Suture / anchor and delivery device combination
By using a combination of micro fully suture anchors and delivery devices, the expansion of flexible strands can achieve interference fixation with bone, which solves the problem of easy displacement and insufficient fixation strength of anchors in the prior art, and improves the safety and effect of pre-shoulder dislocation repair.
Patent Information
- Application Number
- CN202380061792.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-09-26
- Filing Date
- 2023-09-20
- Publication Date
- 2025-04-04
AI Technical Summary
In existing anterior shoulder dislocation repair surgery, large hard anchors need to be placed in the bone, which can easily lead to additional damage and insufficient fixation strength.
The combination of micro fully suture anchors and delivery devices, including the first flexible strand and the second flexible strand, is used to increase the diameter of the first flexible strand to achieve interference fixation with bone through the expansion of the second flexible strand.
The additional damage risk caused by unintentional displacement of the anchor is reduced and the anchor fixation strength is improved, showing excellent fixation effect compared to hard anchors of similar size.
Smart Images
Figure CN119768116A_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates to surgical repair of joints, and more particularly to devices and methods for inserting suture anchors for use in such repairs. Background Art
[0002] Anterior shoulder dislocations are common injuries caused, for example, by falls or overhead throws. These dislocations can cause pain, fear during range of motion, and increase the risk of recurrent dislocations. Such recurrent dislocations often result in a "Hill-Sachs defect," a damaged area of bone and cartilage on the humeral head that can lead to further pain, dislocation, and shoulder instability.
[0003] A current surgical solution for reducing the risk of recurrent anterior shoulder dislocation is the Laterjet procedure, in which a bone block is fixed to the front of the glenoid to increase the glenoid surface area and reduce the risk of the humerus falling out of the glenoid fossa. Another procedure is capsular tightening, in which the shoulder joint is surrounded by a joint capsule. When the joint capsule is tightened with sutures, the space in the joint space becomes smaller, reducing the risk of dislocation.
[0004] Current surgical procedures to address Hill-Sachs defects include humeral head transplantation, where a bone graft is placed in the Hill-Sachs defect area. Another procedure is remplissage, where the infraspinatus rotator cuff tissue is pulled into the Hill-Sachs defect with suture anchors. Yet another procedure is disimpaction, where the underside of the Hill-Sachs defect is filled with bone mimics or bone cement. The final procedure is prothesis, which includes full or partial shoulder replacement.
[0005] Each of the above procedures generally requires placement of a large, hard anchor in the bone, which can cause additional trauma if the anchor is inadvertently dislodged from the repair. It would therefore be advantageous to provide a smaller, softer anchor to avoid additional trauma to the repair while also improving the fixation strength of the anchor. Summary of the invention
[0006] The present disclosure describes a suture / anchor and delivery device combination, which includes a micro-all-suture anchor that can be used to reattach the labrum to the glenoid in a shoulder dislocation repair. The micro-anchor is generally defined as an anchor having a diameter of less than 1 mm. The device includes a first tubular suture and a second stepped or graded suture having a smaller diameter section connected to a larger diameter section. The smaller diameter of the second suture passes through the first suture, and the suture assembly further passes through an elongated tube that acts as an inserter. In order to actuate the device, the larger diameter of the second suture is pulled into the lumen of the first suture, thereby expanding the first diameter of the first suture. This increased diameter produces an interference fixation with the bone. The soft suture anchor advantageously reduces the risk of additional damage that may occur if the anchor becomes inadvertently displaced from the repair portion. In addition, due to the expansion of the all-suture anchor, the soft anchor allows excellent fixation compared to a hard anchor of similar size.
[0007] Additional 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 so that the distal end of the first flexible strand extends from the distal end of the tube. A second flexible strand has a first zone and a second zone, the first zone having a first diameter and the second zone having a second diameter. The first diameter is selected to be smaller than the second diameter. The first zone of the second flexible strand extends through an inner cavity defined by the first flexible strand so that the second zone is adjacent to the distal end of the first flexible strand. The second zone of the second flexible strand is configured to be pulled into the inner cavity of the first flexible strand to expand the diameter of the first flexible strand.
[0009] In another example, the tube includes a rigid or semi-rigid material. In an example, the first flexible strand includes a hollow monofilament. In an example, the second flexible strand includes one of a monofilament, a multifilament, a braid or a mesh. In an example, the transition zone extends between the first zone and the second zone of the second flexible strand. In an example, the first flexible strand is configured to expand to about 0.5 mm. In an example, the first zone of the second flexible strand includes a 2-0 suture. In an example, the second zone of the second flexible strand includes a No. 2 suture. In an example, the size of the second zone of the second flexible strand is selected so that the second flexible strand can slide through the lumen of the first flexible strand without substantial interference. In an example, the size of the first flexible strand is selected so that the first flexible strand forms a friction fit with the passage of the tube. In an example, the first flexible strand extends through the passage of the tube so that the proximal end of the first flexible strand extends from the proximal end of the tube. In an example, the first zone of the second flexible strand extends through the lumen defined by the first flexible strand so that the first zone extends from the proximal end of the first flexible strand.
[0010] An example of a surgical repair method disclosed herein includes inserting a suture / anchor delivery device combination 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 so that the distal end of the first flexible strand extends from the distal end of the tube. A second flexible strand has a first zone and a second zone, the first zone having a first diameter and the second zone having a second diameter. The first diameter is selected to be smaller than the second diameter. The first zone of the second flexible strand extends through an inner cavity defined by the first flexible strand so that the second zone is adjacent to the distal end of the first flexible strand. The method also includes pulling the second zone of the second flexible strand into the inner cavity of the first flexible strand to expand the diameter of the first flexible strand.
[0011] In another example, the expanded diameter of the first flexible strand is greater than the diameter of the passage of the tube. In an example, the expanded diameter of the first flexible strand forms an interference fit with the hole. In an example, the method also includes drilling a hole in the bone. In an example, the bone is the glenoid. In an example, the method also includes removing the tube from the hole after expanding the diameter of the first flexible strand. In an example, the first flexible strand extends through the passage of the tube such that the proximal end of the first flexible strand extends from the proximal end of the tube. In an example, the first zone of the second flexible strand extends through the inner cavity defined by the first flexible strand such that the first zone extends from the proximal end of the first flexible strand.
[0012] Advantages of these and other features will become apparent upon reading the following detailed description and examining the associated drawings.Both the foregoing general description and the following detailed description are intended to be explanatory only and are not restrictive of the various aspects of the present disclosure as claimed. BRIEF DESCRIPTION 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, in which:
[0014] Figure 1A and 1B The shoulder joint during a shoulder dislocation is shown;
[0015] Figure 1C A Hill-Sachs defect caused by frequent dislocation of the shoulder joint is shown;
[0016] Figure 2A An example of a suture / anchor and delivery device combination of the present disclosure is shown in exploded view;
[0017] Figure 2B is a detailed view of an example of a first flexible strand of a device of the present disclosure;
[0018] Figure 2C is a detailed view of a portion of a second flexible strand of a device of the present disclosure;
[0019] Figure 2D An example of the apparatus of the present disclosure is shown in an assembled view;
[0020] Figure 3A An example of deployment of the disclosed device in surgical repair is shown;
[0021] Figure 3B An example of a deployed apparatus of the present disclosure is shown in a disassembled state;
[0022] Figure 3C is a detailed view of the distal end of a first flexible member of the present disclosure; and
[0023] Figure 4A -E shows an example of the use of the device of the present disclosure in surgical repair. DETAILED DESCRIPTION
[0024] In the following description, similar parts have the same reference numerals regardless of whether the examples shown are different or not. In order to clearly and concisely illustrate the examples, the drawings may not necessarily reflect proper scale and may have certain features shown in some schematic form. The present disclosure may describe and / or illustrate features in one example and describe and / or illustrate features in the same manner or in a similar manner in one or more other examples, and / or describe and / or illustrate features in combination with or in place of features of other examples.
[0025] In the specification and claims, for the purposes of describing and defining the invention, the terms "about" and "substantially" represent the inherent degree of uncertainty attributed to any quantitative comparison, value, measurement, or other representation. The terms "about" and "substantially" also represent the degree to which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. Open-ended terms such as "comprising," "including," and / or the plural form of each term include the listed parts and may include additional parts that are not listed, while terms such as "and / or" include one or more of the listed parts and combinations of the listed parts.
[0026] Figure 1A and 1B Shows a dislocation of the shoulder joint. Figure 1A As shown in FIG, in normal anatomy, the humeral head 20 is located within the labrum 30, which is a cup-shaped cartilage rim that lines the socket of the glenoid 40 and reinforces the ball and socket shoulder joint 10. Figure 1B As shown in , when the shoulder joint 10 is dislocated, the humeral head 20 becomes displaced from the labrum 30 . Figure 1C A Hill-Sachs defect 50 caused by frequent dislocation of the shoulder joint 10 is shown.
[0027] Figure 2A An example of a suture / anchor delivery device 100 of the present disclosure is shown in exploded view. Figure 2A As shown in FIG. 1 , the device 100 may generally include an elongated tube 102, a first flexible strand 104, and a second flexible strand 106. The tube 102 may have a distal end 102a and a proximal end 102b. The tube 102 may define a channel 103 ( Figure 3B In an example, the tube 102 can be made of a rigid or semi-rigid material such as a hard plastic or metal. The first flexible strand 104 can have a distal end 104a and a proximal end 104b. The first flexible strand 104 can further define a lumen 105 ( Figure 2B ). In an example, the first flexible strand 104 can be made of a hollow flexible material such as a monofilament. The second flexible strand 106 can have a distal end 106a and a proximal end 106b. In an example, the second flexible strand 106 can be made of a flexible material such as a monofilament or multifilament, a braid, or a mesh. The present disclosure contemplates that the second flexible strand can be tubular or not tubular.
[0028] Figure 2C Detailed view of a portion of the second flexible strand 106. Figure 2C, the diameter of the distal end 106a of the second flexible strand 106 may be selected to be larger than the diameter of the proximal end 106b. The transition zone 106c may extend between the distal end 106a and the proximal end 106b of the flexible strand 106. The size of both the distal end 106a and the proximal end 106b of the second flexible strand 106 may be selected so that the second flexible strand 106 can slide through the lumen 105 of the first flexible strand 104 without substantial interference. In an example, the proximal end 106b of the second flexible strand 106 may transition from a 2-0 suture to a No. 2 suture at the distal end 106a.
[0029] Figure 2D An example of the device 100 of the present disclosure is shown in an assembled view. Figure 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 further extend 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 can also extend from the proximal end 102b of the tube 102. The size of the first flexible strand 104 can be selected so that the first flexible strand forms a friction fit with the channel 103 of the tube 102.
[0030] Figure 3A An example of the deployment of the device 100 in surgical repair is shown. Figure 3A As shown in , to deploy the device 100, the user can pull the proximal end 106b of the second flexible strand 106 proximally so that the distal end 106a of the second flexible strand 106 enters the lumen 105 of the first flexible strand 104, thereby expanding the distal end 104a of the first flexible strand 104 against the distal end 102a of the tube. When expanding, the distal end 104a of the first flexible strand 104 may have a diameter larger than the diameter of the passage 103 of the tube 102, so that the expanded distal end 104a cannot be pulled proximally through the tube 102. For example, the diameter of the expanded distal end 104a can be about 0.5mm. Due to the extended length of the tube 102 and the friction fit between the tube 102 and the first flexible member 104, the first flexible member 104 remains substantially stationary within the tube 102 during deployment. Figure 3B An example of a deployed device 100 is shown in an exploded state, including an expanded distal end 104a of a first flexible member relative to an unexpanded proximal end 104b, and a tube 102 including a channel 103 . Figure 3CA detailed view of the expanded distal end 104a of the first flexible member 104 is shown relative to the unexpanded proximal end 104b.
[0031] Figure 4A -E shows the use of the device 100 in a surgical repair such as an anterior shoulder dislocation. However, the present disclosure contemplates that the device 100 may also be used in any suitable repair using suture anchors. Figure 4A As shown in , a user may first drill a hole 60 in a bone such as the glenoid 40. Then, as shown in Figure 4B As shown in FIG. 1 , using tube 102 as a delivery device, a user can insert device 100 into hole 60. Figure 4C As shown in , the user can then deploy the device 100 so that the expanded distal end 104a of the first flexible member 104 forms an interference fit with the hole 60. Figure 4D As shown in FIG. 1 , the user can then withdraw the tube 102 from the hole 60, leaving the proximal end 106b of the second flexible member 106 extending from the hole 60 and ready for completion of the repair ( Figure 4E ).
[0032] In examples not shown, the present disclosure also contemplates the use of an outer tube or drive tube in the device 100. The present disclosure also contemplates the use of more than two flexible members 104, 106. In addition, the present disclosure contemplates that the second flexible member 106 can be pulled within the tube 102 alongside the first flexible member 104, rather than pulling the second flexible member 106 into the lumen 105 of the first flexible member 104. Finally, the present disclosure contemplates that the described expansion mechanism can be paired with a knotless trap (not shown) to create a reduced suture anchor.
[0033] Although the present disclosure particularly shows and describes preferred embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made 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 encompass these changes. Thus, the foregoing description of the examples 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 passage 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 passageway of the tube such that the distal end of the first flexible strand extends from the distal end of the tube; as well as a second flexible strand having a first region and a second region, the first region having a first diameter and the second region having a second diameter, the first diameter being selected to be smaller than the second diameter; wherein a first region of the second flexible strand extends through a lumen defined by the first flexible strand such that the second region is adjacent a distal end of the first flexible strand; and Wherein the second region of the second flexible strand is configured to be pulled 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 a 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 number 2 suture.
9. The suture / anchor and delivery device combination of claim 1, wherein the second region of the second flexible strand is sized to enable 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 first flexible strand is sized such that the first flexible strand forms a friction fit with the channel of the tube.
11. The suture / anchor and delivery device combination of claim 1 , wherein the first flexible strand extends through the passageway of the tube such that a proximal end of the first flexible strand extends from a proximal end of the tube.
12. 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 a proximal end of the first flexible strand.
13. A method of surgical repair, comprising: The suture / anchor and delivery device combination is inserted into a hole in the bone, the device comprising: a tube having a distal end and a proximal end, the tube defining a passage 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 passageway of the tube such that the distal end of the first flexible strand extends from the distal end of the tube; and a second flexible strand having a first region and a second region, the first region having a first diameter and the second region having a second diameter, the first diameter being selected to be smaller than the second diameter; wherein a first region of the second flexible strand extends through a lumen defined by the first flexible strand such that the second region is adjacent a distal end of the first flexible strand; and The second region of the second flexible strand is drawn 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 passageway of the tube.
15. The method of claim 13, wherein the expanded diameter of the first flexible strand forms an interference fit with the aperture.
16. The method of claim 13, further comprising drilling the hole in the bone.
17. The method of claim 13, wherein the bone is the glenoid.
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 a passageway of the tube such that a proximal end of the first flexible strand extends from a proximal end of the tube.
20. 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 a proximal end of the first flexible strand.