KR20220060109A - Artificial bone piece for cranioplasty - Google Patents

Artificial bone piece for cranioplasty Download PDF

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KR20220060109A
KR20220060109A KR1020200145670A KR20200145670A KR20220060109A KR 20220060109 A KR20220060109 A KR 20220060109A KR 1020200145670 A KR1020200145670 A KR 1020200145670A KR 20200145670 A KR20200145670 A KR 20200145670A KR 20220060109 A KR20220060109 A KR 20220060109A
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bone
cranioplasty
suture
bone fragment
artificial bone
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KR1020200145670A
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Korean (ko)
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KR102478854B1 (en
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이원희
권용욱
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인제대학교 산학협력단
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2/2875—Skull or cranium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30461—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]

Abstract

The present invention relates to an artificial bone fragment for cranioplasty. The artificial bone fragment includes: a bone fragment body mounted on an opening of the skull remaining after the cranial puncture, and covering the opening; and an inner expansion unit attached to the bone fragment body and expanding by fluid injected from the outside to occupy an epidural space covered by the bone fragment body. Since the artificial bone fragment for cranioplasty according to the present invention structured as described above has an inner expansion part that fills the epidural space and an outer prosthetic part that can be expanded by injecting fluid in consideration of temporal bone atrophy, there is no accumulation of exudate or blood in the epidural space. The shape of the head is made symmetrical, so that a prognosis of a surgery is good and a patient's satisfaction can be enhanced.

Description

두개골 성형술용 인공골편{Artificial bone piece for cranioplasty}Artificial bone piece for cranioplasty

본 발명은 두개골 성형술에 사용되는 인공골편에 관한 것으로서, 보다 상세하게는, 수술 후 두개골 내부의 삼출물이나 혈액의 고임현상을 방지함은 물론 두부(頭部)의 전체적인 대칭을 맞출 수 있는, 두개골 성형술용 인공골편에 관한 것이다.The present invention relates to an artificial bone fragment used in cranioplasty, and more particularly, to prevent puddle of exudate or blood inside the skull after surgery, as well as to align the overall symmetry of the head, cranioplasty It is about an artificial bone fragment for a dragon.

두개골 절제술은, 두부(頭部) 외상으로 인한 출혈이나 자발성 뇌출혈 또는 뇌경색을 처치하거나, 두개강 내에서 발생하는 압력을 완화시키기 위해 진행되는 수술법이다. 이러한 두개골 절제술은 두개골의 일부를 절단하는 것이니만큼 수술 후 두부의 모양이 크게 변형되기 때문에 후속적으로 두개골 성형술을 시행하여야 한다.Skull resection is a surgical method performed to treat bleeding, spontaneous cerebral hemorrhage, or cerebral infarction due to head trauma, or to relieve pressure within the cranial cavity. Since this craniectomy cuts a part of the skull, the shape of the head is greatly changed after surgery, so a subsequent cranioplasty must be performed.

두개골 성형술은, 두개골의 절제된 구멍에 골편을 위치시켜, 뇌를 물리적으로 보호하고, 두부의 함몰부위를 없애 미용적인 효과를 제공하는 목적을 갖는다.Cranioplasty has the purpose of providing a cosmetic effect by placing a bone fragment in an excised hole of the skull, physically protecting the brain, and removing the depression of the head.

두개골 성형을 위하여, 과거에는, 자가 이식 골편을 사용하였으나, 자가골편은, 수술 후 염증 발생율이 높고 골흡수에 따른 미용적인 문제를 야기할 수 있다. 이에 따라, 최근에는 본시멘트나 금속 또는 폴리머로 제작된 인공골편이나, 티타늄 합금을 이용한 적층 제조방식의 인공골편이 사용되고 있다.In the past, autologous bone fragments were used for cranioplasty, but autologous bone fragments have a high rate of inflammation after surgery and may cause cosmetic problems due to bone resorption. Accordingly, in recent years, artificial bone fragments made of bone cement, metal, or polymer, or artificial bone fragments of a laminated manufacturing method using a titanium alloy have been used.

도 1은 두개골 절제술을 위해 두개골(11)의 일부를 제거한 모습을 도시한 도면이고, 도 2는 종래 인공골편(13)을 이용한 두개골 성형술의 문제점을 설명하기 위한 두부(頭部)의 단면도이다.1 is a view showing a state in which a part of the skull 11 is removed for craniectomy, and FIG. 2 is a cross-sectional view of the head for explaining the problem of cranioplasty using the conventional artificial bone piece 13.

두개골 절제술은, 두개골(11)의 일부를 절단하여 뇌(16)를 노출시키는 것이므로, 도 1에 도시한 바와 같이 두개골의 일측에 개방부(12)를 남긴다. 개방부(12)는, 추후, 두개골 성형술을 통해 도 2에 도시한 바와 같이 인공골편(13)으로 채워져 차단된다. Since craniectomy is to expose the brain 16 by cutting a part of the skull 11, an opening 12 is left on one side of the skull as shown in FIG. The opening 12 is, later, filled with an artificial bone piece 13 and blocked through cranioplasty as shown in FIG. 2 .

인공골편(13)은 개방부(12)의 모양에 형합 하도록 제작된 것으로서, 개방부(12)에 끼워져 두부가 함몰됨 없이 전체적으로 구형의 형상을 이루게 한다. 인공골편(13)을 개방부(12)에 맞추어 고정한 다음 두피(15)를 씌운 후 두피의 경계부분을 봉합함으로써 두개골 성형술이 마무리된다.The artificial bone piece 13 is manufactured to conform to the shape of the opening 12, and is inserted into the opening 12 to form a spherical shape as a whole without the head being depressed. After fixing the artificial bone piece 13 to the opening 12, the scalp 15 is covered, and then the skull border is sutured to complete cranioplasty.

그런데 종전의 두개골 성형술은 다음과 같은 부작용을 갖는다. 하나는 인공골편(13)과 경막(17)의 사이에 경막외공간(19)이 남는 것이다. 두개골 내부에 공간이 있으면, 해당 공간으로 삼출물이나 혈액이 고이게 된다. 고여 있는 삼출물이나 혈액은 순환하지 못하므로 염증을 유발할 수 있다. 두개골 성형술 환자의 50% 정도는 이러한 부작용을 경험한다고 알려져 있다. 이러한 문제는, 경막외공간(19)을 남기지 않으면 해결될 것이나, 종래의 인공골편에는 경막외공간(19)을 없애기 위한 기능이 없었다.However, conventional cranioplasty has the following side effects. One is that the epidural space (19) is left between the artificial bone piece (13) and the dura mater (17). If there is a space inside the skull, exudate or blood can pool into that space. Accumulated exudate or blood does not circulate and can cause inflammation. It is known that about 50% of cranioplasty patients experience these side effects. This problem will be solved if you do not leave the epidural space 19 , but the conventional artificial bone piece did not have a function to remove the epidural space 19 .

또 다른 부작용은, 측두근(側頭筋)의 위축에 따른 두부의 비대칭이다. 측두근이 위축됨에 따라 측두근을 커버하고 있는 인공골편(13)이 함몰되는 것이다.Another side effect is the asymmetry of the head due to atrophy of the temporal muscle. As the temporal muscle is atrophied, the artificial bone piece 13 covering the temporal muscle is depressed.

국내 공개특허공보 제10-2020-0101480호 (두개골 성형술에 사용되는 3차원 임플란트 및 이의 제작방법)Domestic Patent Publication No. 10-2020-0101480 (3D implant used in cranioplasty and manufacturing method thereof)

본 발명은 상기 문제점을 해소하고자 창출한 것으로서, 경막외공간에 삼출액이나 혈액의 고임현상이 없고, 머리 모양의 대칭을 맞추어 수술의 예후가 양호하고 환자의 만족감을 높일 수 있게 하는, 두개골 성형술용 인공골편을 제공함에 목적이 있다.The present invention was created to solve the above problems, and there is no puddle of exudate or blood in the epidural space, and the prognosis of surgery is good by aligning the symmetry of the head shape, and the patient's satisfaction is improved. The purpose is to provide bone fragments.

상기 목적을 달성하기 위한 과제의 해결수단으로서의 본 발명의 두개골 성형술용 인공골편은, 두개골 천공술의 시행 후 남겨진 두개골 개방부에 장착되어 개방부를 커버하는 골편본체와; 상기 골편본체에 장착되며 외부로부터 주입된 유체에 의해 팽창하여 골편본체가 커버하고 있는 경막외공간을 점유하는 내측팽창부를 포함한다.The artificial bone piece for cranioplasty of the present invention as a means of solving the problem for achieving the above object includes: a bone piece body mounted on the skull opening left after the perforation of the skull to cover the opening; It is mounted on the bone fragment body and expands by the fluid injected from the outside, and includes an inner expansion unit occupying the epidural space covered by the bone fragment body.

또한, 상기 내측팽창부는; 상기 골편본체의 내측면에 고정되며 골편본체와의사이에 밀폐공간을 제공하고 상기 주입유체에 의해 팽창 가능한 팽창백과, 상기 골편본체에 설치되고, 외부로부터 제공되는 유체를 상기 밀폐공간으로 유도하는 제1통로부를 갖는다.In addition, the inner expansion unit; The first is fixed to the inner surface of the bone piece body and provides a closed space between the bone piece body and the inflatable bag expandable by the injection fluid, and is installed in the bone piece body, and guides the fluid provided from the outside into the closed space. have a passageway.

아울러, 상기 골편본체에는 암나사구멍이 형성되어 있고, 상기 제1통로부는; 상기 암사사구멍에 나사 결합하고 주사바늘을 통과시키는 밀폐플러그와, 상기 골편본체의 외측부에서 밀폐플러그를 커버하여 보호하는 보호커버를 포함한다.In addition, the bone fragment body has a female screw hole is formed, the first passage portion; It includes a protective cover to cover and protect the sealing plug from the outer part of the closure plug and the screw coupled to the female sasa hole and passing the injection needle, the bone body.

또한, 상기 골편본체의 외측부에는, 외부로부터 주입된 유체에 의해 팽창하여 머리의 외부 형상을 보정하는 외측보형부가 더 구비된다.In addition, the outer portion of the bone fragment body, expanded by the fluid injected from the outside to correct the external shape of the head is further provided.

그리고, 상기 외측보형부는; 골편본체의 외측면에 고정되고, 골편본체와의 사이에 밀폐공간을 제공하는 보형백과, 상기 보형백에 장착되며, 외부로부터 제공된 유체를 보형백 내부로 유도하는 제2통로부를 포함한다.And, the outer protrusion; It is fixed to the outer surface of the bone piece body, and a bag prosthesis providing a closed space between the bone piece body, and is mounted on the bag prosthesis, and includes a second passage for guiding the fluid provided from the outside into the bag prosthetic bag.

또한, 상기 제2통로부는; 보형백에 형성된 캡고정구멍과, 상기 캡고정구멍에 끼워지며 주사바늘을 통과시키는 밀폐캡과, 상기 밀폐캡을 커버하여 보호하는 차단판을 구비한다.In addition, the second passage portion; A cap fixing hole formed in the shape retaining bag, a sealing cap fitted in the cap fixing hole and allowing a needle to pass through, and a blocking plate for protecting the sealing cap are provided.

아울러, 상기 골편본체에는; 두피를 골편본체에 고정시키기 위한 봉합사와 결합하는 것으로서, 골편본체에 대해 착탈 가능한 봉합사고정부가 더 포함된다.In addition, the bone fragment body; As a combination of a suture for fixing the scalp to the bone fragment body, a detachable suture accident part is further included with respect to the bone fragment body.

또한, 상기 골편본체에는 다수의 끼움구멍이 형성되어 있고, 상기 봉합사고정부는, 상기 봉합사와 결합한 상태로 상기 끼움구멍에 박혀 고정되는 봉합사홀더이다.In addition, a plurality of fitting holes are formed in the bone fragment body, and the suture accident part is a suture holder that is fixed in the fitting hole in a state coupled with the suture.

또한, 상기 봉합사홀더는; 봉합사가 통과하는 다수의 봉합사통로를 가지고, 각 봉합사통로에는 봉합용 바늘을 통과시키는 실리콘마개가 내장된다.In addition, the suture holder; It has a plurality of suture passages through which the suture passes, and a silicone stopper for passing the suture needle is embedded in each suture passage.

상기와 같이 이루어지는 본 발명의 두개골 성형술용 인공골편은, 경막외공간을 채우는 내측팽창부와, 측두골 위축을 감안하여 유체를 주입하여 팽창시킬 수 있는 외측보형부를 구비하므로, 경막외공간에 삼출액이나 혈액의 고임현상이 없고, 머리 모양의 대칭을 맞추어 수술의 예후가 양호하고 환자의 만족감을 높일 수 있게 한다.The artificial bone piece for cranioplasty of the present invention, which is made as described above, has an inner expansion part that fills the epidural space and an external prosthesis part that can be expanded by injecting fluid in consideration of temporal bone atrophy. There is no stagnant phenomenon, and the prognosis of the operation is good by adjusting the symmetry of the head shape, and the satisfaction of the patient can be increased.

도 1은 두개골 절제술을 위해 두개골의 일부를 제거한 모습을 도시한 도면이다.
도 2는 종래 인공골편을 이용한 두개골 성형술의 문제점을 설명하기 위한 두부(頭部)의 단면도이다.
도 3은 본 발명의 일 실시예에 따른 두개골 성형술용 인공골편의 사시도이다.
도 4는 도 3의 A-A선 단면도이다.
도 5는 도 4에 도시한 인공골편의 동작을 설명하기 위한 단면도이다.
도 6은 도 3의 B-B선 단면도이다.
도 7은 도 3에 도시한 두피고정부의 분해 사시도이다.
도 8은 도 7에 도시한 두피고정부의 사용 방식을 설명하기 위한 도면이다.
도 9는 도 7에 도시한 두피고정부의 단면도이다.1 is a view showing a state in which a portion of the skull is removed for cranioectomy.
Figure 2 is a cross-sectional view of the head (頭部) for explaining the problems of the conventional cranioplasty using artificial bone fragments.
3 is a perspective view of an artificial bone piece for cranioplasty according to an embodiment of the present invention.
4 is a cross-sectional view taken along line AA of FIG. 3 .
5 is a cross-sectional view for explaining the operation of the artificial bone piece shown in FIG.
6 is a cross-sectional view taken along line BB of FIG. 3 .
7 is an exploded perspective view of the scalp fixing unit shown in FIG.
8 is a view for explaining a method of using the scalp fixing unit shown in FIG.
9 is a cross-sectional view of the scalp fixing unit shown in FIG.

이하, 본 발명에 따른 하나의 실시예를 첨부된 도면을 참조하여 보다 상세히 설명하기로 한다.Hereinafter, one embodiment according to the present invention will be described in more detail with reference to the accompanying drawings.

본 발명의 인공골편은, 두개골 천공술에 의해 형성된 두개골의 천공부위, 즉 구멍에 장착되어 구멍을 메우는 것으로서, 경막외공간에 삼출물이나 혈액이 고이는 것을 방지하고, 더 나아가 머리 모양을 양호하게 보형할 수 있는 것이다. 이러한 인공골편은, 두개골 천공술의 시행 후 남겨진 두개골 개방부에 장착되어 개방부를 커버하는 골편본체와; 상기 골편본체에 장착되며 외부로부터 주입된 유체에 의해 팽창하여 골편본체가 커버하고 있는 경막외공간을 점유하는 내측팽창부의 기본 구성을 갖는다.The artificial bone fragment of the present invention is installed in the perforation site, that is, the hole of the skull formed by cranial perforation, to fill the hole, and prevents exudate or blood from accumulating in the epidural space, and furthermore, it can shape the head well. there will be These artificial bone fragments are mounted on the skull opening left after the perforation of the skull is performed and the bone fragment body covering the opening; It is mounted on the bone fragment body and expands by fluid injected from the outside to occupy the epidural space covered by the bone fragment body and has a basic configuration of the inner expansion unit.

도 3은 본 발명의 일 실시예에 따른 두개골 성형술용 인공골편의 사시도이고, 도 4는 도 3의 A-A선 단면도이다. 또한, 도 5는 도 4에 도시한 인공골편의 동작을 설명하기 위한 단면도이다. 그리고, 도 6은 도 3의 B-B선 단면도이며, 도 7은 도 3에 도시한 두피고정부의 분해 사시도이다. 도 8은 도 7에 도시한 두피고정부의 사용 방식을 설명하기 위한 도면이고, 도 9는 도 7에 도시한 두피고정부의 단면도이다.3 is a perspective view of an artificial bone piece for cranioplasty according to an embodiment of the present invention, and FIG. 4 is a cross-sectional view taken along line A-A of FIG. 3 . In addition, Figure 5 is a cross-sectional view for explaining the operation of the artificial bone piece shown in Figure 4. And, FIG. 6 is a cross-sectional view taken along line B-B of FIG. 3 , and FIG. 7 is an exploded perspective view of the scalp fixing unit shown in FIG. 3 . FIG. 8 is a view for explaining a method of using the scalp fixing unit shown in FIG. 7 , and FIG. 9 is a cross-sectional view of the scalp fixing unit shown in FIG. 7 .

도시한 바와 같이, 본 실시예에 따른 두개골 성형술용 인공골편(30)은, 골편본체(31), 내측팽창부(70), 외측보형부(40), 봉합사고정부(50)를 갖는다. As shown, the artificial bone piece 30 for cranioplasty according to this embodiment has a bone piece body 31 , an inner expansion part 70 , an outer shape part 40 , and a suture accident part 50 .

골편본체(31)는, 본시멘트나 합성수지 또는 금속으로 제작된 것으로서, 두개골 천공술의 시행 후 남겨진 두개골 개방부(12), 즉 구멍에 장착되어, 구멍을 막을 수 있는 형상을 갖는다. 이러한 골편본체(31)는 3D프린터나 기타 종전 제작 방식을 통해 제작할 수 있다.The bone fragment body 31 is made of bone cement, synthetic resin or metal, and is mounted on the skull opening 12 left after the perforation of the skull is performed, that is, the hole, and has a shape that can block the hole. This bone fragment body 31 can be manufactured through a 3D printer or other conventional manufacturing method.

내측팽창부(70)는, 팽창백(71)과 제1통로부(77)를 구비한다. 팽창백(71)은, 골편본체(31)의 내측부(뇌를 향하는 오목한 면)에 고정되며, 골편본체와의 사이에 밀폐공간(71a)을 제공하는 시트형 부재이다.The inner inflation unit (70) includes an inflation bag (71) and a first passage portion (77). The inflation bag 71 is a sheet-like member that is fixed to the inner side (a concave surface facing the brain) of the bone fragment body 31, and provides a closed space (71a) between the bone fragment body and the body.

또한, 제1통로부(77)는, 골편본체(31)에 설치되고, 외부로부터 제공되는 유체를 밀폐공간(71a)으로 유도하여 팽창백(71)이 팽창하도록 한다. 팽창백(71)은, 제1통로부(77)를 통해 주입된 유체에 의해 팽창하여 골편본체가 커버하고 있는 경막외공간(도 2의 19)을 점유한다.In addition, the first passage portion 77 is installed in the bone fragment body 31, and induces the fluid provided from the outside into the closed space (71a) so that the inflation bag 71 is inflated. The inflation bag 71 is expanded by the fluid injected through the first passage 77 and occupies the epidural space (19 in FIG. 2 ) covered by the bone fragment body.

팽창백(71)을 부풀려 경막외공간(19)을 채우는 이유는, 경막외공간(19)이 비어 있을 경우, 삼출물이나 혈액이 고이기 때문이다. 고여 있는 삼출물이나 혈액은 염증을 일으킬 수 있다. 팽창백(71)의 팽창정도는 경막외공간(19)의 부피에 따라 당연히 달라진다. 즉, 경막외공간(19)이 클수록 팽창백(71)을 크게 팽창시키는 것이다.The reason for filling the epidural space 19 by inflating the inflatable bag 71 is that exudate or blood accumulates when the epidural space 19 is empty. Accumulated exudate or blood can cause inflammation. The degree of expansion of the inflatable bag 71 naturally depends on the volume of the epidural space 19 . That is, the larger the epidural space 19 is, the larger the inflation bag 71 is.

위에 언급한 바와 같이, 팽창백(71)은 시트형 부재로서, 그 외곽부가 골편본체(31)의 내측면에 접착 고정된다. 골편본체(31)에 대한 팽창백(71)의 고정은 의료용 접착제로 이루어진다. 아울러 팽착백(71)은 방수성 시트로서 탄성력을 가질 수 있다. 팽창백(71)의 소재로서 의료용 실리콘을 사용 가능하다.As mentioned above, the inflatable bag 71 is a sheet-like member, and its outer portion is adhesively fixed to the inner surface of the bone fragment body 31 . The fixation of the inflatable bag 71 to the bone fragment body 31 is made of a medical adhesive. In addition, the inflatable bag 71 may have elasticity as a waterproof sheet. Medical silicone can be used as a material of the inflatable bag 71 .

제1통로부(77)를 설치하기 위하여 골편본체(31)에는 암나사구멍(31f)이 형성되어 있다. 암나사구멍(31f)은 내주면에 암나사산이 형성되어 있는 관통구멍이다.A female screw hole (31f) is formed in the bone piece body (31) in order to install the first passage (77). The female threaded hole 31f is a through hole in which a female thread is formed on the inner peripheral surface.

제1통로부(77)는, 밀폐플러그(73)와 보호커버(75)를 갖는다. 밀폐플러그(73)는 암나사구멍(31f)내에 나사 결합하는 부재로서, 암나사구멍(31f)의 통로를 차단하고, 주사기(80)의 주사바늘(81)을 통과시키는 연질부재이다. 밀폐플러그(73)의 중심부에는 가이드홈(73a)이 형성되어 있다. 가이드홈(73a)는 주사바늘(81)의 사용 시, 주사바늘의 바람직한 피어싱 위치를 알려주는 홈이다.The first passage portion (77) has a sealing plug (73) and a protective cover (75). The sealing plug 73 is a member screwed into the female screw hole 31f, and is a soft member that blocks the passage of the female screw hole 31f and allows the injection needle 81 of the syringe 80 to pass therethrough. A guide groove (73a) is formed in the center of the sealing plug (73). The guide groove (73a) is a groove that informs the preferred piercing position of the needle when using the injection needle (81).

또한, 보호커버(75)는 골편본체(31)의 외측부에서 밀폐플러그(73)를 커버하여 보호하는 역할을 한다. 보호커버(75)는 일정두께를 갖는 판상부재로서, 밀폐플러그(73)와 같은 재질을 가질 수 있다. 도면부호 31h는 보호커버(75)를 수용 고정하는 홀딩홈이다. 보호커버(75)는 홀딩홈(31h)에 삽입된 상태로, 골편본체(31)의 표면으로 돌출되지 않는다.In addition, the protective cover 75 serves to cover and protect the sealing plug 73 from the outer portion of the bone fragment body (31). The protective cover 75 is a plate-shaped member having a certain thickness, and may have the same material as the sealing plug 73 . Reference numeral 31h denotes a holding groove for receiving and fixing the protective cover 75 . The protective cover 75 is inserted into the holding groove (31h), does not protrude to the surface of the bone fragment body (31).

상기 밀폐공간(71a)에 유체를 주입하기 위해서는, 먼저, 도 5에 도시한 바와 같이 보호커버(75)를 개방한다. 보호커버(75)를 개방함에 따라 밀폐플러그(73)가 노출된다. 사용자는 밀폐플러그(73)의 가이드홈(73a)에 주사바늘(81)을 위치시키고 주사바늘을 찔러 밀폐플러그(73)를 통과시킨 후 유체를 주입한다. 유체는 밀폐공간(71a)을 팽창시킬 수 있는 한 여러 가지 종류를 사용할 수 있으며, 가령, 공기나 식염수를 포함할 수 있다. In order to inject the fluid into the sealed space 71a, first, as shown in FIG. 5, the protective cover 75 is opened. As the protective cover 75 is opened, the sealing plug 73 is exposed. The user places the injection needle 81 in the guide groove 73a of the sealing plug 73, pierces the injection needle, passes the sealing plug 73, and then injects the fluid. As long as the fluid can inflate the closed space 71a, various types may be used, and for example, it may include air or saline.

유체의 주입에 의해 팽창백(71)이 필요한 만큼 팽창되었다면, 주사바늘(81)을 빼낸 후 홀딩홈(31h)에 보호커버(75)를 끼운다. 또한 환자 상태의 변화에 따라, 팽창백(71)을 수축시켜야 할 경우에는, 밀폐플러그(73)를 통해 주사바늘을 다시 삽입한 후 유체를 흡입하여 외부로 빼낸 후 보호커버(75)를 닫는다.If the inflation bag 71 has been inflated as much as necessary by injection of the fluid, the injection needle 81 is removed and the protective cover 75 is inserted into the holding groove 31h. Also, when the inflation bag 71 needs to be contracted according to a change in the patient's condition, the injection needle is re-inserted through the sealing plug 73, the fluid is sucked out, and the protective cover 75 is closed.

한편, 외측보형부(40)는, 골편본체(31)의 외측부에 설치되는 것으로서, 외부로부터 주입된 유체에 의해 팽창하여 머리의 외부 형상을 보정하는 역할을 한다. 예를 들어, 측두근의 위축에 의해 골편본체(31)가 내측으로 함몰될 경우, 함몰된 만큼 팽창시켜 머리의 모양을 정상범위로 보정하는 것이다.On the other hand, the lateral prosthesis 40, as being installed on the outer side of the bone fragment body 31, expands by the fluid injected from the outside serves to correct the external shape of the head. For example, when the bone fragment body 31 is depressed inward due to atrophy of the temporal muscle, it expands as much as it is depressed to correct the shape of the head to a normal range.

외측보형부(40)는, 보형백(41)과 제2통로부(43)를 포함한다. 외측보형부(40)는 다수 개가 적용될 수 있다, 다수의 보형백 중 함몰 위치에 따라 사용되는 외측보형부가 있는 반면 사용되지 않는 외측보형부도 있다. 즉 함몰부위에 위치한 외측보형부(40)만 사용되는 것이다. 하지만 상황에 따라 모두 다 사용될 수도 있다. 외측보형부(40)는 도 8에 도시한 바와 같이 두피(15)에 의해 커버된다.The outer shape-retaining part 40 includes a shape-retaining bag 41 and a second passage part 43 . A plurality of lateral prosthetic parts 40 may be applied. Among the plurality of prosthetic bags, there are lateral prosthetic parts that are used depending on the recessed position, while there are lateral prosthetic parts that are not used. That is, only the outer protrusion 40 located in the depression is used. However, all of them may be used depending on the situation. The outer prosthesis 40 is covered by the scalp 15 as shown in FIG. 8 .

보형백(41)은, 골편본체(31)의 외측면에 고정되고 골편본체와의 사이에 밀폐공간(41a)을 제공하는 시트형 부재이다. 보형백(41)은 팽창백(71)과 같은 소재로 제작될 수 있으며, 골편본체(31)에 대해 의료용 접착제로 고정된다.The prosthetic bag 41 is a sheet-like member that is fixed to the outer surface of the bone fragment body 31 and provides a closed space (41a) between the bone fragment body and the body. The prosthetic bag 41 may be made of the same material as the inflatable bag 71 , and is fixed to the bone fragment body 31 with a medical adhesive.

제2통로부(43)는, 각 보형백(41)의 측부에 장착되며, 외부로부터 제공된 유체를 보형백(41) 내부로 유도하는 역할을 한다. 제2통로부(43)는, 캡고정구멍(43c), 밀폐캡(43e), 홀딩홈(43a), 차단판(43f)을 포함한다.The second passage part 43 is mounted on the side of each of the cosmetic bags 41 , and serves to guide the fluid provided from the outside into the interior of the cosmetic bag 41 . The second passage portion 43 includes a cap fixing hole 43c, a sealing cap 43e, a holding groove 43a, and a blocking plate 43f.

캡고정구멍(43c)은 보형백(41)에 형성된 관통구멍으로서 밀폐캡(43e)을 수용 고정하는 통로이다. 또한 밀폐캡(43e)은 캡고정구멍(43c)에 끼워지며 주사바늘을 통과시킨다. 주사바늘로 밀폐캡(43e)을 찔러, 밀폐공간(41a)에 유체를 주입하거나 주입된 유체를 외부로 빼낼 수 있다. The cap fixing hole 43c is a through hole formed in the shape retaining bag 41 and is a passage for receiving and fixing the sealing cap 43e. In addition, the sealing cap (43e) is fitted in the cap fixing hole (43c) and passes the injection needle. By piercing the sealing cap (43e) with an injection needle, the fluid can be injected into the sealed space (41a) or the injected fluid can be withdrawn to the outside.

홀딩홈(43a)은 밀폐캡(43e)을 그 내부 영역에 포함하는 사각홈으로서 차단판(43f)을 수용 고정하는 역할을 한다. 차단판(43f)을 홀딩홈(43a)에 삽입함으로써 밀폐캡(43e)이 보호된다. 밀폐캡(43e)이나 차단판(43f)은, 위에 설명한 밀폐플러그(73) 및 보호커버(75)와 동일한 소재로 제작할 수 있다.The holding groove 43a is a rectangular groove including the sealing cap 43e in its inner region, and serves to receive and fix the blocking plate 43f. By inserting the blocking plate 43f into the holding groove 43a, the sealing cap 43e is protected. The sealing cap 43e or the blocking plate 43f may be made of the same material as the sealing plug 73 and the protective cover 75 described above.

봉합사고정부(50)는, 두피(15)와 골편본체(31)를 상호 고정시키는 역할을 한다. 골편본체(31)가 개방부(12)에 정위치되고, 내측팽창부(70) 및 외측보형부(40)에 대한 필요 과정이 완료된 후, 두피(15)를 씌워 봉합하여야 하는데, 이 때 골편본체(31)에 두피를 고정시키는 것이다.The suture accident part 50 serves to mutually fix the scalp 15 and the bone fragment body 31 . After the bone fragment body 31 is positioned in the open portion 12 and the necessary processes for the inner expansion portion 70 and the outer prosthesis portion 40 are completed, the scalp 15 should be covered and sutured, at this time the bone fragment It is to fix the scalp to the main body (31).

봉합사고정부(50)를 장착하기 위해 골편본체(31)에는 다수의 끼움구멍(31c)이 형성되어 있다. 끼움구멍(31c)은 골편본체(31)를 관통하는 장공형 관통구멍으로서 내주면에 지지턱(31e)을 갖는다.A plurality of fitting holes (31c) are formed in the bone fragment body (31) to mount the suture accident part (50). The fitting hole (31c) has a support protrusion (31e) on the inner peripheral surface as a long hole-type through-hole penetrating the bone piece body (31).

또한, 봉합사고정부(50)는, 두 개의 봉합사통로(55)가 형성되어 있는 봉합사홀더(50a)와 실리콘마개(57)를 포함한다. 봉합사홀더(50a)는 합성수지로 성형 제작된 것으로서, 삽입부(51)와 걸림부(53)를 갖는다. 삽입부(51)는 끼움구멍(31c)에 삽입되는 부분이고, 걸림부(53)는 지지턱(31e)에 걸리는 부분이다. 상기 봉합사홀더(50a)는 끼움구멍(31c)에 대해 착탈 가능하다.In addition, the suture accident part 50 includes a suture holder 50a and a silicone stopper 57 in which two suture passages 55 are formed. The suture holder 50a is molded and manufactured from synthetic resin, and has an insertion portion 51 and a locking portion 53 . The insertion part 51 is a part inserted into the fitting hole 31c, and the locking part 53 is a part caught on the support jaw 31e. The suture holder 50a is detachable with respect to the fitting hole 31c.

아울러 실리콘마개(57)는 의료용 연질 실리콘으로서 봉합용 바늘(미도시)을 통과시킨다. 봉합용 바늘에 꿰어 있는 봉합사(61)가, 도 9에 도시한 바와 같이, 실리콘마개(57)를 통과할 수 있는 것이다.In addition, the silicone stopper 57 passes through a suture needle (not shown) as medical soft silicone. The suture 61 threaded on the suture needle can pass through the silicone stopper 57 as shown in FIG. 9 .

상기 구성을 갖는 봉합사고정부는, 봉합사(61)를 통해 두피(15)와 결합한 상태로 끼움구멍(31c)에 박혀 고정된다. 즉, 골편본체(31)에 두피를 먼저 씌운 상태에서, 두피(15)를 골편본체(31)에 고정시키는 것이 아니라, 두피(15)에 봉합사고정부(50)를 먼저 고정하고, 그 후 봉합사고정부(50)를 끼움구멍(31c)에 박아 고정하는 것이다. 이와 같이, 봉합사고정부(50)를 두피(15)에 먼저 결합한 상태로 골편본체(31)에 고정시키므로 두피의 고정이 한결 수월하다. 상기 골편본체(31)에 대한 봉합사홀더(50a)의 결합은 의료용 접착제를 통해 유지된다.The suture accident part having the above configuration is fixed by being inserted into the fitting hole 31c in a state in which it is coupled to the scalp 15 through the suture 61 . That is, in a state in which the scalp is first covered on the bone fragment body 31, rather than fixing the scalp 15 to the bone fragment body 31, the suture accident part 50 is first fixed to the scalp 15, and then sutured It is to fix the accident part 50 by driving it into the fitting hole 31c. As such, since the suture accident part 50 is fixed to the bone fragment body 31 in a state in which it is first coupled to the scalp 15, the fixing of the scalp is much easier. The bonding of the suture holder 50a to the bone fragment body 31 is maintained through a medical adhesive.

이상, 본 발명을 구체적인 실시예를 통하여 상세하게 설명하였으나, 본 발명은 상기 실시예에 한정하지 않고, 본 발명의 기술적 사상의 범위 내에서 통상의 지식을 가진 자에 의하여 여러 가지 변형이 가능하다.As mentioned above, although the present invention has been described in detail through specific embodiments, the present invention is not limited to the above embodiments, and various modifications are possible by those of ordinary skill within the scope of the technical spirit of the present invention.

11:두개골 12:개방부 13:인공골편
15:두피 16:뇌 17:경막
19:경막외공간 30:인공골편 31:골편본체
31c:끼움구멍 31e:지지턱 31f:암나사구멍
31h:홀딩홈 40:외측보형부 41:보형백
41a:밀폐공간 43:제2통로부 43a:홀딩홈
43c:캡고정구멍 43e:밀폐캡 43f:차단판
50:봉합사고정부 50a:봉합사홀더 51:삽입부
53:걸림부 55:봉합사통로 57:실리콘마개
61:봉합사 70:내측팽창부 71:팽창백
71a:밀폐공간 73:밀폐플러그 73a:가이드홈
75:보호커버 77:제1통로부 80:주사기
81:주사바늘11: skull 12: open part 13: artificial bone piece
15: scalp 16: brain 17: dura mater
19: epidural space 30: artificial bone piece 31: bone piece body
31c: Fitting hole 31e: Support jaw 31f: Female thread hole
31h: holding groove 40: external prosthesis 41: prosthetic bag
41a: closed space 43: second passage 43a: holding home
43c: cap fixing hole 43e: sealing cap 43f: blocking plate
50: suture accident part 50a: suture holder 51: insertion part
53: locking part 55: suture passage 57: silicone stopper
61: suture 70: inner expansion part 71: expansion bag
71a: sealed space 73: sealed plug 73a: guide groove
75: protective cover 77: first passage 80: syringe
81: injection needle

Claims (9)

두개골 천공술의 시행 후 남겨진 두개골 개방부에 장착되어 개방부를 커버하는 골편본체와;
상기 골편본체에 장착되며 외부로부터 주입된 유체에 의해 팽창하여 골편본체가 커버하고 있는 경막외공간을 점유하는 내측팽창부를 포함하는,
두개골 성형술용 인공골편.a bone fragment body mounted on the skull opening left after the perforation of the skull and covering the opening;
It is mounted on the bone fragment body and expands by the fluid injected from the outside, including an inner expansion part occupying the epidural space covered by the bone fragment body,
Artificial bone fragments for cranioplasty. 제1항에 있어서,
상기 내측팽창부는;
상기 골편본체의 내측면에 고정되며 골편본체와의사이에 밀폐공간을 제공하고 상기 주입유체에 의해 팽창 가능한 팽창백과,
상기 골편본체에 설치되고, 외부로부터 제공되는 유체를 상기 밀폐공간으로 유도하는 제1통로부를 갖는,
두개골 성형술용 인공골편.According to claim 1,
The inner expansion unit;
An inflatable bag fixed to the inner surface of the bone fragment body and providing a closed space between the bone fragment body and inflatable by the injection fluid;
It is installed in the bone fragment body, having a first passage for guiding the fluid provided from the outside to the closed space,
Artificial bone fragments for cranioplasty. 제2항에 있어서,
상기 골편본체에는 암나사구멍이 형성되어 있고,
상기 제1통로부는;
상기 암사사구멍에 나사 결합하고 주사바늘을 통과시키는 밀폐플러그와,
상기 골편본체의 외측부에서 밀폐플러그를 커버하여 보호하는 보호커버를 포함하는,
두개골 성형술용 인공골편.3. The method of claim 2,
The bone piece body is formed with a female screw hole,
The first passage portion;
A sealing plug that is screwed into the female thread hole and passes the needle through;
Containing a protective cover to cover and protect the sealing plug from the outer part of the bone fragment body,
Artificial bone fragments for cranioplasty. 제1항에 있어서,
상기 골편본체의 외측부에는,
외부로부터 주입된 유체에 의해 팽창하여 머리의 외부 형상을 보정하는 외측보형부가 더 구비되는,
두개골 성형술용 인공골편.According to claim 1,
On the outer side of the bone fragment body,
An outer prosthesis part that expands by the fluid injected from the outside to correct the external shape of the head is further provided,
Artificial bone fragments for cranioplasty. 제4항에 있어서,
상기 외측보형부는;
골편본체의 외측면에 고정되고, 골편본체와의 사이에 밀폐공간을 제공하는 보형백과,
상기 보형백에 장착되며, 외부로부터 제공된 유체를 보형백 내부로 유도하는 제2통로부를 포함하는,
두개골 성형술용 인공골편.5. The method of claim 4,
The outer protrusion part;
A prosthetic bag that is fixed to the outer surface of the bone piece body and provides a closed space between the bone piece body and the body;
It is mounted on the prosthetic bag and includes a second passage for guiding the fluid provided from the outside into the prosthetic bag,
Artificial bone fragments for cranioplasty. 제5항에 있어서,
상기 제2통로부는;
보형백에 형성된 캡고정구멍과,
상기 캡고정구멍에 끼워지며 주사바늘을 통과시키는 밀폐캡과,
상기 밀폐캡을 커버하여 보호하는 차단판을 포함하는,
두개골 성형술용 인공골편.6. The method of claim 5,
the second passage part;
A cap fixing hole formed in the shape retaining bag,
A sealing cap fitted into the cap fixing hole and passing the needle through;
Including a blocking plate to cover and protect the sealing cap,
Artificial bone fragments for cranioplasty. 제1항에 있어서,
상기 골편본체에는;
두피를 골편본체에 고정시키기 위한 봉합사와 결합하는 것으로서, 골편본체에 대해 착탈 가능한 봉합사고정부가 더 구비되는,
두개골 성형술용 인공골편.According to claim 1,
In the bone fragment body;
As combined with a suture for fixing the scalp to the bone piece body, a suture accident part detachable for the bone piece body is further provided,
Artificial bone fragments for cranioplasty. 제7항에 있어서,
상기 골편본체에는 다수의 끼움구멍이 형성되어 있고,
상기 봉합사고정부는,
상기 봉합사와 결합한 상태로 상기 끼움구멍에 박혀 고정되는 봉합사홀더인,
두개골 성형술용 인공골편.8. The method of claim 7,
A plurality of fitting holes are formed in the bone fragment body,
The suture accident government,
It is a suture holder that is fixed in the fitting hole in a state coupled with the suture,
Artificial bone fragments for cranioplasty. 제8항에 있어서,
상기 봉합사홀더는;
봉합사가 통과하는 다수의 봉합사통로를 가지고,
각 봉합사통로에는 봉합용 바늘을 통과시키는 실리콘마개가 내장된,
두개골 성형술용 인공골편.9. The method of claim 8,
The suture holder;
Having a plurality of suture passages through which the suture passes,
Each suture passage has a built-in silicone stopper that allows the suture needle to pass.
Artificial bone fragments for cranioplasty.
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