Annulus fibrosus repair apparatus

Abstract

Provided is an annulus fibrosus repair apparatus, comprising a degradable elastic constraint bag and a filler filling same. The space in the elastic constraint bag comprises a positioning space, a support space, and a limiting space. The filler comprises a first filler and a second filler. The first filler is located in the positioning space and is fixed in shape to form a positioning portion located outside an annulus fibrosus tear and configured for delivery and positioning. Portions corresponding to the support space and the limiting space in the elastic constraint bag can be folded in an unfilled condition and then enter the annulus fibrosus tear, and then the second filler flows into the support space and the limiting space and forms a support portion and a limiting portion respectively after solidification. The portion corresponding to the support space in the elastic constraint bag can be elastically deformed under the filling of the second filler to adapt to the shape of the annulus fibrosus tear. The limiting portion is located on the inner side of the annulus fibrosus tear and is provided with a limiting surface abutting against the inner side wall around the annulus fibrosus tear, so as to prevent the annulus fibrosus repair apparatus from being extruded from the annulus fibrosus tear by the nucleus pulposus.

Description

A device for repairing annulus fibrosus Technical Field

[0001] This invention belongs to the field of annulus fibrosus repair technology, and particularly relates to an annulus fibrosus repair device. Background Technology

[0002] With advancements in medical technology and a growing demand for faster surgical recovery, more and more patients are requesting minimally invasive surgery. Minimally invasive surgery offers advantages such as less trauma, less pain, and faster recovery, minimizing patient suffering and improving their quality of life.

[0003] Lumbar disc herniation is a relatively common disease. It is mainly caused by the degeneration of various parts of the lumbar intervertebral disc, especially the nucleus pulposus, under the influence of force factors. The annulus fibrosus of the intervertebral disc ruptures, forming a gap in the annulus fibrosus. The nucleus pulposus protrudes from the rupture point to the back or into the spinal canal, causing stimulation or compression of adjacent spinal nerve roots, resulting in a series of clinical symptoms such as lower back pain, numbness and pain in one or both lower limbs.

[0004] Discectomy is a minimally invasive surgery performed on patients whose lumbar disc herniation has not responded to conservative treatment. It is highly effective and especially suitable for patients with recurrent lumbar disc herniation. It is relatively inexpensive, requires a short hospital stay, has a fast recovery time, and is minimally invasive.

[0005] To remove the nucleus pulposus compressing the nerve, this discectomy requires creating a tear in the annulus fibrosus (if the herniation has already broken through the annulus fibrosus, the tear needs to be repaired). Because the annulus fibrosus has a very weak self-repairing ability, there is a high rate of recurrence after surgery, causing significant suffering for patients. Studies have shown that the risk of recurrence after simple discectomy is related to the size of the annulus fibrosus defect; the larger the defect, the higher the recurrence rate. Literature indicates that tears smaller than 4 mm can be closed with sutures; however, for tears larger than 4 mm, there are currently no effective methods for repair, resulting in a very high re-protrusion rate. Patients with large tears account for approximately 30% of disc herniation patients. Therefore, during the initial discectomy, the annulus fibrosus should be repaired to reduce the incidence of postoperative re-protrusion and complications.

[0006] Currently, special instruments are also used to suture and seal the annulus fibrosus. However, existing instruments have problems such as high cost, complicated operation, poor sealing effect, implant displacement, and inflammatory reactions caused by implant degradation products. These problems seriously affect the biomechanical characteristics of the intervertebral disc itself and lead to a high incidence of complications.

[0007] The following are some examples of existing medical devices used for suturing and sealing annulus fibrosus.

[0008] (1) Repair device for the annulus fibrosus of the intervertebral disc (Authorization Announcement No.: CN 105796165B)

[0009] The repair device consists of: an anchor 100 for inserting into the lower side of the endplate of the lower vertebral body to fix the annulus fibrosus of the intervertebral disc; and a sealing member 200, one end of which is connected to the anchor 220, and the other end is used to insert into the intervertebral disc through the gap in the annulus fibrosus so that the sealing member surrounds the posterosuperior part of the nucleus pulposus to seal the gap in the annulus fibrosus and prevent the nucleus pulposus from protruding again.

[0010] Procedure: After removing the protrusion, a groove is cut on the surface of the first vertebral endplate near the first vertebral body, and a delivery device is installed at the connection between the anchor 100 and the sealing device 200. Then, the anchor 100 is placed in the appropriate position, and the delivery device handle is gently tapped with a wooden mallet to insert the anchor 100 into the lower side of the lower vertebral endplate. Finally, the delivery device is removed from the repair device 10, and the sealing part 210 is inserted into the annulus fibrosus through the opening to complete the sealing.

[0011] Insufficient equipment:

[0012] ① It requires slotting in the vertebral body, which causes additional damage to the bone and can easily lead to fractures. For patients with osteoporosis, there is also a possibility of implant dislodgement.

[0013] ② The anchors are made of titanium metal, which has a sharp surface (otherwise it would be difficult to fix the bone to the anchors), and it is easy to damage the bone; moreover, the properties of bone and titanium metal are very different, which can easily cause problems such as stress shielding.

[0014] ③The sealing part 200 is made of medical polyester woven material, part of which is outside the rupture and part of which is inside the rupture, blocking the chance of the rupture healing again; in addition, fatigue and breakage are inevitable after long-term use.

[0015] ④ One side of the sealing part 200 is connected and fixed to the vertebral body with the anchor, but the other side is not fixed. There is not much relevant research on whether the mesh polymer can be tightly bonded to the annulus fibrosus tear, and there is still a risk of re-protrusion.

[0016] (2) A fiber ring plugging device and plugging method (Application No.: 202210265230.5)

[0017] The invention includes a first sealing part 1, a second sealing part 2, and a first guide rod 3. The first guide rod can penetrate the second sealing part and extend into the interior of the first sealing part, changing the first sealing part from its initial state to a state ready for insertion. The cross-sectional diameter of the first sealing part in the ready-to-insert state is smaller than that in the initial state, making it easier to enter the interior of the annulus fibrosus through the opening. After the first guide rod is released, the first sealing part returns to its initial disc shape, adhering tightly to the inner wall of the annulus fibrosus. The second sealing part also has a fixing part for securing the first guide rod when it is in the ready-to-insert state. Rotating the second guide rod 7 removes the limiting shell 5, allowing the elastic support part to open and its upper and lower ends to abut against two adjacent vertebrae of the annulus fibrosus. The elastic support part 6 can provide a counterforce when the vertebrae undergo relative displacement, thus acting as a buffer to prevent wear between the vertebrae. Furthermore, barbs can be provided on the outer edge of the elastic support part, which, acting on the vertebrae, improves the stability between the elastic support part and the vertebrae. This invention is simpler to operate and can avoid further widening of the fiber ring opening, which would cause further damage to the fiber ring.

[0018] Insufficient equipment:

[0019] ① Relying on rotating the first guide rod to deform the first sealing part may damage the integrity of the inner sealing device, and the effect of reducing the diameter of the sealing part is questionable; if the inner structure is soft enough, it will deform more easily and enter easily, and similarly, it will be easy to fall out, and the sealing effect needs to be verified.

[0020] ②The second occluder is located outside the rupture and fixed to the vertebra. It is equipped with barbs to grip the vertebra to enhance the fixation effect, which may cause further damage to the annulus fibrosus and the vertebra.

[0021] ③ The second plug has a threaded channel in the middle, which does not help to seal the fiber ring; the whole device is a hollow structure with no actual sealing structure, so the sealing effect of the whole device is questionable.

[0022] (3) Fiber ring plugging device (Application No.: 202210134753.6)

[0023] The fiber ring sealing device includes a frame 1, a first clamping assembly 21, and a driving assembly 31. The first clamping assembly includes a first clamping member 211 and a second clamping member 212, one of which is fixed to the frame, and the other is movably mounted on the frame. The two members can move closer together to clamp the fiber ring or move further apart to release the fiber ring. The driving assembly is mounted on the frame and connected to the other of the first and second clamping members to drive the other clamping member. An annular groove 3111 is formed on the peripheral wall of the operating part 311, and the annular groove is arranged along the circumference of the operating part. The frame is provided with anti-retraction protrusions 11 for engaging within the annular groove, which can improve the overall stability. The fiber ring sealing device of this invention has the advantages of simple operation, good support effect, and high stability.

[0024] Insufficient equipment:

[0025] ①Barbs are provided on the metal clamp to enhance the fixation of the occluder and the annulus fibrosus, but this may further damage the annulus fibrosus;

[0026] ②The device is relatively complex and has a relatively high manufacturing cost;

[0027] ③ The entire device is made of solid metal, which completely blocks the chance of the annulus fibrosus healing, leading to more complications in the later stages.

[0028] (4) A fiber ring plug (201820014726.4)

[0029] The fiber ring occluder provided by this utility model includes a tubular support 10, a connector 30, and a disc-shaped support 20 connected in sequence. The tubular support has a mesh structure, is hollow inside, and is cylindrical or dumbbell-shaped. The tubular support 10 is woven from super-elastic shape memory alloy wire (nickel-titanium alloy). The tubular support can be any one of a single-layer mesh structure, a double-layer mesh structure, or a multi-layer mesh structure. The disc-shaped support has a mesh structure, is umbrella-shaped or mushroom-shaped, and has a metal fixing member in the center to close the mesh surface. The edge of the disc-shaped support has multiple barbs that tightly engage with the fiber ring tears, thus preventing the internal support from dislodging. Each support is covered with a support membrane made of fiber material, which more effectively repairs fiber ring defects. The connector connects the tubular support and the disc-shaped support.

[0030] Insufficient equipment:

[0031] ① The patent does not clearly explain the specific usage of the plug. It is understood that the tubular support 10 is placed at the rupture like a plug, and the disc support 20 is located outside the fiber ring to hold the plugging device in place to prevent it from sinking in. If so, the risk of the entire device being dislodged is high.

[0032] ② The tubular structure is designed with barbs that directly contact the opening, but the quality of the fiber ring around the opening is relatively poor. Such a design may further damage the fiber ring.

[0033] ③ There is a metal fastener in the center of the disc-shaped structure to close the mesh, which is difficult to achieve in the confined space of a minimally invasive surgery.

[0034] ④ The patent uses a high-cost shape memory alloy, but does not fully utilize its shape memory function. The function described in the patent can also be achieved using a metal with good toughness, so there is no need to emphasize the use of shape memory alloy.

[0035] In summary, existing medical devices used for suturing and sealing the annulus fibrosus have the following drawbacks:

[0036] ① The procedure is complex and the operation time is prolonged;

[0037] ② The degradation products of the material components may induce inflammation and other risks;

[0038] ③Because the surgery is difficult, the research and development costs are high, and the device is also priced high;

[0039] ④ There is a possibility that the procedure may cause secondary damage to the annulus fibrosus and vertebral fractures;

[0040] ⑤ Poor closure effect;

[0041] ⑥ Implants carry a high risk of displacement and retraction. Summary of the Invention

[0042] The purpose of this invention is to provide a device for repairing annulus fibrosus, so as to solve the problems of complex operation and poor sealing effect of existing medical devices used for suturing and sealing annulus fibrosus.

[0043] The technical solution of this invention is as follows:

[0044] A ring of fiber repair device, delivered to the ring of fiber tear by a delivery device, includes a biodegradable elastic restraint bag and filler filling the elastic restraint bag;

[0045] The space within the elastic constraint bag includes a positioning space, a support space, and a limiting space. The support space is located between the positioning space and the limiting space and is connected to both the positioning space and the limiting space.

[0046] The filler includes a first filler and a second filler; the first filler is located within the positioning space, and its shape is fixed and it is conveyed to the fiber ring rupture along with the elastic restraint bag; the first filler and the portion of the elastic restraint bag wrapped around the first filler cooperate to form a positioning part, which is located on the outside of the fiber ring rupture, and has a positioning surface that abuts against the outer side wall of the fiber ring rupture for conveying and positioning;

[0047] The portions of the support space and the limiting space in the elastic constraint bag can be folded and enter the fiber ring rupture when unfilled, and the portions of the limiting space in the elastic constraint bag can extend into the inside of the fiber ring rupture; the second filler can flow into the support space and the limiting space through the flow pipe in the delivery device to open the portions of the support space and the limiting space in the elastic constraint bag and fill the support space and the limiting space, and the second filler can solidify into a solid state under the triggering conditions provided by the triggering element from the flow pipe and solidify and fix it on the first filler during solidification;

[0048] The portion of the elastic constraint bag corresponding to the support space and the second filler located in the support space cooperate to form a support part. The support part is located inside the fiber ring tear, and the portion of the elastic constraint bag corresponding to the support space can undergo elastic deformation under the filling of the second filler to adapt to the shape of the fiber ring tear.

[0049] The portion of the elastic constraint bag corresponding to the limiting space and the second filler located within the limiting space cooperate to form a limiting part. The limiting part is located inside the annulus fibrosus tear and has a limiting surface. The limiting surface abuts against the inner sidewall of the annulus fibrosus tear to prevent the annulus fibrosus repair device from being squeezed out of the annulus fibrosus tear by the nucleus pulposus.

[0050] In a preferred embodiment of the annulus fibrosus repair device, the filler is a photocurable hydrogel.

[0051] In a preferred embodiment of the fiber ring repair device, the strength of the hydrogel after curing is 6-8 MPa.

[0052] In a preferred embodiment of the annulus fibrosus repair device, the elastic constraint bag is made of hyaluronic acid, polycaprolactone, collagen, or polylactic acid-glycolic acid copolymer.

[0053] In a preferred embodiment of the fiber ring repair device, the first filler is provided with a connecting hole, which is connected to the support space and the opening on the elastic constraint bag for the second filler to flow in.

[0054] In a preferred embodiment of the fiber ring repair device, the space inside the elastic constraint bag further includes a connecting space, which is connected to the positioning space, and the connecting space is an opening on the elastic constraint bag for the inflow of the second filling material;

[0055] The portion of the elastic constraint bag corresponding to the connecting space includes a connecting portion and a cutting portion. The interior of the cutting portion is connected to both the positioning space and the interior of the connecting portion. The connecting portion is used to be fitted onto the connecting part of the delivery device, and the interior of the connecting portion is used to communicate with the flow channel in the delivery device. The cutting portion is used to be cut or severed by surgical instruments to separate the connecting portion from the portion of the elastic constraint bag corresponding to the positioning space.

[0056] In a preferred embodiment of the annulus fibrosus repair device, the limiting part further has a force-bearing surface facing the nucleus pulposus. The force-bearing surface is a curved surface that protrudes towards the nucleus pulposus at the position corresponding to the annulus fibrosus tear, and the protruding part of the curved surface abuts against the nucleus pulposus.

[0057] In a preferred embodiment of the annulus fibrosus repair device, the curved surface is a spherical cap surface obtained by cutting a sphere with a plane, and the height of the spherical cap surface is less than the radius of the sphere.

[0058] In a preferred embodiment of the fiber ring repair device, when the elastic constraint bag is filled and does not undergo elastic deformation, the distance between the positioning surface of the positioning part and the limiting surface of the limiting part is less than the distance between the inner sidewall and the outer sidewall of the fiber ring.

[0059] In a preferred embodiment of the fiber ring repair device, anti-slip textures are provided on the outer surfaces corresponding to the support portion, the positioning surface, and the limiting surface of the elastic constraint bag.

[0060] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art:

[0061] The annulus fibrosus repair device provided by this invention has a simple structure and is easy to operate. It is performed under the surgical channel of nucleotomy. An elastic restraint bag and its first filler are implanted by delivery. The positioning surface on the positioning part abuts against the outer wall around the annulus fibrosus tear to achieve positioning. Then, a second filler is filled to fill the support space and limiting space of the elastic restraint bag. Finally, the second filler is solidified by the triggering condition provided by the triggering element, thereby sealing the tear, strengthening the support performance of the defect, and stabilizing the function of the implant (i.e., the annulus fibrosus repair device). The surgical operation can meet the requirements of small space operation and the operation time is short.

[0062] The annulus fibrosus repair device provided by the present invention utilizes an elastic constraint bag to achieve minimally invasive implantation through volume changes of folding and filling. After filling, it can adapt to the shape of the annulus fibrosus tear to achieve a tight fit with the annulus fibrosus.

[0063] The annulus fibrosus repair device provided by the present invention adapts to the shape of the annulus fibrosus tear by elastically deforming the portion corresponding to the support space in the elastic constraint bag under the filling of the second filler, so that the support portion can fill the annulus fibrosus tear. At the same time, the limiting portion is located inside the annulus fibrosus, and the limiting surface on the limiting portion abuts against the inner wall around the annulus fibrosus tear. Therefore, it can prevent the annulus fibrosus repair device from being squeezed out of the annulus fibrosus tear by the nucleus pulposus.

[0064] The annulus fibrosus repair device provided by the present invention adopts a double-layer sealing of the annulus fibrosus (an outer positioning part and an inner limiting part), which can achieve a better sealing effect and reduce the risk of nucleus pulposus re-protrusion.

[0065] The annulus fibrosus repair device provided by the present invention uses an elastic constraint bag that is biodegradable. After degradation, the internal solid first and second fillers are exposed. Compared with the elastic constraint bag, the first and second fillers are more conducive to the attachment and proliferation of fibroblasts, thus promoting the healing of the annulus fibrosus. Attached Figure Description

[0066] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention.

[0067] Figures 1 and 2 are schematic diagrams of a fiber ring repair device according to the present invention (the parts corresponding to the connecting spaces are not shown in the figures);

[0068] Figures 3 and 4 are schematic diagrams of a fiber ring repair device of the present invention for sealing fiber rings (the parts corresponding to the connecting spaces in the figures are not shown);

[0069] Figures 5 to 9 are schematic diagrams illustrating the operation method of a fiber ring repair device according to the present invention;

[0070] Figure 10(a) is a top view of a first filler in the solid state according to this embodiment;

[0071] Figures 10(b), 10(c), and 10(d) are top views of the first filler in solid state in other embodiments.

[0072] Explanation of reference numerals in the attached drawings: 1: Positioning part; 2: Supporting part; 3: Limiting part; 4: Connecting part; 5: Supporting space; 6: Limiting space; 7: Fiber ring repair device; 8: Fiber ring; 9: Delivery device; 10: Optical fiber; 11: Scalpel; 12: Syringe; 13: Light source; 14: First filler; 15: Connecting hole. Detailed Implementation

[0073] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0074] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0075] Referring to Figures 1 to 9, this embodiment provides a fibrous ring repair device 7, which is delivered to the tear in the fibrous ring 8 via a delivery device 9. The fibrous ring repair device 7 includes a biodegradable elastic restraint bag and filler filling the elastic restraint bag.

[0076] The space inside the elastic constraint bag includes a positioning space, a support space 5, and a limiting space 6. The support space 5 is located between the positioning space and the limiting space 6 and is connected to both the positioning space and the limiting space 6.

[0077] The filling material includes a first filling material 14 and a second filling material. The first filling material 14 is located within the positioning space. The shape of the first filling material 14 is fixed and it is conveyed to the fiber ring 8 opening along with the elastic restraint bag. The first filling material 14 and the portion of the elastic restraint bag that wraps around the first filling material 14 cooperate to form a positioning part 1. The positioning part 1 is located on the outside of the fiber ring 8 opening and has a positioning surface that abuts against the outer side wall of the fiber ring 8 opening for conveying and positioning.

[0078] The portions corresponding to the support space 5 and the limiting space 6 in the elastic restraint bag can be folded and inserted into the rupture of the fiber ring 8 when unfilled, and the portions corresponding to the limiting space 6 in the elastic restraint bag can extend into the inside of the rupture of the fiber ring 8. The second filler can flow into the support space 5 and the limiting space 6 through the flow channel in the delivery device 9 to open the portions corresponding to the support space 5 and the limiting space 6 in the elastic restraint bag and fill the support space 5 and the limiting space 6, and the second filler can solidify into a solid state under the triggering conditions provided by the triggering element from the flow channel, and solidify and fix it on the first filler 14 during solidification.

[0079] The portion corresponding to the support space 5 in the elastic constraint bag and the second filler located in the support space 5 cooperate to form the support part 2. The support part 2 is located inside the fiber ring 8 tear, and the portion corresponding to the support space 5 in the elastic constraint bag can undergo elastic deformation under the filling of the second filler to adapt to the shape of the fiber ring 8 tear.

[0080] The portion corresponding to the limiting space 6 in the elastic constraint bag and the second filler located in the limiting space 6 cooperate to form the limiting part 3. The limiting part 3 is located inside the rupture of the annulus fibrosus 8. The limiting part 3 has a limiting surface, which abuts against the inner sidewall of the circumference of the rupture of the annulus fibrosus 8 to prevent the annulus fibrosus repair device 7 from being squeezed out of the rupture of the annulus fibrosus 8 by the nucleus pulposus.

[0081] The elastic restraint bag is made of medical-grade elastic membrane material that is biocompatible and biodegradable, such as hyaluronic acid, polycaprolactone, collagen, or polylactic acid-glycolic acid copolymer, to avoid inflammatory reactions. At the same time, after being filled, it can adapt to the shape of the rupture of the fibrous ring 8 to achieve a tight fit with the fibrous ring 8.

[0082] The filler can be a high-strength hydrogel capable of photocuring, preferably with a strength of 6–8 MPa. It can be photocured in seconds, providing mechanical strength and elasticity matching the original annulus fibrosus 8, and better withstanding axial and radial pressure on the intervertebral disc. Furthermore, the hydrogel material has excellent biocompatibility; its transformation from gel to solid within seconds via photocuring technology avoids hydrogel leakage and reduces surgical time, preventing complications such as hydrogel leakage. Moreover, the high-strength hydrogel employs a porous structure, curing within the elastic restraint bag; after the elastic restraint bag degrades, the exposed porous structure of the hydrogel further promotes the attachment and proliferation of fibroblasts, accelerating the healing of the annulus fibrosus 8.

[0083] The elastic restraint bag is highly malleable and pre-formed. After implantation, it is filled with filler to form an "I"-shaped structure (that is, the positioning part 1 and the limiting part 3 at both ends are large, and the supporting part 2 in the middle is small). The inner and outer double-layer barrier prevents the nucleus pulposus from leaking and has better airtightness.

[0084] When the elastic restraint bag is folded, it is T-shaped (the positioning part 1 cannot be folded because the first filler 14 has already solidified before implantation, and it does not deform during the operation; while the parts corresponding to the support space 5 and the limiting space 6 are not filled at the time of implantation, so they can be folded), which can be easily implanted into the rupture of the annulus fibrosus 8. After filling, it can adapt to the shape of the rupture of the annulus fibrosus 8 to achieve good incision and good tightness.

[0085] Preferably, the limiting part 3 also has a force-bearing surface facing the nucleus pulposus. This force-bearing surface is a curved surface protruding towards the nucleus pulposus at the location corresponding to the tear in the annulus fibrosus 8, with the protruding portion abutting against the nucleus pulposus. Thus, the surface of the limiting part 3 that contacts the nucleus pulposus (i.e., the force-bearing surface) is curved, which can disperse the hydrostatic pressure of the nucleus pulposus on the annulus fibrosus repair device 7 to the periphery, thereby reducing the force on the center of the annulus fibrosus repair device 7 (the center of the annulus fibrosus repair device 7 is located on the support part 2), thus preventing the annulus fibrosus repair device 7 from being squeezed out by the nucleus pulposus. More preferably, the curved surface is a spherical cap obtained by truncating a sphere with a plane, and the height of the spherical cap is less than the radius of the sphere.

[0086] Specifically, in this embodiment, the limiting part 3 is dome-shaped (R=4mm), which helps to disperse the stress from the nucleus pulposus; wherein, the outer surface of the dome is the spherical cap surface of the force-bearing surface. The dome-shaped design can disperse the force of the nucleus pulposus on the implant (i.e., the annulus fibrosus repair device 7) to the periphery of the limiting part 3. The dome is thicker in the middle (2mm) and thinner at the periphery (1mm). The increased peripheral pressure enhances the fit between the limiting part 3 and the inner annulus fibrosus 8, further preventing the implant (i.e., the annulus fibrosus repair device 7) from dislodging.

[0087] When the positioning part 1 reaches the outer side of the rupture in the annulus fibrosus 8, it will be stuck on the outside, playing a positioning role. The positioning function of the positioning part 1 improves the operability and precision of the operation. The positioning part 1 is designed to be very thin (relative to the limiting part 3) and occupy a small space, thereby preventing compression of surrounding nerves; the outer surface of the elastic restraint bag corresponding to the positioning part 1 is smooth except for the positioning surface, which can further reduce the stimulation of the annulus fibrosus repair device 7 on the tissues and nerves around the rupture. The outer surface of the support part 2, the positioning surface and the limiting surface of the elastic restraint bag (that is, the surface that will come into contact with the annulus fibrosus 8) is rough and has anti-slip texture, which can increase the friction between the annulus fibrosus repair device 7 and the annulus fibrosus 8, further preventing displacement.

[0088] When the elastic restraint bag is inflated and has not undergone elastic deformation, the distance between the positioning surface of the positioning part 1 and the limiting surface of the limiting part 3 is less than the distance between the inner and outer sidewalls of the fiber ring 8. That is, in the design, the distance between the positioning part 1 and the limiting part 3 is slightly less than the thickness of the fiber ring 8. Thus, after the elastic restraint bag is inflated, a clamping force is applied to the fiber ring 8, thereby fixing the fiber ring repair device 7 at the tear in the fiber ring 8. Furthermore, the rough surface of the fiber ring repair device 7 that contacts the fiber ring 8 increases the friction between the fiber ring repair device 7 and the fiber ring 8; the dimensions of the positioning part 1 and the limiting part 3 are much larger than the tear (meaning the positioning and limiting surfaces will abut against the outer and inner sidewalls around the tear in the fiber ring 8), making it difficult for the positioning part 1 and the limiting part 3 to pass through the tear, while simultaneously increasing the contact area between the fiber ring repair device 7 and the fiber ring 8. All of these designs reduce the risk of the fiber ring repair device 7 detaching and shifting.

[0089] Preferably, the space inside the elastic constraint bag also includes a connecting space, which is connected to the positioning space. The connecting space is an opening on the elastic constraint bag for the inflow of the second filler. As shown in Figure 10(a), the solid first filler 14 is provided with a connecting hole 15, which is connected to the support space 5 and the connecting space respectively. Of course, in other embodiments, the overall shape of the solid first filler 14 in top view may not be circular, and the solid first filler 14 may not be provided with a connecting hole 15. The shape of the solid first filler 14 is not limited and other options are possible, such as the shapes shown in Figures 10(b), 10(c), and 10(d).

[0090] On the elastic constraint bag, the connection points between the part corresponding to the support space 5 and the parts corresponding to the positioning space and the limiting space 6 can all be rounded. That is, the connection points between the part corresponding to the support space 5 and the parts corresponding to the positioning space (and limiting space 6) are not perpendicular, but have a rounded transition. Because the area where the rounded corners are made is a stress concentration area, it is easy for stress concentration to occur and damage the elastic constraint band. The rounded corner design can effectively overcome this problem. Moreover, the diameter of the rounded corner is designed to be small, thereby ensuring that there is a significant diameter change from the support part 2 to the positioning part 1 and the limiting part 3, so as to better realize the function of the positioning part 1 and the limiting part 3 in clamping the fiber ring 8.

[0091] The portion of the elastic restraint bag corresponding to the connecting space includes a connecting portion 4 and a cutting portion. The interior of the cutting portion communicates with both the positioning space and the interior of the connecting portion 4. The connecting portion 4 is used to fit onto the connecting part of the delivery device 9, and its interior communicates with the flow channel in the delivery device 9. The cutting portion is used to be cut or severed by surgical instruments to separate the connecting portion 4 from the portion corresponding to the positioning space in the elastic restraint bag. In fact, the portion corresponding to the connecting space in the elastic restraint bag is the opening of the elastic restraint bag. The connecting part of the delivery device 9 has a rod-like structure. The opening of the elastic restraint bag fits onto the connecting part of the delivery device 9, and then the opening of the elastic restraint bag can be bound to the connecting part of the delivery device 9 by a metal ring. The portion bound by the metal ring is the connecting portion 4. When the delivery device 9 needs to be withdrawn, the cutting portion can be cut open with surgical scissors (or by using a scalpel 11 to cut the cutting portion), thus separating the delivery device 9 from the annulus fibrosus repair device 7 (here referring to the portion remaining at the tear in the annulus fibrosus 8). Of course, in addition to using a metal ring to bind the opening of the elastic constraint bag to the connecting part of the delivery device 9, other methods can be used to achieve the connection, such as making the connecting part 4 very long and using the friction when the connecting part 4 is fitted onto the connecting part of the delivery device 9 to achieve the connection, etc. There are no restrictions here.

[0092] The annulus fibrosus repair device 7 provided in this embodiment utilizes the deformation capability of the elastic constraint bag to achieve minimally invasive implantation and tight fit with the rupture. It uses high-strength hydrogel to fill and light-cur the rupture to achieve closure and support. It is an annulus fibrosus repair device 7 that is simple to operate, safe, and has a good closure effect.

[0093] An operating method of the annulus fibrosus repair device 7 of this embodiment is provided. It should be noted that this method of use is only for illustration and is not a limitation of the annulus fibrosus repair device 7 of the present invention. The operating method is as follows:

[0094] The folded annulus fibrosus repair device 7 is implanted into the rupture site through a minimally invasive surgical channel (Figure 5). When the positioning part 1 of the annulus fibrosus repair device 7 reaches the outside of the rupture site of the annulus fibrosus 8, it is stuck on the outside and plays a positioning role. At this time, high-strength hydrogel, which is the second filler, is slowly injected through the flow channel on the delivery device 9. The annulus fibrosus repair device 7 is filled and unfolded to form an "I" shape (Figure 6). The optical fiber 10 is then implanted through the flow channel to solidify the high-strength hydrogel, which is the second filler (Figure 7). After a few seconds, the optical fiber 10 is withdrawn from the annulus fibrosus 8. The interface between the main body of the annulus fibrosus repair device 7 and the delivery device 9 (that is, the cut part) is cut with a scalpel 11 (Figure 8). The delivery device 9 is withdrawn. A small amount of hydrogel is injected again with a syringe 12 to seal the opening of the annulus fibrosus repair device 7 (that is, the cut part is separated) and cover the cut end of the annulus fibrosus repair device 7 (also referring to the cut part is separated) to prevent the cut end from contacting the surrounding tissue. Finally, the light emitted by the light source 13 is used to solidify this part of the gel (Figure 9). The optical fiber 10 is withdrawn, and the implantation of the annulus fibrosus repair device 7 is completed.

[0095] During the process of implanting the folded annulus repair device 7 into the tear, an auxiliary guide wire can be further provided. The auxiliary guide wire extends into the limiting space 6 of the elastic restraint bag and abuts against the far end inside the elastic restraint bag. The auxiliary guide wire moves together with the delivery device 9 to assist the folded part in the elastic restraint bag to move forward. (Since the folded part in the elastic restraint bag is at the front end of the entire conveying system during delivery, if there is no auxiliary guide wire, the resistance during the forward movement may cause the part corresponding to the upper limit space 6 and the support space 5 of the elastic restraint bag to be pushed onto the positioning part 1 and stacked with the positioning part 1 instead of forming a vertical strip perpendicular to the positioning part 1. This situation will make it difficult for the part corresponding to the upper limit space 6 and the support space 5 of the elastic restraint bag to enter the tear of the annulus 8.)

[0096] Furthermore, the first filler 14 can be cured and molded before surgery, and then the elastic restraint bag can be fitted with the cured first filler 14 through the connecting space, so that it reaches and is located in the positioning space. Since the overall size of the annulus fibrosus repair device 7 in this embodiment is small, and the elastic restraint bag has good elasticity, the part corresponding to the connecting space on the elastic restraint bag can be elastically deformed to fit the cured first filler 14 into it, so that it moves to the positioning space. Of course, in other embodiments, other methods can also be used to complete the preoperative assembly of the elastic restraint bag and the first filler 14. For example, the cured first filler 14 can be fitted into the elastic restraint bag in advance when it is pre-molded, etc., which is not limited here.

[0097] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A fiber ring repair device, which is delivered to the fiber ring tear via a delivery device, characterized in that, Includes a biodegradable elastic restraint bag and filler filling the elastic restraint bag; The space within the elastic constraint bag includes a positioning space, a support space, and a limiting space. The support space is located between the positioning space and the limiting space and is connected to both the positioning space and the limiting space. The filler includes a first filler and a second filler; the first filler is located within the positioning space, and its shape is fixed and it is conveyed to the fiber ring rupture along with the elastic restraint bag; the first filler and the portion of the elastic restraint bag wrapped around the first filler cooperate to form a positioning part, which is located on the outside of the fiber ring rupture, and has a positioning surface that abuts against the outer side wall of the fiber ring rupture for conveying and positioning; The portions of the support space and the limiting space in the elastic constraint bag can be folded and enter the fiber ring rupture when unfilled, and the portions of the limiting space in the elastic constraint bag can extend into the inside of the fiber ring rupture; the second filler can flow into the support space and the limiting space through the flow pipe in the delivery device to open the portions of the support space and the limiting space in the elastic constraint bag and fill the support space and the limiting space, and the second filler can solidify into a solid state under the triggering conditions provided by the triggering element from the flow pipe and solidify and fix it on the first filler during solidification; The portion of the elastic constraint bag corresponding to the support space and the second filler located in the support space cooperate to form a support part. The support part is located inside the fiber ring tear, and the portion of the elastic constraint bag corresponding to the support space can undergo elastic deformation under the filling of the second filler to adapt to the shape of the fiber ring tear. The portion of the elastic constraint bag corresponding to the limiting space and the second filler located within the limiting space cooperate to form a limiting part. The limiting part is located inside the annulus fibrosus tear and has a limiting surface. The limiting surface abuts against the inner sidewall of the annulus fibrosus tear to prevent the annulus fibrosus repair device from being squeezed out of the annulus fibrosus tear by the nucleus pulposus.

2. The fiber ring repair device according to claim 1, characterized in that, The filler is a photocurable hydrogel.

3. The fiber ring repair device according to claim 2, characterized in that, The strength of the hydrogel after curing is 6-8 MPa.

4. The annulus fibrosus repair device according to claim 1, characterized in that, The elastic restraint bag is made of hyaluronic acid, polycaprolactone, collagen, or polylactic acid-glycolic acid copolymer.

5. The annulus fibrosus repair device according to claim 1, characterized in that, The first filler has a connecting hole, which is connected to the support space and the opening on the elastic constraint bag for the second filler to flow in.

6. The annulus fibrosus repair device according to claim 1 or 5, characterized in that, The space inside the elastic constraint bag also includes a connecting space, which is connected to the positioning space. The connecting space is an opening on the elastic constraint bag for the second filling material to enter. The portion of the elastic constraint bag corresponding to the connecting space includes a connecting portion and a cutting portion. The interior of the cutting portion is connected to both the positioning space and the interior of the connecting portion. The connecting portion is used to be fitted onto the connecting part of the delivery device, and the interior of the connecting portion is used to communicate with the flow channel in the delivery device. The cutting portion is used to be cut or severed by surgical instruments to separate the connecting portion from the portion of the elastic constraint bag corresponding to the positioning space.

7. The annulus fibrosus repair device according to claim 1, characterized in that, The limiting part also has a force-bearing surface facing the nucleus pulposus. The force-bearing surface is a curved surface that protrudes towards the nucleus pulposus at the position corresponding to the annulus fibrosus tear. The protruding part of the curved surface abuts against the nucleus pulposus.

8. The annulus fibrosus repair device according to claim 7, characterized in that, The curved surface is the spherical cap surface obtained by cutting a sphere with a plane, and the height of the spherical cap surface is less than the radius of the sphere.

9. The annulus fibrosus repair device according to claim 1, characterized in that, When the elastic constraint bag is filled and does not undergo elastic deformation, the distance between the positioning surface of the positioning part and the limiting surface of the limiting part is less than the distance between the inner and outer sidewalls of the fiber ring.

10. The annulus fibrosus repair device according to claim 1, characterized in that, The outer surfaces of the support portion, the positioning surface, and the limiting surface of the elastic constraint bag are provided with anti-slip textures.

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