WO2021071235A1

WO2021071235A1 - Implant for amputated bone having mesh flange for directly connecting prosthesis to skeleton

Info

Publication number: WO2021071235A1
Application number: PCT/KR2020/013640
Authority: WO
Inventors: 강현귀
Original assignee: 국립암센터
Priority date: 2019-10-11
Filing date: 2020-10-07
Publication date: 2021-04-15
Also published as: KR20210043329A; KR102287458B1

Abstract

The present invention relates to an implant for an amputated bone having a mesh flange for directly connecting a prosthesis to the skeleton of an amputee, the amputated bone implant comprising: a stem inserted into the bone marrow of an amputated bone; a mesh flange coupled to the stem and surrounding an end of the amputated bone, the mesh flange being at least partially formed of mesh; and an abutment coupled to the stem and the mesh flange and allowing connection of an external limb orthosis.

Description

Intersection bone implant with mesh flange to connect the prosthesis directly to the skeleton

The present invention relates to an implant that is inserted into a cut bone in order to mount a prosthesis directly on a brace of a bone in a limb amputation patient.

The implant surgery, which started in the dental field, involves inserting a metal brace directly into the bone where the tooth is missing, and then attaching a tooth model. Similarly, attempts to directly connect the prosthetic limbs to the bones in patients with upper and lower limb amputations are continuing, and accordingly, bone insertion type amputation implants are being developed. This not only replaces the socket-type prosthetic limb, which has many complications and is difficult to overcome functional obstacles, but is the basis for installing a future-type electronic prosthetic limb. The cut bone implant consists of a fixture that is inserted into the patient's bone and an abutment that connects the prosthetic limb.

Methods and designs for making fixtures inserted in the bone marrow into well osteointegration have been reported in various artificial joint surgery areas for decades. Among the complications of amputation implants previously invented and reported in the literature, bone-related contents include osteolytic loosening in the bone marrow into which the fixture is inserted, osteolysis at the entrance to the fixture, fracture and metal breakage. . In the existing literature, complications related to soft tissues include infection at the abutment insertion site, and skin and soft tissue necrosis defects. Existing amputated implants did not have a reinforcing structure to prevent osteolysis at the entrance to the bone where the fixture enters, and there was no implant structure to increase the bonding strength of the muscle skin to prevent infection by adhering the implant to the surrounding soft tissue.

Accordingly, an object of the present invention is to provide an implant for an amputated patient capable of minimizing complications by enhancing adhesion of skin and muscles to an amputated bone implant for prosthesis and enabling bone transplantation.

An object of the present invention is to provide a cut bone implant having a mesh flange to directly connect a prosthesis to a skeleton in a cut patient, comprising: a stem inserted into the bone marrow of the cut bone; A mesh flange coupled to the stem, surrounding an end of the cut bone, and at least partially formed of a mesh; And an abutment coupled with the stem and the mesh flange and connectable to the external limb orthosis.

The mesh flange may form an upper receiving space surrounding the stem, and an end of the cut bone may be located within the upper receiving space.

The mesh flange has a narrower width toward the bottom, and a surface of the mesh flange adjacent to the abutment may have a denser mesh than a surface of the mesh flange farther from the abutment.

The mesh flange may have a drainage pipe groove that extends over the outer surface of the mesh flange and the inside of the mesh flange and into which an external drainage pipe can be inserted.

It is located in the upper receiving space of the mesh flange and may further include a space adjusting unit for changing the shape of the upper receiving space according to the shape of the cut bone.

The mesh flange and the space control unit may be integrally formed.

The space control unit may be provided so that the upper accommodation space has a customized shape of a cross section of the cut bone.

According to the present invention, it is possible to prevent infection by strengthening adhesion with the skin and muscles of the cut site, and to prevent osteolysis and fracture by reinforcing bone.

1 is a perspective view of an implant according to a first embodiment of the present invention,

2 is a cross-sectional view taken along II-II' of FIG. 1,

3 is an exploded perspective view of the implant according to the first embodiment of the present invention,

4A and 4B show a stem according to a first embodiment of the present invention,

5 shows a stem extender according to the first embodiment of the present invention,

6A and 6B show a flange according to a first embodiment of the present invention,

7A and 7B show an abutment according to the first embodiment of the present invention,

8 shows a coupling screw according to the first embodiment of the present invention,

9 shows a cap screw according to the first embodiment of the present invention,

10 shows a state in which the implant according to the first embodiment of the present invention is coupled to the femur,

11 shows an implant according to a second embodiment of the present invention,

12 is a cross-sectional view of a lower femur to which an implant according to a second embodiment of the present invention is applied.

Hereinafter, the present invention will be described in more detail with reference to the drawings.

The accompanying drawings are only an example illustrated to describe the technical idea of the present invention in more detail, so the spirit of the present invention is not limited to the accompanying drawings. In the accompanying drawings, the thickness or length of each part may be exaggerated for description.

In the following description, "upper part" refers to a direction toward the end of the part inserted into the bone, and "lower part" refers to the opposite direction. That is, as seen in FIG. 2, the side toward the end of the stem extender 20 is the upper direction, and the side toward the end of the abutment 40 is the lower direction.

The implant of the present invention will be described with reference to FIGS. 1 to 3.

1 is a perspective view of an implant according to a first embodiment of the present invention, FIG. 2 is a cross-sectional view taken along II-II' of FIG. 1, and FIG. 3 is an exploded perspective view of an implant according to a first embodiment of the present invention.

The implant 1 includes a stem 10, a stem extender 20, a mesh flange 30, an abutment 40, a coupling screw 50, and a cap screw 60.

The stem 10 is inserted into the patient's cut bone, and the stem extender 20 is coupled to the end. The stem extender 20 may be used by selecting from a plurality of pieces having different lengths.

The mesh flange 30 is coupled to the outside of the receptor 120 located outside the bone of the stem 10 to protect the cut bone and provide a space for supplying the bone implant. The mesh flange 30 is partially or entirely formed in a mesh shape.

As the abutment 40 is connected to the inside of the receptor 120 of the stem 10, it is fixed to the lower surface of the receptor 120 and the mesh flange 30, and exits the skin and is connected to the cutting will.

The coupling screw 50 fixes the mesh flange 30 while screwing the abutment 40 to the receptor 120 of the stem 10. The cap screw 60 is for fixing the coupling screw 50 and is screwed with the abutment 40.

Hereinafter, each configuration of the implant 1 will be described in detail with reference to FIGS. 4A to 9.

4A and 4B show a stem according to the first embodiment of the present invention, Fig. 5 shows a stem extender according to the first embodiment of the present invention, and Figs. 6A and 6B are the first embodiment of the present invention. It shows the mesh flange according to the embodiment, Figures 7a and 7b shows the abutment according to the first embodiment of the present invention, Figure 8 shows the coupling screw according to the first embodiment of the present invention, 9 shows a cap screw according to the first embodiment of the present invention.

The stem 10 includes a stem body 110 and a receptor 120. The stem body 110 is elongated to a site inserted into the bone marrow of the cut bone, and the receptor 120 is located in the stem body 110 in a downward direction.

A slot 111 is formed in an intermediate region of the stem body 110. The slot 111 is to provide stability against rotation of the stem in the bone marrow and increase the contact surface with the surrounding bone tissue. The surface of the stem body 110 may have a porous surface that promotes bonding with bone, and may be coated with a material that promotes bone formation.

A screw hole 112 and a coupling thread 113 are formed in the upper portion of the slot part 111. The stem extender 20 is coupled to the coupling thread 113, and the screw hole 112 is for inserting a screw to fix the stem 10 and the bone when necessary.

The receptor 120 has a diameter larger than that of the stem body 110 and has a shape in which a diameter of a portion in contact with a cut surface of a bone along a lower direction increases, and a portion to which a mesh flange is connected is tapered in diameter. An abutment coupling portion 123 and a coupling screw coupling portion 124 are provided inside the receptor 120.

A cut-out abutment coupling groove 121 is formed at the lower end of the receptor 120, and a stem protrusion 122 protruding long along the longitudinal direction is formed on the side surface.

The stem extender 20 includes an extender body 210 and a coupling screw groove 211. The coupling screw groove 211 is connected to the coupling thread 113 of the stem 10. The stem extender 20 is provided in various lengths and can be selected and used.

The mesh flange 30 includes a flange body 310. The flange body 310 has a cylindrical or hemispherical shape that becomes narrower toward the bottom. A skirt portion 315 is provided inside the flange body 310, and an upper receiving space 322 having a large diameter and a stem receiving space 323 having a small diameter are formed around the skirt portion 315.

There is a long stem receiving groove 313 inside the flange body 310.

A suture hole 314 is formed at the lower end of the flange body 310. A drain pipe groove 321 connected to the porous space of the mesh flange 310 is formed outside the flange body 310.

Flange body 310 is made of a mesh form forming a porous. The upper outer surface 311 located at the upper part is made of a sparse mesh, and the lower outer surface 312 is made of a finer mesh than the upper outer surface 311.

The mesh flange 30 is not limited thereto, but may be manufactured in various mesh surface shapes using 3D printing technology.

The abutment 40 is composed of a main body 410, a coupling part 420, and an extension part 430. An upper receiving space 451 is provided inside the coupling part 420, and a seating part 440, a lower receiving space 452 and a coupling screw 461 are provided inside the main body 410 and the expansion part 430. It is prepared.

An expansion support portion 411 having an increased diameter is provided at an upper end of the main body 410, and an abutment protrusion 421 is provided on the expansion support portion 411.

The coupling screw 50 and the cap screw 60 are for coupling and fixing the abutment 40 to the stem 10 and the mesh flange 30.

The coupling screw 50 includes an elongated body 510 and an extension part 520. A coupling screw 511 is formed at the upper end of the main body 510. The expansion part 520 extends from the lower end of the main body 510 and has a coupling hole 521 formed therein.

The cap screw 60 includes a body 610, and a coupling screw 611 and a coupling hole 612 are formed at a lower end of the body 610.

In each of the above-described configurations, the material of the mesh flange 30 may be a titanium alloy. More specifically, the material of the mesh flange 30 may be Ti6Al4V, but is not limited thereto. The mesh flange 30 may include a bioprinting sheet for promoting skin regeneration or a fiber binding promoting material in the mesh structure.

The surface of the stem 10 may be coated with a material that promotes bone union such as hydroxyapatite.

The abutment 50 may be a titanium alloy or a cobalt chromium alloy, but is not limited thereto.

Materials of different configurations can be appropriately selected and used by those skilled in the art.

Hereinafter, a method of using the implant 1 of the present invention and a combination and function of each component will be described with reference to FIG. 10. 10 shows a state in which the implant according to the first embodiment of the present invention is coupled to the femur in a patient with a femoral amputation.

The implant surgery method according to the present invention is as follows.

The implant surgery method includes the steps of inserting a stem into the cut bone of the patient; Coupling the mesh flange to the stem; Connecting the drain pipe to the drain pipe groove of the mesh flange; And discharging blood and body fluid to the outside by applying negative pressure to the drainage pipe.

Here, the step of filling at least one of a bone and bone substitute material between the upper receiving space of the mesh flange and the cut bone may be further included.

Here, before insertion of the stem, it may include exposing the end of the cut bone and grinding and reinforcing the bone marrow of the cut bone.

Hereinafter, the implant surgery method according to the present invention will be described in detail.

First, the skin at the end of the limb cut and the soft tissue of the muscle are incised to expose the end of the cut bone.

The end of the amputation bone is usually blocked by the bone marrow and is a bone atrophy. After detaching the soft tissue and periosteum from the end of the incisal bone, the atrophic bone is excised to form a parallel cross section at the healthy bone site.

The end of the cut bone grinds a part of the cortical bone to fit the shape at the boundary of the stem (10).

After reaming the bone marrow of the incisal bone and reaming (reaming, rasping), the thickness and length of the stem (10) in the bone marrow are measured and determined.

The stem extender 20 of a size suitable for the length of the stem 10 to be inserted into the bone marrow is coupled with a screw fastening method.

Thereafter, the stem 10 coupled with the stem extender 20 is inserted into the bone marrow of the cut bone by pressing it with a hammer.

Next, the mesh flange 30 is coupled to the stem 10. The coupling is made through the stem protrusion 122 of the stem 10 and the stem receiving groove 313 of the mesh flange 30, and the inclined form of the receptor 120 in which the stem 10 is exposed outside the valley is mesh flange ( It is combined in accordance with the stem receiving space 323 of 30).

The lower part is located in the stem receiving space 323 of the mesh flange 30. The upper part of the stem protrusion 122 and the lower part of the stem body 110 are located in the upper receiving space 322 of the mesh flange 30. With this structure, the outer surfaces of the lower end of the cut bone are wrapped with a space equal to the thickness of the skirt part 315 by the upper receiving space 322 of the mesh flange 30. The upper receiving space 322 provides a space for supplying bone grafts.

The coupling system so that the protrusion 122 is inserted into the stem receiving groove 313 of the mesh flange 30. Thereby, the mesh flange 30 and the stem 10 do not rotate with each other and the relative position is fixed. A bone or bone substitute material is filled between the upper receiving space 322 of the mesh flange 30 and the cut bone.

A drainage tube is inserted into the drainage tube groove 321 of the mesh flange 30, penetrates the surrounding muscles and skin, and is pulled out to the outside. Along with this, the skin suture is passed through the suture hole 314 of the mesh flange 30 in advance.

The mesh flange 30 is in a mesh shape except for the stem receiving space 323 to promote growth adhesion between muscle and skin. The upper outer surface 311 in contact with the muscle is provided with a relatively sparse mesh, and the lower outer surface 312 in contact with the skin is provided with a relatively dense mesh. The complex shape of the mesh flange 30 is manufactured using 3D printing technology.

Pull out the muscles and skin that have been peeled around, trimming the loose skin and muscles, and suturing the muscles and skin while giving tension.

Skin marking is performed by touching the abutment coupling portion 123 of the stem 10 to which the abutment 40 is coupled, and a hole is made by punching the skin in a circular shape smaller than the penetration diameter of the abutment 40.

Next, the abutment 40 is coupled to the stem 10. The coupling portion 420 of the abutment 40 is positioned on the abutment coupling portion 123, and the rest of the abutment 40 is positioned outside the stem 10.

The abutment protrusion 421 is inserted into the abutment coupling groove 121 of the coupling system 10. This prevents the abutment 40 from rotating.

The expansion support 411 of the abutment 40 comes into contact with the lower end of the stem 10 and the lower end of the mesh flange 30.

Next, the mesh flange 30 and the abutment 40 are fixed to the stem 10 using the coupling screw 50. The coupling hole 521 is rotated using a wrench or the like, and the upper end of the extended portion 520 of the coupling screw 50 contacts the seating portion 440 of the abutment 40. The body 510 of the coupling screw 50 is located in the upper receiving space 451 of the abutment 40, and the coupling screw 511 is coupled with the coupling screw fastening portion 124 of the stem 10.

Next, the coupling screw 50 is stably fixed using the cap screw 60. The coupling hole 612 is rotated using a wrench or the like, and the cap screw 60 is located in the lower receiving space 452 of the abutment 40.

Afterwards, it is checked the stable fixation of the cut bone and the stem 10 and the abutment 40.

The skin in contact with the abutment 40 is sutured using a skin suture that has been previously penetrated through the mesh flange 30.

The drainage pipe that is connected to the drainage pipe groove 321 of the mesh flange 30 and exits the skin is fixed to the skin, and is connected to a negative suction bag or a drainage machine.

Drainage penetration exerts negative pressure by the force of a spring to discharge blood and body fluids from the surgical site. Drainage machines are commonly used in negative pressure wound management to expel blood and body fluids by applying negative pressure electromechanically and to promote wound healing.

When managing the wound on the surgical site after surgery, it promotes adhesion between the muscles around the mesh flange 30 and the skin through the internal negative pressure without external pressure.

Firm adhesion between the muscle at the cut site and the skin can reduce the rate of skin infection around the abutment 40 penetrating the skin and prevent the spread of inflammation.

Thereafter, when the stem 10 and/or the mesh flange 30 and the patient's bone are combined and the surrounding muscles and skin are stabilized, the prosthetic limb is connected to the main body 410 and the extension 430 of the abutment 40.

Hereinafter, an implant according to a second embodiment of the present invention will be described with reference to FIGS. 11 and 12.

In the second embodiment, the mesh flange 30 further includes a space adjustment unit 330. The space control unit 330 adjusts the shape of the upper receiving space 322 according to the cross-sectional shape of the cut bone. For example, in the case of targeting the lower femur having a triangular cross-section as shown in FIG. 12, the space adjustment unit 330 is provided in the form of a triangular pillar so that the upper receiving space 322 can insert the end of the cut bone as shown in FIG. It is prepared.

When the upper receiving space 322 is provided in the form of a triangular column to correspond to the shape of the lower femur, the side of the cut bone end is in close contact with the upper receiving space 322 so that the relative rotation of the cut bone and the mesh flange 30 is prevented and fixed. Is strengthened.

The space adjustment unit 330 may be provided integrally with the mesh flange 30 or may be provided separately. The space control unit 330 may also have a mesh shape, but is not limited thereto. Anatomically, the cut bone portion where the bone is located directly under the skin (eg, the anterior-medial side of the lower femur) can be customized in shape and shape so that the mesh flange 30 does not protrude from under the skin. That is, the mesh flange 30 and the space adjustment unit 330 may be provided in a patient-customized form using a 3D printer according to the surgical site or the condition of the cut bone.

The above-described embodiments are examples for explaining the present invention, and the present invention is not limited thereto. Since those of ordinary skill in the art to which the present invention pertains will be able to implement the present invention by various modifications therefrom, the technical protection scope of the present invention should be determined by the appended claims.

Claims

In the amputation bone implant having a mesh flange to directly connect the prosthesis to the skeleton in the amputated patient,

A stem inserted into the bone marrow of the cut bone;

A mesh flange coupled to the stem, surrounding an end of the cut bone, and at least partially formed of a mesh; And

An implant comprising an abutment coupled to the stem and the mesh flange and capable of connecting an external limb orthosis.
The method of claim 1,

The mesh flange forms an upper receiving space surrounding the stem, and an end of the cut bone is located within the upper receiving space.
The method of claim 2,

The mesh flange,

The width gets narrower toward the bottom,

An implant in which a surface of the mesh flange adjacent to the abutment is provided with a denser mesh than a surface of the mesh flange far from the abutment.
The method of claim 3,

An implant in which a drain pipe groove is formed in the mesh flange, which spans the outer surface of the mesh flange and the inside of the mesh flange and into which an external drain pipe can be inserted.
The method of claim 4,

An implant further comprising a space adjusting unit located in the upper receiving space of the mesh flange and changing the shape of the upper receiving space according to the shape of the cut bone.
The method of claim 5,

An implant formed integrally with the mesh flange and the space control unit.
The method of claim 6,

The space control unit is an implant provided so that the upper receiving space has a customized shape of the cut bone cross section.