Anti-drop sleeve for implanted prosthesis

Abstract

The present invention discloses an anti-slip bushing for implant prosthesis, comprising a tubular body, the inner diameter of which matches the diameter of the implant, and is used to wrap a fixed object, and is characterized in that the tubular body is made of a bio-inert and non-biodegradable resin material. A preparation method thereof is also disclosed. The anti-slip bushing for the implant prosthesis of the present invention does not change the mechanical strength of the prosthesis after implantation, thereby ensuring its functional use, while effectively shielding and shielding particles such as grinding chips between the implant prosthesis and the bone, thereby avoiding the occurrence of non-bacterial loosening. At the same time, the anti-slip bushing can effectively improve the use effect and service life of the implant.

Description

Technical Field

[0001] The invention relates to a bushing, in particular to an anti-drop bushing for implanting a prosthesis, belonging to the technical field of medical devices. Background Art

[0002] Arthroplasty is a common orthopedic surgery, which is a surgical procedure in which artificial joints are implanted into the human body to replace diseased joints. It is mainly used to treat joint diseases or joint injuries, and can significantly relieve symptoms and improve the quality of life of patients. In recent years, joint replacement has developed rapidly and has been widely used worldwide. However, more than 10% of patients who undergo joint replacement need revision due to aseptic loosening of artificial joints, which not only increases the pain of patients but also brings them additional economic burden. The particles produced by the wear of the implant interact with the surrounding bone tissue cells, causing chronic inflammatory reactions, which is one of the important reasons for aseptic loosening and affecting the prognosis of patients. Its occurrence mechanism is complex, including wear particles, autophagy, stress shielding, etc. The most important reason is that the abnormal bone metabolism induced by wear particles causes bone loss. Especially for patients with osteoporosis, the risk of prosthetic loosening may be aggravated. Osteoporosis is a disease with reduced bone density, which causes bones to become fragile and brittle. In joint replacement surgery, the prosthesis is implanted into the bone. If osteoporosis causes the bone to become fragile, the bone cannot provide sufficient support for the prosthesis, which can easily lead to prosthesis loosening. In response to the above clinical needs, it is necessary to develop instruments and related materials for preventing implant loosening, and provide means and strategies for the prevention and treatment of prosthesis loosening.

[0003] Chinese invention patent CN118178058A discloses a novel barbed shoulder joint humerus body, including a humeral implant, having a bone contact surface formed on the peripheral side, and the bone contact surface is provided with a plurality of anti-rotation ribs along its circumference, and each anti-rotation rib is distributed along the height direction of the bone contact surface; at least one anti-rotation rib is provided with at least one limiting notch along the length direction, so that the anti-rotation rib has at least an anti-pull-out blocking surface in the height direction, and there is a blocking angle of 80-135° between the anti-rotation rib and the bone contact surface. The anti-rotation ribs adopted in this patent can not only prevent the problem of rotation after implantation and affect the fixation, but also can play an anti-pulling role in the axial direction through the anti-pulling blocking surface formed by its upper limit notch, which is not easy to loosen and fall out, and more firmly anchors the humeral head; Chinese invention patent CN114159620A discloses an antibacterial anti-loosening coating for titanium and titanium alloy implant materials, including the following preparation steps: 1) using branched polyethyleneimine and nitric oxide as raw materials to prepare polyethyleneimine azodiol olefin salt as NO donor material; 2) preparing positively ionized titanium and titanium alloy matrix; 3) preparing a surface gelatin monolayer film. This invention uses gelatin and NO donor substances to modify titanium metal materials, and by extending the release time of NO, it gives the material a continuous antibacterial effect, solving the problems of easy infection and loosening of titanium and titanium alloy implants in the body.

[0004] Chinese utility model patent CN208838250U discloses a novel biological fixation type tibial implant, including a tibial tray, a tibial tray platform is fixedly installed on the top and provided with a tibial tray groove, and the bottom of the tibial tray is symmetrically provided with four rectangularly distributed threaded grooves, and a first screw is installed and extends into the corresponding positioning groove. The top of the first screw is provided with a through hole and a limit hole, which can prevent the tibial tray and the tibial wing from being too loose and causing the tibial tray and the tibial wing to be separated, thereby preventing the implant from being separated as a whole, and also improving the service life of the implant; Chinese invention patent CN118476833A discloses an activated implant, an interface screw and a wire anchor. The activated implant includes a main body with a cavity, a connecting part arranged on the circumference of the main body, and a filling body accommodated in the cavity. The pores formed by the porous structure of the main body can penetrate the main body and be exposed at the connecting part, so that while the connecting part fixes the main body on the host bone, the pores connect the cavity with the outside world, so that the components of the filling body can be released between the main body and the host bone through the pores, forming a microenvironment that is conducive to the integration of soft tissue and host bone and the formation of new bone, reducing bone absorption, improving the bonding strength between soft tissue and host bone, and reducing the risk of bone screw loosening. Summary of the invention

[0005] The purpose of the present invention is to provide an anti-dropping sleeve for implant prosthesis, which is based on highly plastic bio-inert materials to physically shield the contact surface between the implant and the bone and regulate the mechanical properties.

[0006] The technical solution adopted by the present invention is:

[0007] An anti-dropout bushing for implanting a prosthesis comprises a tubular body, the inner diameter of which matches the diameter of the implant and is used to wrap a fixture. The tubular body is made of a bio-inert and non-biodegradable resin material.

[0008] Preferably, the bio-inert and non-biodegradable resin material is thermoplastic polyurethane elastomer, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, perfluoroalkyl compound, or a blend or copolymer of the above polymers.

[0009] Preferably, the bioinert and non-biodegradable material is a fluorinated ethylene-propylene copolymer having a viscosity-average molecular weight in the range of 0.1 to 60×10 4 moor.

[0010] Preferably, the viscosity average molecular weight of the fluorinated ethylene propylene copolymer is 30×10 4 moor.

[0011] Preferably, the inner diameter of the tubular body is 101% to 105% of the diameter of the implant.

[0012] Preferably, the inner diameter of the tubular body is 103% of the diameter of the implant.

[0013] The present invention also discloses a method for preparing the above-mentioned anti-slip bushing, wherein a biologically inert and non-biodegradable resin material is processed and formed according to a predetermined size, and the processing method is selected from mold injection molding, extrusion, solution processing, powder hot melt die casting, additive manufacturing, 3D printing, and spinning.

[0014] Preferably, the processing method is mold injection molding, specifically, melting the bio-inert and non-biodegradable resin material at 360-420° C. and then injecting it into a mold for molding.

[0015] Preferably, the melt temperature of the mold injection is 385°C.

[0016] The anti-slip bushing of the implant prosthesis of the present invention does not change the mechanical strength of the prosthesis after implantation, thereby ensuring its functional use. At the same time, it effectively blocks and shields particles such as grinding chips between the implant prosthesis and the bone, thereby avoiding the occurrence of non-bacterial loosening. At the same time, the anti-slip bushing can effectively improve the use effect and service life of the implant. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the use of an anti-drop sleeve for implanting a prosthesis. DETAILED DESCRIPTION

[0018] The present invention is further described below in conjunction with embodiments, but the description of the embodiments does not impose any limitation on the protection scope of the present invention.

[0019] Unless otherwise defined, all technical terms and scientific terms used herein have the same meaning as those generally understood by those skilled in the art of the present invention, and the terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments, and are not intended to limit the present invention. In addition, although demonstrations of parameters containing specific values ​​may be provided herein, it should be understood that the parameters do not need to be exactly equal to the corresponding values, but can be approximated to the corresponding values ​​within an acceptable error tolerance or design constraint. The directional terms mentioned in the embodiments, such as "up", "down", "front", "back", "left", "right", etc., are only directions with reference to the accompanying drawings. Therefore, the directional terms used are used to illustrate rather than to limit the scope of protection of the present invention.

[0020] Unless otherwise specified, the materials and instruments used in the following examples can be obtained from conventional commercial channels.

[0021] The "biological inertness" mentioned in the present invention means that under physiological conditions, the material has high biocompatibility and safety with the body, has no or only weak physical, chemical and biological effects with surrounding tissues, has no harmful reactions to the host, and maintains the material properties of stable composition and structure.

[0022] The "non-biodegradable" mentioned in the present invention means that under physiological conditions, the material does not undergo obvious dissolution, molecular chain breakage, mechanical property degradation, etc. Example 1

[0023] like Figure 1 As shown, an anti-drop sleeve for implanting a prosthesis comprises a tubular body, the inner diameter of which matches the diameter of the implant, and is used to wrap a fixture. The tubular body is made of a bio-inert and non-biodegradable resin material, such as a resin having a viscosity average molecular weight of 30×10 4 It is made of fluorinated ethylene propylene copolymer (FEP).

[0024] It can also be made of thermoplastic polyurethane elastomer (TPU), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), perfluoroalkyl compound (PFA), or blends or copolymers of the above polymers. When FEP is used, the viscosity average molecular weight (Mv) is controlled to be 0.1 to 60×10 4 moor.

[0025] The inner diameter of the anti-drop sleeve is set to 101% to 105%, for example, 103%, of the diameter of the implant, so as to facilitate the insertion and fixation of the implant.

[0026] The anti-slip bushing can be prepared by a mold injection molding method. A mold of a predetermined size is prepared in advance, FEP is heated to 360-420°C to melt it, and then injected into the mold to cool and shape it.

[0027] When in use, a hole is made on the bone, the implant is inserted into the anti-drop bushing, and then the implant and the anti-drop bushing are embedded in the hole. If there is no anti-drop bushing, the implant is usually made of hard materials such as metal. The implant is directly embedded in the bone. Over time, the implant will wear against the bone, and the particles generated will interact with the surrounding bone tissue cells, causing chronic inflammatory reactions, resulting in aseptic loosening and osteoporosis. After adding the anti-drop bushing, the anti-drop bushing can effectively block and shield the particles such as grinding debris between the implant and the bone, delaying the occurrence of symptoms such as aseptic loosening and osteoporosis.

[0028] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with this technology to understand the contents of the present invention and implement them accordingly. They cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. An anti-drop sleeve for implanting a prosthesis, comprising a tubular body, the inner diameter of which matches the diameter of the implant, and is used to wrap a fixture, characterized in that: The tubular body is made of a biologically inert and non-biodegradable resin material.

2. The anti-drop bushing according to claim 1, characterized in that: The bio-inert and non-biodegradable resin material is thermoplastic polyurethane elastomer, polytetrafluoroethylene, fluorinated ethylene-propylene copolymer, perfluoroalkyl compound, or a blend or copolymer of the above polymers.

3. The anti-drop bushing according to claim 2, characterized in that: The biologically inert and non-biodegradable material is a fluorinated ethylene-propylene copolymer with a viscosity-average molecular weight in the range of 0.1 to 60×10 4 moor.

4. The anti-drop bushing according to claim 3, characterized in that: The viscosity average molecular weight of the fluorinated ethylene propylene copolymer is 30×10 4 moor.

5. The anti-drop bushing according to any one of claims 1 to 4, characterized in that: The inner diameter of the tubular body is 101% to 105% of the diameter of the implant.

6. The anti-drop bushing according to claim 5, characterized in that: The inner diameter of the tubular body is 103% of the implant diameter.

7. The method for preparing the anti-drop bushing according to any one of claims 1 to 6, characterized in that: The bio-inert and non-biodegradable resin material is processed and formed according to a predetermined size, and the processing method is selected from mold injection molding, extrusion, solution processing, powder hot melt die casting, additive manufacturing, 3D printing, and spinning.

8. The preparation method according to claim 7, characterized in that: The processing method is mold injection molding, specifically, melting the bio-inert and non-biodegradable resin material at 360-420° C. and then injecting it into a mold for molding.

9. The preparation method according to claim 8, characterized in that: The melt temperature for mold injection is 385°C.

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