3D printing porous tantalum fixing system for bone nonunion

Abstract

The utility model relates to a 3D printing porous tantalum fixing system for bone nonunion. The 3D printing porous tantalum fixing system comprises an implanting part attached to a broken end area of a bone, the fixing part is connected with the implanting part and is fixed at the broken end of the bone. Compared with the prior art, the bone fracture fixing system has the advantages that the bone fracture fixing system holds the basic morphological structure of the bone at the non-connected part in a short time and plays a role in supporting, and promotes the ingrowth, repair and regeneration of the bone tissue in the long-term process, so that the bone fracture part and the fixing system form a stable integrated structure in which bone cells and tissues grow.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical biomaterial orthopedic implants, and in particular relates to a 3D printed porous tantalum fixation system for bone nonunion. Background Art

[0002] Nonunion refers to the long-term failure of a fracture to heal. Delayed healing is when a fracture heals slowly. Nonunion is when a fracture fails to heal. Nonunion is clinically defined when a patient's fracture does not heal for more than nine months, or when X-rays taken for three consecutive months show no signs of growth at the fracture. Among all fracture patients, approximately 5% have difficulty healing and are prone to developing nonunion. Once nonunion occurs, it is not only difficult to maintain the normal structure and function of bone tissue, but it also causes long-term pain, which will greatly reduce the patient's quality of life.

[0003] At present, the main clinical treatment methods for nonunion are bone graft plate fixation, bone transplantation and Ilizarov technique. However, autologous bone and allogeneic bone transplantation materials are difficult to obtain, and Ilizarov technique cannot be applied to all cases. Therefore, the treatment of nonunion with metal implant materials is a reliable and universal treatment method. Most of the existing bone graft fixation plates can only play a role of mechanical fixation.

[0004] Tantalum is a stable biophilic metal with almost no cytotoxicity and rarely causes tissue rejection. The porous tantalum scaffold not only has excellent mechanical and mechanical properties, but also has a good effect in promoting bone tissue ingrowth and repair. Therefore, it is an ideal bone scaffold material.

[0005] Furthermore, the bone grafting plates commonly used to treat nonunion only play a fixing role and cannot effectively treat the nonunion.

[0006] CN210697792U discloses a bone grafting steel plate for femoral neck fracture nonunion, comprising: a steel plate body, the shape of which is consistent with the anatomical structure of the proximal femur; the steel plate body comprises: a femoral shaft fixing hole, which is arranged at the first end of the steel plate body; a first locking hole, which is arranged on the left side of the second end of the steel plate body; a second locking hole, which is arranged on the right side of the second end of the steel plate body; a third locking hole, which is arranged on the lower side of the first locking hole; a fourth locking hole, which is arranged on the lower side of the second locking hole; and a distance between the first locking hole and the third locking hole is greater than a distance between the second locking hole and the fourth locking hole. Its advantage is that by setting four locking holes and implanting four screws, the bone graft implanted at the nonunion site is supported to avoid bone graft displacement. However, this application only solves the basic morphological structure of the bone that maintains the nonunion site in the early stage, and cannot promote the ingrowth, repair and regeneration of the bone tissue itself. Utility Model Content

[0007] The purpose of the present invention is to provide a 3D printed porous tantalum fixation system for bone nonunion in order to overcome the defects of the above-mentioned prior art. The fixation system provided by the present application can not only maintain the basic morphological structure of the bone at the nonunion site and play a supporting role in the short term, but also utilize the excellent mechanical properties and good osteogenesis-promoting ability of the porous tantalum material to promote the growth, repair and regeneration of bone tissue itself in the long term, so that the fracture site and the fixation system form a stable integrated structure with the growth of bone cells and tissues.

[0008] The purpose of the utility model can be achieved through the following technical solutions:

[0009] A 3D printed porous tantalum fixation system for bone nonunion, comprising:

[0010] An implant portion that fits the fractured region of the bone;

[0011] and a fixing part connected to the implant part and fixed at the broken end of the bone.

[0012] Further, the implantation part comprises:

[0013] An implant body that fits the fracture end area of ​​the bone;

[0014] and a clamping piece having one end clamped with the fixing portion and the other end connected with the implant body.

[0015] Furthermore, the implant body and the clamping piece are porous tantalum implant bone blocks.

[0016] Furthermore, the porous tantalum implant bone block has a porosity of 60-90% and a pore size of 300-000 μm.

[0017] Furthermore, the shape of the implant body matches the crack in the fracture end area of ​​the bone.

[0018] Furthermore, the shape of the clamping member is an inverted T-shape;

[0019] The clamping member includes a clamping body connected to the implant body and a clamping strip connected to the clamping body. The clamping body has the same shape as the implant body and has a length of 1-3 cm. The length of the clamping strip is at least greater than the maximum diameter of the clamping body.

[0020] Furthermore, the fixing portion includes:

[0021] A fixation body that fits the broken end of the bone;

[0022] A connecting groove is arranged on a side of the fixing body facing the broken end of the bone, and the connecting groove is engaged with the connecting piece;

[0023] And screw components are arranged on the upper and lower sides of the fixing body, with at least one screw component on each side, and the screw components are connected to the upper and lower sides of the broken end of the bone.

[0024] Furthermore, the connecting groove is T-shaped and matches the clamping strip, and the fixing body is provided with an elastic strip for the clamping strip to be clamped into near the connecting groove;

[0025] The fixing body is a titanium alloy fixing piece, and the screw piece is a porous tantalum screw.

[0026] Furthermore, the porous tantalum screw has a porosity of 60-90% and a pore size of 300-1000 μm.

[0027] Furthermore, the titanium alloy fixing piece is also provided with a screw hole for the porous tantalum screw to pass through.

[0028] Compared with the prior art, the utility model has the following beneficial effects:

[0029] 1. The utility model uses the fixing function of the fixing part to fix the implant part well on the broken end of the bone, so as to better stabilize the structure of the fractured bone in the early stage of implantation.

[0030] 2. The implant part of the utility model is a porous tantalum implant bone block, which solves the problem of the source of bone graft materials, and the porous structure is designed to facilitate bone growth into the pores of the porous tantalum implant bone block, so that in the long term, the porous tantalum material promotes the growth, repair and regeneration of bone tissue itself, so that the fracture site and the fixation system form a stable integrated structure with bone cells and tissue growth. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is an exploded schematic diagram of the fixing system of the utility model in Example 1 and Example 2.

[0032] Numbers in the figure:

[0033] 1-implantation part, 101-implantation body, 102-clamping piece, 103-clamping body, 104-clamping strip, 2-fixing part, 201-fixing body, 202-connecting groove, 203-screw part, 204-elastic strip. DETAILED DESCRIPTION

[0034] The present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. This embodiment is implemented based on the technical solution of the present invention, and provides a detailed implementation method and a specific operation process, but the protection scope of the present invention is not limited to the following embodiments.

[0035] Features such as component models, material names, connection structures, control methods, etc. that are not clearly stated in this technical solution shall be deemed as common technical features disclosed in the prior art.

[0036] In the description of the present invention, it should be understood that the terms "upper", "lower", "vertical", "horizontal", "top", "bottom", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0037] In the description of the present invention, "multiple" means two or more than two, unless otherwise specifically defined. In addition, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a bolt connection or a welding connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0038] In order to maintain the basic morphological structure of the bone at the nonunion site and play a supporting role in the short term, and to promote the ingrowth, repair and regeneration of bone tissue in the long term, so that the fracture site and the fixation system form a stable integrated structure with the ingrowth of bone cells and tissues, the utility model provides a 3D printed porous tantalum fixation system for nonunion. Please refer to the structure of Figure 1 As shown, including:

[0039] An implant portion 1 that fits the fracture end area of ​​the bone;

[0040] and a fixing part 2 connected to the implant part 1 and fixed to the broken end of the bone.

[0041] It should be noted that the fixing part 2 and the implant part 1 are individually prepared by 3D printing technology before the operation according to the specific location of the fracture and the specific morphology and position of the fracture of the patient.

[0042] In some specific implementations, please refer to Figure 1 As shown, the implant part 1 comprises:

[0043] An implant body 101 that fits the fracture end area of ​​the bone;

[0044] And a clamping piece 102 having one end clamped with the fixing portion 2 and the other end connected with the implant body 101 .

[0045] For more specific implementations, please refer to Figure 1 As shown, the implant body 101 and the clamping member 102 are porous tantalum implant bone blocks.

[0046] In this embodiment, the porous tantalum implant bone block is prepared by 3D printing integrated with laser micro-area thermal field change precise control technology. The porous tantalum bone block itself has a multi-layer gradient pore structure of a bionic structure, which has good mechanical and mechanical properties.

[0047] For more specific implementations, please refer to Figure 1 As shown, the porosity of the porous tantalum implanted bone block is 60-90%, and the pore size is 300-1000 μm.

[0048] It should be noted that in this embodiment, the porous tantalum implant bone block has a microstructure pore size of 300-1000 μm and an elastic modulus of 1-10 GPa. The porosity is 60-90%. The bending strength is at least greater than 100 MPa, the pore density is at least greater than 99%, the pore size is 300-1000 μm, and the fatigue resistance is at least greater than 10 6 Second-rate.

[0049] For more specific implementations, please refer to Figure 1 As shown, the shape of the implant body 101 matches the crack in the bone end region.

[0050] For more specific implementations, please refer to Figure 1 As shown, the shape of the clamping member 102 is an inverted T-shape;

[0051] The clamping member 102 includes a clamping body 103 connected to the implant body 101, and a clamping strip 104 connected to the clamping body 103. The clamping body 103 has the same shape as the implant body 101 and has a length of 1-3 cm. The length of the clamping strip 104 is at least greater than the maximum diameter of the clamping body 103.

[0052] For more specific implementations, please refer to Figure 1 As shown, the fixing portion 2 includes:

[0053] A fixing body 201 that fits the broken end of the bone;

[0054] A connecting groove 202 is provided on a side of the fixing body 201 facing the bone end, and the connecting groove 202 is engaged with the clamping member 102;

[0055] And there are at least one screw member 203 disposed on the upper and lower sides of the fixing body 201, and the screw member 203 is connected to the upper and lower sides of the broken end of the bone.

[0056] In the present embodiment, the clamping member 102 is clamped with the connecting groove 202. It should be noted that the connection method between the implant part 1 and the fixing part 2 includes but is not limited to clamping. Of course, those skilled in the art should understand that the clamping of the clamping member 102 and the connecting groove 202 is only a preferred embodiment of one aspect of the connection method between the implant part 1 and the fixing part 2. Other existing or future possible connection methods such as riveting, threaded connection, etc., if applicable to the present application, should also be included in the scope of protection of the present application and are included here by reference.

[0057] For more specific implementations, please refer to Figure 1 As shown, the connecting groove 202 is T-shaped and matches the clamping strip 104, and the fixing body 201 is provided with an elastic strip 204 for the clamping strip 104 to be clamped into near the connecting groove 202;

[0058] The fixing body 201 is a titanium alloy fixing part, and the screw part 203 is a porous tantalum screw.

[0059] It should be noted that the titanium alloy fixture is made by 3D printing of titanium alloy material adapted to the parameters of porous tantalum implant bone blocks. Before the operation, the location and condition of the fracture nonunion are evaluated based on imaging examinations, and the size and properties of the implanted bone blocks are determined. Then, based on mechanical analysis and calculations, 3D modeling is used to determine the size of the titanium alloy fixture, and finally different titanium alloy fixtures are printed.

[0060] For more specific implementations, please refer to Figure 1 As shown, the porosity of the porous tantalum screw is 60-90%, and the pore size is 300-1000 μm.

[0061] It should be noted that in this embodiment, the porous tantalum screw microstructure has a pore size of 300-1000 μm, an elastic modulus of 1-10 GPa, a porosity of 60-90%, a bending strength of at least 100 MPa, a pore density of at least 99%, a pore size of 300-1000 μm, and a fatigue resistance of at least 10 6 Second-rate.

[0062] For more specific implementations, please refer to Figure 1 As shown, the titanium alloy fixing piece is also provided with a screw hole for the porous tantalum screw to pass through.

[0063] In this embodiment, the porous tantalum screw passes through the screw hole and the titanium alloy fixing piece and is wedged into the bone to play a role of fixing and connecting.

[0064] The above embodiments may be implemented individually or in any combination of two or more.

[0065] The above implementation is described in more detail below in conjunction with specific examples.

[0066] Example 1

[0067] In order to maintain the basic morphological structure of the bone at the nonunion site and provide support in the short term, and to promote the ingrowth, repair and regeneration of bone tissue in the long term, so that the fracture site and the fixation system form a stable integrated structure with the ingrowth of bone cells and tissues, this embodiment provides a 3D printed porous tantalum fixation system for nonunion. For its structure, please refer to Figure 1 As shown, it includes an implant part 1 and a fixing part 2.

[0068] The implant part 1 is arranged to fit the upper and lower surfaces of the broken end of the bone, and the fixing part 2 is connected to the implant part 1 and fixed at the broken end of the bone. The fixing part 2 and the implant part 1 are individually prepared by 3D printing technology according to the specific location of the patient's fracture and the specific morphological position of the fracture before the operation.

[0069] Example 2

[0070] In order to maintain the basic morphological structure of the bone at the nonunion site and play a supporting role in the short term, and to promote the ingrowth, repair and regeneration of bone tissue itself in the long term, so that the fracture site and the fixation system form a stable integrated structure with the ingrowth of bone cells and tissues, this embodiment provides a 3D printed porous tantalum fixation system for nonunion. For its structure, please refer to Figure 1 As shown, it includes an implant part 1 and a fixing part 2. The implant part 1 is arranged to fit the broken end area of ​​the bone, and the fixing part 2 is connected to the implant part 1 and fixed at the broken end of the bone.

[0071] like Figure 1 As shown, the implant part 1 includes an implant body 101 and a clamping piece 102, the implant body 101 fits the upper and lower surfaces of the broken end of the bone, one end of the clamping piece 102 is connected to the fixing part 2 and the other end is connected to the implant body 101, the implant body 101 and the clamping piece 102 are both made of porous tantalum implant bone blocks, the porous tantalum implant bone blocks are prepared by 3D printing integrated with laser micro-area thermal field change precise control technology, the porous tantalum bone block itself has a multi-layer gradient aperture structure of a bionic structure, the structure has good mechanical and mechanical properties, in this embodiment, the porous tantalum implant bone block has a pore size of 1000 μm, an elastic modulus of 8 Gpa, a porosity of 75%, a bending strength of 200 MPa, a pore-reinforcement density of 100%, and an anti-fatigue number of more than 10 6 Secondly, the shape of the implant body 101 matches the broken end of the bone, and the shape of the clamping member 102 is T-shaped.

[0072] like Figure 1 As shown, the clamping member 102 includes a clamping body 103 connected to the implant body 101, and a clamping strip 104 connected to the clamping body 103. The clamping body 103 has the same shape as the implant body 101 and has a length of 1-3 cm. The length of the clamping strip 104 is at least greater than the maximum diameter of the clamping body 103.

[0073] like Figure 1 As shown, the fixing part 2 includes a fixing body 201, a connecting groove 202, and a screw member 203. The fixing body 201 fits the broken end of the bone. The connecting groove 202 is arranged on the side of the fixing body 201 facing the broken end of the bone. The connecting groove 202 is clamped with the clamping member 102. The screw member 203 is arranged on the upper and lower sides of the fixing body 201, and two are arranged on each side. The connecting groove 202 is T-shaped and matches the clamping strip 104. The fixing body 201 is provided with an elastic strip 204 for the clamping strip 104 to be clamped near the connecting groove 202. The fixing body 201 is a titanium alloy fixing part, and the screw member 203 is a porous tantalum screw. The fixing body 201 is a titanium alloy fixing part, and the screw member 203 is a porous tantalum screw. The porous tantalum screw has a pore size of 1000μm, an elastic modulus of 8Gpa, a porosity of 75%, a bending strength of 200MPa, a pore-reinforcement density of 100%, and a fatigue resistance of more than 10 6 Secondly, the titanium alloy fixing piece is also provided with a screw hole for the porous tantalum screw to pass through. The porous tantalum screw passes through the screw hole and the titanium alloy fixing piece and is wedged into the bone to play a role of fixing and connecting.

[0074] The working principle of this embodiment is as follows:

[0075] According to the patient's fracture condition, the implant part 1 and the fixing part 2 are customized using 3D printing technology. During the surgical treatment of bone nonunion, the implant body 101 is first filled and implanted into the corresponding bone injury site. Since it is prepared using 3D printing technology, the upper and lower parts of the bone can fit well with the filled bone block, and the transverse diameter and force line can achieve a good matching relationship. After implantation, the connecting groove 202 on the fixing body 201 is then clamped with the clamping piece 102 of the implant part 1. Finally, the porous tantalum screw is wedged into the bone through the screw hole of the fixing body 201.

[0076] The above description of the embodiments is to facilitate the understanding and use of the utility model by those skilled in the art. It is obvious that those familiar with the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the utility model is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the utility model without departing from the scope of the utility model should be within the scope of protection of the utility model.

Claims

1. A 3D printed porous tantalum fixation system for bone nonunion, characterized in that: include: An implant portion (1) adapted to fit the fractured region of the bone; and a fixing part (2) connected to the implant part (1) and fixed to the broken end of the bone.

2. A 3D printed porous tantalum fixation system for bone nonunion according to claim 1, characterized in that: The implant part (1) comprises: An implant body (101) that fits the fracture end area of ​​the bone; and a clamping piece (102) having one end clamped with the fixing portion (2) and the other end connected with the implant body (101).

3. A 3D printed porous tantalum fixation system for bone nonunion according to claim 2, characterized in that: The implant body (101) and the clamping piece (102) are porous tantalum implant bone blocks.

4. A 3D printed porous tantalum fixation system for bone nonunion according to claim 3, characterized in that: The porous tantalum implant bone block has a porosity of 60-90% and a pore size of 300-000 μm.

5. A 3D printed porous tantalum fixation system for bone nonunion according to claim 2, characterized in that: The shape of the implant body (101) matches the crack in the bone end region.

6. A 3D printed porous tantalum fixation system for bone nonunion according to claim 2, characterized in that: The shape of the clamping piece (102) is an inverted T-shape; The clamping member (102) comprises a clamping body (103) connected to the implant body (101), and a clamping strip (104) connected to the clamping body (103); the clamping body (103) is consistent in shape with the implant body (101) and has a length of 1-3 cm; the length of the clamping strip (104) is at least greater than the maximum diameter of the clamping body (103).

7. A 3D printed porous tantalum fixation system for bone nonunion according to claim 6, characterized in that: The fixing part (2) comprises: A fixing body (201) that fits the broken end of the bone; A connecting groove (202) is arranged on a side of the fixing body (201) facing the broken end of the bone, and the connecting groove (202) is engaged with the engaging member (102); And at least one screw member (203) is arranged on the upper and lower sides of the fixing body (201), and the screw member (203) is connected to the upper and lower sides of the broken end of the bone.

8. A 3D printed porous tantalum fixation system for bone nonunion according to claim 7, characterized in that: The connecting groove (202) is T-shaped and matches the clamping strip (104); the fixing body (201) is provided with an elastic strip (204) for the clamping strip (104) to be clamped into near the connecting groove (202); The fixing body (201) is a titanium alloy fixing part, and the screw part (203) is a porous tantalum screw.

9. A 3D printed porous tantalum fixation system for bone nonunion according to claim 8, characterized in that: The porosity of the porous tantalum screw is 60-90%, and the pore diameter is 300-1000 μm.

10. A 3D printed porous tantalum fixation system for bone nonunion according to claim 8, characterized in that: The titanium alloy fixing piece is also provided with a screw hole for the porous tantalum screw to pass through.

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