Titanium-nickel alloy material medullary cavity extension handle and medullary cavity extension repair system

Abstract

The invention relates to the technical field of medical instruments, and discloses a titanium-nickel alloy material medullary cavity extension handle and a medullary cavity extension repair system.The titanium-nickel alloy material medullary cavity extension handle comprises a near-end handle body, one end of the near-end handle body is fixedly connected with a circular handle body, and an annular groove is formed in the outer side of the circular handle body; a porous structure is arranged at the end, away from the near-end handle body, of the round handle body, a middle-section handle body is arranged at one end of the porous structure, a connecting handle body is arranged at the bottom of the middle-section handle body, a threaded groove is formed in the outer portion of the connecting handle body, and a far-end conical handle body is arranged at the bottom of the connecting handle body. By combining the titanium-nickel alloy material with the shape memory effect and the hyperelastic technology, the medullary cavity extension handle can adapt to the irregular shape of the medullary cavity in the human body environment of 37 DEG C and is tightly attached to the wall of the medullary cavity, and the technical effects of high stability and low loosening risk after implantation are achieved. The technical defects of insufficient adaptability and postoperative instability in the prior art are overcome.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a medullary cavity extension handle made of a titanium-nickel alloy and a medullary cavity extension repair system. Background Art

[0002] With the development of medical technology, tumor resection surgery has become an important means of treating bone tumors. Bone tumors usually refer to malignant tumors that occur in bones or their surrounding tissues. Such diseases not only destroy normal bone tissue, but may also cause symptoms such as fractures, pain, and dysfunction. During the treatment process, in order to completely remove the tumor and prevent its recurrence or metastasis, the surgery needs to remove the diseased bone tissue together with a certain range of healthy bone tissue around it. This large-scale bone tissue resection is an important measure to ensure the patient's survival, but it can also cause serious damage to the bone structure; Existing medullary cavity extension handles mainly rely on mechanical fixation and bone cement anchoring to achieve mechanical support and stability in the bone defect area. However, the adaptability of existing medullary cavity extension handle devices is poor. Because the fixed form design cannot adapt to the complex morphology of the medullary cavity of different patients, it does not fit tightly with the medullary cavity wall after implantation, causing loosening, sinking and other problems. In addition, its porous structure and coating technology are relatively simple, and the parameter design of porosity and coating thickness lacks scientific optimization. The biological fixation effect of bone tissue is poor, making it difficult to achieve rapid bone integration. Summary of the invention

[0003] In view of the shortcomings of the prior art, the present invention provides a medullary cavity extension handle and medullary cavity extension repair system made of titanium-nickel alloy, which solves the problem that the existing medullary cavity extension handle device has poor adaptability and the fixed form design cannot adapt to the complex form of the medullary cavity of different patients, resulting in loose fit with the medullary cavity wall after implantation, thus causing loosening, sinking and other problems. In addition, its porous structure and coating technology are relatively simple, the parameter design of porosity and coating thickness lacks scientific optimization, the biological fixation effect of bone tissue is poor, and it is difficult to achieve rapid bone integration.

[0004] To achieve the above objectives, the present invention is implemented through the following technical solutions: a medullary cavity extension handle made of titanium-nickel alloy material, comprising a proximal handle body, one end of the proximal handle body is fixedly connected to a circular handle body, an annular groove is provided on the outer side of the circular handle body, a porous structure is provided on the end of the circular handle body away from the proximal handle body, a middle handle body is provided on one end of the porous structure, a connecting handle body is provided at the bottom of the middle handle body, a threaded groove is provided on the outside of the connecting handle body, and a distal conical handle body is provided at the bottom of the connecting handle body.

[0005] Preferably, the porous structure is processed by laser sintering technology, and has a porosity range of 30%-50%, a pore size of 200-500 μm, and a random or partitioned gradient distribution of pores to simulate the microstructure of natural bone tissue, enhance the proliferation rate and adhesion strength of bone cells, and reduce stress concentration in the medullary cavity after implantation.

[0006] Preferably, the middle section of the handle is made of a titanium-nickel alloy layer, and a hydroxyapatite coating is coated on its surface. The coating has a thickness of 50-100 μm, which is used to improve biological activity and accelerate the fusion of bone tissue and implants. The hydroxyapatite coating is coated on the surface of the porous structure and the middle section of the handle by plasma spraying technology, and the coating has the following characteristics: High biocompatibility, promoting the proliferation and differentiation of bone cells; The coating thickness ranges from 50-100 μm, which helps to quickly form bone integration; The coating is dense and wear-resistant, ensuring that the coating will not fall off during long-term use.

[0007] Preferably, the surfaces of the middle handle body and the connecting handle body are roughened by micro-sandblasting or electrochemical etching process, and the roughness range is 0.5-1.5 μm, which is used to increase the adhesion of bone cement and further improve the bonding strength between bone cement and the handle body.

[0008] Preferably, the thread direction of the thread groove is designed to be counterclockwise, and the side of the thread is provided with a micro-protrusion to further enhance the interlocking effect between the thread and the medullary cavity wall and prevent rotation or loosening after implantation.

[0009] Preferably, the titanium-nickel alloy layer has a superelastic modulus of 40-70 GPa, and its shape memory effect is adjusted by heat treatment technology so that it can achieve the following functions in a 37°C human body environment: Adapts to slight changes in the shape of the medullary cavity to ensure a perfect fit; During the implantation process, stress is absorbed by deformation, thus avoiding mechanical damage to the medullary cavity wall.

[0010] Preferably, the surface of the distal conical handle is treated by nano-sandblasting and coated with an antibacterial coating, and the characteristics of the antibacterial coating are: Antibacterial rate ≥ 99%, used to reduce the risk of postoperative infection; The coating thickness is 10-30μm and is wear-resistant, ensuring that the coating does not fall off during implantation and long-term use; The surface friction coefficient is reduced by 10%-20%, which makes it easier to reduce friction damage to the medullary cavity wall during implantation.

[0011] Preferably, the entire surface of the middle handle and the connecting handle is subjected to vacuum anodizing treatment, including: Thickness ranges from 5-20 μm; The surface hardness is significantly improved, which can resist long-term corrosion in human body fluid environment; The surface has a micron-scale porous structure, which helps to enhance the adhesion of bone cells and further improve the bone integration effect.

[0012] Preferably, the proximal handle body, the circular handle body and the middle handle body together form a mechanical support structure, and the synergistic effect of the porous structure and the annular groove achieves initial biological fixation and long-term mechanical stability.

[0013] On the other hand, the medullary cavity lengthening and repairing system comprises the following modules: A data acquisition module, used to obtain key parameters of bone defects and medullary cavity based on the patient's imaging data; An extended stem implantation module, including a medullary cavity extended stem and bone cement required for implantation, is used to complete the implantation operation during surgery; Fixation module, initial stability after implantation and long-term fixation effect; The postoperative monitoring module is used to regularly monitor the implantation effect of the medullary cavity extension handle and the growth of bone tissue after surgery.

[0014] The present invention provides a titanium-nickel alloy medullary cavity extension handle and a medullary cavity extension repair system, which have the following beneficial effects: 1. The present invention uses titanium-nickel alloy materials and combines shape memory effect and superelasticity technology to enable the medullary cavity extension handle to adapt to the irregular shape of the medullary cavity under the human body's 37°C environment and fit closely with the medullary cavity wall, achieving the technical effect of high stability and low loosening risk after implantation. Compared with the problem that the medullary cavity extension handle is not tightly combined with the bone tissue and is prone to loosening and sinking in the prior art using ordinary metal materials, the present invention solves the technical defects of insufficient adaptability and postoperative instability in the prior art.

[0015] 2. The present invention adopts a porous structure design through the proximal handle body, with a porosity of 30%-50% and a pore size of 200-500μm, and a hydroxyapatite coating on the surface with a coating thickness of 50-100μm. These technical solutions are used to promote the attachment, proliferation and differentiation of bone cells, and significantly improve the biological fixation ability of bone tissue. Compared with the existing technology that lacks porous structure or bioactive coating in the medullary cavity extension handle, resulting in slow growth of bone tissue and poor fixation effect, this solves the shortcomings of insufficient long-term fixation ability and poor bone integration effect.

[0016] 3. The design of the distal conical handle and the thread groove of the present invention realizes mechanical interlocking during the implantation process, and combined with the roughening treatment of the middle handle, improves the friction and initial fixation strength. At the same time, the superelasticity of the titanium-nickel alloy material effectively reduces the implantation stress concentration phenomenon and reduces the risk of mechanical damage to the medullary cavity wall, achieving the technical effect of improving the mechanical properties of the implant and reducing postoperative pain. Compared with the problems of simple implant design and uneven stress conduction leading to frequent postoperative pain and complications in the prior art, the technical defects of insufficient mechanical properties and low stress conduction efficiency are solved. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A perspective view of the present invention; Figure 2 It is a cross-sectional view of the middle section of the handle of the present invention; Figure 3 for Figure 1 Enlarged view of point A in the middle; Figure 4 for Figure 1 Enlarged view of point B in the middle; Figure 5 This is a schematic diagram of the medullary cavity lengthening and repairing system of the present invention.

[0018] Among them, 1. proximal handle body; 2. circular handle body; 3. annular groove; 4. porous structure; 5. middle handle body; 6. connecting handle body; 7. distal conical handle body; 8. threaded groove; 9. hydroxyapatite coating; 10. titanium-nickel alloy layer. DETAILED DESCRIPTION

[0019] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] Please refer to the attached Figure 1 , Attachment Figure 2 and attached Figure 4The embodiment of the present invention provides a medullary cavity extension handle made of a titanium-nickel alloy material, comprising a proximal handle body 1, the proximal handle body 1 is used to connect with a joint prosthesis component, one end of the proximal handle body 1 is fixedly connected with a circular handle body 2, the circular handle body 2 is located between the proximal handle body 1 and a porous structure 4, an annular groove 3 is provided on the outer side of the circular handle body 2, the annular groove 3 is arranged on the outer side of the circular handle body 2, the depth is 0.5-1mm, the width is 1-2mm, the end of the circular handle body 2 away from the proximal handle body 1 is provided with a porous structure 4, which is arranged in the proximal region, the porosity is 30% to 50%, the pore size is 200-500μm, the porous structure 4 is used to promote bone cell adhesion, proliferation and differentiation, and realize the biological fixation of bone tissue, the porous structure A middle handle body 5 is arranged at one end of 4, and the surface of the middle handle body 5 is roughened with a roughness of 0.5-1.5 μm to increase the friction with bone cement and bone tissue. A connecting handle body 6 is arranged at the bottom of the middle handle body 5, and the connecting handle body 6 connects the middle handle body 5 and the distal conical handle body 7 to ensure mechanical stability. A thread groove 8 is arranged on the outside of the connecting handle body 6, and the thread groove 8 is arranged on the outside of the distal conical handle body 7, and the thread pitch is 1-2 mm and the depth is 0.3-0.5 mm, which is used to be closely combined with the medullary cavity wall during the implantation process. A distal conical handle body 7 is arranged at the bottom of the connecting handle body 6, and the distal conical handle body 7 has a taper of 3°-5°, which is used to facilitate implantation deep into the medullary cavity and reduce damage to the medullary cavity wall.

[0021] Please refer to the attached Figure 1 and attached Figure 3 The porous structure 4 is processed by laser sintering technology, and its porosity ranges from 30% to 50%, the pore size is 200-500μm, and the pore distribution is random or partitioned gradient arrangement to simulate the microstructure of natural bone tissue, enhance the proliferation rate and adhesion strength of bone cells, and reduce the stress concentration phenomenon in the medullary cavity after implantation. The uniformity of mechanical properties is improved through the gradual pore distribution, ensuring that bone tissue can gradually penetrate into pores of different depths to form a stable biological fixation.

[0022] Please refer to the attached Figure 1 , Attachment Figure 2 and attached Figure 3The middle handle body 5 is made of a titanium-nickel alloy layer 10, and its surface is coated with a hydroxyapatite coating 9 with a thickness of 50-100 μm, which is used to improve biological activity and accelerate the fusion of bone tissue and implants; the hydroxyapatite coating 9 is coated on the surface of the porous structure 4 and the middle handle body 5 by plasma spraying technology, and the coating has the following characteristics: high biocompatibility, promoting the proliferation and differentiation of bone cells; the coating thickness ranges from 50-100 μm, which helps to quickly form bone integration; the coating is dense and wear-resistant, ensuring that the coating does not fall off during long-term use; at the same time, the coating guides bone cells to grow deeply along the inside of the porous structure 4 through its excellent surface activity, thereby accelerating the three-dimensional expansion speed of bone tissue; the uniformity of the coating avoids the difference in biological binding properties caused by insufficient local thickness, and improves the overall fixation performance.

[0023] Please refer to the attached Figure 2 , Attachment Figure 3 and attached Figure 4 The surfaces of the middle handle body 5 and the connecting handle body 6 are roughened by micro-sandblasting or electrochemical etching process, and the roughness range is 0.5-1.5μm, which is used to increase the adhesion of bone cement and further improve the bonding strength between bone cement and the handle body; the titanium-nickel alloy layer 10 has a superelastic modulus of 40-70GPa, and its shape memory effect is adjusted by heat treatment technology, so that it can achieve the following functions in a 37°C human body environment: adaptive adjustment according to slight changes in the shape of the medullary cavity to ensure complete fit; stress is absorbed by deformation during implantation to avoid mechanical damage to the medullary cavity wall; the shape memory effect of the titanium-nickel alloy layer 10 ensures that any slight deformation after surgery can be restored to the original state, thereby ensuring the long-term stable mechanical properties of the medullary cavity extension handle, and the synergistic effect of the roughened surface and the titanium-nickel alloy not only improves the reliability of initial fixation.

[0024] Please refer to the attached Figure 4The thread direction of the thread groove 8 is designed to be counterclockwise, and a micro-protrusion is provided on the side of the thread to further enhance the interlocking effect between the thread and the medullary cavity wall. The micro-protrusion structure can significantly increase the bite force between the thread groove 8 and the medullary cavity wall, and reduce the bone tissue damage caused by local force concentration during implantation; the surface of the distal conical handle body 7 is nano-sandblasted and coated with an antibacterial coating. The characteristics of the antibacterial coating are: antibacterial rate ≥ 99%, which is used to reduce the risk of postoperative infection; the coating thickness is 10-30μm, which is wear-resistant, ensuring that the coating is durable during implantation and long-term use The surface friction coefficient is reduced by 10% to 20%. The nano-sandblasting further optimizes the surface roughness of the distal conical handle 7, making the adhesion of the antibacterial coating more firmly, thereby improving the coating's anti-falling performance in long-term use. The antibacterial coating can form a continuous antibacterial barrier after implantation, effectively inhibiting the proliferation of bacteria at the implantation site and reducing the postoperative infection rate. The distal conical handle 7 achieves efficient implantation through its optimized taper design and the cooperation with the thread groove 8, further enhancing the initial fixation effect of the implant and the postoperative mechanical stability.

[0025] Please refer to the attached Figure 1 and attached Figure 3 The entire surface of the middle handle body 5 and the connecting handle body 6 is subjected to vacuum anodizing treatment, including: the thickness range is 5-20μm; the surface hardness is significantly improved, which can resist long-term corrosion in the human body fluid environment; the surface has a micron-level pore structure, which helps to enhance the adhesion of bone cells and further improve the bone integration effect; the vacuum anodizing treatment improves the corrosion resistance by forming a dense oxide layer on the surface, thereby ensuring that the implant can remain stable in the long-term contact with the body fluid environment; the proximal handle body 1, the circular handle body 2 and the middle handle body 5 together form a mechanical support structure, and the synergistic effect of the porous structure 4 and the annular groove 3 is effective. Initial biological fixation and long-term mechanical stability are achieved; the proximal handle body 1 plays a key role in connecting with the joint prosthesis component, and transmits the load generated by the joint movement to the middle handle body 5 through its mechanical stability; the circular handle body 2 provides additional support area in the combination of bone cement and the handle body, reducing the stress concentration problem; the roughened surface of the middle handle body 5 further improves the adhesion effect of bone cement by enhancing friction, the porous structure 4 promotes the rapid growth of bone cells, and the annular groove 3 synergistically enhances the anti-rotation and anti-displacement properties with the anchoring effect of bone cement, thereby achieving efficient fixation of the implant and mechanical stability for long-term use.

[0026] On the other hand, please see the attached Figure 1 , Attachment Figure 3 and attached Figure 5The medullary cavity extension and repair system includes the following modules: a data acquisition module, which is used to obtain the key parameters of the bone defect and the medullary cavity according to the patient's imaging data, by accurately measuring the length of the bone defect, the diameter of the medullary cavity and the shape; an extension handle implantation module, including a medullary cavity extension handle and the bone cement required for implantation, which is used to complete the implantation operation during the operation. The medullary cavity extension handle achieves adaptive fitting through the shape memory effect, and the bone cement is filled into the porous structure 4 and the annular groove 3 to enhance the fixation effect of the implant; a fixation module, which is used to provide initial stability and long-term fixation effect after implantation, wherein the porous structure 4 and the annular groove 3 work together to achieve mechanical anchoring of the bone cement, and the antibacterial coating and the anodized layer ensure long-term stability; a postoperative monitoring module, which is used to regularly monitor the implantation effect of the medullary cavity extension handle and the growth of bone tissue after surgery, and evaluate the degree of bone tissue growth in the porous structure 4 and the position stability of the extension handle through imaging review, so as to provide data support for the optimization of subsequent rehabilitation plans and the iterative design of the medullary cavity extension handle.

[0027] Working principle: Before implantation, the medullary cavity extension handle is precisely matched with the joint prosthesis component by using the design of the proximal handle body 1 and the circular handle body 2 according to the patient's imaging examination data. At the same time, the presence of the annular groove 3 provides a space for the bone cement to be firmly anchored, thereby increasing the stability of the initial fixation through the filling of bone cement; During the implantation process, the porous structure 4 utilizes its 30%-50% porosity and 200-500 μm pore size to promote the attachment and proliferation of bone cells, so that bone tissue can grow into the pores, gradually achieving the effect of biological fixation. The surface of the middle handle 5 is roughened to a roughness of 0.5-1.5 μm. This treatment increases the friction with the bone cement and increases the contact area, thereby significantly improving the fixation effect of the implant and reducing the risk of postoperative displacement. The connecting handle 6 serves as a load-bearing structure to ensure that the middle handle 5 and the distal conical handle 7 are connected. The mechanical conduction between the stem and the medullary cavity is uniform and the concentration of mechanical stress is avoided. At the same time, the 3°-5° taper design of the distal conical handle body 7 enables it to easily enter the deep medullary cavity during implantation, reducing mechanical damage to the medullary cavity wall. The counterclockwise design of the thread groove 8 and the parameter of the thread depth of 0.3-0.5mm can be firmly combined with the medullary cavity wall through rotation operation. The hydroxyapatite coating 9 on the surface of the medullary cavity extension handle is coated by plasma spraying technology with a thickness of 50-100μm. The coating improves biological activity in the medullary cavity and reduces the risk of infection after implantation. The internal core titanium-nickel alloy layer 10 has superelasticity and shape memory effect. It can adapt to the irregular shape of the medullary cavity in the human body at 37°C, and fit the medullary cavity wall through its own fine-tuning, thereby reducing stress concentration and improving long-term biomechanical stability.

[0028] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A medullary cavity extension handle made of titanium-nickel alloy, comprising a proximal handle body (1), characterized in that: One end of the proximal handle body (1) is fixedly connected to a circular handle body (2), an annular groove (3) is provided on the outer side of the circular handle body (2), a porous structure (4) is provided on the end of the circular handle body (2) away from the proximal handle body (1), a middle handle body (5) is provided on one end of the porous structure (4), a connecting handle body (6) is provided at the bottom of the middle handle body (5), a threaded groove (8) is provided on the outside of the connecting handle body (6), and a distal conical handle body (7) is provided at the bottom of the connecting handle body (6).

2. The titanium-nickel alloy medullary cavity extension handle according to claim 1, characterized in that: The porous structure (4) is processed by laser sintering technology, and has a porosity range of 30%-50%, a pore size of 200-500 μm, and a random or partitioned gradient distribution of pores to simulate the microstructure of natural bone tissue, enhance the proliferation rate and adhesion strength of bone cells, and reduce stress concentration in the medullary cavity after implantation.

3. The titanium-nickel alloy medullary cavity extension handle according to claim 1, characterized in that: The middle handle (5) is made of a titanium-nickel alloy layer (10), and its surface is coated with a hydroxyapatite coating (9). The coating has a thickness of 50-100 μm and is used to improve biological activity and accelerate the fusion of bone tissue and implant. The hydroxyapatite coating (9) is coated on the surface of the porous structure (4) and the middle handle (5) by plasma spraying technology. The coating has the following characteristics: High biocompatibility; The coating thickness ranges from 50-100 μm; The coating is dense and wear-resistant.

4. The titanium-nickel alloy medullary cavity extension handle according to claim 1, characterized in that: The surfaces of the middle handle body (5) and the connecting handle body (6) are roughened by micro-sandblasting or electrochemical etching, with a roughness range of 0.5-1.5 μm, so as to increase the adhesion of bone cement and further improve the bonding strength between the bone cement and the handle body.

5. The titanium-nickel alloy medullary cavity extension handle according to claim 1, characterized in that: The thread direction of the thread groove (8) is designed to be counterclockwise, and a micro-protrusion is provided on the side of the thread, which is used to further enhance the engagement between the thread and the medullary cavity wall and prevent rotation or loosening after implantation.

6. The titanium-nickel alloy medullary cavity extension handle according to claim 3, characterized in that: The titanium-nickel alloy layer (10) has a superelastic modulus of 40-70 GPa, and its shape memory effect is adjusted by heat treatment technology, so that it can achieve the following functions in a 37°C human body environment: Adapts to small changes in the shape of the medullary cavity; Absorbs stress by deforming during implantation.

7. The titanium-nickel alloy medullary cavity extension handle according to claim 1, characterized in that: The surface of the distal conical handle (7) is treated by nano-sandblasting and coated with an antibacterial coating, the characteristics of the antibacterial coating being: Antibacterial rate ≥99%; The coating thickness is 10-30μm; The surface friction coefficient is reduced by 10%-20%.

8. The titanium-nickel alloy medullary cavity extension handle according to claim 1, characterized in that: The entire surface of the middle handle body (5) and the connecting handle body (6) is subjected to vacuum anodizing treatment, including: Thickness ranges from 5-20 μm; The surface has a micron-scale pore structure.

9. The titanium-nickel alloy medullary cavity extension handle according to claim 1, characterized in that: The proximal handle body (1), the circular handle body (2) and the middle handle body (5) together form a mechanical support structure, and the synergistic effect of the porous structure (4) and the annular groove (3) achieves initial biological fixation and long-term mechanical stability.

10. A medullary cavity lengthening and repairing system, applied to a medullary cavity lengthening handle made of a titanium-nickel alloy material as claimed in any one of claims 1 to 9, characterized in that: The medullary cavity lengthening and repairing system comprises the following modules: A data acquisition module, used to obtain key parameters of bone defects and medullary cavity based on the patient's imaging data; An extended stem implantation module, including a medullary cavity extended stem and bone cement required for implantation, is used to complete the implantation operation during surgery; Fixation module, initial stability after implantation and long-term fixation effect; The postoperative monitoring module is used to regularly monitor the implantation effect of the medullary cavity extension handle and the growth of bone tissue after surgery.

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