Repair of shoulder joint injury
The bone implant assembly, with a bone anchor and osteoconductive material, addresses the challenge of repairing shoulder joint injuries by transitioning to a radially expanded configuration for secure attachment and osseointegration, effectively healing Hill-Sachs and Bankart injuries.
Patent Information
- Application Number
- JP2023553987
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-11-09
- Filing Date
- 2022-03-02
- Publication Date
- 2026-08-25
- Estimated Expiration
- 2042-03-02
AI Technical Summary
Existing technologies are inadequate in effectively repairing shoulder joint injuries such as Hill-Sachs and Bankart injuries, which often result from anterior shoulder dislocation, particularly in terms of minimally invasive surgical methods.
A bone implant assembly comprising a bone anchor, a container, and osteoconductive bone-filling material, which transitions from an elongated delivery configuration to a radially expanded deployment configuration, facilitating attachment to adjacent tissue and integration with the bone, using sutures to secure the implant and promote osseointegration.
The bone implant assembly effectively fills and heals bone damage by osseointegrating with the humeral head or glenoid rim, providing a stable repair for Hill-Sachs and Bankart injuries through minimally invasive procedures.
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Abstract
Description
[Technical Field]
[0001] This application is a continuation of U.S. Patent Application No. 17 / 522,034 filed on 9 November 2021, and claims priority to U.S. Provisional Patent Application No. 63 / 156,418 filed on 4 March 2021 and U.S. Provisional Patent Application No. 63 / 216,590 filed on 30 June 2021. The contents of the above applications are incorporated by reference as if they were entirely contained herein.
[0002] In some embodiments, the present invention relates to means and methods for repairing shoulder joint injuries. More specifically, and not limited to, to minimally invasive surgical means and methods for repairing shoulder joint injuries. [Background technology]
[0003] In anterior shoulder dislocation, the humeral head typically impinges on the anterior edge of the glenoid fossa, often resulting in Hill-Sachs injury and / or Bankart injury. A Hill-Sachs injury is a compression fracture of the posterior superior lateral aspect of the humeral head, while a Bankart injury is a tear of the anterior (inferior) glenoid labrum of the shoulder.
[0004] As additional background technology, U.S. Patent No. 10905409(B2) discloses a tissue repair assembly for attaching tissue to bone or tissue to tissue, having a flexible anchor implant through which a suture of a certain length is passed to provide tension to the implant and facilitate attachment to other tissue. The implant is a flexible, pliable, three-dimensional structure with an inherent volume. An insertion tube facilitates the placement of the implant within bone or into adjacent, deployable soft tissue. When deployed, the flexible anchor implant contracts axially and expands radially to a diameter larger than the hole through which it was placed, providing resistance to pull-out.
[0005] U.S. Patent Application Publication No. 20190290256(A1) discloses a full suture anchor for attaching soft tissue to bone by creating an interference interlock in a bone hole, and a deployment device for the full suture anchor. The full suture anchor includes an anchor body having a first end and a second end. The second end folds toward the first end to form a loop, forming the distal end of the anchor body, and the first and second ends of the anchor body form the proximal end. The anchor body is made of a first material having a first density. Through filaments having a second (different) density are woven through the anchor body at the passage position, with a pair of free ends of the through filaments extending from the proximal end of the anchor body. The full suture anchor additionally includes binding filaments at the proximal end of the anchor body, axially bonded around the first and second ends of the anchor body.
[0006] U.S. Patent No. 9526621(B2) discloses a method for correcting many bone abnormalities, including bone tumors and cysts, ischemic osteonecrosis of the femoral head, tibial plateau fractures, and vertebral compression fractures. The abnormality may be corrected by first accessing and perforating the damaged tissue or bone and removing the damaged and / or diseased area with a reamer by any currently accepted procedure, or by adjusting the damaged area by expanding a bag inside the damaged bone to compress the cancellous bone. After removal and / or compression of the diseased tissue, the bone is stabilized. [Overview of the project]
[0007] According to one aspect of several embodiments of the present invention, a bone implant for treating bone damage is provided, comprising (a) a bone anchor, (b) a container communicating with the bone anchor, and (c) an osteoconductive bone-filling material within the container.
[0008] According to some embodiments of the present invention, the container is configured to act as the bone anchor for the bone implant.
[0009] According to some embodiments of the present invention, the container comprises a cylindrical sleeve.
[0010] According to some embodiments of the present invention, the bone implant further comprises one or more threads fixed to the container and extending proximal from the container.
[0011] According to some embodiments of the present invention, the container and the one or more threads are arranged such that one or more knots, formed by joining together two or more longitudinal thread portions of the one or more threads, enable the container to transition from an elongated, thin delivery configuration to a shortened, radially expanded deployment configuration.
[0012] According to some embodiments of the present invention, the one or more threads are used to attach adjacent tissue to the graft site of the bone implant.
[0013] According to some embodiments of the present invention, the bone-conductive bone-filling material comprises one or more organic materials.
[0014] According to some embodiments of the present invention, the one or more organic materials include one or more of bone marrow, bone marrow stem cells, osteogenic cells, preosteoblasts, osteoblasts, mesenchymal stem cells, bone marrow mesenchymal stem cells, and pluripotent stem cells.
[0015] According to some embodiments of the present invention, the container comprises one or more of the following: (i) a hole having dimensions from about 0.5 mm (height) × 0.5 mm (width) to about 3 mm (height) × 3 mm (width); (ii) a porous scaffold; (iii) an average of about 20 CPI to about 30 CPI; and (iv) an average of about 10 WPI to about 20 WPI.
[0016] According to some embodiments of the present invention, the container includes a biodegradable or non-biodegradable substrate.
[0017] According to some embodiments of the present invention, the bone-conductive bone-filling material includes a biodegradable or non-biodegradable base.
[0018] According to some embodiments of the present invention, the bone implant further includes one or more additional sutures at the proximal end of the container for closing the proximal end after inserting the osteoconductive bone filling material into the container.
[0019] According to some embodiments of the present invention, when the proximal end of the tubular sleeve of the container slides distally along one or more sutures towards the distal folded end, the container is configured to transition from an elongated thin delivery configuration to a shortened and radially expanded deployment configuration with respect to the bone.
[0020] According to some embodiments of the present invention, the container is configured to be folded while transitioning from an elongated thin delivery configuration to a shortened and radially expanded deployment configuration.
[0021] According to some embodiments of the present invention, a method of treating a bone injury is provided. The method includes: (a) implanting a bone void filling implant including a container containing a bone void filling material at the damaged portion of the bone; and (b) transitioning at least a portion of the bone void filling implant from an elongated thin delivery configuration to a shortened and radially expanded deployment configuration such that the bone void filling implant at least partially fills the damaged portion and the bone void filling material within the container causes the bone void filling implant to osseointegrate with the bone.
[0022] According to some embodiments of the present invention, the transition includes tying one or more threads that extend proximally from the bone void filling implant.
[0023] According to some embodiments of the present invention, the tying includes pressing the bone void filling implant against the bone.
[0024] According to some embodiments of the present invention, the method further includes tying two or more longitudinal thread portions of the one or more threads after the transition.
[0025] According to some embodiments of the present invention, the method further includes drilling a hole in the bone that enables implantation of the bone anchor before implanting the bone anchor.
[0026] According to some embodiments of the present invention, the implantation of the bone anchor includes implanting the bone anchor into the damaged portion when at least a part of the bone void filling implant is disposed outside the damaged portion.
[0027] The following is a non-exclusive list including some examples of embodiments of the present invention. The present invention also includes embodiments that include fewer features than all the features in one example and embodiments that use features from multiple examples, even if not explicitly listed below.
[0028] Example 1. A bone implant for treating bone damage, including (a) a bone anchor, (b) a container communicating with the bone anchor, and (c) a bone-conductive bone filling material within the container.
[0029] Example 2. The bone implant according to Example 1, wherein the container is configured to act as a bone anchor for the bone implant.
[0030] Example 3. The bone implant according to Example 1 or Example 2, wherein the container comprises a cylindrical sleeve.
[0031] Example 4. The bone implant according to any one of Examples 1 to 3, further including one or more threads fixed to the container and extending in the proximal direction from the container.
[0032] Example 5. A bone implant according to any of Examples 1 to 4, wherein the container and one or more threads are arranged such that one or more knots, formed by joining together two or more longitudinal thread portions of one or more threads, allow the container to transition from an elongated, thin delivery configuration to a shortened, radially expanded deployment configuration.
[0033] Example 6. A bone implant according to any of Examples 1 to 5, wherein one or more threads are configured to be used to attach adjacent tissue to the site where the bone implant will be transplanted.
[0034] Example 7. A bone implant according to any of Examples 1 to 6, wherein the osteoconductive bone graft material contains one or more organic materials.
[0035] Example 8. A bone implant according to any of Examples 1 to 7, wherein one or more organic materials include one or more of bone marrow, bone marrow stem cells, osteogenic cells, preosteoblasts, osteoblasts, mesenchymal stem cells, bone marrow mesenchymal stem cells, and pluripotent stem cells.
[0036] Example 9. A bone implant according to any of Examples 1 to 8, the container containing a porous scaffold.
[0037] Example 10. The container is a bone implant according to any of Examples 1 to 9, containing a hole having dimensions ranging from approximately 0.5 mm (height) x 0.5 mm (width) to approximately 3 mm (height) x 3 mm (width).
[0038] Example 11. The container is a bone implant according to any of Examples 1 to 10, with an average container size of approximately 20 CPI to 30 CPI.
[0039] Example 12. The container is approximately 10 WPI to 20 WPI, and the bone implant is one of the examples 1 to 11.
[0040] Example 13. A bone implant according to any of Examples 1 to 12, wherein the container contains a biodegradable or non-biodegradable substrate.
[0041] Example 14. A bone implant according to any of Examples 1 to 13, comprising an osteoconductive bone graft material including a biodegradable or non-biodegradable substrate.
[0042] Example 15. A bone implant according to any of Examples 1 to 14, further comprising one or more additional sutures at the proximal end to close the proximal end after inserting the osteoconductive bone graft material into the container.
[0043] Example 16. A bone implant according to any of Examples 1 to 15, wherein when the proximal end of a tubular sleeve slides distally toward the distal folded end along one or more sutures, the container transitions from an elongated, thin delivery configuration to a shortened, radially expanded deployment configuration relative to the bone.
[0044] Example 17. A bone implant according to any of Examples 1 to 16, wherein the container is configured to fold during the transition from an elongated, thin delivery configuration to the shortened, radially expanding deployment configuration.
[0045] Example 18. An implant system comprising a bone implant according to Example 1, further comprising an anchor inserter having a proximal end and a distal end, the distal end of the anchor inserter communicating with a container, and the proximal ends of one or more threads extending toward the proximal end of the anchor inserter.
[0046] Example 19. A method for treating bone injury, comprising: (a) implanting a bone space filling implant comprising a container containing bone space filling material into the injured bone; and (b) transitioning at least a portion of the bone space filling implant from an elongated, thin delivery configuration to a shortened, radially expanded deployment configuration so that the bone space filling implant fills at least partially the injured area and the bone space filling material in the container causes the bone space filling implant to fuse with the bone.
[0047] Example 20. The transition involves tying one or more threads, which extend proximal to the bone space filling implant, according to the method of Example 19.
[0048] Example 21. The lacing method, according to Example 19 or Example 20, includes pressing the bone space-filling implant against the bone.
[0049] Example 22. The method according to Examples 19 to 21 further comprises tying together two or more longitudinal thread portions of one or more threads after the transition.
[0050] Example 23. The method according to Examples 19 to 22 further includes drilling holes in the bone to allow for the implantation of bone anchors before implanting the bone anchors.
[0051] Example 24. Bone anchor grafting is a method according to Examples 19 to 23, which involves grafting a bone anchor to the injured area when at least a portion of the bone space-filling implant is positioned outside the injured area.
[0052] According to one aspect of several embodiments of the present invention, a bone implant assembly for treating Hill-Sachs injury of the humeral head is provided. According to one aspect of several embodiments of the present invention, the bone implant assembly comprises a suture anchor, which comprises (a) a bone anchor configured to be implanted in a Hill-Sachs injury of the humeral head, and (b) one or more sutures fixed to the bone anchor and extending proximal from the bone anchor. According to several embodiments of the present invention, the bone implant assembly further comprises a bone cavity filling implant, which comprises an osteoconductive bone filling material and is coupled to the suture anchor.
[0053] According to some embodiments of the present invention, to treat a Hill-Sachs injury of the humeral head, a bone anchor is implanted in a Hill-Sachs injury such that one or more sutures fixed to the bone anchor extend proximal to the Hill-Sachs injury. According to some embodiments of the present invention, at least a portion of a bone space-filling implant is advanced along one or more sutures toward the implanted bone anchor so that the bone space-filling implant fills at least partially the Hill-Sachs injury. In some embodiments, after the bone space-filling implant has been advanced toward the implanted bone anchor, the bone space-filling implant is ligated using one or more sutures.
[0054] According to some embodiments of the present invention, depending on the specific dimensions and shape of the injury and the dimensions and shape of the implant, one or more bone cavity filling implants may be implanted in the Hill-Sachs injury.
[0055] According to some embodiments of the present invention, one or more bone cavity filling implants fuse with the humeral head over time, thereby filling and healing the Hill-Sachs injury.
[0056] According to several embodiments of the present invention, a bone implant assembly for treating Bankart injury is provided. According to several embodiments of the present invention, the bone implant assembly includes a bone anchor which is shaped to define a distal portion configured to be implanted in the glenoid rim. According to several embodiments of the present invention, the bone implant assembly further includes an elongated labral receptacle which is shaped to define (a) a distal articular surface and (b) a proximal groove, the proximal groove which is oriented in a direction that (i) moves proximal away from the distal articular surface and (ii) is shaped to receive the detached anteroinferior labrum.
[0057] According to some embodiments of the present invention, the elongated labral receptacle is connected to each proximal portion of the bone anchor so that (a) the distal articular surface rests on the glenoid rim, and (b) the proximal groove is positioned proximal to the glenoid rim and opposite to the detached anteroinferior labrum in order to receive the detached anteroinferior labrum. According to some embodiments of the present invention, the elongated labral receptacle increases and enlarges the glenoid rim to allow the reattachment of the thus detached anteroinferior labrum to the glenoid rim.
[0058] According to some embodiments of the present invention, the bone implant assembly further includes one or more sutures fixed to a bone anchor and extending proximal from the proximal portion of the bone anchor. According to some embodiments of the present invention, the one or more sutures pass through the distal articular surface of an elongated labral receptacle and, optionally, through the proximal groove. The elongated labral receptacle is advancing along the one or more sutures toward the proximal portion of the bone anchor.
[0059] According to one aspect of several embodiments of the present invention, a bone implant assembly for treating Hill-Sachs injury of the humeral head is provided. The bone implant assembly includes (a) a bone anchor configured to be implanted in a Hill-Sachs injury of the humeral head, and (b) a suture anchor comprising one or more sutures fixed to the bone anchor 32 and extending proximal from the bone anchor, and a bone space-filling implant comprising an osteoconductive bone-filling material and coupled to the suture anchor.
[0060] According to some embodiments of the present invention, the bone space filling implant includes a porous scaffold.
[0061] According to some embodiments of the present invention, the bone-conductive bone graft material includes a biodegradable or non-biodegradable substrate.
[0062] According to some embodiments of the present invention, the bone anchor is threaded.
[0063] According to some embodiments of the present invention, the bone space filling implant is connected to the suture anchor by being attached to at least one or more sutures of the suture anchor.
[0064] According to some embodiments of the present invention, the bone space filling implant is configured to connect to at least a bone anchor and to a suture anchor.
[0065] According to some embodiments of the present invention, the bone space filling implant can be bonded to a bone anchor.
[0066] According to some embodiments of the present invention, bone space-filling implants and bone anchors include respective joints that are shaped to be connectable to one another.
[0067] According to some embodiments of the present invention, the bone space filling implant is configured to connect to at least a bone anchor and to a suture anchor.
[0068] According to some embodiments of the present invention, the bone space filling implant is configured to (a) have a proximal portion that is slidably connected to one or more sutures for connection to a suture anchor, and (b) to transition from an elongated, thin delivery configuration relative to the humeral head to a shortened, radially expanded deployment configuration by sliding the proximal portion of the bone space filling implant distally toward the bone anchor along one or more sutures.
[0069] According to some embodiments of the present invention, the distal portion of the bone space filling implant is fixed to a bone anchor.
[0070] According to some embodiments of the present invention, the distal portion of the bone space filling implant is fixed non-articulately to one or more sutures.
[0071] According to some embodiments of the present invention, the bone space filling implant includes a patch.
[0072] According to some embodiments of the present invention, the length of the patch is between 1 and 15 times the width of the patch when the bone space filling implant is in an elongated, thin delivery configuration.
[0073] According to some embodiments of the present invention, the patch is arranged as a tubular sleeve.
[0074] According to some embodiments of the present invention, the patch is formed to define at least a first hole and a second hole that penetrate between a first surface and a second surface facing each other, with at least one suture thread passing through the first hole from the first surface to the second surface and through the second hole from the second surface to the first surface.
[0075] According to some embodiments of the present invention, the patch is configured to form accordion-like folds when in a shortened and radially expanding unfolded configuration.
[0076] According to some embodiments of the present invention, the patch is configured to wrinkle as it transitions from an elongated, thin delivery configuration to a shortened, radially expanding unfolded configuration.
[0077] According to some embodiments of the present invention, the patch and one or more sutures are arranged such that one or more knots formed by tying together two or more longitudinal suture portions of one or more sutures are covered by the patch.
[0078] According to some embodiments of the present invention, the patch is arranged as a tubular sleeve, and the tubular sleeve and one or more sutures are arranged such that one or more knots formed by tying together two or more longitudinal suture portions of the one or more sutures are located inside the proximal part of the tubular sleeve, and the one or more knots are covered by the tubular sleeve of the patch.
[0079] According to some embodiments of the present invention, when the bone space filling implant is in a shortened and radially expanded deployment configuration, it has a maximum lateral dimension between 0.2 and 4 cm.
[0080] According to some embodiments of the present invention, an implant system is provided which includes a bone implant assembly and further includes a delivery tube having a proximal end opening and a distal end opening. The bone implant assembly is partially positioned within the delivery tube, with (a) at least a portion of a bone anchor, (b) a bone space-filling implant, and (c) the distal portions of one or more sutures positioned within the delivery tube, the proximal portion of the bone space-filling implant being close to the bone anchor, and the proximal portions of the one or more sutures extending outside the proximal end opening of the delivery tube.
[0081] According to some embodiments of the present invention, when the bone implant assembly is partially positioned within the delivery tube, at least two longitudinal suture portions of the suture are loosely tied.
[0082] According to some embodiments of the present invention, the delivery tube has an outer diameter of 7 mm or less.
[0083] According to some embodiments of the present invention, the bone space filling implant is formed in a ball shape.
[0084] According to some embodiments of the present invention, one or more sutures penetrate the ball.
[0085] According to some embodiments of the present invention, the ball is substantially spherical.
[0086] According to some embodiments of the present invention, the ball is substantially ellipsoidal.
[0087] According to some embodiments of the present invention, the bone space filling implant comprises a sponge impregnated with an osteoconductive bone grafting material.
[0088] According to some embodiments of the present invention, the bone space filling implant comprises a sponge impregnated with an osteoconductive bone grafting material.
[0089] According to some embodiments of the present invention, the bone space filling implant includes bone.
[0090] According to some embodiments of the present invention, the bone space filling implant is formed in a slice shape.
[0091] According to some embodiments of the present invention, the bone space filling implant comprises a tubularly woven mesh which, when shortened and expanded radially, is configured to define one or more radial bulges.
[0092] According to some embodiments of the present invention, a method for treating Hill-Sachs injury of the humeral head is provided. The method includes implanting a bone anchor of a bone implant assembly into the Hill-Sachs injury of the humeral head, such that one or more sutures fixed to the bone anchor extend proximal to the Hill-Sachs injury from the bone anchor, and advancing at least a portion of a bone space-filling implant of the bone implant assembly toward the implanted bone anchor along one or more sutures, such that the bone space-filling implant fills at least partially the Hill-Sachs injury, and that the osteoconductive bone-filling material of the bone space-filling implant causes the bone space-filling implant to fuse with the humeral head.
[0093] According to some embodiments of the present invention, this method further includes advancing the bone space filling implant in the direction of the implanted bone anchor, and then tying the bone space filling implant with one or more sutures.
[0094] According to some embodiments of the present invention, ligating a bone space filling implant with one or more sutures includes pressing the bone space filling implant against the humeral head.
[0095] According to some embodiments of the present invention, this method further includes advancing the bone space filling implant in the direction of the implanted bone anchor, and then tying together two or more longitudinal suture portions of one or more sutures.
[0096] According to some embodiments of the present invention, the bone space filling implant is connected to the suture anchor by being bound to at least one or more sutures of the suture anchor.
[0097] According to some embodiments of the present invention, the bone space filling implant is configured to connect to at least a bone anchor and to a suture anchor.
[0098] According to some embodiments of the present invention, this method further includes connecting a bone space filling implant to a bone anchor.
[0099] According to some embodiments of the present invention, the bone space filling implant is configured to connect to at least a bone anchor and to a suture anchor.
[0100] According to some embodiments of the present invention, bone anchor implantation includes implanting a bone anchor into a Hillsachs injury when at least a portion of a bone space-filling implant is positioned outside the Hillsachs injury.
[0101] According to some embodiments of the present invention, implanting a bone anchor involves implanting a bone anchor into a Hill-Sachs injury while leaving at least a portion of a bone space-filling implant within the Hill-Sachs injury.
[0102] According to some embodiments of the present invention, advancing a bone space-filling implant along one or more sutures toward a transplanted bone implant involves sliding the proximal portion of the bone space-filling implant distally toward a transplanted bone anchor along one or more sutures, thereby transitioning the bone space-filling implant from an elongated, thin delivery configuration to a shortened, radially expanded deployment configuration pressed toward the humeral head.
[0103] According to some embodiments of the present invention, the distal portion of the bone space filling implant is fixed to a bone anchor.
[0104] According to some embodiments of the present invention, the distal portion of the bone space filling implant is fixed non-articulately to one or more sutures.
[0105] According to some embodiments of the present invention, the bone space filling implant includes a patch.
[0106] According to some embodiments of the present invention, the length of the patch is between 1 and 15 times the width of the patch when the bone space filling implant is in an elongated, thin delivery configuration.
[0107] According to some embodiments of the present invention, the patch is arranged as a tubular sleeve.
[0108] According to some embodiments of the present invention, the patch is formed to define at least a first hole and a second hole that penetrate between a first surface and a second surface facing each other, with at least one suture thread passing through the first hole from the first surface to the second surface and through the second hole from the second surface to the first surface.
[0109] According to some embodiments of the present invention, the patch is configured to form accordion-like folds when in a shortened and radially expanding unfolded configuration.
[0110] According to some embodiments of the present invention, the patch is configured to wrinkle as it transitions from an elongated, thin delivery configuration to a shortened, radially expanded unfolded configuration.
[0111] According to some embodiments of the present invention, the method further includes advancing the bone space filling implant in the direction of the implanted bone anchor, and then tying together two or more longitudinal suture portions of one or more sutures.
[0112] According to some embodiments of the present invention, tying together two or more longitudinal suture portions of one or more sutures involves making one or more knots such that one or more knots are covered by a patch.
[0113] According to some embodiments of the present invention, this method further involves cutting off the excess portions of two or more longitudinal sutures after making one or more knots, so that the proximal ends of the two or more longitudinal sutures are covered with patches.
[0114] According to some embodiments of the present invention, the patch is arranged as a tubular sleeve, and making one or more knots involves making one or more knots within the proximal portion of the tubular sleeve, such that the one or more knots are covered by the tubular sleeve of the patch.
[0115] According to some embodiments of the present invention, this method further involves cutting off the excess portions of two or more longitudinal sutures after making one or more knots, so that the proximal ends of the two or more longitudinal sutures are covered by a tubular sleeve.
[0116] According to some embodiments of the present invention, the method includes introducing a bone implant assembly into a Hill-Sachs injury before implanting a bone anchor. The bone implant assembly is partially positioned within a delivery tube, such that (a) at least a portion of the bone anchor, (b) a bone cavity filling implant, and (c) the distal portions of one or more sutures are positioned within the delivery tube, with the proximal portion of the bone cavity filling implant being close to the bone anchor, and the proximal portions of the one or more sutures extending outside the proximal end opening of the delivery tube.
[0117] According to some embodiments of the present invention, introducing a bone implant into a Hill-Sachs injury involves introducing the bone implant assembly into the Hill-Sachs injury while at least two longitudinal suture portions of the suture are loosely tied when the bone implant assembly is partially positioned within the delivery tube.
[0118] According to some embodiments of the present invention, the bone space filling implant is formed in a ball shape.
[0119] According to some embodiments of the present invention, one or more sutures penetrate the ball.
[0120] According to some embodiments of the present invention, the ball is substantially spherical.
[0121] According to some embodiments of the present invention, the ball is substantially ellipsoidal.
[0122] According to some embodiments of the present invention, the bone space filling implant comprises a sponge impregnated with an osteoconductive bone grafting material.
[0123] According to some embodiments of the present invention, the bone space filling implant comprises a sponge impregnated with an osteoconductive bone grafting material.
[0124] According to some embodiments of the present invention, the bone space filling implant includes bone.
[0125] According to some embodiments of the present invention, the bone space filling implant is formed in a slice shape.
[0126] According to some embodiments of the present invention, the bone space filling implant comprises a tubularly woven mesh which, when shortened and expanded radially, is configured to define one or more radial bulges.
[0127] According to one aspect of several embodiments of the present invention, a bone implant assembly is provided for treating a Bankart injury characterized by detachment of the anteroinferior labrum from the glenoid rim. The bone implant assembly includes a bone anchor shaped to define a distal portion configured to be implanted in the glenoid rim, and an elongated labral receptacle, which is shaped to define (a) a distal articular surface and (b) a proximal groove, the proximal groove being oriented (i) in a direction that moves proximal to the distal articular surface and (ii) in a shape that receives the detached anteroinferior labrum. Here, the elongated labral receptacle is coupled to the proximal portion of the bone anchor so that the distal articular surface of the elongated labral receptacle rests on the glenoid rim, and the proximal groove is configured to move proximal to the glenoid rim and face the detached anteroinferior labrum in order to receive the detached anteroinferior labrum.
[0128] According to some embodiments of the present invention, the proximal groove extends along the entire length of the elongated labral receptacle and is open at both ends of the labral receptacle.
[0129] According to some embodiments of the present invention, the proximal groove has a constant depth along the entire length of the elongated labral receptacle.
[0130] According to some embodiments of the present invention, the proximal groove has a length between 0.5 and 2 cm.
[0131] According to some embodiments of the present invention, the proximal groove has a maximum width between 1 and 10 mm.
[0132] According to some embodiments of the present invention, the proximal groove has a depth between 1 and 10 mm.
[0133] According to some embodiments of the present invention, the proximal groove has a length between 0.5 and 2 cm.
[0134] According to some embodiments of the present invention, the proximal groove has a maximum width between 1 and 10 mm.
[0135] According to some embodiments of the present invention, the distal articular surface of the elongated labral receptacle has a maximum width between 1 and 12 mm.
[0136] According to some embodiments of the present invention, the proximal groove includes a woven fabric.
[0137] According to some embodiments of the present invention, the fabric is porous.
[0138] According to some embodiments of the present invention, the proximal groove is flexible.
[0139] According to some embodiments of the present invention, the bone implant assembly further includes one or more sutures that (a) are fixed to the proximal portion of a bone anchor and extend proximal therefrom, and (b) penetrate the distal articular surface of an elongated labral receptacle, the elongated labral receptacle being able to advance along the one or more sutures toward the proximal portion of the bone anchor.
[0140] According to some embodiments of the present invention, two or more longitudinal suture portions of one or more sutures are configured to be tied when passing through the distal articular surface of the elongated articular labrum receptacle in order to connect the elongated articular labrum receptacle to the proximal part of the bone anchor.
[0141] According to some embodiments of the present invention, each of the one or more openings is 0.2 to 10 mm 2 It has a cross-sectional area between [the two points].
[0142] According to some embodiments of the present invention, the distal articular surface of the elongated labral receptacle is shaped to define exactly two openings through which one or more sutures can pass, each of which is 0.04 to 1.5 mm 2 It has a cross-sectional area between [the two points].
[0143] According to some embodiments of the present invention, the elongated labral receptacle further includes a rigid base frame which defines at least partially the distal articular opposing surface.
[0144] According to some embodiments of the present invention, the distal surface of the rigid base frame defines at least a portion of the distal articular surface of the elongated articular labrum receptacle.
[0145] According to some embodiments of the present invention, the proximal portion of the bone anchor is formed to define an anchor head, one of the anchor head and the rigid base frame is formed to define at least one projection, and the other of the anchor head and the rigid base frame is formed to define at least one projection receiving portion configured to receive at least one projection such that the elongated labral receiving portion does not rotate relative to the bone anchor when the elongated labral receiving portion is coupled to the bone anchor.
[0146] According to some embodiments of the present invention, at least one projection and at least one projection receiving portion are non-circular.
[0147] According to some embodiments of the present invention, the proximal groove is more flexible than the rigid base frame.
[0148] According to some embodiments of the present invention, the proximal portion of the bone anchor is formed to define an anchor head, one of the anchor head and the rigid base frame is formed to define at least one projection, and the other of the anchor head and the distal articular-opposed surface of the elongated labral receptacle is formed to define at least one projection receptacle configured to receive at least one projection, such that the elongated labral receptacle does not rotate relative to the bone anchor when the elongated labral receptacle is coupled to the bone anchor.
[0149] According to some embodiments of the present invention, at least one projection and at least one projection receiving portion are non-circular.
[0150] According to some embodiments of the present invention, the bone implant assembly includes a plurality of bone anchors formed to define each of a plurality of distal portions configured to be implanted in the glenoid rim.
[0151] According to some embodiments of the present invention, the bone implant assembly comprises a plurality of elongated labral receptacles, each configured to connect to the proximal portion of at least one bone anchor.
[0152] According to some embodiments of the present invention, the elongated labral receptacle is configured to connect to at least two proximal portions of a plurality of bone anchors.
[0153] According to some embodiments of the present invention, the bone implant assembly further comprises (a) a plurality of sutures, each fixed to the proximal part of a bone anchor and extending proximal therefrom, and (b) penetrating the distal articular-opposing surface of an elongated labral receptacle, each of which is advancing along the sutures toward the proximal part of the bone anchor.
[0154] According to some embodiments of the present invention, the bone implant assembly comprises exactly a first number of bone anchors, and the distal articular surface of the elongated labral receptacle is formed to define exactly a second number of openings through which sutures pass. The second number is equal to twice the first number, and each opening is 0.04 to 1.5 mm. 2 It has a cross-sectional area between [the two points].
[0155] According to some embodiments of the present invention, at least two bone anchors are formed to define their respective anchor heads and their respective projections proximal to each anchor head. The distal articular-opposing surface of the elongated labral receptacle is formed to define their respective slots, configured to receive each projection of the respective bone anchor, so as to prevent the elongated labral receptacle from rotating relative to the bone anchor when it is coupled to the bone anchor.
[0156] According to some embodiments of the present invention, at least two bone anchors are formed to define respective anchor heads formed to define their respective slots. The distal articular surfaces of the elongated labral receptacle are formed to define each projection configured to be inserted into each slot of the anchor head, so as to prevent the elongated labral receptacle from rotating relative to the bone anchor when it is coupled to the bone anchor.
[0157] According to some embodiments of the present invention, the elongated labral receptacle further comprises a plurality of rigid base frames which define at least partially distal articular surfaces.
[0158] According to some embodiments of the present invention, at least two bone anchors are formed to define their respective anchor heads and their respective projections proximal to each anchor head. A rigid base frame is formed to define each projection receptacle configured to receive its respective projection, so as to prevent the elongated labral receptacle from rotating relative to the bone anchor when the labral receptacle is coupled to the bone anchor.
[0159] According to some embodiments of the present invention, at least two bone anchors are formed to define respective anchor heads formed to define their respective slots. The rigid base frame is formed to define respective projections configured to be inserted into each slot of the anchor head to prevent the elongated labral receptacle from rotating relative to the bone anchor when the labral receptacle is coupled to the bone anchor.
[0160] According to one aspect of several embodiments of the present invention, a method is provided for treating a Bankart injury characterized by the detachment of the anteroinferior labrum from the glenoid rim. The method includes implanting the distal portion of a bone anchor onto the glenoid rim, connecting an elongated labral receptacle to the proximal portion of the bone anchor, placing the distal articular-opposing surface of the elongated labral receptacle on the glenoid rim, so that the proximal groove of the elongated labral receptacle is separated proximal to the distal articular-opposing surface and the glenoid rim, and facing the detached anteroinferior labrum, and inserting the detached anteroinferior labrum into the proximal groove.
[0161] According to some embodiments of the present invention, the bone implant assembly further comprises one or more sutures that (a) are fixed to the proximal portion of the bone anchor and extend proximal therefrom, and (b) penetrate the distal articular surface of the elongated labral receptacle, and connecting the elongated labral receptacle to the proximal portion of the bone anchor comprises advancing the elongated labral receptacle toward the proximal portion of the bone anchor along the one or more sutures.
[0162] According to some embodiments of the present invention, connecting an elongated labral receptacle to the proximal portion of a bone anchor involves tying together two or more longitudinal suture portions of one or more sutures.
[0163] According to some embodiments of the present invention, this method further includes suturing the detached anteroinferior labrum to the proximal groove using one or more sutures.
[0164] According to some embodiments of the present invention, the elongated labral receptacle further includes a rigid base frame which defines at least partially the distal articular opposing surface.
[0165] According to some embodiments of the present invention, the distal surface of the rigid base frame defines at least a portion of the distal articular surface of the elongated articular labrum receptacle.
[0166] According to some embodiments of the present invention, the proximal portion of a bone anchor is formed to define an anchor head, one of the anchor head and a rigid base frame is formed to define at least one projection, and the other of the anchor head and a rigid base frame is formed to define at least one projection receptacle configured to receive at least one projection, and connecting an elongated labral receptacle to the proximal portion of the bone anchor includes inserting at least one projection into at least one projection receptacle in order to prevent the elongated labral receptacle from rotating relative to the bone anchor.
[0167] According to some embodiments of the present invention, at least one projection and at least one projection receiving portion are non-circular.
[0168] According to some embodiments of the present invention, the proximal groove is more flexible than the rigid base frame.
[0169] According to some embodiments of the present invention, the proximal portion of a bone anchor is formed to define an anchor head, one of the anchor head and a rigid base frame is formed to define at least one projection, the other of the anchor head and the distal articular-facing surface of an elongated labral receptacle is formed to define at least one projection receptacle configured to receive at least one projection, and connecting the elongated labral receptacle to the proximal portion of the bone anchor includes inserting at least one projection into at least one projection receptacle in order to prevent the elongated labral receptacle from rotating relative to the bone anchor.
[0170] According to some embodiments of the present invention, at least one projection and at least one projection receiving portion are non-circular.
[0171] According to some embodiments of the present invention, the proximal groove extends along the entire length of the elongated labral receptacle and is open at both ends of the labral receptacle.
[0172] According to some embodiments of the present invention, the proximal groove has a constant depth along the entire length of the elongated labral receptacle.
[0173] According to some embodiments of the present invention, the proximal groove includes a woven fabric.
[0174] According to some embodiments of the present invention, the fabric is porous.
[0175] According to some embodiments of the present invention, the proximal groove is flexible.
[0176] According to some embodiments of the present invention, transplanting the distal portion of a bone anchor to the glenoid rim includes transplanting the distal portions of each of a plurality of bone anchors to the glenoid rim.
[0177] According to some embodiments of the present invention, connecting an elongated labral receptacle to the proximal part of a bone anchor includes connecting each of a plurality of elongated labral receptacles to the proximal part of at least one bone anchor.
[0178] According to some embodiments of the present invention, connecting an elongated labral receptacle to the proximal portion of a bone anchor includes connecting the elongated labral receptacle to the proximal portions of at least two of a plurality of bone anchors.
[0179] According to some embodiments of the present invention, the bone implant assembly further comprises a plurality of sutures that (a) are fixed to the proximal part of a bone anchor and extend proximal therefrom, and (b) penetrate the distal articular surface of an elongated labral receptacle, and joining the elongated labral receptacle to the proximal part of the bone anchor involves advancing the elongated labral receptacle along the sutures toward the proximal part of the bone anchor.
[0180] According to some embodiments of the present invention, at least two bone anchors are formed to define an anchor head and a projection proximal to each anchor head. The distal articular surface of the elongated labral receptacle is formed to define a slot configured to receive the projection of each bone anchor, and connecting the elongated labral receptacle to the proximal portion of the bone anchor includes inserting the projection into the respective slot to prevent the elongated labral receptacle from rotating relative to the bone anchor.
[0181] According to some embodiments of the present invention, at least two bone anchors are formed to define respective anchor heads formed to define their respective slots. The distal articular surfaces of the elongated labral receptacle are formed to define each projection, which is configured to be inserted into each slot of the anchor head, in order to prevent the elongated labral receptacle from rotating relative to the bone anchor when it is coupled to the bone anchor. Coupling the elongated labral receptacle to the proximal portion of the bone anchor involves inserting the projections into their respective slots to prevent the elongated labral receptacle from rotating relative to the bone anchor.
[0182] According to some embodiments of the present invention, the elongated labral receptacle further comprises a plurality of rigid base frames which define at least partially distal articular surfaces.
[0183] According to some embodiments of the present invention, at least two bone anchors are formed to define an anchor head and a projection proximal to each anchor head. A rigid base frame is formed to define projection receptacles configured to receive each projection. Connecting an elongated labral receptacle to the proximal portion of the bone anchor includes inserting each projection into its respective projection receptacle to prevent the elongated labral receptacle from rotating relative to the bone anchor.
[0184] According to some embodiments of the present invention, at least two bone anchors are formed to define each anchor head, which is formed to define each slot. The rigid base frame is formed to define each projection, which is configured to be inserted into each slot of the anchor head, in order to prevent the elongated labral receptacle from rotating relative to the bone anchor when the elongated labral receptacle is coupled to the bone anchor. Coupling the elongated labral receptacle to the proximal part of the bone anchor involves inserting each projection into its respective projection receptacle to prevent the elongated labral receptacle from rotating relative to the bone anchor.
[0185] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which the present invention pertains. Similar or equivalent methods and materials to those described herein may be used in carrying out or trying out embodiments of the present invention, but exemplary methods and / or materials are described below. In case of any conflict, the specification of the present invention, including definitions, shall prevail. Furthermore, the materials, methods and examples are illustrative and not necessarily intended to be restrictive. [Brief explanation of the drawing]
[0186] Some embodiments of the present invention are described herein by reference only to the accompanying drawings. It is emphasized here, with detailed and specific reference to the drawings, that the details shown are illustrative and intended to illustrate embodiments of the present invention. In this regard, the description provided in conjunction with the drawings will make it clear to those skilled in the art how embodiments of the present invention may be carried out. [Figure 1] This is a schematic diagram of a bone implant assembly for treating Hill-Sachs injury of the humeral head, according to several embodiments of the present invention. [Figure 2] This is a schematic diagram of a bone implant assembly partially deployed for Hill-Sachs injury of the humeral head according to several embodiments of the present invention. [Figure 3A] This is a schematic diagram of another bone implant assembly according to some embodiments of the present invention. [Figure 3B] This is a schematic diagram of another bone implant assembly according to some embodiments of the present invention. [Figure 4] Figures 3A and 3B show schematic diagrams of a kit comprising one or more bone implant assemblies and multiple interchangeable bone space filling implants, according to several embodiments of the present invention. [Figure 5] This is a schematic diagram of multiple bone implant assemblies of the kit shown in Figure 4, partially deployed for Hill-Sachs injury of the humeral head, according to some embodiments of the present invention. [Figure 6A] This is a schematic diagram of a part of a method for treating Hillsachs injury using an implant system according to some embodiments of the present invention. [Figure 6B] This is a schematic diagram of a part of a method for treating Hillsachs injury using an implant system according to some embodiments of the present invention. [Figure 7] This is a schematic diagram of a bone implant assembly according to several embodiments of the present invention. [Figure 8A] This is a schematic diagram of another bone implant assembly according to some embodiments of the present invention. [Figure 8B]This is a schematic diagram of another bone implant assembly according to some embodiments of the present invention. [Figure 8C] This is a schematic diagram of another bone implant assembly according to some embodiments of the present invention. [Figure 9] This is a schematic diagram of an implant system according to several embodiments of the present invention. [Figure 10A] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 10B] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 10C] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 10D] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 10E] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 10F] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 10G] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 10H] Figure 9 is a schematic diagram illustrating a method for treating Hill-Sachs injury of the humeral head using the implant system shown in Figure 9, according to several embodiments of the present invention. [Figure 11A] This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 11B]This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 11C] This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 11D] This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 11E] This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 11F] This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 11G] This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 11H] This is a schematic diagram of the configuration of a bone implant assembly and a method for tying the suture portion thereof, according to several embodiments of the present invention. [Figure 12A] This is a schematic diagram of a bone implant assembly for treating Bankart injury according to some embodiments of the present invention. [Figure 12B] This is a schematic diagram of a bone implant assembly for treating Bankart injury according to some embodiments of the present invention. [Figure 13A] Figures 12A and 12B show schematic diagrams of the elongated labral receptacle of a bone implant assembly according to several embodiments of the present invention. [Figure 13B] Figures 12A and 12B show schematic diagrams of the elongated labral receptacle of a bone implant assembly according to several embodiments of the present invention. [Figure 14] Figures 12A and 12B show schematic cross-sectional views of the elongated labral receptacle of a bone implant assembly according to several embodiments of the present invention. [Figure 15A] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 15B] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 15C] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 15D] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 15E] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 15F] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 16] This is a schematic diagram of another bone implant assembly for treating Bankart injury, according to some embodiments of the present invention. [Figure 17A] Figure 16 is a schematic diagram of the elongated labral receptacle of a bone implant assembly according to several embodiments of the present invention. [Figure 17B] Figure 16 is a schematic diagram of the elongated labral receptacle of a bone implant assembly according to several embodiments of the present invention. [Figure 18] Figure 16 shows a schematic cross-sectional view of the elongated labral receptacle of a bone implant assembly according to several embodiments of the present invention. [Figure 19A] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 19B] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 19C] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 19D] This is a schematic diagram of a method for treating Bankart injury according to several embodiments of the present invention. [Figure 20] This is a schematic diagram of exemplary space-filling bone-filling implants according to some embodiments of the present invention. [Figure 21]This is a schematic diagram of an exemplary bone implant with an exemplary funnel according to some embodiments of the present invention. [Figure 22] This is a schematic diagram of an exemplary space-filling implant, which has been implanted into bone, according to some embodiments of the present invention. [Figure 23] This is a flowchart illustrating an exemplary procedure according to several embodiments of the present invention. [Figure 24a] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24b] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24c] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24d] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24e] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24f] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24g] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24h] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24i] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24j] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24k] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24l] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24m] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24n] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24o]This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24p] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24q] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24r] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24s] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24t] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24u] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24v] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24w] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 24x] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25a] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25b] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25c] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25d] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25e] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25f] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25g] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25h] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25i] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25j] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25k] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Figure 25l] This is a schematic diagram illustrating exemplary procedures according to several embodiments of the present invention. [Modes for carrying out the invention]
[0187] In some embodiments, the present invention relates to means and methods for repairing shoulder joint injuries. More specifically, and not limited to, to minimally invasive surgical means and methods for repairing shoulder joint injuries. Overview
[0188] One aspect of several embodiments of the present invention relates to a bone implant comprising one or more anchors and one or more bone graft materials. In some embodiments, the bone graft material is housed in an implant body and / or implant container (also simply called “container”). In some embodiments, the implant container is attached to an anchor, and the anchor is configured to be attached to bone and / or a portion of bone. In some embodiments, the implant body is configured to become an anchor. In some embodiments, the anchor is a soft tissue anchor. In some embodiments, the anchor is a full suture anchor. In some embodiments, the anchor is a screw and / or other anchor known in the art. In some embodiments, the bone implant comprises one or more threads for changing the configuration of the implant body / container. In some embodiments, one or more threads change the configuration of the implant body / container from an elongated, thin implant body / container to a compressed, wide implant body / container. In some embodiments, one or more threads compress the implant body / container toward the anchor and / or bone. In some embodiments, the implant body / container includes an internal space for inserting one or more bone graft materials. In some embodiments, the implant body / container includes one or more additional threads for closing the implant / container after one or more bone graft materials have been inserted therein. In some embodiments, one or more threads are configured for use in holding one or more tissues in bone. In some embodiments, the implant body is physically pressed toward the anchor by the user, rather than being pressed toward the anchor by the threads. In some embodiments, there is a mounting mechanism between a portion of the implant body / container and the anchor, configured to maintain the implant body / container in a compressed, wide shape. Examples include a locking mechanism and an interlocking mechanism.
[0189] Before describing in detail at least one embodiment of the present invention, it should be understood that the application of the present invention is not necessarily limited to the details of the structure, arrangement and / or method of its components presented in the following description and / or shown in the drawings and / or examples. Other embodiments of the present invention are possible and can be carried out or implemented in a variety of ways.
[0190] Refer to Figure 1, a schematic diagram of a bone implant assembly 20 for treating Hill-Sachs injury 22 of the humeral head 24 according to some embodiments of the present invention.
[0191] See also Figure 2, which is a schematic diagram of a bone implant assembly 20 partially deployed in a Hill-Sachs injury 22 of the humeral head 24 according to some embodiments of the present invention.
[0192] In some embodiments, the bone implant assembly 20 includes (a) a bone anchor 32 configured to be implanted in a Hill-Sachs injury 22 of the humeral head 24, as shown in Figure 2; (b) a suture anchor 30 comprising typically one or more (e.g., two or four) sutures 34 fixed to the bone anchor 32 and extending proximal therefrom; and a bone space-filling implant 40 comprising an osteoconductive bone-filling material 42 and coupled to the suture anchor 30.
[0193] In some embodiments, the bone anchor 32 may be any bone anchor known in the art. In some embodiments, the bone anchor 32 is optionally a screw-in anchor, in which case the anchor is threaded as known in the art. Alternatively, in some embodiments, the bone anchor 32 may be a non-screw-in anchor, and may be configured to change shape after being pressed into the bone, as known in the art. In some embodiments, the bone anchor 32 may be biodegradable (absorbable) or non-biodegradable (non-absorbable), as known in the art of bone anchors. For example, the bone anchor 32 may contain titanium or PEEK, as known in the art. In some embodiments, optionally, the bone anchor 32 has a diameter of at least 1.3 mm, 5 mm or less (e.g., 2.8 mm or less), and / or between 1.3 mm and 5 mm, for example, between 1.3 mm and 2.8 mm, such as 1.3 mm, 1.8 mm, 2.3 mm, or 2.8 mm.
[0194] In some embodiments, one or more sutures 34 may be any suture known in the art, such as braided, unbraided, absorbable, non-absorbable, or hybrid sutures. In some embodiments, one or more sutures 34 are optionally connected to small holes in the bone anchor 32.
[0195] In some embodiments, one or more sutures 34 define one or more longitudinal sutures. These may be formed by separate sutures or by one or more sutures that loop through the head of the bone anchor 32.
[0196] In some embodiments, the bone space filling implant 40 includes a porous scaffold.
[0197] In some embodiments, the osteoconductive bone graft material 42 includes a biodegradable or non-biodegradable base.
[0198] For example, the osteoconductive bone graft material 42 may consist of polyester braided tubing sold by Secant Group (Telford, Pennsylvania, USA) and calcium phosphate spheres sold by Himed (Old Bethpage, New York, USA).
[0199] In some embodiments, the bone space filling implant 40 is connected to at least one or more sutures 34 of the suture anchor 30, so as to be connected to the suture anchor 30, which is shown in Figures 1 and 2 and will be described later with reference to Figures 6A and 6B.
[0200] In some embodiments, an additional or alternative bone space filling implant 40 is coupled to a bone anchor 32 for coupling to a suture anchor 30.
[0201] In some embodiments, the bone space filling implant 40 is formed as a ball 50. In some embodiments, one or more sutures 34 optionally pass through the ball 50 as shown in Figures 1 and 2.
[0202] In some embodiments, the ball 50 is generally spherical or generally elliptical.
[0203] In some embodiments, the bone space filling implant 40 includes a sponge impregnated with an osteoconductive bone grafting material 42.
[0204] In some embodiments, the bone space filling implant 40 includes bone (either autogenous bone or allogeneic bone such as from a bone bank).
[0205] Refer to Figure 2. In some embodiments, to treat a Hill-Sachs injury 22 of the humeral head 24, a bone anchor 32 is implanted in the Hill-Sachs injury 22 of the humeral head 24, and one or more sutures 34 fixed to the bone anchor 32 extend proximal out of the Hill-Sachs injury 22 from the bone anchor 32. In some embodiments, at least a portion (e.g., all) of a bone space-filling implant 40 advances along one or more sutures 34 toward the implanted bone anchor 32 so that the bone space-filling implant 40 at least partially fills the Hill-Sachs injury 22. In some embodiments, at least after the bone space-filling implant 40 has advanced along one or more sutures 34 toward the implanted bone anchor 32, the bone space-filling implant 40 contacts the bone anchor 32 as shown in Figure 2. In some embodiments, the bone space filling implant may optionally advance toward the implanted bone anchor 32 along one or more sutures 34, and the bone space filling implant may also come into contact with the bone anchor.
[0206] In some embodiments, one or more sutures 34 are not provided as an alternative. In this case, the bone space-filling implant 40 advances toward the bone anchor 32 without advancing along the sutures. In some embodiments, as a further alternative, the bone space-filling implant 40 is coupled to the bone anchor 32 before the bone anchor is implanted into the Hill-Sachs injury.
[0207] In some embodiments, when the bone anchor 32 is implanted in the Hillsachs injury 22, at least a portion of the bone space-filling implant 40 (e.g., the entire bone space-filling implant 40) is positioned outside the Hillsachs injury 22, and at least a portion of the bone space-filling implant 40 positioned outside the Hillsachs injury 22 is advanced into the Hillsachs injury 22 on one or more sutures 34 after the bone anchor 32 has been implanted.
[0208] In some embodiments, after the bone space-filling implant 40 is advanced toward the implanted bone anchor 32, the bone space-filling implant 40 is secured with one or more sutures 34 (not shown in Figure 2, but shown with respect to the bone space-filling implant 340 in Figures 10G to 10H). In some embodiments, the bone space-filling implant 40 is pressed against the humeral head 24 (and / or against the bone anchor 32) by optionally securing it with one or more sutures 34.
[0209] In some embodiments, depending on the specific dimensions and shape of the injury and the dimensions and shape of the implant, one or more bone space filling implants 40 may be implanted in the Hillsachs injury 22.
[0210] In some embodiments, over time, one or more bone space filling implants 40 fuse with the humeral head 24, thereby filling and healing the Hill-Sachs injury 22.
[0211] Now refer to Figures 3A to 3B. These are schematic diagrams of bone implant assemblies 120 according to some embodiments of the present invention. In some embodiments, the bone implant assembly 120 is a component of the bone implant assembly 20 described above with reference to Figures 1 and 2, and can be implemented by applying any of its features.
[0212] In some embodiments, the bone implant assembly 120 includes a suture anchor 130 and a bone space-filling implant 140. In some embodiments, the suture anchor 130 includes a bone anchor 132 and one or more sutures 34 fixed to the bone anchor 132 and extending proximal therefrom. In some embodiments, the bone space-filling implant 140 is coupled to the suture anchor 130, for example, via one or more sutures 34. In some embodiments, the suture anchor 130, bone anchor 132, one or more sutures 34 and the bone space-filling implant 140 can be implemented by applying any features of the suture anchor 30, bone anchor 32, one or more sutures 34 and the bone space-filling implant 40, respectively, as described above with reference to Figures 1 and 2. Similar reference numerals represent similar parts.
[0213] In some embodiments, the bone space filling implant 140 is connectable to the bone anchor 132. In some embodiments, the bone space filling implant 140 and the bone anchor 132 are each provided with joints 136A and 136B, respectively, which are shaped to be connectable to each other, and optionally the joints are designed so that they cannot be separated from each other without damaging the bone implant assembly 120.
[0214] In some embodiments, the joint 136A is male and the joint 136B is female. In some embodiments, for example, the joint 136A of the bone space filling implant 140 may be shaped to define an axis 138, and the joint 136B of the bone anchor 132 may be shaped to define a conduit 142 formed to receive the axis 138 internally. In some embodiments, the joint 136A is female and the joint 136B is male (configuration not shown).
[0215] In some embodiments, one or more sutures 34 extend through a bone space filling implant 140, for example, through an internal space defined by penetrating the axis 138 of the bone space filling implant 140 and / or through its ball 150, if provided.
[0216] Refer to Figure 4 here. This is a schematic diagram of a kit 152 comprising one or more bone implant assemblies 120 and a plurality of interchangeable space-filling implants 140, according to some embodiments of the present invention. (One interchangeable space-filling implant 140 is shown in Figures 3A-3B.) In some embodiments, the interchangeable space-filling implants 140 differ in size and / or shape from one another. In some embodiments, based on the specific shape of the patient's Hill-Sachs injury 22, the surgeon selects one or more interchangeable space-filling implants 140 and connects them to each suture anchor 130. In some embodiments, the interchangeable space-filling implants 140 and suture anchors 130 can be implemented by applying any features of the space-filling implants 40 and suture anchors 30 described herein, respectively, with reference to Figures 1 and 2.
[0217] In some embodiments, as described above, the interchangeable bone space-filling implants 140 differ in size and / or shape from one another. In some embodiments, for example, bone space-filling implant 140A is generally spherical, bone space-filling implant 140B is generally elliptical, and bone space-filling implant 140C is partially generally spherical and partially generally elliptical.
[0218] Refer to Figure 5 here. This is a schematic diagram of several bone implant assemblies 120 of a kit 154 partially deployed in a Hill-Sachs injury 22 of the humeral head 24, according to some embodiments of the present invention. In some embodiments, each bone implant assembly 120 is shown to include a space-filling implant 140, but the bone implant assemblies 120 may instead include the space-filling implants 40 described above, with reference to Figures 1-2 and 3A-3B. Furthermore, usually one or more sutures 34 are provided (and optionally used to ligate the space-filling implants), but sutures are not shown in Figure 5.
[0219] In some embodiments, as shown in the figure, each bone space-filling implant 140 of the bone implant assembly 120 has different dimensions and / or shapes to accommodate and fill the specific shape of the patient's Hill-Sachs injury 22.
[0220] In some embodiments, depending on the specific dimensions and shape of the Hillsachs injury 22, between one and five bone implant assemblies 120 are used to fill the Hillsachs injury 22.
[0221] Referring again to Figures 1 and 2, and additionally to Figures 6A-6B which schematically show some of the methods for treating Hill-Sachs injury 22 using the implant system 400 according to some embodiments of the present invention. In some embodiments, the implant system 400 includes the bone implant assembly 20 described above with reference to Figures 1 and 2 and a delivery tube 370 described below with reference to Figures 9 and 10A-10D. In some embodiments, as described above and as can be seen in Figure 6A, the bone space filling implant 40 is typically connected to at least one or more sutures 34 of a suture anchor 30 and is connected to the suture anchor.
[0222] In some embodiments, as shown in Figure 6A, the bone implant assembly 20 is partially located inside the delivery tube 370, such that (a) at least a portion of the bone anchor 32, (b) the bone space-filling implant 40, and (c) the distal portions of one or more sutures 34 are located inside the delivery tube 370. In some embodiments, the proximal portions 376 of one or more sutures 34 extend outside the proximal end opening 372A of the delivery tube 370.
[0223] In some embodiments, the bone void filling implant 40 is configured to transition from a thin, compressed delivery configuration 446 when disposed within the delivery tube 370, as shown in FIG. 6A, to an expanded deployment configuration 448, as shown in FIG. 6B, when released from the delivery tube 370. In some embodiments, the bone void filling implant 40 is configured to automatically transition from the thin, compressed delivery configuration 446 to the expanded deployment configuration 448 when released from the delivery tube 370.
[0224] Referring now to FIG. 7, this is a schematic view of a bone implant assembly 520 according to some embodiments of the present invention. In some embodiments, except as otherwise described below, the bone implant assembly 520 is generally the same as the bone implant assembly 20 previously described with reference to FIGS. 1 and 2, and any of its features can be implemented by applying them accordingly. Like reference numbers represent like parts.
[0225] In some embodiments, the bone void filling implant 540 of the bone implant assembly 520 is shaped to define, for example, thin slices that radiate radially from the distal portion of the bone void filling implant 540 that couples to the bone anchor 32. In some embodiments, for example, this thin slice may be fan-shaped or shaped like a Hasselback potato. In some embodiments, for example, the bone void filling implant 540 may define between 3 and 50 slices, such as 5 to 30 slices.
[0226] Referring now to FIGS. 8A - 8C, these are schematic views of bone implant assemblies 620A, 620B, 620C according to respective embodiments of the present invention. In some embodiments, except as otherwise described below, the bone implant assemblies 620A, 620B, 620C are generally the same as the bone implant assembly 20 previously described with reference to FIGS. 1 and 2, and any of its features can be implemented by applying them accordingly. Like reference numbers represent like parts.
[0227] In some embodiments, the bone void filling implant 640A of the bone implant assembly 620A includes a cylindrical sleeve 656. In some embodiments, the material of the cylindrical sleeve 656 either includes the osteoconductive bone filling material 42 or the cylindrical sleeve 656 includes the osteoconductive bone filling material 42 in an internal space defined by the cylindrical sleeve. In some embodiments, the bone void filling implant 640A is configured such that the proximal portion 644 of the bone void filling implant 640A slides distally along one or more sutures 34 toward the bone anchor 32, transitioning from an elongated, thin delivery configuration (not shown) to a shortened and radially expanded deployment configuration 648 (as shown in FIG. 8A) with respect to the humeral head 24.
[0228] In some embodiments, when the bone void filling implant 640A is in the shortened and radially expanded deployment configuration 648, the cylindrical sleeve 656 is formed to define one or more radial protrusions 680, forming a plurality of radially protruding radial protrusions 680, each having a different radial protrusion, as shown in the figure. In some embodiments, the cylindrical sleeve 656 may have a shape similar to a slit Chinese lantern, as known in decorative arts.
[0229] In some embodiments, optionally, the cylindrical sleeve 656 is formed to define one or more axial slits 682, generally a plurality of slits, which assist the bone void filling implant 640A in transitioning to the shortened and radially expanded deployment configuration 648 and cause the cylindrical sleeve 656 to define one or more radial protrusions 680. In some embodiments, optionally, the number of slits is equal to the number of radial protrusions.
[0230] In some embodiments, optionally, the cylindrical sleeve 656 constitutes a knitted mesh.
[0231] In some embodiments, the bone space-filling implants 640B and 640C of the bone implant assemblies 620B and 620C each consist of a thin, elongated element that curves to define a hollow, ball-shaped sleeve. In some embodiments, the bone implant assemblies 620B and 620C are substantially the same as the bone implant assembly 620A and can be implemented by applying all of its features.
[0232] See Figure 9, which is a schematic diagram of an implant system 300 according to several embodiments of the present invention. See also Figures 10A to 10H, which are schematic diagrams of a method for treating Hill-Sachs injury 22 of the humeral head 24 using an implant system 300 according to several embodiments of the present invention.
[0233] In some embodiments, the implant system 300 comprises a bone implant assembly 320, which can be implemented by applying all the features of the bone implant assembly 20 described herein with reference to Figures 1 and 2. Similar reference numerals represent similar parts.
[0234] In some embodiments, the bone implant assembly 320 comprises a bone space-filling implant 340 in addition to the suture anchor 30. This can be implemented by applying all the features of the bone space-filling implant 40 described herein with reference to Figures 1 and 2. In some embodiments, the bone space-filling implant 340 has a proximal portion 344 slidably coupled to one or more sutures 34 and is coupled to the suture anchor 30, as can be seen in the transition between Figure 10D and Figure 10F. In some embodiments, the bone space-filling implant 340 is configured to transition from an elongated, thin delivery configuration 346 shown in Figures 9 and 10D-10E to a shortened, radially expanded deployment configuration 348 pressed against the humeral head 24, as shown in Figures 10G and 10H, by sliding the proximal portion 344 of the bone space-filling implant 340 distally along one or more sutures 34 toward the bone anchor 32, as shown in Figure 10F. In Figures 9 and 10A to 10E, the bone space-filling implant 340 is an elongated, thin delivery configuration 346, which is best shown in Figures 9, 10D, and 10E. In some embodiments, the surgeon controls how tightly the bone space-filling implant 340 is pressed against the humeral head 24 by controlling the degree of transition of the thin delivery configuration 346.
[0235] In some embodiments, the bone space-filling implant 340 is coupled to at least a bone anchor 32 for coupling to a suture anchor 30. In some embodiments, for example, as shown in Figure 9, the distal portion 352 of the bone space-filling implant 340 is fixable to the bone anchor 32 (in this case, a portion of the bone space-filling implant 340 is introduced into the Hill-Sachs injury 22 when the bone anchor 32 is introduced). In some embodiments, the distal portion 352 of the bone space-filling implant 340 is not fixed to the bone anchor 32, and the proximal portion 344 of the bone space-filling implant 340 slides distally along one or more sutures 34 toward the bone anchor 32 when and / or after sliding along one or more sutures 34.
[0236] In some embodiments, as an alternative or addition, the distal portion of the bone space-filling implant 340 is fixed non-slidably to one or more sutures 34 (configuration not shown).
[0237] In some embodiments, the bone space filling implant 340 includes a patch 354.
[0238] In some embodiments, the patch 354 is arranged as a tubular sleeve 356, as shown in the figure. In some embodiments, the material of the tubular sleeve 356 is either the osteoconductive bone graft material 42 or the osteoconductive bone graft material 42 is contained in the internal space defined by the tubular sleeve 356.
[0239] In some embodiments, when the bone space filling implant 340 is an elongated, thin delivery configuration 346, the length L of the patch 354 is between 1 and 15 times the width W of the patch 354 (shown in Figure 9), for example, between 3 and 10 times. In some embodiments, as an alternative or addition, the length of the patch 354 is between 20 and 60 mm, for example, 40 mm, and the width W of the patch 354 is between 3 and 10 mm, for example, 5 mm.
[0240] In some embodiments, when the bone space filling implant 340 is in a shortened and radially expanded deployment configuration (as shown in Figures 10G and 10H), it has a maximum lateral dimension LD of 0.2 to 4 cm, for example, 1 to 3 cm, for example, 1.35 cm.
[0241] In some embodiments, the patch 354 is formed to define at least a first hole 358 and a second hole 360 that penetrate between the opposing first surface 362A and second surface 362B of the patch 354, as shown in Figure 10F. In some embodiments, at least one suture thread 34 penetrates the first hole 358 in a direction 364A from the first surface 362A toward the second surface 362B, and penetrates the second hole 360 in a direction 364B from the second surface 362B toward the first surface 362A.
[0242] In some embodiments, when the patch 354 is in the deployed configuration 348 that is shortened and radially expanded, it is configured to be an accordion-like fold as shown in FIGS. 10F-10H.
[0243] In some embodiments, the patch 354 is configured to collapse as it transitions from the elongated and thin delivery configuration 346 to the shortened and radially expanded deployed configuration 348.
[0244] In some embodiments, the patch 354 can be regarded as such a collapsing tower.
[0245] Refer to FIGS. 9 and 10A-10D. In some embodiments, the implant system 300 further includes a delivery tube 370 having a proximal end opening 372A and a distal end opening 372B. In some embodiments, as shown in FIG. 9, the bone implant assembly 320 is partially disposed within the delivery tube 370 such that (a) at least a portion of the bone anchor 32, (b) the bone void filling implant 340, and (c) the distal portions of one or more suture threads 34 are disposed within the delivery tube 370, and the proximal portion 344 of the bone void filling implant 340 is adjacent to the bone anchor 32. In some embodiments, the proximal portion 376 of each of the one or more suture threads 34 extends out of the proximal end opening 372A of the delivery tube 370.
[0246] In some embodiments, when the bone implant assembly 320 is partially disposed within the delivery tube 370, at least two longitudinal suture thread portions of the suture thread 34 are loosely tied.
[0247] In some embodiments, the delivery tube 370 has an outer diameter of 7 mm or less, such as 6 mm or less, such as 5 mm or less.
[0248] Refer to FIGS. 10A-10H. In some embodiments of the present invention, a method for treating a Hill-Sachs lesion 22 of the humeral head 24 is provided.
[0249] As shown in Figures 10A to 10B, the bone anchor 32 of the suture anchor 30 of the bone implant assembly 20 is implanted into the Hill-Sachs injury 22 of the humeral head 24, and one or more sutures 34 fixed to the bone anchor 32 are made to extend proximal outwards from the bone anchor 32 to the Hill-Sachs injury 22.
[0250] As shown in Figure 10B, in some embodiments, a bone anchor 32 is implanted in the Hillsachs injury 22, and at least a portion of the bone space filling implant 40 is positioned outside the Hillsachs injury 22.
[0251] As shown in Figure 10C, in some embodiments, a bone anchor 32 is implanted in the Hillsachs injury 22, and at least a portion of the bone space filling implant 40 is positioned within the Hillsachs injury 22.
[0252] As shown in Figures 10D to 10G, at least and part of the bone space-filling implant 40 of the bone implant assembly 20 is advanced toward the transplanted bone anchor 32 over one or more sutures so that the bone space-filling implant 40 fills at least partially the Hill-Sachs injury 22.
[0253] In some embodiments, optionally, advancing the bone space-filling implant 40 toward the implanted bone anchor 32 on one or more sutures 34, as shown in Figures 10D to 10G, includes sliding the proximal portion 344 of the bone space-filling implant 40 distally toward the implanted bone anchor 32 along one or more sutures 34, thereby transitioning the bone space-filling implant 40 from an elongated, thin delivery configuration 346 to a shortened, radially expanded deployment configuration 348 toward the humeral head 24.
[0254] In some embodiments, optionally, as shown in Figures 10G to 10H, the bone space filling implant 40 is advanced toward the implanted bone anchor 32, and then the bone space filling implant 40 is secured with one or more sutures 34. In some embodiments, securing the bone space filling implant 40 with one or more sutures 34 optionally presses the bone space filling implant 40 against the humeral head 24.
[0255] In some embodiments, as optionally shown in Figures 10G to 10H, the bone space filling implant 40 is advanced toward the implanted bone anchor 32, after which at least two longitudinal suture portions of one or more sutures 34 are tied.
[0256] Refer to Figures 11A to 11H here. These are schematic diagrams of the configuration of a bone implant assembly 320 and the method of tying the suture portion thereof according to some embodiments of the present invention. In some embodiments, the patch 354 and one or more sutures 34 are arranged such that one or more knots 366 formed by tying together two or more longitudinal suture portions of the one or more sutures 34 are covered by the patch 354, as shown in Figure 11H. In some embodiments where the patch 354 is arranged as a tubular sleeve 356, the tubular sleeve 356 and one or more sutures 34 are arranged such that one or more knots 366 formed by tying together two or more longitudinal suture portions of the one or more sutures 34 are inside the proximal portion 368 (shown in Figure 11G) of the tubular sleeve 356, so that the one or more knots 366 are covered by the tubular sleeve 356 of the patch 354. It should be noted that of the two or more longitudinal suture portions of one or more sutures 34, one or more longitudinal suture portions 374 may be positioned outside the tubular sleeve 356 so as to go outside the sleeve and then return to the sleeve, as shown in Figure 11H.
[0257] In some embodiments, the tying method shown in Figures 11A to 11H is performed after the bone space filling implant 40 has been advanced toward the implanted bone anchor 32, as described above with reference to Figures 10A to 10F. In some embodiments, the tying method can optionally be performed in the steps of the method described above with reference to Figures 10G to 10HF, in which two or more longitudinal sutures of one or more sutures 34 are tied.
[0258] In some embodiments, in the knotting method shown in Figures 11A to 11H, two or more longitudinal suture portions of one or more sutures 34 are knotted by making one or more knots 366 (e.g., two or more knots 366, exactly two knots 366, etc.) as shown in Figures 11D to 11G, and the one or more knots 366 are covered by a patch 354 as shown in Figure 11H.
[0259] In some embodiments, the method further involves cutting off the excess portions of two or more longitudinal sutures after creating one or more knots 366 so that the proximal ends of the two or more longitudinal sutures are covered by the patch 354.
[0260] In some embodiments where patch 354 is arranged as a tubular sleeve 356, one or more knots 366 are made within the proximal portion 368 of the tubular sleeve 356, as shown in Figure 11G, so that one or more knots 366 are covered by the tubular sleeve 356 of patch 354, as shown in Figure 11H.
[0261] In some embodiments, a knot pusher, such as the knot pusher commercially available from Anthrex, Inc. (Naples, Florida, USA), may be used for knot tying, by option.
[0262] Refer here to Figures 12A and 12B, which are schematic diagrams of bone implant assemblies 720 for the treatment of Bankart injury 702 according to some embodiments of the present invention. As is known in the art, Bankart injury 702 may present as a detachment of the anteroinferior labrum 704 from the glenoid rim 706.
[0263] See also Figures 13A and 13B. These are schematic diagrams of the elongated labral receptacle 736 of a bone implant assembly 720 according to several embodiments of the present invention.
[0264] Referring further to Figure 14, this is a schematic cross-sectional view of an elongated labral receptacle 736 according to several embodiments of the present invention.
[0265] In some embodiments, the bone implant assembly 720 includes a bone anchor 732 formed to define a distal portion 733 configured to be implanted in the glenoid rim 706, and an elongated labral receptacle 736, the labral receptacle formed to define (a) a distal articular surface 738 and (b) a proximal groove 740, the proximal groove being (i) oriented in a direction that moves proximal away from the distal articular surface 738 and (ii) formed to receive a detached anteroinferior labrum 704 as shown in Figure 15F.
[0266] As used in this application, including in the claims, “groove” means any elongated depression or recess, such as one between two peaks or waves.
[0267] In some embodiments, the elongated labrum receptacle 736 is configured to connect to the proximal portion 737 of the bone anchor 732, and to receive the detached anteroinferior labrum 704, (a) the distal articular surface 738 rests on the glenoid rim 706, and (b) the proximal groove 740 faces the detached anteroinferior labrum 704, moving proximal away from the glenoid rim 706.
[0268] In some embodiments, the bone implant assembly 720 further includes one or more sutures 734 fixed to the proximal portion 737 of the bone anchor 732 and extending proximal therefrom. In some embodiments, one or more sutures 734 penetrate the distal articular surface 738 of the elongated labral receptacle 736 and optionally the proximal groove 740. In some embodiments, the elongated labral receptacle 736 is advanceable toward the proximal portion 737 of the bone anchor 732 on the one or more sutures 734.
[0269] As can be seen in Figure 12A, in some embodiments, the distal joint opposing surface 738 is formed to define one or more openings through which one or more sutures 734 pass. In some embodiments, each of the one or more openings 744 is optionally 0.04 to 1.5 mm 2 Between, for example, 0.04 to 1 mm 2 Between, for example, 1 mm 2 It has the following cross-sectional area. In some embodiments, optionally, one or more openings 744 extend to the end of the distal joint-opposing surface 738, as shown in the figure. In some embodiments, alternatively, one or more openings 744 are positioned away from the end (configuration not shown).
[0270] In some embodiments, the distal articular surface 738 of the elongated articular labrum receptacle 736 is formed to define exactly two openings 744 through which one or more sutures 734 pass, each of which is 0.2 to 10 mm 2 It has a cross-sectional area between [the two points].
[0271] In some embodiments in which one or more sutures 734 also penetrate the proximal groove 740, the proximal groove 740 is formed to define one or more openings through which the one or more sutures 734 pass. During manufacturing, these openings may be created either before the sutures pass through the openings or when the sutures pass through them (for example, for configurations in which the proximal groove 740 is made of a flexible material such as a woven fabric).
[0272] In some embodiments, two or more longitudinal suture portions 735 of one or more sutures 734 are configured to be tied when passing through the distal articular surface 738 of the elongated articular labral receptacle 736 in order to connect the elongated articular labral receptacle 736 to the proximal portion 737 of the bone anchor 732.
[0273] In some embodiments, as shown in Figures 12A-12B and Figure 14, the elongated labral receptacle 736 further includes a rigid base frame 746, which at least partially defines the distal articular surface 738. In some embodiments, the distal surface 748 of the rigid base frame 746 defines at least a portion of the distal articular surface 738 of the elongated labral receptacle 736; that is, the distal surface 748 of the rigid base frame 746 is exposed distally. In some embodiments, as an alternative or addition, the elongated labral receptacle 736 is made of a more flexible material than the rigid base frame 746. In some embodiments, this material defines the distal articular surface 738. In some embodiments, the rigid base frame 746 at least partially defines the distal articular surface 738 by providing a structure for the more flexible material.
[0274] In some embodiments, the proximal groove 740 is more flexible than the rigid base frame 746.
[0275] As can be seen in FIG. 12A, in some embodiments, the proximal portion 737 of the bone anchor 732 is formed to define an anchor head 749. In some embodiments, one of the anchor head 749 and the rigid base frame 746 is formed to define at least one protrusion 750. In some embodiments, the other of the anchor head 749 and the rigid base frame 746 is formed to define at least one protrusion receiving portion 752 configured to receive the at least one protrusion 750 to prevent rotation of the elongated articular lip receiving portion 736 relative to the bone anchor 732 when the elongated articular lip receiving portion 736 is coupled to the proximal portion 737 of the bone anchor 732. In some embodiments, the protrusion receiving portion 752 may be a recess or a small hole. In some embodiments, in the configuration shown as an example in FIGS. 12A-12B, the anchor head 749 is formed to define at least one protrusion 750 that protrudes in the proximal direction from the anchor head 749, and the rigid base frame 746 is formed to define at least one protrusion receiving portion 752.
[0276] In some embodiments, the protrusion receiving portion 752 is between 0.2 and 10 mm 2 for example, between 0.5 and 5 mm 2 for example, 2.25 mm 2 and has a cross-sectional area.
[0277] In some embodiments, the at least one protrusion 750 and the at least one protrusion receiving portion 752 are non-circular. In some embodiments, for example, the at least one protrusion receiving portion 752 may each be a slot and an elongated recess, neither of which need be rectangular.
[0278] In some embodiments where the protrusion receiving portion 752 is rectangular, the length of the long side is between 0.5 and 5 mm, and the length of the short side is between 0.4 and 2 mm.
[0279] In some embodiments, the elongated labral receptacle 736 does not include a rigid base frame 746 (not shown in bone implant assembly 720, but similar to the configuration of bone implant assembly 820 described herein with reference to Figures 16-19C). In some embodiments, one of the anchor head 749 and the distal articular opposing surface 738 of the elongated labral receptacle 736 is formed to define at least one projection. In some embodiments, the other of the anchor head 749 and the distal articular opposing surface 738 of the elongated labral receptacle 736 is formed to define at least one projection receptacle configured to receive at least one projection in order to prevent rotation of the elongated labral receptacle 736 relative to the bone anchor 732 when the elongated labral receptacle 736 is coupled to the bone anchor 732.
[0280] In some embodiments, at least one projection and at least one projection receiving portion are non-spherical. In some embodiments, for example, at least one projection receiving portion may each be a slot or an elongated recess.
[0281] In some embodiments, the proximal groove 740 extends along the entire length of the elongated labral receptacle 736, with both ends 756 of the elongated labral receptacle 736 being open (as shown in Figures 13A and 13B). In some embodiments, optionally, the proximal groove 740 has a constant depth D along the entire length of the elongated labral receptacle 736 (as shown in Figure 14).
[0282] In some embodiments, the proximal groove 740 has one or more of the following dimensions. • The length L is between 0.5 and 2 cm, for example between 0.5 and 1.5 cm, for example 1 cm. • Maximum width W is between 1 and 10 mm, for example, between 2 and 8 mm. • Depth D is between 1 and 10 mm, for example between 1.5 and 5 mm, for example 2.5 mm.
[0283] In some embodiments, the distal articular surface 738 of the elongated articular labrum receptacle 736 has a maximum width W between 1 and 12 mm, for example between 3 and 8 mm. G It holds.
[0284] In some embodiments, the proximal groove 740 includes a woven fabric. In some applications, the woven fabric is porous.
[0285] In some embodiments, the proximal groove 740 is flexible.
[0286] Refer to Figures 15A to 15F here. These are schematic diagrams of methods for treating Bankart injuries 702 according to several embodiments of the present invention.
[0287] In some embodiments, as shown in Figures 15A to 15C, the distal portion 733 of the bone anchor 732 is implanted in the glenoid fossa rim 706. In some embodiments, as shown in Figures 15A to 15B, one or more sutures 734 of the bone implant assembly 720 are optionally fixed to the proximal portion 737 of the bone anchor 732 and extend proximal.
[0288] In some embodiments, as shown in Figure 15D, the elongated labral receptacle 736 is connected to the proximal portion 737 of the bone anchor 732, with the distal articular-facing surface 738 of the elongated labral receptacle 736 resting on the glenoid fossa rim 706, and the proximal groove 740 of the elongated labral receptacle 736 facing away from the distal articular-facing surface 738 and the glenoid fossa rim 706 in the proximal direction toward the detached anteroinferior labrum 704 (this is not visible in Figure 15C, but will be shown later in Figure 15F).
[0289] In some embodiments, as shown in Figure 15D, two or more longitudinal suture portions 735 of one or more sutures 734 are tied together when passing through the distal articular surface 738 of the elongated labral receptacle 736 to connect the elongated labral receptacle 736 to the proximal portion 737 of the bone anchor 732.
[0290] Figure 15E is explained below.
[0291] In some embodiments, as shown in Figure 15F, the detached anteroinferior labrum 704 is inserted into the proximal groove 740 of the elongated labral receptacle 736.
[0292] In some embodiments, the anterior inferior labrum 704 is optionally sutured to the proximal groove 740, usually using one or more sutures 734. Alternatively, in some embodiments, the anterior inferior labrum 704 is either sutured to the proximal groove 740 using another suture, or it is not sutured to the proximal groove 740 at all.
[0293] Next, Figure 15E will be described. In some embodiments, the bone implant assembly 720 includes a plurality of bone anchors 732. In some embodiments, the bone implant assembly 720 additionally includes a plurality of elongated labral receptacles 736, each configured to be coupled to at least one bone anchor 732. In some embodiments, for example, the bone implant assembly 720 may include the same number of bone anchors 732 and elongated labral receptacles 736, as shown in Figure 15E.
[0294] Here, we refer again to Figures 15A to 15F. In some embodiments, a method for treating Bankart injury 702 is provided, characterized by the dissection of the anteroinferior labrum 704 from the glenoid rim 706.
[0295] In some embodiments, as shown in Figures 15A to 15C, the distal portion 733 of the bone anchor 732 is implanted on the glenoid fossa rim 706.
[0296] In some embodiments, as shown in Figure 15D, the elongated labral receptacle is coupled to the proximal portion 737 of the bone anchor 732, the distal articular surface 738 of the elongated labral receptacle 736 rests on the glenoid fossa rim 706, and the proximal groove 740 of the elongated labral receptacle 736 is positioned so as to move proximal to the distal articular surface 738 and the glenoid fossa rim 706 and face toward the detached anteroinferior labrum 704.
[0297] In some embodiments, as shown in Figure 15D, the elongated labral receptacle 736 is joined to the proximal portion 737 of the bone anchor 732 by advancing the elongated labral receptacle 736 toward the proximal portion 737 of the bone anchor 732 over one or more sutures 734. In some embodiments, optionally, the elongated labral receptacle 736 is joined to the proximal portion 737 of the bone anchor 732 by tying two or more longitudinal suture portions 735 of one or more sutures 734. In some embodiments, a knot pusher, such as a commercially available knot pusher from Anthrex, Inc. (Naples, Florida, USA), can be used for tying.
[0298] In some embodiments, as shown in Figure 15E, multiple distal portions 733 of each of the multiple bone anchors 732 are implanted into the glenoid rim 706. In some embodiments, as shown in Figure 15E, each of the multiple elongated glenoid labral receptacles 736 is coupled to the proximal portion 737 of at least one bone anchor 732.
[0299] In some embodiments, as shown in Figure 15F, the detached anteroinferior labrum 704 is inserted into the proximal groove 740. In some embodiments, the optionally detached anteroinferior labrum 704 is sutured to the proximal groove 740 using one or more sutures 734.
[0300] Now refer to Figure 16. This is a schematic diagram of a bone implant assembly 820 for the treatment of Bankart injury 702 according to several embodiments of the present invention. In some embodiments, the bone implant assembly 820 is similar to the bone implant assembly 720 described so far with reference to Figures 12A to 15F, except as described below, and any of its features can be implemented by analogy. Similar reference numerals represent similar parts.
[0301] See also Figures 17A to 17B, which are schematic diagrams of the elongated labral receptacle of a bone implant assembly 820 according to some embodiments of the present invention. In some embodiments, the bone implant assembly 836 is the same as the bone implant assembly 736 described so far with reference to Figures 12A to 15F, except as described below, and any of its features can be implemented by analogy.
[0302] Referring further to Figure 18, this is a schematic cross-sectional view of an elongated labral receptacle 836 according to several embodiments of the present invention.
[0303] In some embodiments, the bone implant assembly 820 includes a plurality of bone anchors 732 shaped to define each distal portion 733 configured to be implanted in the glenoid rim 706, and an elongated labral receptacle 836, the labral receptacle having a shape that defines (a) a distal articular surface 838 and (b) a proximal groove 840, the proximal groove having a shape that (i) faces in a direction that moves proximal away from the distal articular surface 838 and (ii) receives a detached anteroinferior labrum 704 as shown in Figure 15F.
[0304] In some embodiments, the elongated labral receptacle 836 is connected to at least two proximal portions 737 of a plurality of bone anchors 732 so that (a) the distal articular surface 838 rests on the glenoid rim 706, and (b) the proximal groove 840 is positioned away from the glenoid rim 706 and facing toward the detached anteroinferior labrum 704 to receive the detached anteroinferior labrum 704 as shown in Figure 19D.
[0305] In some embodiments, the bone implant assembly 820 further includes a plurality of sutures 734, each fixed to the proximal portion 737 of the bone anchor 732 and extending proximal therefrom. In some embodiments, the sutures 734 penetrate the distal articular surface 838 of the elongated labral receptacle 836, penetrate the proximal groove 840, or penetrate both the distal articular surface 838 and the proximal groove 840. In some embodiments, optionally, the material of the distal articular surface 838 of the elongated labral receptacle 836 is not pre-formed to define an opening, but rather the opening is formed during manufacturing when the sutures 734 penetrate the material. In some embodiments, each elongated labral receptacle 836 is advanceable along the sutures 734 toward the proximal portion 737 of the bone anchor 732.
[0306] As shown in Figures 16 and 19A to 19D, in some embodiments, each of at least two bone anchors 732 is formed to define an anchor head 749 and at least one projection 750 projecting proximally from the anchor head 749 (for example, at least 0.5 mm, 5 mm or less, or between 0.5 and 5 mm, for example, only 1 mm). In some embodiments, the distal articular surface 838 of the elongated labral receptacle 836 is formed to define a slot 853 configured to receive at least one projection 750 of each of the at least two bone anchors 732, so as to prevent the elongated labral receptacle 836 from rotating relative to the bone anchor 732 when the elongated labral receptacle 836 is coupled to the bone anchor 732.
[0307] In some embodiments (configuration not shown), the elongated labral receptacle 836 further includes a plurality of rigid base frames, which at least partially define the distal articular surface 838. In some embodiments, the rigid base frames may be similar to the rigid base frames 746 described above with reference to Figures 12A-12B and 14, although they are not shown in Figures 16-19D. In some embodiments, the distal surface of the rigid base frame defines at least a portion of the distal articular surface 838 of the elongated labral receptacle 836; that is, the distal surface of the rigid base frame is exposed distally. In some embodiments, as an alternative or addition, the elongated labral receptacle 836 includes a material that is more flexible than the material of the rigid base frame. In some embodiments, this material defines the distal articular surface 838. In some embodiments, the rigid base frame defines the distal articular surface 838 at least partially by providing the structure with a more flexible material. In some embodiments, the proximal groove 840 is more flexible than the rigid base frame. In some embodiments, the bone anchor 732 and the rigid base frame are formed to define their respective projections and projection receiving portions, as described above with reference to the rigid base frame 746 with reference to Figures 12A to 12B and Figure 14.
[0308] In some embodiments, the elongated labral receptacle 836 does not include a rigid base frame, as shown in Figures 16 to 19D.
[0309] In some embodiments (configurations not shown), at least two bone anchors 732 are formed to define individual anchor heads 749, each formed to define a slot. In some embodiments, the distal articular surface 838 of the elongated labral receptacle 836 is formed to define a projection. This prevents the elongated labral receptacle 836 from rotating relative to the bone anchor 732 when it is inserted into each slot of the anchor head 749 and coupled to the bone anchor 732.
[0310] In some embodiments, as shown in Figures 16 to 19D, the proximal groove 840 extends along the entire length of the elongated labral receptacle 836 and is open at both ends 856 of the elongated labral receptacle 836. In some embodiments, optionally, the proximal groove 840 has a constant depth D2 along the entire length of the elongated labral receptacle 836.
[0311] In some embodiments, the proximal groove 840 has one or more of the following dimensions: length between 0.5 and 3 cm, for example between 1 and 2.5 cm, for example 2 cm; maximum width W between 1 and 10 mm, for example between 2 and 8 mm (shown in Figure 18); and / or depth D between 1 and 10 mm, for example between 1.5 and 5 mm, for example 2.5 mm (shown in Figure 18).
[0312] In some embodiments, the distal articular surface 838 of the elongated articular labrum receptacle 836 has a maximum width W between 1 and 12 mm, for example between 3 and 8 mm. G It holds.
[0313] In some embodiments, the proximal groove 840 includes a fabric. In some embodiments, the fabric is porous.
[0314] In some embodiments, the proximal groove 840 is flexible.
[0315] Refer to Figures 19A to 19D here. These are schematic diagrams of methods for treating Bankart injuries 702 according to several embodiments of the present invention.
[0316] In some embodiments, as shown in Figure 19A, the distal portion 733 of the bone anchor 732 is implanted in the glenoid rim 706. In some embodiments, optionally, as shown in Figure 19A, each of the sutures 734 of the bone implant assembly 720 is fixed to the proximal portion 737 of the bone anchor 732 and extends proximal therefrom.
[0317] In some embodiments, as shown in Figure 19B, the elongated labral receptacle 836 is connected to the proximal portion 737 of each bone anchor 732, the distal articular surface 838 of the elongated labral receptacle 836 rests on the glenoid fossa rim 706, and the proximal groove 840 of the elongated labral receptacle 836 moves proximal to the distal articular surface 838 and the glenoid fossa rim 706, facing the detached anteroinferior labrum 70 (this is not visible in Figure 19B, but is shown in Figure 19D, which will be discussed below).
[0318] In some embodiments, as shown in Figure 19C, two or more longitudinal suture portions 735 of each suture 734 are knotted as they pass through the distal articular surfaces 838 of the elongated labral receptacle 836 in order to connect the elongated labral receptacle 836 to each of the proximal portions 837 of the bone anchor 732.
[0319] In some embodiments, as shown in Figure 19D, the detached anteroinferior labrum 704 is inserted into the proximal groove 840.
[0320] In some embodiments, the anterior inferior labrum 704 is optionally sutured to the proximal groove 840, typically using sutures 734. In some embodiments, alternatively, the anterior inferior labrum 704 is either sutured to the proximal groove 840 using a different suture, or it is not sutured to the proximal groove 840 at all.
[0321] Exemplary space-filling implant In some embodiments, a space-space bone-filling implant comprises an implant body or implant container (hereinafter referred to as the container) and a bone anchor (hereinafter referred to as the anchor). In some embodiments, the anchor is a bone screw anchor. In some embodiments, the anchor is any known anchor adapted for use with bone. In some embodiments, the anchor is a full suture anchor, a soft tissue anchor, or a soft material / fabric-based anchor. The terms “full suture anchor” and “soft material / fabric-based bone anchor” are interchangeable, meaning that both include full sutures or soft material / fabric-based anchors as means of anchoring to bone. In some embodiments, the container serves both the role of housing the bone space-filling material in the implant and the role of a bone anchor. Similar reference numbers represent similar parts.
[0322] Refer to Figure 20, which is a schematic representation of an exemplary space-space bone-filling implant 1000 according to several embodiments of the present invention. In some embodiments, the space-space bone-filling implant 1000 includes an implant body / container 1002 made of osteoconductive bone-filling material 42. In some embodiments, the container 1002 includes one or more sutures 34 or threads (hereinafter referred to as sutures, also referred to as threads; the two terms are intended to be synonymous). In some embodiments, one or more threads 34 serve two purposes: to compress the container 1002, which serves as an anchor and / or a vessel for the osteoconductive bone-filling material, and optionally to ligate adjacent tissue to the implant, thereby attaching the adjacent tissue to the bone in which the implant is placed. In some embodiments, the bone space-filling implant 1000 is attached and / or mounted to an anchor inserter 1004, as is commonly done in the art with respect to conventional sutures / soft tissue bone anchors.
[0323] Exemplary osteoconductive bone graft material 42 In some embodiments, one or more osteoconductive bone graft materials are used for the repair of the bone in question. In some embodiments, the osteoconductive bone graft material of a bone space graft implant causes the bone space graft implant to fuse with the bone. In some embodiments, as described above, the osteoconductive bone graft material includes a biodegradable or non-biodegradable substrate. For example, the osteoconductive bone graft material 42 may consist of polyester braided tubing sold by Secant Group (Telford, Pennsylvania, USA) and calcium phosphate spheres sold by Himed (Old Bethpage, New York, USA).
[0324] In some embodiments, the osteoconductive bone graft material 42 comprises one or more organic materials, such as bone marrow, bone marrow stem cells, osteogenic cells, preosteoblasts, osteoblasts, mesenchymal stem cells, bone marrow mesenchymal stem cells, and pluripotent stem cells. In some embodiments, the organic material is extracted from the patient, generally before implanting the bone implant assembly, specifically before implanting the space-filling bone implant 1000. In some embodiments, the material to be inserted is autologous bone harvested during surgery. In some embodiments, the diameter of the harvested bone material, which is optionally in roll form, depends on the dimensions of the bone marrow aspiration needle used. For example, with an 11G needle, a roll with a diameter of about 2.3 mm to about 2.4 mm is harvested. In some embodiments, the length of the bone roll depends on the depth of the puncture. For example, the length of the roll is about 10 mm to about 40 mm. In some embodiments, the harvested material is optionally crushed before being inserted into the container 1002.
[0325] Exemplary container 1002 In some embodiments, the container 1002 includes a tubular sleeve. In some embodiments, the tubular sleeve is made of one or more biodegradable materials such as braided polyester, braided UHMWPE (ultra-high molecular weight polyethylene), braided polyethylene, PLA, PLLA, PGA, PLGA and PHB, and any combination thereof. In some embodiments, the tubular sleeve includes a woven or braided mesh. In some embodiments, the tubular sleeve includes a porous material. For example, the tubular sleeve includes pores with dimensions ranging from about 0.5 mm (height) × 0.5 mm (width) to about 3 mm (height) × 3 mm (width). Optionally, these range from about 0.3 mm (height) × 0.3 mm (width) to about 5 mm (height) × 5 mm (width). Optionally, these range from about 0.1 mm (height) × 0.1 mm (width) to about 10 mm (height) × 10 mm (width). In some embodiments, the height and width dimensions are the same. For example, 1mm x 1mm, 1.5mm x 1.5mm, and 2mm x 2mm. In some embodiments, the height and width dimensions are not the same. For example, 1mm x 1.5mm, 0.5mm x 2mm, and 1.5mm x 2mm. In some embodiments, the tubular sleeve is made of a single fiber having a diameter of approximately 0.3mm to approximately 0.6mm. Optionally, it is approximately 0.1mm to approximately 0.8mm, and also optionally, approximately 0.05mm to approximately 1mm.
[0326] In some embodiments, when defining the structure of a tubular sleeve made of a woven or braided mesh, horizontal rows of loops or stitches traversing the width of the braided fibers correspond to courses of the braided fibers. In the art, the number of courses in one inch of braided fibers is called courses per inch (CPI). On the other hand, rows of loops in the longitudinal direction of the fibers are known as wales. In the art, the number of wales in one inch of braided fibers is called wales per inch (WPI). In some embodiments, the tubular sleeve has an average of about 20 CPI to about 30 CPI, optionally about 15 CPI to about 40 CPI, optionally about 10 CPI to about 50 CPI, e.g., 24 CPI, 27 CPI, 34 CPI. In some embodiments, the tubular sleeve has an average of about 10 WPI to about 20 WPI, optionally about 8 WPI to about 30 WPI, optionally about 5 WPI to about 50 WPI, e.g., 16 WPI, 18 WPI, 23 WPI.
[0327] In some embodiments, at least a portion of the tubular sleeve is used as an anchor portion of a space-filling bone implant. In some embodiments, the tubular sleeve includes a distal end and a proximal end. In some embodiments, the distal end is folded so that the tubular body is folded over, for example as shown in Figure 21 (see 1006). In some embodiments, one or more longitudinal threads 1008 penetrate from one side of the proximal end of the tubular sleeve, along the body of the tubular sleeve, closing the distal end (which is folded), and then, as shown in Figure 21, again along the body of the tubular sleeve, reaching the opposite side of the proximal end of the tubular sleeve. This thereby forms at least two longitudinal thread portions. In some embodiments, the proximal end includes one or more horizontal threads 1010 configured to close its proximal end after one or more osteoconductive bone-filling materials have been inserted into the tubular sleeve.
[0328] In some embodiments, the container 1002 is configured to transition from an elongated, thin delivery configuration (e.g., as shown in Figures 20 and 21) to a shortened and radially expanded deployment configuration 2202 (e.g., as shown in Figure 22). In some embodiments, the shortened and radially expanded deployment configuration presses the container against the bone and / or an anchor within the bone. In some embodiments, as will be detailed later, the shortened and radially expanded deployment configuration is created by, for example, making one or more knots distally using at least two longitudinal thread sections.
[0329] In some embodiments, the shortened and radially extended deployment configuration is held in place by an attachment mechanism positioned between the anchor and the container. Examples include male-female attachment mechanisms, screw connection mechanisms, organic adhesives, sutures, and / or any other attachment mechanisms known in the art.
[0330] In some embodiments, for ease of explanation, the implant comprises two parts: a distal folding side (also called the "anchor") that acts as an anchor for the implant in the bone, and a proximal side that constitutes a container having a material for filling the damaged area in the bone (also called the "bone graft") that fills the damaged area. In some embodiments, the above description is valid for both the anchor portion inside the bone and the container portion above the bone.
[0331] In some embodiments, the thread 1008 is positioned such that one or more knots, formed by tying together at least two longitudinal thread portions of one or more longitudinal threads, are located within the proximal portion of the tubular sleeve, so as to attach the container 1002 to the surface of the bone.
[0332] Exemplary filling and preparation of container 1002 with bone conduction bone graft material 42 As described above, in some embodiments, one or more organic materials are used as the osteoconductive bone graft material 42. In some embodiments, when autologous organic material is used, the organic material is taken from the same patient to whom the implant is applied. In some embodiments, once the organic material is taken, it is optionally inserted into a container 1002 using a dedicated funnel 1012, for example, as shown in Figure 21. In some embodiments, once the organic material is inserted, the container 1002 is closed / sealed using, for example, one or more horizontal threads 1010.
[0333] Exemplary procedure The following sections describe exemplary procedures. For illustrative purposes, we will use an exemplary procedure for treating Hill-Sachs injury 22. It should be understood that the same or similar procedures may be used to treat other types of injuries. Hereinafter, we refer to Figure 23, a flowchart of an exemplary procedure according to several embodiments of the present invention. Furthermore, we also refer to Figures 24a to 24x, which schematically show exemplary different steps performed during the exemplary procedure. In some embodiments, exemplary procedures for treating bone injuries include the following: 1. As schematically shown in Figures 24a and 24b, the size and type of the injury, e.g., Hill-Sachs injury 22 and / or labral tear, are determined using, for example, CT and / or MRI (2302). In some embodiments, the dimensions (see 2402 in Figure 24b) and / or percentage of the bone defect are calculated while the determination is being made. 2. Selection of implants / anchors and amounts of organic material (2304). In some embodiments, the type and number of anchors are selected based on the dimensions of the identified bone defect and / or a calculated percentage. In some embodiments, the amount of organic material required is calculated according to the size of the defect and the number of anchors to be deployed. Examples: Approximately one sample is taken per container. Optionally, two samples are taken per container. Optionally, one to three samples are taken per container. Further samples are taken at the discretion of the user. 3. Harvesting of organic material. In some embodiments, if bone marrow is used as the organic material, harvesting is performed according to a pre-calculated amount of organic material, as schematically shown in Figure 24c. In some embodiments, a see-through cannula 2412 (window - stainless steel / transparent plastic - see-through) is introduced into the harvesting area (as shown, for example, in Figure 24k). In some embodiments, if the harvesting and implantation areas are the same, the same cannula 2412 is used for the entire procedure. An example where the harvesting area 2404 is the bone to be repaired is shown in Figure 24d. In some embodiments, harvesting is performed in a non-articular area. In some embodiments, harvesting is performed in an empty area near, for example, the HSL (Hill-Sachs injury) site or its footprint. 4. Insertion of the collected organic material into the bone space filling implant (2308). In some embodiments, once the organic material 2406 is collected, it is inserted into the container 1002 of the bone space filling implant 1000 via its proximal end. In some embodiments, the container 1002 is already mounted on the anchor inserter 2408. In some embodiments, insertion of the organic material 2406 is optionally performed using a dedicated funnel 2410. Figures 24e and 24f schematically show the insertion of the organic material 2406 into the container 1002 using the dedicated funnel 2410. In some embodiments, after the organic material has been inserted into the container 1002, the proximal end is sealed using, for example, one or more horizontal threads 1010, as schematically shown in Figures 24g and 24h. In some embodiments, the funnel 410 is then removed as schematically shown in Figure 24i to make the device ready for use on a patient. Figure 24j shows an exemplary device ready for use on a patient according to some embodiments of the present invention. 5. Drilling according to anchor dimensions (2310). In some embodiments, if the harvest area is not the same as the implantation area, a see-through cannula 2412 (window - stainless steel / transparent plastic - see-through) is introduced into the area where the implant is to be inserted, for example as shown in Figure 24k. In some embodiments, a hole 2416 is drilled to the required depth according to the selected anchor using a drill 2414, for example as shown in Figures 24l and 24m. In some embodiments, once the hole is drilled, the drill is removed from the cannula. 6. Insert the implant via the cannula (2312). In some embodiments, as schematically shown in Figures 24n, 24o, 24p, and 24q, for example, a space-filling implant attached to an anchor inserter 2408 is inserted into the cannula 2412. The distal end of the implant acting as an anchor is then inserted using a hammer 2418, optionally, to a depth specified by the user, for example, by setting the anchor inserter to a depth that matches the posterior end of the cannula (see 2424 in Figure 24o). 7. Remove the anchor inserter while retaining one or more longitudinal threads (2314). In some embodiments, the anchor inserter 2408 is then removed while retaining one or more longitudinal threads 1008, for example as shown in Figure 24r. In some embodiments, optionally, the cannula 2412 is then removed, for example as shown in Figure 24s. In some embodiments, the cannula 2412 is removed only at the end of the procedure. 8. Implant tying (2316). In some embodiments, the implant is tyed by making one or more knots 2420 using one or more longitudinal threads 1008, as shown in Figures 24t and 24u, for example. In some embodiments, the implant tying operation performs two separate actions: one to initiate the anchoring action of the implant, and the other to radially expand the container 1002 to cover as much of the bone surface as possible.
[0334] In some embodiments, multiple implants are optionally implanted, for example, as shown in Figure 24v.
[0335] In some embodiments, as schematically shown in Figures 24w and 24x, after some time the organic material in the container 1002 induces the filling of damage 2422.
[0336] Exemplary procedure for the glenoid fossa Herein, we refer to Figures 25a to 25l, schematic diagrams of exemplary procedures for the glenoid rim according to several embodiments of the present invention. In Figures 25a to 25l, the part numbers remain the same as in Figures 24a to 24x. In some embodiments, if repair of the glenoid rim is required, similar and / or additional actions are performed to the procedures disclosed above. For example, as follows: 1. Prepare the glenoid rim at the Bankart defect site. 2. Place the cannula 2412 at that location and insert the drill 2414 to perforate the bone, for example, as shown in Figures 25a and 25b. 3. Insert the anchor inserter 2408 with implant 1000 attached into the cannula, and optionally use the hammer 2418 to insert the anchor, for example, as shown in Figures 25c and 25d. 4. Release the longitudinal threads 1008 of 4.1 or longer from the anchor inserter 2408, and extract the anchor inserter 2408, for example, as shown in Figures 25e and 25f. 5. Using longitudinal thread 1008 of 5.1 or longer, the implant is secured by making one or more knots 2420, as shown in Figures 25g and 25h. 6. In some embodiments, two or more bone space filling implants 1002 are used, for example, as shown in Figure 25i, which shows two bone space filling implants 1002. 7. For example, as shown in Figure 25j, the labral tear 2504 is sutured (2502) using a thread attached to the glenoid anchor. 8. Check stability and visually inspect joint alignment. 9. In some embodiments, after a while, as schematically shown in Figures 25k and 25l, the organic material in container 1002 induces damage to the filling of container 2506.
[0337] In this specification, the term "about" as used in relation to quantity or value means "within ±20%."
[0338] The terms "to prepare," "to be prepared," "to include," "to have," "to possess," and their conjugations all mean "to include, but not limited to."
[0339] The term "consisting of" means "including and limiting."
[0340] The term "essentially consisting of" means that the composition, method, or structure may include additional components, steps, and / or parts, but only if such additional components, steps, and / or parts do not substantially alter the basic and novel characteristics of the claimed composition, method, or structure.
[0341] As used herein, the singular forms “a, an” and “the” can also refer to multiple compounds unless the context explicitly indicates otherwise. For example, the terms “one compound” or “at least one compound” can include multiple compounds, including mixtures thereof.
[0342] Throughout this application, embodiments of the present invention may be presented with reference to range forms. It should be understood that range forms are merely for convenience and simplification and should not be interpreted as a fixed and immutable limitation of the scope of the present invention. Therefore, range forms should be considered to specifically disclose all possible subranges, along with the individual numerical values within that range. For example, a range form such as "1-6" should be considered to have specifically disclosed subranges such as "1-3," "1-4," "1-5," "2-4," "2-6," and "3-6," along with the individual numbers within that range, e.g., 1, 2, 3, 4, 5, 6. This applies regardless of the breadth of the range.
[0343] Whenever a numerical range is given herein (e.g., “10 to 15”, “10 to 15”, or any pair of digits joined by another such range), it is meant that any number (fraction or integer) within the limits of the given range is included, including the limits of that range, unless the context explicitly indicates otherwise. The phrases “to” the first and second designations and “the range of” and the phrases “to” the first designation and the second designation and “up to” the second designation, “up to” the first designation and “through” the second designation (or another such range-indicating word) are used interchangeably herein to mean that the first and second designations, as well as all fractions and integers between them, are included.
[0344] Unless otherwise indicated, the numbers used herein and any range of numbers derived therefrom are approximations within reasonable measurement and rounding error tolerances as understood by those skilled in the art.
[0345] As used herein, the term “method” means, but does not include, methods, means, techniques and procedures for accomplishing a given task, including methods, means, techniques and procedures that are known to experts in chemistry, pharmacology, biology, biochemistry and medicine, or that can be readily developed by such experts from known methods, means, techniques and procedures.
[0346] As used herein, the term “treating” includes negating, substantially inhibiting, delaying or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of clinical or aesthetic symptoms of a condition.
[0347] It is understood that certain features of the present invention, even if described in the context of separate embodiments for clarity, may be provided in combination in a single embodiment. Conversely, various features of the present invention described in the context of a single embodiment for brevity may be provided separately, in any suitable partial combination, or in a manner suitable for any other described embodiment of the present invention. Certain features described in the context of various embodiments are not considered essential features of those embodiments unless the embodiment would be inoperable without those elements.
[0348] While the present invention has been described in relation to its specific embodiments, it will be obvious to those skilled in the art that many alternatives, modifications, and variations are apparent. Therefore, the spirit of the appended claims and all such alternatives, modifications, and variations within their broad scope are intended to be encompassed.
[0349] All publications, patents, and patent applications referenced herein are intended to be incorporated herein by reference in their entirety, as if each individual publication, patent, and patent application were specifically and individually noted to be incorporated herein by reference. Furthermore, no citation or specification of any reference within this application should be construed as an admission that such reference is available as prior art to the present invention. Section titles, to the extent that they are used, should not necessarily be construed as restrictive. Furthermore, all priority documents of this application are incorporated herein by reference in their entirety.
Claims
1. A bone implant with dimensions for treating a joint injury, a. A bone anchor that is sized to be inserted into a hole drilled in the bone of the injured area and holds the bone implant in the bone, b. A container connected to the bone anchor and having dimensions such that it is positioned outside the hole within the damaged area, c. The bone-conductive bone-filling material in the container, d. Including one or more sutures fixed to the container and extending proximal to the container, The container comprises a cylindrical sleeve having a proximal end, a distal end, and an internal space containing the osteoconductive bone-filling material, the distal end of the cylindrical sleeve being directly fixed to the proximal end of the bone anchor, The one or more sutures pass through one or more holes provided in the tubular sleeve, As the proximal end of the tubular sleeve slides toward the distal end along one or more sutures, it transitions from an elongated, thin delivery configuration to an expanded configuration that is shortened axially and expands radially relative to the injured area. Bone implants.
2. The bone implant according to claim 1, wherein the container is configured to act as the bone anchor for the bone implant.
3. The bone implant according to claim 1 or 2, wherein the tubular sleeve and the one or more sutures are arranged such that one or more knots formed by tying together two or more longitudinal suture portions of the one or more sutures allow the tubular sleeve to transition from an elongated, thin delivery configuration to a shortened, radially expanded deployment configuration.
4. The bone implant according to any one of claims 1 to 3, wherein the one or more sutures are used to attach adjacent tissue to the site where the bone implant is to be implanted.
5. The bone implant according to any one of claims 1 to 4, wherein the bone-conductive bone graft material comprises one or more organic materials.
6. The bone implant according to any one of claims 1 to 5, wherein one or more organic materials include one or more of bone marrow, bone marrow stem cells, osteogenic cells, preosteoblasts, osteoblasts, mesenchymal stem cells, bone marrow mesenchymal stem cells, and pluripotent stem cells.
7. The cylindrical sleeve comprises one or more of the following: i. A pore having dimensions ranging from approximately 0.5 mm (height) x 0.5 mm (width) to approximately 3 mm (height) x 3 mm (width), ii. Porous scaffolding, iii. Average course density of 20-30 courses per inch (8-12 courses per centimeter), 1V. Average watt density of 10-20 watts per inch (4-8 watts per centimeter), A bone implant according to any one of claims 1 to 6.
8. The tubular sleeve comprises a biodegradable or non-biodegradable substrate, as described in any one of claims 1 to 7, for the bone implant according to any one of claims.
9. The bone implant according to any one of claims 1 to 8, wherein the bone-conductive bone graft material includes a biodegradable or non-biodegradable substrate.
10. The bone implant according to any one of claims 1 to 9, further comprising one or more additional sutures at the proximal end of the tubular sleeve for closing the proximal end after inserting the osteoconductive bone graft material into the tubular sleeve.
11. The bone implant according to any one of claims 1 to 10, wherein the hole in the bone is formed by a drill.
12. The bone implant according to any one of claims 1 to 11, wherein the bone anchor comprises a screw.
13. A bone implant with dimensions for treating a joint injury, a. A bone anchor that holds the bone implant in the bone, with dimensions such that it is inserted into a hole drilled in the bone of the injured area, b. A container having dimensions that are positioned outside the hole within the damaged area, c. The bone-conductive bone-filling material in the container, d. Including one or more sutures fixed to the container and extending proximal to the container, The container comprises a cylindrical sleeve having a proximal end, a distal end, and an internal space containing the osteoconductive bone-filling material, the distal end of the cylindrical sleeve being directly fixed to the proximal end of the bone anchor, The one or more sutures pass through one or more holes provided in the tubular sleeve, As the proximal end of the tubular sleeve slides toward the distal end along one or more sutures, it transitions from an elongated, thin delivery configuration to an expanded configuration that is shortened axially and expands radially relative to the injured area. Bone implants.
14. The bone implant according to claim 13, wherein the container is coupled to the bone anchor by the container and the bone graft material sliding from the proximal end to the distal end of the bone implant.
15. The bone implant according to claim 14, wherein the sliding motion is performed along one or more sutures extending from the distal end of the bone implant in a proximal direction.
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