WO2022154424A1

WO2022154424A1 - Pelvic implant and method for manufacturing same

Info

Publication number: WO2022154424A1
Application number: PCT/KR2022/000435
Authority: WO
Inventors: 주민욱
Original assignee: 가톨릭대학교 산학협력단
Priority date: 2021-01-12
Filing date: 2022-01-11
Publication date: 2022-07-21
Also published as: KR20220102045A; KR102566535B1

Abstract

Disclosed are a pelvic implant and a method for manufacturing same. A pelvic implant according to the present invention comprises: a bone substitution part including a body disposed to substitute a bone loss portion of a pelvis; and a fixing part connected to the bone substitution part and fixed to a bone-remaining portion of the pelvis, wherein the fixing part includes a fixing plate connected to the bone substitution part and disposed in contact with the surface of the bone-remaining portion of the pelvis and a spike connected to the bone substitution part and inserted and settled in the bone-remaining portion of the pelvis.

Description

Pelvic implant and manufacturing method thereof

The present invention relates to a pelvic implant and a method for manufacturing the same, and more particularly, to a patient-specific pelvic implant that is fixed and replaces a bone defect of a patient's pelvis and a manufacturing method thereof.

The pelvis is a skeleton that forms the lower back of a person, protects internal organs and connects the spine and both legs. The pelvis is very important for human gait because it performs the function of transferring the weight coming down through the spine to the legs. The pelvis includes the ilium, ischium, and pubis that form the left and right girdle, and the sacrum portion that combines them, and has a funnel shape as a whole.

Bone defects in the pelvis can occur due to fractures caused by trauma such as traffic accidents, or bone tumors. In general, when a bone defect occurs in the pelvis, a substitute is inserted and fixed in the bone defect to maintain or restore the function of the pelvis.

Conventionally, autogenous bone or allogeneic bone has been considered as a substitute for insertion and fixation in the bone defect site. However, when autogenous bone is transplanted, the weak strength of the implant is pointed out as a problem, and in the case of allograft, it is not easy to obtain a bone suitable for the size of the patient's pelvis.

In order to overcome these shortcomings, a pelvic implant that can replace the bone defect of the pelvis is used. However, the conventional ready-made type of pelvic implant, which is manufactured without considering the size of the pelvis, the bone defect site, etc. different for each patient, has a disadvantage in that the functional reconstruction is incomplete.

Meanwhile, to solve this problem, a pelvic implant that is custom-made for a patient through 3D printing is also being introduced. However, the conventional pelvic implant manufactured through 3D printing method is generally in the form of simply fixing the bone substitute to the autogenous bone through a compression plate and screws (compression plate and screws). Accordingly, it is difficult to expect satisfactory initial fixation power or longevity.

(Patent Document 1) Korean Patent Publication No. 10-2016-0001316

The present invention is to solve the problems of the prior art described above, and an object of the present invention is to provide a pelvic implant that can be customized to a patient and has excellent initial fixation power and long-term durability, and a manufacturing method thereof.

According to an aspect of the present invention, a bone replacement unit comprising a body disposed to replace the bone defect portion of the pelvis; and a fixing unit connected to the bone replacement unit and fixed to the bone remnant portion of the pelvis, wherein the fixing unit is connected to the bone replacement unit and disposed in contact with the surface of the bone remnant portion of the pelvis and the bone frame There is provided a pelvic implant including a spike that is connected to the body and is inserted into and fixed to the inside of the bone remaining portion of the pelvis.

At this time, the body may be provided with a porous layer in the portion in contact with the bone residual portion.

In addition, the body may be provided with a processing unit abrasive processing or cutting processing in a portion disposed adjacent to the nerve.

In addition, the body may have an empty space therein.

In addition, the bone replacement unit may include a suture hole formed through the body so that a suture for coupling with the soft tissue is fastened.

In addition, the fixing plate may be formed to be bent in a form that can be in close contact with the surface of the bone residual region.

In addition, the fixing plate may have a screw hole through which a screw for coupling the fixing plate to the bone remaining portion is disposed.

In addition, the spike may be arranged to be inserted into the bone marrow cavity of the bone remaining site.

In addition, the spike may have a porous layer on the surface.

According to another aspect of the present invention, analyzing the patient's pelvic image and pelvic statics; designing a bone replacement part to be placed while replacing the bone defect part of the patient's pelvis; and designing a fixing part connected to the bone replacement part and fixed to the bone remaining part of the pelvis; a pelvic implant manufacturing method is provided.

In this case, the method for manufacturing the pelvic implant may further include 3D printing the bone replacement part and the fixing part.

In addition, in the pelvic implant manufacturing method, the fixing part is connected to the bone replacement part and is connected to a fixing plate disposed in contact with the surface of the bone residual part of the pelvis and the bone substitute part to the inside of the bone residual part of the pelvis. It may include a spike that is inserted and fixed.

In the pelvic implant and its manufacturing method according to the present invention, a bone replacement part disposed to replace a bone defect in the pelvis is connected to the bone replacement part and is connected to a fixed plate and a bone replacement part disposed in contact with the surface of the bone remaining part of the pelvis. It provides an effect of improving the initial fixation power and long-term sustainability of the pelvic implant by allowing it to be fixed by a fixing unit including a spike inserted and fixed inside the bone remnant portion of the pelvis.

The pelvic implant and its manufacturing method according to the present invention provide the effect of enabling customized pelvic implant surgery by allowing the bone replacement part to replace the bone defect portion of the pelvis to have a shape suitable for each patient.

1 is a perspective view of a pelvic implant according to an embodiment of the present invention.

Figure 2 is a perspective view showing the pelvic implant according to an embodiment of the present invention from another angle.

3 is a view showing a state in which the pelvic implant is operated according to an embodiment of the present invention.

4 is a perspective view of a modified example of a pelvic implant according to an embodiment of the present invention.

5 is a flowchart of a method for manufacturing a pelvic implant according to an embodiment of the present invention.

Hereinafter, with reference to the accompanying drawings, embodiments of the present invention will be described in detail so that those of ordinary skill in the art to which the present invention pertains can easily implement them. The present invention may be embodied in many different forms and is not limited to the embodiments described herein. In order to clearly explain the present invention, parts irrelevant to the description are omitted from the drawings, and the same reference numerals are assigned to the same or similar components throughout the specification.

In this specification, terms such as "comprises" or "have" are intended to describe the existence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, but one or more other features It is to be understood that it does not preclude the possibility of the presence or addition of numbers, steps, operations, components, parts, or combinations thereof.

In this specification, spatially relative terms "front", "rear", "upper" or "lower" may be used to describe a correlation with the components shown in the drawings. These are relative terms determined based on what is shown in the drawings, and the positional relationship may be conversely interpreted according to the orientation. In addition, when a component is "connected" with another component, it includes not only direct connection to each other but also indirect connection to each other unless otherwise specified.

1 is a perspective view of a pelvic implant according to an embodiment of the present invention. Figure 2 is a perspective view showing the pelvic implant according to an embodiment of the present invention from another angle. In addition, FIG. 3 is a view showing a state in which the pelvic implant is operated according to an embodiment of the present invention.

The pelvic implant according to an embodiment of the present invention replaces the bone defect portion of the patient's pelvis and is coupled to the bone residual portion of the patient's pelvis to maintain or restore the function of the patient's pelvis. In addition, the pelvic implant according to an embodiment of the present invention can be customized to the patient, and provides a structure that can be stably fixed to the bone remaining portion of the patient's pelvis.

The pelvic implant according to an embodiment of the present invention may be designed and manufactured to be customized to the patient in consideration of the patient's pelvic image, pelvic statics, and the like. More specifically, the pelvic implant may be manufactured in a different shape depending on the patient's pelvis and the bone defect region of the patient's pelvis through 3D printing.

1 to 3 , the pelvic implant according to an embodiment of the present invention may include a bone replacement unit 10 and a fixing unit 20 .

The bone replacement unit 10 is disposed to replace the bone defect portion of the pelvis. In one embodiment of the present invention, the bone replacement part 10 may include a body 11 and a suture hole 13 .

The body 11 is disposed to replace the bone defect portion of the pelvis. In other words, the body 11 is formed to replace the function of the bone defect region of the patient's pelvis. Referring to FIG. 3 , in one embodiment of the present invention, the pelvic implant replaces the bone defect portion of the patient's left pelvis, and is fixed to the iliac bone (B1) portion of the patient's left pelvis by the fixing unit 20 . .

The pelvic implant according to an embodiment of the present invention may be customized to a patient. Accordingly, the body 11 of the pelvic implant may have a shape suitable for the bone defect portion of the patient's pelvis, tailored to the patient.

In an embodiment of the present invention, customized to the patient does not mean that the shape of the body 11 of the pelvic implant reproduces the original shape of the bone defect portion of the patient's pelvis as it is. The pelvic implant is a foreign substance in the patient's body, and the larger the size of the pelvic implant, the higher the risk of infection during and after the procedure. In addition, after extensive resection of the tumor, the soft tissue defect is large, and the larger the pelvic implant is, the more difficult it may be to perform primary repair after surgery. In consideration of these matters, in one embodiment of the present invention, the body 11 is not made to reproduce the original shape of the bone defect portion of the patient's pelvis, and minimizes unnecessary parts in the restoration or maintenance of the pelvic function. It can be made smaller than the part to be replaced.

For example, the body 11 may be manufactured in consideration of biomechanics information of the lumbar spine, pelvic bone, and femur in order to minimize unnecessary parts. More specifically, in orthopedic reconstruction, it is important to maintain the function as a stable mean of load transfer between the axial skeleton (mainly the spine) of the sacroiliac joint and the lower extremities. The body 11 of (10) may be formed in a form that only an essential part of the bone defect region of the patient's pelvis is reconstructed as a means of stabilizing the load transfer and the rest is not reconstructed.

Referring to FIG. 3 , in one embodiment of the present invention, the pelvic implant reconstructs only the load transmission path (arrow direction) through the posterior arch portion, and does not reconstruct the support of the anterior arch, which is not essential for load transmission.

In addition, when inserting the pelvic implant into the human body according to an embodiment of the present invention, since the bone replacement unit 10 can give stimulation to nearby neurovascular structures, the body 11 of the bone replacement unit 10 is preferably a neurovascular structure. It is preferable to manufacture in consideration of the gap with the structures.

As best shown in FIG. 3 , in one embodiment of the present invention, the body 11 of the bone replacement part 10 is the iliac (B1), pubic (B2), and ischial (B3) bone defect regions of the left pelvis of the patient. Only part of it is being reconstructed. More specifically, the body 11 may have a shape to reconstruct only the bone defect portion corresponding to the portion forming the path essential for load transfer, including the acetabulum.

In one embodiment of the present invention, the body 11 may be provided with a porous layer 111 in the portion in contact with the bone residual region. The porous layer 111 provides a space for bone growth in the bone residual region. The porous layer 111 of the body 11 may be formed of a porous coating layer.

The porous layer 111 provides a space for the growth of bone in the bone remnant area, and as the bone in the bone remnant area grows into the porous layer 111, the bonding force between the bone remnant area and the body 11 is increased. can be Accordingly, the porous layer 111 may serve to increase the fastening force between the body 11 and the bone remaining portion.

In one embodiment of the present invention, the body 11 may be provided with a polishing (polishing) processing or machining processing unit 113 in a portion disposed adjacent to the nerve. As described above, when the pelvic implant is inserted into the human body, the bone replacement unit 10 may give stimulation to nearby neurovascular structures, and the processing unit 113 is for reducing or avoiding such stimulation.

For example, the processing unit 113 may be formed in a polished form in a portion adjacent to the sciatic nerve passing through the pelvis in the middle of the body 11 to minimize stimulation of the sciatic nerve. In addition, the processing unit 113 may be formed in the form of a cutting process in a portion adjacent to the sciatic nerve passing through the pelvis in the body 11 to prevent contact between the body 11 and the sciatic nerve.

In an embodiment of the present invention, stimulation avoidance may also be required for a portion that comes into contact with soft tissue, even if it is not a portion close to the nerve. Accordingly, the processing unit 113 may be formed in any other portion of the body 11 .

Meanwhile, the body 11 of the pelvic implant according to an embodiment of the present invention may further include an acetabular replacement part 115 to replace the original acetabulum when the bone defect portion of the patient's pelvis includes an acetabulum. The acetabular replacement part 115 connects the femur and the pelvis and reconstructs the acetabulum, which is important for load transfer.

The acetabular body part 115 has a groove shape into which the femoral ball head can be inserted. The acetabular body part 115 may have a mesh structure 115a on its inner surface. A polyliner is coupled to the inner surface of the acetabular replacement portion 115 of the pelvic implant, and cement may be used to fix the polyliner. At this time, when the mesh structure 115a is formed on the inner surface of the acetabular replacement part 115, the cement can be well fixed when the polyliner is fixed, so that the polyliner can be stably fixed.

The suture hole 13 is formed through the body 11 so that a suture for coupling with the soft tissue is fastened. In one embodiment of the present invention, a plurality of suture holes 13 may be formed in the edge portion of the body 11 . Also, the suture hole 13 may be formed around the acetabular portion 115 of the body 11 .

In order to achieve stable fixation and functional performance of the pelvic implant according to an embodiment of the present invention, it is important to combine the pelvic implant with the bone remnant of the patient's pelvis, but also to reconstruct the pelvic implant using soft tissue remaining after tumor resection. The suture hole 13 facilitates reconstruction using the soft tissue remaining after tumor resection by providing a passage through which the suture can pass.

The fixing unit 20 is connected to the bone replacement unit 10 and is fixed to the bone remaining portion of the pelvis. In one embodiment of the present invention, the fixing unit 20 has a dual structure to stably fix the bone replacement unit 10 to the bone remaining portion of the patient's pelvis. In more detail, the fixing part 20 may include a fixing plate 21 and a spike 23 .

The fixing plate 21 is connected to the bone replacement unit 10 and is disposed in contact with the surface of the bone remaining portion of the pelvis. In one embodiment of the present invention, the fixing plate 21 may be formed to be bent in a form that can be in close contact with the surface of the bone remaining. For example, the fixing plate 21 may be extended from the body 11 toward the bone remnant portion to cover or surround a portion of the bone remnant portion.

In addition, the fixing plate 21 may be provided with a screw hole 211 through which the screw (S) for coupling the fixing plate 21 to the bone remaining portion is disposed. In other words, by coupling the screw S to the screw hole 211 of the fixing plate 21 , the fixing plate 21 is fixed to the bone residual region, and thus the pelvic implant can be fixed.

The spike 23 is connected to the bone replacement unit 10 and is inserted and fixed in the bone remaining portion of the pelvis. In one embodiment of the present invention, the spike 23 may be arranged to be inserted into the intramedullary cavity of the bone remnant site. For efficient insertion into the intramedullary cavity, the spike 23 may be formed with a sharp outer end. More specifically, the spike 23 may be formed in a conical shape.

In addition, the spike 23 may have a porous layer 231 on the surface. The porous layer 231 provides a space for bone growth in the bone residual region. The porous layer 231 provided on the surface of the spike 23 may be formed of a porous coating layer. The porous layer 231 provides a space for bone growth in the bone residual region. When the bone of the residual bone region grows into the porous layer 231 , the bonding force between the spike 23 and the bone residual region increases, and accordingly, the fixation of the pelvic implant can be made more stably.

If, in one embodiment of the present invention, when the fixing part 20 includes only the fixing plate 21 , it is difficult to expect satisfactory initial fixing force or longevity. This is because there is a limit to reproducing the detailed structure of the locking plate when 3D printing technology is used to manufacture a patient-specific pelvic implant.

However, the fixing part 20 of the pelvic implant according to an embodiment of the present invention further includes a spike 23 inserted into the intramedullary cavity between the cortical holes in addition to the fixing plate 21 . As described above, the spike 23 compensates for the insufficient fixing force of the fixing plate 21 and increases the fixing strength of the pelvic implant.

On the other hand, when the fixing unit 20 includes only a single cone-shaped spike 23 inserted into the intramedullary cavity between the cortical bones, there is a risk of rotational instability in fixing the pelvic implant. However, in one embodiment of the present invention, the fixing unit 20 has a fixing plate 21 that is fixed to the surface of the bone residual region through a screw, so that rotational instability does not occur.

As described above, the fixing part 20 of the pelvic implant according to an embodiment of the present invention attaches the bone replacement part 10 to the bone remaining part of the patient's pelvis through a dual fixing structure including the fixing plate 21 and the spike 23 . fixed stably. Accordingly, the fixing unit 20 provides sufficient initial fixing force and long-term durability to the pelvic implant.

On the other hand, the screw (S) coupled to the screw hole (211) of the plate (21) reaches up to the spike (23) can be inserted or penetrated. If the screw (S) is disposed through the spike (23) as well as the plate (21), the stability will be further increased.

In one embodiment of the present invention, the pelvic implant may be made of a biocompatible material. For example, the pelvic implant may be made of a biocompatible metal. More specifically, the pelvic implant may be made of titanium.

In addition, the pelvic implant according to an embodiment of the present invention may be manufactured through a 3D printing method. When the 3D printing method is applied, it is possible to economically manufacture pelvic implants that are designed differently according to the shape of the pelvis of each patient and the bone defect area of the pelvis.

Referring to FIG. 4 , the body 11 of the bone replacement unit 10 may have an empty space 117 therein. In other words, in one embodiment of the present invention, the body 11 of the bone substitute 10 may be manufactured in a hollow form. As such, when the body 11 of the bone replacement unit 10 has a hollow structure, it is advantageous for the pelvic implant to implement elasticity and rigidity similar to that of human bones.

The pelvic implant according to an embodiment of the present invention preferably has elasticity and rigidity similar to that of the human body. In addition, it is necessary to minimize the infection rate during the procedure. In this regard, the body 11 of the pelvic implant may have a mesh structure or the like to implement elasticity and rigidity similar to that of the human body or to reduce the infection rate.

Hereinafter, a method for manufacturing a pelvic implant according to an embodiment of the present invention will be described.

The pelvic implant according to the embodiment of the present invention described above can be manufactured through the method for manufacturing a pelvic implant according to an embodiment of the present invention. Referring to FIG. 5 , in the method for manufacturing a pelvic implant according to an embodiment of the present invention, the step of analyzing the patient's pelvic image and pelvic statics (S10), the bone replacement part 10 to be disposed while replacing the bone defect part of the patient's pelvis ) designing step (S20), the step of designing the fixing part 20 connected to the bone replacement part 10 and fixed to the bone remaining portion of the pelvis (S30) and the bone replacement part 10 and the fixing part 20 3D printing may include (S40).

In the step (S10) of analyzing the pelvic image and pelvic statics, the pelvic image is used as data for determining the bone defect site and the bone residual site of the patient's pelvis. For example, the pelvic image may be an X-ray image, a CT image, or an MRI image of a patient's pelvis.

As described above, in orthopedic reconstruction, it is important to maintain the function as a means of stabilizing the load transmission between the axial skeleton (mainly the spine) of the sacroiliac joint and the lower extremities. Looking in a little more detail, considering the load transfer function, the pelvis can be anatomically divided into an anterior arch and a posterior arch. is responsible for Therefore, if necessary, the support for the long bones (B1) and the pubis (B2), which are not important for load transmission, may be neglected.

On the other hand, in a special situation after extensive resection of the tumor, the larger the size of the pelvic implant due to the large soft tissue defect, the more difficult the primary suturing after surgery and the stimulation of nearby neurovascular structures. do.

From this point of view, in one embodiment of the present invention, pelvic statics and mechanics is used to minimize the remaining unnecessary parts except for the part necessary for the pelvic implant to function as a means of stabilizing the load transfer of the pelvis. It may mean biomechanics information of the lumbar spine, pelvic bone, and femur.

In the step ( S20 ) of designing the bone replacement part 10 to replace the bone defect part of the patient's pelvis and to be disposed, the bone replacement part 10 may be designed according to the pelvic image and the pelvic static analysis result.

As described above, in one embodiment of the present invention, the bone replacement part 10 may include a body 11 and a suture hole 13 . The body 11 and the suture hole 13 are the same as those described in relation to the pelvic implant according to an embodiment of the present invention.

In the step (S30) of designing the fixing part 20 connected to the bone replacement part 10 and fixed to the bone remaining part of the pelvis (S30), the fixing part 20 is to be designed according to the shape of the bone replacement part 10 above. can

The fixing part 20 is connected to the bone replacement part 10 and connected to the fixing plate 21 and the bone replacement part 10 disposed in contact with the surface of the bone residual part of the pelvis and inserted into the bone residual part of the pelvis. It may include a spike 23 to be fixed. That is, the fixing unit 20 designed in this step stably fixes the bone replacement unit 10 to the bone residual site of the patient's pelvis through a dual fixing structure including the fixing plate 21 and the spike 23, and sufficient It can provide initial fixation and long-term durability.

Details of the fixing plate 21 and the spike 23 are the same as those described in relation to the pelvic implant according to an embodiment of the present invention. Therefore, further detailed description will be omitted.

In the step (S40) of 3D printing the bone replacement part 10 and the fixing part 20, the bone replacement part 10 and the fixing part 20 may be manufactured through 3D printing. Specifically, the bone replacement part 10 and the fixing part 20 may be integrally manufactured at once, and it is also possible that the bone replacement part 10 and the fixing part 20 are separately manufactured and then combined.

Since the pelvis has a three-dimensional shape, good results can be expected by using a pelvic implant made with 3D printing technology when reconstruction of a bone defect is required. In addition, it is possible to easily implement a patient-specific pelvic implant through 3D printing technology.

Meanwhile, the pelvic implant may be made of a biocompatible material. For example, as described above, titanium may be used as a material of the pelvic implant.

As described above, according to the pelvic implant and its manufacturing method according to the present invention, the bone replacement part 10 arranged to replace the bone defect portion of the patient's pelvis is customized to the patient and is connected to the bone replacement part 10 so that the bone remains of the pelvis It is stably fixed by the fixing part 20 including the fixing plate 21 disposed in contact with the surface of the site and the spike 23 which is connected to the bone replacement part 10 and is inserted into the inside of the bone residual part of the pelvis and is fixed. This makes it possible to secure the initial fixation strength and long-term sustainability of the pelvic implant.

Although one embodiment of the present invention has been described, the spirit of the present invention is not limited by the embodiments presented herein, and those skilled in the art who understand the spirit of the present invention can add components, within the scope of the same spirit, Other embodiments may be easily proposed by changes, deletions, additions, etc., but these will also fall within the scope of the present invention.

Claims

A bone replacement unit including a body disposed to replace the bone defect portion of the pelvis; and

Including; and a fixing part connected to the bone replacement part and fixed to the bone remaining part of the pelvis;

The fixing part,

A fixed plate connected to the bone substitute and disposed in contact with the surface of the bone remaining portion of the pelvis; and

A pelvic implant comprising a spike that is connected to the bone substitute and is inserted into and fixed to the inside of the bone remaining portion of the pelvis.
The method of claim 1,

The body is a pelvic implant having a porous layer in contact with the bone residual region.
The method of claim 1,

The body is a pelvic implant provided with a processing unit abrasive processing or cutting processing in the portion disposed adjacent to the nerve.
The method of claim 1,

The body is a pelvic implant having an empty space therein.
The method of claim 1,

The bone replacement part is a pelvic implant having a suture hole formed through the body so that a suture for coupling with the soft tissue is fastened.
The method of claim 1,

The fixing plate is a pelvic implant formed to be curved in a form that can be in close contact with the surface of the bone remaining.
7. The method of claim 6,

The fixing plate is a pelvic implant having a screw hole through which a screw for coupling the fixing plate to the bone remaining portion is disposed.
The method of claim 1,

The spike is a pelvic implant disposed to be inserted into the intramedullary cavity of the bone remnant site.
The method of claim 1,

The spike is a pelvic implant having a porous layer on its surface.
analyzing the patient's pelvic image and pelvic statics;

designing a bone replacement part to be placed while replacing the bone defect part of the patient's pelvis; and

A method of manufacturing a pelvic implant comprising a; designing a fixing part connected to the bone replacement part and fixed to the bone remaining part of the pelvis.
11. The method of claim 10,

The pelvic implant manufacturing method further comprising the step of 3D printing the bone replacement part and the fixing part.
11. The method of claim 10,

The fixing part,

A fixed plate connected to the bone substitute and disposed in contact with the surface of the bone remaining portion of the pelvis; and

A method for manufacturing a pelvic implant comprising a spike connected to the bone substitute and inserted into and fixed to the inside of the bone remaining portion of the pelvis.