WO2020171493A1 - Stent having double edge grooves for bile discharge and biliary tract cancer biopsies - Google Patents

Stent having double edge grooves for bile discharge and biliary tract cancer biopsies Download PDF

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Publication number
WO2020171493A1
WO2020171493A1 PCT/KR2020/002188 KR2020002188W WO2020171493A1 WO 2020171493 A1 WO2020171493 A1 WO 2020171493A1 KR 2020002188 W KR2020002188 W KR 2020002188W WO 2020171493 A1 WO2020171493 A1 WO 2020171493A1
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stent
bile duct
wall
biliary tract
tract cancer
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PCT/KR2020/002188
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French (fr)
Korean (ko)
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이종찬
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서울대학교병원
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy

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  • the present invention relates to a medical stent, and more particularly, to a stent for biliary discharge and biliary cancer biopsy that can conveniently obtain bile duct epithelial tissue for a biopsy to determine whether or not biliary tract cancer.
  • Bile is made in the liver and sent to the duodenum, and the path connecting the liver and duodenum is called the bile duct.
  • the part that passes through the liver is called the intrahepatic bile duct, and the part from the outside of the liver to the part connected to the duodenum is also classified as an extrahepatic bile duct.
  • Biliary duct cancer or bile duct cancer refers to a malignant tumor that occurs in the epithelium of the biliary tract. In the early stages, most patients have no symptoms, but when the bile duct is blocked due to a tumor, painless jaundice and jaundice urine symptoms appear. Biliary duct obstruction progresses slowly and there are no initial symptoms, so when biliary tract cancer is clinically diagnosed, it is already quite advanced.
  • the operator can perform a biopsy while directly viewing the lesion on the endoscopic screen.
  • Bory duct cancer is located inside the bile duct so that the lesion is not viewed directly, but is almost entirely on a two-dimensional screen through fluoroscopy.
  • a tissue biopsy should be performed as in a nearly blinded experiment.
  • biopsy using a general endoscope can obtain tissue while looking at the lesion in front, but in the case of biopsy of biliary tract cancer, biopsy forceps and biliary wall are arranged at about 90 degrees, so the amount of tissue that can be obtained is very small. . Because of this, in the case of biliary tract cancer, the diagnostic yield according to the traditional biopsy is only about 50%. In most cases, when the tumor is diagnosed only by imaging without histological confirmation, and then a treatment policy such as surgery is determined. There are many.
  • the stent for biliary cancer biopsy is a stent inserted into the bile duct for biliary cancer biopsy: a zigzag-shaped groove is formed on the outer wall of the insertion tube made of synthetic resin.
  • the groove portion includes a bottom portion, a first sidewall connecting one side of the bottom portion and the outer wall, and a second sidewall connecting the other side of the bottom portion and the outer wall, and consisting of the first sidewall and the outer wall.
  • the first corner portion collects the bile duct epithelial tissue when the stent is inserted into the bile duct
  • the second corner portion composed of the second side wall and the outer wall stores the bile duct epithelial tissue collected when the stent is withdrawn from the bile duct
  • an artificial polymer used as an extracellular matrix for three-dimensional cell culture of the collected bile duct epithelial tissue and a cell growth inducing agent for inducing cell growth may be formed.
  • the first and second corners are disposed to face each other in the longitudinal direction of the insertion tube, and each corner may have an acute angle.
  • the artificial polymer may be a hydrogel, a scaffold, or a decellularized extracellular matrix (dECM).
  • dECM decellularized extracellular matrix
  • the cell growth inducing agent may be a cytokine.
  • Biliary duct cancer biopsy stent has a dual edge groove (dual edge groove), specifically, the groove formed in the outer wall of the cannula consists of two corners.
  • the first corner part serves to scrape the bile duct epithelial tissue when inserting the stent into the bile duct, and the second corner part securely holds the cell cultured epithelial tissue in the groove when the stent is pulled out from the bile duct so that it can be extracted to the outside.
  • the stent for bile duct cancer biopsy according to the present invention is maintained for about 2 to 3 days after being inserted into the bile duct, during which the bile duct epithelial tissue collected from the lesion using an artificial polymer and a cell growth inducing agent provided in the groove 3D cell culture. Therefore, since a sufficient amount of cells can be obtained, the diagnosis rate of biliary tract cancer can be increased.
  • biliary tract obstruction may be solved.
  • FIG. 1 is a human anatomy diagram showing a process of inserting a stent for biliary cancer biopsy according to an embodiment of the present invention.
  • FIG. 2 is a perspective view showing a stent for biliary cancer biopsy according to an embodiment of the present invention.
  • FIG. 3 is a cross-sectional view of the stent of FIG. 2 taken along line AA′.
  • FIG. 1 is a human anatomy diagram showing a process of inserting a stent for bile discharge and biliary cancer biopsy according to an embodiment of the present invention.
  • the stent for biliary tract cancer biopsy of the present invention is inserted into the bile duct 342 using an endoscopic system.
  • the endoscope system includes an endoscope 40 inserted into the body, a control device that receives photographic information from the endoscope 40 and performs image processing, and a monitor that displays image-processed image information from the control device.
  • the endoscope 40 is inserted into a tube in the insertion part through an opening formed on the side of the handle and a handle part that controls the movement of the endoscope by hand, an insertion part connected to the handle part and inserted into the body. It may include a catheter 42 protruding from the tip.
  • the endoscope 40 of the present invention may include a sideoscope for observing and examining the duodenum 320, the duodenal papilla 322, the bile duct 342, and the pancreatic duct 332. That is, in the case of using a sideoscope with a photographing unit, an illumination unit, and a catheter 42 installed on the distal end of the endoscope 40, the catheter 42 is conveniently inserted into the bile duct 342 while observing the duodenal papilla 322 in the front. can do. After the catheter 42 is inserted into the bile duct 342, a contrast agent is injected to observe the stricture or expansion of the bile duct 342, gallstones, tumors, etc., and a fluoroscopic picture may be taken.
  • the stent of the present invention is compressed and inserted into the catheter 42, and a guide wire may be located inside the stent and the catheter 42.
  • the stent may be introduced into the lesion 344 in the bile duct 342 in the following manner. First, through the endoscope 40, when the guide wire passes through the duodenal papilla 322 and passes through the lesion 344 in the bile duct 342, the catheter 42 with the stent attached along the guide wire is the lesion 344 ) To pass. When the catheter 42 is retracted from the lesion 344, the stent is exposed and expands to expand the constricted lesion 344.
  • the stent of the present invention collects the bile duct epithelial tissue in the process of being installed in the lesion 344 and maintains the collected bile duct epithelial tissue for several days at the lesion 344, for example, for 2 to 3 days. Cells are cultured and used for later biliary cancer biopsy.
  • FIGS. 2 and 3 are perspective views showing a stent for biliary cancer biopsy according to an embodiment of the present invention.
  • 3 is a cross-sectional view of the stent of FIG. 2 taken along line AA′.
  • the stent 100 of the present invention is composed of a tube-shaped insertion tube 101 as a whole and a groove portion 110 formed in a zigzag shape on the outer wall 102 of the insertion tube 101.
  • the insertion tube 101 is made of an elastic synthetic resin, for example, a silicone material. Therefore, when the insertion tube 101 is inserted into the catheter 42 in a compressed state and then exposed to the outside of the catheter 42, it is restored to its original shape, and the path of movement of the bile 10 is secured to solve biliary tract obstruction. have.
  • the stent 100 of the present invention has a special structure for biopsy of biliary tract cancer in the process of being inserted into the bile duct 342.
  • the groove portion 110 includes a bottom portion 114, a first side wall 113 connecting one side of the bottom portion 114 and the outer wall 102, and the other side and the outer wall 102 of the bottom portion 114. It includes a second sidewall 115 connecting.
  • the first corner part 112 made of the first side wall 113 and the outer wall 102 is collected by scratching the bile duct epithelial tissue when the stent 100 is inserted into the bile duct 342.
  • the second edge portion 116 consisting of the second side wall 115 and the outer wall 102 safely stores the previously collected bile duct epithelial tissue in the bottom portion 114 when the stent 100 is withdrawn from the bile duct 342. It acts as a fence.
  • the first edge portion 112 and the second edge portion 116 may be disposed to face each other in the longitudinal direction of the insertion tube 101.
  • the first corner portion 112 is preferably made of a sharp reservation to effectively collect tissue from the lesion.
  • the second corner portion 116 is preferably made of an acute angle so that the tissue collected when the stent 100 is pulled out is not swept to the outside and is well stored.
  • the practitioner maintains the stent 100 in the state of being inserted into the bile duct for a biopsy of biliary tract cancer for several days, and performs three-dimensional cell culture on the collected bile duct epithelial tissue.
  • an artificial polymer 200 and a cell growth inducer 202 are formed in the bottom portion 114 of the groove portion 110.
  • the artificial polymer 200 is used as an extracellular matrix for 3D cell culture, and may be formed of, for example, a hydrogel, a scaffold, or a decellularized extracellular matrix (dECM).
  • the cell growth inducing agent 202 is a substance that induces cell growth of the bile duct epithelial tissue, and may be made of, for example, cytokines.
  • the size of the groove portion 110 it is preferable to design the size of the groove portion 110 so that the inner wall of the bile duct 342 can physically contact the artificial polymer 200 while the stent 100 is inserted into the bile duct 342, in this case More effectively, three-dimensional cell culture can be performed.

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Abstract

Provided is a stent for bile discharge and biliary tract cancer biopsies, with which a biopsy for biliary tract cancer can be conveniently performed. This stent has a zigzag-shaped groove portion which is formed on the outer wall of an insertion tube made of synthetic resin. The groove portion includes a bottom portion, a first side wall connecting one side of the bottom portion to the outer wall, and a second side wall connecting the other side of the bottom portion to the outer wall. A first edge portion formed by the first side wall and the outer wall collects bile duct epithelial tissue when the stent is inserted into a bile duct, and a second edge portion formed by the second side wall and the outer wall stores the collected bile duct epithelial tissue when the stent is withdrawn from the bile duct. Also, artificial polymer, which is used as an extracellular matrix for 3-dimensional cell culturing of the collected bile duct epithelial tissue, and a cell growth inducer for inducing cell growth are formed in the bottom portion.

Description

이중 모서리 홈을 가진 담즙배출 및 담도암 조직검사용 스텐트Bile drainage and bile duct cancer biopsy stent with double corner groove
본 발명은 의료용 스텐트에 관한 것으로서, 더욱 상세하게는 담도암 여부를 판단하기 위한 조직검사를 위해 담관 상피 조직을 편리하게 수득할 수 있는 담즙배출 및 담도암 조직검사용 스텐트에 관한 것이다.The present invention relates to a medical stent, and more particularly, to a stent for biliary discharge and biliary cancer biopsy that can conveniently obtain bile duct epithelial tissue for a biopsy to determine whether or not biliary tract cancer.
담즙은 간에서 만들어져 십이지장으로 보내지는데, 간과 십이지장을 잇는 길을 담관이라 한다. 간 속을 지나는 부분을 간내담관이라 하고, 간 밖으로 나온 부분부터 십이지장에 연결된 부분까지를 간외담관이라 구분하기도 한다.Bile is made in the liver and sent to the duodenum, and the path connecting the liver and duodenum is called the bile duct. The part that passes through the liver is called the intrahepatic bile duct, and the part from the outside of the liver to the part connected to the duodenum is also classified as an extrahepatic bile duct.
담도암 또는 담관암은 담관 상피에서 생기는 악성 종양을 말한다. 초기 단계에서는 대부분의 환자에게서 증상이 없지만 종양으로 인해 담관이 막히면 통증이 없는 황달과 황달뇨 증상이 나타난다. 담도 폐쇄는 서서히 진행되고 또한 초기 증상이 없기 때문에 임상적으로 담도암이 진단될 때에는 이미 상당히 진행되어 있는 경우가 많다.Biliary duct cancer or bile duct cancer refers to a malignant tumor that occurs in the epithelium of the biliary tract. In the early stages, most patients have no symptoms, but when the bile duct is blocked due to a tumor, painless jaundice and jaundice urine symptoms appear. Biliary duct obstruction progresses slowly and there are no initial symptoms, so when biliary tract cancer is clinically diagnosed, it is already quite advanced.
한편, 다른 소화기암의 경우 시술자가 내시경 화면으로 병변을 직접 보면서 조직 검사를 수행할 수 있는데, 담도암은 담관 내부에 위치해 있어서 병변을 직접 보는 게 아니라 투시 장비(fluoroscopy)를 통해 2차원 화면 상에서 거의 맹검(nearly blinded experiment)과 같이 조직 생검을 해야 한다. 더구나 일반 내시경을 이용한 조직 검사는 병변을 정면으로 보면서 조직을 수득할 수 있지만, 담도암의 조직 검사의 경우 생검용 포셉(forcep)과 담도 벽이 약 90도로 배치되어 있어서 수득 가능한 조직 양이 매우 적다. 이로 인해 담도암의 경우 전통적인 조직검사에 따른 진단적 검출률(diagnostic yield)이 50% 정도에 불과하기 때문에, 대부분의 경우 조직학적 확진 없이 영상학적 검사로만 종양을 진단한 후에 수술 등 치료방침을 정하는 경우가 많다.On the other hand, in the case of other gastrointestinal cancer, the operator can perform a biopsy while directly viewing the lesion on the endoscopic screen.Biliary duct cancer is located inside the bile duct so that the lesion is not viewed directly, but is almost entirely on a two-dimensional screen through fluoroscopy. A tissue biopsy should be performed as in a nearly blinded experiment. In addition, biopsy using a general endoscope can obtain tissue while looking at the lesion in front, but in the case of biopsy of biliary tract cancer, biopsy forceps and biliary wall are arranged at about 90 degrees, so the amount of tissue that can be obtained is very small. . Because of this, in the case of biliary tract cancer, the diagnostic yield according to the traditional biopsy is only about 50%. In most cases, when the tumor is diagnosed only by imaging without histological confirmation, and then a treatment policy such as surgery is determined. There are many.
본 발명이 해결하고자 하는 과제는, 담즙배출을 용이하게 하면서 편리하게 담도암의 조직검사를 수행할 수 있는 담도암 조직검사용 스텐트를 제공하고자 하는 것이다.It is an object to be solved by the present invention to provide a stent for biliary cancer biopsy that facilitates bile discharge and can conveniently perform a biopsy of biliary tract cancer.
본 발명이 해결하고자 하는 과제들은 이상에서 언급한 과제들로 제한되지 않으며, 언급되지 않은 또 다른 과제들은 아래의 기재로부터 당업자에게 명확하게 이해될 수 있을 것이다.The problems to be solved by the present invention are not limited to the problems mentioned above, and other problems that are not mentioned will be clearly understood by those skilled in the art from the following description.
상기 과제를 달성하기 위한 본 발명의 일 실시예에 따른 담도암 조직검사용 스텐트는, 담도암 조직검사를 위해 담관 내에 삽입되는 스텐트로서: 합성수지로 이루어진 삽입관의 외벽에 지그재그 형상의 홈부가 형성되고, 상기 홈부는, 바닥부와, 상기 바닥부의 일측과 상기 외벽을 연결하는 제1 측벽과, 상기 바닥부의 타측과 상기 외벽을 연결하는 제2 측벽을 포함하고, 상기 제1 측벽과 상기 외벽으로 이루어진 제1 모서리부는 담관에 스텐트가 인입될 때 담관 상피 조직을 채취하고, 상기 제2 측벽과 상기 외벽으로 이루어진 제2 모서리부는 담관에서 스텐트가 인출될 때 채취된 담관 상피 조직을 보관하고, 상기 바닥부에는, 채취된 담관 상피 조직의 3차원 세포배양을 위한 세포외기질로 사용되는 인공 폴리머와, 세포 생장을 유도하는 세포생장유도제가 형성될 수 있다.The stent for biliary cancer biopsy according to an embodiment of the present invention for achieving the above object is a stent inserted into the bile duct for biliary cancer biopsy: a zigzag-shaped groove is formed on the outer wall of the insertion tube made of synthetic resin. , The groove portion includes a bottom portion, a first sidewall connecting one side of the bottom portion and the outer wall, and a second sidewall connecting the other side of the bottom portion and the outer wall, and consisting of the first sidewall and the outer wall. The first corner portion collects the bile duct epithelial tissue when the stent is inserted into the bile duct, and the second corner portion composed of the second side wall and the outer wall stores the bile duct epithelial tissue collected when the stent is withdrawn from the bile duct, and the bottom portion In this, an artificial polymer used as an extracellular matrix for three-dimensional cell culture of the collected bile duct epithelial tissue and a cell growth inducing agent for inducing cell growth may be formed.
상기 제1 모서리부 및 제2 모서리부는 상기 삽입관의 길이방향으로 서로 대향하게 배치되고, 각 모서리부는 예각으로 이루어질 수 있다.The first and second corners are disposed to face each other in the longitudinal direction of the insertion tube, and each corner may have an acute angle.
상기 인공 폴리머는 하이드로겔, 스캐폴드(scaffold), 또는 탈세포화된 세포외기질(decellularized extracellular matrix, dECM)일 수 있다.The artificial polymer may be a hydrogel, a scaffold, or a decellularized extracellular matrix (dECM).
상기 세포생장유도제는 시토카인(cytokine)일 수 있다.The cell growth inducing agent may be a cytokine.
기타 실시예들의 구체적인 사항들은 구체적인 내용 및 도면들에 포함되어 있다.Specific details of other embodiments are included in the specific content and drawings.
상술한 바와 같이 본 발명에 따른 담도암 조직검사용 스텐트에 의하면, 3차원 세포배양을 이용하여 병변부의 담관 상피 조직을 효과적으로 수득하여 담도암 조직검사에 활용할 수 있다. 담도암 조직검사용 스텐트는 이중 모서리 홈(dual edge groove)을 가지는데, 구체적으로, 삽입관 외벽에 형성된 홈부는 두 개의 모서리부로 이루어져 있다. 제1 모서리부는 담관에 스텐트를 인입할 때 담관 상피 조직을 긁어서 채취하는 역할을 하며, 제2 모서리부는 담관으로부터 스텐트를 인출할 때 세포배양된 상피 조직을 홈부 내에 안전하게 담아서 외부로 추출할 수 있게 한다.As described above, according to the stent for biliary tract cancer biopsy according to the present invention, the bile duct epithelial tissue of the lesion can be effectively obtained by using three-dimensional cell culture and can be used for biliary cancer biopsy. Biliary duct cancer biopsy stent has a dual edge groove (dual edge groove), specifically, the groove formed in the outer wall of the cannula consists of two corners. The first corner part serves to scrape the bile duct epithelial tissue when inserting the stent into the bile duct, and the second corner part securely holds the cell cultured epithelial tissue in the groove when the stent is pulled out from the bile duct so that it can be extracted to the outside. .
또한, 본 발명에 따른 담도암 조직검사용 스텐트는 담관에 삽입된 후 2 내지 3일 정도 유지하게 되는데, 그 동안 홈부 내의 구비된 인공 폴리머와 세포생장유도제를 이용하여 병변부로부터 채취된 담관 상피 조직을 3차원 세포배양하게 된다. 따라서 충분한 양의 세포를 수득할 수 있기 때문에 담도암의 진단율을 높일 수 있다.In addition, the stent for bile duct cancer biopsy according to the present invention is maintained for about 2 to 3 days after being inserted into the bile duct, during which the bile duct epithelial tissue collected from the lesion using an artificial polymer and a cell growth inducing agent provided in the groove 3D cell culture. Therefore, since a sufficient amount of cells can be obtained, the diagnosis rate of biliary tract cancer can be increased.
나아가, 본 발명에 따른 담도암 조직검사용 스텐트는 담즙의 이동 경로를 확보할 수 있기 때문에 담도 폐쇄를 해결할 수도 있다.Further, since the stent for biliary tract cancer biopsy according to the present invention can secure a path of bile movement, biliary tract obstruction may be solved.
도 1은 본 발명의 일 실시에에 따른 담도암 조직검사용 스텐트를 인체에 삽입하는 과정을 나타낸 인체 해부도이다.1 is a human anatomy diagram showing a process of inserting a stent for biliary cancer biopsy according to an embodiment of the present invention.
도 2는 본 발명의 일 실시예에 따른 담도암 조직검사용 스텐트를 나타낸 사시도이다.2 is a perspective view showing a stent for biliary cancer biopsy according to an embodiment of the present invention.
도 3은 도 2의 스텐트를 AA'선으로 자른 단면도이다.3 is a cross-sectional view of the stent of FIG. 2 taken along line AA′.
본 발명의 이점 및 특징, 그리고 그것들을 달성하는 방법은 첨부되는 도면과 함께 상세하게 후술되어 있는 실시예들을 참조하면 명확해질 것이다. 그러나 본 발명은 이하에서 개시되는 실시예들에 한정되는 것이 아니라 서로 다른 다양한 형태로 구현될 것이며, 단지 본 실시예들은 본 발명의 개시가 완전하도록 하며, 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자에게 발명의 범주를 완전하게 알려주기 위해 제공되는 것이며, 본 발명은 청구항의 범주에 의해 정의될 뿐이다. 명세서 전체에 걸쳐 동일 참조 부호는 동일 구성 요소를 지칭한다.Advantages and features of the present invention, and a method of achieving them will become apparent with reference to the embodiments described below in detail together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but will be implemented in various forms different from each other, and only these embodiments make the disclosure of the present invention complete, and common knowledge in the technical field to which the present invention pertains. It is provided to completely inform the scope of the invention to those who have it, and the invention is only defined by the scope of the claims. The same reference numerals refer to the same components throughout the specification.
도 1은 본 발명의 일 실시에에 따른 담즙배출 및 담도암 조직검사용 스텐트를 인체에 삽입하는 과정을 나타낸 인체 해부도이다.1 is a human anatomy diagram showing a process of inserting a stent for bile discharge and biliary cancer biopsy according to an embodiment of the present invention.
본 발명의 담도암 조직검사용 스텐트는 내시경 시스템을 이용하여 담관(342) 내에 인입된다. 여기서, 내시경 시스템은 몸 속에 삽입되는 내시경(40)과, 내시경(40)으로부터 촬영정보를 수신하여 이미지 처리를 수행하는 제어장치와, 제어장치로부터의 이미지 처리된 영상정보를 디스플레이하는 모니터를 포함할 수 있다. 내시경(40)은 시술자가 손으로 잡아 내시경의 움직임을 제어하는 손잡이부와, 손잡이부에 연결되어 몸 속에 삽입되는 삽입부와, 손잡이부의 측부에 형성된 개구부를 통해 삽입부 내의 관으로 삽입되고 삽입부 선단으로 돌출되는 카테터(42)를 포함할 수 있다.The stent for biliary tract cancer biopsy of the present invention is inserted into the bile duct 342 using an endoscopic system. Here, the endoscope system includes an endoscope 40 inserted into the body, a control device that receives photographic information from the endoscope 40 and performs image processing, and a monitor that displays image-processed image information from the control device. I can. The endoscope 40 is inserted into a tube in the insertion part through an opening formed on the side of the handle and a handle part that controls the movement of the endoscope by hand, an insertion part connected to the handle part and inserted into the body. It may include a catheter 42 protruding from the tip.
본 발명의 내시경(40)은 십이지장(320), 십이지장 유두부(322), 담관(342), 및 췌관(332) 등을 관찰하여 검사하기 위한 측시경을 포함할 수 있다. 즉, 내시경(40) 선단 측부에 촬영부, 조명부 및 카테터(42)가 설치된 측시경을 이용하는 경우, 십이지장 유두부(322)를 정면으로 관찰하면서 담관(342)에 카테터(42)를 편리하게 삽입할 수 있다. 담관(342) 내부에 카테터(42)가 삽입된 후에, 조영제를 주입하여 담관(342)의 협착, 확장 여부나 담석, 종양 등을 관찰하면서 투시 사진을 촬영할 수 있다.The endoscope 40 of the present invention may include a sideoscope for observing and examining the duodenum 320, the duodenal papilla 322, the bile duct 342, and the pancreatic duct 332. That is, in the case of using a sideoscope with a photographing unit, an illumination unit, and a catheter 42 installed on the distal end of the endoscope 40, the catheter 42 is conveniently inserted into the bile duct 342 while observing the duodenal papilla 322 in the front. can do. After the catheter 42 is inserted into the bile duct 342, a contrast agent is injected to observe the stricture or expansion of the bile duct 342, gallstones, tumors, etc., and a fluoroscopic picture may be taken.
본 발명의 스텐트는 카테터(42) 내에는 압축되어 삽입되고, 안내 철사가 스텐트 및 카테터(42)의 안쪽에 위치할 수 있다. 다음과 같은 방식으로 스텐트를 담관(342) 내의 병변부(344)에 인입시킬 수 있다. 먼저 내시경(40)을 통해 안내 철사가 십이지장 유두부(322)를 통과하여 담관(342) 내의 병변부(344)를 지나가면, 안내 철사를 따라 스텐트를 장착한 카테터(42)가 병변부(344)를 지나가도록 위치시킨다. 병변부(344)에서 카테터(42)를 뒤로 후퇴시키면 스텐트가 노출되면서 팽창하여 협착된 병변부(344)를 확장시킨다. 또한, 본 발명의 스텐트는 병변부(344)에 설치되는 과정에서 담관 상피 조직을 채취하고 병변부(344)에서 수일 동안, 예를 들어 2 내지 3일정도 유지하면서 채취된 담관 상피 조직을 3차원 세포배양하여 추후 담도암 조직검사에 사용한다.The stent of the present invention is compressed and inserted into the catheter 42, and a guide wire may be located inside the stent and the catheter 42. The stent may be introduced into the lesion 344 in the bile duct 342 in the following manner. First, through the endoscope 40, when the guide wire passes through the duodenal papilla 322 and passes through the lesion 344 in the bile duct 342, the catheter 42 with the stent attached along the guide wire is the lesion 344 ) To pass. When the catheter 42 is retracted from the lesion 344, the stent is exposed and expands to expand the constricted lesion 344. In addition, the stent of the present invention collects the bile duct epithelial tissue in the process of being installed in the lesion 344 and maintains the collected bile duct epithelial tissue for several days at the lesion 344, for example, for 2 to 3 days. Cells are cultured and used for later biliary cancer biopsy.
이하 도 2 및 도 3을 참조하여 본 발명의 일 실시예에 따른 담도암 조직검사용 스텐트에 대해 자세히 설명한다. 도 2는 본 발명의 일 실시예에 따른 담도암 조직검사용 스텐트를 나타낸 사시도이다. 도 3은 도 2의 스텐트를 AA'선으로 자른 단면도이다.Hereinafter, a stent for biliary cancer biopsy according to an embodiment of the present invention will be described in detail with reference to FIGS. 2 and 3. 2 is a perspective view showing a stent for biliary cancer biopsy according to an embodiment of the present invention. 3 is a cross-sectional view of the stent of FIG. 2 taken along line AA′.
본 발명의 스텐트(100)는 전체적으로 튜브형상의 삽입관(101)과, 삽입관(101)의 외벽(102)에 지그재그 형상으로 형성된 홈부(110)로 구성된다. 삽입관(101)은 탄성이 있는 합성수지, 예를 들어 실리콘 소재로 이루어져 있다. 따라서, 삽입관(101)이 카테터(42) 내에 압축된 상태로 삽입되어 있다가 카테터(42) 외부로 노출되면 원래 형상으로 회복되면서, 담즙(10)의 이동 경로를 확보하여 담도 폐쇄를 해결할 수 있다.The stent 100 of the present invention is composed of a tube-shaped insertion tube 101 as a whole and a groove portion 110 formed in a zigzag shape on the outer wall 102 of the insertion tube 101. The insertion tube 101 is made of an elastic synthetic resin, for example, a silicone material. Therefore, when the insertion tube 101 is inserted into the catheter 42 in a compressed state and then exposed to the outside of the catheter 42, it is restored to its original shape, and the path of movement of the bile 10 is secured to solve biliary tract obstruction. have.
또한 본 발명의 스텐트(100)는 담관(342) 내에 삽입되는 과정에서 담도암 조직검사를 위한 특별한 구조를 가진다. 구체적으로 홈부(110)는 바닥부(114)와, 바닥부(114)의 일측과 외벽(102)을 연결하는 제1 측벽(113)과, 바닥부(114)의 타측과 외벽(102)을 연결하는 제2 측벽(115)을 포함한다. 제1 측벽(113)과 외벽(102)으로 이루어진 제1 모서리부(112)는 담관(342)에 스텐트(100)가 인입할 때 담관 상피 조직을 긁어서 채취한다. 제2 측벽(115)과 외벽(102)으로 이루어진 제2 모서리부(116)는 담관(342)에서 스텐트(100)가 인출될 때 앞서 채취된 담관 상피 조직을 바닥부(114) 내에 안전하게 보관하는 펜스 역할을 한다. In addition, the stent 100 of the present invention has a special structure for biopsy of biliary tract cancer in the process of being inserted into the bile duct 342. Specifically, the groove portion 110 includes a bottom portion 114, a first side wall 113 connecting one side of the bottom portion 114 and the outer wall 102, and the other side and the outer wall 102 of the bottom portion 114. It includes a second sidewall 115 connecting. The first corner part 112 made of the first side wall 113 and the outer wall 102 is collected by scratching the bile duct epithelial tissue when the stent 100 is inserted into the bile duct 342. The second edge portion 116 consisting of the second side wall 115 and the outer wall 102 safely stores the previously collected bile duct epithelial tissue in the bottom portion 114 when the stent 100 is withdrawn from the bile duct 342. It acts as a fence.
제1 모서리부(112) 및 제2 모서리부(116)는 삽입관(101)의 길이방향으로 서로 대향하게 배치될 수 있다. 제1 모서리부(112)는 병변부에서 효과적으로 조직을 채취하도록 날카로운 예약으로 이루어지는 것이 좋다. 또한 제2 모서리부(116)는 스텐트(100)를 인출할 때 채취된 조직이 외부로 쓸려나가지 않고 잘 보관되도록 예각으로 이루어지는 것이 좋다.The first edge portion 112 and the second edge portion 116 may be disposed to face each other in the longitudinal direction of the insertion tube 101. The first corner portion 112 is preferably made of a sharp reservation to effectively collect tissue from the lesion. In addition, the second corner portion 116 is preferably made of an acute angle so that the tissue collected when the stent 100 is pulled out is not swept to the outside and is well stored.
시술자는 담도암 조직검사를 위해 스텐트(100)를 담관에 삽입된 상태로 수일 동안 유지시키는데, 그 동안 채취된 담관 상피 조직에 대해 3차원 세포배양을 실시한다. 구체적으로, 홈부(110)의 바닥부(114)에는 인공 폴리머(200)와 세포생장유도제(202)가 형성되어 있다. 인공 폴리머(200)는 3차원 세포배양을 위한 세포외기질로 사용되며, 예를 들어 하이드로겔, 스캐폴드(scaffold), 또는 탈세포화된 세포외기질(decellularized extracellular matrix, dECM) 등으로 이루어질 수 있다. 세포생장유도제(202)는 담관 상피 조직의 세포 생장을 유도하는 물질로서, 예를 들어 시토카인(cytokine) 등으로 이루어질 수 있다. 또한, 스텐트(100)가 담관(342) 내에 삽입된 상태에서 담관(342)의 내벽이 인공 폴리머(200)와 물리적으로 접촉할 수 있도록 홈부(110)의 크기를 설계하는 것이 바람직하며, 이 경우 더욱 효과적으로 3차원 세포배양을 수행할 수 있다.The practitioner maintains the stent 100 in the state of being inserted into the bile duct for a biopsy of biliary tract cancer for several days, and performs three-dimensional cell culture on the collected bile duct epithelial tissue. Specifically, an artificial polymer 200 and a cell growth inducer 202 are formed in the bottom portion 114 of the groove portion 110. The artificial polymer 200 is used as an extracellular matrix for 3D cell culture, and may be formed of, for example, a hydrogel, a scaffold, or a decellularized extracellular matrix (dECM). . The cell growth inducing agent 202 is a substance that induces cell growth of the bile duct epithelial tissue, and may be made of, for example, cytokines. In addition, it is preferable to design the size of the groove portion 110 so that the inner wall of the bile duct 342 can physically contact the artificial polymer 200 while the stent 100 is inserted into the bile duct 342, in this case More effectively, three-dimensional cell culture can be performed.
시술자가 스텐트(100)를 담관(342)에서 인출한 후, 스텐트(100)의 홈부(110)에서 3차원 세포배양된 담관 상피 조직을 이용할 경우, 병변부로부터 충분한 양의 세포를 수득할 수 있기 때문에 담도암 조직검사 시에 높은 진단율을 얻을 수 있다.After the surgeon pulls out the stent 100 from the bile duct 342, when using the bile duct epithelial tissue cultured with three-dimensional cells in the groove 110 of the stent 100, a sufficient amount of cells can be obtained from the lesion. Therefore, a high diagnosis rate can be obtained during biopsy of biliary tract cancer.
이상 첨부된 도면을 참조하여 본 발명의 실시예를 설명하였지만, 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자는 본 발명이 그 기술적 사상이나 필수적인 특징을 변경하지 않고서 다른 구체적인 형태로 실시될 수 있다는 것을 이해할 수 있을 것이다. 그러므로 이상에서 기술한 실시예들은 모든 면에서 예시적인 것이며 한정적이 아닌 것으로 이해해야만 한다.Although the embodiments of the present invention have been described with reference to the accompanying drawings, those of ordinary skill in the art to which the present invention pertains can be implemented in other specific forms without changing the technical spirit or essential features. You can understand. Therefore, it should be understood that the embodiments described above are illustrative and non-limiting in all respects.

Claims (4)

  1. 담도암 조직검사를 위해 담관 내에 삽입되는 스텐트로서: As a stent inserted into the bile duct for biopsy of biliary tract cancer:
    합성수지로 이루어진 삽입관의 외벽에 지그재그 형상의 홈부가 형성되고, A zigzag-shaped groove is formed on the outer wall of the insertion tube made of synthetic resin,
    상기 홈부는, 바닥부와, 상기 바닥부의 일측과 상기 외벽을 연결하는 제1 측벽과, 상기 바닥부의 타측과 상기 외벽을 연결하는 제2 측벽을 포함하고,The groove portion includes a bottom portion, a first sidewall connecting one side of the bottom portion and the outer wall, and a second sidewall connecting the other side of the bottom portion and the outer wall,
    상기 제1 측벽과 상기 외벽으로 이루어진 제1 모서리부는 담관에 스텐트가 인입될 때 담관 상피 조직을 채취하고, 상기 제2 측벽과 상기 외벽으로 이루어진 제2 모서리부는 담관에서 스텐트가 인출될 때 채취된 담관 상피 조직을 보관하고,The first corner portion consisting of the first side wall and the outer wall collects the bile duct epithelial tissue when the stent is inserted into the bile duct, and the second corner portion composed of the second side wall and the outer wall is collected when the stent is withdrawn from the bile duct. Store epithelial tissue,
    상기 바닥부에는, 채취된 담관 상피 조직의 3차원 세포배양을 위한 세포외기질로 사용되는 인공 폴리머와, 세포 생장을 유도하는 세포생장유도제가 형성된 것을 특징으로 하는, 담도암 조직검사용 스텐트.An artificial polymer used as an extracellular matrix for three-dimensional cell culture of the collected bile duct epithelial tissue, and a cell growth inducing agent for inducing cell growth are formed on the bottom portion, a stent for biliary tract cancer biopsy.
  2. 제1항에 있어서, The method of claim 1,
    상기 제1 모서리부 및 제2 모서리부는 상기 삽입관의 길이방향으로 서로 대향하게 배치되고, 각 모서리부는 예각으로 이루어지는 것을 특징으로 하는 담도암 조직검사용 스텐트.The first corner portion and the second corner portion are arranged to face each other in the longitudinal direction of the insertion tube, each corner portion of the bile duct cancer biopsy stent, characterized in that the acute angle.
  3. 제1항에 있어서, The method of claim 1,
    상기 인공 폴리머는 하이드로겔, 스캐폴드(scaffold), 또는 탈세포화된 세포외기질(decellularized extracellular matrix, dECM)인 것을 특징으로 하는 담도암 조직검사용 스텐트.The artificial polymer is a hydrogel, a scaffold, or a decellularized extracellular matrix (dECM), characterized in that the biliary tract cancer biopsy stent.
  4. 제1항에 있어서, The method of claim 1,
    상기 세포생장유도제는 시토카인(cytokine)인 것을 특징으로 하는 담도암 조직검사용 스텐트.The cell growth inducer is a cytokine (cytokine), characterized in that the biliary tract cancer biopsy stent.
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