Suture / Anchor and Delivery Device Combination

Abstract

The suture / anchor and delivery device combination includes a first cannulated suture and a second stepped or staged suture having a smaller diameter section connected to a larger diameter section. The smaller diameter second suture is passed through the first suture, and the suture assembly is further passed through a tube that acts as an inserter. To actuate the device, the larger diameter second suture is drawn into the lumen of the first suture, thereby expanding the first diameter of the first suture and creating an interference fixation in the bone.

Description

[Technical Field]

[0001] The present disclosure relates to surgical repair of joints, and more particularly to devices and methods for inserting suture anchors used in such repairs. [Background technology]

[0002] Anterior shoulder dislocations are common injuries, resulting from falls or overthrows, for example. These dislocations can result in pain, instability throughout the range of motion, and an increased risk of recurrent dislocations. These recurrent dislocations often result in a "Hill-Sachs defect," a damaged area of ​​bone and cartilage over the humeral head, which can lead to further pain, dislocation, and shoulder instability.

[0003] One current surgical solution to reduce the risk of recurrent anterior shoulder dislocation is the Latagé procedure, in which a bone block is fixed to the anterior surface of the glenoid cavity to increase the glenoid surface area and reduce the risk of the humerus slipping out of the glenoid socket. Another procedure is capsular tightening, in which a capsule is placed around the shoulder joint. Tightening the capsule with sutures reduces the space within the joint cavity, reducing the risk of dislocation.

[0004] Current surgical procedures to address Hill-Sachs defects include humeral head transfer, in which a bone graft is placed into the area of ​​the Hill-Sachs defect. Another procedure is lempresurgery, in which infraspinous rotator cuff tissue is drawn into the Hill-Sachs defect using suture anchors. Yet another procedure is impacted bone fragment removal, in which the underside of the Hill-Sachs defect is filled with a bone simulant or bone cement. The ultimate procedure is a joint prosthesis, which includes total or partial shoulder replacement.

[0005] Each of the above procedures generally requires the placement of large, rigid anchors within the bone that can cause additional damage if the anchor inadvertently becomes dislodged from the repair. Therefore, it would be advantageous to provide smaller, softer anchors that also improve the fixation strength of the anchor while avoiding additional damage to the repair. Summary of the Invention

[0006] The present disclosure describes a suture / anchor and delivery device combination, including a micro-sized all-suture anchor, that can be used to reattach the labrum to the glenoid cavity in shoulder dislocation repair. A micro-sized anchor is generally defined as an anchor having a diameter smaller than 1 mm. The device includes a first cannulated suture and a second stepped or staged suture having a smaller diameter section connected to a larger diameter section. The smaller diameter second suture is passed through the first suture, and the suture assembly is further passed through an elongated tube that acts as an inserter. To actuate the device, the larger diameter second suture is drawn into the lumen of the first suture, thereby expanding the first diameter of the first suture. This increase in diameter creates an interference fixation with the bone. The soft suture anchor advantageously reduces the risk of additional injury that could occur if the anchor inadvertently becomes dislodged from the repair. Additionally, soft anchors allow for superior fixation compared to similarly sized hard anchors due to the expansion of the entire suture anchor.

[0007] Further examples of suture / anchor and delivery device combinations of the present disclosure may include one or more of the following, in any suitable combination:

[0008] An example of a suture / anchor delivery and device combination of the present disclosure includes a tube having a distal end and a proximal end. The tube defines a channel extending from the distal end to the proximal end. A first flexible strand has a distal end and a proximal end. The first flexible strand extends through the channel of the tube such that the distal end of the first flexible strand extends from the distal end of the tube. The second flexible strand has a first region having a first diameter and a second region having a second diameter. The first diameter is selected to be smaller than the second diameter. The first region of the second flexible strand extends through a lumen defined by the first flexible strand such that the second region is adjacent the distal end of the first flexible strand. The second region of the second flexible strand is configured to be retracted into the lumen of the first flexible strand to expand the diameter of the first flexible strand.

[0009] In further embodiments, the tube comprises a rigid or semi-rigid material. In embodiments, the first flexible strand comprises a hollow monofilament. In embodiments, the second flexible strand comprises one of a monofilament, a multifilament, a braid, or a mesh. In embodiments, a transition region extends between the first region and the second region of the second flexible strand. In embodiments, the first flexible strand is configured to expand to approximately 0.5 mm. In embodiments, the first region of the second flexible strand comprises 2-0 suture. In embodiments, the second region of the second flexible strand comprises No. 2 suture. In embodiments, the size of the second region of the second flexible strand is selected to allow the second flexible strand to slide through the lumen of the first flexible strand without substantial interference. In embodiments, the size of the first flexible strand is selected to form a friction fit with the channel of the tube. In some embodiments, the first flexible strand extends through a channel in the tube such that a proximal end of the first flexible strand extends from a proximal end of the tube, and in some embodiments, the first region of the second flexible strand extends through a lumen defined by the first flexible strand such that the first region extends from the proximal end of the first flexible strand.

[0010] An example of a surgical repair method of the present disclosure includes inserting a combination suture / anchor delivery device into a hole in a bone. The device includes a tube having a distal end and a proximal end. The tube defines a channel extending from the distal end to the proximal end. A first flexible strand has a distal end and a proximal end. The first flexible strand extends through the channel of the tube such that the distal end of the first flexible strand extends from the distal end of the tube. The second flexible strand has a first region having a first diameter and a second region having a second diameter. The first diameter is selected to be smaller than the second diameter. The first region of the second flexible strand extends through a lumen defined by the first flexible strand such that the second region is adjacent to the distal end of the first flexible strand. The method also includes retracting a second region of the second flexible strand into the lumen of the first flexible strand to expand a diameter of the first flexible strand.

[0011] In further embodiments, the expanded diameter of the first flexible strand is larger than the diameter of the channel in the tube. In embodiments, the expanded diameter of the first flexible strand forms an interference fit with the hole. In embodiments, the method also includes drilling a hole in the bone. In embodiments, the bone is a glenoid. In embodiments, the method also includes removing the tube from the hole after expanding the diameter of the first flexible strand. In embodiments, the first flexible strand extends through the channel in the tube such that a proximal end of the first flexible strand extends from the proximal end of the tube. In embodiments, a first region of the second flexible strand extends through a lumen defined by the first flexible strand such that the first region extends from the proximal end of the first flexible strand.

[0012] These and other feature advantages will become apparent upon reading the following detailed description and upon reference to the associated drawings. Both the foregoing general description and the following detailed description are explanatory only and are not restrictive of the aspects of the disclosure, as set forth in the claims. [Brief explanation of the drawings]

[0013] The present disclosure will be more fully understood by reference to the detailed description taken in conjunction with the following drawings. [Figure 1A] 1A and 1B show the shoulder joint during a shoulder dislocation. [Figure 1B] Same as above. [Figure 1C] Figure 1C shows a Hill-Sachs defect resulting from frequent dislocation of the shoulder joint. [Figure 2A] FIG. 2A shows an exploded view of an example of a combined suture / anchor and delivery device of the present disclosure. [Figure 2B] FIG. 2B is a detailed view of an embodiment of a first flexible strand of a device of the present disclosure. [Figure 2C] FIG. 2C is a detailed view of a portion of a second flexible strand of a device of the present disclosure. [Figure 2D] FIG. 2D shows an assembled view of an embodiment of the device of the present disclosure. [Figure 3A] FIG. 3A shows an example of deployment of the device of the present disclosure in a surgical repair. [Figure 3B] FIG. 3B shows an embodiment of a deployed device of the present disclosure in an exploded state. [Figure 3C] FIG. 3C is a detailed view of the distal end of the first flexible member of the present disclosure. [Figure 4A] 4A, 4B, 4C, 4D and 4E show an example of the use of the device of the present disclosure in surgical repair. [Figure 4B] Same as above. [Figure 4C] Same as above. [Figure 4D] Same as above. [Figure 4E] Same as above. DETAILED DESCRIPTION OF THE INVENTION

[0014] In the following description, similar components are designated by the same reference numerals regardless of the different illustrated embodiments. To clearly and concisely illustrate the embodiments, the drawings may not necessarily be to scale and may have certain features shown somewhat diagrammatically. The present disclosure may describe and / or illustrate features in one embodiment and in one or more other embodiments in the same or similar manner and / or may be combined with or instead of features of other embodiments.

[0015] For purposes of describing and defining the present invention, the terms "about" and "substantially" used in this specification and claims represent the inherent degree of uncertainty associated with any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" also further represent the degree to which a quantitative representation may vary from the stated basis without altering the basic functionality of the subject matter under consideration. Open-ended terms such as "comprises," "includes," and / or each plural form may include the recited components and may include additional unrecited components, while terms such as "and / or" include one or more of the recited components and combinations of the recited components.

[0016] Figures 1A and 1B illustrate a dislocation of the shoulder joint. As shown in Figure 1A, in standard anatomy, the humeral head 20 resides within the labrum 30, a cup-shaped rim of cartilage that lines the glenoid fossa 40 socket and strengthens the ball-and-socket shoulder joint 10. As shown in Figure 1B, when the shoulder joint 10 dislocates, the humeral head 20 dislocates from the labrum 30. Figure 1C illustrates a Hill-Sachs defect 50 that results from frequent dislocations of the shoulder joint 10.

[0017] FIG. 2A illustrates an example of a suture / anchor delivery device 100 of the present disclosure in an exploded view. As shown in FIG. 2A, device 100 may generally include an elongate tube 102, a first flexible strand 104, and a second flexible strand 106. Tube 102 may have a distal end 102a and a proximal end 102b. Tube 102 may define a channel 103 (FIG. 3B) extending from distal end 102a to proximal end 102b. In examples, tube 102 may be made from a rigid or semi-rigid material, such as a rigid plastic or metal. First flexible strand 104 may have a distal end 104a and a proximal end 104b. First flexible strand 104 may further define a lumen 105 (FIG. 2B) extending from distal end 104a to proximal end 104b. In embodiments, first flexible strand 104 may be made from a hollow, flexible material such as monofilament. Second flexible strand 106 may have a distal end 106a and a proximal end 106b. In embodiments, second flexible strand 106 may be made from a flexible material such as monofilament or multifilament, braid, or mesh. The present disclosure contemplates that the second flexible strand may or may not be cannulated.

[0018] FIG. 2C is a detailed view of a portion of the second flexible strand 106. As shown in FIG. 2C, the diameter of the distal end 106a of the second flexible strand 106 can be selected to be larger than the diameter of the proximal end 106b. A transition region 106c can extend between the distal end 106a and the proximal end 106b of the flexible strand 106. The sizes of both the distal end 106a and the proximal end 106b of the second flexible strand 106 can be selected to allow the second flexible strand 106 to slide through the lumen 105 of the first flexible strand 104 without substantial interference. In an embodiment, the proximal end 106b of the second flexible strand 106 can transition from a 2-0 suture to a No. 2 suture at the distal end 106a.

[0019] 2D shows an assembled view of an embodiment of a device 100 of the present disclosure. As shown in FIG. 2D , prior to deployment, the second flexible strand 106 can extend through the lumen 105 of the first flexible strand 104 such that the distal end 106a of the second flexible strand 106 is adjacent to the distal end 104a of the first flexible strand 104 and the proximal end 106b of the second flexible strand 106 extends from the proximal end 104b of the first flexible strand 104. Both the first flexible strand 104 and the second flexible strand 106 can extend further through the tube 102 such that the distal end 104a of the first flexible strand 104 and the distal end 106a of the second flexible strand 106 extend from the distal end 102a of the tube 102. The proximal end 104b of the first flexible strand 104 and the proximal end 106b of the second flexible strand 106 may also extend from the proximal end 102b of the tube 102. The size of the first flexible strand 104 may be selected to form a friction fit with the channel 103 of the tube 102.

[0020] 3A illustrates an example of deployment of device 100 during surgical repair. As shown in FIG. 3A, to deploy device 100, a user may proximally retract proximal end 106b of second flexible strand 106 such that distal end 106a of second flexible strand 106 enters lumen 105 of first flexible strand 104, expanding distal end 104a of first flexible strand 104 relative to distal end 102a of tube 102. When expanded, distal end 104a of first flexible strand 104 may have a diameter greater than the diameter of channel 103 of tube 102 so that expanded distal end 104a is not retracted proximally through tube 102. For example, the diameter of expanded distal end 104a may be approximately 0.5 mm. Due to the extended length of tube 102 and the friction fit between tube 102 and first flexible member 104, first flexible member 104 remains substantially stationary within tube 102 during deployment. Figure 3B shows an example of device 100 in an exploded state, including expanded distal end 104a of first flexible member relative to unexpanded proximal end 104b, and tube 102 including channel 103. Figure 3C shows a detailed view of expanded distal end 104a of first flexible member 104 relative to unexpanded proximal end 104b.

[0021] 4A, 4B, 4C, 4D, and 4E illustrate the use of device 100 in a surgical repair, such as an anterior shoulder dislocation. However, the present disclosure contemplates that device 100 may be used in any suitable repair employing suture anchors. As shown in FIG. 4A, a user may first drill a hole 60, such as glenoid fossa 40, into bone. Then, as shown in FIG. 4B, using tube 102 as a delivery device, the user may insert device 100 into hole 60. As shown in FIG. 4C, the user may then deploy device 100 so that expanded distal end 104a of first flexible member 104 forms an interference fit with hole 60. As shown in FIG. 4D, the user then withdraws tube 102 from hole 60, leaving proximal end 106b of second flexible member 106 extending from hole 60 and ready for use to complete the repair (FIG. 4E).

[0022] In embodiments not shown, the present disclosure also contemplates the use of an outer or driver tube within the device 100. The present disclosure also contemplates the use of more than two flexible members 104, 106. Furthermore, the present disclosure contemplates that rather than retracting the second flexible member 106 into the lumen 105 of the first flexible member 104, the second flexible member 106 may be retracted alongside the first flexible member 104 within the tube 102. Finally, the present disclosure contemplates that the described expansion mechanisms may be paired with a knotless trap (not shown) to create a reduced suture anchor.

[0023] While the present disclosure has particularly shown and described preferred embodiments, those skilled in the art will recognize that various changes in form and details may exist without departing from the spirit and scope of the present application as defined by the appended claims. The scope of the present application is intended to cover such variations. Accordingly, the foregoing description of embodiments of the present application is not intended to limit the full scope conveyed by the appended claims.

Claims

1. A suture / anchor and delivery device combination comprising: a tube having a distal end and a proximal end, the tube defining a channel extending from the distal end to the proximal end; a first flexible strand having a distal end and a proximal end, the first flexible strand extending through the channel of the tube such that the distal end of the first flexible strand extends from the distal end of the tube; a second flexible strand having a first region having a first diameter and a second region having a second diameter, the first diameter being selected to be smaller than the second diameter; the first region of the second flexible strand extends through a lumen defined by the first flexible strand such that the second region is adjacent the distal end of the first flexible strand; A suture / anchor and delivery device combination configured such that the second region of the second flexible strand is retracted into the lumen of the first flexible strand to expand a diameter of the first flexible strand.

2. The suture / anchor and delivery device combination of claim 1 , wherein the tube comprises a rigid or semi-rigid material.

3. The suture / anchor and delivery device combination of claim 1 , wherein the first flexible strand comprises a hollow monofilament.

4. The suture / anchor and delivery device combination of claim 1 , wherein the second flexible strand comprises one of a monofilament, a multifilament, a braid, or a mesh.

5. The suture / anchor and delivery device combination of claim 1 , further comprising a transition region extending between the first region and the second region of the second flexible strand.

6. The suture / anchor and delivery device combination of claim 1 , wherein the first flexible strand is configured to expand to approximately 0.5 mm.

7. The suture / anchor and delivery device combination of claim 1, wherein the first region of the second flexible strand comprises 2-0 suture.

8. The suture / anchor and delivery device combination of claim 1 , wherein the second region of the second flexible strand comprises a No. 2 suture.

9. 10. The suture / anchor and delivery device combination of claim 1, wherein a size of the second region of the second flexible strand is selected to allow the second flexible strand to slide through the lumen of the first flexible strand without substantial interference.

10. The suture / anchor and delivery device combination of claim 1 , wherein the size of the first flexible strand is selected to form a friction fit with the channel of the tube.

11. 2. The suture / anchor and delivery device combination of claim 1, wherein the first flexible strand extends through the channel of the tube such that the proximal end of the first flexible strand extends from the proximal end of the tube.

12. 2. The suture / anchor and delivery device combination of claim 1, wherein the first region of the second flexible strand extends through the lumen defined by the first flexible strand such that the first region extends from the proximal end of the first flexible strand.

13. 1. A method of surgical repair comprising: Inserting a suture / anchor and delivery device combination into a hole in a bone, said device comprising: a tube having a distal end and a proximal end, the tube defining a channel extending from the distal end to the proximal end; a first flexible strand having a distal end and a proximal end, the first flexible strand extending through the channel of the tube such that the distal end of the first flexible strand extends from the distal end of the tube; a second flexible strand having a first region having a first diameter and a second region having a second diameter, the first diameter being selected to be smaller than the second diameter; inserting the first region of the second flexible strand extending through a lumen defined by the first flexible strand such that the second region is adjacent the distal end of the first flexible strand; and retracting the second region of the second flexible strand into the lumen of the first flexible strand to expand a diameter of the first flexible strand.

14. The method of claim 13 , wherein the expanded diameter of the first flexible strand is greater than the diameter of the channel of the tube.

15. The method of claim 13 , wherein the expanded diameter of the first flexible strand forms an interference fit with the hole.

16. The method of claim 13 further comprising drilling the hole in the bone.

17. The method of claim 13 , wherein the bone is a glenoid cavity.

18. The method of claim 13 , further comprising removing the tube from the hole after expanding the diameter of the first flexible strand.

19. The method of claim 13 , wherein the first flexible strand extends through the channel of the tube such that the proximal end of the first flexible strand extends from the proximal end of the tube.

20. 14. The method of claim 13, wherein the first region of the second flexible strand extends through the lumen defined by the first flexible strand such that the first region extends from the proximal end of the first flexible strand.

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