A bidirectional knotless suture anchor

Abstract

The invention provides a bidirectional knotless suture anchor for repairing a damaged soft tissue. The anchor includes an external hollow conical structure having an external region and an internal region. The external region is provided with threads and the internal region has a top portion and a bottom portion. The anchor also includes a detachably mounted internal support. The internal support is configured to form two distinct parts, a first part having a flange, and a second part configured to form a partially threaded screw. The movement of the internal support enables the bi¬ directional adjustment of the suture.

Description

[0001] A BIDIRECTIONAL KNOTLESS SUTURE ANCHOR

[0002] FIELD OF THE INVENTION

[0003] The present invention generally relates to the field of suture anchors. In particular, the invention relates to a bidirectional knotless suture anchor.

[0004] BACKGROUND

[0005] A suture anchor is an indispensable tool for orthopedic surgery, which facilitates the secure fixation of a soft tissue to a bone. One of the functions of the suture anchor is to secure a strong and stable location, during bone fixation. Another function of the suture anchor is to enable a knot, of the suture, connecting the soft tissue to the bone, during the surgery. Many suture anchors have been developed in the art to meet different arthroscopic surgical requirements. One distinct disadvantage of the developed suture anchor is that of the complexity involved in the tying of an arthroscopic knot. Various knotless suture anchors have been developed to overcome the aforementioned disadvantage. The knotless suture anchors eliminate the knot tying process in the arthroscopic surgery, making soft tissue fixation easier and consistent.

[0006] One such knotless suture anchor is disclosed in Patent Application US11000267B2 titled “Knotless suture anchor and methods of use”. The document discloses devices, systems and methods for knotless suturing of tissue. The devices allow sutures to be anchored to bone, and more specifically provide a i suture anchor which eliminates the need for knotting the suture. Thus, damaged tissue may be re-attached to a substrate tissue. But, the bidirectional adjustment of the suture after the insertion of the anchor is not possible with such a system and method.

[0007] Another knotless suture anchor is disclosed in Patent Application US11317904B2 titled “Knotless suture anchor with internal suture locking mechanism” that provides a readily implantable knotless suture anchor. The implantable knotless suture anchor de-couples the angle of insertion of the anchor from the tissue passage step and other steps of conventional procedures. The said anchor provides an internal locking mechanism configured such that the suture knots do not have to be tied. The suture and tissue tension can be easily adjusted intra-operatively. The suture passage and tensioning can be done at a variety of positions and angles. The method includes passing a first suture through a patient's tissue and then through a loop of a shuttle suture, pulling the free end of the shuttle suture until the first suture passes through an internal suture locking mechanism, applying tension in the first suture until adequate tension is achieved with respect to the tissue, automatically engaging an internal locking member and securing the first suture against further relative movement with respect to the anchor. Here, the anchor has a two-suture and one-way lock mechanism in which the suture can be pulled and adjusted in only one direction. Also, the adjustment of the suture is not possible after the anchor is inserted into the tissue. One significant disadvantage of the knotless suture anchors, available in the art, is that the existing knotless suture anchors are designed such that it will be locked after insertion into the bone and cannot be readjusted later. Therefore, there is a need in the art for a bidirectional knotless suture anchor which allows the bidirectional adjustment of the suture after the anchor insertion even without a handle.

[0008] SUMMARY

[0009] One aspect of the invention provides a bidirectional knotless suture anchor for repairing a damaged soft tissue. The anchor includes an external hollow conical structure having an external region and an internal region. The external region is provided with threads and the internal region has a top portion and a bottom portion. The anchor then includes a detachably mounted internal support. The support is configured to form two distinct parts, a first part comprising of a flange, and a second part configured to form a partially threaded screw. The movement of the internal support enables the bi-directional adjustment of the suture.

[0010] BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The following detailed description may be better understood by referencing the accompanying drawings, which contain specific examples of numerous objects and features of the disclosed subject matter. FIG. 1 shows a cross-sectional view of a bidirectional knotless suture anchor, according to an embodiment of the invention.

[0012] FIG. 2 shows the bidirectional knotless suture anchor, according to an embodiment of the invention.

[0013] FIG.3a shows the internal support of the bidirectional knotless suture anchor, according to an embodiment of the invention.

[0014] FIG. 3b shows the internal region of the hollow conical structure, according to an embodiment of the invention.

[0015] FIG. 4a shows a first section view and a top view of the hollow conical structure assembled with the internal support of the bidirectional knotless suture anchor, according to an embodiment of the invention.

[0016] FIG. 4b shows a second section view and a top view of the hollow conical structure assembled with the internal support of the bidirectional knotless suture anchor, according to an embodiment of the invention.

[0017] FIG. 5 shows a cross-sectional view of a bidirectional knotless suture anchor with a suture, according to an embodiment of the invention.

[0018] FIG. 6a is a front view showing the suture around the internal support of the bidirectional knotless suture anchor, according to an embodiment of the invention. FIG. 6b is a side view showing the suture around the internal support of the bidirectional knotless suture anchor, according to an embodiment of the invention.

[0019] FIG. 7 shows the working principle of the flange of the internal support of the bidirectional knotless suture anchor, according to an embodiment of the invention.

[0020] FIG. 8 shows a detachably mounted lock of the bidirectional knotless suture anchor, according to an embodiment of the invention.

[0021] Further, skilled artisans will appreciate that elements in the figures are illustrated for simplicity and may not have been necessarily been drawn to scale. Furthermore, in terms of the design of the circuits, one or more components of the circuit may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the figures with details that will be readily apparent to those of ordinary skill in the art having benefit of the description herein.

[0022] DETAILED DESCRIPTION OF THE INVENTION

[0023] Various embodiment of the invention relates to a bidirectional knotless suture anchor for repairing a damaged soft tissue. The anchor allows re-adjustability of the suture tension in a knotless anchor technique even after the anchor insertion. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting of the invention. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, the use of the terms a, an, etc. does not denote a limitation of quantity, but rather denotes the presence of at least one of the referenced items. It will be further understood that the terms “comprises” and / or “comprising,” or “includes” and / or “including” when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof. It will be further understood that for the purposes of this disclosure, “at least one of” will be interpreted to mean any combination of the enumerated elements following the respective language, including combination of multiples of the enumerated elements.

[0024] Unless otherwise defined, all terms used herein have the same meaning as commonly understood by one of ordinary skills in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure, and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Throughout the drawings and the detailed description, unless otherwise described, the same drawing reference numerals are understood to refer to the same elements, features, and structures. The relative size and depiction of these elements may be exaggerated for clarity, illustration, and convenience.

[0025] FIG. 1 shows a cross-sectional view of a bidirectional knotless suture anchor, according to an embodiment of the invention. The bidirectional knotless suture anchor includes an external hollow conical structure 1 and a detachably mounted internal support 2. The external hollow conical structure 1 has an external region 1a and an internal region 1 b. The external region 1a of the hollow conical structure 1 is provided with threads 3. The internal region 1 b of the hollow conical structure 1 has a top portion and a bottom portion. The top portion of the internal region 1 b is configured to form a quadrilateral. The bottom portion of the internal region 1 b is provided with a partially threaded surface 4 towards the tapering end 5 of the conical structure 1 .

[0026] The detachably mounted internal support 2 is configured to form two distinct parts, a first part that includes a flange 2a and a second part configured to form a partially threaded screw 2b capable of interlocking with the partially threaded surface 4 of the internal region 1 b. The flange 2a is configured for a toggle movement that enables the bidirectional adjustment of a suture (Not shown). In one example, the flange 2a allows bidirectional loosening and tightening of the suture.

[0027] FIG. 2 shows the bidirectional knotless suture anchor, according to an embodiment of the invention. The bidirectional knotless suture anchor includes an external hollow conical structure 1. The anchor is made up of a material that includes but are not limited to a metal, a non-biodegradable material, a biodegradable material, a polymer, copolymer, a composite material, and a bioceramic. The size of the anchor varies from about 4mm to about 12mm. The external hollow conical structure 1 has an external region 1a and an internal region 1 b. The external region 1a of the hollow conical structure 1 is provided with threads 3 to facilitate the insertion of the anchor. The top portion of the internal region 1 b is configured to form a quadrilateral to facilitate the toggle motion of the flange 2a.

[0028] FIG. 3a shows the internal support of the bidirectional knotless suture anchor, according to an embodiment of the invention. The internal support 2 of the bidirectional knotless suture anchor is detachably mounted and is configured to form two distinct parts. The first part includes the flange 2a and the second part is configured to form a partially threaded screw 2b capable of interlocking with the hollow conical structure 1 (Not Shown). The screw 2b is partly not threaded to allow the smooth passage of a suture. 2b of FIG. 3a shows a representative pattern of the partially threaded screw according to an embodiment of the invention. All such patterns that enable a partially threaded screw as realizable and as obvious to a person skilled in the art are included under the scope of the invention.

[0029] FIG. 3b shows the internal region of the hollow conical structure, according to an embodiment of the invention. The partially threaded surface 4 of the internal region 1 b is configured for interlocking with the partially threaded screw 2b shown in FIG. 3a.

[0030] FIG. 4a shows a first section view AA’ and a top view of the hollow conical structure 1 assembled with the internal support 2 of the bidirectional knotless suture anchor, according to an embodiment of the invention. As shown in the section view AA’, the partially threaded screw 2b of the internal support 2 is capable of being adjustably screwed into the partially threaded surface 4 to form a passage 6 towards the tapering end 5 of the internal region 1a of the hollow conical structure 1. The passage 6 is as shown in the top view of the bidirectional knotless suture anchor.

[0031] FIG. 4b shows a second section view BB’ and a top view of the hollow conical structural assembled with the internal support 2 of the bidirectional knotless suture anchor, according to an embodiment of the invention. As shown in the section view BB’, the partially threaded screw 2b of the internal support 2 is capable of being adjustably screwed into the partially threaded surface 4 to form a passage 6 towards the tapering end 5 of the internal region 1a of the hollow conical structure 1. The passage 6 is as shown in the top view of the bidirectional knotless suture anchor.

[0032] FIG. 5 shows a cross-sectional view of a bidirectional knotless suture anchor with a suture 7, according to an embodiment of the invention. The detachably mounted internal support 2 having the flange 2a and the partially threaded screw 2b is interlocked to the partially threaded surface 4 of the hollow conical structure 1 to form the passage 6. The formation of the passage 6 enables the introduction of a guidewire (Not shown), which in turn enables the movement of the suture 7. In one example of the invention, the suture is a braided suture that has a plurality of color-coded filaments of varying sizes that break at specific tensions without breaking the suture. In another example, the suture is a tape suture. The bi-directional adjustment of the suture 7 is enabled by the movement of the internal support 2. In one embodiment of the invention, the toggle motion of the flange 2a allows the suture to be adjusted in bi-direction.

[0033] FIG. 6a is a front view showing the suture 7 around the internal support 2 of the bidirectional knotless suture anchor, according to an embodiment of the invention. The toggle motion of the flange 2a allows bidirectional movement of the suture 7. The flange 2a is also configured to act as a brake for locking the suture. FIG. 6b is a side view showing the suture 7 around the internal support 2 of the bidirectional knotless suture anchor, according to an embodiment of the invention. The bottom portion of the internal support 2 is configured to be partially threaded to allow easy movement of the suture 7 within the anchor. In one embodiment of the invention, the suture is moved along a passage formed around the internal support 2, where there are no threads.

[0034] FIG. 7a and 7b show the working principle of the flange 2a of the internal support 2 of the bidirectional knotless suture anchor, according to an embodiment of the invention. The toggle motion of the flange 2a allows bidirectional movement of the suture 7. The flange 2a is also configured to act as a brake for locking the suture 7. The flange is said to be in a normally locked position when the flange is in a resting position as shown in FIG. 7a. The brake is released by pulling the suture as shown in FIG. 7b. Once the brake is released, the suture can be pulled in both the directions. The suture is pulled until a desired tension is obtained. When the pulling force is released, the brake feature is activated back to the normally locked position and locks the suture 7. When the tension is as required, an extra locking feature (shown in FIG.8) secures the position and the tension on the suture.

[0035] FIG. 8 shows a detachably mounted lock of the bidirectional knotless suture anchor, according to an embodiment of the invention. The anchor is additionally provided with a detachably mounted lock 8 to arrest the motion of the flange2a and thereby the movement of the suture. The arrested motion of the flange allows the suture to be knotless.

[0036] Working of the bidirectional knotless suture anchor

[0037] The invention provides a method for fixation of a soft tissue using a bidirectional knotless suture anchor. The method includes identifying at least one desired position on a bone proximal to the identified soft tissue. Upon identifying the desired position on the bone, the anchor is implanted at the said position on the bone. The external region 1 a of the bidirectional knotless suture anchor is provided with threads 3 to facilitate the implantation of the anchor to the bone. The internal support 2 is adjustably screwed into the partially threaded surface 4 to form an internal passage 6 towards the tapering end 5 of the internal region 1a. A guidewire is inserted through the internal passage 6 of the anchor to form a loop. In one embodiment of the invention, the guidewire is folded and then passed through the passage 6 to form a looped end outside the anchor and the free ends of the guidewire comes out through the other end of the passage 6. Subsequent to the formation of the loop, at least one tension member is passed through the soft tissue and is oriented by passing the tension member through the loop of the guidewire. The guidewire aids in passage of the tension member through the passage6 of the bidirectional knotless suture anchor. The tension member described herein is a suture. The suture is then adjusted in bidirections by determining a load for the identified soft tissue. The toggle motion of the flange 2a allows bidirectional adjustment of the suture 7. When the desired tension is achieved, the movement of the suture is arrested. The detachably mounted lock 8 aids in arresting the motion of the flange 2a and thereby arrests the movement of the suture by allowing the suture to be knotless.

[0038] The invention thus provides a bidirectional knotless suture anchor for repairing a damaged soft tissue. The invention provides a method for soft tissue fixation without the hassle of tying knots and allows bidirectional readjustment of the suture to increase the tension on the sutures after insertion of the anchor into the bone, providing adequate strength for the soft tissue fixation. The invention further provides flexibility for the surgeons to choose the position of the knotless anchor and can also be used in the cases where there is a requirement for more than one anchor.

[0039] In one example of the invention, the bidirectional knotless suture anchor is used during a rotator cuff shoulder surgery. Initially, a torn / damaged soft tissue is identified by means of an arthroscope. The ability of the damaged tissue to withstand traction during soft tissue-to-bone fixation is determined. A tunnel is drilled in the bone proximal to an identified region for attaching the damaged tissue. A first anchor is fixed in the drilled region, the first anchor is attached to one end of tissue by means of a suture. Another hole is drilled for positioning a second anchor. The second anchor is attached to another end of the tissue by means of the suture. Normally, when the second anchor is used, the first anchor sutures get laxity, which can be avoided by using the bidirectional knotless suture anchor. The first anchor is capable of being adjusted without repositioning due to the bi-directional movement of the suture, without the need for removal of the first anchor.

[0040] The foregoing description of the invention has been set for merely to illustrate the invention and is not intended to be limiting. Since modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to person skilled in the art, the invention should be construed to include everything within the scope of the appended claims and equivalents thereof.

Claims

We Claim:

1. A bidirectional knotless suture anchor for repairing a damaged soft tissue, the anchor comprising of: an external hollow conical structure, the structure having an external region and an internal region, the external region provided with threads, the internal region having a top portion and a bottom portion; and a detachably mounted internal support, the support configured to form two distinct parts, a first part comprising of a flange, and a second part configured to form a partially threaded screw, the said screw capable of interlocking with the bottom portion of internal region, wherein the movement of the internal support enables the bidirectional adjustment of the suture.

2. The anchor as claimed in claim 1 , wherein the top portion of the internal region of the hollow conical structure is configured to form a quadrilateral to facilitate the toggle motion of the flange.

3. The anchor as claimed in claim 1 , wherein the bottom portion of the internal region is provided with a partially threaded surface towards the tapering end of the internal region.

4. The anchor as claimed in claim 1 , wherein the partially threaded screw is capable of interlocking with the partially threaded surface of the bottom portion of the internal region.

5. The anchor as claimed in claim 1 , wherein the partially threaded screw of the internal support is capable of being adjustably screwed into the partially threaded internal region to form a passage towards the tapering end of the internal region.

6. The anchor as claimed in claim 1 , wherein the formation of the passage enables the introduction of a guidewire.

7. The anchor as claimed in claim 1 , wherein the guidewire enables movement of a suture.

8. The anchor as claimed in claim 1 , wherein the partially threaded screw of the internal support allows easy movement of the suture within the anchor.

9. The anchor as claimed in claim 1 , wherein the toggle motion of the flange allows bidirectional movement of the suture.

10. The anchor as claimed in claim 1 , wherein the anchor is additionally provided with a detachably mounted lock to arrest the motion of the flange.11 . The anchor as claimed in claim 1 , wherein the arrested motion of the flange allows the suture to be knotless.

12. A method for fixation of a soft tissue using a bidirectional knotless suture anchor, the method comprising of: identifying at least one desired position on a bone proximal to the soft tissue;implanting the anchor at each of the said positions on the bone; inserting a guidewire through an internal passage of the anchor to form a loop; passing at least one tension member through the soft tissue; orienting the tension member by passing the tension member through the loop; adjusting the tension member by determining a load for the identified soft tissue; and arresting the tension member at the adjusted load to form a knotless suture.

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