Degradable fracture fixation device

Abstract

The application discloses a degradable fracture fixation device, which comprises a fixing part, a suture and a tensioning mechanism, one end of the suture is connected with the fixing part, the other end of the suture is connected with the tensioning mechanism after passing through a separation site and a bone body, and the tensioning mechanism is used for tightening the suture so as to fix the separation site on the bone body; the tensioning mechanism comprises a positioning cylinder, a tensioning part is movably arranged in the positioning cylinder, and the tensioning part is connected with the suture. The fixing part and the tensioning mechanism are both made of degradable materials, and the degradable materials are any one of magnesium or a magnesium alloy or a magnesium-based composite material, zinc or a zinc alloy or a zinc-based composite material, and iron or an iron alloy or an iron-based composite material. The fixing device has the advantages of simple structure, convenient use, simplified operation process, shortened operation time, favorable operation completion of doctors, good fixing effect on the separation site, prevention of tearing of the separation site, promotion of post-operation recovery of patients and the like.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a biodegradable fracture fixation device. Background Technology

[0002] Avulsion fractures are a common type of fracture. Most are caused by external trauma and frequently occur at the attachment points of muscles and ligaments. Therefore, significant displacement often occurs due to the traction of muscles and ligaments, and bone healing occurs with closed reduction. Currently, most surgeons use multiple screws to fix the detached bone fragments or ligaments back in place for avulsion fractures. Sutures are then used to weave the screws at the detachment site back into place to prevent re-avulsion. This surgical method requires a high level of surgical skill, is complex, time-consuming, and carries a relatively high risk to the patient.

[0003] Some doctors also use fixation devices to fix avulsion fractures. For example, CN112472266A discloses a fixation device for ligament tibial insertion avulsion fractures, including a first fixation block, a second fixation block, and sutures. Multiple wings extend from the outer periphery of both the first and second fixation blocks, with a recessed area between each wing. The first fixation block has a groove in its recessed area, and the second fixation block has holes in its recessed area. Using arthroscopy, the tissue near the fracture fragment is cleaned to expose the fracture ends; a tunnel is drilled, passing through the bone fragment to the fracture ends; the first fixation block is placed at the tunnel opening on the medial side of the tibia, and the second fixation block is placed at the tunnel opening at the fracture ends; the other end of the suture forms two arc-shaped loops; the two arc-shaped loops are passed through the tunnel and respectively fitted into the two opposite grooves of the first fixation block; the suture ends are then tightened. This invention can be used in conjunction with arthroscopy to achieve minimally invasive fixation of fracture ends, shortening postoperative recovery time and reducing patient pain and treatment costs.

[0004] The fixation device of the aforementioned patent has an 8-shaped knot and tightens the sutures with a tightening band. Its surgical operation is complicated, increases the operation time, and is not conducive to the operation of doctors. Moreover, the tightening band is difficult to meet the tension required to fix the detached part to the bone, resulting in poor fixation effect of the detached part and affecting the patient's postoperative recovery time. Summary of the Invention

[0005] The purpose of this invention is to provide a biodegradable fracture fixation device to solve the above-mentioned problems existing in the prior art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a biodegradable fracture fixation device, comprising a fixation element, a suture, and a tensioning mechanism, wherein one end of the suture is connected to the fixation element, and the other end of the suture passes through the detachment site and the bone body and is connected to the tensioning mechanism, the tensioning mechanism being used to tighten the suture so that the detachment site is fixed to the bone body; the tensioning mechanism includes a positioning cylinder, and a tensioning element is movably disposed inside the positioning cylinder, the tensioning element being connected to the suture.

[0007] As an optional embodiment of the above technical solution, the tensioning component includes a tensioning rotor, which is rotatably disposed inside the positioning cylinder. The tensioning rotor is provided with a first winding and shrinking part, and one end of the sewing thread is wound around the first winding and shrinking part. The winding tightness of the sewing thread is adjusted by controlling the forward and reverse rotation of the tensioning rotor.

[0008] As an optional implementation of the above technical solution, the tensioning rotor is equipped with an anti-rotation mechanism.

[0009] As an optional implementation of the above technical solution, the anti-rotation mechanism includes a first annular ratchet and a second annular ratchet that match each other. The first annular ratchet is disposed on the surface of the tensioning rotor, and the second annular ratchet is disposed on the inner wall of the positioning cylinder.

[0010] As an optional embodiment of the above technical solution, the end face of the tensioning rotor is provided with a first inlet hole, the first winding and shrinking part on the side of the tensioning rotor is provided with a first outlet hole, and the interior of the tensioning rotor is provided with a first threading channel. One end of the sewing thread passes through the first inlet hole, the first threading channel and the first outlet hole and then wraps around the first winding and shrinking part.

[0011] As an optional implementation of the above technical solution, the positioning cylinder is provided with a thread outlet channel, and one end of the sewing thread is wound around the first winding and shrinking part and then passes out through the thread outlet channel.

[0012] As an optional embodiment of the above technical solution, the surface of the tensioning rotor is provided with a limiting protrusion, and the inner wall of the positioning cylinder is provided with an annular limiting groove, wherein the limiting protrusion and the annular limiting groove are slidably engaged.

[0013] As an optional implementation of the above technical solution, the end of the tensioning rotor away from the first inlet hole is provided with a drive hole, which is a cross hole.

[0014] As an optional implementation of the above technical solution, both the fastener and the tensioning mechanism are made of biodegradable materials.

[0015] As an optional embodiment of the above technical solution, the degradable material is any one of magnesium or magnesium alloy or magnesium-based composite material, zinc or zinc alloy or zinc-based composite material, iron or iron alloy or iron-based composite material.

[0016] As an optional embodiment of the above technical solution, the fastener includes a fixing hook, and one end of the sewing thread is fixed to the fixing hook.

[0017] As an optional embodiment of the above technical solution, the fixing hook includes a nail head and a rod. One end of the rod is connected to the nail head, and the other end of the rod is provided with a second thread inlet hole. The surface of the rod is provided with a second winding and shrinking part, and the second winding and shrinking part is provided with a second thread outlet hole. The inside of the rod is provided with a second thread passage. One end of the sewing thread passes through the second thread inlet hole, the second thread passage, and the second thread outlet hole and then wraps around the second winding and shrinking part.

[0018] The beneficial effects of this invention are as follows:

[0019] This invention provides a biodegradable fracture fixation device. One end of the suture is connected to a fixation element, and the other end of the suture passes through the detachment site and the bone body before connecting to a tensioning mechanism. The tensioning mechanism tightens the suture to fix the detachment site to the bone body. The fixation device of this invention only requires controlling the movement of the tensioning element within a positioning cylinder, causing both ends of the suture to tighten the fixation element and the tensioning element. The fixation element and the positioning cylinder then compress and fix the detachment site and the bone body. This fixation device has a simple structure, is easy to use, simplifies the surgical procedure, shortens the surgical time, and helps doctors complete the surgery smoothly. Furthermore, it provides good fixation of the detachment site, effectively preventing detachment and promoting postoperative recovery. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the structure of a biodegradable fracture fixation device according to one embodiment of the present invention;

[0021] Figure 2 This is an exploded view of the tensioning mechanism in one embodiment of the present invention;

[0022] Figure 3 This is a schematic diagram of the internal structure of the tensioning mechanism in one embodiment of the present invention;

[0023] Figure 4 This is a schematic diagram of the structure of the tensioning rotor in one embodiment of the present invention;

[0024] Figure 5 This is a schematic diagram of the structure of the fastener in one embodiment of the present invention;

[0025] Figure 6 This is a diagram showing the usage state of the biodegradable fracture fixation device in one embodiment of the present invention.

[0026] In the diagram: 1-Fixed component; 2-Sewing thread; 3-Tightening mechanism; 4-Disengagement part; 5-Bone body; 6-Positioning cylinder; 7-Tightening rotor; 8-First winding and contraction part; 9-First annular ratchet; 10-Second annular ratchet; 11-First inlet hole; 12-First outlet hole; 13-First threading channel; 14-Outlet channel; 15-Limiting protrusion; 16-Annular limiting groove; 17-Cross hole; 18-Nail head; 19-Rod part; 20-Second winding and contraction part. Detailed Implementation

[0027] Example

[0028] like Figures 1-6 As shown, this embodiment provides a biodegradable fracture fixation device, mainly used in avulsion fractures, which can fix detached bone fragments or ligaments back to their original position, promoting patient recovery. The fixation device includes a fixator 1, a suture 2, and a tensioning mechanism 3. One end of the suture 2 is connected to the fixator 1, and the other end passes through the detachment site 4 and the bone body 5 before connecting to the tensioning mechanism 3. The suture 2 is an absorbable suture, which can degrade or be completely absorbed by tissues within the human body. The tensioning mechanism 3 is used to tighten the suture 2 to fix the detachment site 4 to the bone body 5. Figure 6 As shown, the detachment part 4 and the bone body 5 are located between the fixation member 1 and the tensioning mechanism 3. The fixation member 1 abuts against the detachment part 4, and the tensioning mechanism 3 abuts against the bone body 5. Alternatively, the fixation member 1 can abut against the bone body 5, and the tensioning mechanism 3 can abut against the detachment part 4. When the suture 2 is tightened by the tensioning mechanism 3, the fixation member 1 and the tensioning mechanism 3 apply pressure to the detachment part 4 and the bone body 5 respectively, so that the detachment part 4 is fixed to the bone body 5.

[0029] like Figure 2 and Figure 3 As shown, the tensioning mechanism 3 includes a positioning cylinder 6, within which a tensioning member is movably disposed. The tensioning member is connected to the suture 2. The positioning cylinder 6 rests against the bone body 5, and the tensioning member can move within the positioning cylinder 6, such as rotating or sliding. The tensioning member can pull the suture 2 to move and tighten it, bringing the fixing member 1 closer to the positioning cylinder 6, thereby locking and fixing the detached part 4 and the bone body 5.

[0030] The fixation device of the present invention only requires controlling the movement of the tensioning member within the positioning cylinder 6, so that the two ends of the suture 2 tighten the fixation member 1 and the tensioning member, and the detached part 4 and the bone body 5 are pressed and fixed by the fixation member 1 and the positioning cylinder 6. The fixation device has a simple structure and is easy to use, which can simplify the surgical procedure, shorten the surgical time, and help doctors complete the surgery smoothly. Moreover, it has a good fixation effect on the detached part 4, which can effectively prevent the detached part 4 from tearing off and promote the patient's postoperative recovery.

[0031] Specifically, the tensioning component includes a tensioning rotor 7, which is rotatably mounted inside the positioning cylinder 6. The tensioning rotor 7 has a first winding and contracting section 8. One end of the suture 2 is wound around the first winding and contracting section 8. The tightness of the suture 2 is adjusted by controlling the forward and reverse rotation of the tensioning rotor 7. For example, when the tensioning rotor 7 rotates forward, the suture 2 gradually winds around the first winding and contracting section 8, tightening the suture 2 and pulling the fixing component 1 closer to the tensioning rotor 7, gradually increasing the pressure between the detachment part 4 and the bone body 5. When the tensioning rotor 7 rotates in the reverse direction, the suture 2 gradually loosens, and the pressure between the detachment part 4 and the bone body 5 gradually decreases.

[0032] To prevent the tensioning rotor 7 from rotating, the tensioning rotor 7 is equipped with an anti-rotation mechanism. After the tensioning rotor 7 rotates in the forward direction and tightens the suture 2, the detachment part 4 is pressed tightly against the bone body 5. The anti-rotation mechanism can prevent the tensioning rotor 7 from rotating, avoid the suture 2 from loosening, and ensure the fixation effect between the detachment part 4 and the bone body 5.

[0033] like Figure 2 As shown, in an optional embodiment of this invention, the anti-rotation mechanism includes a first annular ratchet 9 and a second annular ratchet 10 that match each other. The first annular ratchet 9 is disposed on the surface of the tensioning rotor 7, and the second annular ratchet 10 is disposed on the inner wall of the positioning cylinder 6. The first annular ratchet 9 and the second annular ratchet 10 mesh with each other, so that the tensioning rotor 7 can only rotate in the forward direction, thereby gradually tightening the stitch 2 and preventing the stitch 2 from loosening. It should be noted that the anti-rotation mechanism can also be implemented using a ratchet and pawl structure.

[0034] In this embodiment, the end face of the tensioning rotor 7 is provided with a first inlet hole 11, the first winding and shrinking part 8 on the side of the tensioning rotor 7 is provided with a first outlet hole 12, and the interior of the tensioning rotor 7 is provided with a first threading channel 13. One end of the thread 2 passes through the first inlet hole 11, the first threading channel 13, and the first outlet hole 12 and then wraps around the first winding and shrinking part 8. The left end face of the tensioning rotor 7 has a first inlet hole 11, the first winding and shrinking part 8 is located in the middle of the tensioning rotor 7, and a first annular ratchet 9 is provided on the left side of the first winding and shrinking part 8. The thread 2 is wound around the first winding and shrinking part 8 through the first inlet hole 11, the first threading channel 13, and the first outlet hole 12 without affecting the engagement of the first annular ratchet 9 and the second annular ratchet 10. The positioning cylinder 6 is provided with an outlet channel 14, and one end of the thread 2 is wound around the first winding and shrinking part 8 and then passes through the outlet channel 14. The thread 2 can be reserved to a certain length and wrapped and fixed in the first winding shrinkage part 8, or one end of the thread 2 can be wrapped in the first winding shrinkage part 8 and then passed out through the thread outlet channel 14, which makes it convenient to cut the thread 2.

[0035] like Figure 4As shown, the surface of the tensioning rotor 7 is provided with a limiting protrusion 15, and the inner wall of the positioning cylinder 6 is provided with an annular limiting groove 16. The limiting protrusion 15 and the annular limiting groove 16 are slidably engaged. The limiting protrusion 15 is located on the right side of the first winding and shrinking part 8, and the annular limiting groove 16 limits the limiting protrusion 15, so that the tensioning rotor 7 can only rotate within the positioning cylinder 6 and cannot undergo axial displacement.

[0036] To facilitate control of the tensioning rotor 7, a drive hole is provided at the end of the tensioning rotor 7 furthest from the first suture inlet 11. A tool is inserted into the drive hole on the right end face of the tensioning rotor 7 to drive it to rotate. Preferably, the drive hole is a cross-shaped hole 17, which can be driven to rotate the tensioning rotor 7 during surgery using a Phillips screwdriver, thereby wrapping the suture 2 around the first winding contraction part 8 to tighten the suture 2.

[0037] like Figure 5 As shown, in this embodiment, the fixing member 1 includes a fixing hook, and one end of the sewing thread 2 is fixed to the fixing hook. Specifically, the fixing hook includes a nail head 18 and a rod 19. One end of the rod 19 is connected to the nail head 18, and the other end of the rod 19 is provided with a second thread inlet hole. The nail head 18 and the rod 19 are integrally formed, and the size of the nail head 18 is larger than the size of the rod 19. The nail head 18 abuts against the disengagement part 4. The surface of the rod 19 is provided with a second winding and shrinking part 20, which is provided with a second thread outlet hole. The inside of the rod 19 is provided with a second thread passage. One end of the sewing thread 2 passes through the second thread inlet hole, the second thread passage, and the second thread outlet hole and then wraps around the second winding and shrinking part 20, thereby achieving the connection and fixation between the fixing hook and the sewing thread 2.

[0038] In this embodiment, both the fixation element 1 and the tensioning mechanism 3 are made of biodegradable materials. Specifically, the fixation hook, positioning cylinder 6, and tensioning rotor 7 are all made of biodegradable materials and do not need to be removed after surgery. Preferably, the biodegradable material is any one of magnesium or magnesium alloy or magnesium-based composite material, zinc or zinc alloy or zinc-based composite material, or iron or iron alloy or iron-based composite material. The raw materials of the fixation hook, positioning cylinder 6, and tensioning rotor 7 are all biodegradable metallic materials, which can provide sufficient mechanical properties for a certain period of time to ensure the fixation effect of the detachment site 4 and bone body 5. As the metallic material degrades and the patient recovers, the pressure of the fixation element 1 and the tensioning mechanism 3 on the detachment site 4 and bone body 5 is gradually lost, and the detachment site 4 and bone body 5 can achieve a transition from mechanical fixation (AO) to biological fixation (BO) until the metallic material is completely degraded, without affecting postoperative recovery.

[0039] The fixation device of this invention can realize the transition from mechanical fixation (AO) to biological fixation (BO) in fracture repair. The mechanical fixation (AO) involved is a mature and applied bone repair method, which has been verified in long-term practice for its great advantages such as reliability and repair performance. Moreover, the improved scheme of this design can be realized without much modification to many types of mechanical fixation (AO) repair instruments. In addition, the raw materials of fixation nail hooks, positioning cylinder 6 and tensioning rotor 7 are all biodegradable metals with good biocompatibility and degradability. Furthermore, their elastic modulus is closer to that of human bone, which can effectively avoid stress shielding effect.

[0040] It should be noted that when multiple fixing hooks are needed to fix certain detached parts 4, only one tensioning mechanism 3 can be set up. That is, each fixing hook is connected to one or more sutures 2, and the end of each suture 2 is connected to the tensioning rotor 7 of the tensioning mechanism 3, so as to realize the function of locking multiple sutures 2 at the same time and ensure the fixation effect between the detached part 4 and the bone 5.

[0041] In the description of this invention, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. They can refer to fixed connections, detachable connections, or integral connections; they can be mechanical or electrical connections; they can be direct connections or indirect connections through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art will understand the specific meanings of these terms in this invention. Furthermore, the specific features and structures described in the embodiments are included in at least one implementation method. Those skilled in the art can combine features from different implementation methods without contradiction. The scope of protection of this invention is not limited to the specific implementation methods described above. Based on the basic technical concept of this invention, implementation methods that can be conceived by those skilled in the art without creative effort are all within the scope of protection of this invention.

Claims

1. A biodegradable fracture fixation device, characterized in that, The device includes a fixation element (1), a suture (2), and a tensioning mechanism (3). One end of the suture (2) is connected to the fixation element (1), and the other end of the suture (2) passes through the detachment part (4) and the bone body (5) and is connected to the tensioning mechanism (3). The tensioning mechanism (3) is used to tighten the suture (2) so that the detachment part (4) is fixed to the bone body (5). The tensioning mechanism (3) includes a positioning cylinder (6), and a tensioning element is movably disposed inside the positioning cylinder (6). The tensioning element is connected to the suture (2). The fastener (1) includes a fixing hook, and one end of the sewing thread (2) is fixed to the fixing hook; the fixing hook includes a nail head (18) and a rod (19), one end of the rod (19) is connected to the nail head (18), the other end of the rod (19) is provided with a second thread inlet hole, the surface of the rod (19) is provided with a second winding shrinkage part (20), the second winding shrinkage part (20) is provided with a second thread outlet hole, the inside of the rod (19) is provided with a second thread passage, and one end of the sewing thread (2) passes through the second thread inlet hole, the second thread passage and the second thread outlet hole and then wraps around the second winding shrinkage part (20); The tensioning component includes a tensioning rotor (7), which is rotatably disposed inside the positioning cylinder (6). The tensioning rotor (7) is provided with a first winding shrinkage part (8). One end of the sewing thread (2) is wound around the first winding shrinkage part (8). The winding tightness of the sewing thread (2) is adjusted by controlling the forward rotation of the tensioning rotor (7). The tensioning rotor (7) is equipped with an anti-rotation mechanism; the anti-rotation mechanism includes a first annular ratchet (9) and a second annular ratchet (10) that match each other. The first annular ratchet (9) is disposed on the surface of the tensioning rotor (7), and the second annular ratchet (10) is disposed on the inner wall of the positioning cylinder (6).

2. The biodegradable fracture fixation device according to claim 1, characterized in that, The end face of the tensioning rotor (7) is provided with a first inlet hole (11), the first winding shrinkage part (8) on the side of the tensioning rotor (7) is provided with a first outlet hole (12), and the interior of the tensioning rotor (7) is provided with a first threading channel (13). One end of the sewing thread (2) passes through the first inlet hole (11), the first threading channel (13) and the first outlet hole (12) and then wraps around the first winding shrinkage part (8).

3. The biodegradable fracture fixation device according to claim 2, characterized in that, The positioning cylinder (6) is provided with a wire outlet channel (14), and one end of the sewing thread (2) is wrapped around the first winding shrinkage part (8) and then passes out through the wire outlet channel (14).

4. The biodegradable fracture fixation device according to claim 2, characterized in that, The surface of the tensioning rotor (7) is provided with a limiting protrusion (15), and the inner wall of the positioning cylinder (6) is provided with an annular limiting groove (16). The limiting protrusion (15) and the annular limiting groove (16) are slidably engaged. The end of the tensioning rotor (7) away from the first inlet hole (11) is provided with a driving hole, which is a cross hole (17).

5. The biodegradable fracture fixation device according to claim 1, characterized in that, Both the fastener (1) and the tensioning mechanism (3) are made of biodegradable materials; the biodegradable materials are any one of magnesium or magnesium alloy or magnesium-based composite materials, zinc or zinc alloy or zinc-based composite materials, iron or iron alloy or iron-based composite materials.

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