These fibers can be made from any biocompatible material, including but not limited to bioabsorbable materials such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), copolymers or blends thereof. The fibers can also be made from any biocompatible material based on natural polymers, including silk and collagen-based materials. Alternatively, the fibers can also be made from any non-reabsorbable biocompatible fiber, such as polyethylene, nylon, polyester, polyethylene terephthalate, poly(tetrafluoroethylene), polycarbonate, polypropylene, polyurethane, and poly(vinyl alcohol).

[0295] In another embodiment, the structure may incorporate hydroxyapatite, tricalcium phosphate, bioglass, biphasic calcium phosphate, calcium sulfate, or other bone-promoting materials throughout the structure or locally in the portion of the structure where bone regeneration is required. Bioglass is a silicate containing calcium phosphate glass, or calcium phosphate glass with varying amounts of solid particles added to control reabsorption time. Bioglass is an example of a material that can be spun into glass fibers and used as a reinforcing material. Bioglass may also be added to the structure in powder form. Suitable solid particles that can be added include iron, magnesium, sodium, potassium, and combinations thereof.

[0296] In some embodiments, both the biocompatible construct and the reinforcing material can be formed from a thin, perforated elastomer sheet with pores or perforations to allow tissue to grow inward. The sheet may be made from blends or copolymers of polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), and polydioxane (PDO).

[0297] The structure may be formed partially or entirely of a porous polymer foam component, the pores having an open-cell structure. The pore size may vary, but preferably, the pore size is designed to allow tissue to grow inward. In some embodiments, the pore size ranges from about 40 micrometers to about 1000 micrometers, and in other embodiments, the pore size ranges from about 50 micrometers to about 500 micrometers. The polymer foam component may be made of natural and / or synthetic materials, such as reconstituted collagen. The polymer foam may be non-crosslinked or crosslinked. The polymer foam component may optionally include reinforcing components, such as the textiles discussed above. In some embodiments, the polymer foam component may include reinforcing components that can be integrated with the reinforcing component such that the pores of the foam component penetrate the mesh of the reinforcing component and interlock with the reinforcing component.

[0298] In some embodiments, the polymer foam component of the tissue implant can be formed into a foam using a variety of techniques well known to those skilled in the art. For example, the polymer raw material can be foamed by freeze-drying, supercritical solvent foaming (as described at least in European Patent Application 464,163, the entire contents of which are incorporated herein by reference), gas injection extrusion, gas injection molding, or casting with an extractable material (e.g., salt, sugar, or a similar suitable material).

[0299] The polymer foam component of the engineered tissue repair implant device disclosed herein can be prepared by polymer-solvent phase separation techniques, such as lyophilization. The polymer solution can be separated into two phases by any of four techniques: (a) thermally induced gelation / crystallization; (b) non-solvent-induced separation of the solvent and polymer phases; (c) chemically induced phase separation; and (d) thermally induced metastable decomposition. The polymer solution can be separated into two distinct phases or two bicontinuous phases in a controlled manner. Subsequent removal of the solvent phase typically leaves a porous structure with a density and pore size in the micrometer range less than that of the bulk polymer. Further information regarding the solvent phase is provided in the paper "Phase Separation in Microporous Foams," J. Vac. Sci. Technol., AT Young, Vol. 4, No. 3, May / June 1986, the contents of which are incorporated herein by reference in their entirety.

[0300] The steps involved in preparing these foams include, for example, selecting a solvent suitable for the polymer to be lyophilized and preparing a homogeneous solution. The polymer solution can then be subjected to cycles of freezing and vacuum drying. The freezing step separates the polymer solution, while the vacuum drying step removes the solvent through sublimation and / or drying, leaving a porous polymer structure or an internally interconnected open-cell porous foam. Suitable solvents that can be used to prepare the foam components may include, for example, formic acid, ethyl formate, acetic acid, hexafluoroisopropanol (HFIP), cyclic ethers (e.g., tetrahydrofuran (THF), dimethylene fluoride (DMF), and polydioxanone (PDO)), acetone, acetates of C2 to C5 alcohols (e.g., ethyl acetate and tert-butyl acetate), and glycol dimethyl ethers (e.g., monoethylene glycol dimethyl ether, ethyl glycol dimethyl ether, diethylene glycol dimethyl ether, ethyl diethylene glycol dimethyl ether, triethylene glycol dimethyl ether, butyl diethylene glycol dimethyl ether, and tetraethylene glycol dimethyl ether). The solvents include methyl ethyl ketone, dipropylene glycol methyl ether, lactones (e.g., γ-valerolactone, δ-valerolactone, β-butyrolactone, γ-butyrolactone), 1,4-dioxolane, 1,3-dioxolane, 1,3-dioxolane-2-one (ethylene carbonate), dimethyl carbonate, benzene, toluene, benzyl alcohol, o-xylene, naphthalene, tetrahydrofuran, N-methylpyrrolidone, dimethylformamide, chloroform, 1,2-dichloromethane, morpholine, dimethyl sulfoxide, hexafluoroacetone hemihydrate (HFAS), anisole, and mixtures thereof. One exemplary solvent among these is 1,4-dioxolane. Homogeneous solutions of the polymer in the solvents are prepared using standard techniques.

[0301] The available polymer concentration or solvent amount can vary from system to system. In one embodiment, the amount of polymer in the solution can vary from about 0.5 wt% to about 90 wt%. In another embodiment, preferably, the amount of polymer in the solution can vary from about 0.5 wt% to about 30 wt%. The amount of polymer in the solution can be varied based on various factors such as the solubility of the polymer in a given solvent and the desired final performance in the foam.

[0302] In embodiments of structures comprising polymer foam, solids can be added to the polymer-solvent system to alter the composition of the resulting polymer foam surface. As the added particles precipitate from the solution to the bottom surface, regions will form that will have the composition of the added solids, rather than the composition of the foamed polymer material. Alternatively, the added solids can be more concentrated in desired regions of the resulting tissue-reinforced structure (i.e., near the top, sides, or bottom), thereby resulting in compositional changes in all these regions. For example, a solid concentration at a selected location can be achieved by adding metallic solids to a solution placed in a mold made of magnetic material (or vice versa).

[0303] Various types of solids can be added to the polymer-solvent system. In one embodiment, the solid is of a type that does not react with the polymer or solvent. The added solid may have an average diameter of less than about 2 millimeters. In one embodiment, the average diameter of the added solid may be from about 50 micrometers to about 1000 micrometers. The solid may be present in such a quantity that they will account for about 1% to about 50% of the total volume of the particles and the polymer-solvent mixture (where the total volume percentage is equal to 100% by volume).

[0304] Exemplary solids include, for example, demineralized bone for bone repair, calcium phosphate particles, bioglass particles, calcium sulfate or calcium carbonate particles, filterable solids for pore formation, and bioabsorbable natural polymer particles, bioabsorbable synthetic polymers, non-bioabsorbable materials, fine extracellular particles, fine tissue fragments, or any biocompatible material insoluble in solvent systems.

[0305] Exemplary filterable solids include, for example, non-toxic filterable materials such as salts (e.g., sodium chloride, potassium chloride, calcium chloride, sodium tartrate, sodium citrate, etc.); biocompatible monosaccharides and disaccharides (e.g., glucose, fructose, dextrose, maltose, lactose, and sucrose); polysaccharides (e.g., starch, alginate, deacetylated chitosan); and water-soluble proteins (e.g., gelatin and agarose). The filterable material can be removed by immersing a foam containing the filterable material in a solvent in which the particles dissolve sufficiently for a period of time to allow substantially all particles to dissolve. The solvent can be selected so that it does not dissolve or adversely alter the foam. A preferred embodiment may include water as the extraction solvent, such as distilled deionized water. Such a process is further described in U.S. Patent 5,514,378, the entire contents of which are incorporated herein by reference. Preferably, after the dissolution process is complete, the foam is dried at low temperature and / or under vacuum to minimize foam hydrolysis unless accelerated foam absorption is desired.

[0306] Non-bioresorbable materials may include, for example, bio-inert ceramic particles (e.g., alumina, zirconium oxide, and calcium sulfate particles), polymers such as polyethylene, polyvinyl acetate, polymethyl methacrylate, polypropylene, polyethylene terephthalate, silicone, polyethylene oxide, polyethylene glycol, polyurethane, polyvinyl alcohol, natural polymers (e.g., cellulose particles, chitin, and keratin), and fluorinated polymers and copolymers (e.g., fluorides, polytetrafluoroethylene, and hexafluoropropylene). In one embodiment, a solid that will render the tissue implant radiopaque (e.g., barium sulfate) may be added. Those solids that may be added also include those that will promote tissue regeneration or healing, and those that act as buffers, reinforcing materials, or porosity modifiers.

[0307] As described above, polymer foam components may include reinforcing elements. The structure can be manufactured by injecting, pouring, or otherwise placing a suitable polymer solution into a molding apparatus comprising a mold and the reinforcing elements of this disclosure. The molding apparatus can be cooled on a suitable bath or cold storage rack and then freeze-dried to obtain the reinforced structure.

[0308] In embodiments utilizing polymer foam, one or more biological components provided throughout this disclosure may be added before or after the freeze-drying step. Controlling the freezing rate of the polymer-solvent system during the formation of the polymer foam component may be advantageous. The type of pore morphology formed during the freezing step depends on factors such as solution thermodynamics, freezing rate, temperature to which cooling occurs, solution concentration, and whether homogeneous or heterogeneous nucleation occurs. The orientation of the polymer fibers can be adjusted to control pore orientation. For example, the pore orientation in the polymer foam component can be tailored by controlling the temperature gradient induced during freezing cycles. Controlling fiber orientation can lead to improvements in mechanical properties along the fiber orientation direction.

[0309] The general processing steps required for constructs using polymer foam may include selecting appropriate materials for making the polymer foam. Additional processing steps may include selecting materials for reinforcing components to be used. If a mesh-like reinforcing material is used, a suitable mesh density should be selected. Furthermore, the reinforcing material should be properly aligned in the mold, the polymer solution should be added at an appropriate rate, and preferably added to a mold tilted at an appropriate angle to avoid bubble formation, and the polymer solution must be freeze-dried.

[0310] In embodiments utilizing a mesh reinforcement in polymer foam, for example, the reinforcement mesh should be selected to have a certain density. That is, the openings in the mesh should not be so small that they would hinder proper bonding between the foam and the reinforcement mesh when the foam material and its openings and pore walls penetrate the mesh. Without proper bonding, the integrity of the layered structure may be compromised, making the structure brittle and difficult to handle. The mesh density determines the mechanical strength of the structure. The mesh density can vary depending on the intended use of the tissue repair. Furthermore, the type of weave used in the mesh determines the directionality of the mechanical strength of the structure, as well as the mechanical properties of the reinforcement, such as elasticity, stiffness, burst strength, suture retention strength, and ultimate tensile strength of the structure. As a non-limiting example, the mesh reinforcement in the foam-based biocompatible structures of this disclosure can be designed to be rigid in one direction and elastic in another, or alternatively, the mesh reinforcement can be made isotropic.

[0311] In embodiments utilizing a mesh-like reinforcing material within a polymer foam, several parameters and steps during the freeze-drying process of the reinforcing foam can contribute to the fabrication of an implant with the desired integrity and mechanical properties. For example, if a reinforcing material is used, it may be advantageous to keep it substantially flat when placed in a mold. To ensure proper flatness, the reinforcing material (e.g., a mesh) can be flattened using a heated press before being placed into the mold. Furthermore, if the reinforcing structure is not isotropic, it may be desirable to indicate this anisotropy by marking the structure to indicate its orientation. Marking can be achieved by embedding one or more indicators (e.g., staining marks or staining lines) within the fabrication of the reinforcing material. For example, the orientation or direction of the indicators can indicate to the surgeon the size of an implant with superior physical properties.

[0312] In embodiments utilizing polymer foam as described above, the manner in which the polymer solution is added to the mold prior to freeze-drying contributes to the formation of a tissue implant with sufficient mechanical integrity. Assuming a mesh reinforcement material is used and positioned between two thin (e.g., approximately 0.75 mm) pads, the mesh can be positioned at the desired depth in the mold with a substantially flat orientation. The polymer solution can be poured in a manner that allows air bubbles to escape between the layers of the foam component. The mold can be tilted at a desired angle and poured at a controlled rate to adequately prevent air bubble formation. Several variables will control the tilt angle and pouring rate. For example, the mold should be tilted at an angle greater than approximately one degree to avoid air bubble formation. Additionally, the pouring rate should be slow enough to allow any air bubbles to escape from the mold rather than become trapped within it.

[0313] In embodiments utilizing a mesh reinforcement in a polymer foam, the mesh density can be an important factor in forming a structure with the desired mechanical properties. For example, low-density or open-cell knitted mesh materials can be used. An example of such a material is a 90:10 copolymer of glycolide and lactide sold under the trade name VICRYL, available from Ethicon, Somerville, New Jersey. An exemplary low-density open-cell knitted mesh is KnittedVICRYL VKM-M, also available from Ethicon, Somerville, New Jersey. Other materials may include, but are not limited to, polydioxanone and blends of 95:5 copolymers of lactide and glycolide.

[0314] In embodiments utilizing polymer foam, through-holes can be formed by placing rods within the polymer foam solution / slurry before it solidifies. The rods can be removed after the polymer foam has formed. For example, if the polymer foam is made by freeze-drying, the rods are removed after a cycle of freeze-drying and vacuum drying. The rods can have any desired shape.

[0315] The polymer foam component may optionally comprise one or more layers made of the materials described above. In one embodiment, the foam component can be integrated with the material by forming pores in the material, and then the polymer foam component penetrates the pores formed in the material and interlocks with the material. In another embodiment, pores are formed in both material layers, and the two layers are placed together to fully align the pores. The bilayer assembly can be placed in a polymer solution or slurry, and the polymer foam can be formed by one of the methods provided herein or other methods known to those skilled in the art.

[0316] In some embodiments, the structure may be formed of an expansion medium that advantageously provides additional compression at the repair site. A non-limiting example of such a structure 2910 is shown below. Figure 29AAs shown, the structure is a patch or support (described in more detail below). For example, structure 2910 may be formed from a fabricated or woven mesh having a core 2904 surrounded or sandwiched between two layers 2902a, 2902b. The two layers 2902a, 2902b may be referred to as jackets. The core 2904 may be made of a variety of expandable materials, such as salt-loaded silicone, sodium polyacrylate, polyacrylamide copolymers, polyurethane, and other absorbent polymers and hydrogels, while the jackets 2902a, 2902b may be more rigid so that the core can press against the jackets when the core expands during use. Non-limiting exemplary materials that can be used to form jackets 2902a, 2909b include fabrics and filaments, such as polyethylene, polypropylene, polyester, polyethylene terephthalate, nylon, polyurethane, and silk. Other non-limiting exemplary materials that may be used to form jackets 2902a and 2902b include bioabsorbable materials such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), copolymers or blends thereof. Some materials that may be used in conjunction with the structure include, but are not limited to, those disclosed and provided in U.S. Patent 8,870,915 entitled “Joining Element,” the entire contents of which are incorporated herein by reference. Structure 2910 may have a length L P and thickness T P ,like Figure 29A As shown, the structure may include at least one suture branch 2911 to attach the structure to one or more repair sites. In the example shown, the structure 2910 includes four suture branches 2911, 2912, 2913, and 2914 associated with it. The branches may be formed from the same or different sutures.

[0317] In use, such as Figure 29BAs shown, the construct 2910 can be placed on the repair sites 2938a, 2938b, and suture branches 2911, 2912, 2913, 2914 can be secured to the corresponding anchors 2961, 2962, 2963, 2964. As with other disclosures, the repairs associated with the repair sites 2938a, 2938b can be any type of repair provided herein or known to those skilled in the art. The construct 2910 can be further attached to a location inside the repairs 2938a, 2938b using sutures, staples, or other devices and components for fixing to bone tissue. As shown, sutures 2940a-2940c provide fixation. The construct 2910 can be exposed to an aqueous solution, for example, after installation, so that the silicone and salt-filled core can absorb fluid, causing the construct to expand in at least one dimension and contract in at least one other dimension based on the configuration of the construct 2910. In the example shown, the expansion results in a thickness T of the construct 2910. P Increase, while in its length L P The upper part contracts and decreases. The length L after installing structure 2910 P The reduction in the core can increase the compressive force on the soft tissue 2930, allowing for more uniform contact between the tissue and bone 2950. This is at least in part due to the limited space available for fixing the structure 2910, the configuration of the structure 2910, and the surface geometry of the attachment site. Those skilled in the art will understand that configurations of structures having a core capable of expansion and being sandwiched between layers or jackets can be used in conjunction with other structure configurations provided herein, including those not necessarily patches or scaffolds, to provide additional compressive force at the repair site. Further discussion of tissue-reinforcing patches and scaffolds is provided below.

[0318] Unless otherwise specified, any material and any technique used to form the material may be used in conjunction with any of the structures provided herein. This includes any combination of materials. Similarly, the manufacturing techniques disclosed in this invention are generally applicable to or suitable for forming the various structures provided herein. The use of materials and manufacturing techniques for various tissue-reinforcing structures is within the spirit of this disclosure.

[0319] Tissue-enhancing structures - tissue-enhancing patches

[0320] Tissue-reinforcing constructs can also appear in the form of patches or scaffolds, which can be associated with one or more branches of a suture to increase the coverage area of ​​said one or more branches and provide additional surface areas on which forces are distributed, as well as other benefits set forth throughout this disclosure, such as enhancing the healing of other damaged tissues and / or providing body for other damaged or degenerated tissues and / or tendons. Patches can be placed on or even attached to sutures, rather than simply sitting on top of surgical sutures. Furthermore, the patch can be delivered to the surgical site and threaded onto the suture using the suture threader described herein, thereby eliminating the need for extensive suturing at each edge of the patch. A variety of different techniques can be used to associate the illustrated patch with the suture, including threading the suture through the patch and / or placing the suture between layers of the scaffold. The patch can be placed near the surgical site, as described above. Methods for manufacturing scaffolds or patches, and methods for mounting various scaffolds and patches, are also provided below. The systems and methods disclosed herein allow for rapid, simple, and cost-effective techniques to prevent tissue damage from tensioned sutures. Similar to the other constructs described above, surgeons can apply patches as needed to form the desired suture coverage area for repair. Those skilled in the art will recognize that the disclosure provided herein relates to tissue reinforcement blocks, and, for example, by way of non-limiting example, materials used to form constructs such as tissue reinforcement blocks 10, 110, 3010, 3110, 310, 410, etc., can be applied to the patches discussed below.

[0321] exist Figure 30A and Figure 30B An exemplary embodiment of a tissue-reinforcing structure 2210 with a patch or support configuration is provided. As shown, the tissue-reinforcing patch 2210 has a rectangular body and may be disposed on or otherwise associated with suture branches 2212a, 2212b. In the illustrated embodiment, the patch 2210 includes holes or lumens 2214a, 2214b formed in the body and extending from the nearest end 2210p through it to the farthest end 2210d. The holes 2214a, 2214b can be used, for example, to receive suture branches 2212a, 2212b, such that the patch 2210 and branches 2212a, 2212b can be associated with each other. Figure 30B As shown, patch 2210 can be pre-threaded using suture threaders 2206a and 2206b. Threaders 2206a and 2206b have similar properties to threader 206' and can be constructed in a manner similar to threader 206 or in a manner known to those skilled in the art and / or available in this disclosure. As shown, patch 2210 has a width W substantially equal to... P Length L P And it also has a thickness T PIn addition, thickness T P It can be larger than the diameter of the filaments or sutures associated with the tissue reinforcement patch 2210, such as the suture branch 2212a.

[0322] Those skilled in the art will recognize that the length L of the tissue-enhancing patch 2210 P Width W P and thickness T P The dimensions of the holes 2214a and 2214b can depend on a variety of factors, including, but not limited to, the size of the associated filament, the patient's anatomy, and the type of surgery being performed. Some exemplary non-limiting dimensions for the tissue-enhancing patch 2210 may be useful in understanding this disclosure.

[0323] In some implementations, the length L P It can cover a considerable portion, encompassing almost the entire length of the tissue extending between the stitches formed within the tissue and the bone anchors used to help fix the tissue in place. In some embodiments, the length L... P and width W P It can range from approximately 10 mm to approximately 50 mm, and the thickness T P The diameter can range from approximately 0.5 mm to approximately 5 mm. The diameter of holes 2214a and 2214b can also depend on various factors, including but not limited to the size of the branch to be passed through. In some embodiments, the diameter can range from approximately 0.5 mm to approximately 3 mm.

[0324] Various techniques known to those skilled in the art can be used to associate patch 2210 with suture branches 2212a, 2212b. Suture branches 2212a, 2212b can pass from the nearest end 2210p to the farthest end 2210d of patch 2210 without passing through the body of patch 2210, i.e., without passing through the sidewalls of defining holes 2214a, 2214b. Therefore, patch 2210 can freely pass along the length of branches 2212a, 2212b without obstruction or restriction. In other embodiments, branches 2212a, 2212b can pass through the body once or multiple times, for example, similar to... Figure 1BThe illustrated strip or band 10 is used to further secure the patch 2210 relative to the branches 2212a, 2212b. In other embodiments, the branches 2212a, 2212b may extend from the nearest end 2210p through the body to the farthest end 2210d, entering and exiting the body only once, for example when holes 2214a, 2214b are not provided. Of course, the branches 2212a, 2212b do not necessarily have to extend all the way to the nearest or farthest ends 2210p, 2210d, but may enter and / or exit the patch 2210 at some other location in their surface area. Those skilled in the art will recognize that the patch 2210 may be associated with the branches 2212a, 2212b in various other ways without departing from the spirit of this disclosure.

[0325] The tissue-reinforcing patch 2210 can be manually passed through suture branches 2212a and 2212b at the surgical site or outside the body. Alternatively, as... Figure 30B As shown, suture threaders 2206a and 2206b are operable to associate suture branches 2212a and 2212b with patch 2210, operating similarly to suture threaders 206 or 206' described above, and thus include proximal shank portions 2208a and 2208b, intermediate elongated portions 2207a and 2207b, and distal suture receiving ends 2209a and 2209b. Therefore, as shown by passing the intermediate elongated portions 2207a and 2207b through lumens 2214a and 2214b, tissue-reinforcing patch 2210 can be associated with the intermediate elongated portions 2207a and 2207b, and branches 2212a and 2212b can be connected to the distal suture receiving ends 2209a and 2209b. The proximal shank portions 2208a and 2208b can be grasped and pulled away from the tissue-reinforcing patch 2210 to push the branches 2212a and 2212b toward and into the patch 2210. After the patch 2210 is successfully associated with the branches 2212a and 2212b, the threaders 2206a and 2206b can be deassociated with the branches 2212a and 2212b and the tissue-reinforcing patch 2210, and can be discarded or reused.

[0326] Similar to the previously described tissue-reinforcing strips, associating the tissue-reinforcing patch 2210 with suture branches 2212a, 2212b increases the coverage area of ​​the suture branches 2212a, 2212b and allows the forces applied to the tissue through the suture branches 2212a, 2212b to be distributed over a large surface area (i.e., the surface area of ​​the patch 2210). This increased force distribution of the tissue-reinforcing patch 2210 can result in a reduction in peak pressure on the soft tissue. In cases of soft tissue degeneration due to injury or age, increased tissue surface area coverage and reduced pressure may reduce the chance of tissue abrasion. Furthermore, the larger surface area of ​​the tissue-reinforcing patch 2210 provides a larger scaffold for new tissue to develop during repair, further reinforcing the repair site. The greater tissue coverage provided by the patch 2210 can promote the healing of otherwise damaged tissue and / or provide a body for otherwise damaged or degenerated tissue and / or tendons.

[0327] Methods for manufacturing tissue-reinforced structures - tissue-reinforced patches

[0328] The tissue-reinforcing patch 2210 can be manufactured using a variety of different techniques, some of which have been discussed above with respect to tissue-reinforcing blocks 10 and 110. In one exemplary embodiment of manufacturing the tissue-reinforcing patch, such as… Figures 30C to 30E As shown, the material used to make patch 2210 can be harvested or collected using techniques known to those skilled in the art. The material can then be shaped using any of the techniques described above, such as those described with respect to strip 10, or other techniques known to those skilled in the art according to this disclosure. A material with a length L can be harvested. P Width 2W P Thickness 1 / 2T P Material component. Width 2W P It can be the width W obtained from patch 2210 P Twice the size, and 1 / 2T thick P It can be half the thickness of the resulting patch 2210. For example... Figure 30D As shown, the material component 2220 may have a first end 2220a and a second end 2220b, with an extension width of 2W between them. P Alternatively, material 2220 may have any shape.

[0329] Once the material part 2220 is cut out, the two pins 2222A and 2222b can be placed on the same side of the material, respectively, at a distance of width 2W from the first end and the second end 2220A and 2220B. P One-quarter of it. The two ends 2220a, 2220b can be folded onto corresponding pins 2222a, 2222b, brought close to each other, and subsequently attached to each other to form patch 2210. As... Figure 30C and Figure 30D As shown, four rows of stitches 2224a-2224d can be sewn into the folded patch, making them substantially parallel to each other. Furthermore, the first and fourth stitches 2224a and 2224d can be positioned substantially parallel to and close to pins 2222a and 2222b, respectively. Additionally, stitches 2224a and 2224d can form two lumens 2214a and 2214b that are kept open by pins 2222a and 2222b. After suturing is completed, pins 2222a and 2222b can be removed, leaving patch 2210, as shown. Figure 30E As shown. Alternatively, pins are not required to manufacture patch 2210. The second and third stitches 2224b, 2224c can be positioned substantially parallel to and close to the two ends 2220a, 2220b. Further alternatively, instead of stitches, material 2220 can be secured by using adhesives, collagen binders, staples, light curing, or other techniques known to those skilled in the art and provided herein for attaching soft tissue to soft tissue. In embodiments including threaders pre-positioned in patch 2210, threaders 2206a, 2206b can be inserted into lumens 2214a, 2214b before or after attaching the two ends 2220a, 2220b. Similar to other constructions provided herein, patch 2220 can be dried for packaging at any suitable point during the manufacturing process.

[0330] Alternative methods for manufacturing patch 2210 may include harvesting a material having a length L P Width W P and thickness T P A harvestable material component. Material component 2220 may have a first end 2220a and a second end 2220b, with a width W extending therebetween. P A first pin 2222a may be inserted or pierced into material 2220 near and parallel to the first end 2220a to form a first lumen 2214a. A second pin 2222b may be inserted or pierced into material 2220 near and parallel to the second end 2220b to form a second lumen 2214b. In another alternative, a core tube may be used instead of pins 2222a and 2222b, as described above regarding... Figures 26A to 26I The patch 2210 may be made of any of the materials described above with respect to blocks 10, 110, 3010, 3110, 310, and 410, as well as any other constructions described above. Furthermore, the patch 2210 may have any shape, including rectangular, trapezoidal, oval, circular, square, pentagonal, hexagonal, octagonal, etc.

[0331] Another alternative method for manufacturing patch 3320 may include using a parallel fabrication tunnel station 3300, similar to... Figures 27A to 27M Tunnel work positions 3200 and 3200'. For example... Figure 31A As shown, platform 3320 can accommodate a larger length L of material 3330. For example, as Figure 31A As shown, platform 3320 can accommodate two patch structures 3310a and 3310b. Alternatively, platform 3320 can be extended to accommodate any number of structures. Similar to the platform of tunnel station 3200, platform 3320 may have multiple semi-circular reliefs that can be aligned with lumen forming tools 3324a, 3324b, 3324c, and 3324d, and platform 3320 may be self-centered.

[0332] Similar to Figures 27A to 27M Tunneling stations 3200 and 3200', and tunneling station 3300 may include a plurality of lumen-forming tools 3324a, 3324b, 3324c, and 3324d. In the illustrated embodiment, lumen-forming tools 3324a and 3324b form a first station 3323a, and lumen-forming tools 3324c and 3324d form a second station 3323b. As shown, lumen-forming tools 3324a and 3324b may be offset from each other at an angle, for example, by about 30 degrees. In one embodiment, lumen-forming tools 3324a and 3324b may be offset from each other at an angle of about 16 degrees. The lumen-forming tools 3324c and 3324d of the second station 3323b may similarly be offset from each other, or alternatively, may be offset at different angles. The second station 3323b can be located on the opposite side of the platform 3320 from the first station 3323a, thereby providing easier parallel lumen formation. In an alternative embodiment, each of the lumen forming tools 3324a, 3324b, 3324c, 3324d can be aligned parallel to each other. The lumen forming tools 3324a, 3324b, 3324c, 3324d can be aligned such that each of the corresponding cutting tools 3322a, 3322b, 3322c, 3322d can be translated toward the platform to form lumens 3314a, 3314b, 3314c, 3314d in the material 3330. In the illustrated embodiment, two lumen forming stations 3323a, 3323b are shown, but any number of lumen forming stations can also be provided.

[0333] After each of the lumen-forming tools 3324a, 3324b, 3324c, and 3324d is actuated and retracted to form cavities 3314a, 3314b, 3314c, and 3314d in the material 3330, the material 3330 can be advanced in direction D, such as... Figure 31AAs shown. The individual structures 3310a, 3310b, and 3310c can then be separated by punches 3190a-3190c or by other cutting mechanisms provided throughout this disclosure or known to those skilled in the art. The resulting structures 3310a, 3310b, 3310c, and 3310d are shown in... Figure 31B and Figure 31C In this process, the resulting patches 3310a, 3310b, 3310c, and 3310d have a generally trapezoidal shape. Those skilled in the art will recognize that any number of patch shapes can be formed according to this disclosure. For example, lumen forming tools 3324a, 3324b, 3324c, and 3324d can be parallel to each other to form patches with parallel lumens and rectangular shapes.

[0334] Usage Instructions - Tissue Reinforcement Patch

[0335] An exemplary method for installing tissue enhancement patch 2210 is shown in Figure 30F The method shown provides a piece of soft tissue 2230, such as a rotating sleeve, fixed to bone 2250. Single-row or double-row repairs can be used. Once the surgeon has entered the surgical site and prepared the tissue, bone, and tissue-reinforcing patch according to recognized surgical techniques (including those provided herein), the surgeon can perform tissue repair (which is not visible because it is located beneath patch 2210) according to recognized surgical techniques. Figure 30F As shown, a suture 2212 extending from an anchor (not shown) in the repair is installed from the repair into the tissue 2230, such that two suture branches 2212a and 2212b extend from the tissue 2230.

[0336] The tissue-reinforcing patch 2210 can be threaded onto the suture branches 2212a, 2212b using the techniques provided throughout this disclosure, and subsequently advanced along the respective suture branches 2212a, 2212b until it approaches the medial suture 2242. After the tissue-reinforcing patch 2210 is attached to the suture branches 2212a, 2212b, the free end of each suture branch 2212a, 2212b can be secured to the body. For example, the free end of each suture branch 2212a, 2212b can be connected to the corresponding anchors 2260a, 2260b via a lateral fixation method. The suture branches 2212a, 2212b can then be tightened to secure the patch 2210 against the repair before the anchors 2260a, 2260b are fully secured to the bone 2250.

[0337] The tissue-reinforcing patch 2210 provides greater coverage for the suture branches 2212a and 2212b and a larger surface area to distribute the load of the suture branches 2212a and 2212b onto the soft tissue 2230. As the patient heals from surgery, the patch can remodel into tendon-like tissue and integrate with the underlying natural tissue. The additional coverage of the tendon-like tissue on the soft tissue increases the strength of the soft tissue-bone connection and can prevent further injury.

[0338] exist Figures 30G to 30I Another exemplary method for installing the tissue-reinforcing patch 2210' is provided, this time illustrating the use of a double-row repair material, such as a rotating sleeve, to secure a piece of soft tissue 2230' to bone 2250'. Once the surgeon has entered the surgical site and prepared the tissue, bone, and tissue-reinforcing patch according to recognized surgical techniques (including those provided herein), the surgeon can install the first and second medial anchors 2260a', 2260b' in the bone 2250'. The first and second medial anchors 2260a', 2260b' have associated sutures 2212', 2216'. Figure 30G As shown, sutures 2212' and 2216' may have suture branches 2212a', 2212b' and 2216a', 2216b' extending from the respective anchors 2260a' and 2260b', wherein the branches pass through tissue 2230', for example, using one or more inner needles 2242a', 2242b'.

[0339] The patch 2210' may have similar characteristics to patch 2210 and can be inserted into suture branches 2212a' and 2216a' using the techniques provided in this disclosure. The patch 2210' can then be advanced in direction D1 along the corresponding suture branches 2212a' and 2216a', as... Figure 30H As shown, until it approaches the inner stitches 2242a', 2242b'. After attaching patch 2210' to suture branches 2212a', 2216a', the free ends of each suture branch 2212b', 2216b' can be placed on patch 2210' in an X or cross configuration, as shown. Figure 30IAs shown. Then, suture branches 2212a' and 2216b' can be installed into the lateral anchor 2262a', and suture branches 2212b' and 2216a' can be installed into the lateral anchor 2262b' in a lateral fixation manner. The suture branches 2212a', 2212b', 2216a', and 2216b' can then be tightened to fix the soft tissue 2230' to the bone 2250' before the lateral anchors 2262a' and 2262b' are fully fixed into the bone 2250'. The same benefits described above regarding the method of using patch 2210 also apply to this embodiment using patch 2210'. Furthermore, the crisscrossing nature of the suture configuration provides additional stability for holding the tissue 2230' relative to the bone 2250' in the desired position.

[0340] Another exemplary embodiment of “installing tissue enhancement patch 2210” is shown in Figures 30J to 30L In, and can be related to the above about Figures 30F to 30I The described single-row or double-row repairs are used together. The patch 2210” shown has been threaded onto suture branches 2212a”, 2216a” according to the technique provided throughout this disclosure. The method shown forms collapsible collars 2212l”, 2216l” and associated knots 2270a”, 2270b” disposed on the distal end 2210d” of the patch 2210”. The collapsible collars 2212l”, 2216l” and associated knots 2270a”, 2270b” may be formed on the respective suture branches 2212a”, 2216a” after the suture branches have passed through the patch 2210”. In one exemplary embodiment, the knots may be, for example, slip knots, figure-eight knots, or finger catchers, as well as other knot types. Knots 2270a” and 2270b” may be larger than the associated lumen, and suture branches 2212a” and 2212b” pass through the lumen, so that knots 2270a” and 2270b” cannot be pulled through. Knots 2270a” and 2270b” may be formed after patch 2210” is advanced in direction D1 until it approaches soft tissue 2230”.

[0341] After forming the collars 2212l” and 2216l”, the suture branch 2216b” can be guided through the collar 2212l”, and the suture branch 2212b” can be guided through the collar 2216l”, as shown. Figure 30KAs shown. Once the suture branches 2212b” and 2216b” pass through the suture loops 2212l” and 2216l”, the suture branches advantageously maintain the desired configuration. Then, the suture branches 2212a” and 2216b” can be installed into the lateral anchor 2262a”, and the suture branches 2212b” and 2216a” can be installed into the lateral anchor 2262b” in a side-mounted fixing manner. At this time, the collapsible loops 2212l” and 2216l” can collapse by applying force to the suture branches 2212a” and 2216a”, thereby fixing the suture branches 2212b” and 2216b” as shown. Figure 30K and Figure 30L The X or cross configuration is shown. The suture branches 2212a”, 2212b”, 2216a”, 2216b” can then be tightened to secure the soft tissue 2230” to the bone 2250” before the lateral anchors 2262a”, 2262b” are fully secured to the bone 2250”. One benefit of the knots 2270a”, 2270b” and the collars 2212l”, 2216l” is that they prevent the patch 2210” from sliding laterally toward the anchors 2262a”, 2262b” and being secured relative to the bone 2250” and 2230”. By causing the loops 2212l” and 2216l” to collapse around the suture branches 2212a”, 2212b”, 2216a”, and 2216b”, unintentional slippage of the patch 2210” relative to the suture branches 2212a”, 2212b”, 2216a”, and 2216b” can be prevented. The loops and knots can be advantageously applied to any of the constructions provided herein to prevent lateral slippage and to retain the construction after implantation, including but not limited to tissue-reinforcing blocks and tissue-reinforcing patches.

[0342] Tissue-reinforcing constructs - additional tissue-reinforcing patches, their application methods and manufacturing methods

[0343] Another exemplary embodiment of the tissue reinforcement structure 2310 with patch or brace type is shown in Figure 32A As shown in the figure, the tissue-reinforcing patch 2310 has a rectangular body and is generally similar in nature and construction to the tissue-reinforcing patch 2210. The difference with patch 2310 is that it includes additional lumens 2314a-2314d extending from the proximal end 2310p to the distal end 2310d, to house suture threaders 2306a-2306d, and thus, after operation of suture threaders 2306a-2306d, suture branches 2312a, 2312b, 2316a, 2316b. Optionally, suture threaders 2306a-2306d may be omitted, and suture branches 2312a, 2312b, 2316a, 2316b may be associated with patch 2310 using any techniques provided herein or known to those skilled in the art. Figure 32A As shown, lumens 2314a and 2314d may be substantially parallel to the side of patch 2310 extending between the nearest end surface 2310p and the farthest end surface 2310d, and lumens 2314b and 2314c may form a generally X-shaped or cross configuration. When threaders 2306a and 2306b are associated with patch 2310 in the illustrated embodiment, or in other embodiments of a patch having two threaders associated therewith as shown herein, the middle portion 2307a of the first threader 2306a may be located closer to the first side surface 2310a of patch 2310 than the second opposing side surface 2310b of patch 2310, and the middle portion 2307b of the second threader 2306b may be located closer to the second side surface 2310b than the first side surface 2310a. When threaders 2306c and 2306d are also associated with patch 2310, the middle portion 2307c of the third threader can be diagonally positioned relative to patch 2310, such that the distal receiving end 2309c of the third threader 2306c is close to the distal receiving end 2309a of the first threader 2306a, and the proximal handle 2308c of the third threader 2306c is close to the proximal handle 2308b of the second threader 2306b. Similarly, the middle portion 2307d of the fourth threader can be diagonally positioned relative to patch 2310, such that the distal receiving end 2309d of the fourth threader 2306d is close to the distal receiving end 2309b of the second threader 2306b, and the proximal handle 2308d of the fourth threader 2306d is close to the proximal handle 2308a of the first threader 2306a.

[0344] Those skilled in the art will recognize that in any embodiment in which multiple sutures are used in conjunction with the structure, the positions of the proximal and distal ends of the sutures may differ from those in the illustrated embodiments, depending at least in part on the type of surgery being performed, the components used to perform the surgery, and the user's preferences. Therefore, in any illustrated embodiment, the positions of the proximal and distal ends of the sutures may be manipulated in other embodiments. Furthermore, in any of the illustrated embodiments, the position of any suture relative to the tissue-reinforcing structure before the suture is associated with the tissue-reinforcing structure using the suture is considered a pre-installed configuration, and after the suture has been used to associate the suture with the tissue-reinforcing structure and subsequently removed, such a configuration is considered a post-installation configuration.

[0345] As shown in the figure, patch 2310 has a width W that is substantially equal to the width W. P The length L of ′ P ′, and it also has a thickness T P In addition, thickness T PThe diameter may be larger than that of the filament or suture associated with the tissue reinforcement patch 2310, such as suture branch 2312a. In other embodiments, suture branches 2312a, 2312b, 2316a, 2316b may extend through lumens 2314a-2314d without necessarily being positioned within lumens 2314a-2314d using a threader. Branches 2312a, 2312b, 2316a, 2316b may extend in the same mixed parallel and cross configuration shown and described with respect to the position of threaders 2306a-2306d.

[0346] Those skilled in the art will recognize that the length L of the tissue-enhancing patch 2310 P ′, width W P ′ and thickness T P The dimensions of the patch 2310 and the diameters of the holes 2314a-2314d can depend on various factors, including but not limited to the size of the associated filaments, the patient's anatomy, and the type of surgery being performed. Alternatively, the patch 2310 can have any other shape (e.g., rectangular, trapezoidal, oval, circular, square, pentagonal, hexagonal, octagonal, etc.), and the lumens 2314a-2314d can follow any path (e.g., they can follow an edge). The exemplary, non-limiting dimensions of the patch 2210 provided above are also applicable to the size of the patch 2310, and it is understood that other dimensions are possible. Similarly, various techniques known to those skilled in the art can be used to associate the patch 2310 with suture branches 2312a, 2312b, 2316a, 2316b, and the techniques described above with respect to patch 2210 can be adapted for use in conjunction with patch 2310. Therefore, based on this disclosure, those skilled in the art will understand how to operate the threaders 2306a-2306d to associate the suture branches 2312a, 2312b, 2316a, 2316b with the patch 2310.

[0347] exist Figures 32B to 32E An exemplary method for installing patch 2310 is provided. The method shown provides a piece of soft tissue 2330, such as a rotating sleeve, fixed to bone 2350. Single-row or double-row repairs can be used. Once the surgeon has entered the surgical site and prepared the tissue, bone, and tissue-reinforcing patch according to recognized surgical techniques (including those provided herein), the surgeon can perform single-row repairs 2340a, 2340b of tissue 2330 according to recognized surgical techniques. Alternatively, tissue 2330 can be repaired once, or more than twice. Figure 32CAs shown, the first suture 2312 can be inserted medially into the tissue 2330 from the repair materials 2340a and 2340b, such that two suture branches 2312a and 2312b extend from the tissue 2230. Similarly, the second suture 2316 can be inserted medially into the tissue 2330 from the repair materials 2340a and 2340b, such that two suture branches 2316a and 2316b extend from the tissue 2230. In the illustrated embodiment, the sutures 2312 and 2316 are inserted into the tissue 2330 using mattress sutures 2342a and 2342b, respectively, but other sutures may also be used.

[0348] like Figure 32D As shown, using the techniques provided in this disclosure, such as operating threaders 2306a-2306d, suture branches 2312a, 2312b, 2316a, and 2316b are respectively inserted into lumens 2314a-2314d, and the patch 2310 can be advanced along the corresponding suture branches 2312a, 2312b, 2316a, and 2316b until the proximal end 2310p approaches the inner stitches 2342a and 2342b. After the patch 2310 is installed onto the suture branches 2312a, 2312b, 2316a, and 2316b, the free end of each suture branch 2312a and 2316b can be secured within the body. For example, as... Figure 32E As shown, the free ends of each suture branch 2312a, 2316b and 2312b, 2316a can be connected to the lateral anchors 2362a and 2362b respectively in a lateral fixation manner. The suture branches 2312a, 2312b, 2316a, 2316b can then be tightened to secure the patch 2310 against the repair 2340 before the lateral anchors 2360a, 2360b are fully fixed into the bone 2350.

[0349] exist Figures 32F to 32H Another exemplary method for mounting a tissue-reinforced patch 2310' is provided, this time illustrating the use of a double-row repair material, such as a rotating sleeve, to secure a piece of soft tissue 2330' to bone 2350'. Once the surgeon has entered the surgical site and prepared the tissue, bone, and patch according to recognized surgical techniques (including those provided herein), the surgeon can install a first medial anchor and second medial anchors 2360a', 2360b' in bone 2350'. The first medial anchor and second medial anchors 2360a', 2360b' have associated sutures 2312', 2316'. Figure 32FAs shown, sutures 2312' and 2316' may have suture branches 2312a', 2312b' and 2316a', 2316b' extending from the respective anchors 2360a' and 2360b', wherein the branches pass through tissue 2330', for example, using one or more inner needles 2342a', 2342b'.

[0350] The patch 2310' may have similar characteristics to patch 2310 and may be inserted into the suture branches 2312a', 2312b', 2316a', 2316b' using the techniques provided in this disclosure. The patch 2310' may then be advanced along the suture branches 2312a', 2312b', 2316a', 2316b' until the proximal end 2310p' approaches the inner sutures 2342a', 2342b', as shown below. Figure 32G and Figure 32H As shown. After patch 2310' is installed onto suture branches 2312a', 2312b', 2316a', 2316b', the free ends of each of suture branches 2312a', 2316b' and 2312b', 2316a' can be laterally fixed to the corresponding lateral anchors 2362a' and 2362b'. The suture branches 2312a', 2312b', 2316a', 2316b' can then be tightened to secure patch 2310' against the repair 2340' before the lateral anchors 2360a', 2360b' are fully fixed into the bone 2350'. The same benefits described above regarding the method of using patch 2210' also apply to embodiments using patches 2310 and 2310', including the benefits derived from the cross-hatching nature of the suture configuration. The additional benefits of these two embodiments will also be apparent to those skilled in the art based on this disclosure.

[0351] Patch 2310 can be manufactured using a variety of different techniques, some of which have been discussed above at least with respect to tissue reinforcement blocks 10, 110, and other constructs. Patch 2310, and therefore patch 2310', can be made from any of the materials provided above with respect to tissue reinforcement blocks 10, 110, 3010, 3110, 310, and 410 and / or other constructs described above. In one exemplary embodiment of patch fabrication, such as Figure 32I and Figure 32J As shown, the material used to make patch 2310 can be harvested or collected using the same techniques described above regarding patch 2210. For example... Figure 32I As shown, the material part 2320 may have a first end 2320a and a second end 2320b, with an extension width of 2W between them. P Alternatively, material 2320 may have any shape.

[0352] Once the material part 2320 is cut out, the two ends 2320a and 2320b can be respectively positioned at a distance of 2W from the first end and the second end 2320a and 2320b. P Approximately one-quarter of the '' is folded up, and the pieces are brought close together and then attached to each other to form patch 2310. (See also...) Figure 32J As shown, patches 2310 are stitched together to form a folded patch. Stitches 2324a-2324d are performed such that two parallel lumens 2314a, 2314b are combined with X-shaped lumens 2314c, 2314d to form a folded patch. The first stitch 2324a may be substantially V-shaped, with its ends located at the farthest end 2310d of patch 2130, and the apex of the V-shape pointing towards the nearest end 2310p of patch 2130. The second stitch 2324b may be substantially V-shaped, with its ends located at the farthest end 2310p of patch 2130, and the apex of the V-shape pointing towards the nearest end 2310d of patch 2130. The third and fourth stitches 2324c, 2324d may be substantially triangular in shape and may be substantially mirror images of each other to define lumens 2314a, 2314d. Alternatively, pins can be placed along lumens 2314a-2314d to position the patch 2310, which can then be sewn together to form the patch 2310. Once the patch is formed, the pins can be removed. Further alternatively, instead of stitches, material 2320 can be secured to itself using adhesives, collagen binders, staples, light curing, or other techniques known to those skilled in the art and provided throughout this disclosure for attaching soft tissue to soft tissue.

[0353] In embodiments including threaders pre-installed in patch 2310, threaders 2306a-2306d can be inserted into lumens 2314a-2314d before or after attaching the two ends 2320a, 2320b. Patch 2320 can be dried for packaging at any suitable point during the manufacturing process. Other alternatives for forming patch 2310 according to this disclosure include, but are not limited to, harvesting material and piercing or punching it with a pin to form lumens 2314a-2314d, as at least regarding Figures 30C to 30E The aforementioned, and / or the use of a core sampling device or tube to form lumens 2314a-2314d, as at least regarding Figures 26A to 26I As stated above.

[0354] Further configurations of the patch and sutures are within the scope of this disclosure. Configurations can be obtained by adjusting various parameters or variables provided and discussed throughout this application. Some parameters or variables that can be changed to provide various configurations include: (1) the number of layers used to form the patch (e.g., one layer, two layers); (2) the orientation of the first set of suture branches relative to each other and the patch (e.g., passing through the patch with branches not intersecting, or passing through the patch with branches intersecting); (3) the position of the second set of suture branches relative to the patch (e.g., on top of the patch, passing through the patch); (4) the orientation of the second set of suture branches relative to each other and the patch (e.g., passing through the patch with branches not intersecting, or passing through the patch with branches intersecting). (5) The first set of suture branches includes one or more “stitches”, referred to herein as “loops” and “concave-convex”, to secure the patch relative to at least one suture branch; (6) Whether the second set of sutures is disposed in a lumen formed in the patch; (7) Whether additional sutures (e.g., medial central suture, lateral central suture) are provided; and (8) The position of the first set of suture branches relative to the second set of suture branches (e.g., inside the second set of suture branches, outside the second set of suture branches).

[0355] Figures 33A to 33E A small sample of patch configurations is shown, illustrating options for the parameters or variables listed above. Some configurations may be better than others at facilitating patch delivery and / or attachment to soft tissue. Those skilled in the art will understand that various parameters can be mixed and matched to obtain a large number of configurations, many of which are not explicitly shown herein, but can be more generally derived from an understanding of each of the variables and constructs disclosed herein. To aid in understanding some of the options associated with the parameters listed above, each parameter is discussed in more detail below with a limited number of exemplary configurations shown. However, it is contemplated that this disclosure covers every discrete combination of parameters combined with the many different patch configurations provided herein. Additionally, similar reference numerals are used for… Figures 33A to 33E Each example shown is interchangeable because the parameters for using the same material in various configurations (e.g., patches, sutures, and anchors).

[0356] One parameter that can be changed to achieve various patch configurations is the number of layers forming each patch. For example, each patch may include a single material layer with a lumen formed in a monolayer for placing suture branches passing through it, such as... Figures 26D to 26F , Figure 30A , Figure 30B and Figures 31A to 31CAs shown. A single layer may include a tissue-facing surface or tissue-joining surface (also referred to herein as the bottom side 3410d of patch 3410) and a second surface opposite to the tissue-facing surface (e.g., in...). Figures 33A to 33E The visible surface (also referred to herein as the top side 3410p of patch 3410). Alternatively, each patch may comprise two or more layers of material sutured together to form a single patch, wherein a lumen is formed between the two or more layers for placing suture branches passing through therethrough, such as Figures 32A to 32J As shown. When a second layer is used, each layer includes a tissue-facing surface and a second surface opposite to the tissue-facing surface. In such an embodiment, the tissue-facing surface of the patch is formed by the tissue-facing surface at the bottom or more distal side of the patch, and the second surface opposite to the tissue-facing surface of the patch is formed by the second surface at the top or more proximal side of the patch. Even in patches comprising multiple layers, lumens can be formed in a single layer. In embodiments where the patch comprises two layers, sutures can be formed as shown in the reference. Figures 32A to 32J The lumen is described. For simplicity, the first set of suture branches 3412, 3414 and the second set of suture branches 3416, 3418 will be referred to in the following discussion, but a single set may also be used. As described above, in embodiments using two material layers, each layer can be formed of different materials to provide various advantages, including but not limited to: the overall thickness of the patch configuration can be unrestricted by biological origin, the level of cell activity can be controlled (e.g., a highly tissue-integrated layer on the tissue-facing side and an adhesion-barrier layer on the opposite side), and other material properties between the layers can be modified (e.g., toughness, bio / synthetic, thick / thin, high / low porosity, etc.).

[0357] like Figure 33A As shown, two inverted mattress sutures 3440a and 3440b can be formed in soft tissue, inside any restoration (not shown). More specifically, a first suture 3411a can be used to form a first inverted mattress suture 3440a, and a second suture 3411b can be used to form a second inverted mattress suture 3440b. The first mattress suture 3440a can produce suture branches 3412 and suture branches 3416 extending therefrom, and the second mattress suture 3440b can produce suture branches 3414 and suture branches 3418 extending therefrom. For the purposes of discussion only, suture branches 3412 and 3414 are defined as the first group of suture branches, and suture branches 3416 and 3418 are defined as the second group of suture branches. For simplicity, Figures 33A to 33E Each embodiment shown illustrates two mattress suture stitches, so they will not be discussed again for each figure.

[0358] Furthermore, as shown in each embodiment, suture branches 3412, 3414 in the first set of suture branches generally pass through patch 3410. This may include a configuration in which suture branches 3412, 3414 pass through patch 3410 extending the entire length of patch (i.e., from the inner edge 3410M to the opposite outer edge 3410L), or a configuration in which suture branches 3412, 3414 pass through a portion of the extended length of patch 3410. Typically, suture branches 3412, 3414 extend along a length that extends substantially between the inner edge 3410M and the outer edge 3410L. For example, as Figure 33D As shown, suture branches 3412 and 3414 do not extend the entire length of patch 3410, but extend a substantial portion of that length. This substantial portion may be at least about 50% of the length, or alternatively at least about 75% of the length, or further alternatively at least about 90% of the length.

[0359] When suture branches 3412, 3414 and suture branches 3416, 3418 pass through the patch, they pass through a portion of the patch 3410, above and / or below it, by guiding the ends of the suture branches. The ends described in the illustrated embodiment as passing through the patch can be considered outer ends because these ends are those passed toward the outer edge 3410L and toward the illustrated anchors 3460a, 3460b. When the outer ends are described as being attached to the anchors, those skilled in the art will recognize that the outer ends of the suture branches themselves do not necessarily need to be attached to the anchors, because when the suture is associated with the anchor, for example by tying the suture to the anchor, the ends can extend beyond the anchor by a certain distance. Therefore, the description of the outer ends of the suture branches being attached to or otherwise attached to the anchors does not require that the very end of the suture itself directly contact or be directly attached to the anchor. Rather, it merely indicates that certain portions of the branch, as those skilled in the art will understand according to this disclosure, are considered the ends of the system when forming the patch suture configuration as the said outer ends. Furthermore, as shown in the figures, anchors 3460a and 3460b are disposed on opposite sides of a central longitudinal axis 3410c extending between the inner and outer sides 3410M and 3410L of patch 3410. Generally, when the lateral ends of various suture branches are associated with anchors, the lateral ends can be described as being close to each other. Those skilled in the art will recognize that even if the lateral ends are associated with different anchors on the same side of the stent, and / or with one or more other clamps (including but not limited to bone, tissue, and medical implants) located on the same side of the stent, the lateral ends of the suture branches on that side can still be described as being close to each other according to this disclosure.

[0360] The second parameter, which can be varied to achieve various patch configurations, relates to the orientation of the first set of suture branches relative to each other and to the patch. For example, each of the first set of suture branches 3412, 3414 can be positioned across patch 3410 from the inner edge 3410M to the outer edge 3410L in a manner that prevents the branches from intersecting each other, as shown below. Figure 33A As shown. In the illustrated embodiment, branches 3412, 3414 extend substantially parallel to the respective outer edges 3410S, 3410T of patch 3410 and are positioned on the separated half of the central longitudinal axis 3410c. This configuration provides additional fixation to the edges 3410S, 3410T as the branches 3412, 3414 extend along the edges. Those skilled in the art will recognize that branches 3412, 3414 can be oriented relative to each other and patch 3410 in many other ways without intersecting them. For example, the first set of suture branches 3412, 3414 can be positioned across patch 3410 from the inner edge 3410M to the outer edge 3410L in a manner that the branches extend substantially straight across patch 3410 and thus substantially parallel to each other. Examples of branches constructed in this way are at least in Figures 30A to 30L The diagram shows (e.g., branches 2212a and 2212b, branches 2212a' and 2216a', and branches 2212a” and 2216a”).

[0361] In a further alternative, the first set of suture branches 3412, 3414 can be positioned across patch 3410 from the inner edge 3410M to the outer edge 3410L in a manner that ensures the branches intersect each other. For example, branches 3412, 3414 can be positioned across patch 3410 to form an "X" configuration or shape, such as... Figure 30I Branches 2212b' and 2216b', Figures 32A to 32E Branches 2312b and 2316b, Figures 32F to 32H Branches 2312b' and 2316b', and Figure 33BBranches 3416 and 3418 (described as a second set of branches, but referenced for the sake of roughly illustrating the intersecting configuration) provide a more dispersed compression over a larger area of ​​the structure. Those skilled in the art will recognize that branches 3412 and 3414 can be oriented relative to each other and patch 3410 in many other ways while still intersecting each other. Furthermore, to the extent that branches 3412 and 3414 are described as crossing the patch arrangement, they can extend across the top surface of the patch, through the patch (e.g., through a single layer disposed between two layers), or a combination of both. Additionally, branches 3412 and 3414 need not be oriented in a similar manner. For example, branch 3412 may extend substantially parallel to the outer edge 3410S, or extend substantially straight across patch 3410, wherein branch 3412 remains on one side of the central longitudinal axis 3410c, while branch 3414 extends more diagonally such that it crosses the central longitudinal axis 3410c.

[0362] The third parameter, which can be varied to achieve various patch configurations, relates to the position of the second set of suture branches relative to the patch. For example, the second set of suture branches 3416, 3418 can be configured to pass through the patch as they extend from the inner edge 3410M to the outer edge 3410L, similar to... Figures 32A to 32J The orientation of branches 2312b and 2316b, and branches 2312b' and 2316b'. Advantageously, the patch can be more secure after installation when at least one suture branch is arranged to pass through the patch. Alternatively, a second set of suture branches 3416, 3418 can be positioned above the top surface of the patch 3410, similar to... Figures 30A to 30L The orientation of branches 2212b and 2216b, branches 2212b' and 2216b', and branches 2212b” and 2216b”. In some cases, some portions of any second branch may extend through the patch, while some other portions extend on top of the patch, and the configuration of this parameter of any branch need not be the same as any other branch.

[0363] A fourth parameter, which can be varied to achieve various patch configurations, relates to the orientation of the second set of suture branches relative to each other and to the patch. For example, each of the second set of suture branches 3416, 3418 can be positioned across the patch 3410 from the inner edge 3410M to the outer edge 3410L in a manner that prevents the branches from intersecting each other or in a manner that ensures the branches do intersect. This configuration possibility is similar to the configuration possibilities discussed above with respect to the second parameter concerning the orientation of the first set of suture branches relative to each other and to the patch. Additionally, in some cases, the second suture branches 3416, 3418 may not extend above or through the patch 3410, but may extend around and / or near the patch 3410. The first suture branches 3412, 3414 may also be constructed such that at least a portion of them extends around and / or adjacent to the patch 3410, rather than extending on top of or through the patch.

[0364] As a non-restrictive example, Figure 33A An embodiment is shown in which the second set of branches 3416, 3418 do not intersect but surround and extend adjacent to patch 3410; therefore, branches 3416, 3418 are not above or through the extension of patch 3410. As a further non-limiting example, Figure 33C and Figure 33E Each example illustrates an embodiment where the second set of branches 3416 and 3418 do not intersect but extend on top of patch 3410. For example... Figure 33D As shown, various orientations can be combined across the length extending between the inner edge 3410M and the outer edge 3410L. For example, as shown, branches 3416 and 3418 do not intersect, but the orientation of the branches relative to patch 3410 changes as the branches extend between the inner edge 3410M and the outer edge 3410L. More specifically, as shown, the first portions 3416p1 and 3418p1 of each of branches 3416 and 3418 extend around and / or adjacent to patch 3410, the second portions 3416p2 and 3418p2 of each of branches 3416 and 3418 extend on top of patch 3410, and the third portions 3416p3 and 3418p3 of each of branches 3416 and 3418 extend through patch 3410. The orientations of the first set of suture branches 3412 and 3414 can also have different configurations along their length.

[0365] on the other hand, Figure 33B An implementation scheme is provided in which the second set of suture branches 3416 and 3418 actually intersect. As shown in the figure, branches 3416 and 3418 are positioned across patch 3410 (as shown, passing through the patch) to form an "X" configuration or shape, such as... Figure 30I Branches 2212b and 2216b', Figures 32A to 32EBranches 2312b and 2316b, and Figures 32F to 32H Branches 2312b' and 2316b'. The "X" configuration can provide more dispersed compression over a larger area of ​​the structure. Those skilled in the art will recognize that branches 3416 and 3418 can be oriented relative to each other and patch 3410 in many other ways while still intersecting each other. Furthermore, although in Figure 33B In the illustrated embodiment, branches 3416, 3418 extend through patch 3410, and they may also extend across the top surface of the patch and / or around or adjacent to the patch or any combination thereof. Similarly, branches extending through the patch may extend through a single layer and / or be positioned between two layers.

[0366] The fifth parameter, which can be modified to achieve various patch configurations, involves incorporating one or more "stitches" in conjunction with the first set of suture branches. As described in this disclosure, these "stitches" may be referred to as "loops," as per [the relevant context]. Figure 33C As shown and described, and as "uneven parts", as per the description of Figure 33D As shown and described below in more detail, the stitches used for the collar and the relief portion involve passing the end of the suture branch through at least a portion of the patch (e.g., through the nearest side surface of the patch) and then through the outer edge of the patch. The collar may involve the suture branch passing through the entire length of the patch extending between the inner and outer edges, while the relief portion may involve the suture branch passing through a portion of the length, which is not necessarily the entire length (although it can be a considerable portion of the length). The collar and relief portion are used to assist in securing the patch relative to at least one suture branch.

[0367] like Figure 33CAs shown, a loop stitch or loop 3444a can be formed by passing a suture branch 3412 from the bottom side 3410d of the patch 3410 facing the soft tissue 3430 to a position 3408a near the inner edge 3410M on the top side 3410p of the patch 3410. Position 3408a can be a pre-formed lumen, or it can be a lumen formed as the suture branch 3412 is advanced through the patch 3410, for example, because the material of the patch 3410 is woven to allow the branch 3412 to pass through it. The patch 3410 may include at least one lateral lumen 3407a, 3407b extending from the inner edge 3410M to the outer edge 3410L. Alternatively, the lumen 3407a, 3407b may not be pre-formed or present, and may instead simply be a location where filaments within the patch 3410 can pass, for example, between two layers, or through a single layer of material that facilitates the passage of material. The suture 3412 can then be threaded medially to enter the lumen 3407a at the medial edge 3410M and extend through the lumen to the lateral edge 3410L. Once tension is applied to the collar 3444a and the collar is brought into contact with the patch 3410, the suture branch 3412 can be secured relative to the patch 3410 so that the patch 3410 does not drift along the suture 3412 after implantation. The collar 3444a also provides additional stability during patch installation. This process can be repeated for the suture branch 3414 to form a second collar stitch or collar 3444b. The collars 3444a, 3444b can be formed in vivo or alternatively, before the patch is introduced into the surgical site using the patch delivery system described below. The free ends (also referred to herein as lateral ends) of each suture branch 3412, 3416 and 3414, 3418 can then be secured in vivo using the techniques provided throughout this disclosure. For example, as Figure 33C As shown, the free ends of each suture branch 3412, 3416 and 3414, 3418 can be connected to the lateral anchors 3460a and 3460b respectively in a lateral fixation manner. The suture branches 3412, 3414, 3416, 3418 can then be tightened to abut against the repair patch 3410 before the lateral anchors 3460a, 3460b are fully fixed in the bone 3450.

[0368] Alternatively, instead of a collar, suture branch 3412 of the first set of suture branches 3412 and 3414 can be used to form a concave-convex portion. For example... Figure 33DAs shown, a raised or recessed stitch or raised or recessed section 3446a can be formed by passing the suture branch 3412 from the bottom side 3410d of the patch 3410 to a position 3408a near the inner edge 3410M on the top side 3410p of the patch 3410. Then, before passing the suture branch 3412 back into the patch 3410 from the top side 3410p toward the bottom side 3410d, the suture branch 3412 is advanced toward the outer edge 3410S. The suture branch 3412 can then be advanced toward the outer side 3410L. In the illustrated embodiment, the suture branch 3412 passes through a lateral lumen 3407a extending from the inner edge 3410M to the outer edge 3410L. Alternatively, lumen 3407a and / or its paired lumen 3407b may not be pre-formed or present, and may instead simply be a location through which the filaments within patch 3410 can pass, for example, between two layers, or through a single layer of material that facilitates the passage of material therethrough. Figure 33C Similar to the implementation scheme, position 3408a can be a pre-formed lumen, or it can be a lumen formed when the suture branch 3412 is advanced through the patch 3410, for example, because the material of the patch 3410 is woven to allow the branch 3412 to pass through it. As shown, the portion of the branch 3412 extending through the patch 3410 extends a considerable portion, but not the entire length, of the branch length extending between the inner edge 3410M and the outer edge 3410L.

[0369] When the protrusion 3446a is formed, the suture 3412 can be advanced at least partially, towards the outer edge 3410S, any desired distance based on the size of the patch 3410 and the desired configuration of the patch and suture combination. As a non-limiting example, in some embodiments, the protrusion 3446a may extend substantially perpendicular to the central longitudinal axis 3410c and may have a length of approximately 1.0 mm to approximately 5.0 mm from the location 3408a. Once tension is applied to the protrusion 3446a and the protrusion 3446a is brought into contact with the patch 3410, the suture branch 3412 can be secured relative to the patch 3410 so that the patch 3410 does not drift along the suture branch 3412 after implantation. The protrusion 3446a also provides additional stability during patch installation. A second protrusion stitch 3446b may be formed together with the second branch 3414. The raised and recessed sutures 3446a, 3446b can be formed in vivo, or alternatively, can be formed before the patch 3410 is introduced to the surgical site using the patch delivery system described below. Alternatively, the two sutures of the first set of sutures 3412, 3414 can be associated with the patch 3410 using different sutures, or no additional sutures are required. Furthermore, in some cases, a combination of a collar and raised and recessed sutures can be used.

[0370] The sixth parameter, which can be varied to achieve various patch configurations, relates to whether the second set of suture branches is positioned within a lumen formed in the patch, or alternatively, whether it passes through the portion of the patch through which the first set of suture branches pass. An illustration of this configuration is shown in... Figure 33D As shown in the figure, the second set of suture branches 3416, 3418 can be introduced together with one of the suture branches 3412, 3414 from the first set of suture branches into the corresponding lumens 3407a, 3407b of the patch 3410. This occurs at positions 3409a, 3409b on the outer side of the inner edge 3410M of the patch 3410. This configuration of the second set provides further fixation of the patch in the anterior-posterior direction. Those skilled in the art will recognize that the position of the second or first set of suture branches within the patch 3410 can be changed without departing from the spirit of this disclosure.

[0371] A seventh parameter, which can be modified to achieve various patch configurations, includes additional sutures such as medial or lateral medial sutures to provide additional patch fixation at discrete locations from the lumen. For example, as Figure 33E As shown, one or more centrally inverted mattress sutures 3470 may be formed in the soft tissue 3430 inside the patch 3410. In the illustrated embodiment, the sutures 3470 are substantially collinear with the first and second mattress sutures 3440a, 3440b, but other configurations, positions, and numbers of sutures are possible without departing from the spirit of this disclosure. In some cases, the centrally inverted mattress sutures 3470 may be substantially aligned with the center of the patch 3410, as in the illustrated embodiment. The centrally inverted sutures 3470 may produce suture branches 3472a, 3472b extending therefrom. According to the technology provided herein, the suture branches 3472a, 3472b may be disposed on the proximal side 3410p of the suture patch 3410 and secured with suture anchors 3460a, 3460b, respectively.

[0372] Alternatively, in addition to the centrally inverted medial mattress suture 3470, the centrally lateral mattress suture 3474 may be pre-loaded onto the patch at a location in the lateral half of the patch. Alternatively, the centrally lateral mattress suture 3474 may be formed in vivo within the patch 3410. The centrally lateral mattress suture 3474 may be generally aligned with the center of the patch 3410. Like the medial inverted mattress suture, various configurations, positions, and stitch numbers are possible, and in the illustrated embodiment, the inverted mattress suture 3474 produces suture branches 3476a, 3476b extending from the patch 3410. In the illustrated embodiment, suture branches 3476a, 3476b are disposed on the proximal side 3410p of the suture patch 3410 and additionally secured in suture anchors 3460a, 3460b. Both the central medial stitch and the central lateral stitch can provide additional compression of the soft tissue by the patch to aid healing. Although Figure 33E The patch 3410 shown illustrates a central medial mattress suture and a central lateral mattress suture in the same embodiment, but in other embodiments, only one may be provided or none may be provided. Furthermore, additional sutures may be located in other places without departing from the spirit of this disclosure.

[0373] The eighth parameter, which can be changed to achieve various patch configurations, is the position of the first set of suture branches relative to the second set of suture branches. More specifically, this parameter relates to whether the branches of the first set of suture branches are positioned inside or outside the branches of the second set of suture branches, where "outer" represents being farther from the central longitudinal axis 3410c. Figure 33A and Figure 33D In the illustrated implementation scheme, the first set of suture branches is positioned inside the second set of suture branches, while... Figure 33B , Figure 33C and Figure 33E In the illustrated implementation, the first set of suture branches is positioned outside the second set of suture branches. See more specifically... Figure 33D The first set of suture branches is positioned inside the second set of suture branches until they converge at position 3409a, where they are substantially aligned. Therefore, the orientation of the first set of suture branches relative to the second set of suture branches can vary between the inner edge 3410M and the outer edge 3410L, including having portions inside the other set of suture branches and portions outside the other set of suture branches. Furthermore, those skilled in the art will recognize that it is not necessary for each branch of this set of branches to be positioned in the same aspect; this means that some branches of the first set of branches can be positioned inside one or more branches of the second set of branches, and similarly, some branches of the first set of branches can be positioned outside one or more branches of the second set of branches with the same patch configuration.

[0374] It is worth noting that, without departing from the spirit of this disclosure, the vast majority of the above parameters or variables can be mixed and matched in one or more patch configurations. Therefore, a variety of different configurations can be generated by this disclosure. The term "vast majority" is used because those skilled in the art will recognize that, depending on the values ​​of some of these parameters, some others may be unadjustable, and this will be understood by those skilled in the art given this disclosure and the knowledge of those skilled in the art. Figures 33A to 33E The illustrations are intended to represent a small sample of possible configurations for various designs based on the eight parameters defined in this disclosure. Each illustrated configuration can be used in conjunction with a variety of surgical procedures. Figure 33C This configuration is particularly useful because it provides the stability offered by the collars 3444a and 3444b, and provides a configuration in which the first set of branches is set approximately straight through the patch 3410 to provide additional fixation to the edges 3410S and 3410T. Furthermore, this configuration is particularly useful because the second set of branches is set approximately straight on the patch 3410 (as opposed to an “X” configuration or shape crossing) to aid inward movement of the patch and facilitate tensioning of the branches. The four branches reduce the likelihood of unwanted “cheese-cutting”, and this configuration does not include additional stitching, making it easier and / or faster than some options that include additional stitching.

[0375] Figure 34A and Figure 34B Another exemplary embodiment of a tissue reinforcement structure 2410 with a patch or support structure is shown. As shown, the patch 2410 has a rectangular body with generally rounded corners. Alternatively, the patch 2410 can have any shape, such as a circle. The patch 2410 can be disposed on or otherwise associated with sutures 2412, 2416. As shown, the patch 2410 has a width W that is substantially equal to the width of the suture. P The length L of " P ", and it also has a thickness T P ″.

[0376] Those skilled in the art will recognize that the length L of the reinforcing patch 2410 P ", Width W P "、Thickness T P The size of the patch 2410 can depend on various factors, including but not limited to the size of the associated filament, the patient's anatomy, and the type of surgery being performed. The exemplary, non-limiting size of patch 2210 provided above is also applicable to the size of patch 2410, and it should be understood that other sizes are possible. Similarly, various techniques known to those skilled in the art can be used to associate the reinforcing patch 2410 with sutures 2412, 2416. However, Figure 34A and Figure 34BAn exemplary method is shown for associating patch 2410 with sutures 2412, 2416 using suture threaders 2406a, 2406b.

[0377] like Figure 34A and Figure 34B As shown, suture branches 2412 and 2416 are inserted into patch 2410 at inner positions 2411a and 2411b, respectively, to secure sutures 2412 and 2416 relative to patch 2410 in a pre-installed configuration. In the illustrated embodiment, the inner positions 2411a and 2411b are approximately located midway between opposite sides 2410a and 2410b of patch 2410, but other positions are possible. Sutures 2412 and 2416 may be sutured or otherwise inserted into patch 2410 such that the two suture branches 2412a, 2412b and 2416a, 2416b extend from the proximal surface of patch 2410, respectively. Suture branches 2412a and 2416a may each have a first portion comprising hollow self-locking mechanisms 2470a and 2470b having lumens 2472a and 2472b extending therethrough. In the illustrated embodiment, the self-locking mechanisms 2470a and 2470b are configured similarly to finger catchers, but other self-locking mechanisms provided herein or known to those skilled in the art based on this disclosure may also be used.

[0378] The lengths of the self-locking mechanisms 2470a and 2470b may be less than the distance extending between the side 2410a of the patch 2410 and the corresponding stitches 2411a and 2411b. Suture threaders 2406a and 2406b may be inserted through the corresponding self-locking mechanisms 2470a and 2470b, such that the proximal shank portions 2408a and 2408b are located near the corresponding inner positions 2411a and 2411b, and the distal suture receiving ends 2409a and 2409b are located closer to the side 2410a than the side 2410b. Suture branches 2412a and 2416a may have corresponding guide tails 2413a and 2413b extending from the self-locking mechanisms 2470a and 2470b. As shown in the figure, the guide tails 2413a and 2413b of each suture 2412, 2416 can pass from the proximal side 2410p to the distal side 2410d of the patch 2410 at a position closer to the side 2410a than the side 2410b. Furthermore, as shown in the figure, suture branches 2412b and 2416b pass from the proximal side 2410p to the distal side 2410d of the patch 2410 at a position closer to the side 2410b than the side 2410a, thus forming a trailing tail. Those skilled in the art will recognize that the patch 2410 can be associated with the sutures 2412 and 2416 in various other ways without departing from the spirit of this disclosure.

[0379] Figures 34C to 34J An exemplary method for mounting a tissue-reinforcing patch 2410 is provided to facilitate the fixation of a piece of soft tissue 2430 (e.g., a rotating sleeve) to bone 2450 using a single-row repair 2432. Like many other methods provided herein, the patch 2410 and related techniques can also be used with other types of repairs, such as double-row repairs. Once the surgeon has entered the surgical site and the tissue, bone, and tissue-reinforcing patch are prepared according to recognized surgical techniques (including those provided herein), such as... Figure 34C As shown, tissue 2430 can be secured to bone 2450 using suture 2403 connected to anchor 2404 inserted into bone 2450. Although one suture 2403 and one anchor 2404 are shown, multiple sutures and multiple anchors can be used to effectively secure tissue 2430 relative to bone 2450. Furthermore, in the illustrated embodiment, only one component associated with the threader and suture is visible due to the shown perspective; however, those skilled in the art will understand that the other threader and suture can operate in a similar manner. For ease of description, although only one is visible, both components can be referenced.

[0380] Once tissue 2430 is fixed to bone 2450, guide tails 2413a and 2413b can be sutured to the inside of the repair within the tissue, such as... Figure 34D As shown. In the illustrated embodiment, guide tails 2413a and 2413b are inserted into and withdrawn from tissue 2430 using, for example, mattress suture 2442a. Figure 34E As shown, guide tail 2413a can be connected to the suture receiving end 2409a of suture threader 2406a, and suture threader 2406a can then operate as provided in this disclosure to advance guide tail 2413a into the lumen 2472a of self-locking mechanism 2470a. A similar action can be taken with guide tail 2413b such that it is placed in the lumen 2472b of self-locking mechanism 2470b, however, as mentioned above, this is not visible in the view shown. After the distal ends of tails 2413a and 2413b have passed through the corresponding self-locking mechanisms 2470a and 2440b so that the distal ends are visible to the user and can be grasped by the user, as... Figure 34F As shown, threaders 2406a and 2406b can be disconnected from tails 2413a and 2413b and disposed of and / or prepared for future use. In the illustrated embodiment, self-locking mechanisms 2470a and 2470b can function such that the respective tails 2413a and 2413b can only be advanced in one direction, or can optionally be selectively locked.

[0381] like Figure 34G As shown, the operator can apply force F PForce F is applied to guide tails 2413a and 2413b to advance patch 2410 toward mattress suture 2442a. More specifically, when force F is applied... P When applied to the guide tail 2413a, the collar 2415a defined by the self-locking mechanism 2470a collapses, as if by Figure 34H The resulting configuration is shown. When force F is applied... P A similar result occurs when applied to the guide tail 2413b.

[0382] When the repair material 2432 is covered by the patch 2410, the patch 2410 is in the installation position, such as Figure 34H As shown. More specifically, the illustrated mounting configuration shows that the side 2410a of patch 2410 is close to the mattress suture 2442a. Therefore, when the side 2410b of patch 2410 is attached to its position in the body, patch 2410 can bend as shown and more securely protect and integrate with tissue 2430. This is because patch 2410 is stretchable to provide a tighter fit. Patch 2410 operates together with sutures 2412, 2416 as a single continuous suture or band, which can better distribute the load than using multiple sutures. Those skilled in the art will recognize that other factors such as the length of patch 2410, other positions of the inner sutures 2411a, 2411b, and other positions of the distal ends of the self-locking mechanisms 2472a, 2742b can be adjusted according to this disclosure to achieve other mounting configurations. Alternatively, patch 2410 may be located inside the repair 2432 or in any other position required for a given surgical procedure.

[0383] Any number of techniques for securing the side 2410b of patch 2410 in the body can be used, including those provided herein. In the illustrated embodiment, after patch 2410 is attached to tissue 2430, in Figure 34I and Figure 34J In the first part, guide tails 2413a and trailing tails 2412b are connected to anchors 2460a, and guide tails 2413b and trailing tails 2416b are connected to anchors 2460b. Guide tails 2413a, 2413b and trailing tails 2412b, 2416b can then be tightened to secure patch 2410 against the repair before anchors 2460a, 2460b are fully fixed in bone 2450. Once patch 2410 is fixed within the body, patch 2410 generally does not flex excessively or shift, allowing patch 2410 to be protected and healed in the manner generally described throughout this application regarding reinforcing structures. Alternatively, trailing tails 2412b, 2416b can also be fixed to patch 2410 near anchors 2406a, 2406b to allow the patch to stretch over tissue.

[0384] In an alternative method, guide tail 2413b and trailing tail 2412a can be connected to anchor 2460a, and guide tail 2413a and trailing tail 2416b can be connected to anchor 2460b, such as Figure 34K As shown. This configuration provides a cross pattern, which offers the benefits described above when discussing the cross pattern. In yet another alternative embodiment, the guide tails 2413a, 2413b may be cut near the points where they exit the self-locking mechanisms 2470a, 2470b, respectively, such that only the trailing tails 2412b, 2416b are secured to the anchors 2406a, 2406b, respectively. This is because in some configurations of the self-locking mechanism, such as the finger-like catcher configuration shown, the trailing tails 2412b, 2416b are allowed to bear the load. In view of this disclosure, those skilled in the art will further recognize that various suture sizes and configurations can be adjusted according to the flexible patch 2410 to help distribute the load.

[0385] The tissue-reinforcing patch 2410 can be manufactured using a variety of different techniques, which have been discussed above regarding tissue-reinforcing constructs (including, but not limited to, tissue-reinforcing patches 2210 and 2310). Furthermore, patch 2410 can be made from any of the materials described above regarding patches 2210 and 2310, including materials that promote healing and tissue growth, such as collagen. Therefore, as the patient heals from surgery, the patch can be remodeled into tendon-like tissue and integrate with the underlying natural tissue. This additional coverage of tendon-like tissue on the soft tissue increases the strength of the soft tissue-bone connection and can prevent further injury.

[0386] Figures 35A to 35D Another exemplary embodiment of a tissue reinforcement structure 2510 with a patch or support configuration is shown. The patch 2510 has a shape and size similar to that of the patch 2410 and may be disposed on or otherwise associated with sutures 2512a, 2512b, 2516a, 2516b. Various techniques provided throughout this disclosure can be used to join or otherwise associate the patch 2510 with the sutures 2512a, 2512b, 2516a, 2516b. Figure 35AAs shown, sutures 2512a and 2516a are threaded into patch 2510 at inner positions 2511a and 2511b, respectively, to secure sutures 2512a and 2516a relative to patch 2510. The inner positions 2511a and 2511b can be similar to comparable inner positions 2411a and 2411b of patch 2410, and thus can produce some of the same benefits as described above. Sutures 2512a and 2516a can be sutured or otherwise secured to patch 2510 such that sutures 2512a and 2516a extend from the proximal surface of patch 2510. The first portion of sutures 2512a and 2516a may each include hollow self-locking mechanisms 2570a and 2570b having lumens 2572a and 2572b extending therethrough. In the illustrated embodiments, the self-locking mechanisms 2570a and 2570b are configured similarly to finger catchers, but other self-locking mechanisms provided herein or known to those skilled in the art based on this disclosure may also be used.

[0387] The lengths of the self-locking mechanisms 2570a and 2570b may be less than the distance extending between the side surface 2510a and the corresponding inner positions 2511a and 2511b of the patch 2510. The suture threaders 2506a and 2506b may be inserted through the corresponding lumens 2572a and 2572b of the self-locking mechanisms 2570a and 2572b, and may be constructed in a similar manner to the suture threaders 2406a and 2406b described above. The sutures 2512a and 2516a may include guide tails 2513a and 2513b, as shown, which may extend from the self-locking mechanisms 2570a and 2570b, respectively. Figure 35A and Figure 35B As shown, guide tails 2513a and 2513b extend from the proximal side 2510p to the distal side 2510d of patch 2510 at a position close to the side 2510a of patch 2510.

[0388] Unlike the aforementioned embodiments of tissue-reinforced structure 2410 in which the trailing portion is part of the filaments used to form the self-locking mechanism and the guide tail, the trailing portion of tissue-reinforced structure 2510 is an independent filament, rather than part of the filaments used to form the self-locking mechanisms 2570a, 2570b or the guide tails 2513a, 2513b. As shown, suture 2512b is a trailing portion including mattress sutures at a location near the side 2510b of patch 2510, and suture 2516b is a trailing portion including simple stitches at a location also near the side 2510b. More specifically, each of the trailing portions 2512b and 2516b extends from the proximal side 2510p of patch 2510 to the distal side 2510d of patch 2510. By providing independent guide tails and trailing portions, the user can gain additional control over structure 2510 because the tails can be operated independently. It can, for example, enhance the tension of the structure 2510 occurring at either end 2510a, 2510b. It is worth noting that this embodiment illustrates some non-limiting ways in which sutures can be associated with tissue-reinforcing structures, and therefore in other embodiments, similar stitches can be used for the two tails 2512b, 2516b. Those skilled in the art will recognize various other ways in which the patch 2510 can be associated with sutures 2512a, 2512b, 2516a, 2516b without departing from the spirit of this disclosure.

[0389] like Figure 35C and Figure 35D The method of mounting the tissue reinforcement patch 2510 using the mounting configuration shown is similar to the method described above with respect to patch 2410, and the mounting configuration is shown as excluding the step of generating it. As shown, the inner positions 2511a, 2511b of patch 2510 are close to the edge of tissue 2530, and the edge 2510b is positioned close to the anchors 2560a, 2560b by trailing ends 2512b, 2516b attached and fastened thereto. Alternatively, patch 2510 may be located inside the repair or at any other location required by the surgery.

[0390] Figures 36A to 36I Another exemplary embodiment of a tissue reinforcement structure 2610 with a patch or support configuration is shown. The patch 2610 has a shape and size similar to that of patches 2410 and 2510, and may be disposed on or otherwise associated with sutures 2612, 2616. Various techniques provided throughout this disclosure can be used to join or otherwise associate the patch 2610 with sutures 2612, 2616. Figure 36AAs shown, suture branches 2612 and 2616 are inserted into the patch 2610 at inner positions 2611a and 2611b, respectively, to secure the sutures 2612 and 2616 relative to the patch 2610. The inner positions 2611a and 2611b can be similar to the comparable inner positions 2411a and 2411b of the patch 2410, and thus can produce some of the same benefits as described above.

[0391] The suture 2612 may be sutured or otherwise secured to the patch 2610 such that two suture branches 2612a, 2612b extend from the proximal surface 2610p of the patch 2610. Each suture branch 2612a and 2612b may have a first portion comprising hollow self-locking mechanisms 2670a, 2670b having lumens 2672a, 2672b extending therethrough, respectively. In the illustrated embodiment, the self-locking mechanisms 2670a, 2670b are configured like finger traps, but other self-locking mechanisms provided herein or known to those skilled in the art based on this disclosure may also be used.

[0392] The lengths of the self-locking mechanisms 2670a and 2670b may be less than the distance extending between the corresponding sides 2610a and 2610b (as shown) and the inner position 2611a of the patch 2610. The suture threaders 2606a and 2606b may be inserted through the corresponding lumens 2672a and 2672b of the self-locking mechanisms 2670a and 2672b, and may be constructed in a similar manner to the suture threaders 2406a and 2406b described above. The suture branches 2612a and 2612b may include guide tails 2613a and 2613b, as shown, which may extend from the self-locking mechanisms 2670a and 2670b, respectively. Figure 36A and Figure 36B As shown, the guide tails 2613a and 2613b extend from the proximal side 2610p to the distal side 2610d of the patch 2610 at positions close to the corresponding sides 2610a and 2610b of the patch 2610.

[0393] The suture 2616 can be sutured or otherwise secured to the patch 2610 in substantially the same manner as the suture 2612, and therefore...

Claims

1. A foldable soft tissue repair system, comprising: Tissue-enhancing scaffold, the tissue-enhancing scaffold having: First material layer; The surface facing the organization; and A second surface, the second surface being opposite to the tissue-facing surface. The first material layer includes one or more intrusion features forming at least one fold axis, the at least one fold axis spanning at least a portion of the length of the material, and The one or more invasive features allow the tissue-enhancing scaffold to be folded around the at least one folding axis to reduce the insertion profile of the tissue-enhancing scaffold relative to the at least one folding axis. The tissue-facing surface defines a first intrusion feature along a first fold axis, the first intrusion feature being configured to bias the fold of the material along a first direction, and The second surface defines a second intrusion feature along the second fold axis, the second intrusion feature being configured to bias the fold of the material along a second direction opposite to the first direction, and Each of the one or more intrusion features defines a cut and / or notch channel in the material along a corresponding fold axis from the inner edge to the outer edge.

2. The foldable soft tissue repair system according to claim 1, wherein, The one or more intrusion features are spaced apart along the fold axis to define a plurality of holes that pass through the material.

3. The foldable soft tissue repair system according to claim 1, wherein, Tissue-enhancing scaffolds comprise at least one of the following: fabrics, plastics, synthetic polymers, natural polymers, collagen, collagen scaffolds, reconstructed collagen, autologous connective tissue, allogeneic connective tissue, xenograft connective tissue, human epidermal matrix, porcine epidermal matrix, bovine epidermal matrix, periosteum, pericardium, and fascia.

4. The foldable soft tissue repair system according to claim 3, wherein, The tissue-enhancing scaffold contains collagen.

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