Fiber ring repairing device

Abstract

The invention discloses a fiber ring repairing device. The fiber ring repairing device comprises a degradable elastic restraining bag and filler filled in the elastic restraining bag. Space in the elastic constraint bag comprises a positioning space, a supporting space and a limiting space, and the filler comprises first filler and second filler. The first filler is located in the positioning space, fixed in shape to form a positioning part, located on the outer side of the fiber ring crevasse and used for conveying and positioning. Corresponding parts of the supporting space and the limiting space in the elastic constraint bag can be folded under the non-filling condition and then enter the fiber ring crevasse, and then the second filling part flows into the supporting space and the limiting space and forms a supporting part and a limiting part after being solidified. And the part, corresponding to the supporting space, in the elastic constraint bag can be elastically deformed under the filling of the second filler so as to adapt to the shape of the crevasse of the fiber ring. The limiting part is located on the inner side of the fibrous ring crevasse, provided with a limiting face abutting against the inner side wall of the periphery of the fibrous ring crevasse and used for preventing the fibrous ring repairing device from being extruded out of the fibrous ring crevasse by the nucleus pulposus.

Description

Technical Field

[0001] The invention belongs to the technical field of annular fiber repair, and in particular relates to an annular fiber repair device. Background Art

[0002] With the advancement of medical technology and people's demand for faster recovery from surgery, more and more patients are seeking minimally invasive surgery. Minimally invasive surgery has the advantages of less trauma, less pain, and faster recovery, which can reduce the pain of patients to the greatest extent and improve their quality of life.

[0003] Lumbar disc herniation is one of the more common diseases. It is mainly caused by the degenerative changes of various parts of the lumbar disc, especially the nucleus pulposus, to varying degrees. Under the action of force factors, the annulus fibrosus of the disc ruptures, forming an annulus fibrosus gap. The nucleus pulposus tissue protrudes from the rupture to the back or into the spinal canal, causing the adjacent spinal nerve roots to be stimulated or compressed, resulting in a series of clinical symptoms such as low back pain, numbness and pain in one or both lower limbs.

[0004] Nucleus pulposus removal is a minimally invasive surgery performed on patients who have not responded to conservative treatment for lumbar disc herniation. It has significant effects and is especially suitable for patients with recurrent lumbar disc herniation. It has relatively low costs, short hospitalization time, quick recovery, and little trauma.

[0005] In order to remove the nucleus pulposus that compresses the nerves, the nucleus pulposus removal surgery needs to create a rupture in the annulus fibrosus (if the protrusion has broken through the annulus fibrosus, the rupture needs to be repaired to a certain extent). Since the annulus fibrosus has very weak self-repair ability, there is a high secondary recurrence rate after surgery, which brings great pain to patients. Studies have shown that the risk of recurrence after simple nucleus pulposus removal of the intervertebral disc is related to the size of the annulus fibrosus defect. The larger the annulus fibrosus defect, the higher the postoperative recurrence rate. The literature indicates that for ruptures smaller than 4mm, the rupture can be closed by suturing. However, for ruptures larger than 4mm, there is currently a lack of effective means to repair them, and the re-protrusion rate is extremely high. Patients with such large ruptures account for about 30% of patients with intervertebral disc herniation. Therefore, when performing the first discectomy, the annulus fibrosus should be repaired to reduce the incidence of postoperative re-protrusion and postoperative complications.

[0006] Currently, special instruments are used to suture and seal the annulus fibrosus. However, the existing instruments have the problems of high cost, complicated operation, poor sealing effect, implant displacement, inflammatory response caused by implant degradation products, etc., which 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 fiber ring suturing and occlusion.

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

[0009] The repair device consists of: an anchor 100 inserted into the lower side of the lower vertebral end plate to fix the annulus fibrosus repair device 10 of the intervertebral disc; a plugging 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 annulus fibrosus gap, so that the plugging member surrounds the posterior and upper part of the nucleus pulposus to plug the annulus fibrosus gap and prevent the nucleus pulposus from protruding again.

[0010] Operation method: After removing the protrusion, a groove is made on the surface of the first vertebral endplate bone near the first vertebra, and a delivery device is installed at the connection between the anchor 100 and the plugging member 200. Then the anchor 100 is placed in a suitable position, and the delivery device handle is gently hammered with a wooden hammer, so that the anchor 100 is inserted into the lower side of the lower vertebral endplate. Finally, the delivery device is removed from the repair device 10, and the plugging part 210 is inserted into the annulus fibrosus through the breach to complete the plugging.

[0011] Insufficient equipment:

[0012] ① It is necessary to make grooves on the vertebral body, which causes additional damage to the bone and easily leads to fractures. For patients with osteoporosis, there is a greater possibility of implant dislocation;

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

[0014] ③ The material of the sealing part 200 is a medical polyester braided piece, one part of which is outside the rupture and the other part is inside the rupture, blocking the chance of the rupture to heal again; in addition, fatigue and breakage are inevitable after long-term use;

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

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

[0017] The invention includes a first blocking part 1, a second blocking part 2, and a first guide rod 3. The first guide rod can penetrate the second blocking part and extend into the first blocking part, so that the first blocking part changes from the initial state to the state to be extended, and the cross-sectional diameter of the first blocking part in the state to be extended is smaller than the cross-sectional diameter in the initial state, so that it is easier to enter the annulus fibrosus from the opening of the annulus fibrosus. After the first guide rod is released, the first blocking part returns to the disc shape of the initial state and is close to the inner wall of the annulus fibrosus; the second blocking part is also provided with a fixing part for fixing the first guide rod when the second blocking part is in the state to be extended; the second guide rod 7 is rotated to remove the limiting shell 5, and the elastic support part is opened after losing the restriction, and the upper and lower ends are respectively against the two adjacent vertebrae of the annulus fibrosus. The elastic support part 6 can provide a reverse force when the vertebrae are relatively displaced, thereby playing a buffering role to avoid wear between the vertebrae, and barbs can also be provided on the outer edge of the elastic support part, and the barbs act on the vertebrae to improve the stability between the elastic support part and the vertebrae. The invention is easier to operate and can avoid further enlarging the annulus fibrosus opening and causing further damage to the annulus fibrosus.

[0018] Insufficient equipment:

[0019] ① Relying on rotating the first guide rod to make the first blocking part resist deformation, this may destroy the integrity of the inner layer occluder, and the effect of reducing the cross-sectional diameter of the blocking part is questionable; if the inner layer structure is soft enough, it is easy to enter due to large deformation, and it is easy to come out by the same token, and the sealing effect needs to be verified;

[0020] ② The second occluder is outside the rupture and fixed to the vertebrae. It is provided with barbs to grasp the vertebrae to enhance the fixation effect, which may further damage the annulus fibrosus and vertebrae.

[0021] ③ There is a channel with internal threads in the middle of the second occluder, which has no effect on the sealing effect of the fiber ring; the entire device is a hollow structure, and there is no actual structure that can be sealed, so the sealing effect of the entire device is questionable.

[0022] (3) Annular fiber plugging device (application number: 202210134753.6)

[0023] The fiber annulus plugging device includes a frame 1, a first clamping assembly 21 and a driving assembly 31, wherein the first clamping assembly includes a first clamping member 211 and a second clamping member 212, one of which is fixed on the frame and the other is movably arranged on the frame, and the two can be moved closer to each other to clamp the fiber annulus or move away from each other to release the fiber annulus. The driving assembly is arranged on the frame, and the driving assembly is connected to the other of the first clamping member and the second clamping member so as to drive the other of the first clamping member and the second clamping member. An annular groove 3111 is provided on the peripheral wall surface of the operating part 311, and the annular groove is arranged along the circumference of the operating part. The frame is provided with an anti-retraction protrusion 11 for matching in the annular groove, which can improve the overall stability. The fiber annulus plugging device of the invention has the advantages of simple operation, good support effect and high stability.

[0024] Insufficient equipment:

[0025] ① Barbs are set 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 the manufacturing cost is relatively high;

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

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

[0029] The fiber annulus occluder provided by the patent includes a tubular stent 10, a connector 30 and a disc-shaped stent 20 connected in sequence. The tubular stent has a mesh structure, is hollow inside, and is shaped like a cylinder or a dumbbell. The tubular stent 10 is woven with superelastic memory alloy wire (nickel-titanium alloy), and the tubular stent is any one of a single-layer mesh structure, a double-layer mesh structure and a multi-layer mesh structure; the disc-shaped stent has a mesh structure, which is umbrella-shaped or mushroom-shaped, and a metal fixing piece for closing the mesh surface is arranged in the center; the edge of the disc-shaped stent is provided with a plurality of barbs with barbs, which are tightly combined with the fiber annulus fissure, thereby preventing the built-in stent from falling out. The stent is provided with a stent coating made of fiber material to more effectively repair the defect of the fiber annulus. The connector connects the tubular stent and the disc-shaped stent.

[0030] Insufficient equipment:

[0031] ① The patent does not explain the specific use of the occluder. It is understood that the tubular stent 10 is placed at the rupture to block it like a plug, and the disc-shaped stent 20 is located outside the fiber ring to clamp the occlusion device to prevent it from sinking in. If so, the risk of the entire device being withdrawn is high;

[0032] ② The tubular structure is set with barbs in direct contact with the rupture, but the quality of the fiber ring around the rupture is relatively poor, and such a setting may further damage the fiber ring;

[0033] ③ There is a metal fixing piece in the center of the disc-shaped structure to close the mesh surface, which is difficult to achieve in the narrow minimally invasive surgical space;

[0034] ④ A more expensive shape memory alloy is used, but its shape memory function is not fully utilized. The function described in the patent can also be achieved by using metal with good toughness without emphasizing the use of shape memory alloy.

[0035] In summary, the existing medical devices for suturing and occluding the annulus fibrosus have the following defects:

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

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

[0038] ③ Because the operation is difficult, the R&D cost is high and the device pricing is also high;

[0039] ④ The operation may cause secondary damage to the annulus fibrosus and vertebral fractures;

[0040] ⑤Poor closure effect;

[0041] ⑥The implant has a higher risk of displacement and dislocation. Summary of the invention

[0042] The purpose of the present invention is to provide an annulus fibrosus repair device to solve the problems of complicated operation and poor sealing effect of medical devices used for suturing and sealing the annulus fibrosus in the prior art.

[0043] The technical solution of the present invention is:

[0044] A fiber ring repair device is delivered to the fiber ring rupture through a delivery device, comprising a degradable elastic restraint bag and a filler filled in the elastic restraint bag;

[0045] The space in the elastic restraint bag includes a positioning space, a supporting space and a limiting space, wherein the supporting space is located between the positioning space and the limiting space and is communicated with the positioning space and the limiting space respectively;

[0046] The filler includes a first filler and a second filler; the first filler is located in the positioning space, the shape of the first filler is fixed and is transported to the fiber annulus rupture together with the elastic constraint bag; the first filler and the part of the elastic constraint bag wrapped outside the first filler cooperate to form a positioning portion, the positioning portion is located outside the fiber annulus rupture, the positioning portion has a positioning surface, the positioning surface abuts against the outer side wall of the fiber annulus rupture for transportation and positioning;

[0047] The portions corresponding to the support space and the limit space in the elastic restraint bag can be folded into the fiber ring rupture when not filled, and the portions corresponding to the limit space in the elastic restraint bag can extend into the inner side of the fiber ring rupture; the second filler can flow into the support space and the limit space through the circulation pipe in the delivery device to open the portions corresponding to the support space and the limit space in the elastic restraint bag and fill the support space and the limit space, and the second filler can solidify into a solid state under the triggering condition provided by the triggering member from the circulation pipe and be fixed on the first filler when solidifying;

[0048] The portion of the elastic restraint bag corresponding to the support space and the second filler located in the support space cooperate to form a support portion, the support portion is located in the fiber ring breach, and the portion of the elastic restraint bag corresponding to the support space can be elastically deformed under the filling of the second filler to adapt to the shape of the fiber ring breach;

[0049] The portion corresponding to the limiting space in the elastic constraint bag and the second filler located in the limiting space cooperate to form a limiting portion, and the limiting portion is located on the inner side of the annulus fibrosus rupture. The limiting portion has a limiting surface, and the limiting surface abuts against the inner side wall around the annulus fibrosus rupture to prevent the annulus fibrosus repair device from being squeezed out of the annulus fibrosus rupture by the nucleus pulposus.

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

[0051] In the annulus fibrosus repair device provided in a preferred embodiment, the strength of the hydrogel after curing is 6 to 8 MPa.

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

[0053] In the annulus fibrosus repair device provided in a preferred embodiment, the first filler is provided with a communicating hole, and the communicating hole is respectively communicated with the supporting space and an opening on the elastic restraint bag for the second filler to flow in.

[0054] In a fiber ring repair device provided in a preferred embodiment, the space in the elastic restraint bag further includes a connection space, the connection space is connected to the positioning space, and the connection space is an opening on the elastic restraint bag for the second filler to flow in;

[0055] The part corresponding to the connecting space in the elastic restraint bag includes a connecting part and a cutting part, the interior of the cutting part is respectively connected with the positioning space and the interior of the connecting part; the connecting part is used to be sleeved on the connecting part of the delivery device and the interior of the connecting part is used to be connected with the circulation pipeline in the delivery device; the cutting part is used to be cut or cut by a surgical instrument to separate the connecting part from the part corresponding to the positioning space in the elastic restraint bag.

[0056] In a preferred embodiment of the annulus fibrosus repair device, the limiting portion further has a force-bearing surface facing the nucleus pulposus, and the force-bearing surface is a curved surface convex toward the nucleus pulposus at a position corresponding to the annulus fibrosus rupture, and the convex portion of the curved surface abuts against the nucleus pulposus.

[0057] In a fiber ring repair device provided in a preferred embodiment, the curved surface is a spherical crown surface obtained by cutting a sphere by a plane, and the height of the spherical crown surface is smaller than the radius of the sphere.

[0058] In a fiber ring repair device provided in a preferred embodiment, when the elastic constraint bag is filled and no elastic deformation occurs, the distance between the positioning surface of the positioning portion and the limiting surface of the limiting portion is smaller than the distance between the inner wall and the outer wall of the fiber ring.

[0059] In the annulus fibrosus repair device provided in a preferred embodiment, anti-slip patterns are provided on the outer surfaces corresponding to the support portion, the positioning surface and the limiting surface on the elastic restraint bag.

[0060] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0061] The annulus fibrosus repair device provided by the present invention has a simple structure and is easy to operate. It is performed under the surgical channel of nucleus pulposus removal. The elastic constraint bag and the first filler therein are implanted by delivery. The positioning is achieved by the positioning surface on the positioning part abutting against the outer wall around the annulus fibrosus rupture. Then the second filler is filled to fill the supporting space and the limiting space of the elastic constraint bag. Finally, the second filler is solidified by the trigger condition provided by the trigger member to seal the rupture, strengthen the supporting performance of the defect, and stabilize the function of the implant (that is, the annulus fibrosus repair device). The surgical operation can meet the needs of operation in a small space and the operation time is short.

[0062] The annulus fibrosus repair device provided by the present invention realizes minimally invasive implantation by utilizing the volume change of the elastic constraint bag through folding and filling, and can adapt to the shape of the annulus fibrosus rupture after filling to achieve a close fit with the annulus fibrosus.

[0063] The annulus fibrosus repair device provided by the present invention adapts to the shape of the annulus fibrosus rupture by elastically deforming the portion corresponding to the supporting space in the elastic constraint bag when filled with the second filler, so that the supporting portion can fill the annulus fibrosus rupture. At the same time, the limiting portion is located on the inner side of the annulus fibrosus, and the limiting surface on the limiting portion abuts against the inner wall around the annulus fibrosus rupture. Therefore, the annulus fibrosus repair device can be prevented from being squeezed out of the annulus fibrosus rupture by the nucleus pulposus.

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

[0065] The annulus fibrosus repair device provided by the present invention adopts a degradable elastic restraint bag, which exposes the solid first filler and second filler inside after degradation. Compared with the elastic restraint bag, the first filler and the second filler are more conducive to the attachment and reproduction of fibroblasts and promote the healing of the annulus fibrosus. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the following detailed description of the preferred embodiment.The drawings are only for the purpose of illustrating the preferred embodiments and are not to be construed as limiting the invention.

[0067] Figure 1 and Figure 2 It is a structural schematic diagram of a fiber ring repair device of the present invention (the part corresponding to the connection space in the figure is not drawn);

[0068] Figure 3 and Figure 4 A schematic diagram of a fiber ring repair device of the present invention for plugging a fiber ring (the portion corresponding to the connecting space is not drawn in the figure);

[0069] Figures 5 to 9 A schematic diagram of an operation method of a fiber ring repair device of the present invention;

[0070] Fig.10 (a) is a schematic top view of a first filler in a solid state according to the present embodiment;

[0071] Fig.10 (b) Fig.10 (c) Fig.10 (d) is a schematic top view of the first filler in a solid state in other embodiments.

[0072] Description of reference numerals:

[0073] 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 filling material; 15: connecting hole. DETAILED DESCRIPTION

[0074] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings and other implementation methods can be obtained based on these drawings without creative work.

[0075] In order to simplify the drawings, only the parts related to the present invention are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked. In this article, "one" not only means "only one", but also means "more than one".

[0076] See also Figures 1 to 9 This embodiment provides a fiber ring repair device 7, which is delivered to the rupture of the fiber ring 8 by a delivery device 9. The fiber ring repair device 7 includes a degradable elastic constraint bag and a filler filled in the elastic constraint bag.

[0077] The space in the elastic restraint 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 communicated with the positioning space and the limiting space 6 respectively.

[0078] The filler includes a first filler 14 and a second filler. The first filler 14 is located in the positioning space, and the shape of the first filler 14 is fixed and is transported to the rupture of the fiber ring 8 together with the elastic constraint bag. The first filler 14 and the part of the elastic constraint bag wrapped outside the first filler 14 cooperate to form a positioning portion 1, which is located outside the rupture of the fiber ring 8. The positioning portion 1 has a positioning surface, which abuts against the outer side wall of the circumferential side of the rupture of the fiber ring 8 for transportation and positioning.

[0079] The corresponding parts of the support space 5 and the limiting space 6 in the elastic restraint bag can be folded and enter the rupture of the fiber ring 8 when not filled, and the corresponding parts of the limiting space 6 in the elastic restraint bag can extend into the inner side 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 circulation channel in the delivery device 9 to open the corresponding parts of 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 condition provided by the triggering member from the circulation channel and be fixed on the first filler 14 when solidifying.

[0080] 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 a support part 2, and the support part 2 is located in the rupture of the fiber ring 8. The portion corresponding to the support space 5 in the elastic constraint bag can be elastically deformed under the filling of the second filler to adapt to the shape of the rupture of the fiber ring 8.

[0081] 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 a limiting portion 3, which is located on the inner side of the rupture of the annulus fibrosus 8. The limiting portion 3 has a limiting surface, which abuts against the inner wall around 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.

[0082] Among them, the elastic restraint bag is made of medical-grade elastic membrane materials made of biocompatible and degradable polymer materials, such as hyaluronic acid or polycaprolactone or collagen or polylactic acid-glycolic acid copolymer, to avoid inflammatory response; at the same time, after filling, it can adapt to the shape of the rupture of the annulus fibrosus 8 to achieve a close fit with the annulus fibrosus 8.

[0083] The filler can be a high-strength hydrogel that can be photocured, with a strength of preferably 6 to 8 MPa. It can be photocured in a few seconds, and can provide mechanical strength and elasticity that match the native annulus fibrosus 8, and can better withstand the axial and radial pressure of the intervertebral disc. Moreover, the hydrogel material has good biocompatibility. Through photocuring technology, it changes from a gel state to a solid state within a few seconds, which can avoid hydrogel leakage and reduce surgical time, and complications such as hydrogel leakage will not occur. Moreover, the high-strength hydrogel adopts a porous structure and solidifies in an elastic constraint bag; after the elastic constraint bag degrades, the porous structure of the hydrogel is exposed, which is more conducive to the attachment and reproduction of fibroblasts and promotes the healing of the annulus fibrosus 8.

[0084] The elastic restraint bag is highly plastic and pre-formed. After implantation, it is filled with fillers to obtain 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 barriers prevent nucleus pulposus leakage and have better airtightness.

[0085] The elastic constraint bag is T-shaped when folded (the positioning part 1 cannot be folded and does not deform during the operation because the first filler 14 has solidified into a solid state before implantation; and the parts corresponding to the support space 5 and the limiting space 6 have not been filled at the time of implantation, so they can be folded). It can be easily implanted into the rupture of the annulus fibrosus 8, and after filling, it can adapt to the shape of the rupture of the annulus fibrosus 8 to achieve a good fit and good tightness.

[0086] Preferably, the limiting portion 3 also has a force-bearing surface facing the direction of the nucleus pulposus, and the force-bearing surface is a curved surface convex toward the direction of the nucleus pulposus at the position corresponding to the rupture of the annulus fibrosus 8, and the convex part of the curved surface abuts against the nucleus pulposus. In this way, the surface of the limiting portion 3 that contacts the nucleus pulposus (that is, the force-bearing surface) has an arc, 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 portion 2), so as to prevent the annulus fibrosus repair device 7 from being squeezed out by the nucleus pulposus. More preferably, the curved surface is a spherical crown surface obtained by cutting a sphere by a plane, and the height of the spherical crown surface is less than the radius of the sphere.

[0087] Specifically in this embodiment, the limiting portion 3 is dome-shaped (R=4mm), which is conducive to dispersing the stress from the nucleus pulposus; wherein, the outer surface of the dome is the spherical crown surface of the force-bearing surface. The dome-shaped design can disperse the force of the nucleus pulposus on the implant (that is, the annulus fibrosus repair device 7) to the periphery of the limiting portion 3. The dome is thick in the middle (2mm) and thin at the periphery (1mm). The increase in the peripheral pressure strengthens the fit between the limiting portion 3 and the inner annulus fibrosus 8, further preventing the implant (that is, the annulus fibrosus repair device 7) from falling out.

[0088] When the positioning part 1 reaches the outside of the rupture of the annulus fibrosus 8, it will be stuck on the outside, playing a positioning role. The design of the positioning function of the positioning part 1 improves the operability and accuracy of the operation. The positioning part 1 is designed to be very thin (relative to the limiting part 3) and occupies a small space, so as to prevent compression of the peripheral nerves; the outer surface corresponding to the positioning part 1 on the elastic restraint bag is smooth except for the positioning surface, which can further reduce the stimulation of the annulus fibrosus repair device 7 to the tissues and nerves around the rupture. The outer surfaces corresponding to the support part 2, the positioning surface and the limiting surface on the elastic restraint bag (that is, the surface that will contact the annulus fibrosus 8) are rough and have anti-slip textures, which can increase the friction between the annulus fibrosus repair device 7 and the annulus fibrosus 8 and further prevent displacement.

[0089] When the elastic constraint bag is filled and no elastic deformation occurs, the distance between the positioning surface of the positioning part 1 and the limiting surface of the limiting part 3 is smaller than the distance between the inner wall and the outer wall of the annulus fibrosus 8. That is, when designing, the distance between the positioning part 1 and the limiting part 3 is slightly smaller than the thickness of the annulus fibrosus 8, so that after the elastic constraint bag is filled, a clamping force will be applied to the annulus fibrosus 8, thereby fixing the annulus fibrosus repair device 7 at the rupture of the annulus fibrosus 8. Moreover, the surface of the annulus fibrosus repair device 7 that contacts the annulus fibrosus 8 is rough, which increases the friction between the annulus fibrosus repair device 7 and the annulus fibrosus 8; the size of the positioning part 1 and the limiting part 3 is much larger than the rupture (that is, the positioning surface and the limiting surface will abut against the outer wall and the inner wall around the rupture of the annulus fibrosus 8), making it difficult for the positioning part 1 and the limiting part 3 to pass through the rupture, while increasing the contact area between the annulus fibrosus repair device 7 and the annulus fibrosus 8. The above designs reduce the risk of the annulus fibrosus repair device 7 coming out and shifting.

[0090] Preferably, the space in the elastic restraint bag further includes a connecting space, the connecting space is connected to the positioning space, and the connecting space is an opening on the elastic restraint bag for the second filling to flow in; Fig.10 As shown in (a), the solid first filler 14 is provided with a connecting hole 15, and the connecting hole 15 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 a top view may not be circular, and the solid first filler 14 may not be provided with the connecting hole 15. The shape of the solid first filler 14 is not limited, and other options may be available, such as Fig.10 (b) Fig.10 (c) Fig.10 (d) The shape shown, etc.

[0091] On the elastic restraint bag, the connection between the part corresponding to the support space 5 and the part corresponding to the positioning space and the limiting space 6 can be designed with rounded corners, that is, the connection between the part corresponding to the support space 5 and the part corresponding to the positioning space (and the limiting space 6) is not vertical, but has an arc transition. Because the area where the rounding is performed is a stress concentration area, it is easy for stress concentration to occur and damage the elastic restraint belt, and the rounded corner design can overcome this problem well. In addition, the diameter of the rounded corner is designed to be small, so as to ensure 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 cooperating to clamp the fiber ring 8.

[0092] The part corresponding to the connection space in the elastic constraint bag includes a connection part 4 and a cutting part, and the interior of the cutting part is respectively connected to the positioning space and the interior of the connection part 4. The connection part 4 is used to be sleeved on the connection part of the delivery device 9, and the interior of the connection part 4 is used to communicate with the circulation pipeline in the delivery device 9. The cutting part is used to be cut or cut by a surgical instrument to separate the connection part 4 from the part corresponding to the positioning space in the elastic constraint bag. In fact, the part corresponding to the connection space in the elastic constraint bag is the bag opening of the elastic constraint bag. The connection part of the delivery device 9 is a structure similar to a rod. The bag opening of the elastic constraint bag is sleeved on the connection part of the delivery device 9, and then the bag opening of the elastic constraint bag can be bound to the connection part of the delivery device 9 by a metal ring. Among them, the part bound by the metal ring is the connection part 4. When the delivery device 9 needs to be withdrawn, the cutting part can be cut open by surgical scissors (it can also be cut open by a scalpel 11, etc.), so that the delivery device 9 can be separated from the annulus fibrosus repair device 7 (here refers to the part left at the rupture of the annulus fibrosus 8). Of course, in addition to using a metal ring to bind the bag opening of the elastic constraint bag to the connecting part of the delivery device 9, the connection can also be achieved in other ways, such as making the connecting part 4 very long and achieving the connection by the friction force when the connecting part 4 is put on the connecting part of the delivery device 9, etc., which is not limited here.

[0093] The annulus fibrosus repair device 7 provided in this embodiment utilizes the deformation ability of the elastic constraint bag to achieve minimally invasive implantation and close fitting with the rupture, and utilizes high-strength hydrogel filling and light curing to achieve closure and support of the rupture. The annulus fibrosus repair device 7 is simple to operate, safe, and has a good closure effect.

[0094] A method for operating the annulus fibrosus repair device 7 of this embodiment is now provided. It should be noted that this method of use is only for illustration and is not intended to limit the annulus fibrosus repair device 7 of the present invention. The method of operation is as follows:

[0095] The folded annulus fibrosus repair device 7 is implanted into the rupture 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 of the annulus fibrosus 8, it is stuck on the outside to play a positioning role. At this time, the high-strength hydrogel, that is, the second filler, is slowly injected through the circulation channel on the delivery device 9, and the annulus fibrosus repair device 7 is filled and expanded to form a "work" ( Figure 6 ), and then implant the optical fiber 10 through the circulation 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 fiber ring 8, and the interface (i.e., the cutting part) between the fiber ring repair device 7 and the delivery device 9 is cut with a scalpel 11 ( Figure 8), withdraw the delivery device 9, inject a small amount of hydrogel with the syringe 12 to seal the opening of the annulus fibrosus repair device 7 (that is, the cut-off part), cover the cut-off end of the annulus fibrosus repair device 7 (also refers to the cut-off part), and avoid contact between the cut-off end and the surrounding tissue; finally, use the light emitted by the light source 13 to cure this part of the gel ( Fig. 9 ), withdraw the optical fiber 10, and complete the implantation of the fiber ring repair device 7.

[0096] Among them, in the process of implanting the folded fiber ring repair device 7 into the rupture, an auxiliary guide wire can be further set, and the auxiliary guide wire extends into the limiting space 6 of the elastic constraint bag and presses against the distal end of the elastic constraint bag. The auxiliary guide wire moves with the delivery device 9 to assist the folded part in the elastic constraint bag to advance (because during the delivery process, the folded part in the elastic constraint bag is at the front end of the entire conveying system, so if there is no auxiliary guide wire, the resistance during the advancement process may cause the parts corresponding to the upper limit space 6 and the support space 5 of the elastic constraint bag to be pushed on the positioning part 1 and overlap the positioning part 1, instead of forming a vertical bar perpendicular to the positioning part 1. This situation will make it difficult for the parts corresponding to the upper limit space 6 and the support space 5 of the elastic constraint bag to enter the rupture of the fiber ring 8).

[0097] In addition, before the operation, the first filler 14 can be solidified and formed first, and then the elastic constraint bag can insert the solidified first filler 14 into it through the connection space, so that it reaches and is located in the positioning space; because the fiber ring repair device 7 of this embodiment has a small overall size and the elasticity of the elastic constraint bag is good, the part corresponding to the connection space on the elastic constraint bag can be elastically deformed to insert the solidified 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 constraint bag and the first filler 14. For example, the solidified first filler 14 can be inserted in advance when the elastic constraint bag is preformed, etc., which is not limited here.

[0098] The embodiments of the present invention are described in detail above in conjunction with 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 still fall within the protection scope of the present invention.

Claims

1. A fiber ring repair device, which is delivered to the fiber ring rupture by a delivery device, characterized in that: It comprises a degradable elastic restraint bag and a filler filled in the elastic restraint bag; The space in the elastic restraint bag includes a positioning space, a supporting space and a limiting space, wherein the supporting space is located between the positioning space and the limiting space and is communicated with the positioning space and the limiting space respectively; The filler includes a first filler and a second filler; the first filler is located in the positioning space, the shape of the first filler is fixed and is transported to the fiber annulus rupture together with the elastic constraint bag; the first filler and the part of the elastic constraint bag wrapped outside the first filler cooperate to form a positioning portion, the positioning portion is located outside the fiber annulus rupture, the positioning portion has a positioning surface, the positioning surface abuts against the outer side wall of the fiber annulus rupture for transportation and positioning; The portions corresponding to the support space and the limit space in the elastic restraint bag can be folded into the fiber ring rupture when not filled, and the portions corresponding to the limit space in the elastic restraint bag can extend into the inner side of the fiber ring rupture; the second filler can flow into the support space and the limit space through the circulation pipe in the delivery device to open the portions corresponding to the support space and the limit space in the elastic restraint bag and fill the support space and the limit space, and the second filler can solidify into a solid state under the triggering condition provided by the triggering member from the circulation pipe and be fixed on the first filler when solidifying; The portion of the elastic restraint bag corresponding to the support space and the second filler located in the support space cooperate to form a support portion, the support portion is located in the fiber ring breach, and the portion of the elastic restraint bag corresponding to the support space can be elastically deformed under the filling of the second filler to adapt to the shape of the fiber ring breach; The portion corresponding to the limiting space in the elastic constraint bag and the second filler located in the limiting space cooperate to form a limiting portion, and the limiting portion is located on the inner side of the annulus fibrosus rupture. The limiting portion has a limiting surface, and the limiting surface abuts against the inner side wall around the annulus fibrosus rupture to prevent the annulus fibrosus repair device from being squeezed out of the annulus fibrosus rupture by the nucleus pulposus.

2. The annulus fibrosus repair device according to claim 1, characterized in that: The filler is a photocurable hydrogel.

3. The annulus fibrosus repair device according to claim 2, characterized in that: The strength of the hydrogel after solidification 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 or polycaprolactone or collagen or polylactic acid-glycolic acid copolymer.

5. The annulus fibrosus repair device according to claim 1, characterized in that: The first filler is provided with a communicating hole, and the communicating hole is respectively communicated with the supporting space and an opening on the elastic restraining 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 in the elastic restraint bag also includes a connection space, the connection space is connected to the positioning space, and the connection space is an opening on the elastic restraint bag for the second filling to flow in; The part corresponding to the connecting space in the elastic restraint bag includes a connecting part and a cutting part, the interior of the cutting part is respectively connected with the positioning space and the interior of the connecting part; the connecting part is used to be sleeved on the connecting part of the delivery device and the interior of the connecting part is used to be connected with the circulation pipeline in the delivery device; the cutting part is used to be cut or cut by a surgical instrument to separate the connecting part from the part corresponding to the positioning space in the elastic restraint bag.

7. The annulus fibrosus repair device according to claim 1, characterized in that: The limiting portion also has a force-bearing surface facing the direction of the nucleus pulposus. The force-bearing surface is a curved surface convex toward the direction of the nucleus pulposus at a position corresponding to the rupture of the annulus fibrosus, and the convex 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 a spherical cap surface obtained when a sphere is cut by 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 restraint bag is filled and has not been elastically deformed, the distance between the positioning surface of the positioning portion and the limiting surface of the limiting portion is smaller than the distance between the inner side wall and the outer side wall of the fiber ring.

10. The annulus fibrosus repair device according to claim 1, characterized in that: The supporting portion, the positioning surface and the outer surfaces corresponding to the limiting surface on the elastic restraint bag are provided with anti-slip patterns.

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