A new full-line anchor and implant system

Abstract

The present invention discloses a novel full-line anchor and implantation system, belonging to the technical field of medical devices. The full-line anchor comprises: a wire tube, which adopts a tubular structure and is woven from soft wires. The wire tube comprises a tube body, a first end and a second end which are identical along the length direction of the tube body, the first end and the second end are provided with a plurality of threading rings formed by bending the soft wires, and the first end and the second end are both closed ends composed of a plurality of threading rings; a wire body group, which is passed through the wire tube and is used to shrink the wire tube into a ball-shaped structure; and an implantation system. The two ends of the wire tube of the novel full-line anchor and implantation system disclosed by the present invention adopt closed ends composed of threading rings formed by bending the soft wires, which can avoid the occurrence of hair and wire tube damage at both ends of the wire tube during processing and use.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a novel full-line anchor and implantation system. Background Art

[0002] Wires and anchors are often used to fix soft tissue to bone during repair surgery. Specifically, tears in soft tissues such as cartilage, ligaments or muscles can be repaired by suturing. When fixed with sutures, products with wire anchors can be used to provide attachment sites. The mechanism of action of products with wire anchors is to insert the anchor into a pre-formed bone channel as a fulcrum, and then use the wire for fixation. Commonly used suture anchors are made of metal materials or polymer materials, and the main processing technology is machining or injection molding. The operation process of installing suture anchors is complicated, and a large amount of autologous bone needs to be removed. If revision is required after surgery, it is often necessary to drill additional holes or drill deeper into the original holes, which causes great harm to the human body. In addition, suture anchors have an adverse effect on postoperative imaging.

[0003] With the development of weaving and other methods of polymer fiber soft materials, full suture anchors have appeared on the market in recent years, which can preserve bone reserves, improve postoperative imaging, and make revision surgery easier when necessary. In the bone channel with pre-selected bone holes, the full suture anchor can be stretched and deformed to increase its diameter to a diameter larger than the bone hole diameter, so that it can be fixed in the cancellous bone and under the cortical bone. Since the full suture anchor is woven with fiber soft materials, its ends are sheared and separated. In clinical practice, there are burrs at the ends of the full suture anchor, which is very easy to loosen, making the entire full suture anchor scrapped. If it becomes loose during use, it will affect the realization of the fixation function of the full suture anchor. In actual applications, the ends can be hardened. This operation complicates the production process of the full suture anchor. At the same time, due to the increase in the hardness of the ends, the hardness of the full suture anchor is increased during fixation, which is easy to cause wear on the cancellous bone or cortical bone, causing damage to the human body. Summary of the invention

[0004] The present invention is proposed to solve the problems existing in the prior art. Its purpose is to provide a new full-line anchor nail in which both ends of the wire tube are closed ends composed of threading rings formed by bending soft wires, which can avoid the occurrence of lint and damage to the wire tube at both ends during processing and use.

[0005] The second object of the present invention is to provide a novel full-line anchor implantation system.

[0006] In order to achieve the above-mentioned object, a first embodiment of the present invention provides a new full-line anchor, and the full-line anchor comprises:

[0007] A wire tube, wherein the wire tube adopts a tubular structure and is woven from soft wires. The wire tube comprises a tube body, a first end and a second end which are identical along the length direction of the tube body, wherein the first end and the second end are provided with a plurality of threading rings formed by bending the soft wires, and the first end and the second end are both closed ends composed of a plurality of threading rings;

[0008] A wire body group is inserted into the wire tube and is used to shrink the wire tube into a ball-shaped structure.

[0009] Further, the wire body group includes a first wire body and a second wire body that are identical, the first wire body is passed through the plurality of threading rings at the first end along the circumferential direction of the wire tube and the first wire body tightens the first end, the second wire body is passed through the plurality of threading rings at the second end along the circumferential direction of the wire tube and the second wire body tightens the second end, and both ends of the second wire body extend out of the wire tube from the first end of the wire tube;

[0010] After the full-line anchor is implanted into the positioning hole of the bone tissue to be repaired, the first wire body and the second wire body are tightened, so that the wire tube can be compressed into a ball-shaped structure to be fixed at the bone tissue repair site.

[0011] Furthermore, two ends of the second wire body pass through the inside of the wire tube to the outside of the first end.

[0012] Furthermore, two ends of the second wire body sequentially pass through the interior of the second end of the wire tube, alternately pass through opposite side walls of the tube along the length direction of the tube, and pass through the interior of the first end of the wire tube to the outside of the first end.

[0013] Furthermore, the braiding density of the wire tube body is greater than the braiding density of the first end and the second end, the braiding density of the wire tube ranges from 10PPI to 100PPI, the wire diameter of the wire tube ranges from 1mm to 30mm, and the length of the wire tube ranges from 10mm to 50mm.

[0014] Furthermore, the soft wire is made of a medical polymer material, and the polymer material includes a first material that cannot be absorbed by the human body, and the first material includes polypropylene, polyethylene, nylon 6, nylon 66, polyester, and polytetrafluoroethylene.

[0015] Furthermore, the first thread body and the second thread body are both made of suture thread or thread tape.

[0016] Furthermore, when the first thread body and the second thread body are suture threads, the thread diameters of the first thread body and the second thread body range from #4-0 to #5.

[0017] Furthermore, the first thread body and the second thread body are made of medical polymer materials, which include a second material that can be absorbed by the human body and a third material that cannot be absorbed by the human body. The second material includes polyglycolic acid, polylactic acid, polydioxanone, and polyglycolic acid lactic acid. The third material includes polypropylene, polyethylene, nylon 6, nylon 66, polyester, and polytetrafluoroethylene.

[0018] In order to achieve the above-mentioned object, a second embodiment of the present invention provides a novel full-line anchor implantation system, the full-line anchor implantation system comprising:

[0019] The full-line anchor according to any one of the above technical solutions;

[0020] The pusher is used to push the full-line anchor into the positioning hole of the bone tissue to be repaired.

[0021] In the currently used full suture anchors, both ends need to be hardened before being cut and separated; the wire tube of the present invention is woven from soft wires, and both ends of the wire tube are closed ends consisting of threading rings formed by bending the soft wires, which do not need to be hardened, and can avoid the occurrence of lint and wire tube damage at both ends of the wire tube during processing and use. The structure is simple and the operation steps are simplified. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is a schematic diagram of the structure of a wire tube provided by an embodiment of the present invention;

[0023] Figure 2 It is an enlarged structural schematic diagram of two ends of a wire tube when a first wire body and a second wire body provided in an embodiment of the present invention are passed through two ends of the wire tube;

[0024] Figure 3 2 is a schematic diagram of the structure of the first wire body and the second wire body provided by an embodiment of the present invention when the two ends of the wire tube are tightened;

[0025] Figure 4 This is a schematic diagram of the structure of the embodiment 1 of the present invention after the full-line anchor is implanted into the positioning hole and before the suture is tightened;

[0026] Figure 5 This is a schematic diagram of the structure after the full-line anchors are implanted into the positioning holes and the sutures are tightened according to Embodiment 1 of the present invention;

[0027] Figure 6 It is a schematic diagram of the structure when the second wire body provided by Example 2 of the present invention passes through the first end.

[0028] Among them: 1. wire tube; 11. soft wire; 12. tube body; 13. first end; 14. second end; 15. threading ring; 2. wire body group; 21. first wire body; 22. second wire body; 3. positioning hole. DETAILED DESCRIPTION

[0029] Hereinafter, the present invention will be described in detail with reference to the accompanying drawings and embodiments:

[0030] like Figures 1 to 6 As shown, an embodiment of the present invention provides a novel full-line anchor, which includes a line tube 1 and a line body group 2.

[0031] The wire tube 1 adopts a tubular structure, and the wire tube 1 is woven from a soft wire 11. The wire tube 1 includes a tube body 12, and a first end 13 and a second end 14 that are identical along the length direction of the tube body 12. The first end 13 and the second end 14 are provided with a plurality of threading rings 15 formed by bending the soft wire 11. The first end 13 and the second end 14 are both closed ends composed of a plurality of threading rings 15.

[0032] The wire group 2 is inserted into the wire tube 1 and is used to shrink the wire tube 1 into a ball-shaped structure.

[0033] In the currently used full suture anchors, both ends need to be hardened before being cut and separated; the wire tube 1 of the present invention is woven from soft wires 11, and both ends of the wire tube 1 are closed ends consisting of threading rings 15 formed by bending the soft wires 11, and no hardening treatment is required, which can avoid the occurrence of fuzz and damage to the wire tube 1 at both ends during processing and use, and the structure is simple, which simplifies the operation steps.

[0034] Further, if Figure 2 , Figure 3 As shown, the wire body group 2 includes the same first wire body 21 and second wire body 22, the first wire body 21 is passed through the several threading rings 15 at the first end 13 along the circumferential direction of the wire tube 1, and the first wire body 21 tightens the first end 13, the second wire body 22 is passed through the several threading rings 15 at the second end 14 along the circumferential direction of the wire tube 1, and the second wire body 22 tightens the second end 14, and both ends of the second wire body 22 extend out of the wire tube 1 from the first end 13 of the wire tube.

[0035] Specifically, the first wire body 21 and the second wire body 22 can tighten the two ends of the wire tube 1, and the two ends of the second wire body 22 extend from the first end 13 of the wire tube to further tighten the wire tube 1 to form a ball-shaped structure.

[0036] After the full-line anchor is implanted into the positioning hole 3 of the bone tissue to be repaired, the first wire body 21 and the second wire body 22 are tightened, so that the wire tube 1 can be compressed into a ball-shaped structure to be fixed at the bone tissue repair site.

[0037] The width of the ball-like structure is much larger than the diameter of the positioning hole 3 of the bone tissue to be repaired, so that the entire line of anchors is fixed at the bone tissue repair site.

[0038] When in use, firstly pass the first wire body 21 through the several threading rings 15 arranged at the first end 13 and tighten the first end 13, pass the second wire body 22 through the several threading rings 15 arranged at the second end 14 and tighten the second end 14, extend the two ends of the second wire body 22 out of the wire tube 1 from the first end 13 of the wire tube 1, and then tighten the first wire body 21 and the second wire body 22. Under the action of the pulling force at the two ends of the first wire body 21 and the two ends of the second wire body 22, the wire tube 1 can be tightened into a ball-shaped structure and then fixed to the bone tissue repair site. At the same time, this design can avoid the occurrence of hair at both ends of the wire tube 1 and damage to the wire tube 1 during processing and use.

[0039] Embodiment 1: The present invention provides a new full-line anchor, such as Figure 4 , Figure 5 As shown, both ends of the second wire body 22 pass through the inside of the wire tube 1 to the outside of the first end 13. Under the action of the tension at both ends of the first wire body 21 and the second wire body 22, the wire tube 1 can be tightened into a ball-shaped structure and then fixed to the bone tissue repair site. The design structure is simple and easy to operate.

[0040] The braiding density of the wire tube body 12 is greater than the braiding density of the first end 13 and the second end 14, the braiding density of the wire tube 1 is in the range of 10PPI to 100PPI, the wire diameter of the wire tube 1 is in the range of 1mm to 30mm, and the length of the wire tube 1 is in the range of 10mm to 50mm. Preferably, the wire tube 1 is woven by a braiding machine or a warp knitting machine.

[0041] Furthermore, the soft wire 11 is made of a medical polymer material, which includes a first material that cannot be absorbed by the human body, and the first material includes polypropylene, polyethylene, nylon 6, nylon 66, polyester, and polytetrafluoroethylene. The soft wire 11 can be retained in the patient's body for a long time, so that the anchor nails along the entire line have a long-term fixed support function. Among them, the polyethylene includes ultra-high molecular weight polyethylene.

[0042] The first thread body 21 and the second thread body 22 are both made of sutures or thread bands. Preferably, when the first thread body 21 and the second thread body 22 are made of sutures, in order to make the sutures meet the use requirements, according to the national industry standard "Non-absorbable surgical sutures" (YY 0167-2005), the diameter range of the first thread body 21 and the second thread body 22 is #4-0 to #5.

[0043] Furthermore, the first thread body 21 and the second thread body 22 are made of medical polymer materials, which include a second material that can be absorbed by the human body and a third material that cannot be absorbed by the human body. The second material includes polyglycolic acid, polylactic acid, polydioxanone, and polyglycolic acid lactic acid. The material can be absorbed by the human body to reduce the body's rejection reaction to the thread body group; the third material includes polypropylene, polyethylene, nylon 6, nylon 66, polyester, and polytetrafluoroethylene. The third material can remain in the patient's body for a long time, so that the entire line of anchors has a long-term fixed support function, wherein the polyethylene includes ultra-high molecular weight polyethylene.

[0044] Both ends of the wire tube 1 of this embodiment are closed ends composed of a threading ring 15 formed by bending the soft wire 11, and no hardening treatment is required, which can avoid the appearance of hair and wire tube damage at both ends of the wire tube 1 during processing and use, and the structure is simple, simplifying the operation steps. The two ends of the second wire body 22 pass through the inside of the wire tube 1 to the outside of the first end 13. Under the tension of the two ends of the first wire body 21 and the two ends of the second wire body 22, the wire tube 1 can be compressed into a ball-shaped structure and then fixed to the bone tissue repair site. The design structure is simple and easy to operate.

[0045] Embodiment 2: The present invention provides a new full-line anchor, such as Figure 6 As shown, the two ends of the second wire body 22 sequentially pass through the interior of the second end 14 of the wire tube, alternately pass through the opposite side walls of the tube body 12 along the length direction of the tube body 12, and pass through the interior of the first end 13 of the wire tube to the outside of the first end 13. The shape of the ball-shaped structure formed by the second wire body 22 can be adjusted by controlling the intervals at which the second wire body 22 passes through the opposite side walls of the tube body 12, so that the present invention can be fixed on positioning holes 3 of different sizes.

[0046] Furthermore, the second wire bodies 22 pass through the opposite side walls of the tube body 12 alternately and evenly along the length direction of the tube body 12, so that the shape of the ball-shaped structure formed by the anchors of the entire line is more regular, and the fixation is more stable.

[0047] The remaining technical measures of this embodiment are the same as those of Embodiment 1 and will not be described in detail in this embodiment.

[0048] Both ends of the wire tube 1 of this embodiment adopt closed ends composed of threading rings 15 formed by bending soft wires 11, and no hardening treatment is required, which can avoid the appearance of hair and damage to the wire tube 1 at both ends during processing and use, and the structure is simple, simplifying the operation steps. The two ends of the second wire body 22 alternately pass through the opposite side walls of the tube body 12 along the length direction of the tube body 12, and pass from the inside of the first end 13 of the wire tube to the outside of the first end 13. Under the action of the tension at both ends of the first wire body 21 and the second wire body 22, the wire tube 1 can be compressed into a ball-shaped structure and then fixed to the bone tissue repair site. The shape of the ball-shaped structure formed by the second wire body 22 can be adjusted by controlling the interval between the second wire body 22 passing through the opposite side walls of the tube body 12. This design structure is simple and easy to operate.

[0049] Embodiment 3: The embodiment of the present invention provides a novel full-line anchor implantation system, which comprises an inserter and the full-line anchor described in any one of the above embodiments, wherein the inserter is used to insert the full-line anchor into the positioning hole 3 of the bone tissue to be repaired.

[0050] Currently, when suture anchors are implanted into bone holes, a screw-on implantation method is mostly used. The present invention can use an inserter to push the entire line of anchors into the bone canal. The implantation method is simple, the required bone canal diameter is small, the amount of autologous bone to be removed is small, the damage to the human body is small, and the overall structure is simple and easy to operate. After implantation, it is firmly fixed and is also conducive to postoperative repair, repair, replacement and other operations.

[0051] The remaining technical measures of this embodiment are the same as those of Embodiment 1 or Embodiment 2 and will not be described in detail in this embodiment.

[0052] A specific embodiment of the present invention provides a novel full-line anchor and implantation system, wherein the manufacturing process of the novel full-line anchor includes:

[0053] First, a braiding machine is used to make a wire tube 1, such as Figures 1 to 3 As shown, the braiding density of the wire tube body 12 is greater than the braiding density of the first end 13 and the second end 14, the first end 13 and the second end 14 both have a plurality of threading rings 15 formed by bending the soft wire 11, and the raw material of the wire tube 1 includes ultra-high molecular weight polyethylene material, wherein the wire diameter of the wire tube 1 is 10 mm, the PPI is 50, and the length is 20 mm.

[0054] Then, the first thread body 21 and the second thread body 22 are formed by using the suture thread. Figure 2 , Figure 3 As shown, the first wire body 21 is passed through several threading rings 15 at the first end 13 along the circumferential direction of the wire tube 1 and the first wire body 21 tightens the first end 13, and the second wire body 22 is passed through several threading rings 15 at the second end 14 along the circumferential direction of the wire tube 1 and the second wire body 22 tightens the second end 14, wherein the wire diameter of the suture is #2-0.

[0055] Then, two ends of the second wire body 22 are passed through the wire tube 1 to the outside of the first end 13 .

[0056] The use process of the new full-line anchor implant system includes:

[0057] First, use the pusher to implant the above-mentioned full suture anchor into the bone canal;

[0058] By tightening the first wire body 21 and the second wire body 22, the wire tube 1 implanted in the bone channel can be compressed into a ball-shaped structure, thereby achieving fixation of the entire wire anchor at the bone tissue repair site.

[0059] Both ends of the wire tube 1 of this embodiment are closed ends composed of a threading ring 15 formed by bending the soft wire 11, and no hardening treatment is required, which can avoid the appearance of hair and damage to the wire tube 1 at both ends during processing and use, and the structure is simple, simplifying the operation steps. The two ends of the second wire body 22 pass through the inside of the wire tube 1 to the outside of the first end 13. Under the tension of the two ends of the first wire body 21 and the two ends of the second wire body 22, the wire tube 1 can be compressed into a ball-shaped structure and then fixed to the bone tissue repair site. The design structure is simple and easy to operate.

[0060] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A new type of full-line anchor, characterized in that: The full line of anchors includes: A wire tube, wherein the wire tube adopts a tubular structure and is woven from soft wires. The wire tube comprises a tube body, a first end and a second end which are identical along the length direction of the tube body, wherein the first end and the second end are provided with a plurality of threading rings formed by bending the soft wires, and the first end and the second end are both closed ends composed of a plurality of threading rings; A wire body group, which is inserted into the wire tube and used to shrink the wire tube into a ball-shaped structure; The wire body group includes a first wire body and a second wire body that are identical, wherein the first wire body is passed through a plurality of threading rings at the first end along the circumferential direction of the wire tube and the first wire body tightens the first end, the second wire body is passed through a plurality of threading rings at the second end along the circumferential direction of the wire tube and the second wire body tightens the second end, and both ends of the second wire body extend out of the wire tube from the first end of the wire tube; After the full-line anchor is implanted into the positioning hole of the bone tissue to be repaired, the first wire body and the second wire body are tightened, so that the wire tube can be compressed into a ball-shaped structure to be fixed to the bone tissue repair site; The braiding density of the wire tube body is greater than the braiding density of the first end and the second end. The braiding density of the wire tube ranges from 10PPI to 100PPI. The wire diameter of the wire tube ranges from 1mm to 30mm. The length of the wire tube ranges from 10mm to 50mm.

2. The new full-line anchor as claimed in claim 1 is characterized in that: Two ends of the second wire body pass through the inside of the wire tube to the outside of the first end.

3. The new full-line anchor as claimed in claim 1 is characterized in that: The two ends of the second wire body sequentially pass through the interior of the second end of the wire tube, alternately pass through the opposite side walls of the tube body along the length direction of the tube body, and the interior of the first end of the wire tube to the outside of the first end.

4. The new full-line anchor as claimed in claim 1 is characterized in that: The soft wire is made of a medical polymer material, which includes a first material that cannot be absorbed by the human body. The first material is polypropylene, polyethylene, nylon 6, nylon 66, polyester or polytetrafluoroethylene.

5. The new full-line anchor as claimed in claim 1 is characterized in that: The first thread body and the second thread body are both made of suture thread or thread tape.

6. The new full-line anchor as claimed in claim 1, characterized in that: When the first thread body and the second thread body are suture threads, the thread diameters of the first thread body and the second thread body range from #4-0 to #5.

7. The new full-line anchor as claimed in claim 6, characterized in that: The first thread body and the second thread body are made of medical polymer materials, which include a second material that can be absorbed by the human body and a third material that cannot be absorbed by the human body. The second material is polyglycolic acid, polylactic acid, polydioxanone or polyglycolic acid lactic acid, and the third material is polypropylene, polyethylene, nylon 6, nylon 66, polyester or polytetrafluoroethylene.

8. A new full-line anchor implantation system, characterized in that: The full-line anchor implantation system includes: The full-line anchor according to any one of claims 1 to 7; The pusher is used to push the full-line anchor into the positioning hole of the bone tissue to be repaired.

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