WO2022247099A1 - Dispositif d'opération d'intervention cardiovasculaire sur la base de l'intégration du retrait de tissu calcifié, récupération et refroidissement, et procédé de fonctionnement associé - Google Patents

Dispositif d'opération d'intervention cardiovasculaire sur la base de l'intégration du retrait de tissu calcifié, récupération et refroidissement, et procédé de fonctionnement associé Download PDF

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Publication number
WO2022247099A1
WO2022247099A1 PCT/CN2021/122954 CN2021122954W WO2022247099A1 WO 2022247099 A1 WO2022247099 A1 WO 2022247099A1 CN 2021122954 W CN2021122954 W CN 2021122954W WO 2022247099 A1 WO2022247099 A1 WO 2022247099A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
drive shaft
step drill
drill
fixed
Prior art date
Application number
PCT/CN2021/122954
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English (en)
Chinese (zh)
Inventor
朱兆聚
高楚航
孙鑫辉
朱云祺
何炳蔚
Original Assignee
福州大学
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Publication date
Application filed by 福州大学 filed Critical 福州大学
Publication of WO2022247099A1 publication Critical patent/WO2022247099A1/fr
Priority to ZA2023/07533A priority Critical patent/ZA202307533B/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22081—Treatment of vulnerable plaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P70/00—Climate change mitigation technologies in the production process for final industrial or consumer products
    • Y02P70/10—Greenhouse gas [GHG] capture, material saving, heat recovery or other energy efficient measures, e.g. motor control, characterised by manufacturing processes, e.g. for rolling metal or metal working

Definitions

  • the invention belongs to the technical field of vascular calcified tissue removal, and in particular relates to a cardiovascular interventional operation device based on the integration of calcified tissue removal, recovery and cooling and a working method thereof.
  • Calcified tissue is a harmful substance caused by the deposition of fat, thrombus, connective tissue and calcium carbonate on the inner wall of arteries. It will thicken and harden with age until it blocks the blood vessel. If the calcified tissue in the blood vessel If the treatment is not timely, some unstable plaque rupture will also cause acute myocardial infarction, unstable angina pectoris and other cardiovascular malignant events; research is very necessary.
  • the present invention makes improvements to the problems existing in the above-mentioned prior art, that is, the technical problem to be solved by the present invention is to provide a working method of a cardiovascular interventional surgery device based on the integration of calcified tissue removal, recovery and cooling. It is reasonable, improves the removal efficiency, has a remarkable heat suppression effect during the removal process, and is convenient to collect the removed grinding debris.
  • the present invention is based on the working method of a cardiovascular interventional operation device integrating calcified tissue removal, recovery and cooling, and is characterized in that it includes a guide wire, a screw transmission shaft sleeved on the periphery of the guide wire, and a screw drive shaft fixed on the periphery of a partial section of the screw transmission shaft.
  • Step drill 6 thin-walled curved surface connectors for fixedly connecting the step drill with the helical drive shaft, a sheath tube covering a part of the periphery of the helical drive shaft, and an elastic filter that can be opened and closed at the front side of the step drill
  • the screw drive shaft is driven to rotate by the power mechanism; the front part of the step drill is fixed with a sleeve, the step drill is evenly opened with through holes, and the elastic filter is a cylindrical filter with an open rear end.
  • the above-mentioned sheath tube is a transparent PVC hose, and the inner diameter of the tube is larger than the outer diameter of the screw drive shaft, so that the liquid can flow in the space in the tube, and the step drill is evenly opened with through holes, so that the liquid can flow out from the through holes .
  • the above-mentioned step drill includes three sets of successively connected cylindrical sections and conical frustum sections connected with the cylindrical sections, the inner peripheral wall of the cylindrical section and the screw drive shaft are connected and fixed by a thin-walled curved surface connecting piece in a circular array, the The outer wall of the cylindrical section is provided with laser engraving micro marks, and the outer wall of the truncated cone section is provided with cutting blades.
  • the distance between the fixed sleeve on the above-mentioned stepped drill and the rear end of the elastic filter screen is adjusted by the relative displacement of the guide wire and the screw drive shaft, so as to change the angle between the connecting rod and the guide wire, and then control the elastic filter screen.
  • the maximum diameter of the elastic filter mesh is kept stable when it is working.
  • the thin-walled curved surface connecting piece is a helical blade, which is used to connect the fixed stepped drill and the helical drive shaft, and at the same time, is used to increase the speed of medicine, saline and blood.
  • the above-mentioned screw drive shaft is a flexible drive shaft with tiny threads arranged on its outer surface, and there is a tube gap between the sheath and the screw drive shaft, which drives the step drill to rotate when the screw drive shaft rotates, and plays a role in The liquid that enters the sheath tube is pumped to the through hole opened on the stepped drill through the reserved multi-hole inlet outside the body.
  • the present invention is based on the working method of a cardiovascular interventional surgery device integrating calcified tissue removal, recovery and cooling, characterized in that: the cardiovascular interventional surgery device includes any one of claims 1 to 6, when working, the The device enters the human artery through the femoral artery or radial artery and moves to the affected part in the blood vessel, and then the power mechanism drives the step drill to rotate through the screw drive shaft.
  • the device When the device does not start to rotate, that is, the device is still moving in the blood vessel and has not reached
  • the relative distance between the elastic filter fixed on the guide wire and the stepped drill fixed on the helical drive shaft is relatively far, and the rear end of the elastic filter is deformed under the tension of the connecting rod, so that The mesh is always in a shrinking state before reaching the affected area; after the device arrives at the affected area, the guide wire completes the guiding work, and adjusts the relative position of the guide wire and the step drill, so that the rear end of the elastic filter is stretched by the connecting rod to realize the removal
  • the function of collecting excessively large grinding debris during the process; the step drill is divided into a cutting part and a grinding part.
  • the cutting part is composed of several cutting blades arranged on the conical surface of the conical truncated section.
  • the grinding part is controlled by the laser engraving machine according to the preset
  • the set fine grid pattern is formed by laser engraving micro-marks carved on the cylindrical surface of the stepped drill cylinder.
  • the inner cavity of the sheath tube and the screw drive shaft form a liquid material delivery device.
  • the outer peripheral surface of the screw drive shaft is arranged with tiny threads.
  • the thread acts as a water pump, transporting saline and drugs from the outside of the body through the sheath to the back end of the step drill, and then the thin-walled curved surface connector inside the step drill accelerates , acts directly on the removal part through the through hole, which has the effect of reducing the temperature generated during the rotational atherectomy and directly delivering the medicine to the affected part.
  • the present invention has the following effects: the design of the present invention is reasonable, and the efficiency of removing calcified tissue is improved by arranging two ways to remove calcified tissue on the stepped drill; at the same time, an elastic filter is installed on the guide wire , use the connecting rod connected with the stepped drill to control the opening and closing of the elastic filter, intercept the oversized wear debris, thus avoiding the wear debris from clogging capillaries, and through the specially designed thin-walled curved surface connector, to ensure blood flow during the operation
  • the function of smooth flow can prevent debris from re-depositing around the heart and become a focus of calcified tissue remodeling; opening a through hole on the stepped drill can reduce heat accumulation by increasing the flow of liquid.
  • Fig. 1 is a schematic diagram of a three-dimensional structure of the present invention
  • Fig. 2 is a front view structural schematic diagram of the present invention
  • Fig. 3, 4 are the front view structure schematic diagrams of two working states of the present invention.
  • Fig. 5 is the structural representation of step drill
  • FIG. 6 is a schematic diagram of the connection structure of the guide wire, the helical drive shaft and the sheath;
  • Fig. 7 is a schematic diagram of a three-dimensional structure of a thin-walled curved surface connector
  • Fig. 8 is a schematic diagram of the structure of the use state of the present invention.
  • A1-wear debris, A2-vascular, A3-plaque A1-wear debris, A2-vascular, A3-plaque.
  • the present invention is based on the working method of a cardiovascular interventional operation device integrating calcified tissue removal, recovery and cooling, including a guide wire 1, a helical transmission shaft 2 sleeved on the periphery of the guide wire, the guide wire 1 is a metal wire, and is fixed on the helical drive shaft.
  • Step drills 3 and 6 on the periphery of the partial section of the shaft are thin-walled curved surface connectors 4 for fixedly connecting the step drill 3 with the screw drive shaft 2, a sheath 5 set on the partial section of the periphery of the screw drive shaft, and the stepped drill
  • the elastic filter screen 6 that can be opened and closed on the front side is controllable.
  • the screw drive shaft 2 is driven to rotate by the power mechanism;
  • the cylindrical structure is fixed at the position near the end of the guide wire, and four connecting rods 8 are fixed at the rear end of the elastic filter to connect with the front end of the step drill sleeve; the end of the guide wire is covered with a soft silicone protection Cover 9 to prevent the guide wire from damaging the inner wall of the blood vessel.
  • Power mechanism is arranged in vitro, and it can be motor etc., and elastic filter screen 6 can be the elastic material harmless to human body such as plastic mesh;
  • the surface is threaded, so that the screw drive shaft is driven by the power mechanism, and the liquid can flow in the space in the tube.
  • the stepped drill is evenly opened with through holes 10, so that the liquid can flow out from the through hole. 3, when grinding and cutting calcified tissues, the liquid (including liquid medicine, etc.) flowing out through the through hole plays the role of cooling and blood anticoagulation; the length of the sleeve can be 5mm; the through hole 10 is drilled in a step The holes in the circumferential direction are separated by 60°.
  • the above-mentioned stepped drill 3 includes three sets of successively connected cylindrical sections 11 and conical frustum sections 12 connected with the cylindrical sections, and the inner peripheral wall of the cylindrical section and the screw drive shaft pass through a thin-walled curved surface in a circular array
  • the connecting piece 4 is connected and fixed, and the outer wall of the cylindrical section is provided with laser engraving micro-marks 13 , and the outer wall of the truncated cone section is provided with a cutting edge 14 .
  • the calcified tissue is removed in a step-by-step manner.
  • the cutting edge 14 on the conical frustum section with a smaller diameter at the front end of the stepped drill 3 first contacts the calcified tissue to quickly remove the more prominent part of the calcified tissue.
  • the elastic filter screen 6 intercepts the grinding debris produced by the step drill 3, avoiding the grinding debris blocking the capillaries and causing other surgical complications.
  • the apex angle of the cutting blade 14 can be about 120°; Choose a combination of stepped drills 2 of different sizes to adapt to various levels of blood vessel blockage scenarios.
  • the distance between the sleeve 7 fixed on the above-mentioned stepped drill and the rear end of the elastic filter screen 6 is adjusted by the relative displacement of the guide wire 1 and the screw drive shaft 2, so as to change the angle between the connecting rod 8 and the guide wire 1, and then control
  • the relative position between the opening and closing of the elastic filter in the blood vessel and the size of the opening of the elastic filter can realize the stability of the expanded size of the filter.
  • the above-mentioned thin-walled curved surface connector is a spiral blade, and while connecting the stepped thin-walled cylindrical stepped drill and the drive shaft, the thin-walled curved surface connector can also play a role similar to an impeller to ensure smooth blood flow during the operation and transport Physiological saline and medicine are directly removed from the operation area to avoid surgical complications caused by poor blood flow during the operation.
  • the above-mentioned screw transmission shaft is a flexible transmission shaft, and its outer surface is arranged with tiny threads 15. There is a tube gap 16 between the sheath tube and the screw transmission shaft. The liquid that enters the sheath through the reserved multi-hole inlet is pumped to the through hole 10 opened on the stepped drill.
  • the position of the end of the sheath tube 5 is close to the thin-walled curved surface connector 4 (helical blade) of the stepped drill 3, so that after the medicinal liquid etc. are pumped out from the end of the sheath tube 5, it enters the helical guidance of the thin-walled curved surface connector 4, Thereby, it is beneficial for the liquid medicine to be sprayed out from the through hole 10 on the stepped drill 3, and the heat generated during grinding and blood clots can be improved.
  • the removal device enters the arterial vessel of the human body through the femoral artery and moves to the affected part in the blood vessel.
  • the calcified tissue is removed in a pecking-like manner. Contact the calcified tissue, quickly remove the protruding part of the calcified tissue, and then pass through the stepped drill with a larger diameter than the former one by one.
  • the grinding part of the stepped drill with each diameter size slowly grinds and removes the calcified tissue, making the surface of the calcified tissue smoother ;
  • the elastic filter is subjected to the force of the connecting rod to maintain a stable opening degree, intercepting the oversized wear debris generated during the removal process, and preventing the wear debris from clogging capillaries and causing other surgical complications.
  • the thin-walled curved surface connector used to fix the stepped drill can also function as an impeller to increase blood flow, and the accelerated blood, saline and medicine can pass through the reserved through-holes on the stepped drill It flows out and directly acts on the affected area to ensure smooth blood flow. At the same time, it can also flow the tiny debris generated during the drilling process to the farther end with the blood, avoiding accumulation in the blood vessels around the heart, reducing the risk of blood vessel blockage and reducing the risk of damage to the heart. The effect of blood circulation flow.
  • the distance between the filter screen and the stepped drill is relatively far, and the filter screen is in a convergent state due to the tension of the connecting rod.
  • the cross-sectional area is small, so that the device can pass through relatively narrow blood vessels to reach the affected area smoothly.
  • reduce the relative distance between the filter screen and the step drill reduce the relative distance between the filter screen and the step drill.
  • the filter screen is opened by the thrust of the connecting rod, and the angle between the connecting rod and the guide wire increases, and because the relative distance is fixed, the opening degree of the filter screen is maintained.
  • the diameter of the expanded filter is close to the maximum diameter of the stepped drill and strictly smaller than the lumen diameter of the blood vessel; among the abrasive debris generated, some larger abrasive debris will be removed by the filter Intercepted, thereby effectively avoiding wear debris blocking capillaries and causing other surgical complications.
  • the present invention is based on the working method of a cardiovascular interventional surgery device integrating calcified tissue removal, recovery and cooling.
  • the device enters the human arterial vessel through the femoral artery or radial artery and moves to the affected part in the blood vessel, and then the power mechanism passes through The screw drive shaft drives the step drill to rotate.
  • the device does not start to rotate, that is, when the device is still moving in the blood vessel and has not reached the affected area, the elastic filter fixed on the guide wire and the stepped drill fixed on the helical drive shaft are relatively far away from each other. Under the tension of the connecting rod, the end is deformed by force, so that the elastic filter is always in a shrinking state before reaching the affected area.
  • the end of the guide wire is covered with a soft material protective sheath (such as silica gel, etc.).
  • a soft material protective sheath such as silica gel, etc.
  • the step drill is divided into a cutting part and a grinding part.
  • the cutting part is composed of a number of tiny blades arranged on the conical surface.
  • the grinding part is drilled on the three-stage cylindrical surface by the laser engraving machine according to the preset dense grid pattern. Composed of micro-marks carved on it.
  • the stepped drill is fixedly connected with the screw transmission shaft through the thin-walled curved surface connecting piece, and the thin-walled curved surface connecting piece also has the effect of speeding up the liquid.
  • the inner cavity of the sheath tube and the screw transmission shaft constitute the material delivery device. There are tiny threads arranged on the outer surface of the screw transmission shaft.
  • the threads play the role of a water pump, and the normal saline and drugs are transferred from It is delivered to the back end of the stepped drill through the sheath outside the body, and then accelerated by the thin-walled curved surface connector inside the stepped drill, and directly acts on the removal site through the through hole, which reduces the temperature generated during rotational atherectomy and directly sends the drug to the effect on the affected area.
  • the fixed connection can be understood as: a detachable fixed connection (for example, using bolts or screws), or it can also be understood as: Non-detachable fixed connection (such as riveting, welding), of course, the mutual fixed connection can also be replaced by an integrated structure (such as manufactured by casting process in one piece) (except that the integral forming process cannot be adopted obviously).
  • any of the technical solutions disclosed in the present invention to indicate positional relationships or shapes include states or shapes that are similar, similar or close to them.
  • Any component provided by the present invention can be assembled from multiple individual components, or can be a single component manufactured by integral forming process.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif d'opération d'intervention cardiovasculaire sur la base de l'intégration du retrait d'un tissu calcifié, la récupération et le refroidissement, et un procédé de fonctionnement associé. Le dispositif d'opération d'intervention cardiovasculaire comprend un fil de guidage (1), un arbre de transmission en spirale (2) qui est emmanché sur la périphérie du fil de guidage (1), un foret étagé (3) qui est fixé à la périphérie d'une section locale de l'arbre de transmission en spirale (2), six éléments de raccordement (4) à surface incurvée et paroi fine qui sont utilisés pour le raccordement de manière fixe du foret étagé (3) à l'arbre de transmission en spirale (2), une gaine (5), et un tamis de filtre élastique (6) qui est disposé sur un côté avant du foret étagé (3) et dont l'ouverture et la fermeture peuvent être commandées. L'arbre de transmission en spirale (2) est entraîné par un mécanisme d'alimentation pour tourner; un manchon (7) est disposé de manière fixe sur une portion avant du foret étagé (3), et des trous traversants (10) sont disposés de manière uniforme dans le foret étagé (3); le tamis de filtre élastique (6) est une structure cylindrique ayant une ouverture dans une extrémité arrière et est fixé dans une position du fil de guidage (1) proche de la pointe; et quatre tiges de raccordement (8) sont fixées à l'extrémité arrière du tamis de filtre élastique (6) et raccordées à une portion d'extrémité avant du manchon (7) du foret étagé; la pointe du fil de guidage (1) est revêtue d'un matériau souple afin d'empêcher le fil de guidage (1) d'endommager une paroi interne d'un vaisseau sanguin; et les trous traversants (10) sont disposés dans le foret étagé (3), et l'effet de réduction d'accumulation de chaleur est atteint en accroissant l'écoulement d'un liquide.
PCT/CN2021/122954 2021-05-28 2021-10-11 Dispositif d'opération d'intervention cardiovasculaire sur la base de l'intégration du retrait de tissu calcifié, récupération et refroidissement, et procédé de fonctionnement associé WO2022247099A1 (fr)

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Application Number Priority Date Filing Date Title
ZA2023/07533A ZA202307533B (en) 2021-05-28 2023-07-28 Operating method of cardiovascular interventional surgical device based on integration of calcified tissue removal, recovery and cooling

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CN202110593491.5 2021-05-28
CN202110593491.5A CN113288334B (zh) 2021-05-28 2021-05-28 心血管介入手术装置

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CN117224197A (zh) * 2023-11-13 2023-12-15 泓欣科创(北京)科技有限公司 血管疏通冲洗装置及血管疏通冲洗方法

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CN113288334B (zh) * 2021-05-28 2023-08-04 福建珞创医疗科技有限公司 心血管介入手术装置
CN114948107A (zh) * 2022-06-20 2022-08-30 上海微创旋律医疗科技有限公司 旋磨装置

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CN112451045A (zh) * 2020-12-16 2021-03-09 福州大学 一种血管钙化组织高效去除装置及其工作方法
CN113288334A (zh) * 2021-05-28 2021-08-24 福州大学 基于钙化组织去除、回收及降温一体化的心血管介入手术装置的工作方法

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US20150182252A1 (en) * 2006-06-30 2015-07-02 Atheromed, Inc. Atherectomy devices and methods
CN201079423Y (zh) * 2007-09-29 2008-07-02 成正辉 血管内血栓及栓塞物切除器
CN110520069A (zh) * 2017-03-28 2019-11-29 泰尔茂株式会社 医疗设备以及处置方法
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