WO2018110737A1 - Stent médical ayant des parties d'extrémité à résistance renforcée - Google Patents

Stent médical ayant des parties d'extrémité à résistance renforcée Download PDF

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Publication number
WO2018110737A1
WO2018110737A1 PCT/KR2016/014698 KR2016014698W WO2018110737A1 WO 2018110737 A1 WO2018110737 A1 WO 2018110737A1 KR 2016014698 W KR2016014698 W KR 2016014698W WO 2018110737 A1 WO2018110737 A1 WO 2018110737A1
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WO
WIPO (PCT)
Prior art keywords
stent
resistance
washer
cylindrical body
medical
Prior art date
Application number
PCT/KR2016/014698
Other languages
English (en)
Korean (ko)
Inventor
명병철
Original Assignee
주식회사 비씨엠
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 주식회사 비씨엠 filed Critical 주식회사 비씨엠
Priority to PCT/KR2016/014698 priority Critical patent/WO2018110737A1/fr
Publication of WO2018110737A1 publication Critical patent/WO2018110737A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure

Definitions

  • the present invention is a medical stent to be used to pass through two adjacent tissues of the human organs (gallbladder, pancreas, etc.) to use as a passage for endoscopic surgery, or to perform drainage or shunts such as bile and yangyang solution.
  • the two ends of the hollow cylindrical body formed by interweaving a superelastic shape memory alloy wire intersected in the shape of a cell on the rhombus are expanded and bent to form a washer-shaped end, but a stent is formed around the outer periphery of the washer-type end.
  • the gap between the end of the cells forming an extremely close contact with each other to form a superimposed resistance reinforcement ring to the end of the medical reinforcement for strengthening the resistance of the end made to secure the position connected through the procedure.
  • stents are used for the stenosis of the body, when the stenosis is caused by arteriosclerosis, thrombosis, benign and malignant tumors, postoperative sequelae or lesions. It is used as an interventional procedure to recover the pain, and has been implemented as an important procedure since the 1980s.
  • stents are largely divided into non-vascular and vascular stents, and are generally known as self-expending type stents, which are metal or polymer network structures that have their own elastic force and contract when they are externally applied and return to their original state when external forces are removed. It is.
  • the procedure using the stent is divided into vascular stent insertion and non-vascular stent insertion.
  • the former vascular stent implantation is known as a procedure that opens a 3mm to 4mm hole in the thigh, and then pushes a thin tube called 'catheter' to the lesion site with a femoral artery and then expands the narrowed vessel by placing a stent. .
  • the stent used in both of the above-described methods has been disclosed to improve the function of the stent with various structures to date.
  • These stents usually cross superelastic shape memory alloy wires or stainless wires at different positions, or connect hooks and fractures to each other in hook form to connect a plurality of rhombic spaces (cells). And a hollow cylindrical body of a predetermined length.
  • a stent for connecting procedure is used to access an endoscope procedure directly to the internal organs of the human body, such as the gallbladder and the longest, or to access a point where it is difficult to drain or shunt such as bile or nocturnal fluid. .
  • This prior art has a problem in that the expansion part slips out of the procedure position frequently when external force of the human body and external force of the internal organs are applied.
  • the space portion of the expansion portion 3 is increased by the expansion pipe as compared to the space portion of the body 2. Since the force supporting the external force is inevitably weakened compared to the body 2 side, the expansion pipe 3 is inevitably weakened, thereby causing problems such as the above-described procedure position deviation.
  • US Pat. No. 8,454,632 shown in FIG. 2 is a technique which slightly improves the above-mentioned problems.
  • Both sides of the hollow cylindrical body 2 formed by interweaving alloy wires such as superelastic shape memory alloys are formed in the holes of the human organs. After inserting it in, a certain portion is pushed inward on both sides to form a double wall flange (4), so as to be hooked to the adjacent tissue (5) to prevent the separation procedure.
  • stents are made by weaving alloy wires intersectingly, but stretching is possible in the axial direction, but stretching is not possible without restriction.
  • the double wall flanges located on both sides of the cylindrical body have to be woven in large diameters in advance and have a complicated manufacturing process of forming thermoforming for shape memory so as to form a double wall in close contact with each other.
  • the present invention has been made to solve the problems of the prior art as described above to solve the following problems.
  • the present invention provides a medical stent reinforced with resistance at the end portion formed to prevent the stent from falling off from the procedure position by integrally forming a resistance strengthening ring made of the material of the stent at the longitudinal end of the stent connecting through two adjacent tissue layers It is.
  • the present invention is to provide a medical stent of the end of the cylindrical stent of the same diameter is formed by bending the washer-type end to stand and thus the end of the easy to manufacture by adding to the stent of the mesh form having the same diameter.
  • the present invention provides a medical stent in which the washer-type end is expanded only by the operator inserting a conventional catheter, and the washer-type end portion substantially provides a rigid locking area in the penetrating tissue layer, thereby increasing the resistance of the end portion, which is easy to perform. To provide.
  • the present invention is to provide a medical resistant stent of the end portion is made to adjust the degree of overlap of the resistive reinforcement ring by adjusting the cylindrical stent section to be transformed to the washer-type end to enable the production of the stent with the desired resistance .
  • the present invention extends in the form of a washer and extends the longitudinal ends of both sides of the central cylindrical body of the stent, which penetrates two adjacent tissue layers and weaves the same diameter.
  • the end resistance is variably produced by adjusting the number of turns (number of turns) of the resistance reinforcing ring that provides a strong elasticity by overlapping the outer periphery of the washer-type end.
  • both the washer-type end portions of the stent central cylindrical body are fastened to the surgical tissue layer of the human body, and the support and fixation force at the procedure position is improved by the resistance reinforcement ring provided around the washer-type outer periphery.
  • the present invention has an effect of preventing the stent from detaching from the position of the procedure because it forms an integrally strengthening ring made of the material of the stent at the longitudinal end of the stent supported over the pyloric portion of the stomach, and has a cylindrical shape having the same diameter. It is formed by bending the washer-type end on the end of the stent so that it is extremely easy to manufacture and the washer-type end expands simply by inserting it into the usual catheter by the operator in the operating room.
  • FIG. 1 is a view of the state of the procedure showing a conventional stent.
  • Figure 2 is an external view of the surgical state showing another conventional stent.
  • FIG 3 is a view of the stent according to the present invention.
  • Figure 4 is an enlarged view of the main portion "A" resistance ring strengthening of Figure 3 invention.
  • Figure 6 is an external view showing several embodiments of the present invention stent.
  • FIG. 7 is a process chart showing a stent manufacturing process of the present invention.
  • Figure 8 is a stent surgical state diagram of the present invention.
  • the present invention provides a cylindrical stent in a medical stent formed by forming an extension or flange larger than the cylindrical body diameter at both ends of the central cylindrical body of the stent so as to penetrate two adjacent tissue layers. ) To form a washer-shaped end portion 14 which is bent outwardly at both longitudinal ends, and overlaps the outer circumference of the extended washer-shaped end 14 against radial force applied from the outside of the stent. By forming a resistance-strengthening ring 16 made to be reinforced resistance by the end of the medical stent 100 is reinforced resistance.
  • the number of times of overlapping the resistance strengthening ring 16 can be varied in accordance with the stent end distance (L) exposed in the longitudinal direction extending to both sides of the cylindrical body 12, thereby making it possible to variably produce end resistance.
  • the elasticity of the resistance-strengthening ring 16 which provides elasticity by overlapping the outer circumference of the washer-shaped end 14 is provided small, and in the opposite case, the elasticity is large.
  • the stent of the present invention is made so that the end diameter is changed in proportion to the diameter of the hollow portion of the stent 10 manufactured to a predetermined diameter.
  • the stent 100 is made smaller.
  • the washer-shaped end portion 14 forms a support surface 14a extending from the cylindrical body 12 to form a structure to be supported by the treatment tissue layer to prevent separation, and to the outer circumference of the support surface 14a.
  • the provided resistance reinforcing ring 16 acts to firmly support the stent 100 by preventing the case from being out of position by the external force in the treated tissue, the stent is a stent made to intersect or bends and fractures Hook to each other in the form of hooks can be applied to any of the stents having a plurality of rhombus-shaped space (cell).
  • the present invention includes a fixing pin 22 to partition a central portion of the material stent 10 interwoven with a single diameter into a jig 20 having a smaller diameter than the diameter to form a cylindrical body 12. ) And fix it in an annular shape (see Figure 7 (b)).
  • the center hole is formed in both ends of the stent tapered while extending in the fallopian tube form, the end of the stent 10 is pressed until it is blocked by the fixing pin 22 while being compressed from the tapered end
  • the disc 26 compresses the end outwardly and forms the washer-shaped end 14, with the excess stent part extending the washer-shaped end 14 with the extended maximum radius. Laminated to the outer circumferential diameter to form a resistance strengthening ring 16 (see Fig. 7 (d)).
  • the washer-shaped end 14 When the washer-shaped end 14 is formed by compressing the disk 26 at both ends, the disks 26 are bound together to bind each other so as not to be separated (see FIG. 7 (e)), and the jig is formed by thermal processing for shape memory. Removing it gives you a finished stent 100.
  • the washer-shaped end portion 14 has been described as being perpendicular to the cylindrical body 12, but may be formed by compressing the inner angle of the inner angle with the disk 26 to form a shape memory process.
  • the surface angle of the disk 26 fitted to the jig 20 is formed at opposite angles.
  • the outer surface of the stent 100 of the present invention made as described above may be made by further forming a synthetic film of PETT or silicon material having affinity with the human body.
  • Such the present invention is inserted into two tissues punctured and adjacent to the human body by a conventional insertion device as shown in Figure 8, when the procedure is completed, the stent 100, the central cylindrical body 12, both ends of the washer-type end
  • the support and fixation force at the procedure position is greatly improved by the resistance reinforcing ring 16 which 14 is hooked to the surgical tissue layer 30 of the human body and is provided around the outside of the washer-type end 14.
  • the washer-type end 14 having a wide diameter is widely supported by the tissue of the human body, and the washer-type end 14 supporting the washer is formed to have a plurality of overlapping outer periphery.
  • Deformation such as shrinkage, is regulated by the ring 16 and strongly supports the external force, thereby acting to eliminate the problem of external force acting on the washer-shaped end 14 resulting in deformation.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un stent médical qui est utilisé comme voie de passage pour une chirurgie endoscopique, etc. en reliant par pénétration les deux tissus adjacents d'un organe du corps humain, ou qui est utilisé pour une intervention de drainage ou de dérivation de la bile, d'abcès, etc. L'invention concerne un stent médical ayant des parties d'extrémité à résistance renforcée, le stent ayant des parties d'extrémité de type rondelle formées en étendant et en pliant les deux côtés d'extrémité d'un corps cylindrique creux qui est formé en tressant des fils d'alliage à mémoire de forme hyperélastique de manière à les croiser et à former des cellules en forme de losange, les circonférences externes respectives des parties d'extrémité de type rondelle ayant sur celles-ci un anneau à résistance renforcée formé en rapprochant fortement les espaces entre les cellules côté extrémités formant le stent de manière à se chevaucher, et, par conséquent, un site relié par pénétration peut être maintenu fermement lors de la mise en œuvre d'une intervention sur un corps humain. Afin de relier par pénétration deux couches de tissu adjacentes, le stent médical présente une partie d'extension de tube, ou une bride ayant un diamètre plus grand que celui du corps cylindrique, formée sur les deux extrémités du corps cylindrique en son centre. Selon la présente invention, sont formés le stent (10) ayant un diamètre uniforme, et les parties d'extrémité de type rondelle (14) formées en pliant vers l'extérieur les côtés d'extrémité respectifs des deux côtés sur la direction de la longueur du corps cylindrique (12) du stent, et l'anneau à résistance renforcée (16), permettant de fournir une élasticité par chevauchement sur plusieurs couches, est formé sur les circonférences externes respectives des parties d'extrémité de type rondelle étendues (14). La présente invention concerne un stent médical qui est utilisé comme voie de passage pour une chirurgie endoscopique, etc. en reliant par pénétration les deux tissus adjacents d'un organe du corps humain, ou qui est utilisé pour une intervention de drainage ou de dérivation de la bile, d'abcès, etc. L'invention concerne un stent médical ayant des parties d'extrémité à résistance renforcée, le stent ayant des parties d'extrémité de type rondelle formées en étendant et en pliant les deux côtés d'extrémité d'un corps cylindrique creux qui est formé en tressant des fils d'alliage à mémoire de forme hyperélastique de manière à les croiser et à former des cellules en forme de losange, les circonférences externes respectives des parties d'extrémité de type rondelle ayant sur celles-ci un anneau à résistance renforcée formé en rapprochant fortement les espaces entre les cellules côté extrémités formant le stent de manière à se chevaucher, et, par conséquent, un site relié par pénétration peut être maintenu fermement lors de la mise en œuvre d'une intervention sur un corps humain. Afin de relier par pénétration deux couches de tissu adjacentes, le stent médical présente une partie d'extension de tube, ou une bride ayant un diamètre plus grand que celui du corps cylindrique, formée sur les deux extrémités du corps cylindrique en son centre. Selon la présente invention, sont formés le stent (10) ayant un diamètre uniforme, et les parties d'extrémité de type rondelle (14) formées en pliant vers l'extérieur les côtés d'extrémité respectifs des deux côtés sur la direction de la longueur du corps cylindrique (12) du stent, et l'anneau à résistance renforcée (16), permettant de fournir une élasticité par chevauchement sur plusieurs couches, est formé sur les circonférences externes respectives des parties d'extrémité de type rondelle étendues (14).
PCT/KR2016/014698 2016-12-15 2016-12-15 Stent médical ayant des parties d'extrémité à résistance renforcée WO2018110737A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/KR2016/014698 WO2018110737A1 (fr) 2016-12-15 2016-12-15 Stent médical ayant des parties d'extrémité à résistance renforcée

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/KR2016/014698 WO2018110737A1 (fr) 2016-12-15 2016-12-15 Stent médical ayant des parties d'extrémité à résistance renforcée

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20110002389A (ko) * 2009-07-01 2011-01-07 주식회사 엠아이텍 스텐트
KR20130005519A (ko) * 2011-07-06 2013-01-16 (주) 태웅메디칼 인체 기관의 인접 조직 연결 시술용 스텐트
KR20130097889A (ko) * 2012-02-27 2013-09-04 국립암센터 돌출형 부분이중구조 스텐트
KR20140094144A (ko) * 2013-01-21 2014-07-30 주식회사 엠아이텍 이탈 방지용 스텐트, 제조 장치 및 그 제조 방법
KR20170005661A (ko) * 2015-07-06 2017-01-16 주식회사 비씨엠 단부의 저항력이 강화된 의료용 스텐트

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20110002389A (ko) * 2009-07-01 2011-01-07 주식회사 엠아이텍 스텐트
KR20130005519A (ko) * 2011-07-06 2013-01-16 (주) 태웅메디칼 인체 기관의 인접 조직 연결 시술용 스텐트
KR20130097889A (ko) * 2012-02-27 2013-09-04 국립암센터 돌출형 부분이중구조 스텐트
KR20140094144A (ko) * 2013-01-21 2014-07-30 주식회사 엠아이텍 이탈 방지용 스텐트, 제조 장치 및 그 제조 방법
KR20170005661A (ko) * 2015-07-06 2017-01-16 주식회사 비씨엠 단부의 저항력이 강화된 의료용 스텐트

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