An annulus fibrosus repair device

Abstract

The application discloses a kind of annulus fibrosus repair devices, including degradable elastic constraint bag and filling in it.Filling in the space of elastic constraint bag includes positioning space, support space and limiting space, and filling includes first filling and second filling.First filling is located in positioning space and is fixed in shape to form positioning part, located outside the annulus fibrosus break, for conveying positioning.Elastic constraint bag corresponding part in support space and limiting space can be folded after being filled into the annulus fibrosus break, then second filling part flows into support space and limiting space and forms support part and limiting part respectively after coagulation.Elastic constraint bag corresponding part in support space can be elastically deformed to adapt to the shape of annulus fibrosus break under the filling of second filling.Limiting part is located inside the annulus fibrosus break, with limiting surface abutting with the inner wall around the annulus fibrosus break, for preventing annulus fibrosus repair device from being extruded from the annulus fibrosus break by nucleus pulposus.

Description

Technical Field

[0001] The present invention belongs to the technical field of annulus fibrosus repair, and in particular relates to an annulus fibrosus 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 requesting minimally invasive surgery. Minimally invasive surgery has the advantages of less trauma, less pain, and faster recovery, which can minimize patients' pain and improve their quality of life.

[0003] Lumbar disc herniation is one of the more common diseases. It is mainly because the various parts of the lumbar intervertebral disc, especially the nucleus pulposus, undergo different degrees of degenerative changes. Under the action of force factors, the annulus fibrosus of the intervertebral 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 irritated 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 with lumbar disc herniation who have not responded to conservative treatment. 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 minimal trauma.

[0005] In order to remove the nucleus pulposus that compresses the nerves, the nucleus pulposus removal surgery requires creating 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 rate of secondary recurrence after surgery, which causes great pain to the patient. 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 of repair, and the re-herniation rate is extremely high. Patients with such large ruptures account for about 30% of patients with intervertebral disc herniation. Therefore, during the initial discectomy, the annulus fibrosus should be repaired to reduce the incidence of postoperative re-herniation and postoperative complications.

[0006] Currently, special instruments are used to suture and seal the annulus fibrosus. However, existing instruments have problems such as high cost, complex operation, poor sealing effect, implant displacement, and inflammatory response 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 annulus fibrosus suturing and occlusion.

[0008] (1) Intervertebral disc annulus fibrosus repair device (Authorization Announcement No.: CN 105796165 B)

[0009] The repair device consists of: an anchor 100 for inserting into the lower side of the lower vertebral end plate to fix the annulus fibrosus repair device 10 of the intervertebral disc; a blocking member 200, one end of which is connected to the anchor 220, and the other end is used to be inserted into the intervertebral disc through the annulus fibrosus gap, so that the blocking member surrounds the posterior and superior part of the nucleus pulposus to block the annulus fibrosus gap and prevent the nucleus pulposus from herniating again.

[0010] Procedure: After removing the protrusion, a groove is made in the surface of the first vertebral endplate bone near the first vertebral body. A delivery device is then installed at the junction of the anchor 100 and the occlusion member 200. The anchor 100 is then positioned appropriately and the delivery device handle is gently struck with a hammer to insert the anchor 100 into the underside of the lower vertebral endplate. Finally, the delivery device is removed from the repair device 10 and the occlusion member 210 is inserted through the opening into the annulus fibrosus to complete the occlusion.

[0011] Insufficient equipment:

[0012] ① It requires slotting on the vertebral body, which causes additional damage to the bone and is prone to fracture. In 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 achieve fixation between the bone and the anchor), which can easily damage the bone. In addition, the properties of bone and titanium metal are very different, which can easily cause problems such as stress shielding.

[0014] ③ The sealing part 200 is made of medical polyester braided material, part of which is outside the wound and part of which is inside the wound, blocking the chance of the wound healing. 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 portion 1, a second blocking portion 2, and a first guide rod 3. The first guide rod is capable of penetrating the second blocking portion and extending into the interior of the first blocking portion, causing the first blocking portion to change from an initial state to a state ready for insertion. The cross-sectional diameter of the first blocking portion 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 annulus fibrosus opening. After the first guide rod is released, the first blocking portion returns to its initial disc shape and adheres closely to the inner wall of the annulus fibrosus. The second blocking portion is also provided with a fixing portion for fixing the first guide rod in the ready-to-insert state. The second guide rod 7 is rotated to remove the limiting housing 5. The elastic support portion is then opened after the restriction is removed, with the upper and lower ends respectively resting against two adjacent vertebrae in the annulus fibrosus. The elastic support portion 6 can provide a reverse force when the vertebrae undergo relative displacement, thereby acting as a buffer to prevent wear between the vertebrae. Barbs can also be provided on the outer edge of the elastic support portion. The barbs act on the vertebrae to improve the stability between the elastic support portion and the vertebrae. The invention is simpler 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 the rotation of the first guide rod to make the first occluding part resist deformation may damage the integrity of the inner layer occluder, and the effect of reducing the cross-sectional diameter of the occluding part is questionable; if the inner layer structure is soft enough, the deformation is large and it is easy to enter, and similarly, it is easy to come out, and the sealing effect needs to be verified;

[0020] ② The second occluder is outside the rupture and fixed to the vertebrae. It is equipped 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 used for sealing, so the sealing effect of the entire device is questionable.

[0022] (3) Annulus Fiber Blocking Device (Application Number: 202210134753.6)

[0023] The fiber annulus sealing device includes a frame 1, a first clamping assembly 21 and a driving assembly 31. The first clamping assembly includes a first clamping part 211 and a second clamping part 212, one of which is fixed on the frame and the other is movably provided on the frame. The two can move closer to each other to clamp the fiber annulus or move away from each other to release the fiber annulus. The driving assembly is provided on the frame, and the driving assembly is connected to the other of the first clamping part and the second clamping part so as to drive the other of the first clamping part and the second clamping part. 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 fitting in the annular groove, which can improve the overall stability. The fiber annulus sealing device of this 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 this 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 provided 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 clearly explain the specific use of the occluder. It is understood that the tubular stent 10 is placed at the rupture like a plug, and the disc-shaped stent 20 is located outside the annulus fibrosus to clamp the occluder and prevent it from collapsing. If this is the case, the risk of the entire device being dislodged is high.

[0032] ② The barbed structure is directly in contact with the annular breakage, but the fiber ring around the breakage has poor quality, which may further damage the fiber ring;

[0033] ③ The disc-shaped structure has a metal fixing part in the center to close the mesh surface, which is difficult to achieve in a small minimally invasive surgical space;

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

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

[0036] ① Complex operation, prolonged operation time;

[0037] ② The degradation products of the material composition have the risk of inducing inflammation;

[0038] ③ Because of the high difficulty of the operation, the research and development cost is high, and the device is also priced high;

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

[0040] ⑤ Poor closure effect;

[0041] ⑥ The implant has a high risk of displacement and withdrawal. SUMMARY

[0042] The purpose of the present application is to provide an annulus fibrosus repair device to solve the problems of complex operation and poor plugging effect of the existing medical devices for annulus fibrosus suture and plugging.

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

[0044] An annulus fibrosus repair device is delivered to the annulus fibrosus breakage by a delivery device, comprising a degradable elastic constraint bag and a filler filled in the elastic constraint bag;

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

[0046] The filling material comprises a first filling material and a second filling material; the first filling material is located in the positioning space, and the shape of the first filling material is fixed and is delivered to the annulus fibrosus breakage together with the elastic constraint bag; the first filling material and the part of the elastic constraint bag wrapped outside the first filling material cooperate to form a positioning part, the positioning part is located outside the annulus fibrosus breakage, and the positioning part has a positioning surface which abuts against the outer wall of the annulus fibrosus breakage to deliver the positioning part;

[0047] The part of the elastic constraint bag corresponding to the supporting space and the part of the elastic constraint bag corresponding to the limiting space can be folded and then enter the annulus fibrosus breakage in the unfilled state, and the part of the elastic constraint bag corresponding to the limiting space can extend into the inside of the annulus fibrosus breakage; the second filling material can flow into the supporting space and the limiting space through the flow channel in the delivery device to open the part of the elastic constraint bag corresponding to the supporting space and the part of the elastic constraint bag corresponding to the limiting space and fill the supporting space and the limiting space, and the second filling material can solidify into a solid state under the triggering condition provided by the trigger from the flow channel and be solidified and fixed on the first filling material when solidifying;

[0048] The part of the elastic constraint bag corresponding to the supporting space and the second filling material located in the supporting space cooperate to form a supporting part, the supporting part is located in the annulus fibrosus breakage, and the part of the elastic constraint bag corresponding to the supporting space can be elastically deformed under the filling of the second filling material to adapt to the shape of the annulus fibrosus breakage;

[0049] The part of the elastic constraint bag corresponding to the limiting space and the second filling material located in the limiting space cooperate to form a limiting part, the limiting part is located in the inside of the annulus fibrosus breakage, the limiting part has a limiting surface which abuts against the inner wall of the annulus fibrosus breakage to prevent the annulus fibrosus repair device from being extruded out of the annulus fibrosus breakage by the nucleus pulposus.

[0050] In the annulus fibrosus repair device provided by a certain preferred embodiment, the filling material is a light-curable hydrogel.

[0051] In the annulus fibrosus repair device provided by a certain preferred embodiment, the strength of the hydrogel after solidification is 6-8 MPa.

[0052] In the annulus fibrosus repair device provided by a certain preferred embodiment, the elastic constraint bag is made of hyaluronic acid, polycaprolactone, collagen or poly-lactic-co-glycolic acid.

[0053] In the annulus fibrosus repair device provided by a certain preferred embodiment, the first filling material is provided with a communication hole, and the communication hole is in communication with the supporting space and the opening of the elastic constraint bag for the flow of the second filling material.

[0054] In a preferred embodiment of the annulus fibrosus repair device, the space within the elastic constraint bag further includes a connecting space, the connecting space being in communication with the positioning space, and the connecting space being an opening on the elastic constraint 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 to 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 to the circulation pipeline in the delivery device; the cutting part is used to be cut or severed 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, 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 preferred embodiment of the annulus fibrosus repair device, 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 preferred embodiment of the annulus fibrosus repair device, when the elastic constraint bag is filled and not 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 wall and the outer wall of the annulus fibrosus.

[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 of the elastic constraint 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 support space and the limit 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 support 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 small space operations 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 during folding and filling, and after filling, it can adapt to the shape of the annulus fibrosus rupture 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 support space in the elastic constraint bag when filled with the second filler, so that the support 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 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 uses a degradable elastic constraint bag, which exposes the internal solid first filler and second filler after degradation. Compared with the elastic constraint bag, the first filler and the second filler are more conducive to the attachment and reproduction of fiber cells, thereby promoting the healing of the annulus fibrosus. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0068] Figure 3 and Figure 4 A schematic diagram of an annulus fibrosus repair device of the present invention for occluding an annulus fibrosus (the portion corresponding to the connecting space is not drawn in the figure);

[0069] Figures 5 to 9 is a schematic diagram of an operating method of an annulus fibrosus repair device of the present invention;

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

[0071] Figure 10 (b) Figure 10 (c) Figure 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: Support part; 3: Limiting part; 4: Connecting part; 5: Support space; 6: Limiting space; 7: Annulus fibrosus repair device; 8: Annulus fibrosus; 9: Delivery device; 10: Optical fiber; 11: Scalpel; 12: Syringe; 13: Light source; 14: First filler; 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 embodiments of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings and other embodiments can be obtained based on these drawings without inventive work.

[0075] To simplify the drawings, only the parts relevant to the present invention are schematically shown in each figure. They do not represent the actual structure of the product. Furthermore, to simplify the drawings and facilitate understanding, in some figures, only one of the components with the same structure or function is schematically depicted or labeled. As used herein, "one" not only means "only one" but also "more than one."

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

[0077] The space inside 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 positioned within the positioning space. Its shape is fixed and it is delivered to the rupture of the annulus fibrosus 8 along with the elastic restraint bag. The first filler 14 and the portion of the elastic restraint bag that surrounds the first filler 14 cooperate to form a positioning portion 1. The positioning portion 1 is located outside the rupture of the annulus fibrosus 8 and has a positioning surface that abuts the outer wall of the rupture of the annulus fibrosus 8 for delivery and positioning.

[0079] 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 annulus fibrosus 8 when unfilled, and the portion corresponding to the limiting space 6 in the elastic restraint bag can extend into the inner side of the rupture of the annulus fibrosus 8. A 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 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. 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 to the first filler 14 during solidification.

[0080] The part 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, and the support part 2 is located in the rupture of the fiber ring 8. The part corresponding to the support space 5 in the elastic constraint bag can undergo elastic deformation when filled with the second filler to adapt to the shape of the rupture of the fiber ring 8.

[0081] The part 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 side wall 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.

[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, polycaprolactone, collagen, or polylactic acid-glycolic acid copolymer, to avoid inflammatory reactions; 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 capable of photocuring, preferably with a strength of 6-8 MPa. It can be photocured in seconds, providing mechanical strength and elasticity that matches the native annulus fibrosus 8 and better able to withstand the axial and radial pressure of the intervertebral disc. Furthermore, the hydrogel material has excellent biocompatibility. Through photocuring technology, it transforms from a gel-like state to a solid state in seconds, preventing hydrogel leakage and reducing surgical time, without complications such as hydrogel leakage. Furthermore, the high-strength hydrogel adopts a porous structure and solidifies within an elastic restraint bag. After the elastic restraint 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 constraint 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 the nucleus pulposus from leaking, and the sealing is better.

[0085] The elastic constraint bag is T-shaped when folded (the positioning part 1 cannot be folded and will not deform during the operation because the first filler 14 has solidified into a solid state before implantation; and the corresponding parts of 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 that bulges toward the nucleus pulposus at the position corresponding to the rupture of the annulus fibrosus 8, and the convex part of the curved surface abuts 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), thereby preventing 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 = 4 mm), which facilitates the dispersion of stress from the nucleus pulposus. The dome-shaped outer surface serves as the spherical crown surface, the force-bearing surface. This dome-shaped design disperses the force exerted by the nucleus pulposus on the implant (i.e., the annulus fibrosus repair device 7) toward the periphery of the limiting portion 3. The dome is thicker in the center (2 mm) and thinner at the periphery (1 mm). This increased peripheral pressure strengthens the fit between the limiting portion 3 and the inner annulus fibrosus 8, further preventing the implant (i.e., the annulus fibrosus repair device 7) from dislodging.

[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 on 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 provided with 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 portion 1 and the limiting surface of the limiting portion 3 is smaller than the distance between the inner and outer walls of the annulus fibrosus 8. That is, when designed, the distance between the positioning portion 1 and the limiting portion 3 is slightly smaller than the thickness of the annulus fibrosus 8. In this way, 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. In addition, 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 portion 1 and the limiting portion 3 is much larger than the rupture (that is, the positioning surface and the limiting surface will abut the outer and inner walls around the rupture of the annulus fibrosus 8), making it difficult for the positioning portion 1 and the limiting portion 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 falling out and shifting.

[0090] Preferably, the space in the elastic restraint bag further includes a connecting space, the connecting space is communicated with the positioning space, and the connecting space is an opening on the elastic restraint bag for the second filling to flow in; Figure 10 As shown in (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 when viewed from above 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 are possible, such as Figure 10 (b) Figure 10 (c) Figure 10 (d) The shape shown, etc.

[0091] On the elastic constraint bag, the connection between the portion corresponding to the support space 5 and the portion corresponding to the positioning space and the portion corresponding to the limiting space 6 can be designed with a chamfered corner, that is, the connection between the portion corresponding to the support space 5 and the portion corresponding to the positioning space (and the limiting space 6) is not vertical, but has an arc transition. Because the area where the chamfer is performed is a stress concentration area, stress concentration is prone to occur and the elastic constraint band is damaged, and the chamfered corner design can well overcome this problem. In addition, the diameter of the chamfer 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, and better realizing the function of the positioning part 1 and the limiting part 3 cooperating to clamp the fiber ring 8.

[0092] The portion of the elastic restraint bag corresponding to the connection space includes a connecting portion 4 and a cutting portion. The interior of the cutting portion communicates with the positioning space and the interior of the connecting portion 4, respectively. The connecting portion 4 is designed to be sleeved and connected to the connection portion of the delivery device 9, and its interior communicates with the flow channel in the delivery device 9. The cutting portion is designed to be sheared or cut by a surgical instrument to separate the connecting portion 4 from the portion corresponding to the positioning space in the elastic restraint bag. In practice, the portion of the elastic restraint bag corresponding to the connection space is the bag opening of the elastic restraint bag. The connection portion of the delivery device 9 is a rod-like structure. The bag opening of the elastic restraint bag is sleeved over the connection portion of the delivery device 9 and can then be secured to the connection portion of the delivery device 9 via a metal ring. The portion secured by the metal ring is the connecting portion 4. When the delivery device 9 needs to be removed, the cutting portion can be cut open with surgical scissors (or alternatively, a scalpel 11 can be used to cut the cutting portion open), thereby separating the delivery device 9 from the annulus fibrosus repair device 7 (here, the portion remaining 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 portion of the delivery device 9, the connection can also be achieved by other means, such as making the connecting portion 4 very long and achieving the connection by the friction force when the connecting portion 4 is put on the connecting portion 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. It is a simple to operate, safe, and effective annulus fibrosus repair device 7.

[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 does not limit the annulus fibrosus repair device 7 of the present invention. The operating method 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 and plays a positioning role. At this time, the high-strength hydrogel, that 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 expanded to form a "work" ( Figure 6 ), and then implant the optical fiber 10 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 to the outside of 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, and 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 portion is cut off) and cover the fracture of the annulus fibrosus repair device 7 (also refers to the cut portion is cut off) to prevent the fracture from contacting the surrounding tissue; finally, use the light emitted by the light source 13 to cure this part of the gel ( Figure 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 annulus fibrosus 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, against the distal end of the elastic constraint bag, and 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 annulus fibrosus 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 overall size of the annulus fibrosus repair device 7 of this embodiment is small, and the elastic constraint bag has good elasticity, the portion 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 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 still fall within the scope of protection of the present invention.

Claims

1. A fiber ring repair device, which is delivered to the fiber ring rupture site 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 inside 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, has a fixed shape, and is delivered to the fiber annulus rupture together with the elastic constraint bag; the first filler and the portion 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, and the positioning portion has a positioning surface, which abuts against the outer side wall of the fiber annulus rupture for delivery and positioning; The portions corresponding to the support space and the limit space in the elastic constraint bag can be folded into the rupture of the annulus fibrosus when not filled, and the portion corresponding to the limit space in the elastic constraint bag can extend into the inner side of the rupture of the annulus fibrosus; the second filler can flow into the support space and the limit space through the circulation channel in the delivery device to open the portions corresponding to the support space and the limit space in the elastic constraint 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 channel and be fixed on the first filler during solidification; 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 rupture of the annulus fibrosus, and the portion of the elastic restraint bag corresponding to the support space can be elastically deformed to adapt to the shape of the rupture of the annulus fibrosus when filled with the second filler; The part corresponding to the limiting space in the elastic restraint 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 of 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 hydrogel that can be photocured and shaped.

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, polycaprolactone, 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 communication hole, and the communication hole is respectively communicated with the support space and an opening on the elastic restraint 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 within the elastic restraint bag further includes a connecting space, the connecting space being in communication with the positioning space, the connecting space being 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 to 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 to the circulation pipeline in the delivery device; the cutting part is used to be cut or severed 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 further comprises 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 portion 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 smaller 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 does not undergo elastic deformation, 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: Anti-slip patterns are provided on the outer surfaces corresponding to the support portion, the positioning surface and the limiting surface of the elastic restraint bag.

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