TWI548390B - Bionic fixing apparatus and apparatus for pulling out the same - Google Patents

Description

Bionic fixation device and its extraction device

The present invention relates to a biomimetic fixture and its extraction device, and more particularly to a biomimetic fixture having a flexible bottom and its extraction device.

With advances in technology and medicine, tissues such as bone nails are used to fix tissues in living organisms for medical purposes such as accidental injury or repair of natural aging. However, the conventional implant is prone to the problem that the implant is dislodged along the original implantation path when the fixation is stressed after the implant is implanted. In addition, when the fixed part contains soft tissue, the prior art must be fixed by using a degradable material, and the medical community still has doubts about the influence of the degradable material on the living body, for example, it may remain in the living body and cannot be smoothly discharged, or cause the organism. The possibility of cytopathic effects.

Furthermore, after the implant is implanted into the living body, if an adverse reaction needs to be taken out, and there is no suitable device, the implant can be easily taken out, which often causes damage to the biological tissue.

The present invention relates to a biomimetic fixing device having a flexible bottom portion, which utilizes a laminate manufacturing process technology to form a specific structure on the surface or inside of the implant, which can effectively reduce the elastic modulus of the implant while avoiding the implant along the edge. The original implant path is prolapsed. Further, the present invention also proposes a device for extracting a bionic fixation device, which can be easily taken out from a living body.

According to the present invention, a biomimetic fixation device is provided comprising a body having a consistent perforation and at least one slit. The through hole extends through the top surface to the bottom surface of the body to form a top surface opening and a bottom surface opening, and the inner diameter of the top surface opening is larger than the inner diameter of the bottom surface opening. The slit system is in communication with the bottom opening and the slit extends upwardly from the bottom surface of the body such that the body has a flexible bottom.

According to the present invention, an extraction device is proposed for extracting a biomimetic fixation device from a living body. The biomimetic fixture includes a body having a consistent perforation and an external thread and an internal thread. The inner screw and the outer screw are respectively disposed on the inner and outer surfaces of the body. The extraction device includes a control portion and a screwing portion. The screwing portion is connected to the control unit. The screwing portion is screwed into the through hole by the internal thread to pull the bionic fixation device out of the living body.

In order to provide a better understanding of the above and other aspects of the present invention, the following detailed description of the embodiments and the accompanying drawings

1, 2, 3 ‧ ‧ bionic fixtures

11‧‧‧Bottom opening

12‧‧‧Top opening

10‧‧‧through holes

101‧‧‧ bottom

20‧‧‧ body

201‧‧‧ slit

202‧‧‧ External thread

2021‧‧‧First bevel

2022‧‧‧second bevel

2023‧‧‧Three oblique sides

2024‧‧‧4th hypotenuse

203‧‧‧ internal thread

204‧‧‧Interval

205‧‧‧ hole

2051‧‧‧first opening

2052‧‧‧second opening

2052-1‧‧‧ first end

2052-2‧‧‧second end

2053‧‧‧First side wall

2054‧‧‧second side wall

206‧‧‧Flexible bottom

208‧‧‧ inner surface

209‧‧‧ outer surface

30‧‧‧Fixed structure

301‧‧‧ thread

5, 6‧‧‧ pull out device

51, 61‧‧‧Control Department

52, 62‧‧‧ Screw-in Department

53‧‧‧ fixed department

80‧‧‧ accommodating space

90‧‧‧Soft organization

A-A’, B-B’, D-D’‧‧‧ hatching

C‧‧‧Partial areas

D1‧‧‧ first direction

Directions D2, D3, D4, D5, D6‧‧

P1, P2, P3, P4‧‧ path

R1‧‧‧ first reference plane

R2‧‧‧ second reference plane

Θ1‧‧‧first outer angle

Θ2‧‧‧second outer angle

θ3‧‧‧The third outer angle

Θ4‧‧‧fourth outer corner

Θ5‧‧‧ first angle

Θ6‧‧‧second angle

X, Y, Z‧‧‧ coordinate axis

FIG. 1A is a schematic view showing a bionic fixing device according to an embodiment of the present invention.

Fig. 1B is a cross-sectional view of the bionic fixture of Fig. 1A taken along line A-A', viewed from the bottom of the bionic fixture to the top.

Figure 2A is a simplified cross-sectional view of the bionic fixture of Figure 1A taken along the line B-B' in the X-Z plane.

FIG. 2B is a simplified schematic view showing the fixing structure of the embodiment of the present invention fixed to the through hole.

FIG. 3A is a partially enlarged schematic view showing a region C of FIG. 2B.

FIG. 3B is a schematic cross-sectional view showing the outer thread of the embodiment of the present invention in a transverse section (X-Y plane).

FIG. 4A is a schematic view showing a bionic fixation device according to another embodiment of the present invention.

Figure 4B is a schematic cross-sectional view of the bionic fixture of Figure 4A taken along line D-D'.

5A and 5B are schematic views showing the fixation of soft tissue by the bionic fixation device of the embodiment of the present invention.

FIG. 5C is a schematic cross-sectional view showing a bionic fixing device according to an embodiment of the present invention in a lateral cross section (X-Y plane).

6A and 6B are schematic views showing the extraction device of the embodiment of the present invention with a bionic fixture removed.

7A and 7B are schematic views showing the pulling out of a bionic fixing device according to another embodiment of the present invention.

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The same reference numerals are used to designate the same or similar parts. It is to be noted that the drawings have been simplified to clearly illustrate the contents of the embodiments, and the dimensional ratios in the drawings are not drawn to the scale of the actual products, and thus are not intended to limit the scope of the present invention.

FIG. 1A is a schematic view showing a bionic fixation device 1 according to an embodiment of the present invention. Fig. 1B is a cross-sectional view of the bionic fixture 1 of Fig. 1A taken along the line A-A', viewed from the bottom of the bionic fixture 1 to the top.

As shown in FIGS. 1A and 1B, the bionic fixation device 1 of the embodiment of the present invention includes a body 20. The body 20 has a consistent through hole 10 and at least one slit 201. The through hole 10 extends through the top surface to the bottom surface of the body 20 to form a top surface opening 12 and a bottom surface opening 11. The inner diameter of the top surface opening 12 is larger than the inner diameter of the bottom surface opening 11. The slit 201 is in communication with the bottom opening 11 and the slit 201 extends upwardly from the bottom surface of the body 20 such that the body 20 has a flexible bottom 206. That is, the slit 201 extends from the outer surface 209 of the body 20 to the through hole 10 and penetrates the flexible bottom 206. In the present embodiment, the body 20 can include an external thread 202 that is disposed on the outer surface 209 of the body 20.

In one embodiment, the number of the slits 201 may be plural. As shown in FIG. 1B, the number of the slits 201 is three, but the present invention is not limited thereto.

Fig. 2A is a simplified cross-sectional view of the bionic fixture 1 of Fig. 1A taken along the line B-B' in the X-Z plane. It is to be noted that in order to facilitate the presentation of the technical features of the embodiments of the present invention, the following drawings are shown in simplified schematic form, and the connection between the components and the components may be omitted. As shown in the figure, the bottom portion 101 of the through hole 10 of the bionic fixing device 1 of the embodiment of the present invention may be, for example, a tapered shape. Here, the bottom 101 of the through hole 10 corresponds to The position of the flexible bottom 206 of the body 20. In addition, the biomimetic fixture 1 can further include an internal fixation structure 30 that can be secured to the flexible bottom 206.

FIG. 2B is a simplified schematic view showing the fixing structure 30 of the embodiment of the present invention fixed to the through hole 10. In this embodiment, the body 20 can also include an internal thread 203. The internal thread 203 is disposed on the inner surface 208 of the body 20, and the thread direction of the inner thread 203 and the outer thread 202 can be the same or opposite.

Referring to FIGS. 2A and 2B, the inner fixing structure 30 can be, for example, a screw having a thread on the surface of the screw, and the screw 301 and the inner thread 203 of the body 20 can be used to fix the inner fixing structure 30 along the first direction D1. Rotate into the through hole 10. In this embodiment, the first direction D1 is, for example, parallel to the direction in which the biomimetic fixation device 1 is implanted into the living body (ie, an implantation direction), that is, the bottom of the biomimetic fixation device 1 may first follow the first direction. D1 enters the living body for implantation of the biomimetic fixation device 1.

As shown in FIG. 2B, when the inner fixing structure 30 is screwed to the flexible bottom 206, the flexible bottom 206 is subjected to the inner fixing structure 30 due to the design of the slit 201 and the bottom 101 of the through hole 10 being tapered. The pushing causes deformation and pushes to the outside along directions D2 and D3, for example, in the figure.

In the embodiment of the present invention, the bionic fixation device 1 is fixed to the living body through the external thread 202 of the body 20. That is, when the flexible bottom portion 206 is deformed by the pushing of the inner fixing structure 30 and pushed outward, the flexible bottom portion 206 is expanded outwardly and more firmly embedded in the living body even if the bionic fixing device When the external force is applied to the direction opposite to the first direction D1 (i.e., in the direction of pulling out), the bionic fixing device 1 does not easily release the thread 202 from the living body outside the living body.

It should be noted that although the above embodiment of the present invention uses the inner fixing structure 30 as a screw and the inner fixing structure 30 is locked in the through hole 10 by the inner thread 203 of the body 20, the present invention is not limited thereto. In contrast, the present invention can also utilize other non-threaded structural designs, such as cassettes or other similar structural designs, to fix the inner fixed structure 30 to the flexible bottom 206 and push it to the outside to make the bionic fixture 1 It is more firmly embedded in the organism and will not be described here.

When the inner fixing structure 30 is fixed to the through hole 10, since the flexible bottom portion 206 of the embodiment of the present invention has flexibility and is provided with at least one slit 201, the bionic fixing device 1 has flexibility, and therefore, the inner fixing structure 30 does not The body 20 is destroyed, and only the flexible bottom portion 206 is deformed and pushed to the outside, thereby enabling the bionic fixing device 1 to be more firmly fixed in the living body.

In addition, the external thread 202 of the embodiment of the present invention may also have different implementations. FIG. 3A is a partially enlarged schematic view showing a region C of FIG. 2B. As shown, the outer thread 202 is in a longitudinal section (here, for example, a section cut along the line B-B', ie, the XZ plane, which is parallel to the bionic fixture. 1 is implanted in the direction of the living body) having a first oblique side 2021 and a second oblique side 2022. The angle between the first oblique side 2021 and the body 20 is a first outer angle θ1, and the second oblique side 2022 is at an angle with the body 20. It is a second outer angle θ2. In the present embodiment, the first bevel 2021 is located above the second bevel 2022.

In the present embodiment, the first outer angle θ1 is less than 90 degrees, and the second outer angle θ2 is greater than 90 degrees. That is to say, in the embodiment of the present invention, the external thread 202 can be in the shape of a barb on the XZ plane, so that the bionic fixing device 1 is subjected to an external force in a direction opposite to the first direction D1 (extraction direction). It is also not easy to escape from the body.

It should be noted that the first oblique side 2021 of the external thread 202 of the embodiment of the present invention is noted. The second bevel 2022 can also have a curvature. As shown in FIG. 3A, when the first oblique side 2021 and the second oblique side 2022 have a curvature, the first outer angle θ1 is defined as a tangent to the contact point of the first oblique side 2021 and the body 20, and an angle between the first body 20 and the body 20; The second outer angle θ2 is defined as a tangent to the contact point of the second oblique side 2022 and the body 20, and an angle with the body 20.

FIG. 3B is a schematic cross-sectional view showing the external thread 202 of the embodiment of the present invention on a transverse section (X-Y plane) of the body 20. In the present embodiment, the transverse cross section is perpendicular to the first direction D1 and the longitudinal section (X-Z plane). As shown in FIG. 3B, the external thread 202 of the embodiment of the present invention has a third oblique side 2023, a fourth oblique side 2024 and at least one spacing area 204, and a third oblique side 2023 in a lateral section (XY plane). The fourth beveled edge 2024 is located on opposite sides of the spacer 204. In addition, the angle between the third oblique side 2023 and the body 20 is a third external angle θ3, the angle between the fourth oblique side 2024 and the body 20 is a fourth external angle θ4, and the third external angle θ3 and the fourth external angle θ4 are greater than 0 degrees and less than 90 degrees.

Similarly, the third oblique side 2023 and the fourth oblique side 2024 of the external thread 202 of the embodiment of the present invention may also have a curvature. As shown in FIG. 3B, when the third oblique side 2023 and the fourth oblique side 2024 have a curvature, the third outer angle θ3 is defined as a tangent to the contact point of the third oblique side 2023 and the body 20, and an angle with the body 20; The fourth outer angle θ4 is defined as the tangent to the contact point of the fourth oblique side 2024 and the body 20, and the angle between the body 20.

The outer thread 202 of the embodiment of the present invention may have a plurality of spacers 204 in a lateral cross section. As shown in FIG. 3B, in the present embodiment, the outer thread 202 has two spacers 204. Referring also to FIG. 1A, the plurality of spacers 204 of the outer thread 202 can cause the outer thread 202 to be discontinuous.

When the biomimetic fixation device 1 is implanted in the living body, for example, the bionic fixation device The 1 is used as a bone nail and is screwed into the bone of the human body by the design of the external thread 202. At this time, the bone is generated during the process of screwing the external thread 202 into the bone, and the bone fragments can be concentrated outside. In the plurality of spacers 204 of the thread 202, the purpose of collecting chips is achieved. In addition, since the third oblique side 2023 and the fourth oblique side 2024 of the thread 202 are in the form of a barb of the external thread 202, when the biomimetic fixing device 1 is implanted into the living body, if desired, The bionic fixation device 1 is unscrewed in the opposite direction to the path of screwing in, and the bone debris concentrated in the spacer 204 blocks the barbed outer thread 202, preventing the bionic fixation device 1 from being unscrewed.

FIG. 4A is a schematic view showing a bionic fixation device 2 according to another embodiment of the present invention. Similar to the biomimetic fixture 1 of Figure 1A, the biomimetic fixture 2 also includes a body 20 having a consistent perforation 10. In addition, the body 20 can include an outer thread 202 that is disposed on the outer surface 209 of the body 20.

In this embodiment, the body 20 can include a plurality of holes 205. Fig. 4B is a schematic cross-sectional view of the bionic fixture 2 of Fig. 4A taken along line D-D'. It is to be noted that FIG. 4B is a simplified schematic diagram, omitting some of the components (eg, outer thread 202 and inner thread 203) to more clearly illustrate the structure of the hole 205.

As shown in FIG. 4B, the aperture 205 extends from the outer surface 209 of the body 20 to the through hole 10. When the biomimetic fixation device 2 is screwed into an organism, the hard tissue of the living body (for example, the bone debris generated by the bone during the screwing of the external thread 202 into the bone) can extend along the holes 205 to the path of the body 20, focusing. It enters the through hole 10. For example, the bionic fixation device 2 can be screwed into the bone of the human body as a bone nail in the screwing direction D4. At this time, the bones are generated during the screwing of the external thread 202 into the bone, and the bone chips are generated. It can be guided into the bionic fixing device 2 along the paths P1, P2, P3 and P4, and the bone chips can be concentrated to the through holes of the bionic fixing device 2. Within 10.

In the embodiment of the present invention, the size of the hole 205 and the path extending to the through hole 10 can be adjusted according to the direction in which the biomimetic fixing device 2 is screwed into the living body. For example, the aperture 205 forms a first opening 2051 on the outer surface 209 of the body 20 and a second opening 2052 in the inner surface 208 of the body 20. The second opening 2052 has a first end 2052-1 and a second end 2052-2 on the inner surface 208 of the body 20. In this embodiment, the area of the first opening 2051 is larger than the area of the second opening 2052.

In addition, the body 20 has a first sidewall 2053 and a second sidewall 2054 respectively located at two sides of the hole 205, and the second sidewall 2054 faces the first sidewall 2053. The first sidewalls 2053 are formed by rotating a first reference plane R1 along a screwing direction D4 (or a line direction of the outer surface 209 of the body 20) by a first angle θ5, where the first reference plane R1 is vertical. The outer surface 209 and the inner surface 208 of the body 20 pass through the first end 2052-1 of the second opening 2052. The second side wall 2054 is formed by rotating a second reference plane R2 along the screwing direction D4 (or the line direction of the outer surface 209 of the body 20) by a second angle θ6, where the second reference plane R2 is vertical. The outer surface 209 and the inner surface 208 of the body 20 pass through the second end 2052-2 of the second opening 2052.

In this embodiment, the first angle θ5 and the second angle θ6 are both greater than 0 degrees and less than 90 degrees, and the second angle θ6 is greater than the first angle θ5, such that the area of the first opening 2051 is greater than the area of the second opening 2052. The hard tissue (for example, bone chips) of the living body can be effectively promoted to be concentrated in the through hole 10 by the holes 205.

In addition, although the 4A and 4B drawings are not particularly labeled, the outer thread 202 of the bionic fixation device 2 of the embodiment of the present invention also has at least one spacer 204, and the spacer 204 is reachable. For example, the purpose of concentrating bone chips. When the biomimetic fixation device 2 is implanted into the living body, the hard tissue of the living body (for example, bone fragments) may be concentrated toward the spacer 204 of the outer screw 202, or the hole 205 may pass through the body 20 and quickly pass through the through hole 10. Concentrated within. On the contrary, when the hard tissue of the living organism through the hole 10 is occupied, the hard tissue can also be passed through the hole 205 through the body 20, and the excess hard tissue can be quickly discharged through the space 204 of the external thread 202. (chip removal).

In one embodiment, the bionic fixture 2 can also be a bionic fixture 1 as shown in FIG. 1A. The body 20 includes a slit 201 (not shown in FIG. 4A), and the slit 201 is located in the body 20. The bottom portion extends from the outer surface 209 of the body 20 to the through hole 10.

In some embodiments, the biomimetic fixation device of the present invention is also applicable to the fixation of soft tissue 90 (see Figures 5A, 5B) in a living body. 5A and 5B are schematic views showing the fixation of the soft tissue 90 by the bionic fixation device 3 of the embodiment of the present invention. FIG. 5C is a schematic cross-sectional view showing the biomimetic fixing device 3 of the embodiment of the present invention in a transverse section (X-Y plane). The structure of the bionic fixture 3 is similar to that of the bionic fixture 1 of FIGS. 2A and 2B, and the same components will not be described here.

As shown in Figures 5A-5C, the body 20 of the biomimetic fixture 3 can include an accommodating space 80, which can be adjacent to the inner surface 208 of the body 20, for example, to accommodate the soft tissue 90 of the living body. It is accommodated in the space 80 and fixed to the bionic fixing device 3. In the present embodiment, the soft tissue 90 of the living body is, for example, a ligament. Due to the arrangement of the accommodating space 80, the soft tissue 90 can be fixed to the bionic fixing device 3 by the inner fixing structure 30 when it is fixed to the through hole 10.

For example, the soft tissue 90 can be first placed in the accommodating space 80 of the body 20. After the inner fixing structure 30 is screwed into the through hole 10, the soft tissue 90 can also be fixed together. In the housing space 80 of the body 20.

Similarly, the present invention can also utilize other non-threaded structural designs (e.g., cassettes) to secure the inner fixation structure 30 in the through-hole 10 while simultaneously securing the soft tissue 90 within the body 20 of the biomimetic fixture 3. In addition, the fixation effect of the soft tissue 90 can be enhanced by additionally matching a simple suture.

Traditionally, the soft tissue 90 of the fixed organism must be embedded with degradable bone nails, which not only tends to cause foreign body sensation, but also easily causes wear of biological tissues. In addition, there are still doubts about the effects of the degradable materials on the organism after degradation. In contrast, by fixing the soft tissue 90 of the living body by the bionic fixing device 3 of the embodiment of the present invention, the problem caused by the above conventional fixing method can be effectively solved.

As can be seen from the above embodiments, the bionic fixation device of the present invention has the through hole 10 and the body 20, and is fixed to the hard tissue (for example, a bone) of the living body through the external thread 20 of the body 20 while passing through the through hole 10. The cooperation between the accommodating space 80 and the inner fixing structure 30 can fix the soft tissue 90 of the living body in the accommodating space 80 of the body 20, and strengthen the fixing effect of the bionic fixing device, thereby effectively preventing the bionic fixing device from coming out of the living body.

In one embodiment, the thread direction of the inner thread 203 of the body 20 can be the same as the thread direction of the outer thread 202. In another embodiment, the thread direction of the inner thread 203 of the body 20 is opposite to the thread direction of the outer thread 202.

In addition, all of the above embodiments of the present invention can be implemented by an additive manufacturing (AM) process to achieve the above-mentioned complicated microstructure. The thread 202 and the inner thread 203, or the slit 201 and the hole 205 which are provided in some embodiments, are integrally formed in the body 20 . Furthermore, the shapes and arrangements of the components of the embodiments of the present invention can also be easily Completed in a laminate manufacturing process. In contrast, the conventional method of surface treatment by special sintering or surface coating process and laser treatment not only has complicated process and high manufacturing cost, and is not suitable for producing the structure of the embodiment of the present invention.

In the embodiment of the present invention, the material of the biomimetic fixing device may be metal, alloy, ceramic or polymer biomedical material. In addition, the through hole 10 and the slit 201 or the hole 205 of the body 20 in the present invention are an environment for promoting the growth of biological cells or tissues. When the biomimetic fixing device of the embodiment of the present invention is implanted into the living body, the living body The cells or tissue are easily grown through the holes 10 and the slits 201 or holes 205 of the body 20.

Furthermore, the bionic fixation device of the embodiment of the invention can be applied to the fixation of various different parts in a living body. For example, it can be applied to artificial roots, vertebral nails, artificial discs, intramedullary nails or simply as bone nails. Since the present invention can manufacture a biomimetic fixing device by a laminate manufacturing process, it can be simply applied to different parts of the living body, and has a corresponding structural design.

6A and 6B are schematic views showing the extraction device 5 of the embodiment of the present invention for pulling out a bionic fixing device. In this embodiment, the bionic fixing device is, for example, the bionic fixing device 1 shown in FIG. 1A, and includes a body 20. The body 20 has a consistent perforation 10, an internal thread 203, and an external thread 202. The inner thread 203 and the outer thread 202 are respectively disposed on the inner surface 208 and the outer surface 209 of the body 20, and the thread direction of the inner thread 203 is opposite to the thread direction of the outer thread 202.

The unplugging device 5 of the embodiment of the present invention includes a control portion 51 and a screwing portion 52. The screwing portion 52 is connected to the control portion 51, and the screwing portion 52 can be screwed into the through hole 10 by the internal thread 203 of the body 20 of the bionic fixing device 1, so that the bionic fixation device 1 can be pulled out from the living body.

In the embodiment, the unplugging device 5 further includes a fixing portion 53. Fixing portion 53 It is for prohibiting the position of the control portion 51 and the screwing portion 52 in the direction (D5) in which the bionic fixing device 1 is unscrewed. For example, when the screwing portion 52 is screwed into the through hole 10 by the internal thread 203 of the body 20 of the bionic fixing device 1, the fixing portion 53 fixes the position of the control portion 51 and the screwing portion 52, and causes the control portion 51 and the screwing portion. 52 does not produce a displacement in the direction in which the bionic fixture 1 is unscrewed. In contrast, the bionic fixing device 1 generates a displacement in the direction D5 as illustrated in the drawing because the screwing portion 52 is screwed into the through hole 10. In the present embodiment, the direction D5 is parallel to the displacement of the bionic fixation device 1 in the direction of the birth object, and the displacement of the bionic fixation device 1 along the direction D5, thereby rotating the bionic fixation device 1 from the living body.

7A and 7B are schematic views showing the extraction device 6 of the present invention in which a bionic fixing device is pulled out. In the present embodiment, the bionic fixing device is also, for example, the bionic fixing device 1 shown in Fig. 1A. In addition, the biomimetic fixing device 1 may also include an inner fixing structure 30 that is fixed to the bottom of the through hole 10.

The unplugging device 6 of the embodiment of the present invention includes a control portion 61 and a screwing portion 62. The screwing portion 62 is connected to the control portion 61, and the screwing portion 62 can be screwed into the through hole 10 by the internal thread 203 of the body 20 of the bionic fixing device 1, so that the bionic fixing device 1 is pulled out from the living body.

The difference from the extracting device 5 of Figs. 5A and 5B is that the extracting device 6 does not have a fixing portion 53. By the design that the thread direction of the inner thread 203 of the bionic fixing device 1 is opposite to the thread direction of the outer thread 202, when the screwing portion 62 of the pulling device 6 is screwed into the through hole 10, the bionic fixing device 1 is reversed. The direction is unscrewed.

For example, the extracting device 6 rotates the screwing portion 62 to the bottom of the through hole 10 by the internal thread 203 of the body 20 of the bionic fixing device 1, or rotates the screwing portion 62 to the bottom of the through hole 10 as shown in FIG. 7A. Contacting the inner fixing structure 30 to make the screwing portion 62 relative to the bionic fixing device 1 Cannot continue to generate displacement in one direction D6. Here, the direction D6 is parallel to the direction in which the biomimetic fixture 1 is implanted into the living body.

Next, the screwing portion 62 is continuously rotated. At this time, the screwing portion 62 drives the entire bionic fixation device 1 to rotate. At this time, since the thread direction of the outer thread 202 is opposite to the thread direction of the inner thread 203, the bionic fixation device 1 is rotated in the opposite direction to the original biomimetic fixation device 1 screwed into the living body, and The displacement of the direction D5 shown in Fig. 7B. In the present embodiment, the direction D5 is parallel to the direction in which the bionic fixation device 1 is pulled out of the living object, and the displacement generated by the bionic fixation device 1 along the direction D5, thereby pulling the bionic fixation device 1 out of the living body.

Therefore, when the biomimetic fixation device is implanted into the living body, if an adverse reaction is required to be taken out, the implant can be easily taken out by the extraction device of the above embodiment, and the destruction of the biological tissue is not easily caused.

Based on the above embodiments and descriptions, the present invention utilizes a laminate manufacturing process technology to form a specific structure on the surface or inside of a biomimetic fixture, such as a structure having slits and holes in the body of the biomimetic fixture, as compared to conventional bones such as bone. Fixed structure such as nails, which has a low modulus of elasticity, can prevent stress concentration and stress shielding, and can effectively avoid the occurrence of tissue depression, necrosis, wear, or fracture or breakage of the implant due to excessive stress. .

At the same time, the special screw structure of the embodiment of the invention can also effectively prevent the bionic fixation device from coming out along the original implantation path. Furthermore, when the biomimetic fixation device is implanted into the living body, if the adverse reaction needs to be taken out, the device for extracting the bionic fixation device of the present invention can easily take out the biomimetic fixation device from the living body.

Furthermore, various hole sizes, shapes and arrangements of the embodiments of the present invention The formula can also be easily completed in a layered manufacturing process. In contrast, the conventional method of performing special sintering or surface coating processes and then performing laser opening is not only complicated in process, but also has high manufacturing cost, and is not suitable for producing the structure of the embodiment of the present invention.

The laminate manufacturing (AM) also has the titles of Rapid Prototyping (RP), Rapid Manufacturing (RM) or 3D Printing. In 2009, the American Society for Testing and Materials (American Society for Testing and Materials) ASTM) is called the manufacturing of laminates. Researchers divide laminated manufacturing into seven types, as shown in Table 1, including: Vat Photopolymerization, Material Jetting, Binder Jetting, and material extrusion. Material Extrusion, Powder Bed Fusion, Sheet Lamination and Directed Energy Deposition.

The manufacturing feature of laminated manufacturing is to cut three-dimensional (3D) image files into two-dimensional (2D) sections, and then process them layer by layer according to two-dimensional sections and stack them into three-dimensional objects layer by layer. Compared with the traditional processing method, the multi-layer manufacturing process can avoid material waste, and is more suitable for high-complexity, customized and small-scale production applications.

In the manufacture of the biomimetic fixing device of each embodiment of the present invention, the three-dimensional digital model of the biomimetic fixing device is cut into a two-dimensional section having a thickness of 20 to 50 μm, and sealed in a low oxygen environment (O ₂ concentration is less than 10,000 ppm). In the construction zone, a powder material (metal, alloy, ceramic or polymer biomedical material) having a particle diameter of less than 25 μm is deposited through a feeding unit to a flat layer having a thickness of 20 to 50 μm.

Then, the laser beam (wavelength 1070 nm) is used to guide the focused beam (50-150 μm) through the scanning galvanometer to the area of the layer. The focused beam moves according to the required two-dimensional cross-section (moving speed is 500~1500mm/s), so that the powder material irradiated by the focused beam reaches the melting point of the material, and then stacked in a three-dimensional cross-sectional shape to form a three-dimensional bionic fixture. . Such a process can achieve complex topography, internal flow paths and internal structures that are difficult to fabricate in conventional processing methods.

In conclusion, the present invention has been disclosed in the above embodiments, but it is not intended to limit the present invention. A person skilled in the art can make various changes and modifications without departing from the spirit and scope of the invention. Therefore, the scope of the invention is defined by the scope of the appended claims.

1‧‧‧Bionic fixture

10‧‧‧through holes

11‧‧‧Bottom opening

12‧‧‧Top opening

20‧‧‧ body

201‧‧‧ slit

202‧‧‧ External thread

204‧‧‧Interval

206‧‧‧Flexible bottom

209‧‧‧ outer surface

A-A’, B-B’‧‧‧ hatching

X, Y, Z‧‧‧ coordinate axis

Claims (20)

A bionic fixture includes: a body having a continuous perforation and at least one slit; the through hole extending through a top surface to a bottom surface of the body to form a top opening and a bottom opening, the inner diameter of the top opening An inner diameter greater than the bottom opening; and the slit is in communication with the bottom opening, and the slit extends upwardly from the bottom surface of the body such that the body has a flexible bottom; wherein the body includes a screw The outer thread is disposed on the outer surface of the body, and the outer thread has a first oblique side and a second oblique side in a longitudinal section of the body, and the angle between the first oblique side and the main body is a first outer corner, the angle between the second oblique side and the body is a second outer angle, the first outer angle is less than 90 degrees, the second outer angle is greater than 90 degrees, and the first oblique side is located at the second oblique side Above. The biomimetic fixing device according to claim 1, wherein the bottom of the through hole has a tapered shape. The bionic fixation device of claim 1, wherein the external thread is discontinuous. The bionic fixation device of claim 3, wherein the external thread has at least one spacer in a lateral section of the body. The bionic fixture of claim 4, wherein the outer thread has a third oblique side and a fourth oblique side on opposite sides of the spacer, the third oblique side and the body The angle is a third outer angle, the angle between the fourth oblique side and the body is a fourth outer angle, and the third outer angle and the fourth outer angle are both greater than 0 degrees. And less than 90 degrees. The biomimetic fixing device according to claim 1, further comprising an inner fixing structure fixed to the flexible bottom. The bionic fixture of claim 6, wherein the flexible bottom portion is deformed and pushed outward when the inner fixing structure is fixed to the flexible bottom. The bionic fixation device of claim 1, wherein the body comprises an accommodating space for accommodating a soft tissue of a living body in the accommodating space and being fixed in the bionic fixing device. The bionic fixation device of claim 1, wherein the body comprises an internal thread, the internal thread being disposed on an inner surface of the body. The bionic fixing device according to claim 9, wherein the thread direction of the inner thread is the same as the thread direction of the outer thread. The bionic fixing device of claim 9, wherein the thread direction of the inner thread is opposite to the thread direction of the outer thread. The bionic fixture of claim 1, wherein the body comprises a plurality of holes extending from the outer surface of the body to the through hole. The biomimetic fixing device according to claim 12, wherein when the biomimetic fixing device is screwed into a living body, the hard tissue of the living body extends along the holes to the path of the through hole, and is concentrated into the through hole. Inside the hole. The bionic fixing device according to claim 12, wherein the The hole defines a first opening on the outer surface of the body, and a second opening is formed on the inner surface of the body, and the area of the first opening is larger than the area of the second opening. The bionic fixing device of claim 12, wherein the body has a first side wall and a second side wall respectively located on opposite sides of the hole, the second side wall facing the first side wall, and the first side a sidewall is formed by rotating a first angle along a direction of a line of the outer surface of the body, the second sidewall being rotated by a second angle along the tangential direction Forming, the first reference plane and the second reference plane are perpendicular to an outer surface of the body. The bionic fixture of claim 15, wherein the first angle and the second angle are both greater than 0 degrees and less than 90 degrees, and the first angle is greater than the second angle. The biomimetic fixing device according to claim 1, wherein the bionic fixing device is made of metal, alloy, ceramic or polymer biomedical material. An extracting device for extracting a biomimetic fixing device from a living body, the bionic fixing device comprising: a body having a consistent perforation; and an internal thread and an external thread disposed in the body And an outer surface, wherein the outer thread has a first oblique side and a second oblique side in a longitudinal section of the body, the angle between the first oblique side and the body is a first outer angle, and the second oblique The angle between the edge and the body is a second outer angle, the first outer angle is less than 90 degrees, the second outer angle is greater than 90 degrees, and the first oblique side is located above the second oblique side; The pulling device includes: a control portion; and a screwing portion connected to the control portion, wherein the screwing portion is screwed into the through hole by the inner screw, and the bionic fixing device is rotated opposite to the screwing portion The inflow direction is unscrewed from the organism. The extracting device according to claim 18, further comprising: a fixing portion for prohibiting displacement of the control portion and the screwing portion in a direction of screwing out the bionic fixing device. The extraction device of claim 18, wherein the thread direction of the inner thread is opposite to the thread direction of the outer thread.