A rigid-flexible combined internal and external row anchor and a double row repair fixing method thereof

By combining rigid and flexible inner and outer row anchors, the problem of unstable suture fixation in double-row repair is solved, achieving better fixation and pull-out resistance, and simplifying the surgical procedure.

CN117100337BActive Publication Date: 2026-06-02HANGZHOU BERKEMAN BIOTECHNOLOGY CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
HANGZHOU BERKEMAN BIOTECHNOLOGY CO LTD
Filing Date
2023-08-02
Publication Date
2026-06-02

AI Technical Summary

Technical Problem

In existing double-row repair techniques, rigid anchors are difficult to effectively fix the sutures after the inner row is fixed for a long time, while flexible anchors are prone to deformation in the bone tunnel, leading to fixation failure and insufficient pull-out resistance.

Method used

The design employs a combination of rigid and flexible inner and outer row anchors. The rigid anchors are fitted with through holes for flexible anchors, and the flexible anchors are threaded with traction lines that surround and fix the seams. Combined with the segmented hardening seam design, the fixing effect is enhanced.

Benefits of technology

This method achieves dual fixation of the anchor in the bone tunnel, improves pull-out resistance, avoids suture slippage and secondary deformation, and simplifies surgical procedures.

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Abstract

The present application relates to a kind of rigid-flexible combined inner and outer row anchor and its double row repair fixing method, outer row anchor includes rigid anchor I, flexible anchor I and two traction lines (I and II);The head of rigid anchor I is provided with a through hole a, flexible anchor I is sleeved on the through hole a;Traction line I and II are respectively from the position point A and C of flexible anchor I and are encircled in the flexible anchor I line body structure along the circumference of flexible anchor I after being passed into, and are passed out from the position point B and D of flexible anchor I, and the segment is passed out by self-penetration and forms line ring I and II;The difference between inner row anchor and outer row anchor is that one tightening line is replaced by two traction lines, and the two free ends of the tightening line are located outside flexible anchor II;Double row repair fixing method is to use inner row suture to connect outer row anchor.The inner and outer row anchors of the present application are high in pull-out resistance, and are not easy to fail in fixation.
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Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a rigid-flexible combined inner and outer row anchors and a double-row repair and fixation method thereof. Background Technology

[0002] With the development of orthopedic sports medicine, rotator cuff repair surgery, glenoid labrum repair surgery, and other injury repair surgeries have received increasing attention and application. The rotator cuff is composed of tendinous tissues attached to the greater tubercle of the humerus (supraspinatus, infraspinatus, teres minor), and the subscapularis. During shoulder joint movement, the rotator cuff plays a crucial role in supporting, stabilizing, and maintaining the normal fulcrum between the humeral head and the glenoid fossa. However, the rotator cuff is also a weak point in shoulder joint movement; during shoulder rotation, it not only protects joint stability but also bears the heavy responsibility of generating rotational force. Furthermore, its close proximity to the acromion makes it susceptible to compression and friction, leading to micro-injuries and strains to the rotator cuff tendons, ligaments, and bursae. Rotator cuff injuries cause shoulder pain, often a persistent dull ache. To ensure a normal life and reduce patient pain, timely rotator cuff repair surgery is essential.

[0003] Currently, there are two surgical techniques for rotator cuff tear repair: single-row repair and double-row repair. Single-row repair uses only one row of anchors, positioned on the lateral cartilage edge, and is suitable for tears smaller than 3 cm. Double-row repair, also known as suture bridging, uses an inner row of sutures to connect to the outer row of anchors. The inner row of anchors is implanted at the cartilage edge, and the outer row is implanted at the greater tuberosity. The inner and outer rows of sutures cross and bridge each other, pressing the rotator cuff against the bone surface, significantly reducing the risk of anchor pullout. Studies have found that double-row repair results in 42% less tear formation, 46% increased strength, and 48% higher maximum load compared to single-row repair. Therefore, double-row repair has a higher healing rate than single-row repair, and also a lower re-tear rate.

[0004] Currently, double-row internal anchors for fixation include rigid anchors such as titanium alloy anchors and PEEK anchors, as well as the recently developed all-suture anchors, which are entirely flexible. However, the knot shape formed when these flexible anchors are clumped together is uncertain, making them prone to secondary deformation under stress. Therefore, all-suture anchors deformed within the bone canal are easily pulled out, ultimately leading to fixation failure. Furthermore, the pull-out resistance of internal anchors needs further improvement. External anchors commonly used in conjunction with internal anchors include PEEK anchors. After internal fixation, sutures are fixed by squeezing them within the bone canal using rigid anchors. However, long-term friction between the rigid anchors and the bone canal after implantation can cause the bone canal to expand, leading to slippage of the sutures and fixation failure. The failure load is 200–400 N. Therefore, relying solely on the squeezing force of PEEK and sutures within the bone canal cannot achieve long-term effective fixation of the sutures after internal fixation, as cyclic displacement is significant. Summary of the Invention

[0005] The purpose of this invention is to solve the problems existing in the prior art and to provide a rigid-flexible combination of inner and outer row anchors and a double-row repair and fixing method thereof.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] A rigid-flexible external anchor bolt includes a rigid anchor bolt I, a flexible anchor bolt I, and two traction lines;

[0008] The head of the rigid anchor I has a through hole a, and the flexible anchor I is fitted onto the through hole a;

[0009] The two traction lines are designated as traction line I and traction line II, respectively.

[0010] One end of the traction line I enters from position point A of the flexible anchor I, and after wrapping around the flexible anchor I in the circumference of the flexible anchor I line body structure, it exits from position point B of the flexible anchor I. The exiting section forms a loop I by self-penetration.

[0011] One end of the traction line II enters from position point C of the flexible anchor I, and after wrapping around the circumference of the flexible anchor I in the line body structure, it exits from position point D of the flexible anchor I. The exiting section forms a loop II by self-penetration.

[0012] Location points A and D are both located on one side of the top of flexible anchor I, while location points B and C are both located on the other side of the top of flexible anchor I.

[0013] One objective of this invention is to address the problem in existing double-row repair techniques where rigid anchors are insufficient for long-term effective fixation of the inner row of sutures. This invention involves creating a through hole a on the rigid anchor I and fitting a flexible anchor I over the through hole a. Traction sutures I and II are threaded through the flexible anchor I. In rotator cuff repair surgery, the two inner row of sutures are introduced through loop I at one end of traction suture I and loop II at one end of traction suture II, respectively. Pulling the other ends of traction sutures I and II causes the inner row of sutures to wrap around the flexible anchor I and then exit. Traction sutures I and II are then discarded, and the inner row of sutures is tightened. After the suture is fixed, the flexible anchor I contracts into a sphere above the rigid anchor I and rests inside the bone hole. Then, the internally fixed suture is knotted outside the body, ultimately achieving dual fixation of the anchor in the bone tunnel. Part of the fixation force comes from the squeezing force of the rigid anchor I on the bone tunnel, and the other part comes from the squeezing force of the deformed flexible anchor I on the bone tunnel. Therefore, the anchor fixation effect in the bone tunnel is better, and the internally fixed suture that is self-threaded in the flexible anchor is less likely to fail. In addition, the design of the traction suture loop also makes it convenient for doctors to operate. Doctors do not need to use an endoscope to thread the suture under endoscopy. They can complete this operation externally by visual inspection.

[0014] As a preferred technical solution:

[0015] As described above, in a rigid-flexible combined external anchor bolt, traction line I wraps around the flexible anchor I circumferentially within the flexible anchor I's body structure 0.5 to 3 times; traction line II also wraps around the flexible anchor I circumferentially within the flexible anchor I's body structure 0.5 to 3 times. The number of wraps for traction lines I and II is set to 0.5 to 3 times because if the number of wraps is too small, the stitching will be difficult to cause the flexible anchor I to deform and shrink; if the number of wraps is too large, the internal space of the flexible anchor I cannot accommodate the large volume of stitching, making it difficult for the stitching to slide within the flexible anchor I's body structure.

[0016] As described above, in a rigid-flexible combined external anchor, the head of the rigid anchor I faces downwards, and the through hole a penetrates the head of the rigid anchor I radially.

[0017] As described above, a rigid-flexible external anchor has two vertical strip grooves a on the rigid anchor I. The two strip grooves a are located above the through hole a and on both sides of the through hole a. The two strip grooves a and the through hole a together form a U-shaped groove. When the flexible anchor I is in the tightened state, it is stuck on both sides of the U-shaped groove.

[0018] As described above, the external anchor bolts that combine rigidity and flexibility have a flexible anchor I that is either a loop structure or a U-shaped structure.

[0019] As described above, a rigid-flexible external anchor bolt consists of a flexible anchor I composed of stitches and alternating hardened and unhardened sections.

[0020] The sutures in the hardened section are heat-fused and hardened, while the sutures in the non-hardened section are not heat-fused and hardened, and the weaving density of the hardened and non-hardened sections is the same; or, neither the hardened nor the non-hardened sutures are heat-fused and hardened, and the weaving density of the hardened section is greater than that of the non-hardened section, with a difference greater than 30.

[0021] The total length of the hardened section is 1% to 99% of the total length of the flexible anchor I. There are two hardened sections because the traction line I and traction line II need to be wrapped around the flexible anchor I several times before passing through. If there are too many hardened sections, it will affect the self-penetration of the sutures after the inner row is fixed in the flexible anchor I and the smoothness of their sliding in the flexible anchor I.

[0022] The second objective of this invention is to address the problem of secondary deformation that easily occurs after flexible anchors are implanted into the bone tunnel in existing technologies. The knot shape formed when fully flexible anchors are bundled together is uncertain, making them prone to secondary deformation under tensile force. The unique feature of this invention is that the flexible anchor I is not an ordinary flexible suture, but a segmented hardened suture (including hardened and unhardened segments). The hardened segments account for 1% to 99% of the flexible anchor I, and there are two hardened segments. The hardened suture segments do not undergo macroscopic deformation when the sutures after internal fixation are pulled, while the unhardened suture segments contract in all directions when the sutures after internal fixation are pulled. The undeformed hardened segments act as support. Because of the presence of the hardened segments, the entire flexible anchor I is less prone to secondary deformation after being bundled together, thus providing better fixation within the bone hole and avoiding the risk of slippage within the bone hole.

[0023] As described above, in a rigid-flexible external anchor, the main body of the rigid anchor I is provided with a barb structure to increase the friction between the rigid anchor I and the bone channel.

[0024] This invention also provides a method for fixing the inner row of sutures during double-row repair. The method employs a rigid-flexible outer row anchor as described in any of the preceding claims. The two inner row sutures are introduced through loop I at one end of traction suture I and loop II at one end of traction suture II, respectively. The other ends of traction suture I and traction suture II are pulled, causing the inner row sutures to wrap around the flexible anchor I and then pass through it. Traction sutures I and II are discarded, and the inner row sutures are tightened. The flexible anchor I contracts into a sphere above the rigid anchor I and rests against the bone hole. Finally, the inner row sutures are knotted outside the body.

[0025] The present invention also provides a rigid-flexible inner row of anchors, including a rigid anchor II and a deformable body; the deformable body includes a flexible anchor II and a tightening line; the tightening line passes through the flexible anchor II and is used to deform the flexible anchor II by pulling, and the two free ends of the tightening line are located outside the flexible anchor II; the head of the rigid anchor II is provided with a through hole b, and the flexible anchor II is fitted on the through hole b.

[0026] The third objective of this invention is to address the problem that the pull-out resistance of internal anchors in the bone tunnel needs further improvement in the existing technology. This invention solves this problem by combining the rigid anchor II with the deformable body. In use, the rigid anchor II and the flexible anchor II are first placed together in the bone tunnel, and then the tightening line is pulled to deform the flexible anchor II and shrink it into a ball. Friction is generated between the flexible anchor II and the bone tunnel, which prevents the rigid anchor II from leaving the bone tunnel.

[0027] As a preferred technical solution:

[0028] As described above, the inner row of anchors combines rigidity and flexibility, with the flexible anchor II having a loop structure or a U-shaped structure.

[0029] As described above, a rigid-flexible inner row anchor bolt, the flexible anchor II is composed of stitches and also consists of alternating hardened and unhardened sections;

[0030] The sutures in the hardened section are heat-fused and hardened, while the sutures in the non-hardened section are not heat-fused and hardened, and the weaving density of the hardened and non-hardened sections is the same; or, neither the hardened nor the non-hardened sutures are heat-fused and hardened, and the weaving density of the hardened section is greater than that of the non-hardened section, with a difference greater than 30.

[0031] The total length of the hardened section is 1% to 99% of the total length of the flexible anchor II, and the number of hardened sections is 2.

[0032] As described above, in a rigid-flexible inner row of anchors, the tightening line wraps around the flexible anchor II circumferentially within the flexible anchor body structure for 0.5 to 3 turns before exiting.

[0033] As described above, in a rigid-flexible inner row of anchors, the tightening line passes through the flexible anchor II line structure m times, and the intersection points are numbered from 1 to m in the order of appearance, where m is a positive integer greater than 2. The 1st to mth intersection points are arranged sequentially in a counterclockwise direction; the tightening line does not intersect with the hardened section of the flexible anchor II.

[0034] As described above, in a rigid-flexible inner row of anchors, the tightening line passes through the flexible anchor II line structure m times, and the intersection points are numbered from 1 to m in the order of appearance, where m is a positive integer greater than 2. The 1st to m-1st intersection points are arranged sequentially in a counterclockwise direction, and the mth intersection point is located between the 1st and 2nd intersection points. The tightening line does not intersect with the hardened section of the flexible anchor II.

[0035] As described above, in a rigid-flexible inner row of anchors, the head of the rigid anchor II faces downwards, and the through hole b penetrates the head of the rigid anchor II radially.

[0036] As described above, in a rigid-flexible inner row anchor, the rigid anchor II has two vertical strip grooves b. The two strip grooves b are located above the through hole b and on both sides of the through hole b. The two strip grooves b and the through hole b together form a U-shaped groove. When the flexible anchor II is in the tightened state, it is stuck on both sides of the U-shaped groove.

[0037] The materials of all rigid anchors in this invention are not limited and can be metals, polymers or inorganic materials, specifically titanium alloys, stainless steel, PEEK, polylactic acid, etc.

[0038] Beneficial effects

[0039] (1) The inner and outer row of anchors of the present invention combine rigid anchors and flexible anchors, which increases the pull-out resistance of the inner and outer row of anchors and realizes the dual fixation effect of the anchors in the bone tunnel.

[0040] (2) The flexible anchor in the inner and outer row of anchors of the present invention is a segmented hardened suture (including hardened and non-hardened sections). The hardened suture does not undergo macroscopic deformation when the inner row is pulled and fixed or when the suture is tightened. The non-hardened suture contracts in all directions when the inner row is pulled and fixed or when the suture is tightened. The undeformed hardened section serves as a support. After the entire flexible anchor is bundled together, it is not easy to undergo secondary deformation due to the presence of the hardened section. Therefore, the fixation effect in the bone tunnel is better.

[0041] (3) The outer row of anchors of the present invention has a traction suture ring, which is used to guide the inner row of sutures to pass through the flexible anchor and thus deform the flexible anchor. The doctor passes the inner row of fixed sutures through the ring part of the suture ring outside the inlet cannula. The other end of the suture ring is led out from another inlet cannula. Pulling the other end of the suture ring causes the inner row of fixed sutures to pass through the flexible anchor after being wrapped around it. This design is convenient for doctors to operate. Doctors do not need to use an endoscope to pass the sutures under the endoscope. They can complete this operation by visual inspection outside the body. Attached Figure Description

[0042] Figure 1 This is a schematic diagram of a loop-type flexible anchor structure;

[0043] Figure 2 This is a schematic diagram of a U-shaped flexible anchor structure.

[0044] Figure 3 This is a schematic diagram of the connection structure between the flexible anchor II and the tightening line in the embodiment; in the figure, the flexible anchor II is a loop structure, and the tightening line passes through the flexible anchor II in method one;

[0045] Figure 4 This is a schematic diagram of the connection structure between the flexible anchor II and the tightening line in the embodiment; in the figure, the flexible anchor II has a U-shaped structure, and the tightening line passes through the flexible anchor II in method one;

[0046] Figure 5 This is a schematic diagram of the connection structure between the flexible anchor II and the tightening line in the embodiment; in the figure, the flexible anchor II is a loop structure, and the tightening line passes through the flexible anchor II in method two;

[0047] Figure 6 This is a schematic diagram of the connection structure between the flexible anchor II and the tightening line in the embodiment; in the figure, the flexible anchor II has a U-shaped structure, and the tightening line passes through the flexible anchor II in method three;

[0048] Figure 7This is a schematic diagram of the connection structure between the flexible anchor I of the outer row of anchors and the two traction lines in the embodiment; in the figure, the flexible anchor I is a loop structure;

[0049] Figure 8 This is a schematic diagram of the connection structure between the flexible anchor I and the two traction lines in the embodiment; in the figure, the flexible anchor I has a U-shaped structure;

[0050] Figure 9 The figure shows a schematic diagram of the rigid anchor I structure in the embodiment; (a) is a schematic diagram of the axial cross-sectional structure of the rigid anchor along its length direction, and (b) is a schematic diagram of the front view structure of the rigid anchor.

[0051] Figure 10 This is a schematic diagram of the combination of rigid anchor I and external anchor.

[0052] Among them, 1-hardened section, 2-unhardened section, 3-tightening line, 4-traction line I, 5-traction line II, 6-line ring I, 7-line ring II, 8-through hole a, 9-strip groove a. Detailed Implementation

[0053] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0054] A rigid-flexible external anchor bolt includes a rigid anchor bolt I, a flexible anchor I, a traction line I, and a traction line II;

[0055] like Figures 1-2 As shown, the flexible anchor I is a loop structure or U-shaped structure composed of stitches; the flexible anchor I is divided into a hardened section 1 and an unhardened section 2, which are arranged alternately; the number of hardened sections 1 is 2, and the total length of the hardened sections 1 is 1% to 99% of the total length of the flexible anchor I;

[0056] The sutures in hardened section 1 are heat-fused and hardened, while the sutures in unhardened section 2 are not heat-fused and hardened, and the weaving density of hardened section 1 and unhardened section 2 is the same; or, the sutures in hardened section 1 and unhardened section 2 are not heat-fused and hardened, and the weaving density of hardened section 1 is greater than the weaving density of unhardened section 2 and the difference is greater than 30.

[0057] like Figures 7-8As shown, one end of the traction line I 4 enters from position point A of the flexible anchor I, and wraps around the flexible anchor I circumferentially 0.5 to 3 times in the flexible anchor I line structure before exiting from position point B of the flexible anchor I. The exiting section forms a loop I6 through self-penetration. One end of the traction line II 5 enters from position point C of the flexible anchor I, and wraps around the flexible anchor I circumferentially 0.5 to 3 times in the flexible anchor I line structure before exiting from position point D of the flexible anchor I. The exiting section forms a loop II 7 through self-penetration.

[0058] Location points A and D are both located on one side of the top of flexible anchor I, while location points B and C are both located on the other side of the top of flexible anchor I.

[0059] like Figure 9 As shown, the main body of the rigid anchor I is provided with a barb structure; the head of the rigid anchor I faces downwards, and the head of the rigid anchor I is provided with a through hole a8 that penetrates the head of the rigid anchor I radially; the rigid anchor I is provided with two vertical strip grooves a9, which are located above the through hole a8 and on both sides of the through hole a8, and the two strip grooves a9 and the through hole a8 together form a U-shaped groove;

[0060] like Figure 10 As shown, the flexible anchor I is fitted onto the through hole a 8.

[0061] A rigid-flexible inner row of anchors, comprising a rigid anchor II, a flexible anchor II, and a tightening line 3;

[0062] Flexible anchor II is a loop structure or U-shaped structure composed of stitches; flexible anchor II is divided into hardened section 1 and non-hardened section 2, with hardened section 1 and non-hardened section 2 arranged alternately; the number of hardened section 1 is 2, and the total length of hardened section 1 is 1% to 99% of the total length of flexible anchor I;

[0063] The sutures in hardened section 1 are heat-fused and hardened, while the sutures in unhardened section 2 are not heat-fused and hardened, and the weaving density of hardened section 1 and unhardened section 2 is the same; or, the sutures in hardened section 1 and unhardened section 2 are not heat-fused and hardened, and the weaving density of hardened section 1 is greater than the weaving density of unhardened section 2 and the difference is greater than 30.

[0064] The tensioning line 3 passes through the flexible anchor II and is used to deform the flexible anchor II by pulling. The tensioning line 3 can pass through the flexible anchor II in the following three ways:

[0065] Method 1: For example Figures 3-4 As shown, the tightening line 3 wraps around the flexible anchor II circumferentially within the flexible anchor body structure for 0.5 to 3 turns before exiting; the two free ends of the tightening line 3 are located outside the flexible anchor II.

[0066] Method 2: For example Figure 5As shown, the tightening line 3 passes through the flexible anchor II line structure m times, and the intersection points are numbered from 1 to m in the order of appearance, where m is a positive integer greater than 2. The 1st to mth intersection points are arranged in a counterclockwise direction with intervals between them. The tightening line 3 does not intersect with the hardened section 1 of the flexible anchor II. The two free ends of the tightening line 3 are located outside the flexible anchor II.

[0067] Method 3: For example Figure 6 As shown, the tightening line 3 passes through the flexible anchor II's body structure m times. The intersection points are numbered from 1 to m in order of appearance, where m is a positive integer greater than 2. The 1st to m-1st intersection points are arranged in a counterclockwise direction with intervals between them. The mth intersection point is located between the 1st and 2nd intersection points. The tightening line 3 does not intersect with the hardened section 1 of the flexible anchor II. The two free ends of the tightening line 3 are located outside the flexible anchor II.

[0068] The head of the rigid anchor II faces downwards. The head of the rigid anchor II has a through hole b that runs radially through the head of the rigid anchor II. The rigid anchor II has two vertical strip grooves b, which are located above the through hole b and on both sides of the through hole b. The two strip grooves b and the through hole b together form a U-shaped groove.

[0069] Flexible anchor II is fitted onto through hole b.

[0070] A double-row repair and fixation method, the steps of which are as follows:

[0071] (1) Fixation method using the above-mentioned internal anchors: First, use a guide and a depth-limiting drill bit to drill a bone channel, then insert the internal anchors into the bone channel. When the anchor head is fully inserted into the bone channel, pull the tightening line to deform the deformable body part. Then, pull out the guide to tighten the anchors. The deformable body shrinks into a ball above the hard anchor II and presses against the pre-drilled bone hole at the cartilage edge. Repeat the above steps to implant the second anchor. Then, use a suture passer to pass the tightening line of the two anchors through the tissue at the tear site. The internal fixation is completed.

[0072] (2) Method for fixing the inner row of sutures with the above-mentioned external anchors: The two inner row sutures are introduced into the loop I 6 at one end of the traction line I 4 and the loop II 7 at one end of the traction line II 5 respectively. Pull the other end of the traction line I 4 and the other end of the traction line II 5 so that the inner row sutures are wrapped in the flexible anchor I and then pass out. Discard the traction line I 4 and the traction line II 5, tighten the inner row sutures, and the flexible anchor I shrinks into a ball above the rigid anchor I and presses against the bone hole pre-drilled in the greater tubercle. At the same time, it is stuck on both sides of the U-shaped groove. Then tie the inner row sutures outside the body to achieve double fixation of the anchor in the bone tunnel.

Claims

1. A rigid-flexible combined external anchor bolt, comprising a rigid anchor bolt I, characterized in that, It also includes a flexible anchor I and two traction lines; The head of the rigid anchor I has a through hole a, and the flexible anchor I is fitted onto the through hole a; The two traction lines are designated as traction line I and traction line II, respectively. One end of the traction line I enters from position point A of the flexible anchor I, and after wrapping around the flexible anchor I in the circumference of the flexible anchor I line body structure, it exits from position point B of the flexible anchor I. The exiting section forms a loop I by self-penetration. One end of the traction line II enters from position point C of the flexible anchor I, and after wrapping around the circumference of the flexible anchor I in the line body structure, it exits from position point D of the flexible anchor I. The exiting section forms a loop II by self-penetration. Location points A and D are both located on one side of the top of flexible anchor I, while location points B and C are both located on the other side of the top of flexible anchor I.

2. The rigid-flexible combined external anchor bolt according to claim 1, characterized in that, Traction line I wraps around the flexible anchor I circumferentially within the flexible anchor I structure 0.5 to 3 times; traction line II wraps around the flexible anchor I circumferentially within the flexible anchor I structure 0.5 to 3 times.

3. The rigid-flexible combined external anchor bolt according to claim 1, characterized in that, The head of the rigid anchor I faces downwards, and the through hole a penetrates the head of the rigid anchor I radially. The rigid anchor I is provided with two vertical strip grooves a, which are located above the through hole a and on both sides of the through hole a. The two strip grooves a and the through hole a together form a U-shaped groove.

4. The rigid-flexible combined external anchor bolt according to claim 1, characterized in that, The flexible anchor I is a loop structure or a U-shaped structure; the flexible anchor I is composed of stitches and alternating hardened and unhardened sections; the total length of the hardened sections is 1% to 99% of the total length of the flexible anchor I, and the number of hardened sections is 2.

5. The rigid-flexible combined external anchor bolt according to claim 1, characterized in that, The main body of the rigid anchor I is equipped with a barbed structure.

6. A method for fixing the inner row of sutures after fixation during double-row repair, employing an outer row of rigid-flexible anchors as described in any one of claims 1 to 5, characterized in that... Two internally fixed sutures are introduced into loop I at one end of traction suture I and loop II at one end of traction suture II, respectively. The other ends of traction suture I and traction suture II are pulled so that the internally fixed sutures are wrapped around the flexible anchor I and then pass through. Traction sutures I and II are discarded, and the internally fixed sutures are tightened. The flexible anchor I contracts into a ball above the rigid anchor I and presses against the bone hole. The internally fixed sutures are then tied outside the body.

7. A rigid-flexible combined inner row of anchors, comprising a rigid anchor II, characterized in that, It also includes a deformable body; the deformable body includes a flexible anchor II and a tightening line; the tightening line passes through the flexible anchor II and is used to deform the flexible anchor II by pulling, and the two free ends of the tightening line are located outside the flexible anchor II; the head of the rigid anchor II is provided with a through hole b, and the flexible anchor II is fitted on the through hole b.

8. The rigid-flexible combined inner row anchor bolt according to claim 7, characterized in that, The flexible anchor II is a loop structure or a U-shaped structure; the flexible anchor II is composed of stitches and alternating hardened and unhardened sections; the total length of the hardened sections is 1% to 99% of the total length of the flexible anchor II, and the number of hardened sections is 2.

9. The rigid-flexible combined inner row anchor bolt according to claim 8, characterized in that, The tightening line wraps around the flexible anchor II circumferentially 0.5 to 3 times in the flexible anchor body structure and then exits; Alternatively, the tightening line passes through the flexible anchor II line structure m times, with the intersections numbered from 1 to m in the order of appearance, where m is a positive integer greater than 2. The 1st to mth intersections are arranged sequentially in a counterclockwise direction; the tightening line does not intersect with the hardened section of the flexible anchor II. Alternatively, the tightening line passes through the flexible anchor II line structure m times, with the intersections numbered from 1 to m in order of appearance, where m is a positive integer greater than 2. The 1st to m-1st intersections are arranged in a counterclockwise direction with intervals between them, and the mth intersection is located between the 1st and 2nd intersections. The tightening line does not intersect with the hardened section of the flexible anchor II.

10. The rigid-flexible combined inner row anchor bolt according to claim 7, characterized in that, The head of the rigid anchor II faces downwards, and the through hole b penetrates the head of the rigid anchor II radially. The rigid anchor II is provided with two vertical strip grooves b, which are located above the through hole b and on both sides of the through hole b. The two strip grooves b and the through hole b together form a U-shaped groove.