WO2023068798A1

WO2023068798A1 - Hybrid artificial scaffold for bone tissue reconstruction, having window that enables intramedullary injection

Info

Publication number: WO2023068798A1
Application number: PCT/KR2022/015940
Authority: WO
Inventors: 이종원; 문석호; 서태석; 이경돈; 진병주; 류연희
Original assignee: 가톨릭대학교 산학협력단; 고등기술연구원연구조합
Priority date: 2021-10-21
Filing date: 2022-10-19
Publication date: 2023-04-27
Also published as: KR20230056964A; KR102636800B1

Abstract

The present invention relates to a hybrid artificial scaffold for bone tissue reconstruction, having a window that enables intramedullary injection, the scaffold being lightweight and having sufficient durability enabling load endurance until tissue is reconstructed, and enabling intramedullary injection from the outside of the body so that stable autologous reconstruction can be induced, and thus effective treatment can be promoted. According to the present invention, provided is the hybrid artificial scaffold for bone tissue reconstruction, comprising: a cover frame member for connecting, at one end portion or both end portions thereof, bones having bone tissue to be reconstructed; and a bone tissue regeneration connection member which is provided below the cover frame member, and into which the bones having the bone tissue to be reconstructed are inserted from both end portions thereof.

Description

Hybrid prosthesis for bone tissue reconstruction equipped with a window capable of intraosseous injection

The present invention relates to a hybrid prosthesis for bone tissue reconstruction equipped with a window capable of intraosseous injection.

Existing bone transplantation has been performed by separating some bones from autologous human tissue and transplanting them to the defect or transplanting them using metallic materials.

In the existing methods, the external appearance is very different compared to the original shape.

In the case of using autologous bone, there is a difficulty in making secondary scars on the affected area and other normal body parts and cutting the bone before using it, and metallic materials cannot be used in large amounts due to their weight.

On the other hand, in recent years, interest in biomaterials for bone tissue regeneration has been focused, and in particular, scaffolds among biomaterial-related research and development include tissue engineering (i.e., after culturing cells identical to the damaged area in vitro) As one of the major issues of the study for the purpose of tissue regeneration, which is transplanted to the damaged area to exert its function, various research and development on biocompatible materials and manufacturing methods that can help cell deposition, proliferation, and differentiation are being actively conducted. It's going on.

Such an artificial scaffold can minimize the induction time of self-reproduction and rejection in vivo according to the requirement to be slowly decomposed and absorbed into the body while supporting the propagation of cells in the body over time after transplantation, and can minimize the in vivo biodegradation activity. Porous structures are being fabricated using various materials such as biopolymers with active metabolism, synthetic polymers, bioceramics, or metals.

In the 2000s, it was possible to manufacture customized scaffolds using 3D printing technology, so it was possible to manufacture and implant artificial scaffolds with the same shape as the patient's bones based on the results of self-CT to treat bone defects.

Currently, reconstruction methods of the mandible and the like include a method using a single material and a method using a fibula free flap.

Here, as a method of using a single material, there are largely two types of metal materials and methods of using biodegradable materials, respectively.

However, conventional methods have many problems. First, when only metal materials are used, there are bone abrasion and breakage of the junction, side effects of the bone marrow, and heavy heterogeneity.

Second, when only biodegradable materials are used, due to their characteristics, re-fracture, breakage, and joint parts become vulnerable.

Specifically, titanium material is one of the most widely used materials in relation to bone reconstruction in various surgical fields such as orthopedic surgery and plastic surgery, but titanium material frequently protrudes and protrudes after surgery.

This is a phenomenon that occurs when fusion with the surrounding tissue does not occur properly, and the reason is largely due to a mismatch in mechanical strength with the surrounding bone or soft tissue.

In particular, in the case of the mandible, it is essential to use titanium as a part where strong force is added due to masticatory activities. In this case, there is a difficulty in implant placement.

Therefore, the need for hybridization of two different materials by distinguishing between the part receiving force and the part where autologous bone is to be regenerated is emerging.

1 shows an example of a long bone of a patient requiring bone reconstruction. In the reconstruction of a long bone defect patient, a simple bone graft is impossible and fibrous bone must be used, and as a result, only very thin bones are used. There is a problem with remaining.

In addition, external thinning occurs, and Tibia bone cannot be donated for bone grafting, so the current reconstruction has no choice but to apply fibular bone even though its strength is weak.

Next, FIG. 2 shows an example of a skull of a patient requiring bone reconstruction due to a mandible defect 10 due to cancer, and bone regeneration for cosmetic and functional recovery is required.

Currently, mandibular reconstruction is performed using a fibula-free flap graft, but additional surgery is required (economical problems occur), lower extremity pain occurs when walking (complications occur in severe cases), and artificial mandibular flexion shape reconstruction has limitations. there is

Figure 3 shows an example of a structure using a biodegradable material used for conventional bone reconstruction, and the biodegradable single material 20 shown in Figure 3 has a risk of scaffold breakage during mastication ((weak strength), There is a problem that the joint portion is weak.

In addition, FIG. 4 shows an example of a structure using a metal material used for conventional bone reconstruction. The metal single material 30 causes bone wear at the junction, there is a risk of bone damage at the junction, and a heavy foreign body sensation occurs. occurs, and there is a problem that side effects appear in the bone marrow part.

Therefore, in order to solve these conventional problems, a method of providing an artificial scaffold for bone reconstruction can be applied.

Recently, artificial scaffolds for regeneration have been studied by applying artificial scaffolds made using biopolymers or by mixing powder types of ceramic materials (TCP, HA, etc.), and ceramic particles are used for bone tissue induction. It is known to increase the mechanical properties of scaffolds and act as an accelerator for the differentiation of imported cells into bone cells.

However, the development of highly functional scaffolds for bone tissue regeneration still has many shortcomings, and the need for more advanced methods is required.

Therefore, the present invention to solve the above conventional problems is lightweight, yet durable enough to withstand a load until tissue reconstruction, and can be injected outside the body into a bone to stably induce autologous tissue reconstruction. An object of the present invention is to provide a hybrid prosthesis for bone tissue reconstruction equipped with a window capable of intra-osseous injection, which can promote treatment.

The problems of the present invention are not limited to those mentioned above, and other problems not mentioned will be clearly understood by those skilled in the art from the description below.

According to one aspect of the present invention for achieving the objects and other features of the present invention, it comprises a cover frame member configured to connect between bones to be reconstructed bone tissue at one end or both ends. A hybrid artificial support for bone tissue reconstruction is provided.

According to another aspect of the present invention, a cover frame member configured to connect between bones to be reconstructed bone tissue at one end or both ends; and a bone tissue regeneration connecting member provided at a lower portion of the cover frame member and configured to insert a bone for bone tissue reconstruction at both ends.

In the present invention, the cover frame member, the cover body portion; at least one window portion formed in the cover body portion; and one or more fixing piece couplers through which a fixing piece for fixing the cover body to the bone passes.

In the present invention, the cover frame member is formed of a biocompatible metal material, the cover body part is formed in the form of a plate-shaped strap curved to one side, and the window part may be formed in a circular or polygonal hole.

In the present invention, the cover frame member may further include a pore portion formed at one or more locations of the cover body portion.

In another aspect of the present invention, the bone tissue regeneration connection member is formed of a biocompatible material for bone tissue reconstruction, and may be formed in a tubular body that accommodates or surrounds the bone at the end.

According to the hybrid prosthetic support for bone tissue reconstruction having a window capable of injection into a bone according to the present invention, the following effects are provided.

First, the present invention has the effect of minimizing the range of skin incision during surgery and increasing conformity and coupling.

Second, the present invention has the effect of securing product reliability by having a light weight by relatively reducing the length and thickness compared to existing artificial scaffolds, and having durability capable of enduring a sufficient load until tissue reconstruction.

Third, the present invention has the effect of increasing the area surrounding the bone and promoting more efficient treatment by having strength similar to the physical properties of the bone.

Fourth, the present invention can perform intraosseous access of bone induction promoters, cell therapy agents (ASC, MSC, BM), antibiotics, anticancer agents, etc. outside the body after surgery, thereby improving the efficiency of surgery and shortening the patient's recovery period. There is a shortening effect.

The effects of the present invention are not limited to those mentioned above, and other problems not mentioned will be clearly understood by those skilled in the art from the description below.

1 is a diagram showing an example of a long bone of a patient in need of bone reconstruction.

FIG. 2 is a view showing an example of a skull of a patient requiring bone reconstruction due to a mandibular bone defect 10 or the like caused by cancer.

3 is a view showing an example of a structure using a biodegradable material used for conventional bone reconstruction.

4 is a view showing an example of a structure using a metal material used for conventional bone reconstruction.

5 is a perspective view showing a hybrid artificial scaffold for bone tissue reconstruction equipped with a window capable of intra-bone injection according to the present invention.

6 is a plan view illustrating embodiments of a hybrid prosthetic support for bone tissue reconstruction equipped with a window enabling injection into a bone according to the present invention.

7 is a perspective view showing a state in which the hybrid artificial scaffold for bone tissue reconstruction having a window capable of intra-bone injection according to the present invention is placed on an ilium.

8 is a 3D image showing a state in which the hybrid prosthetic scaffold for bone tissue reconstruction having a window capable of injection into a bone according to the present invention is coupled to a bone.

9 is a photograph of a hybrid artificial support for bone tissue reconstruction according to the present invention.

10 is a view showing examples of intra-bone injection through the window of a hybrid prosthesis for bone tissue reconstruction having a window capable of intra-bone injection according to the present invention.

A hybrid prosthesis for bone tissue reconstruction equipped with a window capable of intraosseous injection according to a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.

8 is a 3D image showing a state in which a hybrid prosthetic scaffold for bone tissue reconstruction equipped with a window capable of injection into a bone according to the present invention is coupled to a bone.

As shown in Figs. ) Cover frame member 100 that withstands loads (stresses) until tissue reconstruction, including; It includes; and a bone tissue regeneration connection member 200 that induces self-tissue reconstruction.

Specifically, as shown in FIGS. 5 to 9, the hybrid prosthetic scaffold for bone tissue reconstruction equipped with a window capable of injection into the bone according to the present invention connects the bones to be reconstructed at one end or both ends. A cover frame member 100 configured to; and a bone tissue regeneration connection member 200 provided under the cover frame member 100 and configured to insert bones to reconstruct bone tissue at both ends.

The cover frame member 100 is formed of a metal frame member to provide a function of enduring a load (stress) until tissue reconstruction, and is a component that can be removed later, if necessary.

Specifically, the cover frame member 100 includes a cover body 110 covering one side of a bone to be reconstructed with bone tissue, and a passage through which intracorporeal injection of a prosthetic device is performed outside the body after surgery. At least one window portion 120 formed on the body portion 110, and at least one fixing piece coupling portion 130 to which a fixing piece for fixing the cover body portion 110 to the bone is fastened. do.

In addition, the cover frame member 100 may further include at least one of one or more pore portions 140 formed at one or more locations to reduce weight and protrusions 150 to secure bearing capacity.

The cover body 110 is formed of a known biocompatible metal material.

The cover body 110 can be customized through a 3D printing method in consideration of the shape or shape of a bone to be reconstructed.

That is, the cover body portion 110 has one end or both ends having a shape corresponding to a side covering a bone to be reconstructed.

For example, the cover body part 110 is formed in the form of a plate-shaped strap having a predetermined thickness (preferably, 0.8 mm to 2 mm) and length (preferably 55 mm), but has a curved or cross-sectional shape to one side. It may be formed in a rounded shape on one side.

The window portion 120 is formed as a hole having the highest strength and a shape suitable for stress in consideration of the target bone and bone region to be reconstructed.

For example, the window unit 120 is formed as a polygonal or circular hole including a square or hexagonal shape.

The window part 120 is preferably formed in the central part of the cover body part 110 .

The fixing piece coupling part 130 is a hole to which a fixing piece for fixing the cover body 110 to the bone is fastened.

Specifically, the fixing piece coupling part 130 is preferably formed on both sides of the cover body part 110 with the window part 120 as the center.

Here, the cover frame member 100 may further include pore portions 140 formed at a plurality of locations of the cover body portion 110 to reduce weight.

In addition, a protrusion 150 may be formed on one side of the cover body 110, for example, around the pore 140 to secure positioning in a surgical site.

Next, the bone tissue regeneration connecting member 200 is provided on the lower part of the cover frame member 100, is configured to insert a bone to rebuild bone tissue at the end, and is formed of a biocompatible material that induces self-tissue reconstruction. It is a component that becomes

Specifically, the bone tissue regeneration connection member 200 is provided below the cover frame member 100, and is formed in a tubular body that accommodates or surrounds the bone to be reconstructed bone tissue at both ends or one end.

In other words, the bone tissue regeneration connection member 200 is formed of a biocompatible material that induces bone tissue reconstruction and is configured to connect bones for bone tissue reconstruction.

Here, the bone tissue regeneration connection member 200 may be formed such that the inside communicates with the upper side of the cover body portion 110 through the window portion 120 .

Meanwhile, in the present invention, the hybrid artificial scaffold for bone tissue reconstruction is made capable of securing sufficient stress at the corresponding bone tissue reconstruction site during the thermal reconstruction period.

In other words, in the hybrid artificial scaffold for bone tissue reconstruction of the present invention, the cover frame member 100, the window portion 120 formed on the cover frame member 100, and the pore portion 140 satisfy the following specific design values. done to do

The allowable fatigue load of the material of the cover frame member 100 is Y, the expected maximum load (eg, weight, etc.) applied from the outside is F, the width of the cover frame member 100 is w, the thickness is t, and the window portion 120 When the diameter of is defined as D, it is made to satisfy the design value below.

D ≤ w - 3F/(Yt)

Here, when the cover frame member 100 further includes the pore portion 140 to reduce the weight, when the diameter of the pore portion 140 is d and the number of pore portions 140 is n, the following design made to satisfy the value.

D + nd ≤ w - 3F/(Yt)

The hybrid artificial scaffold for bone tissue reconstruction having a window capable of injection into the bone according to the present invention configured as described above connects the bone through the bone tissue regeneration connection member 200 and at the same time by the bone tissue regeneration connection member 200. In the connected state, the cover frame member 100 stably covers the bone at both ends, and enables load (stress) to be distributed during implantation of the prosthetic support.

And after surgery, as shown in FIG. 10, intraosseous access of bone induction promoters, cell therapy agents (ASC, MSC, BM), antibiotics, anticancer agents, etc. is performed outside the window of the cover frame member 100 ( 120) can be done.

As described above, according to the hybrid prosthetic scaffold for bone tissue reconstruction having a window capable of intraosseous injection according to the present invention, it is possible to minimize the range of skin incision during surgery, increase conformity and coupling, and relatively length and It is lightweight by reducing the thickness, and has the advantage of securing product reliability by having durability that can withstand sufficient load until tissue reconstruction.

In addition, according to the present invention, the area surrounding the bone is increased, and the strength similar to the physical properties of bone can be used to promote more efficient treatment. Since intraosseous access of anticancer drugs can be performed outside the body, the efficiency of surgery can be improved and the patient's recovery period can be shortened.

Claims

Characterized in that it comprises a cover frame member configured to connect between bones to be reconstructed bone tissue at one end or both ends

Hybrid prosthesis for bone tissue reconstruction.
a cover frame member configured to connect between bones to be reconstructed bone tissue at one or both ends; and

A bone tissue regeneration connecting member provided at the lower part of the cover frame member and configured to insert bones to rebuild bone tissue at both ends; characterized in that it comprises a

Hybrid prosthesis for bone tissue reconstruction.
According to claim 1 or 2,

The cover frame member,

a cover body;

at least one window portion formed in the cover body portion; and

Characterized in that it comprises a; at least one fixing piece coupling portion through which the fixing piece for fixing the cover body to the bone passes.

Hybrid prosthesis for bone tissue reconstruction.
According to claim 3,

The cover frame member is formed of a biocompatible metal material,

The cover body is formed in the form of a plate-shaped strap curved to one side,

Characterized in that the window portion is formed as a circular or polygonal hole

Hybrid prosthesis for bone tissue reconstruction.
According to claim 3,

The cover frame member,

Characterized in that it further comprises a pore portion (pore portion) formed in one or more locations of the cover body portion

Hybrid prosthesis for bone tissue reconstruction.
According to claim 2,

The bone tissue regeneration connection member,

Characterized in that it is formed of a biocompatible material for bone tissue reconstruction and is formed into a tubular body that accommodates or wraps the bone at the end.

Hybrid prosthesis for bone tissue reconstruction.