An interlocking structure full suture anchor system with round flat wire

Abstract

This invention belongs to the field of medical device technology and discloses a full-suture anchor system with an interlocking structure and a round flat suture band. The system includes: a full-suture anchor head, which is a circular tubular braided structure with a central cavity; a variable-diameter suture passing through the central cavity of the anchor head, the suture comprising a working section and a guide section, the guide section having a gradually tapering diameter; and a round flat suture band passing through the central cavity of the anchor head, the round flat suture band having circular braided structures at both ends and a flat band-like braided structure in the middle. Through the nested interlocking of the variable-diameter suture and the round flat suture band, parallel "suture bridge" structures can be formed between any anchors. By compressing the soft tissue, the gap between the avulsed soft tissue and bone is reduced, bringing it closer to its pre-avulsion state, which is beneficial for the regrowth and recovery of the soft tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a full suture anchor system with an interlocking structure and a round flat suture band. Background Technology

[0002] Suture anchors are widely used implantable medical devices in the field of sports medicine. They are mainly used to fix soft tissues such as ligaments and tendons to the bone surface, and are commonly used in surgeries such as rotator cuff repair and knee ligament reconstruction. Depending on the material, suture anchors can be divided into rigid anchors (such as metal anchors, PEEK anchors, and absorbable anchors) and soft anchors (such as full suture anchors).

[0003] Rigid anchors have revealed the following drawbacks in long-term clinical use:

[0004] 1. After metal anchors (such as titanium alloys and stainless steel) are implanted into the human body, the mismatch between the material and the mechanical properties of the bone can easily lead to stress shielding effects. This can also trigger a rejection reaction in the body, causing osteolysis at the implantation site, which in turn can lead to anchor loosening or displacement, resulting in fixation failure. For young, active patients, metal anchors also carry a risk of long-term displacement.

[0005] 2. While absorbable anchors (such as PLA-based materials) avoid the permanent implantation problems of metal anchors, their degradation cycle varies significantly among individuals and is difficult to control precisely. Clinical practice has shown that some patients experience premature anchor degradation, leading to anchor breakage, displacement, and a sharp decrease in fixation strength. Furthermore, degradation products may trigger aseptic inflammatory reactions, such as synovitis and osteolysis, affecting postoperative recovery.

[0006] 3. While PEEK anchors, as a new generation of rigid anchors, avoid to some extent the rejection problems of metal anchors and the uncontrollable degradation issues of absorbable anchors, their implantation requires a large amount of bone removal, increasing the risk of intraoperative fractures, especially for patients with osteoporosis. Furthermore, if the rigid anchor dislodges due to osteolysis or mechanical fatigue, the dislodged rigid foreign body may cause secondary mechanical damage to surrounding soft tissues, and revision surgery is significantly more difficult.

[0007] In contrast, fully sutured anchors have gradually become a research hotspot in the field of sports medicine in recent years due to their advantages such as soft material, good biocompatibility, low rejection rate, and minimal bone removal. Fully sutured anchors are made of high-strength braided sutures, requiring only a small-diameter bone hole for implantation, resulting in minimal bone damage and faster postoperative recovery for patients. Even if the anchor accidentally dislodges, its soft texture will not cause serious secondary damage to surrounding soft tissues.

[0008] However, a review of existing technologies reveals that current suture anchor products on the market have a relatively simple structure, mostly using a single suture to make the anchor head, carrying one or two sutures, and only providing a single fixation point. In use, after drilling a hole, an inserter is used to implant the anchor head into the bone tunnel, the suture is tightened to cause the anchor head to expand and lock in place, and finally, the soft tissue is fixed to the bone surface by tying a knot in the suture.

[0009] The aforementioned existing technology has the following technical problems:

[0010] First, for large-area soft tissue tears (such as large-area rotator cuff tears, complete Achilles tendon rupture, etc.), a single fixation point is difficult to achieve uniform compression between the soft tissue and the bone surface, which can easily lead to problems such as poor adhesion and poor healing after surgery, affecting the surgical outcome.

[0011] Second, existing full-suture anchors cannot form an effective connection structure between multiple anchors, making it difficult to construct a multi-point fixation system similar to a "suture bridge" and unable to simulate the anatomical state before soft tissue avulsion.

[0012] Third, when traditional sutures compress soft tissue, their thinner diameter makes them prone to cutting the soft tissue under the same tension, which may cause the sutures to cut the tissue or loosen, affecting the reliability of fixation.

[0013] Fourth, existing full-suture anchors require knotting for fixation, which makes the surgical procedure cumbersome. The quality of the knotting depends on the surgeon's experience, and loose or insecure knots may lead to fixation failure, while also prolonging the operation time.

[0014] Therefore, developing a full suture anchor system that can form an interlocking structure between multiple anchors, achieve multi-point fixation, and effectively disperse soft tissue pressure has important clinical significance and application value. Summary of the Invention

[0015] The purpose of this invention is to overcome the shortcomings of the prior art and to propose a fully stitched anchor system with an interlocking structure and a round flat thread strip.

[0016] To address the aforementioned technical problems, the present invention adopts the following technical solution:

[0017] A fully threaded anchor system with an interlocking structure and round flat thread strip, comprising:

[0018] The fully stitched anchor head has a cylindrical braided structure and a cavity at its center.

[0019] A variable diameter suture passes through the central cavity of the full-suture anchor head. The variable diameter suture includes a working section and a lead section, the diameter of which gradually decreases.

[0020] A round flat thread strip passes through the central cavity of the full-seam anchor head. The round flat thread strip has circular braided structures at both ends and a flat strip-shaped braided structure in the middle.

[0021] A round flat wire loop, wherein one end of the round flat wire loop is a round wire forming a loop, and the other end is a flat wire;

[0022] Insertor used to implant the head of a full-suture anchor into the bone tunnel;

[0023] The variable diameter suture, round and flat suture strip, and round and flat suture ring are used together to form an interlocking "suture bridge" structure between multiple anchors.

[0024] As a preferred technical solution, the working section of the variable diameter suture is a standard No. 2 suture or No. 5 suture, and the lead-in section has a gradually thinning structure.

[0025] As a preferred technical solution, the width of the flat portion of the round flat strip is 1.5mm to 5mm.

[0026] As a preferred technical solution, the diameter of the round flat thread loop is 2cm to 4cm, and it is used to fit the end of the variable diameter suture.

[0027] As a preferred technical solution, the inserter includes a rod and a handle, and the handle is provided with a silicone ring for securing the end of the thread.

[0028] As a preferred technical solution, the fully sewn anchor head and the sewing material are both ultra-high molecular weight polyethylene material, polyester material, or a mixture of the two.

[0029] As a preferred technical solution, the rod material is nickel-titanium alloy or stainless steel, and the handle material is ABS plastic.

[0030] As a preferred technical solution, the variable diameter suture, round and flat suture strip, and round and flat suture ring form a parallel "suture bridge" structure between any two anchors through a nested interlocking method.

[0031] As a preferred technical solution, after the variable diameter suture passes through the central cavity of the full-suture anchor head, the end of its working section extends 3mm to 7mm beyond the end face of the full-suture anchor head.

[0032] As a preferred technical solution, the two ends of the round flat thread strip are aligned after passing through the central cavity of the full-seam anchor head.

[0033] Compared with the prior art, the advantages of this invention are:

[0034] 1. By nesting and interlocking variable diameter sutures and round and flat suture loops, parallel "suture bridge" structures can be formed between any anchors. By compressing the soft tissue, the gap between the avulsed soft tissue and the bone is smaller and closer to the state before avulsion, which is conducive to the regrowth and recovery of soft tissue.

[0035] II. The variable-diameter suture of this invention comprises a working section and a lead section, with the lead section gradually tapering in diameter. During nesting operations, the thinner lead section more easily passes through the round flat suture loop or the anchor head cavity, reducing operational difficulty; during tightening and fixing, the thicker working section enters the anchor head, allowing the anchor head to expand more fully and clamp more securely within the bone tunnel, improving the reliability of fixation. The working section uses standard #2 or #5 suture, ensuring sufficient tensile strength;

[0036] Third, this invention introduces a round-flat strip structure, with round ends for easy threading and a flat strip in the middle as the working section. Under the same tension, the flat strip structure has a larger contact area with soft tissue, resulting in more dispersed stress and effectively avoiding the cutting effect on soft tissue.

[0037] Fourth, this invention combines the principle of knot-free suture anchors, using nested interlocking and interface anchors (outer row anchors) for fixation, eliminating the need for knotting throughout the entire surgical process. This not only reduces surgical steps and shortens surgical time, but also avoids the risk of fixation failure due to differences in knot quality, thus improving the success rate and consistency of the surgery.

[0038] V. This invention still retains all the advantages of general suture anchors, including: small drilling diameter, less bone removal, and less damage to the patient's bones; good biocompatibility and mild rejection reaction; it will not cause osteolysis; even if the anchor accidentally loosens, it will not cause secondary damage to the patient due to its soft texture, and the repair is simple.

[0039] VI. The fully sutured anchor head and suture of this invention are made of ultra-high molecular weight polyethylene, polyester, or a mixture of both, possessing high strength, high toughness, good biocompatibility, and fatigue resistance. The inserter rod is made of nickel-titanium alloy or stainless steel, ensuring sufficient rigidity while allowing for the selection of ultra-elastic properties as needed. The handle is made of ABS plastic, making it lightweight and easy to grip. Attached Figure Description

[0040] Figure 1 This is a schematic diagram of the overall structure of the all-suture anchor system of the present invention;

[0041] Figure 2 For the present invention Figure 1 Enlarged view of point A in the middle;

[0042] Figure 3 For the present invention Figure 1 Enlarged view of the middle handle;

[0043] Figure 4 This is a schematic diagram of the structure of the silicone ring of the present invention;

[0044] Figure 5 This is a schematic diagram of the variable diameter suture of the present invention;

[0045] Figure 6 This is a schematic diagram of the structure of the round flat strip of the present invention;

[0046] Figure 7 This is a schematic diagram of the structure of the circular flat wire ring of the present invention;

[0047] Figure 8 This is a schematic diagram of the implantation of the fully sutured anchor head into the bone tunnel according to the present invention;

[0048] Figure 9 This is a schematic diagram of the variable diameter suture and the round / flat suture loop nested and interlocked to form a suture bridge according to the present invention;

[0049] Figure 10 This is a schematic diagram showing the fixation of the suture bridge to soft tissue after its formation according to the present invention.

[0050] Explanation of the labels in the diagram:

[0051] 1. Full-length anchor head; 2. Variable diameter suture; 21. Working section; 22. Guide section; 3. Round flat thread tape; 4. Round flat thread loop; 41. Thread loop; 5. Insertor; 51. Tool rod; 52. Handle; 53. Silicone ring;

[0052] 6. Bone tunnel; 7. Cortical bone; 8. Cancellous bone; 9. Soft tissue; 10. Interlocking bridge suture; 11. Interface screw (outer row screw); 12. Humerus; 13. Rotator cuff ligament. Detailed Implementation

[0053] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0054] Please see Figure 1-3 A fully threaded anchor system with an interlocking structure and a round flat thread strip, comprising a fully threaded anchor head 1, a variable diameter suture 2, a round flat thread strip 3, a round flat thread ring 4, and an inserter 5.

[0055] like Figure 2 As shown, the full-stitch anchor head 1 is a circular tube braided structure with a cavity in the center. The variable-diameter suture 2 passes through the central cavity of the full-stitch anchor head 1.

[0056] like Figure 5As shown, the variable diameter suture 2 includes a working section 21 and a guide section 22, with the guide section 22 gradually tapering in diameter. The working section 21 of the variable diameter suture 2 is a standard #2 or #5 suture, while the guide section 22 has a gradually tapering structure. This design allows the guide section 22 to easily pass through the round flat thread loop 4 or the cavity of the full-suture anchor head 1, while the working section 21, after tightening, allows the full-suture anchor head 1 to fully expand, enhancing the fixing effect.

[0057] The round flat thread 3 passes through the central cavity of the full-stitch anchor head 1. The round flat thread 3 has circular braided structures at both ends and a flat strip-shaped braided structure in the middle. Figure 6 As shown. The circular segment facilitates threading during assembly, while the flat segment serves as the working end, better distributing pressure on the soft tissue during surgery and avoiding cutting. The width of the flat portion of the circular-flat suture band 3 ranges from 1.5mm to 5mm. Depending on the type of soft tissue and the required stress, different widths of the circular-flat suture band 3 can be selected to optimize pressure distribution and avoid cutting damage to the soft tissue.

[0058] like Figure 7 As shown, one end of the round-flat suture loop 4 is a round suture forming a loop 41, and the other end is a flat suture. The diameter of the loop 41 of the round-flat suture loop 4 is 2cm to 4cm, and it is used to fit the tail of the variable-diameter suture 2. This diameter range has been optimized to facilitate insertion during surgery without being too large and affecting the surgical field of vision.

[0059] Insertor 5 is used to implant the full-length suture anchor head 1 into the bone tunnel 6. Insertor 5 consists of a rod 51 and a handle 52. The handle 52 is equipped with a silicone ring 53 for securing the suture tail, such as... Figure 4 As shown, the silicone ring 53 can temporarily fix the suture end to prevent it from becoming tangled and interfering with the surgical procedure.

[0060] The variable-diameter suture 2, the round-flat suture band 3, and the round-flat suture loop 4 form a parallel "suture bridge" structure between any two anchors through a nested and interlocking mechanism. This structure enables uniform pressure between the soft tissue and the bone surface, promoting healing.

[0061] In addition, both the all-suture anchor head 1 and the suture material are made of ultra-high molecular weight polyethylene, polyester, or a blend of both. These materials possess high strength, good biocompatibility, and flexibility, meeting the requirements for implant mechanical performance and biosafety. The stem 51 is made of nickel-titanium alloy or stainless steel, and the handle 52 is made of ABS plastic. Nickel-titanium alloy has excellent superelasticity and shape memory properties, while stainless steel offers high strength and rigidity, allowing for selection based on clinical needs. The handle 52, made of ABS plastic, is lightweight and easy to grip.

[0062] like Figure 3 As shown, during assembly, the round flat thread 3 passes through the central cavity of the full-seam anchor head 1 and the two ends of the thread are aligned.

[0063] like Figure 2 As shown, after the variable-diameter suture 2 passes through the central cavity of the full-suture anchor head 1, the end of its working section 21 extends 3mm to 7mm beyond the end face of the full-suture anchor head 1. This extension distance has been verified through repeated tests: if it is less than 3mm, the lead suture section 22 is too short, and the nested operation knot is prone to loosening, resulting in fixation failure; if it is greater than 7mm, when the working section 21 contracts within the bone tunnel 6, the excess part may affect the expansion and clamping effect of the anchor head.

[0064] The round flat thread loop 4 is inserted into the center of the round thread portion of the working section 21 of the variable diameter seam 2 at a certain distance from the working section 21 of the variable diameter seam 2, and is then pulled out at a certain distance from the other end of the round thread portion 21 of the variable diameter seam 2, near the end of the nail head. The end of the round flat thread loop 4 with the thread loop 41 is close to the end of the working section 21 of the variable diameter seam 2.

[0065] After the round flat suture band 3 passes through the central cavity of the full suture anchor head 1, the two ends of the suture are aligned. This design ensures that when the round flat suture band 3 is pulled in subsequent surgery, the force on both sides is uniform, and the flat part can flatly compress the soft tissue.

[0066] Assembly method:

[0067] The full-suture anchor system of the present invention is pre-assembled before leaving the factory or before surgery. The specific assembly steps are as follows:

[0068] 1. Assembly of the round flat suture band 3: Pass the round flat suture band 3 through the central cavity of the full suture anchor head 1, and adjust its position to align the two ends of the round flat suture band 3. This alignment design ensures that when the round flat suture band 3 is pulled during subsequent surgery, the force on both sides is uniform, and the flat part can flatly compress the soft tissue, avoiding deviation or twisting.

[0069] 2. Assembly of the variable diameter suture 2: Pass the variable diameter suture 2 through the central cavity of the full-seam anchor head 1, adjust the position so that the end of the working section 21 extends 3mm to 7mm beyond the end face of the full-seam anchor head 1, and the lead thread section 22 passes out from the part exposed at the end of the working section 21.

[0070] 3. Assembly of the round flat thread loop 4: Insert the round flat thread loop 4 into the center of the round thread part of the round flat thread belt 3 from a certain distance from the working section 21 of the variable diameter seam 2, and exit from the other end of the round thread loop 4 at a certain distance from the end of the full seam anchor head 1, so that the end of the round flat thread loop 4 with the thread loop 41 is close to the end of the working section 21 of the variable diameter seam 2.

[0071] IV. Preparation of Insertor 5: Install the fully assembled suture anchor head 1 on the front end of the inserter rod 51, and temporarily tie the ends of each suture to the silicone ring 53 of the handle 52 to prevent them from scattering during the operation.

[0072] How to use:

[0073] The full-suture anchor system of the present invention achieves soft tissue fixation through the following steps:

[0074] The first step is to establish a surgical approach, determine the anchor placement location, and use a drill bit to drill anchor placement holes on the bone surface.

[0075] The second step involves sequentially inserting multiple full-suture anchor heads 1 into the bone tunnel 6 using the inserter 5. Once in the predetermined position, the working section 21 of the variable-diameter suture 2 is pulled, causing the full-suture anchor heads 1 to contract and clamp tightly within the bone tunnel 6. Depending on the extent of the soft tissue tear, two or more full-suture anchor heads 1 are sequentially inserted, such as... Figure 8 As shown.

[0076] The third step involves using suture forceps to thread the round / flat suture band 3, round / flat suture loop 4, and variable-diameter suture 2 attached to each anchor through the soft tissue to be fixed. The penetration point should be rationally selected based on the soft tissue tear morphology and anatomical insertion point to ensure that the soft tissue can be repositioned to its anatomical location after fixation.

[0077] Fourth step: Insert the end of the variable diameter thread 2 attached to the first full-stitch anchor head 1 into the round flat thread loop 4 of the second full-stitch anchor head 1. Then pull the flat end of the round flat thread loop 4, using the guiding action of the round flat thread loop 4 to bring the end of the variable diameter thread 2 into the second full-stitch anchor head 1 and out. Tighten the end of the variable diameter thread 2 to form the first "thread bridge" between the first and second full-stitch anchor heads 1.

[0078] Following this method, the variable-diameter suture 2 of the second full-suture anchor head 1 is threaded onto the round, flat suture loop 4 of the first full-suture anchor head 1, pulled out, and tightened, forming a second "suture bridge" parallel to the first "suture bridge" between the first and second full-suture anchor heads 1. Finally, the excess variable-diameter suture 2 is cut at a position flush with the soft tissue. Figure 9 , 10 As shown;

[0079] Fifth step: Pull the flat round suture band 3 attached to each full suture anchor head 1 to flatten the flat portion of the suture band 3 against the soft tissue surface. Use interface staples (outer row staples) 11 to fix the flat round suture band 3 to the soft tissue or ligament insertion point. Cut off the excess flat round suture band 3 flush with the end face of the interface staples (outer row staples) 11. Figure 10 As shown.

[0080] Step 6: Check the suturing effect, clean the wound, suture the wound, and the surgery is over.

[0081] Through the above operations, the full suture anchor system of the present invention forms two parallel "suture bridges" between the two anchors, making the gap between the avulsed soft tissue and the bone surface smaller and closer to the anatomical state before avulsion, which is conducive to the regrowth and functional recovery of soft tissue.

[0082] The above description is merely a preferred embodiment of the present invention; however, the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and its improved concepts, should be covered within the scope of protection of the present invention.

Claims

1. A fully threaded anchor system with an interlocking structure and a round flat thread strip, characterized in that: include: The full-stitch anchor head (1) is a circular tube braided structure and has a cavity in the center. A variable diameter suture (2) passes through the central cavity of the full suture anchor head (1). The variable diameter suture (2) includes a working section (21) and a lead section (22), the diameter of which gradually decreases. The round flat thread strip (3) passes through the central cavity of the full-seam anchor head (1). The round flat thread strip (3) has a circular braided structure at both ends and a flat strip-shaped braided structure in the middle. A round flat wire loop (4), one end of which is a round wire forming a loop (41), and the other end is a flat wire; Insertor (5) for implanting the full suture anchor head (1) into the bone tunnel; The variable diameter suture (2), the round flat suture strip (3) and the round flat suture ring (4) are used together to form an interlocking "suture bridge" structure between multiple anchors.

2. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: The working section (21) of the variable diameter suture (2) is a standard No. 2 suture or No. 5 suture, and the lead section (22) has a gradually thinning structure.

3. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: The width of the flat portion of the round flat strip (3) is 1.5 mm to 5 mm.

4. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: The diameter of the loop (41) of the round flat loop (4) is 2cm to 4cm, and it is used to fit the end of the variable diameter suture (2).

5. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: The inserter (5) includes a rod (51) and a handle (52), the handle (52) being provided with a silicone ring (53) for securing the end of the thread.

6. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: The fully sewn anchor head (1) and the sewn material are both ultra-high molecular weight polyethylene or polyester or a mixture of the two.

7. The interlocking structure full-seam anchor system with round flat thread strip according to claim 5, characterized in that: The rod (51) is made of nickel-titanium alloy or stainless steel, and the handle (52) is made of ABS plastic.

8. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: The variable diameter suture (2), the round flat suture strip (3), and the round flat suture ring (4) form a parallel "suture bridge" structure between any two anchors through a nested interlocking method.

9. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: After the variable diameter suture (2) passes through the central cavity of the full suture anchor head (1), the end of its working section (21) extends 3 mm to 7 mm beyond the end face of the full suture anchor head (1).

10. The interlocking structure full-seam anchor system with round flat thread strip according to claim 1, characterized in that: After the round flat thread (3) passes through the central cavity of the full-seam anchor head (1), the two ends of the thread are aligned.

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