WO2020138788A9

WO2020138788A9 - Implant having multi-porous structure and method for manufacturing same

Info

Publication number: WO2020138788A9
Application number: PCT/KR2019/017695
Authority: WO
Inventors: 임도형; 서한솔; 곽태양; 반훈영
Original assignee: 세종대학교산학협력단
Priority date: 2018-12-28
Filing date: 2019-12-13
Publication date: 2020-12-03
Also published as: KR102276963B1; WO2020138788A3; WO2020138788A2; KR20200083730A

Abstract

The present invention relates to an implant having a multi-porous structure and a method for manufacturing same and, more particularly, to an implant having a multi-porous structure and a method for manufacturing same, wherein a bone growth part having different porosities according to portions thereof is configured on a bone contact surface of the implant, so as to promote a patient's autogenic bone ingrowth even without a bone cement and thus secure a fixation force between the implant and a bone and so as to prevent weakening of the mechanical strength due to a sudden porosity change at a boundary surface between the implant and the bone growth part.

Description

Implant with multiple porous structure and its manufacturing method

The present invention relates to an implant having a multi-porous structure and a method of manufacturing the same, and more particularly, by constructing a bone growth portion having a different porosity for each portion on the bone contact surface of the implant, the patient's spontaneous intraosseous growth without bone cement The present invention relates to an implant having a multi-porous structure and a method of manufacturing the same, which secures the fixation force between the implant and the bone by facilitation, and prevents the problem of weakening the mechanical strength due to a sudden change in porosity on the interface between the implant and bone growth.

The implant inserted into the patient's body generates a predetermined bonding force by applying bone cement on the bone junction surface of the implant that comes into contact with the bone to solidify the implant for bonding with the patient's bone.

However, this method of fixing an implant using bone cement has caused several problems such as cement fracture, aseptic loosening, and excessive osteolysis around the cement. Recently, these problems of cement-type implants In order to solve this problem, interest in cementless implants that do not use bone cement is increasing.

The cementless implant constitutes a porous layer in which a plurality of voids are formed on a bone junction surface in contact with the bone of the implant, so that the patient's spontaneous bone growth is promoted in the porous layer.

1 is a view showing a conventional cementless implant, which is disclosed in US 2010-0100191A1 (2010.04.22). Referring to FIG. 1, the cementless implant 90 forms a bone growth part 93 of a porous structure on the bone junction surface of the body part 91 of a solid structure, It has an effect of promoting bone growth into the void.

However, this prior art has a limitation in not properly reflecting the patient's anatomical characteristics. The patient's bone is largely divided into a cortical bone and a trabecular bone. The outer side of the bone is formed by the cortical bone, and the inner side of the bone is composed of the cancellous bone. In other words, although the patient's bone has a difference in porosity according to its location, the conventional cementless implant 90 implants only with a certain porosity without reflecting the difference in porosity by location of the patient's bone. The bone contact surface of was constructed.

Therefore, when the conventional cementless implant 90 as shown in FIG. 1 is implanted into a patient, a problem arises in that a strong fixation force is not expressed between the bone contact surface of the implant and the patient's bone. It caused a problem that the implant was separated from

In addition, the conventional cementless implant 90 has a problem of weakening mechanical strength due to a difference in high porosity between the body portion 91 formed in a solid structure and the bone growth portion 93 formed in a porous structure. This is because the body portion 91 is formed in a solid structure and has relatively high rigidity, while the bone growth portion 93 is formed in a porous structure and has relatively weak rigidity.

Due to the large difference in porosity on the interface, the bone growth part 93 was easily damaged, and in this process, the porous particles separated from the bone growth part 93 penetrate into blood vessels, tissues, etc., causing an inflammatory reaction. It also caused problems.

Therefore, the related industry develops a new type of cementless implant that can properly reflect the anatomical patient's bone characteristics so that a strong fixation between the implant and bone can be secured, and complement the structural stability of the implant. The situation is demanding.

The present invention was devised to solve the above problems,

It is an object of the present invention to construct a bone growth portion having a different porosity for each portion on the bone contact surface of an implant, and anatomically divided into a cortical bone and a trabecular bone to show a different porosity depending on the location of the patient. It is to provide an implant having a multiporous structure in which bone characteristics are reflected in the bone growth part of the implant.

Another object of the present invention is to configure a bone growth unit that reflects different bone characteristics for each patient, and promote the patient's spontaneous intraosseous growth without the use of cement, so that a strong fixation force between the implant and the patient's bone can be secured. It is to provide an implant having a multi-porous structure.

Another object of the present invention is to configure a bone contact portion, which is a portion of the bone growth portion in contact with the bone, and to have a porosity that is partially different depending on the porosity of the bone contacting the bone contact portion, It is to provide an implant having a multi-porous structure that mimics rigidity and promotes bone growth.

Another object of the present invention is to configure a bone contact portion that lowers the porosity toward the outside of the bone and increases the porosity toward the inner side of the bone. It is to provide an implant having a multi-porous structure reflecting as it is.

Another object of the present invention is to ensure that the bone contact portion has a certain porosity within the same longitudinal section area based on the longitudinal section boundary, and has a different porosity between different longitudinal section regions, so that patients divided according to the longitudinal section boundary It is to provide an implant having a multi-porous structure that calculates the porosity for each portion of the bone, and allows a certain portion of the bone contact portion contacting the corresponding section to have the calculated porosity.

Another object of the present invention is to ensure that the porosity of the innermost longitudinal segment region of the bone contact portion is 40 to 80%, and the porosity of the outermost longitudinal segment region is 30 to 50%, so that it is divided into cancellous bone and cortical bone. It is to provide an implant having a multi-porous structure reflecting the anatomical characteristics of a patient's bone having different porosities according to the present invention.

Another object of the present invention is to provide an implant having a multiporous structure closer to the anatomical bone structure characteristics of a patient by configuring a plurality of longitudinal segment boundaries to increase longitudinal segment regions having different porosities for each segment.

Another object of the present invention is to configure the body part contact part between the body part and the bone contact part, due to the high porosity difference between the body part of the solid structure and the bone contact part of the porous structure, the mechanical strength on the interface between the body part and the bone growth part The problem of weakening is to provide an implant having a multi-porous structure that complements the strength by configuring the body contact portion.

Another object of the present invention is to enhance the mechanical strength between the body part and the bone contact part by configuring the body part contact part to occupy 0 to 1/3 or 0 to 34% of the total height of the bone growth part, thereby improving the structural stability of the implant. It is to provide an implant having a multi-porous structure to secure.

Another object of the present invention is to provide an implant having a multiporous structure that prevents the possibility of destruction due to delamination on the interface between the body part and the bone growth part by configuring the porosity of the body part contact part to be 0 to 35%.

The present invention is implemented by an embodiment having the following configuration in order to achieve the above object.

According to an embodiment of the present invention, the present invention includes a body portion having a solid structure and a bone growth portion having a porous structure formed on a bone contact surface of the body portion, and the bone growth portion has a different porosity for each portion. To do.

According to another embodiment of the present invention, the bone growth part includes a bone contact part which is a part in contact with the bone, and the bone contact part has a different porosity for each part according to the porosity of the bone to be in contact with It characterized in that it increases.

According to another embodiment of the present invention, the bone contact portion is characterized in that the porosity increases toward the inner side of the bone, and the porosity decreases toward the outer side of the bone.

According to another embodiment of the present invention, the bone contact portion is divided based on a longitudinal section boundary, has a constant porosity in the same longitudinal section region, and has a different porosity between the longitudinal section regions. .

According to another embodiment of the present invention, the bone contact portion is characterized in that the porosity of the innermost longitudinal section region is 40 to 80%, and the porosity of the outermost longitudinal section region is 30 to 50%. .

According to another embodiment of the present invention, the present invention is characterized in that the longitudinal section boundary is composed of a plurality.

According to another embodiment of the present invention, the bone growth part includes a body part contact part which is a part in contact with the body part, and the body part contact part is formed between the body part and the bone contact part. It is characterized in that to enhance the mechanical strength on the interface between the body portion and the bone growth portion.

According to another embodiment of the present invention, the body part contact portion is formed to a point of 0 to 1/3 or 0 to 34% of the total height of the bone growth part based on the bone contact surface of the body part. It is characterized.

According to another embodiment of the present invention, the body portion contact portion is characterized in that it has a porosity of 0 to 35%.

According to another embodiment of the present invention, the present invention provides a patient data acquisition step of acquiring patient bone data, a section designation step of designating a section on the patient's bone data acquired after the patient data acquisition step, A bone extraction step of extracting a bone shape of a designated section after the section designation step, a bone modeling step of modeling the bone shape extracted after the bone extraction step, and a bone having a different porosity for each part after the bone modeling step And a printing step of outputting the bone growth part on the bone contact surface of the body part after the bone growth part formation step of forming the growth part and the bone growth part formation step.

According to another embodiment of the present invention, the section designation step includes a resection line designation step of designating a bone resection line on the patient's bone data, and the patient's bone data after the resection line designation step. And a section region designating step of designating a section region along the section boundary, and a bone growth section height designating step of designating a height of the bone growth section after the resection line designating step.

According to another embodiment of the present invention, in the bone growth part forming step, the bone contact part forming step of forming a bone contact part which is a part in contact with the bone, and the body part after the bone contact part forming step It characterized in that it comprises a body part contact part forming step of forming a body part contact part which is a contact part.

The present invention can obtain the following effects by the configuration, combination, and use relationship that will be described below with the present embodiment.

The present invention comprises a bone growth portion having a different porosity for each portion on the bone contact surface of the implant, and is anatomically divided into cortical bone and trabecular bone, and the bone characteristics of a patient showing different porosity depending on the location It has the effect of providing an implant having a multiporous structure reflecting the bone growth part of the implant.

The present invention constitutes a bone growth unit reflecting different bone characteristics for each patient, and promotes the patient's spontaneous intraosseous growth without the use of cement, so that a strong fixation force can be secured between the implant and the patient's bone, It derives the effect of providing an implant with multiple porous structures.

In the present invention, by configuring a bone contact portion, which is a portion in contact with the bone on the bone growth portion, and having a porosity partially different according to the porosity of the bone contacting the bone contact portion, the porosity and rigidity of the patient bone There is an effect of providing an implant having a multi-porous structure that promotes bone growth.

The present invention constitutes a bone contact portion in which the porosity is lowered toward the outer side of the bone and the porosity increases toward the inner side of the bone. It has the effect of providing an implant having a porous structure.

In the present invention, the bone contact portion has a certain porosity within the same longitudinal section area based on the longitudinal section boundary, and has a different porosity between different longitudinal section regions, so that each part of the patient's bone divided according to the longitudinal section boundary The porosity is calculated, and an effect of providing an implant having a multiporous structure in which a certain portion of the bone contact portion contacting the corresponding section has the calculated porosity is derived.

In the present invention, the porosity of the innermost longitudinal segment region of the bone contact portion is 40 to 80%, and the porosity of the outermost longitudinal segment region is 30 to 50%, so that it is divided into cancellous bone and cortical bone, and differs according to the position. There is an effect of providing an implant having a multi-porous structure reflecting the anatomical characteristics of the patient's bone.

The present invention has an effect of providing an implant having a multiporous structure closer to the anatomical bone structure characteristics of a patient by configuring a plurality of longitudinal segment boundaries to increase longitudinal segment regions having different porosities for each segment.

The present invention is a problem in that mechanical strength on the interface between the body part and the bone growth part is weakened due to a high porosity difference between the body part of the solid structure and the bone contact part of the porous structure by configuring the body part contact part between the body part and the bone contact part. The effect of providing an implant having a multiporous structure that complements the strength by configuring the body contact portion is derived.

In the present invention, the body part contact part is configured to occupy 0 to 1/3 or 0 to 34% of the total height of the bone growth part, thereby reinforcing the mechanical strength between the body part and the bone contact part to secure structural stability of the implant. There is an effect of providing an implant having a structure.

The present invention has the effect of providing an implant having a multiporous structure that prevents the possibility of destruction due to peeling on the interface between the body portion and the bone growth portion by configuring the porosity of the body portion contact portion to be 0 to 35%.

1 is a view showing a conventional cementless implant.

Figure 2 is a view showing an implant having a multi-porous structure according to an embodiment of the present invention.

3 is a view showing a bone contact surface of the body portion.

Figure 4 is a view of the tibia cross section of the patient taken by CT.

5 is a cross-sectional view taken along line A-A' of FIG. 2.

6 is a graph showing the value of the flexural strength according to the porosity of the body part junction.

7 is a view showing a method of manufacturing an implant having a multi-porous structure according to an embodiment of the present invention.

8 is a diagram showing the designation of a section on the bone data of the patient.

9 is a diagram illustrating extraction of a valley in section region 1;

10 is a diagram illustrating extraction of a valley in section area 2;

11 is a diagram illustrating modeling the extracted bone of FIG. 9.

12 is a diagram illustrating modeling the extracted bone of FIG. 10.

13 is a view showing the bone contact portion of the section region 1;

14 is a view showing a bone contact portion of section area 2;

15 is a view showing a body contact portion.

Figure 16 is a state of use of the present invention.

Since the outer side should not be excised more than 10mm, when proximal tibia cutting to insert the base plate, 1.0~2.0mm from the Tibia Plateau to the medial of the proximal tibia Below, select the trabecualr bone structure 7.0~9.9mm below the surgical part (Lateral) as the center. As described above, the body part contact part 33 is up to a point of 0 to 1/3 or 0 to 34% of the total height of the bone growth part 30 based on the bone contact surface 11 of the body part 10. It is formed, through the bone growth part height specifying step (S25), the height of the bone growth part 30, the bone contact part 31 and the body part contact part 33 constituting the bone growth part 30 ) Can be set.

The bone extraction step (S30) refers to a step of extracting a bone shape of a designated section after the section designating step (S20). Since the goals are extracted for each section, the number of extracted goal shapes may vary according to the number of divided sections. FIG. 9 shows the extraction of the valley of the section area 1 (P1), and FIG. 10 shows the extraction of the valley of the section area 2 (P2).

The bone modeling step (S40) refers to a step of modeling the extracted bone shape after the bone extraction step (S30). The extracted bone shape has a complex anatomical shape, and the original shape may be distorted and expressed when the patient's bone is scanned through the medical imaging equipment. In the bone modeling step (S40), the thickness ( Thickness), etc., to simplify complex anatomical shapes or to correct distorted parts. FIG. 11 is a view showing the modeling of the extracted bone of FIG. 9 (P'1), and FIG. 12 is a view showing the modeling of the extracted bone of FIG. 10 (P'2). Through the modeling step S40, the bone shape extracted in FIGS. 9 and 11 may be modeled as shown in FIGS. 11 and 12.

The bone growth part forming step (S50) refers to a step of forming the bone growth part 30 having a different porosity for each part after the bone modeling step (S40). As described above, the bone growth part 30 is composed of a bone contact part 31 which is a part in contact with a bone, and a body part contact part 33 which is a part that contacts the body part 10. The bone growth The shaping step (S50) includes a bone contact part forming step (S51) and a body part contact part forming step (S53).

The bone contact part forming step (S51) is a step of forming a bone contact part 31 having a different porosity for each part while in direct contact with the bone, and the bone modeling step (S40) as shown in FIGS. 11 and 12 By calculating the porosity based on the bone shape modeled in Fig. 13 and 14, the bone contact portion 31 as shown in Figs. 13 and 14 is formed having a porosity complementary thereto. The porosity increases toward the inner side of the bone, and the porosity decreases toward the outer side of the bone. As compared to FIG. 14, the porosity of FIG. 13 located inside the bone may be larger than the porosity of FIG. 14.

The body part contact part forming step (S53) refers to a step of forming the body part contact part 33 which is a part that directly contacts the body part 10 after the bone contact part forming step (S51). The body part contact part 33 is interposed between the bone contact surface 11 of the body part 10 having a solid structure and the bone contact part 31 of the bone growth part 30 having a porous structure, so that a large difference in porosity By alleviating the problem, the mechanical strength on the interface is weakened. 15 is a view showing the body part contact part 33, preferably the body part contact part 33 may have a porosity of 0 to 35%, and the bone contact surface 11 of the body part 10 ) May be formed up to 0 to 1/3 or 0 to 34% of the total height of the bone growth part 10.

The printing step (S60) refers to a step of outputting the bone growth part 30 on the bone contact surface 11 of the body part 10 after the bone growth part formation step (S50). The output method is not limited to a specific concept, but preferably, the bone growth unit 30 may be output on the body unit 10 by a 3D printer.

FIG. 16 is a state diagram of use of the present invention, and referring to FIG. 16, the implant 1 having a multiporous structure according to the present invention has bone growth on the bone contact surface 11 of the body 10 having a solid structure. By forming the part 30, it is possible to secure a fixation force between the implant and the bone through the patient's spontaneous bone growth through the bone growth part 30 without using bone cement. The bone growth part 30 reflects the anatomical characteristics of the patient whose porosity decreases as the bone contact part 31 that is in contact with the bone goes to the outside of the bone and increases the porosity toward the inside of the bone. It is configured to have a bar, it is possible to further promote the bone growth of the patient. In addition, as the body part contact part 33 is formed between the bone contact surface 11 of the body part 10 and the bone contact part 31 to mitigate the sudden change in porosity, mechanical properties due to the sudden change in porosity on the interface It can prevent the phenomenon of decrease in strength.

The detailed description above is illustrative of the present invention. In addition, the above description shows and describes preferred embodiments of the present invention, and the present invention can be used in various other combinations, modifications and environments. That is, changes or modifications may be made within the scope of the concept of the invention disclosed in the present specification, the scope equivalent to the disclosed contents, and/or the skill or knowledge of the art. The above-described embodiments describe the best state for implementing the technical idea of the present invention, and various changes required in the specific application fields and uses of the present invention are possible. Therefore, the detailed description of the invention is not intended to limit the invention to the disclosed embodiment. In addition, the appended claims should be construed as including other embodiments.

Claims

The body of the solid structure,

It includes a bone growth portion of a porous structure formed on the bone contact surface of the body portion,

The bone growth unit, characterized in that having a different porosity for each portion, the implant having a multi-porous structure.
The method of claim 1,

The bone growth portion includes a bone contact portion that is a portion in contact with the bone,

The bone contact portion, the implant having a multi-porous structure, characterized in that to increase the bone growth by having a different porosity for each portion according to the porosity of the contact bone.
The method of claim 2,

The bone contact portion, an implant having a multi-porous structure, characterized in that the porosity increases toward the inner side of the bone and the porosity decreases toward the outer side of the bone.
The method of claim 3,

The bone contact portion is divided based on a longitudinal section boundary, and has a constant porosity in the same longitudinal section region, and has a different porosity between the longitudinal section regions, the implant having a multi-porous structure.
The method of claim 4,

The bone contact portion, an implant having a multi-porous structure, characterized in that the porosity of the innermost longitudinal segment region is 40 to 80%, and the porosity of the outermost longitudinal segment region is 30 to 50%.
The method of claim 5,

The longitudinal section boundary, characterized in that consisting of a plurality of, implant having a multi-porous structure.
The method of claim 2,

The bone growth part includes a body part contact part which is a part in contact with the body part,

The body part contact part is formed between the body part and the bone contact part to enhance mechanical strength on an interface between the body part and the bone growth part, wherein the implant has a multi-porous structure.
The method of claim 7,

An implant having a multi-porous structure, characterized in that the body part contact part is formed to a point of 0 to 1/3 or 0 to 34% of the total height of the bone growth part based on the bone contact surface of the body part.
The method of claim 8,

An implant having a multi-porous structure, characterized in that the body contact portion has a porosity of 0 to 35%.
The patient data acquisition step of acquiring the patient's bone data,

A section designation step of designating a section on the patient's bone data acquired after the patient data acquisition step,

A bone extraction step of extracting a bone shape of a designated section after the section designating step,

A bone modeling step of modeling the bone shape extracted after the bone extraction step,

After the bone modeling step, a bone growth region forming step of forming a bone growth region having a different porosity for each part,

And a printing step of outputting the bone growth part on the bone contact surface of the body part after the bone growth part formation step.
The method of claim 10,

The section designation step includes a resection line designation step of designating a bone resection line on the patient's bone data, and a section region designation step of designating a section region along a section boundary on the patient's bone data after the resection line designation step. And, after the resection line designating step, a bone growth part height designating step of designating a height of the bone growth part.
The method of claim 10,

In the bone growth part forming step, a bone contact part forming step of forming a bone contact part which is a part in contact with a bone, and a body part contact part forming a body part contact part which is a part contacting the body part after the bone contact part forming step A method of manufacturing an implant having a multi-porous structure, characterized in that it comprises a step.
The method of claim 12,

The bone contact portion, characterized in that to increase the intraosseous growth by having a different porosity for each portion according to the porosity of the contacting bone, the implant manufacturing method having a multi-porous structure.
The method of claim 13,

The bone contact portion, characterized in that the porosity increases toward the inner side of the bone, and the porosity decreases toward the outer side of the bone, the method of manufacturing an implant having a multi-porous structure.
The method of claim 14,

The bone contact portion is divided based on a longitudinal section boundary, has a constant porosity in the same longitudinal section region, and has a different porosity between the longitudinal section regions, wherein the implant manufacturing method having a multiporous structure.
The method of claim 15,

The bone contact portion, characterized in that the porosity of the innermost longitudinal section region is 40 to 80%, and the porosity of the outermost longitudinal section region is 30 to 50%, The implant manufacturing method having a multi-porous structure.
The method of claim 16,

The longitudinal section boundary, characterized in that consisting of a plurality of, implant manufacturing method having a multi-porous structure.
The method of claim 12,

The body part contact part is formed between the body part and the bone contact part to enhance mechanical strength on an interface between the body part and the bone growth part.
The method of claim 18,

The body part contact part, characterized in that formed up to a point of 0 to 1/3 or 0 to 34% of the total height of the bone growth part based on the bone contact surface of the body part.
The method of claim 19,

The body contact portion, characterized in that having a porosity of 0 to 35%, implant manufacturing method having a multi-porous structure.