WO2023277264A1 - Endoprothèse vasculaire - Google Patents
Endoprothèse vasculaire Download PDFInfo
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- WO2023277264A1 WO2023277264A1 PCT/KR2021/015975 KR2021015975W WO2023277264A1 WO 2023277264 A1 WO2023277264 A1 WO 2023277264A1 KR 2021015975 W KR2021015975 W KR 2021015975W WO 2023277264 A1 WO2023277264 A1 WO 2023277264A1
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- stent graft
- blood vessel
- branch
- wall
- coupled
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Definitions
- the present invention relates to a stent graft, and more particularly, to a stent graft fixed to a blood vessel in which an aortic aneurysm has occurred.
- An aortic aneurysm is a condition in which the diameter of the aorta is increased 1.5 times or more than normal. If progression of an aortic aneurysm continues, death may result from rupture of the aorta. These aortic aneurysms can occur in the brain, heart, lower limbs, abdomen, etc., and more than 70% occur in the abdomen.
- Methods for treating an aortic aneurysm occurring in the abdomen include artificial blood vessel replacement and stent graft implantation.
- the artificial blood vessel replacement is a treatment method performed when the diameter of the abdominal aortic aneurysm is 5 cm or more and the size of the abdominal aortic aneurysm rapidly increases.
- stent graft insertion In the stent graft insertion, a small incision is made in the patient's groin region, and then the stent graft is inserted into the abdominal aorta where the aortic aneurysm has occurred through the femoral artery in the groin region.
- a part of the stent graft inserted into the abdominal aorta adheres to the inner wall of the blood vessel in a normal state, so that the blood of the abdominal aorta flows through the inside of the stent graft rather than through the portion where the aortic aneurysm occurs. This prevents the size of the aortic aneurysm from increasing any further.
- the stent graft insertion procedure as described above does not incise the patient's abdomen, it has the advantage of less bleeding and shorter hospital stay compared to artificial blood vessel replacement.
- Patent Documents 1 to 3 below disclose stent graft configurations according to the prior art.
- a portion of the stent graft is fixed in close contact with the inner wall of a blood vessel in a normal state by simply expanding the stent graft.
- the stent graft according to the prior art is an endoleak in which the blood of the abdominal aorta leaks to the part where the aortic aneurysm occurs because the stent graft moves from its original position when the patient's blood pressure rises or the internal diameter of the abdominal aorta is generally expanded. ), there was a problem that could cause the phenomenon.
- Patent Document 1 Republic of Korea Patent Publication No. 10-2016-0126548 (published on November 2, 2016)
- Patent Document 2 Republic of Korea Patent Publication No. 10-2002-0082872 (published on October 31, 2002)
- Patent Document 3 Republic of Korea Patent Publication No. 10-2005-0118744 (published on December 20, 2005)
- An object of the present invention is to solve the above problems, to provide a stent graft that can be inserted into a blood vessel in which an aortic aneurysm has occurred and firmly fixed to the inner wall of the blood vessel.
- Another object of the present invention is to provide a stent graft capable of preventing an endolyak phenomenon in which blood from an abdominal aorta leaks to a portion where an aortic aneurysm occurs by moving from a location where the stent graft is installed.
- Another object of the present invention is to provide a stent graft capable of improving the treatment rate by improving the stent graft procedure so that the procedure can be performed even in patients with a narrow bifurcation of the iliac artery.
- the stent graft according to the present invention includes a body portion inserted into a blood vessel site where an aortic aneurysm occurs, and a plurality of branch portions branched from one end of the body portion,
- Each of the branching parts is manufactured by overlapping a plurality of layers of a biocompatible material, and is characterized in that it is fixed by increasing resistance between the branching part and the inner wall of the blood vessel.
- the stent graft according to the present invention it is possible to firmly fix the stent graft by forming strong resistance between the stent graft and the inner wall of the blood vessel.
- the effect that the stent graft can be stably fixed in its original position without moving in the aorta even when the blood pressure of the aorta increases or the inner diameter of the aorta is generally expanded is obtained.
- an effect of preventing an endolyak phenomenon in which the blood of the abdominal aorta leaks to a portion where an aortic aneurysm occurs by moving the stent graft in the original position is obtained.
- the effect of improving the treatment rate of patients with an aortic aneurysm in the iliac artery or the abdominal aorta adjacent to the iliac artery is obtained.
- FIG. 1 is a configuration diagram of a stent graft according to a preferred embodiment of the present invention
- Figure 2 is a view showing a state in which the stent graft shown in Figure 1 is installed in the abdominal aorta and expanded;
- FIG. 3 is a detailed configuration diagram of a stent graft
- Figure 4 is a partial enlarged view of the body portion
- FIGS. 6 to 9 are diagrams illustrating step by step a method of inserting and fixing a stent graft according to a preferred embodiment of the present invention into the inner wall of a blood vessel in which an aortic aneurysm has occurred;
- FIG. 10 is a view showing a state in which an expansion unit is coupled to a stent graft
- a stent graft is inserted into the site where the aortic aneurysm occurs, that is, the site where the abdominal aorta and the iliac artery are connected, and strong resistance is generated between the inner wall of the blood vessel and the stent graft to be firmly fixed explain the configuration.
- the present invention is not necessarily limited thereto, and may be modified to be applicable to the treatment of aortic aneurysms occurring in various locations other than the abdomen.
- FIG. 1 is a configuration diagram of a stent graft according to a preferred embodiment of the present invention
- FIG. 2 is a view showing a state in which the stent graft shown in FIG. 1 is installed in an abdominal aorta and expanded.
- the stent graft 10 includes a body part 20 inserted into a blood vessel site where an aortic aneurysm occurs, and a plurality of parts at one end of the body part 20. It includes a plurality of branching parts 30 branched into.
- the stent graft 10 may further include an extension part 40 coupled to one or more of the body part 20 and the branch part 30.
- the body portion 20 is a portion inserted into the abdominal aorta where an aortic aneurysm has occurred, and the branch portion 20 is a portion inserted into a pair of iliac arteries branching from the lower portion of the abdominal aorta.
- the branch portion 30 may be removed depending on the site where the aortic aneurysm occurs, and the body portion 20 may be formed.
- the stent graft 10 includes the body portion 20 and the branch portion 30. It is desirable to configure
- the branching part 30 may include first and second branching parts 31 and 32 to correspond to the pair of iliac arteries.
- the body portion 20 and the branch portion 30 configured as described above are inserted into the first to third rim covers 11 to 13, respectively, and the entire stent graft 10 is inserted into one outer cover. It is inserted into the blood vessel at the site of the aneurysm.
- a wire 14 is connected to the body portion 20 and the branch portion 30, respectively, and can be inserted into a site where an aortic aneurysm occurs using the wire 14.
- the body portion 20 and the branch portion 30 expand to increase in volume, respectively, and are fixed in close contact with the inner wall of the blood vessel.
- the extension part 40 is coupled to at least one of the upper end of the body part 20 and the lower end of the branch part 30 to correspond to the site where the aortic aneurysm occurs, and serves to extend the length of the stent graft 10.
- the extension portion 40 does not need to be applied.
- the upper end of the body portion 20 and The extension part 40 may be coupled to a necessary part among the lower ends of the branch part 30 .
- the expansion part 40 may not be applied according to the shape or location of the site where the aortic aneurysm occurs, or may be provided in one or a plurality.
- the expansion part 40 may be inserted into the site where the aortic aneurysm has occurred alone instead of the body part 20 and the branch part 30 .
- Each of the body portion 20, the branch portion 30, and the extension portion 40 may be woven into a tube shape using a biocompatible material.
- the biocompatible material is expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene, polyethyleneterephthalate, polybutyleneterephthalate, polyurethane, poly At least one of propylene, polyethylene, polytrimethyleneterephthalate, polyimide, polyvinylpyrrolidone, polyethyleneglycol, and carbon fiber can include
- the stent graft 10 is manufactured using a biocompatible material and does not induce an immune response in the aorta, it does not cause blood coagulation, that is, a thrombus, due to the immune response. don't Therefore, the blood of the aorta can flow smoothly through the stent graft 10 .
- the body portion 20, the branch portion 30, and the extension portion 40 may each have a plurality of layers, for example, a triple structure.
- the branch portion 30, and the extension portion 40 form a triple structure by overlapping three fabrics each of which is woven with a biocompatible material, rigidity and durability can be increased.
- each fabric may be woven so that the body portion 20 and the branch portion 30 are integral with each other, or may be woven together and then connected to each other by a sewing method or the like.
- each fabric may be arranged so that weaving directions are parallel to each other or cross each other so as to prevent flow by increasing resistance between each fabric in a state of being overlapped with each other.
- the diameter of the fibers to be woven is increased or a plurality of fibers are twisted to have a greater resistance than the fabric disposed in the middle or inside. It can be.
- FIG. 3 is a detailed configuration diagram of a stent graft
- FIG. 4 is a partial enlarged view of a body portion
- FIG. 5 is a partial enlarged view of an extension portion.
- the outer surface of the body portion 20 is coupled with a first wire 21 that functions as a skeleton of the body portion 20, and extends outward at the upper end of the body portion 20.
- the second wire 22 fixed to the inner wall of the blood vessel may be coupled.
- a plurality of first wires 21 are disposed spaced apart from each other by a predetermined interval so as to surround the outer surface of the body portion 20, and each first wire 21 and the second wire 22 are sewn to the body portion ( 20).
- the first wire 21 may be formed in a zigzag shape or a sine wave shape.
- the first wire 21 may be manufactured using a metal material such as stainless or Nitinol.
- the second wire 21 is formed in a zigzag shape, triangular wave shape, or sine wave shape so as to be expandable outward, and the upper ends are bundled so that they are in contact with each other and inserted into the first rim cover 11 can be inserted into the site of an aortic aneurysm.
- the second wire 22 expands outward and can adhere to the inner wall of the blood vessel.
- the second wire 22 may be manufactured using a metal material such as stainless or Nitinol.
- the stent graft according to the prior art uses a monofilament type binding yarn using a single strand and is coupled to the body by a sewing method using a wire.
- a coupling yarn (not shown) coupling the first and second wires 21 and 22 to the body 20 is twisted with several strands to increase resistance between the first and second wires 21 and 22 and the inner wall of the blood vessel. It may be provided with a multi-filament type of thread or string made by
- Fiber fluffs 23 that cause blood clots in the aorta may be coupled to all or part of outer surfaces of the plurality of first wires 21 .
- fiber fluff 23 may be coupled to all or part of the body portion 20, that is, to the outer surface of one or more first wires 21.
- the fiber fluff 23 may include thrombin, a proteolytic enzyme related to blood coagulation.
- the fiber fluff 23 may further include a blood clotting agent such as polyphosphate, calcium, or the like.
- the fiber fluff 23 induces a blood clot, and thus the inner wall of the blood vessel in a normal state and A blood clot may be formed between the first wires 21 .
- the stent graft 10 moves from its original position even when the patient's blood pressure rises or the internal diameter of the abdominal aorta is generally expanded. It can be firmly fixed to the inner wall of the blood vessel without
- one or more yarns formed with fiber fluff 23 may be coupled to the outer surface of the first wire 21 .
- the outer surface of the first wire 21 may be coated with a covering material having fiber fluffs 23 formed thereon.
- the fiber fluff 23 formed on the yarn or covering material may contain thrombin, a proteolytic enzyme related to blood coagulation, and may further contain a thrombogenic agent such as polyphosphate and calcium.
- one or more branching parts 30 may be formed on the distal side of the body part 20, that is, at the lower end.
- the first branching part 31 and the second branching part 32 may be branched at the lower end of the body part 20 .
- the first branch part 31 and the second branch part 32 forming the branch part 30 are inserted into the pair of iliac arteries, respectively, and have a diameter smaller than that of the body part 20. It may be formed into a tubular shape.
- the branch portion 30 may be woven into a tubular shape using a biocompatible material.
- At least one third wire 33 and one fourth wire 34 are coupled to the outer surfaces of the first branch 31 and the second branch 32 in a sewing manner using multifilament-type binding yarns.
- Fiber fluffs 23 that cause blood clots may be coupled to outer surfaces of the third and fourth wires 33 and 34 respectively.
- first branch portion 31 and the second branch portion 32 are formed to have the same length or have one shorter length than the other, the length inserted into the iliac artery may also be short.
- the extension part 40 may be woven into a tubular shape having a multi-layer structure, for example, a triple structure, using a biocompatible material, similarly to the body part 20 .
- the expansion part 40 may be formed with a diameter corresponding to the diameter of the object to be coupled.
- extension part 40 when the extension part 40 is coupled to the upper end of the body part 20, at least one end of the extension part 40 can be inserted into the upper end of the body part 20, the diameter of the upper end of the body part 20. It is preferable to form with a slightly smaller diameter.
- At least one end of the extension part 40 is smaller than the lower end diameter of the branch part 30 so that it can be inserted into the lower end of the branch part 30. It is preferably formed with a slightly smaller diameter.
- extension portion 40 may be partially inserted into a coupling target and coupled thereto.
- one or more fifth wires 41 may be coupled to the outer surface of the extension part 40 in a sewing manner.
- the fifth wire 41 may be coupled to the outer surface of the extension part 40 by using a multi-filament type yarn or string prepared by twisting several strands so as to increase resistance between the fifth wire 41 and the bonding target.
- fiber fluff may be formed on all or part of the outer surface of the fifth wire 41 .
- patterns of various shapes such as a dot shape, a lattice shape, or a wavy shape may be formed on the outer surface of the expansion unit 40 to increase resistance between the expansion unit 40 and the bonding target.
- fine protrusions are formed on the outer surface of the extension part 40 to prevent slippage when one end of the extension part 40 is inserted into the inner surface of the body part 20 or the branch part 30. can do.
- the expansion part 40 is provided with a plurality of layers of biocompatible fabric.
- the above-described pattern for example, fine projections, is not formed on the fabric forming the inner surface of the extension portion 40, and a pattern such as fine projections may be formed on the fabric forming the outer surface of the extension portion 40.
- the present invention can be firmly fixed by forming strong resistance between the stent graft and the inner wall of the blood vessel.
- the present invention binds fiber fluffs that cause blood clots to wires forming a skeleton so that the wire adheres to the inner wall of the blood vessel of the aorta in a state where the stent graft is inserted into the aorta, through a blood clot formed between the inner wall of the blood vessel and the fiber fluff.
- the fixation force of the stent graft can be increased.
- the stent graft can be stably fixed at a desired position without moving within the aorta even when the blood pressure of the aorta increases or the internal diameter of the aorta is generally expanded.
- the present invention it is possible to prevent an endolyak phenomenon in which the blood of the abdominal aorta leaks to the portion where the aortic aneurysm occurs when the stent graft moves while being installed on the inner wall of the blood vessel.
- FIG. 6 to 9 are diagrams illustrating step by step a method of inserting and fixing a stent graft according to a preferred embodiment of the present invention into the inner wall of a blood vessel in which an aortic aneurysm has occurred, and FIG. This is the drawing shown.
- the body portion 20 of the stent graft 10 and the first and second branch portions 31 and 32 of the branch portion 30 are inserted into the first to third rim covers 11 to 13, respectively.
- the entire stent graft 10 is inserted into one outer cover using a wire 14 to prevent an aortic aneurysm through either the femoral artery in the groin area or a pair of iliac arteries, the left iliac artery as seen in FIG. 6 . It is inserted into the developing abdominal aorta.
- FIG. 6 shows that the stent graft 10 is inserted into the abdominal aorta through the left iliac artery, but the present invention is not necessarily limited thereto, and may be modified to be inserted into the abdominal aorta through the right iliac artery.
- the body portion 20 and the first and second branch portions 31 and 32 are contracted to reduce the volume of the first to fourth wires 21, 22, 33, and 34, respectively.
- the body portion 20 and the first and second branch portions 31 and 32 are contracted to reduce the volume of the first to fourth wires 21, 22, 33, and 34, respectively.
- the outer cover is separated from the stent graft 10 and removed through the left iliac artery.
- the first branch 31 may remain inserted into the left iliac artery.
- the iliac artery into which the stent graft 10 is inserted and the part where the abdominal aorta branches into the pair of iliac arteries, that is, the lower end of the abdominal aorta connected to the pair of iliac arteries (hereinafter referred to as 'branch of the iliac artery') ) is completely different in diameter for each patient.
- the diameter of the iliac artery and its branches vary from about 1.2 mm to about 22 mm.
- the stent graft 10 is inserted inside one outer cover in a contracted state, and is inserted through a single iliac artery, for example, the left iliac artery, to the abdominal aorta via a branch of the iliac artery.
- the stent graft is formed by pulling the second branch part 32 towards the right iliac artery in a state where the first branch part 31 is inserted into the left iliac artery among the first and second branch parts 31 and 32, thereby opening the right iliac artery. insert into
- the rim capture device is inserted from the right iliac artery and hooked to the link of the third rim cover 34 coupled to the second branch 32 to secure the second branch 32. It is inserted into the right iliac artery.
- the connecting ring may be formed of a spring structure twisted two or more times.
- the connecting ring may be formed of a spring structure that is wound one or more times around the lower end of the second branch portion 32 and one or more times around the outside of the third rim cover.
- the second branch portion 32 inserted into the third rim cover 34 can be inserted into the right iliac artery. there is. At this time, the connecting ring may be separated from the second branch portion 32 while the portion wound inside the third rim cover 34 is unfolded.
- the third rim cover 34 moves the second branch portion 32 ) and can be removed via the right iliac artery.
- the entire stent graft is inserted through one iliac artery to the branch of the iliac artery in a state where the entire stent graft is contracted to minimize its volume, and then the opposite branch is inserted into the contralateral iliac artery. Accordingly, the procedure can be performed even in patients with a narrow branch of the iliac artery and the iliac artery.
- the second branch portion 32 is in a state in which the fourth wire 34 extends outward and adheres to the inner wall of the right iliac artery and is fixed thereto.
- the fixed second branch portion 32 provides a fixing force for fixing the body portion 20 and the first branch portion 31 when the first and second rim covers 11 and 12 are removed,
- the first and second rim covers 11 and 12 can be easily removed.
- the second wire 22 coupled to the upper end of the body portion 20 expands outward to restore the original shape and adheres to the inner wall of the blood vessel.
- first and third wires 21 and 33 respectively coupled to the body portion 20 and the first branch portion 31 extend outwardly and are adhered to and fixed to the inner walls of the abdominal aorta and the left iliac artery.
- the fiber fluff 23 formed on the outer surfaces of the first, third and fourth wires 21, 33 and 34 causes blood clots in a state of close contact with the inner wall of the blood vessel, thereby reducing the resistance between the stent graft 10 and the inner wall of the blood vessel.
- By forming a strong it is possible to increase the fixing force of the stent graft (10).
- FIG. 10 shows a state in which the extension part 40 is coupled to the body part 20 and the first and second branch parts 31 and 32, respectively.
- expansion part 40 may be inserted alone or selectively coupled to any one or more of the body part 20 and the first and second branch parts 31 and 32 so as to correspond to the site where the aortic aneurysm is formed. there is.
- the present invention can be firmly fixed by forming strong resistance between the stent graft and the inner wall of the blood vessel.
- the present invention binds fiber fluffs that cause blood clots to wires forming a skeleton so that the wire adheres to the inner wall of the blood vessel of the aorta in a state where the stent graft is inserted into the aorta, through the blood clot formed between the inner wall of the blood vessel and the fiber fluff.
- the fixation force of the stent graft can be increased.
- the stent graft can be stably fixed at a desired position without moving within the aorta even when the blood pressure of the aorta increases or the internal diameter of the aorta is generally expanded.
- the present invention can prevent the endolyak phenomenon in which the blood of the abdominal aorta leaks to the portion where the aortic aneurysm occurs when the stent graft is moved while being installed on the inner wall of the blood vessel.
- the present invention can be operated even on patients with a narrow bifurcation of the iliac artery, the treatment rate of patients with an aortic aneurysm in the iliac artery or the abdominal aorta adjacent to the iliac artery can be improved.
- the present invention is applied to a stent graft technology that can be firmly fixed by forming strong resistance between the stent graft and the inner wall of the blood vessel.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Prostheses (AREA)
Abstract
La présente invention concerne une endoprothèse vasculaire comprenant : une partie corps insérée dans un site de vaisseau sanguin où un anévrisme aortique s'est produit ; et une pluralité de parties de ramification ramifiées en pluralité à partir d'une extrémité de la partie corps, la partie corps et les parties de ramification étant chacune fabriquée par de multiples couches superposées de matériau biocompatible de sorte qu'une forte résistance est formée entre l'endoprothèse vasculaire et la paroi interne du vaisseau sanguin pour fournir une fixation solide.
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KR1020210085477A KR102609978B1 (ko) | 2021-06-30 | 2021-06-30 | 스텐트 그래프트 |
KR10-2021-0085477 | 2021-06-30 |
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WO2023277264A1 true WO2023277264A1 (fr) | 2023-01-05 |
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Citations (6)
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KR20010006271A (ko) * | 1997-04-10 | 2001-01-26 | 콘스탄티노스 파파조글로우 오우 | 복부 대동맥류의 동맥류를 치유하기 위한 맥관내피 이식 장치 |
KR100434633B1 (ko) * | 1995-11-07 | 2005-08-04 | 코비타 코포레이션 | 자체팽창식내강스텐트이식편 |
WO2006107562A2 (fr) * | 2005-04-01 | 2006-10-12 | Boston Scientific Santa Rosa Corporation | Prothese endovasculaire modulaire hybride |
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KR102037543B1 (ko) * | 2012-01-16 | 2019-10-28 | 메리트 메디컬 시스템즈, 인크. | 회전 방사 재료로 커버링된 의료 기구 및 제조 방법 |
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JP4138144B2 (ja) * | 1999-03-31 | 2008-08-20 | テルモ株式会社 | 管腔内留置物 |
DE60139460D1 (de) | 2000-03-14 | 2009-09-17 | Cook Inc | Endovaskulärer stent-graft |
KR100601969B1 (ko) | 2004-06-15 | 2006-07-14 | 주식회사 에스앤지바이오텍 | 인조혈관 스텐트 |
KR101753203B1 (ko) | 2015-04-24 | 2017-07-03 | 주식회사 엠아이텍 | 이중 스텐트 |
WO2019122944A1 (fr) * | 2017-12-19 | 2019-06-27 | Kardiozis Sas | Dispositif de pose, système de pose, endoprothèse et structure de support |
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2021
- 2021-06-30 KR KR1020210085477A patent/KR102609978B1/ko active IP Right Grant
- 2021-11-05 WO PCT/KR2021/015975 patent/WO2023277264A1/fr active Application Filing
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KR100434633B1 (ko) * | 1995-11-07 | 2005-08-04 | 코비타 코포레이션 | 자체팽창식내강스텐트이식편 |
KR20010006271A (ko) * | 1997-04-10 | 2001-01-26 | 콘스탄티노스 파파조글로우 오우 | 복부 대동맥류의 동맥류를 치유하기 위한 맥관내피 이식 장치 |
US9585668B2 (en) * | 2004-03-31 | 2017-03-07 | Merlin Md Pte Ltd | Medical device |
WO2006107562A2 (fr) * | 2005-04-01 | 2006-10-12 | Boston Scientific Santa Rosa Corporation | Prothese endovasculaire modulaire hybride |
KR102037543B1 (ko) * | 2012-01-16 | 2019-10-28 | 메리트 메디컬 시스템즈, 인크. | 회전 방사 재료로 커버링된 의료 기구 및 제조 방법 |
KR20180051537A (ko) * | 2015-09-09 | 2018-05-16 | 프리드 마인드 테크놀로지스 | 뇌졸중 방지를 위한 분기형 3d 필터 조립체 |
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KR102609978B1 (ko) | 2023-12-06 |
KR20230003874A (ko) | 2023-01-06 |
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