An absorbable open-door maintainer for cervical laminoplasty

Abstract

The application relates to the technical field of medical devices, and discloses an absorbable door opening maintainer for cervical vertebra canal plasty, wherein the maintainer body is integrally formed by using high-strength absorbable material, a hollow bone ingrowth matrix is arranged in the maintainer body in the axial direction, the maintainer body comprises a spiral coupler structure and a zero-cut trace cable structure, and the spiral coupler structure and the zero-cut trace cable structure are both hollow structures. In the application, the whole maintainer is made of high-strength absorbable material, is matched with absorbable sutures of the same type, the degradation periods of the two are mutually adapted, the degradation process is synchronized with the bone growth period, secondary surgery for removal is not needed, secondary damage to bone and soft tissues is avoided, the multi-dimensional bone ingrowth channel is beneficial to the migration, proliferation and angiogenesis of bone cells, biological fusion between the maintainer and the host bone is promoted, and the bone repair process is accelerated.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an absorbable door maintainer for cervical spinal canal enlargement surgery. Background Technology

[0002] In clinical practice, the most commonly used surgical procedure for cervical spinal stenosis is posterior cervical laminectomy with a single-door laminectomy to achieve spinal canal expansion and decompression. However, in most cases, specialized opening and maintenance devices are lacking, and fusion plates are usually implanted for fixation. But the existing fusion plate designs have certain limitations, often resulting in a large number of implanted foreign bodies.

[0003] When using ordinary screws for fixation, the fixation effect is relatively limited. When used in conjunction with lateral mass screws, they can easily cause damage to the vertebral body and surrounding soft tissues. Furthermore, the single screw structure has poor pull-out resistance in patients with osteoporosis, posing a risk of fusion plate dislodgement. In addition, traditional screws are mostly made of metal, which may break after long-term implantation. Once problems occur, a second surgery is usually required to remove them, further increasing the burden on the patient.

[0004] From a structural perspective, most existing screws use a solid screw structure and are often designed with self-tapping heads. This type of structure is not conducive to bone tissue adhesion and growth, and may even damage deep nerves or blood vessels, making it difficult to meet the needs of postoperative bone recovery. In addition, the sutures used in traditional surgery are mostly made of non-absorbable materials, and some patients may experience suture irritation after surgery. If suture adjustment or treatment is required, additional procedures are needed, further increasing the complexity of the surgery and the burden on the patient. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by proposing an absorbable door opening maintainer for cervical spinal canal enlargement surgery.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] An absorbable door-opening maintainer for cervical spinal canal enlargement surgery includes a maintainer body, which is integrally molded from a high-strength absorbable material. A hollow bone ingrowth matrix is ​​axially arranged inside the maintainer body. The maintainer body includes a helical coupler structure and a zero-notch cable structure, both of which are hollow. The helical coupler structure includes a shield body and a cutting edge anchoring point, located at the end of the helical coupler structure furthest from the zero-notch cable structure. The shield body includes an absorbable screw frame and a matrix reinforcement bracket. The outer surface of the matrix reinforcement bracket is provided with a tapered cancellous bone triangular thread. The interior of the cutting edge anchoring point is provided with a reverse thread for driving the extension of the anchoring locking piece.

[0008] The zero-notch cable structure includes a zero-notch base and a cable composite. The outer surface of the zero-notch base is provided with cortical bone triangular threads, and the interior of the zero-notch base integrates several bio-micropores of the nail tail. The cable composite includes bone rivet with thread and suture needle.

[0009] The inner wall of the hollow bone ingrowth matrix is ​​provided with several reinforcing ribs. The reinforcing ribs converge at one end of the spiral coupler structure near the zero notch base to form a fixing node. The end of the bone rivet with suture away from the suture needle passes through the fixing node and is fixed to the zero notch base.

[0010] Preferably, the hollow bone ingrowth matrix is ​​a through-hole hollow cavity.

[0011] Preferably, the number of reinforcing ribs is 4.

[0012] Preferably, the degradation cycle of the high-strength absorbable material is adapted to the bone growth cycle, and the degradation products of the high-strength absorbable material are non-biotoxic.

[0013] Preferably, the end of the zero-trace base away from the helical coupler structure is a zero-trace planar structure.

[0014] Preferably, the cortical bone triangular thread is a shallow triangular thread with a small pitch, used for interlocking and fixing with the cortical bone.

[0015] Preferably, the cancellous bone triangular thread is a deep triangular thread with a large pitch, used for riveting cancellous bone.

[0016] Preferably, the outer diameter of the cancellous bone triangular thread gradually decreases from one end of the matrix reinforcement bracket 10 near the zero-notch base 6 to the other end of the matrix reinforcement bracket 10 away from the zero-notch base 6.

[0017] Preferably, the bone rivet cord is made of absorbable biocompatible material, and the degradation cycle of the bone rivet cord is adapted to the degradation cycle of the maintainer body.

[0018] Preferably, the hollow bone ingrowth matrix, the bio-micropores at the nail tail, and the matrix-reinforced scaffold constitute a multidimensional bone ingrowth channel.

[0019] Preferably, the suture needle has a 3 / 8 arc radius, an arc length of 19 mm, and a needle length of 10 mm.

[0020] Preferably, the bone rivet with wire has a length of 300 mm and a diameter of 0.05 mm.

[0021] Preferably, the zero-trace base has a length of 3 mm and a diameter of 3.2 mm.

[0022] Preferably, the spiral coupler structure has a length of 9 mm, a diameter of 2.8 mm, and a pitch of 1.5 mm for the cancellous bone triangular thread.

[0023] Preferably, the total length of the maintainer body is 12 mm.

[0024] The beneficial effects of this invention are as follows:

[0025] 1. Excellent bone recovery with minimal foreign body residue. The maintainer is made entirely of high-strength absorbable material, paired with similar absorbable sutures. Their degradation cycles are mutually compatible, synchronizing with bone growth, eliminating the need for secondary surgery and preventing secondary damage to bone and soft tissue. The bioporous structure of the zero-notch base, together with the hollow bone ingrowth matrix and matrix-reinforced scaffold of the helical coupler structure, forms a multidimensional bone ingrowth channel, facilitating osteoblast migration, proliferation, and angiogenesis, promoting biofusion between the maintainer and host bone, and accelerating bone repair. The degradation products of the maintainer and absorbable sutures are non-toxic and unlikely to induce significant inflammatory responses. The integrated design allows a single maintainer to achieve the effect of traditional open-door fixation, significantly reducing the number and volume of implanted foreign bodies, thereby minimizing tissue damage and achieving multiple benefits including low trauma, high bone repair, and minimal foreign body residue.

[0026] 2. Stable and safe fixation. Through a segmented threaded structure design, the triangular threads on the cancellous bone of the outer surface of the helical coupler provide initial fixation of the cancellous bone. The triangular threads on the cortical bone of the outer surface of the zero-notch base further provide stable fixation force after engaging with the cortical bone. Simultaneously, the extendable anchoring locking piece within the blade anchoring point provides reinforcement, significantly improving pull-out resistance and meeting surgical fixation requirements. The zero-notch planar structure design of the zero-notch base effectively avoids damage to deep nerves and blood vessels caused by traditional instruments. The absorbable suture maintains stable strength before degradation, continuously providing reliable traction fixation force. Furthermore, its degradation process is gradual, preventing sudden failure from affecting the fixation effect, thereby further improving surgical safety.

[0027] 3. Excellent tissue compatibility. The zero-notch plane of the zero-notch base fits closely to the bone surface, reducing the contact area with surrounding soft tissues, thereby minimizing foreign body reaction and mechanical stimulation of deep tissues. Both the maintainer body and the absorbable sutures are made of absorbable materials, exhibiting excellent biocompatibility, eliminating the risk of metal ion release, and avoiding the adverse effects of long-term stimulation from non-absorbable sutures, making it suitable for long-term implantation needs.

[0028] 4. Convenient operation and stable sutures. The integrated structure simplifies the surgical implantation process, and the connecting needle at the tip of the cable composite facilitates quick suture fixation. The fixation nodes formed by the fusion of reinforcing ribs within the hollow bone ingrowth matrix provide a secure anchoring point for the absorbable sutures, preventing direct contact between the sutures and the bone surface, thereby reducing friction and wear and lowering the risk of breakage. A single retainer achieves the fixation effect of traditional multi-component systems, simplifying the surgical procedure and postoperative care, and improving the patient's experience while ensuring effective postoperative fixation. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of an absorbable door maintainer for cervical spinal canal enlargement surgery according to an embodiment of the present invention.

[0030] In the diagram: 1-suture needle, 2-bone rivet with suture, 3-biological micropore at the rivet tail, 4-cortical bone triangular thread, 5-cable composite, 6-zero notch base, 7-zero notch cable structure, 8-hollow bone ingrowth matrix, 9-absorbable screw frame, 10-matrix reinforcement support, 11-cutting head anchor point, 12-shield body, 13-spiral coupler structure. Detailed Implementation

[0031] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0032] In one embodiment, refer to Figure 1This invention proposes an absorbable door-opening retainer for cervical spinal canal enlargement surgery, comprising a retainer body integrally molded from a high-strength absorbable material. The retainer body has a hollow bone ingrowth matrix 8 arranged axially inside. The retainer body includes a helical coupler structure 13 and a zero-notch cable structure 7, both of which are hollow. The helical coupler structure 13 includes a shield body 12 and a cutting edge anchoring point 11, located at the end of the helical coupler structure 13 furthest from the zero-notch cable structure 7. The shield body 12 includes an absorbable screw frame 9 and a matrix reinforcement bracket 10. The outer surface of the matrix reinforcement bracket 10 has a tapered cancellous bone triangular thread. The interior of the cutting edge anchoring point 11 has a reverse thread for driving the extension of the anchoring locking plate, significantly… Strengthening bone holding force; the zero-notch cable structure 7 includes a zero-notch base 6 and a cable composite 5. The outer surface of the zero-notch base 6 is provided with cortical bone triangular threads 4. The interior of the zero-notch base 6 integrates several bio-micropores 3 of the screw tail to promote bio-bone ingrowth. After the zero-notch base 6 is completely implanted into the bone tissue, there are no fixation notches on the surface, which does not affect the surgical opening range. The cable composite 5 includes bone rivet suture 2 and suture connecting needle 1. The suture connecting needle 1 provides reliable bio-maintenance for the opening state, and innovatively solves the traditional dilemma of no dedicated supporting instruments for this procedure in one go. The inner wall of the hollow bone ingrowth matrix 8 is provided with several reinforcing ribs. The reinforcing ribs converge at the end of the spiral coupler structure 13 near the zero-notch base 6 to form a fixing node. The end of the bone rivet suture 2 away from the suture connecting needle 1 passes through the fixing node and is fixed to the zero-notch base 6.

[0033] In a preferred embodiment of the present invention, the hollow bone ingrowth matrix 8 is a hollow cavity that is arranged through the bone.

[0034] In a preferred embodiment of the present invention, the degradation cycle of the high-strength absorbable material is adapted to the bone growth cycle, and the degradation products of the high-strength absorbable material are non-biotoxic.

[0035] In a preferred embodiment of the present invention, the end of the zero-trace base 6 away from the helical coupler structure 13 is a zero-trace planar structure.

[0036] In a preferred embodiment of the present invention, the cortical bone triangular thread 4 is a shallow triangular thread with a small pitch, used for interlocking and fixing with the cortical bone; the cancellous bone triangular thread is a deep triangular thread with a large pitch, used for riveting the cancellous bone.

[0037] In a preferred embodiment of the present invention, the bone rivet suture 2 is made of absorbable biocompatible material, and the degradation cycle of the bone rivet suture 2 is adapted to the degradation cycle of the maintainer body.

[0038] In a preferred embodiment of the present invention, the hollow bone ingrowth matrix 8, the bio-micropores at the nail tail 3, and the matrix-reinforced scaffold 10 constitute a multidimensional bone ingrowth channel.

[0039] In a preferred embodiment of the present invention, the bone rivet with wire 2 has a length of 300 mm and a diameter of 0.05 mm.

[0040] In a preferred embodiment of the present invention, the zero-trace base 6 has a length of 3 mm and a diameter of 3.2 mm.

[0041] In a preferred embodiment of the present invention, the length of the helical coupler structure 13 is 9 mm, the diameter is 2.8 mm, and the pitch of the cancellous bone triangular thread is 1.5 mm.

[0042] In a preferred embodiment of the present invention, the number of reinforcing ribs is 4.

[0043] In a preferred embodiment of the present invention, the outer diameter of the triangular thread of the cancellous bone gradually decreases from one end of the matrix reinforcement bracket 10 near the zero notch base 6 to the other end of the matrix reinforcement bracket 10 away from the zero notch base 6.

[0044] In a preferred embodiment of the present invention, the suture needle has a 3 / 8 arc, an arc length of 19 mm, and a needle length of 10 mm, in order to facilitate suture fixation during the operation.

[0045] In a preferred embodiment of the present invention, the total length of the retainer body is 12 mm.

[0046] In a preferred embodiment of the present invention, the sutures are inserted into the matrix 8 through the hollow bone to avoid exposure to external tissues and causing irritation.

[0047] During the specific surgical procedure, the implantation position of the maintainer body is first determined based on the imaging data of the patient's cervical spine, and the center point of the bone hole is marked. Then, a special drill bit is used to drill a bone hole in the lateral mass that matches the maintainer body, and the drilling direction is adapted to the anatomical structure of the lateral mass. Then, the maintainer body with pre-filled absorbable sutures is aligned with the bone hole through the appropriate implantation tool and slowly rotated for implantation. This allows the cancellous bone triangular thread of the spiral coupler structure 13 to engage and fix with the cancellous bone, and the cortical bone triangular thread 4 of the zero-notch base 6 to engage and fix with the cortical bone. At the same time, by rotating the tail of the maintainer body, the reverse thread in the driving blade anchor point 11 is rotated to extend the anchoring locking plate, thereby achieving multiple fixation.

[0048] Subsequently, absorbable sutures are sutured and fixed to the ligamentum flavum using a suture needle 1 at the tip of the cable composite 5. The suture tension is adjusted as needed to maintain the ligamentum flavum under the required traction, thereby achieving cervical spine decompression. Finally, excess absorbable sutures are trimmed, leaving suture ends of appropriate length to grow into the hollow bone matrix 8, and the surgical incision is sutured layer by layer.

[0049] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An absorbable door-opening maintainer for cervical laminoplasty, comprising a maintainer body, characterized in that, The maintainer body is integrally molded from a high-strength absorbable material. A hollow bone ingrowth matrix (8) is arranged axially inside the maintainer body. The maintainer body includes a helical coupler structure (13) and a zero-trace cable structure (7). Both the helical coupler structure (13) and the zero-trace cable structure (7) are hollow structures. The helical coupler structure (13) includes a shield body (12) and a cutting edge anchor point (11). The cutting edge anchor point (11) is located at the end of the helical coupler structure (13) away from the zero-trace cable structure (7). The shield body (12) includes an absorbable screw frame (9) and a matrix reinforcement bracket (10). The outer surface of the matrix reinforcement bracket (10) is provided with a cancellous bone triangular thread with a gradually decreasing outer diameter. The inside of the cutting edge anchor point (11) is provided with a reverse thread for driving the anchoring locking plate to extend. The zero-notch cable structure (7) includes a zero-notch base (6) and a cable composite (5). The outer surface of the zero-notch base (6) is provided with cortical bone triangular threads (4). The interior of the zero-notch base (6) integrates several nail tail biological micropores (3). The cable composite (5) includes bone rivet with thread (2) and suture needle (1). The inner wall of the hollow bone ingrowth matrix (8) is provided with several reinforcing ribs. The reinforcing ribs converge at one end of the spiral coupler structure (13) near the zero notch base (6) to form a fixed node. The end of the bone rivet suture (2) away from the suture connecting needle (1) passes through the fixed node and is fixed to the zero notch base (6).

2. The absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The hollow bone ingrowth matrix (8) is a hollow cavity that is set through.

3. The absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The degradation cycle of the high-strength absorbable material is adapted to the bone growth cycle, and the degradation products of the high-strength absorbable material are non-biotoxic.

4. The absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The end of the zero-trace base (6) away from the helical coupler structure (13) is a zero-trace planar structure.

5. An absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The cortical bone triangular thread (4) is a shallow triangular thread with a small pitch, used for interlocking and fixing with the cortical bone; the cancellous bone triangular thread is a deep triangular thread with a large pitch, used for riveting the cancellous bone.

6. An absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The bone rivet cord (2) is made of absorbable biocompatible material, and the degradation cycle of the bone rivet cord (2) is adapted to the degradation cycle of the maintainer body.

7. An absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The hollow bone ingrowth matrix (8), together with the bio-micropores at the nail tail (3) and the matrix-reinforced scaffold (10), constitute a multidimensional bone ingrowth channel.

8. An absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The bone rivet with wire (2) is 300 mm long and 0.05 mm in diameter.

9. An absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The zero-cut base (6) has a length of 3 mm and a diameter of 3.2 mm.

10. An absorbable door-opening maintainer for cervical laminoplasty according to claim 1, characterized in that, The length of the spiral coupler structure (13) is 9 mm, the diameter is 2.8 mm, and the pitch of the cancellous bone triangular thread is 1.5 mm.

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