KR20230040108A - Medical insertion apparatus - Google Patents

Abstract

A medical insertion apparatus according to an embodiment comprises: a screw body which is inserted into an object; and a coating unit which is provided on the screw body. The coating unit includes: an inner coating layer which comes in contact with the screw body, and is made of a metal bonding material; and an outer coating layer which comes in contact with the inner coating layer, and is made of a biocompatible material. The medical insertion apparatus is inserted into the object and can stably fix the object.

Description

Medical insertion device {MEDICAL INSERTION APPARATUS}

The embodiments below relate to medical implantable devices.

Fractures are usually due to injury or overuse, and most fractures heal well, but the time it takes to heal depends on many factors, such as the age of the person, the type and severity of the injury, and other disorders present. Treatment methods for fractures depend on the type and severity of the fracture and may include analgesics, cold compresses, compression, immobilization of the damaged area, and surgery in severe cases.

Among the types of fractures, when bone instability is expected, such as when there is severe back stenosis, when multiple spinal surgeries are performed in the same area, or when bones are fractured or cracked, vertebrae are used to fix two or more vertebrae. Surgery, such as spinal fusion, is required, and a medical insertion instrument inserted into a bone structure may be used during surgery.

Among the common side effects/complications that may occur when an insertion instrument is inserted into a bone structure for bone union and the bone structure is fixed, the insertion instrument loosens while gap with surrounding bone occurs. If the insertion mechanism becomes loose, bone union, which is the purpose of the surgery, cannot be achieved, and furthermore, it may lead to collapse/failure of the insertion mechanism. The insertion instrument can be located very close to the neural tube, and if the insertion instrument is dislocated, it affects the surrounding bones, ranging from simple back pain/neck pain to severe enough to cause paralysis of the limbs such as arms and legs. Problems can arise.

In order to solve this problem, that is, to firmly hold the object by being inserted into the object of the human body structure such as the vertebrae, and ultimately assisting the union, research and technology related to medical metal devices that are excellent in fusion or bonding of the human body structure with the corresponding object this is being developed

Korean Patent Laid-open Publication No. 2006-0033008 discloses an implant for osteosynthesis of femur and tibia.

The above background art is possessed or acquired by the inventor in the process of deriving the disclosure of the present application, and cannot necessarily be said to be known art disclosed to the general public prior to the present application.

An object according to an embodiment is to provide a medical insertion device having functions optimized for each part by using a material tailored to each part of a screw body for fixing an object such as a spine.

An object according to an embodiment is to coat a bioceramic capable of biologic fusion/bonding with an object so as to be fused with the object, thereby significantly lowering the incidence of complications and ultimately increasing the success rate of object fusion surgery. To provide a medical insertion device capable of increasing will be.

An object according to an embodiment is to provide a medical insertion device capable of preventing gap or instability that may occur when a boundary distinguishing compositionally by separately coating two different types of ceramics exists.

A medical insertion device according to an embodiment may include a screw body inserted into a target object, and a coating portion provided on the screw body, wherein the coating portion contacts the screw body and includes an inner coating layer made of a metal bonding material, and It may include an outer coating layer made of a biocompatible material, in contact with the inner coating layer, and inserted into the object to stably fix the object.

According to one side, the screw body, the inner coating layer, and the outer coating layer may be disposed in order, and a conversion layer is further included between the inner coating layer and the outer coating layer, and the material constituting the conversion layer is It can gradually change from a metal compatible material of the inner coating layer to a biocompatible material of the outer coating layer.

According to one side, the screw body may include a first region and a second region arranged in a longitudinal direction of the screw body, and the outer coating layer includes a first outer coating layer disposed in the first region, and It may include a second outer coating layer disposed in the second region, and the first outer coating layer and the second outer coating layer may be composed of different biocompatible materials.

According to one side, the material of the coating unit may include a bioceramic material.

According to one side, the target object may be a bone structure, a joint structure, or a tooth structure.

According to one side, the coating part may be manufactured by electrophoretic coating technology, and the inner coating layer may be applied on each area on the screw body, and then the outer coating layer may be gradually applied.

According to one side, the coating part may be manufactured by a plasma spray coating technique, and the inner coating layer may be applied on each area on the screw body, and then the outer coating layer may be gradually applied.

A medical implantable device according to an embodiment has functions optimized for each part by using materials tailored to the function of each part of a screw body for fixing an object such as a spine.

The medical implantable device according to an embodiment may significantly reduce the incidence of complications and ultimately increase the success rate of object fusion surgery by coating a bioceramic capable of biological fusion/adhesion with the object so as to be fused with the object.

In the medical implantable device according to an embodiment, two different types of ceramics are separately coated to prevent gaps or instability that may occur when a boundary distinguishing compositionally exists.

1 illustrates an embodiment in which a medical insertion device is inserted into an object and fixes the object according to an embodiment.
2 shows a coating of a medical implantable device according to an embodiment.
Figure 3 schematically shows a manufacturing method according to the electrophoretic coating technology of the medical insert device according to an embodiment.
Figure 4 schematically shows a manufacturing method according to the plasma spray coating technology of the medical insert device according to an embodiment.

Hereinafter, embodiments will be described in detail with reference to the accompanying drawings. However, since various changes can be made to the embodiments, the scope of the patent application is not limited or limited by these embodiments. It should be understood that all changes, equivalents or substitutes to the embodiments are included within the scope of rights.

Terms used in the examples are used only for the purpose of explanation and should not be construed as limiting. Singular expressions include plural expressions unless the context clearly dictates otherwise. In this specification, terms such as "include" or "have" are intended to designate that there is a feature, number, step, operation, component, part, or combination thereof described in the specification, but one or more other features It should be understood that the presence or addition of numbers, steps, operations, components, parts, or combinations thereof is not precluded.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the art to which the embodiment belongs. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related art, and unless explicitly defined in the present application, they should not be interpreted in an ideal or excessively formal meaning. don't

In addition, in the description with reference to the accompanying drawings, the same reference numerals are given to the same components regardless of reference numerals, and overlapping descriptions thereof will be omitted. In describing the embodiment, if it is determined that a detailed description of a related known technology may unnecessarily obscure the gist of the embodiment, the detailed description will be omitted.

In addition, in describing the components of the embodiment, terms such as first, second, A, B, (a), and (b) may be used. These terms are only used to distinguish the component from other components, and the nature, order, or order of the corresponding component is not limited by the term. When an element is described as being “connected,” “coupled to,” or “connected” to another element, that element may be directly connected or connected to the other element, but there may be another element between the elements. It should be understood that may be "connected", "coupled" or "connected".

Components included in one embodiment and components having common functions will be described using the same names in other embodiments. Unless stated to the contrary, descriptions described in one embodiment may be applied to other embodiments, and detailed descriptions will be omitted to the extent of overlap.

1 illustrates an embodiment in which a medical insertion device 10 according to an embodiment is inserted into an object B such as a vertebra and fixes the object B. 2 shows the coating 200 of the medical implantable device 10 according to one embodiment.

Referring to FIG. 1 , a medical insertion device 10 according to an embodiment is inserted into an object B such as a vertebra such as a pedicle screw or a lateral mass screw. The screw body 100 and the coating portion 200 provided on the screw body 100 may be included.

The object B on which the medical insertion device 10 is used according to an embodiment may include not only vertebrae but also bone structures such as musculoskeletal extravertebral extremity bones, joint structures, or tooth structures. The medical insertion device 10 may be used for the musculoskeletal system, for fixing human body structures, for dental treatment, for joint insertion, and the like.

For example, the medical insertion device 10 according to an embodiment may be used as an implant for fixing vertebrae used during spinal fusion surgery. The medical insertion device 10 according to an embodiment may be inserted into the vertebrae to firmly hold the vertebrae and ultimately assist in fusion.

The screw body 100 may have various diameters, and the material of the screw body 100 may be made of metal such as titanium alloy. The coating unit 200 for stable fusion with the object (B) may be coated on the screw body 100. The material of the coating unit 200 may include a bioceramic material, and the bioceramic used as the material of the coating unit 200 may have excellent fusion/adhesion with bone when appropriate components and compositions are provided.

Referring to FIG. 2 , the coating unit 200 includes an inner coating layer 210 in contact with the screw body 100 and made of a metal bonding material, and an outer coating layer 220 in contact with the inner coating layer 210 and made of a biocompatible material. ) may be included.

Through the inner coating layer 210 and the outer coating layer 220, the medical insertion device 10 according to an embodiment is inserted into the object (B) to ensure stable fusion or bonding between the screw body 100 and the object (B). Through this, the object (B) can be stably fixed.

The screw body 100, the inner coating layer 210, and the outer coating layer 220 may be arranged in order, and for stable bonding between the inner coating layer 210 and the outer coating layer 220, the inner coating layer 210 and A conversion layer 230 may be further included between the outer coating layers 220 . A material constituting the conversion layer 230 may gradually change from a metal compatible material of the inner coating layer 210 to a biocompatible material of the outer coating layer 220 .

Specifically, the outer coating layer 220 containing bioceramic for inducing biological union with the vertebrae and the inner coating layer 210 containing bioceramic that is firmly fixed to the screw body 100 composed of titanium, etc. Within the entire combined bioceramic coating part 200, the concentration of different bioceramics gradually changes depending on the position so that it is manufactured without intermediate gaps or separations. By utilizing the coating technology, the inner coating layer 210 A conversion layer 230 may be provided between the outer coating layer 220 and the outer coating layer 220 .

In this way, the medical implantation device 10 according to an embodiment can provide functions optimized for each position by using a suitable type of bioceramic according to the position, such as a bone union site or a joint site of the screw body 100.

In addition, the medical implantable device 10 according to an embodiment may provide optimized functions by selectively coating appropriate bioceramics according to different bone positions.

Referring to FIG. 1 , the screw body 100 may include a first area 110 and a second area 120 arranged in the longitudinal direction of the screw body 100 . For example, the first area 110 of the screw body 100 may be disposed at a portion where it meets the first object B1, such as a cortical bone of a bone, and the second area 120 of the screw body 100 It may be disposed at a portion meeting the second object B2, such as medullar bone/cavernous bone.

In line with this, referring to FIG. 2 , the outer coating layer 220 includes a first outer coating layer 221 disposed in the first region 110 and a second outer coating layer 222 disposed in the second region 120. can include In this way, in the first area 110 on the screw body 100, the inner coating layer 210, the first conversion layer 231, and the first outer coaching layer 221 may be sequentially provided, and the second area , the inner coating layer 210, the second conversion layer 232, and the second outer coating layer 222 may be sequentially provided.

The first outer coating layer 221 and the second outer coating layer 222 may be made of different biocompatible materials. For example, the first outer coating layer 221 disposed on the first region 110 may be made of bioceramic optimized for firm fixation of the first region 110 with the cortical bone, and the second region 120 may have The disposed second outer coating layer 222 may be made of bioceramic optimized for firm fixation of the second region 120 with the cancellous bone.

The medical implantation device 10 according to an embodiment can provide optimized functions for each part by using a customized material suitable for the function of each part of the human body structure. may be provided by being coated for each part with different bioceramics according to various bone parts.

When the coating part 200 is formed from the screw body 100, the bioceramic optimal for bonding with titanium is formed on the inner surface of the coating part 200, and the bone is fused on the outer surface of the coating part 200. The inner coating layer 210 for each area on the screw body 100 so that the optimal bioceramic that works is positioned, so that the concentration of two or more different components of the bioceramic gradually changes depending on the location. ) is applied, then the outer coating layer 220 may be applied by performing a functionally-graded coating without gap or instability such that the composition gradually changes without creating a boundary between the corresponding bioceramics.

For example, the coating unit 200 may be manufactured by electrophoretic coating technology, and FIG. 3 schematically shows a manufacturing method of the medical implantable device 10 according to the electrophoretic coating technology according to an embodiment. .

Referring to FIG. 3 , as an electrophoretic coating technology, an example of a ceramic coating technology capable of implementing coating of the medical insertion device 10 according to an embodiment is exemplified. First, a suspension container 300 containing a suspension in which a bioceramic component to be coated is dissolved in a solution (mainly, alcohol) at a required concentration may be provided. An external power source may be provided so that the positive electrode and the screw body 100 to be coated in the suspension (C) become a negative electrode. Then, positively charged bioceramic powder particles are supplied into the suspension (C) from the supply tank (400), and are moved to the surface of the screw body (100), which is the negative electrode, in the suspension (C) to form the coating portion (220). will do When the coating unit 200 is formed, two or more different components of the bioceramic may be coated so that a gradual concentration change (gradation) occurs depending on the location. First, the internal coating layer 210 may be applied by coating the entire screw body 100 only with a bioceramic component that has good bonding with the metal material of the screw body 100 . Then, when the inner coating layer 210 is formed to a desired thickness, the first area 110 of the screw body 100 gradually develops adhesion to the first object B1 disposed in the corresponding area from the supply tank 400. It can be additionally supplied and applied as a good bioceramic component. At this time, the second area 120 is inactive. Thereafter, the first area 110 is inactivated, and in the second area 120, a bioceramic component having good adhesion to the second object B2 disposed in the corresponding area may be additionally supplied and applied. Looking at the process sequence, after the coating of the entire screw body 100 is initially completed with only the material of the screw body 100 and the bioceramic component having good bonding, the second area 120 is inactivated and the first area 110 is formed. After coating, the bioceramic component of the coated first region 110 is drawn out of the coating solution, and finally coating is performed on the second region 120 .

As another example, the coating unit 200 may be manufactured by a plasma spray coating technique, and FIG. 4 schematically shows a manufacturing method of the medical insertion device 10 according to the plasma spray coating technique according to an embodiment.

Referring to FIG. 4 , an example of a ceramic coating technology capable of implementing a coating of the medical insertion device 10 according to an embodiment is exemplified as a plasma spray coating technology. Through the plasma spray coating technology, the bioceramic powder to be coated can be injected through the powder feeder 600 into the high-temperature plasma ejected from the plasma ejector 500, and the bioceramic powder is instantly dissolved and melted. Liquid bioceramic may be coated on the screw body 100 disposed on the substrate 700 . Looking at the process sequence, first, only the metal material of the screw body 100 and the bioceramic component having good adhesion are entirely coated on the screw body 100 to form the inner coating layer 210 . Thereafter, when the inner coating layer 210 is formed to a desired thickness, while gradually increasing the amount of the bioceramic component having good bonding with the first object B1 to the powder feeder 600, continuously supplied from the additional supply tank, the screw The body 100 metal material and bioceramic components that have good bonding properties are gradually reduced, and at the end of the coating, finally, in the first area 110, only the bioceramic components that have good bonding with the first object B1 are coated. . Thereafter, the same process is performed on the second region 120 so that only the bioceramic component having good adhesion to the second object B2 is finally coated gradually.

The medical insertion device 10 according to an embodiment can prevent a risk caused by a failure of the insertion mechanism to fuse with a bone due to the nature of the metal material of the insertion mechanism.

Through the medical insertion device 10 according to an embodiment, a bioceramic capable of biological union/bonding with the object B is coated so that the insertion instrument itself fuses with the object B, thereby significantly reducing the incidence of complications. and ultimately increase the success rate of fusion surgery.

In addition, it does not stop at simply using a single bioceramic in a part in contact with the object, but through the medical insertion device 10 according to an embodiment, the type of bioceramic suitable for the function according to the position on the object (B) and insertion device / The function of optimizing / maximizing by changing the coating shape can be provided.

In the medical insertion device 10 according to an embodiment, a bioceramic that is firmly fixed to the insertion instrument is used at the junction of the insertion instrument, and the junction with the object B is advantageous for bonding with the object B. Bioceramics can be used.

In addition, in the medical insertion device 10 according to an embodiment, two different types of ceramics are separately coated to eliminate gaps or instabilities that may occur when there is a compositionally distinct boundary. Stability can also be secured by using a coating technology in which the composition of the two types of bioceramics gradually changes depending on the position within the coating layer.

Through the medical insertion device 10 according to an embodiment, problems such as difficulties in uniform coating of ceramics and instability of hard union between the ceramic coating and internal metallic materials are prevented, thereby reducing the risk of complications and safety and effectiveness of surgery. can increase

As described above, although the embodiments have been described with limited drawings, those skilled in the art can apply various technical modifications and variations based on the above. For example, the described techniques may be performed in an order different from the method described, and/or components of the described system, structure, device, circuit, etc. may be combined or combined in a different form than the method described, or other components may be used. Or even if it is replaced or substituted by equivalents, appropriate results can be achieved.

Therefore, other implementations, other embodiments, and equivalents of the claims are within the scope of the following claims.

10: medical insertion device
100: screw body
110: first area of the screw body
120: second region of the screw body
200: coating unit
210: inner coating layer
220: outer coating layer
221: first outer coating layer
222: second outer coating layer
230: conversion layer
231: first conversion layer
232: second conversion layer
300: suspension container
400: supply tank
500: plasma ejector
600: powder feeder
700: substrate
B: object
B1: first object
B2: second object

Claims (7)

A screw body inserted into a target object;
a coating portion provided on the screw body;
including,
The coating part,
an inner coating layer in contact with the screw body and made of a metal bonding material;
an outer coating layer made of a biocompatible material and in contact with the inner coating layer;
including,
Inserted into the object to stably fix the object,
medical inserts.
According to claim 1,
The screw body, the inner coating layer, and the outer coating layer are arranged in order,
Between the inner coating layer and the outer coating layer, further comprising a conversion layer,
The material constituting the conversion layer gradually changes from the metal compatible material of the inner coating layer to the biocompatible material of the outer coating layer.
medical inserts.
According to claim 1,
The screw body includes a first region and a second region arranged in the longitudinal direction of the screw body,
The outer coating layer is
a first outer coating layer disposed in the first region; and
a second outer coating layer disposed in the second region;
including,
The first outer coating layer and the second outer coating layer are composed of different biocompatible materials,
medical inserts.
According to claim 1,
The material of the coating part includes a bioceramic material,
medical inserts.
According to claim 1,
The object is a bone structure, joint structure or tooth structure,
medical inserts.
According to claim 2,
The coating part is manufactured by electrophoretic coating technology,
After the inner coating layer is applied area by area on the screw body, the conversion layer is gradually applied from the metal compatible material of the inner coating layer to the biocompatible material of the outer coating layer, and the outer coating layer is applied,
medical inserts.
According to claim 2,
The coating part is manufactured by plasma spray coating technology,
After the inner coating layer is applied area by area on the screw body, the conversion layer is gradually applied from the metal compatible material of the inner coating layer to the biocompatible material of the outer coating layer, and the outer coating layer is applied,
medical inserts.

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