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WO2023071017A1 - Cathéter d'intervention à haute adaptabilité - Google Patents

Cathéter d'intervention à haute adaptabilité Download PDF

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Publication number
WO2023071017A1
WO2023071017A1 PCT/CN2022/080155 CN2022080155W WO2023071017A1 WO 2023071017 A1 WO2023071017 A1 WO 2023071017A1 CN 2022080155 W CN2022080155 W CN 2022080155W WO 2023071017 A1 WO2023071017 A1 WO 2023071017A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
balloon
channel
outer tube
optical fiber
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2022/080155
Other languages
English (en)
Chinese (zh)
Inventor
吴难
潘淑芬
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Micro Medical Technology Co Ltd
Original Assignee
Shenzhen Micro Medical Technology Co Ltd
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 Shenzhen Micro Medical Technology Co Ltd filed Critical Shenzhen Micro Medical Technology Co Ltd
Publication of WO2023071017A1 publication Critical patent/WO2023071017A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop

Definitions

  • the present application relates to the technical field of medical devices, in particular to a highly adaptable interventional catheter.
  • Calcified tissue is a harmful substance caused by the deposition of fat, thrombus, connective tissue and calcium carbonate on the inner wall of arteries.
  • Calcified tissue blocking blood vessels is one of the main causes of cardiovascular diseases.
  • the calcified tissue in the blood vessel that blocks the blood vessel will reduce the inner diameter of the blood vessel, resulting in a decrease in the blood flow rate and poor blood flow, thereby hindering or even blocking the blood flow, resulting in insufficient blood and oxygen supply to the body. Poor blood flow leads to an increase in the internal pressure of blood vessels, which can easily induce various cardiovascular diseases, and in severe cases, cause arterial rupture and massive bleeding.
  • the patients with high degree of calcification have higher rates of all cardiovascular disease events, non-fatal myocardial infarction and sudden death of cardiovascular diseases. The relative risk is higher.
  • PTCA Percutaneous transluminal coronary angioplasty
  • PTCA Percutaneous transluminal coronary angioplasty
  • a catheter inflated to expand calcified tissue in the vessel wall, with a balloon gradually releasing pressure until the calcified tissue ruptures.
  • shock wave generator device is formed by placing one or several pairs of discharge electrodes in the angioplasty balloon, and the shock wave can be selectively generated in the balloon by applying high-voltage pulses to the shock wave generator device. Destroy the calcified tissue in the blood vessel wall while effectively avoiding damage to the blood vessel wall.
  • a catheter capable of generating shock waves capable of treating calcified tissue that is, a shock wave guide
  • the electrodes in the shock wave guide generally adopt single or multiple ring electrodes. Because the ring electrode will increase the overall outer diameter of the catheter, and the ring electrode will reduce the flexibility of the catheter in the axial direction (the catheter is not easy to bend), which will lead to a decrease in the passing performance of the shock waveguide in the target vessel, reducing the shock waveguide
  • the present application provides a highly adaptable interventional catheter, aiming at solving the technical problem of weak blood vessel traversing ability existing in the existing shock waveguide.
  • the highly adaptable interventional catheter includes:
  • a tube structure having a liquid input channel, a wire introduction channel and an optical fiber placement channel;
  • a balloon sealed and sleeved at one end of the tube structure, the balloon communicated with the liquid input channel and the guide wire introduction channel;
  • the tube structure is a double-layer structure and includes an inner tube and an outer tube, the outer tube is sheathed outside the inner tube, the outer tube and the The liquid input channel, the guide wire introduction channel and the optical fiber placement channel are formed between the inner tubes.
  • the inner tube and the outer tube have at least one end that is flush, and the balloon seal is sleeved on the outer tube and is located at this end, the The laser fiber emerges from this end.
  • the ring electrode is sheathed on the outer tube, and the outer tube is provided with a threading hole, and the wire is protruded from the threading hole and electrically connected to to the ring electrode.
  • the outer tube is provided with a liquid injection hole, and the liquid in the liquid input channel can enter the balloon through the liquid injection hole.
  • the inner tube protrudes from the outer tube to form an extension section
  • the balloon is sealed and sleeved on the extension section
  • the ring electrode The laser fiber is sheathed on the inner tube, the laser fiber is attached to the outer wall of the inner tube, and the laser fiber protrudes from the balloon.
  • the tube structure further includes a limiting tube, and the limiting tube is sleeved on the end of the extension section and axially spaced from the outer tube.
  • the two ends of the balloon are respectively sealed and connected to the outer tube and the limiting tube, the limiting tube is connected to the inner tube through a connecting rib, and the two adjacent connecting ribs An optical fiber via hole is formed between them, and the laser optical fiber is exposed from the optical fiber via hole.
  • the tube structure is a three-layer structure and includes an inner tube, an outer tube, and a protective film sleeve arranged on the outer tube, the inner tube and the outer tube
  • the liquid input channel and the optical fiber installation channel are formed between the tubes
  • the wire introduction channel is formed between the protective film sleeve and the outer tube
  • the balloon is sealed and sleeved on the outer tube
  • the ring electrode sleeve It is arranged on the outer tube, and the outer tube is provided with a liquid injection hole, and the liquid in the liquid input channel can enter the balloon through the liquid injection hole.
  • the liquid input channel and the optical fiber installation channel are alternately arranged at intervals, and the laser optical fiber is multiple and uniformly arranged around the outer circumference of the inner tube.
  • the balloon is attached to the tube structure by heat fusion welding or laser welding.
  • the highly adaptable interventional catheter in the above embodiments, it includes a tube structure, a balloon, a ring electrode, a wire, and a laser fiber.
  • the laser fiber will first touch the calcified tissue, The laser emitted by the laser fiber will impact the calcified tissue. As the laser fiber travels further, a passage along the blood vessel axis will be dug in the calcified tissue, and then the balloon will move to the calcified tissue.
  • the pulse generator applies a high-voltage pulse current to the ring electrode, and the ring electrode will discharge to form a shock wave in the balloon.
  • the shock wave will be transmitted to the calcified tissue by means of the liquid medium filled in the balloon through the liquid input channel, from the blood vessel Beat the calcified tissue in the radial direction, so that many tiny cracks appear in the calcified tissue, so that the calcified tissue can be loosened, and then the balloon is expanded by pressurizing the liquid medium inside the balloon, and then the blood vessel is expanded.
  • the shock wave generated by the highly adaptable interventional catheter can selectively destroy the calcified tissue in the blood vessel wall while effectively avoiding damage to the blood vessel wall.
  • the highly adaptable interventional catheter passes through the blood vessel, based on the setting and function of the laser fiber, it can clear the obstacles for the smooth passage of the balloon. Even in the face of severe calcified tissue, the passing action will not be affected.
  • the highly adaptable interventional catheter has ultra-high blood vessel passing ability, and its applicability is strong.
  • Fig. 1 shows a schematic structural view of a highly adaptable interventional catheter in an embodiment
  • Fig. 2 shows a partial enlarged view of place A in Fig. 1;
  • Fig. 3 shows a structural schematic view of another angle of the highly adaptable interventional catheter in an embodiment
  • Fig. 4 shows a structural schematic diagram of another angle of the highly adaptable interventional catheter in an embodiment
  • Fig. 5 shows a schematic structural diagram of a removal balloon of a highly adaptable interventional catheter in an embodiment.
  • 100-tube structure 110-inner tube; 120-outer tube;
  • interventional catheter a highly adaptable interventional catheter (hereinafter referred to as "interventional catheter"), which can break the influence of severe and large plaque calcified tissue on the ability to pass through when passing through blood vessels, and it can act on these calcifications organized to form pathways.
  • the interventional catheter includes a tube structure 100 , a balloon 200 , a ring electrode 300 , a wire 400 and a laser fiber 500 .
  • the tube structure 100 has a liquid input channel, a wire introduction channel and an optical fiber placement channel. It can be understood that, through different structural designs of the tube structure 100, the liquid input channel, the wire introduction channel and the fiber placement channel have different combinations. In the embodiment herein, it should be understood that the liquid input channel, the wire introduction channel and the optical fiber placement channel can be designed in a common form, or can be designed to be formed separately.
  • the balloon 200 is an important part for expanding calcified tissue, and its sealing sleeve is connected to one end of the tube structure 100.
  • the balloon 200 is connected to the liquid input channel and the guide wire introduction channel. Entering into the balloon through the liquid input channel, the guide wire 400 can be inserted into the balloon through the guide guide channel.
  • the ring electrode 300 is sheathed on the tube structure 100 and wrapped by the balloon 200 , and the wire 400 is passed through the wire introduction channel and electrically connected to the ring electrode 300 .
  • the wire is connected to the ring electrode 300, and on the other hand, it also needs to be connected with a high-voltage pulse generator to form a high-voltage pulse electrical signal.
  • the laser fiber 500 is disposed in the fiber installation channel and exposed from the end of the tube structure 100 on which the balloon 200 is disposed.
  • the highly adaptable interventional catheter in the embodiment of the present application includes a tube structure 100, a balloon 200, a ring electrode 300, a guide wire 400, and a laser fiber 500.
  • the laser fiber 500 will first When it touches the calcified tissue, the laser emitted by the laser fiber 500 will impact the calcified tissue.
  • a passage along the blood vessel axis will be dug in the calcified tissue, and then the balloon 200 will move To the calcified tissue, at this time, a high-voltage pulse current is applied to the ring electrode through a high-voltage pulse generator, and the ring electrode 300 will discharge, thereby forming a shock wave in the balloon 200, and the shock wave will fill the balloon 200 through the liquid input channel.
  • the liquid medium in the balloon 200 is delivered to the calcified tissue, and the calcified tissue is hit from the radial direction of the blood vessel, so that many tiny cracks appear in the calcified tissue, so that the calcified tissue can be loosened, and then the liquid medium inside the balloon 200 is pressurized to make the
  • the balloon 200 is inflated and then expands the blood vessel.
  • the shock wave generated by the highly adaptable interventional catheter can selectively destroy the calcified tissue in the blood vessel wall while effectively avoiding damage to the blood vessel wall.
  • the highly adaptable interventional catheter passes through the blood vessel, based on the setting and function of the laser fiber 500, it can clear the obstacles for the smooth passage of the balloon 200, and the passing action will not be affected even in the face of severe calcified tissue , the highly adaptable interventional catheter has ultra-high blood vessel passing ability, and its applicability is strong.
  • the laser fiber 500 can, for example, emit 308nm laser light, which causes chemical bonds to break under very high energy density and short action time, and the released energy further vaporizes the liquid water in the cells to generate steam bubbles. Rapid expansion and contraction lead to disintegration of calcified tissue, allowing calcified material to vaporize.
  • the concept of the application is mainly to set the laser fiber 500 at the front end of the interventional catheter, and the laser optical fiber 500 serves as the "open circuit structure" of the interventional catheter, which can ensure the subsequent passage of the interventional catheter action.
  • the specific connection relationship and structural composition of the tube structure 100 , the balloon 200 , the ring electrode 300 , and the wire 400 are not particularly limited in the embodiment herein.
  • the pipe structure 100 can be designed in various structural forms. The following examples will list the interventional catheters designed based on the basic shapes of the two tube structures 100 .
  • the tube structure 100 is a double-layer structure and includes an inner tube 110 and an outer tube 120 , the outer tube 120 is sleeved outside the inner tube 110 , and the outer tube 120 and the inner tube 110 A liquid input channel, a wire introduction channel and an optical fiber placement channel are formed therebetween.
  • the tube structure 100 with a double-layer structure is a commonly used structural form, which is mostly used in the shock waveguide introduced in the background art, but based on the setting of the laser optical fiber 500, in order to ensure the structural For the compactness and consistency of the catheter, other parts of the interventional catheter need to be changed.
  • the inner tube 110 and the outer tube 120 have at least one end that is flush, the balloon 200 is sealed and sleeved on the outer tube 120 and is located at this end, and the laser optical fiber 500 is exposed from this end.
  • the exposed laser fiber 500 can emit laser light to treat the calcified tissue in front of the travel path, so that the end of the interventional catheter can pass through the calcified tissue. After that, the balloon 200 slowly expands, with the help of the ring electrode 300 and the liquid medium To achieve the purpose of dilating blood vessels.
  • the assembly and combination relationship of the inner tube 110, the outer tube 120 and the balloon 200 in this structural form is convenient for design and assembly, and can reduce the cost to a certain extent.
  • the ring electrode 300 can be sleeved on the outer tube 120, and the outer tube 120 is provided with a threading hole, and the wire 400 protrudes from the threading hole and is electrically connected to the ring electrode 300.
  • a liquid injection hole can be opened in the outer tube 120 , and the liquid in the liquid input channel can enter the balloon 200 through the liquid injection hole.
  • the inner tube 110 protrudes from the outer tube 120 to form an extension section
  • the balloon 200 is sealed and sleeved on the extension section
  • the ring electrode 300 is sleeved on the inner tube 110
  • the laser optical fiber sticks to the outer wall of the inner tube 110
  • the laser fiber 500 protrudes from the balloon 200 .
  • the assembly and combination relationship of the inner tube 110, the outer tube 120 and the balloon 200 in this structural form makes the shrinkage space of the balloon 200 larger, which is beneficial to improve the traversing ability of the interventional catheter, and is also conducive to the natural introduction of liquid media and guide wires.
  • the tube structure 100 further includes a limiting tube (not shown in the figure), which is sleeved at the end of the extension section and spaced apart from the outer tube 120 in the axial direction.
  • the two ends of the capsule 200 are respectively sealed and connected to the outer tube 120 and the limiting tube.
  • the limiting tube is connected to the inner tube 110 through a connecting rib (not shown in the figure), and an optical fiber through hole is formed between two adjacent connecting ribs.
  • the laser fiber 500 is exposed from the fiber via hole.
  • the laser fiber 500 can be better limited.
  • the tube structure 100 can also be a three-layer structure and include an inner tube 110, an outer tube 120, and a protective film cover (not shown in the figure) arranged on the outer tube 120 ), a liquid input channel and an optical fiber installation channel are formed between the inner tube 110 and the outer tube 120, a wire introduction channel is formed between the protective film sleeve and the outer tube 120, the balloon 200 is sealed and sleeved on the outer tube 120, and the ring electrode 300 is sleeved On the outer tube 120 , the outer tube 120 is provided with a liquid injection hole, and the liquid in the liquid input channel can enter the balloon 200 through the liquid injection hole.
  • the liquid input channel and the optical fiber installation channel are alternately arranged at intervals, and the laser optical fiber 500 is multiple and evenly arranged around the outer circumference of the inner tube.
  • the uniform arrangement of multiple laser fibers 500 can form a uniform laser beam to perform uniform and stable vaporization on calcified tissues.
  • the balloon 200 is connected to the tube structure 100 by heat fusion welding or laser welding to ensure the reliability of the connection.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Optics & Photonics (AREA)
  • Vascular Medicine (AREA)
  • Electromagnetism (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
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  • Anesthesiology (AREA)
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  • Media Introduction/Drainage Providing Device (AREA)
  • Laser Surgery Devices (AREA)

Abstract

L'invention concerne un cathéter d'intervention à haute adaptabilité, comprenant une structure de cathéter (100), un ballonnet (200), une électrode annulaire (300), un fil (400) et une fibre optique laser (500). La structure de cathéter (100) est pourvue d'un canal d'entrée de liquide, d'un canal d'entrée de fil et d'un canal de placement de fibre optique ; le ballonnet (200) est relié à une extrémité de la structure de cathéter (100) dans un mode étanche et emmanché ; le ballonnet (200) est en communication avec le canal d'entrée de liquide et le canal d'entrée de fil ; l'électrode annulaire (300) est emmanché sur la structure de cathéter (100) et enveloppé par le ballonnet (200) ; le fil (400) est disposé dans le canal d'entrée de fil dans un mode de pénétration et connecté électriquement à l'électrode annulaire (300) ; et la fibre optique laser (500) est disposée dans le canal de placement de fibre optique et est exposée à partir de l'extrémité, pourvue du ballonnet (200), de la structure de cathéter (100). Lorsque le cathéter d'intervention à haute adaptabilité passe à travers un vaisseau sanguin, les obstacles peuvent être éliminés pour permettre un passage régulier du ballonnet (200) sur la base de l'agencement et de la fonction de la fibre optique laser (500), et l'action de passage ne serait pas affectée même dans la face de tissu calcifié sérieux, de telle sorte que le cathéter d'intervention à haute adaptabilité présente une capacité de passage de vaisseau sanguin ultra-élevé et présente une applicabilité élevée.
PCT/CN2022/080155 2021-10-29 2022-03-10 Cathéter d'intervention à haute adaptabilité Ceased WO2023071017A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202111271503.9A CN113974826A (zh) 2021-10-29 2021-10-29 一种高适应性介入导管
CN202111271503.9 2021-10-29

Publications (1)

Publication Number Publication Date
WO2023071017A1 true WO2023071017A1 (fr) 2023-05-04

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PCT/CN2022/080155 Ceased WO2023071017A1 (fr) 2021-10-29 2022-03-10 Cathéter d'intervention à haute adaptabilité

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CN (1) CN113974826A (fr)
WO (1) WO2023071017A1 (fr)

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US12295654B2 (en) 2020-06-03 2025-05-13 Boston Scientific Scimed, Inc. System and method for maintaining balloon integrity within intravascular lithotripsy device with plasma generator
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US11672585B2 (en) 2021-01-12 2023-06-13 Bolt Medical, Inc. Balloon assembly for valvuloplasty catheter system
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US11806075B2 (en) 2021-06-07 2023-11-07 Bolt Medical, Inc. Active alignment system and method for laser optical coupling
CN113974826A (zh) * 2021-10-29 2022-01-28 深圳微量医疗科技有限公司 一种高适应性介入导管
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