An annulus fibrosus patch and an annulus fibrosus repair method

Abstract

The present invention discloses an annulus fibrosus patch and an annulus fibrosus repair method. By providing corresponding suture units at the folding ends of the foldable patch, the suture units include sutures and suture needles. The sutures are respectively connected to the corresponding folding ends of the foldable patch and the tail ends of the suture needles. The suture needles are used to extend into the inner side wall of the inner layer of the annulus fibrosus and initially drive the sutures to pass from the inner layer to the outer layer of the annulus fibrosus. After the foldable patch is implanted on the surface of the inner side wall of the inner layer of the annulus fibrosus in a folded state, it can be driven to unfold by the sutures. After the foldable patch unfolds, the suture needles can be operated to further drive the sutures to pass through the outside, so that the self-locking unit at the first end of the suture can fit or embed into the inner layer of the annulus fibrosus to achieve relative position fixation relative to the annulus fibrosus, achieving the purpose of attaching the foldable patch to the inner side wall of the annulus fibrosus rupture. During the repair process, only the suture needles and the foldable patch need to be inserted, and the annulus fibrosus repair can be completed by the suture needles driving the sutures and the self-locking unit. The operation is simple, solving the problem of complex operation of the existing annulus fibrosus repair surgery.

Description

Technical Field

[0001] The present invention belongs to the technical field of annulus fibrosus repair, and particularly relates to an annulus fibrosus patch and an annulus fibrosus repair method. Background Art

[0002] The human intervertebral disc consists of three parts: the cartilaginous endplate, the annulus fibrosus, and the nucleus pulposus. The annulus fibrosus is a multi-layer structure, and the fibers of the annulus fibrosus are almost arranged concentrically. The fibers on the outer periphery are more vertical, while the inclination degree increases towards the center. The nucleus pulposus is located in the center of the intervertebral disc, and the water content can account for 75-90% of the total amount of the nucleus pulposus.

[0003] Lumbar disc herniation is one of the more common diseases. Mainly because each part of the lumbar intervertebral disc, especially the nucleus pulposus, after varying degrees of degenerative changes, under the action of force factors, the annulus fibrosus of the intervertebral disc ruptures, forming an annulus fibrosus gap, and the nucleus pulposus tissue protrudes from the rupture to the back or into the spinal canal, resulting in irritation or compression of the adjacent spinal nerve roots, thereby causing a series of clinical symptoms such as low back pain, numbness and pain in one lower limb or both lower limbs. Lumbar disc herniation has the highest incidence rate at the levels of L4-L5 and L5-S1, accounting for about 95%.

[0004] Currently, mainly open surgery is adopted, removing the protruding intervertebral disc tissue that compresses the nerve and the bony structure that causes stenosis due to hyperplasia and hypertrophy of the tissue (surgical decompression). The surgical trauma is large, and the patient's recovery time is long.

[0005] Nucleus pulposus resection is a minimally invasive surgery for patients with ineffective conservative and traditional treatments for lumbar disc herniation, with significant effects, especially suitable for patients with recurrent lumbar disc herniation. This treatment does not use screws or metal rods for fixation. While removing the nucleus pulposus, it can also remove the thickening of the ligamentum flavum and solve the problem of nerve root canal stenosis caused by facet joint hyperplasia. Moreover, the cost is relatively low, the hospital stay is short, the recovery is fast, and the trauma is small. However, currently, the nucleus pulposus resection only removes the protruding nucleus pulposus. While removing the nucleus pulposus, a larger range of damage is done to the annulus fibrosus of the intervertebral disc, that is, the annulus fibrosus gap is larger, but generally the annulus fibrosus of the intervertebral disc is not repaired, resulting in a relatively high secondary recurrence rate after surgery, bringing greater pain to the patient. At the same time, the scar healing of the annulus fibrosus after one surgery also poses a great challenge to secondary treatment. Therefore, when performing discectomy, the annulus fibrosus should be repaired to reduce the incidence of postoperative recurrence and postoperative complications.

[0006] The main techniques for annulus fibrosus repair include: directly suturing the annulus fibrosus by surgical operation, tissue engineering scaffold technology, combined application of cells and gene therapy and scaffolds, etc.

[0007] The following takes some existing technologies as examples:

[0008] 1. Annulus fibrosus repair device for intervertebral disc (Grant Publication No.: CN 105796165 B)

[0009] Composition of the repair device: An anchor for inserting under the lower endplate of the lower vertebra to fix the annulus fibrosus repair device for the intervertebral disc; A plugging member, one end of which is connected to the anchor, and the other end is used to insert into the intervertebral disc from the annulus fibrosus notch, so that the plugging member surrounds the upper posterior part of the nucleus pulposus to plug the annulus fibrosus notch and prevent the nucleus pulposus from protruding again.

[0010] Operation method: After removing the protrusion, groove on the surface of the first vertebral endplate bone close to the first vertebra, and install a delivery device at the connection between the anchor and the plugging member. Then place the anchor in the appropriate position, and gently hammer the handle of the delivery device with a wooden hammer, so that the anchor is inserted under the lower endplate of the lower vertebra. Finally, remove the delivery device from the repair device, and stuff the plugging part into the annulus fibrosus through the break to complete the plugging.

[0011] Deficiencies of the device:

[0012] 1) It is necessary to groove on the vertebra, which causes additional damage to the bone;

[0013] 2) The anchor is made of titanium metal, with a sharp surface (otherwise it is difficult to achieve the fixation of the bone and the anchor), which is easy to damage the bone quality; moreover, the material properties of the bone and the metal titanium are quite different, which is easy to cause problems such as stress shielding;

[0014] 3) The material of the plugging part is a medical polyester knitted piece, part of which is outside the break and part is inside the break, blocking the chance of the break to heal again;

[0015] 4) One side of the plugging part is linked and fixed to the vertebra with the anchor, but the other side is not fixed, with a risk of re-protrusion.

[0016] 2. Annulus fibrosus suture device

[0017] (1) Annulus fibrosus suture device for minimally invasive removal of nucleus pulposus in lumbar disc herniation (Grant Publication No.: CN106063714 B)

[0018] Device composition: It includes a suture needle body and a suture thread. The suture needle body includes a guide wire and a guide needle sleeve. The guide needle sleeve is sleeved on the guide wire and is limited by a limiting device on the guide wire. The suture thread is connected to the guide wire as a whole through a suture connection device. The guide wire includes a needle rod and a needle hook. There is a circumferential sleeve limiting body at the connection of the needle rod and the needle hook. The sleeve limiting body is a raised arc structure around the guide wire. The lower end of the guide needle sleeve is set as a pointed body. The relative position of the guide needle sleeve and the guide wire is limited by the sleeve limiting body and the pointed body at the lower end of the guide needle sleeve. Among them, the needle rod, the needle hook, and the sleeve limiting body are integrally formed structures. The suture thread is fixed at the tapered tip of the suture connection device. When using a surgical needle holder to pull out the suture connection device outward, the suture connection device can be pulled out with the suture thread.

[0019] Operation method: Connect the suture thread to the needle hook, sleeve the guide needle sleeve on the guide wire, push down the guide needle cylinder, the needle hook brings the suture thread into one side of the rupture, hold the position of the fixed needle by hand, take out the guide needle sleeve, use the needle holder to pull out the suture connection device with the suture thread from the needle hook, take out the guide wire, then connect another suture thread to the needle hook, sleeve the guide needle sleeve on the guide wire, push down the guide needle cylinder, the needle hook brings the suture thread into the other side of the rupture, tie the two ends of the suture thread and cut off the excess part, and the suture is completed.

[0020] Device deficiencies:

[0021] 1) By putting in and taking out the guide needle sleeve and the guide wire back and forth like this, the intervertebral disc suture operation is quite complicated and the operation time is relatively long.

[0022] 2) The common surgical method makes the opening of the annulus fibrosus located behind the nerve root. Once the operation is not proper, it is very easy to cause damage to the nerve root and the dura mater, which requires high technical skills for doctors.

[0023] 3) During the operation, when the suture thread has passed through one side of the rupture, the needle is fixed by hand, and then another suture thread is brought in for the operation on the other side. Such a fixing method is very unstable. If the hand moves accidentally, it may cause secondary damage to the annulus fibrosus.

[0024] 4) Such a suture method can only complete single-needle suture, and the sealing of the rupture is very poor.

[0025] (2) Single-needle positioning suture device for herniated intervertebral disc annulus fibrosus (Authorization announcement number: CN 112401957 B)

[0026] Device composition: The device includes a channel tube, an air-driven component is arranged inside the channel tube, and a suture component is arranged at the inner end of the air-driven component; the suture component includes an arc-shaped cylinder, the diameter of the arc-shaped cylinder is not greater than the inner diameter of the channel tube, a suture needle is arranged inside the distal end of the arc-shaped cylinder, the suture needle is arc-shaped, and its radian is consistent with that of the arc-shaped cylinder. The suture needle is fitted inside the arc-shaped cylinder, the needle tip of the suture needle is arranged outward, and the tail end of the suture needle fixes an arc-shaped piston.

[0027] Operation method: Push the push rod A, drive the piston to push air into the C-shaped channel, and then push the piston to drive the needle. The needle and the thread are pasted together by gel. The front end part of the thread is knotted in advance. The needle penetrates through one side of the rupture of the annulus fibrosus with the thread and penetrates out from the other side of the rupture and enters the other end of the C-shaped channel. There are strip-shaped notches and several bayonets at this position. After the needle and the thread reach this position, the knot will hang on the bayonet. Pull the push rod A to drive the piston to draw air to reset the needle. However, because the knot is stuck at the bayonet, the needle and the thread are separated, and then knot again to complete one suture.

[0028] Device deficiencies:

[0029] 1) This device uses pneumatic drive to suture the needle, which requires a very high airtightness for the C-shaped device;

[0030] 2) The suture thread and the needle are pasted together by gel, which has the risk of falling off. Later, the knot tied in advance is hung on the side wall bayonet to separate the needle and the thread, which makes people more suspicious about the connection relationship between the needle and the thread. Because there will also be a certain resistance when the needle penetrates through the annulus fibrosus, it cannot be ensured that the needle and the thread are separated under the resistance of the annulus fibrosus at this time. Therefore, the operation of this device is relatively complicated.

[0031] (3) A hydrophilic lubricating dilation balloon for minimally invasive disc surgery (Publication No.: CN112190822A)

[0032] Device composition: It includes a connecting head, a channel catheter is arranged on the outer wall of one side of the connecting head, an inner catheter is arranged inside the channel catheter, and one end of the inner catheter is connected to the balloon. The balloon is composed of a hydrophilic lubricating coating, a thermoplastic polyurethane layer, a soft polyvinyl chloride layer and a nylon layer. A rotary cutting needle is arranged on the outer wall of the balloon, and longitudinal ribs are arranged at intervals on the inner wall.

[0033] Operation method: Place the uninflated balloon into the annulus fibrosus and inflate the balloon through the channel catheter. In the dry state, the balloon has good toughness, the coating adheres evenly on the surface of the balloon, is colorless and transparent, and is not easily observable by the naked eye; in the wet state, the coating is activated by water to form a colorless and transparent hydrogel. This hydrogel coating is highly lubricating and can withstand repeated friction, improving the biocompatibility between the balloon and the human body, avoiding damage to the human body, effectively enhancing the mechanical strength and stability of the balloon, and its corrosion resistance, fatigue resistance and anti-aging properties are all relatively prominent.

[0034] Device deficiencies:

[0035] 1) The implanted balloon has a large volume, affecting the biomechanical distribution of the intervertebral disc;

[0036] 2) The balloon completes the sealing of the tear by inflation. Due to the limited surgical field of view, the degree of inflation requires relatively high doctor experience;

[0037] 3) The nucleus pulposus is a substance close to water. The balloon may migrate in such an environment and is difficult to stabilize around the tear.

[0038] Therefore, the existing products have the following defects:

[0039] 1) Since it is a minimally invasive surgery, it is all operated under the microscope, but the operating space is small. In order to achieve stable suturing, the design of the suturing device is generally more complex to operate, and the operation time is prolonged; in addition, the surgery requires high doctor skills and a long training period;

[0040] 2) Because the surgery is difficult, the R & D cost is high, and the device price is also high;

[0041] 3) Because the operation is difficult, the tear is generally not sutured very tightly. The nucleus pulposus is approximately liquid, so there is still a risk of nucleus pulposus re-herniation;

[0042] 4) Suturing will damage the biomechanical characteristics of the intervertebral disc, and there is a possibility of secondary damage at the suturing position;

[0043] 5) For the existing products for repairing the tear, in order to fix the patch, a metal device is set to fix the patch on the bone, but this will damage a part of the bone. Summary of the Invention

[0044] The technical problem to be solved by the present invention is to provide an annulus fibrosus patch and an annulus fibrosus repair method to solve the problem of complex operation in the existing annulus fibrosus repair surgery.

[0045] To solve the above problems, the technical solution of the present invention is as follows:

[0046] An annulus fibrosus patch of the present invention is characterized by comprising:

[0047] A foldable patch;

[0048] A plurality of suture units, the suture unit comprising a suture and a sewing needle;

[0049] Among them, the first ends of several of the sutures are respectively connected to the corresponding folding ends of the foldable patch, and a self-locking unit is provided at the first ends of the sutures; the second ends of the sutures are respectively connected to the tail ends of the corresponding suture needles, and the suture needles are used to unfold the foldable patch through the sutures and fix the foldable patch to the inner medial wall at the fiber ring rupture through the self-locking unit.

[0050] For the fiber ring patch of the present invention, the foldable patch includes a foldable support layer and a hydrophilic layer stacked on each other; the hydrophilic layer is arranged facing the inner medial wall of the fiber ring.

[0051] For the fiber ring patch of the present invention, a plurality of folding grooves are provided on the foldable support layer to realize the folding function of the foldable support layer.

[0052] For the fiber ring patch of the present invention, the fiber direction of the hydrophilic layer is the same as the fiber direction of the innermost layer of the fiber ring.

[0053] For the fiber ring patch of the present invention, the hydrophilic layer is provided with a porous structure.

[0054] For the fiber ring patch of the present invention, the shape of the suture needle is semi-elliptical.

[0055] For the fiber ring patch of the present invention, the transverse diameter of the suture needle is 4-6 mm, and the longitudinal diameter of the suture needle is 8-10 mm.

[0056] For the fiber ring patch of the present invention, the suture is a fishbone suture, and the self-locking unit is a plurality of fishbone spines provided at the first end of the fishbone suture.

[0057] For the fiber ring patch of the present invention, the included angle of the fishbone spines on the suture is 100° and the direction is consistent with the advancing direction of the suture needle.

[0058] A fiber ring repair method of the present invention is applied to the fiber ring patch described in the above item, and the steps are as follows:

[0059] Step S1: After completing the decompression surgery, the tail end of a suture needle is clamped by a needle holder and the suture needle is sent through the fiber ring rupture to the inner wall of the inner layer of the fiber ring; one side of the suture needle is aligned with the edge of the rupture, the head end of the suture needle penetrates from the inner layer to the outer layer of the fiber ring, the needle holder releases the tail end of the suture needle, and instead clamps the head end of the suture needle, and the suture needle is withdrawn from the fiber ring, driving part of the suture through the fiber ring;

[0060] Step S2: Repeat step S1 for the remaining suture needles respectively;

[0061] Step S3: Fold the foldable patch and implant it into the inside of the fiber ring through the rupture;

[0062] Step S4: Tighten each of the sutures to deploy the foldable patch on the inner surface of the annulus fibrosus until the self-locking unit on the suture passes through the annulus fibrosus;

[0063] Step S5: Cut off the excess sutures to complete the repair of the annulus fibrosus.

[0064] Due to the adoption of the above technical solutions, the present invention has the following advantages and positive effects compared with the prior art:

[0065] 1. In an embodiment of the present invention, corresponding suture units are provided at the folded ends of the foldable patch. The suture unit includes a suture and a suture needle. The two ends of the suture are respectively connected to the corresponding folded end of the foldable patch and the tail end of the suture needle; the suture needle is used to extend into the inner wall of the inner layer of the annulus fibrosus and initially drive the suture to pass from the inner layer to the outer layer of the annulus fibrosus. After the foldable patch is implanted on the inner surface of the annulus fibrosus in the folded state, it can be driven to unfold by the suture. After the foldable patch unfolds, the suture needle can be operated to further drive the suture to pass through the outer layer, so that the self-locking unit at the first end of the suture can fit or embed into the inner layer of the annulus fibrosus to achieve relative position fixation relative to the annulus fibrosus, thereby achieving the purpose of attaching the foldable patch to the inner side of the annulus fibrosus rupture. The entire repair process only requires inserting the suture needle and the foldable patch, and driving the suture and the self-locking unit thereon through the suture needle to complete the repair of the annulus fibrosus. The operation is simple and does not require threading and knotting back and forth, solving the problem of complex operation of the existing annulus fibrosus repair surgery.

[0066] 2. In an embodiment of the present invention, the foldable patch is set as a stack of a hydrophilic layer and a foldable support layer. The hydrophilic layer is used to fit the annulus fibrosus, which is beneficial to cell growth and the healing of the annulus fibrosus; the foldable support layer is used to provide the required mechanical strength and can better withstand the pressure of the intervertebral disc. At the same time, neither of the two patches contains metal components, so the biocompatibility is better and safer.

[0067] 3. In an embodiment of the present invention, the hydrophilic layer is set as a porous structure, which is beneficial to cell growth and more beneficial to the healing of the annulus fibrosus.

[0068] 4. In an embodiment of the present invention, the fiber direction of the hydrophilic layer is set to be the same as that of the corresponding annulus fibrosus in contact, which can better retain the structure and stress mode of the annulus fibrosus itself.

[0069] 5. In an embodiment of the present invention, the suture needle is set as a semi-elliptical suture needle with a transverse diameter of 4-6 mm, which can realize passing through the annulus fibrosus in a small space to complete the suture. The entire suture process only contacts the annulus fibrosus, the suture resistance is not large, and the suture operation is easier to achieve.

[0070] 6. In an embodiment of the present invention, fishbone spurs are provided at the first end of the fishbone line (i.e., the end close to the foldable patch), and the rest is a smooth section without fishbone spurs. The included angle of the fishbone spurs is 100°, and the direction is the same as the advancing direction of the sewing needle, which is beneficial to penetrate and when subjected to a rearward pulling force, the fishbone spurs are stuck on the tissue, which can firmly lock the tissue and prevent the phenomenon of thread slipping, and has the characteristic of knot-free; the end of the fishbone spurs is blunt to prevent scratching / damaging the annulus fibrosus after the annulus fibrosus is deformed under force. BRIEF DESCRIPTION OF THE DRAWINGS

[0071] Figure 1 is a schematic diagram of the annulus fibrosus patch of the present invention;

[0072] Figure 2 is a repair effect diagram of the annulus fibrosus patch of the present invention;

[0073] Figure 3 is a schematic diagram of the foldable patch of the annulus fibrosus patch of the present invention;

[0074] Figure 4 is another schematic diagram of the foldable patch of the annulus fibrosus patch of the present invention;

[0075] Figure 5 is a schematic diagram of the foldable support layer of the annulus fibrosus patch of the present invention;

[0076] Figure 6 is a schematic diagram of the repair process of the annulus fibrosus patch of the present invention.

[0077] Description of the reference numerals: 1: foldable patch; 101: hydrophilic layer; 102: foldable support layer; 1021: folding groove; 2: fishbone line; 3: sewing needle; 4: fishbone spur; 5: annulus fibrosus. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0078] The following further describes in detail a kind of annulus fibrosus patch and an annulus fibrosus repair method proposed by the present invention in conjunction with the drawings and specific embodiments. According to the following description and the claims, the advantages and features of the present invention will be clearer.

[0079] Embodiment 1

[0080] Refer to Figure 1 and Figure 2 , in one embodiment, a kind of annulus fibrosus patch, characterized in that it includes a foldable patch 1 and a plurality of suture units.

[0081] Among them, the suture unit includes sutures and a suture needle 3. The first ends of a plurality of sutures are respectively connected to the corresponding folding ends of the foldable patch 1, and a self-locking unit is provided at the first ends of the sutures. The second ends of the sutures are respectively connected to the tail ends of the corresponding suture needles 3. The suture needles 3 are used to unfold the foldable patch 1 through the sutures and fix the foldable patch 1 to the inner layer at the rupture of the annulus fibrosus 5 through the self-locking unit.

[0082] In this embodiment, by arranging corresponding suture units at the folding ends of the foldable patch 1, the suture unit includes sutures and a suture needle 3. The two ends of the suture are respectively connected to the corresponding folding end of the foldable patch 1 and the tail end of the suture needle 3. The suture needle 3 is used to extend into the inner wall of the inner layer of the annulus fibrosus 5 and initially drive the suture to pass from the inner layer to the outer layer of the annulus fibrosus 5. After the foldable patch 1 is implanted on the surface of the inner wall of the inner layer of the annulus fibrosus 5 in a folded state, it can be driven by the suture to unfold. After the foldable patch 1 unfolds, the suture needle 3 can be operated to further drive the suture to pass through the outer layer, so that the self-locking unit at the first end of the suture can fit or embed into the inner layer of the annulus fibrosus 5 to achieve relative position fixation relative to the annulus fibrosus 5, thereby achieving the purpose of attaching the foldable patch 1 to the inner side of the rupture of the annulus fibrosus 5. The entire repair process only requires the insertion of the suture needle 3 and the foldable patch 1, and the suture needle 3 can drive the suture and the self-locking unit thereon to complete the repair of the annulus fibrosus 5. The operation is simple and does not require threading and knotting back and forth, solving the problem of complex operation of the existing annulus fibrosus 5 repair surgery.

[0083] Moreover, since the foldable patch 1 of this embodiment is arranged on the inner layer of the annulus fibrosus 5, compared with the existing scheme of arranging an outer patch, the effect of closing the rupture is better, and it avoids the complication that the outer patch deforms and compresses the surrounding nerves after being stressed.

[0084] The specific structure of the annulus fibrosus patch will be further described below:

[0085] Refer to Figure 3 and Figure 4 , in this embodiment, the foldable patch 1 may include a foldable support layer 102 and a hydrophilic layer 101 that are stacked on each other. The hydrophilic layer 101 is arranged facing the inner layer of the annulus fibrosus 5.

[0086] Among them, refer to Figure 5 , a plurality of folding grooves 1021 are provided on the foldable support layer 102, so that the foldable support layer 102 is divided into several regions, and the regions can be folded with each other through the folding grooves 1021, thereby realizing the folding function of the foldable support layer 102.

[0087] Furthermore, the fiber direction of the hydrophilic layer 101 is the same as that of the innermost layer of the annulus fibrosus 5. Setting the fiber direction of the hydrophilic layer 101 to be consistent with that of the corresponding contacting annulus fibrosus 5 can better preserve the structure and stress mode of the annulus fibrosus 5 itself. The hydrophilic layer 101 may be provided with a porous structure. Setting the hydrophilic layer 101 as a porous structure is beneficial to cell growth and more conducive to the healing of the annulus fibrosus 5.

[0088] Specifically, the hydrophilic layer 101 may specifically be a porous structure woven from fibers, with good hydrophilicity and easy to fit.

[0089] In this embodiment, the foldable patch 1 is set as a stack of the hydrophilic layer 101 and the foldable support layer 102. The hydrophilic layer 101 is used to fit the annulus fibrosus 5, which is beneficial to cell growth and the healing of the annulus fibrosus 5. The foldable support layer 102 is used to provide the required mechanical strength and can better withstand the pressure of the intervertebral disc. At the same time, neither of the two patches contains metal components, resulting in better biocompatibility and higher safety.

[0090] Specifically, if the shape of the foldable patch 1 is square, the number of suture units may be four, that is, the suture needles 3 and the sutures are also four respectively. The first ends of the four sutures may be connected to the four corners of the foldable patch 1 respectively.

[0091] In this embodiment, the suture needle 3 may be a suture needle 3 with a semi-elliptical shape. Specifically, the transverse diameter of the suture needle 3 may be 4 - 6 mm, and the longitudinal diameter of the suture needle 3 is 8 - 10 mm.

[0092] In this embodiment, the suture needle 3 is set as a semi-elliptical suture needle 3 with a transverse diameter of 5 mm, which can penetrate the annulus fibrosus 5 in a small space to complete the suture. The entire suture process only contacts the annulus fibrosus 5, with little suture resistance, making the suture operation easier to achieve.

[0093] In this embodiment, the suture may be the fishbone thread 2, and the self-locking unit may be several fishbone spurs 4 provided at the first end of the fishbone thread 2. The included angle of the fishbone spurs 4 on the suture is 100° and the direction is the same as the advancing direction of the suture needle.

[0094] In this embodiment, by setting the fishbone spurs 4 at the first end of the fishbone thread 2 (i.e., the end close to the foldable patch 1), and the rest is a smooth section without fishbone spurs 4, the included angle of the fishbone spurs 4 is 100°, and the direction is the same as the advancing direction of the suture needle 3, which is beneficial to penetrate and when subjected to a rearward pulling force, the fishbone spurs 4 can be stuck on the tissue, firmly locking the tissue and preventing the occurrence of suture slippage, with the characteristic of knot-free. The ends of the fishbone spurs 4 are blunt, preventing scratching / damaging the annulus fibrosus 5 after the annulus fibrosus 5 is deformed under stress.

[0095] In other embodiments, ordinary sutures can also be used. The suture needle 3 is pre-threaded with a suture, and the end of the suture is knotted. Additionally, according to the size of the notch in the annulus fibrosus 5, a patch of the corresponding size and specification is selected. Specifically, a test mold is used to detect and determine the size of the notch in the annulus fibrosus 5, so as to select a patch of the corresponding size and specification. In this embodiment, the suturing can be single-needle suturing or multi-needle suturing, which can be selected according to the size of the patch. Any patch that satisfies the condition that the fiber direction is consistent with the fiber direction of the adjacent annulus fibrosus 5 and has a certain supporting effect can be used, including absorbable or non-absorbable patches.

[0096] Embodiment 2

[0097] This embodiment provides a method for repairing the annulus fibrosus, which is applied to the annulus fibrosus patch in the above-mentioned Embodiment 1. The steps are as follows:

[0098] Step S1: Refer to Figure 6 , after completing the decompression surgery, the holding forceps hold the tail end of a suture needle 3 and send the suture needle 3 through the break in the annulus fibrosus 5 into the inner wall of the inner layer of the annulus fibrosus 5; align one side of the suture needle 3 with the edge of the break, and the head end of the suture needle 3 penetrates from the inner layer to the outer layer of the annulus fibrosus 5. The holding forceps release the tail end of the suture needle 3 and instead hold the head end of the suture needle 3, and withdraw the suture needle 3 from the annulus fibrosus 5, driving part of the fishbone line 2 through the annulus fibrosus 5.

[0099] Step S2: Repeat Step S1 for the other three suture needles 3 respectively.

[0100] Step S3: Fold the foldable patch 1 and implant it through the break on the surface side of the inner wall of the inner layer of the annulus fibrosus 5.

[0101] Step S4: Gently tighten the four fishbone lines 2 to unfold the foldable patch 1 on the inner surface of the annulus fibrosus 5 until the fishbone spurs 4 on the fishbone lines 2 pass through the annulus fibrosus 5. At this time, the pulling resistance significantly increases, and the fishbone spurs 4 can also provide a scale mark, thereby determining that the foldable patch 1 is basically flattened, and avoiding excessive force that may cause the fishbone lines 2 to break.

[0102] Step S5: Since the fishbone suture can achieve self-locking and does not require additional knotting, cut off the excess suture, and the repair of the annulus fibrosus 5 can be completed.

[0103] During the entire suturing process of this embodiment, only the annulus fibrosus 5 is contacted, the suturing resistance is small, and the suturing operation is easier; moreover, the fishbone spurs 4 are arranged at one end of the fishbone line 2 close to the foldable patch 1, which can better fix the relative positions among the fishbone line 2, the foldable patch 1, and the annulus fibrosus 5, and the entire suturing is flatter, avoiding damage to the surrounding tissues or nerves caused by the fishbone spurs 4.

[0104] The embodiments of the present invention have been described in detail above in conjunction with the accompanying drawings. However, the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, provided that these changes fall within the scope of the claims of the present invention and equivalent technologies, they still fall within the protection scope of the present invention.

Claims

1. An annulus fibrosus patch, characterized in that, Comprising: A foldable patch; A plurality of suture units, the suture units comprising sutures and suture needles; Wherein, the first ends of the plurality of sutures are respectively connected to the corresponding folding ends of the foldable patch, and a self-locking unit is provided at the first ends of the sutures; the second ends of the sutures are respectively connected to the tail ends of the corresponding suture needles, and the suture needles are used to unfold the foldable patch through the sutures and fix the foldable patch to the inner medial wall at the fiber ring rupture through the self-locking unit; The suture is a fishbone suture, and the self-locking unit is a plurality of fishbone spines provided at the first end of the fishbone suture; The included angle of the fishbone spines on the suture is 100° and the direction is the same as the advancing direction of the suture needle, and the ends of the fishbone spines are blunt; The foldable patch comprises a foldable support layer and a hydrophilic layer stacked on each other; the hydrophilic layer is arranged facing the inner medial wall of the fiber ring; a plurality of folding grooves are provided on the foldable support layer for realizing the folding function of the foldable support layer; The shape of the suture needle is semi-elliptical, the transverse diameter of the suture needle is 4-6 mm, and the longitudinal diameter of the suture needle is 8-10 mm.

2. The annulus fibrosus patch according to claim 1, wherein, The fiber direction of the hydrophilic layer is the same as the fiber direction of the innermost layer of the fiber ring.

3. The annulus fibrosus patch according to claim 1, characterized in that The hydrophilic layer is provided with a porous structure.

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