CN116392200A - Shock wave electrode assembly, balloon catheter and medical equipment - Google Patents

Shock wave electrode assembly, balloon catheter and medical equipment Download PDF

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Publication number
CN116392200A
CN116392200A CN202310376065.5A CN202310376065A CN116392200A CN 116392200 A CN116392200 A CN 116392200A CN 202310376065 A CN202310376065 A CN 202310376065A CN 116392200 A CN116392200 A CN 116392200A
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China
Prior art keywords
electrode
shock wave
opening
along
balloon catheter
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CN202310376065.5A
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Chinese (zh)
Inventor
王韬
吴方刚
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Feiyinuo Technology Co ltd
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Feiyinuo Technology Co ltd
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Priority to CN202310376065.5A priority Critical patent/CN116392200A/en
Publication of CN116392200A publication Critical patent/CN116392200A/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
    • A61B17/22—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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • 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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/22022—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement using electric discharge
    • 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
    • A61M25/1018—Balloon inflating or inflation-control devices
    • 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
    • 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
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • 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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22071—Steering
    • 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
    • A61B17/22—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
    • A61B2017/22082—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 after introduction of a substance
    • A61B2017/22084—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 after introduction of a substance stone- or thrombus-dissolving
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Abstract

The invention discloses a shock wave electrode assembly, a balloon catheter and medical equipment, wherein the shock wave electrode assembly comprises a first electrode, a second electrode and an insulating part positioned between the first electrode and the second electrode, the first electrode extends along a first direction and comprises an opening penetrating along a second direction perpendicular to the first direction, and the second electrode is assembled in the opening along the second direction and is partially exposed to the opening, so that the assembly process of the shock wave electrode assembly is simplified; and the risk of displacement between the shock wave electrode assemblies is reduced during the generation of the shock wave.

Description

Shock wave electrode assembly, balloon catheter and medical equipment
Technical Field
The invention relates to the technical field of medical equipment, in particular to a shock wave electrode assembly, a balloon catheter and medical equipment.
Background
Vascular plaque shockwave lithotripsy is a new technique that has emerged in recent years, and is now increasingly used to break down vascular calcified plaque, promote vascular compliance, increase the diameter of the vascular lumen, and aid stent placement. The existing electrode scheme releases the shock wave through the insulating layer and the holes on the electrode, and the hole sizes of the electrode and the insulating layer directly influence the intensity of the shock wave generated by electrode discharge and the pulse parameters required by the discharge, so that the holes of the electrode and the insulating layer are required to be aligned and coaxially assembled, the electrode is usually small in size, the holes on the electrode are smaller, and the assembly difficulty is greatly increased by coaxially assembling the holes. In addition, in order to obtain a proper size of shock wave intensity and distribution, a plurality of sets of electrodes are required to be arranged along the support bar. The bracing piece is smooth pipe usually, does not have stop device, and the distance between the electrode is the distance of design when hardly guaranteeing the assembly, and the assembly degree of difficulty is very big.
The electrode used for plaque rubble in blood vessel is very small in size, welding and fixing between the electrode and the wire are very difficult, shock waves generated during electrode discharge can also cause severe vibration, if welding is weak, the wire connected with the electrode is very easy to break, if fixing is poor, vibration generated during electrode discharge can easily cause electrode displacement, so that the electrode cannot be aligned with holes of an insulating layer, the shock wave effect is affected, severe even complete separation is caused, and the discharge cannot be caused, so that shock waves cannot be generated.
Disclosure of Invention
One of the objectives of the present invention is to provide a shock wave electrode assembly, which solves the technical problem of difficult assembly in the prior art.
It is an object of the present invention to provide a balloon catheter.
It is an object of the present invention to provide a medical device.
In order to achieve one of the above objects, an embodiment of the present invention provides a shock wave electrode assembly comprising: the first electrode extends along a first direction and comprises an opening penetrating along a second direction perpendicular to the first direction, and the second electrode is assembled in the opening along the second direction and is partially exposed to the opening.
As a further improvement of an embodiment of the present invention, the first electrode includes at least one opening, the insulating portion is an insulator formed by integrally forming an insulating material and is assembled to the opening along a second direction, a groove communicating with the opening is formed on an outer surface of the insulating portion exposed to the opening along the second direction, and the second electrode is fixed and exposed to the groove.
As a further improvement of an embodiment of the present invention, the first electrode includes at least two openings, the two openings being symmetrical about the axis of the first electrode, the insulating portion extending in the second direction and fitting into the two openings in the second direction, the insulating portion being symmetrical about the axis of the first electrode.
As a further improvement of an embodiment of the present invention, the first electrode includes a first receiving hole extending along a first direction, the first receiving hole is in communication with the opening, the insulating portion includes a second receiving hole extending along the first direction, the second receiving hole is in communication with the groove, and the first receiving hole and the second receiving hole are at least partially overlapped in a radial direction, so that a wire passes through the first receiving hole and the second receiving hole and is connected to the second electrode.
As a further improvement of an embodiment of the present invention, the surface of the second electrode exposed to the opening is provided with grooves, and the surface of the second electrode is coated with an insulating layer except for the bottom surface of the grooves to form the insulating portion.
As a further improvement of one embodiment of the present invention, an inner wall surface of the opening is coated with an insulating layer to form the insulating portion.
In order to achieve one of the above objects, an embodiment of the present invention provides a balloon catheter, including a shock wave electrode assembly according to any one of the above embodiments, a wire connected to the shock wave electrode assembly, and a balloon for accommodating the shock wave electrode assembly, wherein the first electrode includes a first accommodating hole extending along a first direction, the first accommodating hole is in communication with the opening, the wire includes a first wire and a second wire arranged at intervals, the first wire extends along the first direction to be electrically connected with the first electrode, and the second wire extends from the first accommodating hole to a corresponding opening and is electrically connected with the second electrode.
As a further improvement of an embodiment of the present invention, the first electrode includes a middle portion and fixing portions located at two ends of the middle portion along a first direction, the fixing portions are provided with fixing grooves along the first direction for fixing a portion of the first wire in the first electrode, and the opening penetrates through an outer surface of the middle portion along a second direction.
As a further improvement of an embodiment of the present invention, the first electrode includes a middle portion and fixing portions located at two ends of the middle portion along the first direction, the middle portion is a cylinder and forms a transitional step surface with the fixing portions, the balloon catheter includes a mounting tube assembled and fixed with the fixing portions, and the mounting tube is sleeved on the fixing portions and abuts against the step surface.
As a further improvement of one embodiment of the present invention, the fixing portion is a cylinder having an outer diameter smaller than that of the intermediate portion.
As a further improvement of one embodiment of the present invention, the fixing portion is a cone whose outer diameter gradually decreases toward both sides in the first direction, and the maximum outer diameter of the fixing portion is equal to the inner diameter of the mounting tube and smaller than the outer diameter of the intermediate portion.
To achieve one of the above objects, an embodiment of the present invention provides a medical device, including the balloon catheter according to any one of the above aspects and a shock wave generator connected to the balloon catheter, wherein the shock wave generator is used for generating high-voltage pulses.
Compared with the prior art, the invention provides the shock wave electrode assembly, the first electrode extends along the first direction, the second electrode is assembled in the opening along the second direction and is partially exposed to the opening, the alignment assembly is not needed, and the assembly process is simplified; and the risk of displacement between the shock wave electrode assemblies is reduced during the generation of the shock wave.
Drawings
Fig. 1 is a perspective view of a shock wave electrode assembly in accordance with an embodiment of the present invention.
Fig. 2 is an exploded view of a shock wave electrode assembly in accordance with an embodiment of the present invention.
Fig. 3 is a cross-sectional view of a shock wave electrode assembly in accordance with an embodiment of the present invention.
Fig. 4 is a cross-sectional view of a shock wave electrode assembly in a second embodiment of the present invention.
Fig. 5 is a cross-sectional view of a shock wave electrode assembly in a third embodiment of the present invention.
Fig. 6 is a perspective view of a balloon catheter in an embodiment of the invention.
Fig. 7 is an exploded view of a balloon catheter in an embodiment of the invention.
Fig. 8 is a cross-sectional view of a balloon catheter in one direction in an embodiment of the invention.
Fig. 9 is a cross-sectional view of a balloon catheter in another direction in an embodiment of the invention.
Detailed Description
The present invention will be described in detail below with reference to specific embodiments shown in the drawings. These embodiments are not intended to limit the invention and structural, methodological, or functional modifications of these embodiments that may be made by one of ordinary skill in the art are included within the scope of the invention.
Terms such as "upper," "above," "lower," "below," and the like, as used herein, refer to a spatial relative position, and are used for ease of description to describe one element or feature's relationship to another element or feature as illustrated in the figures. The term spatially relative position may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or other orientations) and the spatially relative descriptors used herein interpreted accordingly.
Referring to fig. 1-3, a shock wave electrode assembly 10 according to an embodiment of the invention is shown.
The shock wave electrode assembly 10 includes a first electrode 11, a second electrode 13, and an insulating portion 15 between the first electrode 11 and the second electrode 13. Specifically, the first electrode 11 and the second electrode 13 are made of conductive materials, such as stainless steel, copper, nickel, etc., and the insulating portion 15 is made of insulating materials, such as teflon, PEEK, PA, etc.
Preferably, the first electrode 11 extends along a first direction and includes an opening 110 penetrating along a second direction perpendicular to the first direction, and the second electrode 13 is assembled to the opening 110 along the second direction and partially exposed to the opening 110, so that alignment assembly is not required, and the assembly process is simplified; and the risk of displacement between the shock wave electrode assemblies 10 during the generation of shock waves is reduced.
In a particular embodiment, the first electrode 11 extends axially, the aperture 110 is disposed radially through the surface, where the aperture 110 extends radially inward a distance capable of receiving the second electrode 13 and an outer surface of the second electrode 13 in the second direction is located radially within the aperture. The second electrode 13 is fitted radially within the aperture 110, at which time the formation of the shock wave is not affected even if the second electrode 13 is slightly displaced radially. The second electrode 13 is exposed in the opening 110 of the first electrode, the opening 110 should further store liquid, the first electrode 11 and the second electrode 13 are connected through the insulation part 15, after being electrified, high-voltage pulse is transmitted to the second electrode 13 and the first electrode 11, the liquid in the opening 110 is broken down, a plasma channel generated by the breakdown rapidly expands and extrudes the liquid in the surrounding environment, so that shock waves are generated, and the shock waves are conducted to calcified plaque of the blood vessel along the second direction, so that the function of shock wave lithotripsy is realized.
In a preferred embodiment, the first electrode 11 includes at least one opening 110, the insulating portion 15 is an insulator formed by integrally forming an insulating material and is assembled to the opening 110 along a second direction, a groove 152 communicating with the opening 110 is formed on an outer surface 151 of the insulating portion 15 exposed to the opening 110 along the second direction, and the second electrode 13 is fixed and exposed to the groove 152.
Specifically, the insulating portion 15 and the opening 110 of the first electrode 11 are coaxially matched, which is favorable for stability of the matching, and the fixing manner can be interference fit, gluing, threads and the like. Similarly, the second electrode 13 is located in the groove 152 of the insulating portion 15, and is also coaxially matched, so that the stability of the matching is facilitated, and the fixing manner can be interference fit, gluing, threads and the like. The first electrode 11, the second electrode 13 and the insulating part 15 are coaxially assembled along the second direction through the opening 110 and the groove 152, and are coaxially aligned along the second direction when assembled, so that the alignment is not required to be adjusted after assembly, and the assembly process is simplified.
Specifically, the opening 110 is a circular hole, the insulating portion 15 may be in a disc shape, and an outward outer surface 151 of the insulating portion is located in the opening 110; however, the opening 110 is not limited to a circular shape, and may be square, oval, etc., and the corresponding insulating portion 15 and the second electrode 13, which are engaged with the opening 110, may be square, oval, etc., which are configured such that shock wave energy generated from the electrode assembly 10 propagates toward the opening 110 of the first electrode 11.
Specifically, the groove 152 is formed by continuously recessing the outer surface 151 inward and penetrating the insulating portion 15, and the second electrode 13 is in a shape of a circular plate and is fixed in the groove 152 by interfering with the inner wall surface of the groove 152, which can be understood that if the second electrode 13 and the insulating portion 15 are subjected to vibration displacement, the second electrode and the insulating portion are all along the second direction, so as to reduce the impact on the generated shock wave. The first electrode 11 further includes a first receiving hole 111 extending in the first direction, the first receiving hole 111 communicates with the opening 110, and the groove 152 communicates with the first receiving hole 111 for connecting a wire to the second electrode 13.
The first electrode 11 may include a plurality of openings 110 disposed along a circumferential direction, and a plurality of insulating members respectively disposed in each opening 110, where the plurality of insulating members respectively form grooves 152 to accommodate the plurality of second electrodes 13, so long as the plurality of grooves 152 are all communicated with the first accommodating hole 111 and can be electrically connected with the second electrodes 13 through wires, at this time, the shock wave electrode assembly 10 may generate shock waves at a plurality of positions along the circumferential direction, so as to increase a treatment area.
In a preferred embodiment, the first electrode 11 includes two openings 110, the two openings 110 are symmetrical about the axis of the first electrode 11, the insulating portion 15 extends along the second direction and is fitted into the two openings 110 along the second direction, and the insulating portion 15 is symmetrical about the axis of the first electrode. Specifically, two openings 110 symmetrically arranged correspond to one insulating portion 15, an accommodating space is formed between the two openings 110, the insulating portions 15 are integrally formed, and the insulating portions 15 are assembled into the accommodating space at one time along the second direction, so that the assembly process is simplified.
In a preferred embodiment, the insulating portion 15 includes a second receiving hole 153 extending along a first direction, the second receiving hole 153 communicates with the groove 152, and the first receiving hole 111 and the second receiving hole 153 are at least partially overlapped in a radial direction, so that a wire passes through the first and second receiving holes 111 and 153 and is connected to the second electrode 13. Specifically, the insulating portion 15 is entirely cylindrical and extends in the second direction, the outer diameter of the insulating portion 15 is larger than the diameter of the first receiving hole 111, and the diameter of the second receiving hole 153 is equal to the diameter of the first receiving hole 111, so that the first and second receiving holes 111 and 153 are completely overlapped. In other embodiments, the diameter of the second receiving hole 153 may be different from the diameter of the first receiving hole 111, so long as a portion through which the wire passes can be overlapped. It will be appreciated that in this embodiment, if the outer diameter of the insulating portion 15 is smaller than the diameter of the first receiving hole 111, the middle connecting portion of the insulating portion 15 is cut out to be unable to form a whole, i.e. to be converted into an opening 110 corresponding to one insulating portion 15, in order to provide the second receiving hole 153 inside the insulating portion 15 for the wire to pass through without blocking.
In a preferred embodiment, the first electrode 11 includes an intermediate portion 112 for forming a shock wave. Specifically, the middle portion 112 is a hollow cylindrical portion extending along an axial direction, the hollow structure is a first accommodating hole 111, and the opening 110 penetrates through an outer surface of the middle portion 112 along the second direction, that is, the opening 110 penetrates through an outer circumferential surface of the cylinder and is communicated with the first accommodating hole 111. The opening 110 may be formed by arranging a plurality of openings along the outer circumferential surface at intervals, preferably two openings are symmetrically arranged along the cylindrical axis, and the two openings 110 are formed by penetrating along the second direction at one time, so that a cylindrical accommodating space is formed at the same time, and the cylindrical insulating portion 15 is fixed by interference with the inner wall surface of the accommodating space, so that the processing and the assembly are facilitated.
In other embodiments, the surface 131 of the second electrode 13 exposed to the opening is provided with a groove 132, and the surface of the second electrode is coated with an insulating layer except for the bottom surface 133 of the groove to form the insulating portion 15. Referring to fig. 4, the first and second electrodes are fixed to each other and insulated from each other by applying an insulating paste layer without an insulating member formed separately. The second electrode 13 is in a shape of a circular plate, and the bottom surface 133 of the groove 132 is not provided with an insulating layer, so that the liquid in the gap between the bottom surface 133 of the groove 132 and the opening 110 of the first electrode 11 is broken down, and a shock wave is generated in the groove 132 and propagates outwards towards the opening 110, thereby simplifying the structure of the electrode assembly and reducing the electrode processing difficulty and the assembly difficulty. In this embodiment, the diameter of the second electrode 13 is larger, and the space formed by the second electrode and the opening 110 is larger, so that the effect of generating the shock wave is affected and even the shock wave cannot be generated without the groove 132.
In other embodiments, the inner wall surface of the opening 110 is coated with an insulating layer to form the insulating part, and the opening 110 is kept insulated from the second electrode 13 fixed thereto. Referring to fig. 5, the first and second electrodes are fixed to each other and insulated from each other by applying an insulating adhesive layer, in accordance with the principles of the above embodiment, except for a slight difference in structure. In this embodiment, the diameter of the opening 110 is smaller, and the second electrode 13 is fixed to the inner wall surface and can be directly used for generating a shock wave.
Referring to fig. 6 to 9, the present invention further includes a balloon catheter including the above-described shock wave electrode assembly 10, a lead wire 40 connected to the shock wave electrode assembly 10, a balloon 20 accommodating the shock wave electrode assembly, and a mounting tube 30 fixedly connected to the shock wave electrode assembly 10. The first electrode 11 includes a first accommodating hole 111 and an opening 110 that are in communication with each other, the conductive wire 40 includes a first conductive wire 41 and a second conductive wire 42 that are disposed at intervals, the first conductive wire 41 extends along a first direction to be electrically connected to the first electrode 11, and the second conductive wire 42 extends from the first accommodating hole 111 to the corresponding opening 110 and is electrically connected to the second electrode 13, so as to apply a high voltage pulse to the first and second electrodes 11, 13. The first receiving hole 111 may also be used to guide a wire therethrough for guiding the delivery balloon 20 to the calcified plaque site.
Specifically, the mounting tube 30 penetrates the balloon 20, and the shock wave electrode assembly 10 and a portion of the mounting tube 30 are both disposed inside the balloon 20 and immersed in a conductive liquid inside the balloon 20, which may be physiological saline. The balloon 20 is semi-compliant or rigid and may be inflated by injection of a liquid, such as saline, and the outer wall of the inflated balloon 20 closely conforms to the inner wall of the vessel or calcified plaque, and the shock waves generated by the shock wave electrode assembly 10 at the openings 110 are transmitted to the calcified plaque through the conductive liquid inside the balloon 20, thereby destroying the calcified plaque.
Specifically, the balloon catheter includes a visualization ring 50 mounted on the mounting tube 30, the visualization ring 50 including a proximal visualization ring near one end of the operator, disposed on the proximal side of the balloon 20, and a distal visualization ring remote from one end of the operator, disposed on the distal side of the balloon 20, for visualizing the position of the balloon catheter in the human body during angiography. The balloon catheter includes a snap ring 60 for fixedly sealing the proximal end of the balloon 20 to the mounting tube 30.
Preferably, the first electrode 11 includes fixing portions 113 at both ends of the middle portion 112 in the first direction, and the middle portion 112 is a cylindrical body and forms a step surface 114 in transition with the fixing portion 113, that is, the first electrode 13 has a stepped shaft-like structure. The first wire 41 and the first electrode 11 may be connected by crimping, welding, gluing, etc., and due to the stepped shaft structure of the first electrode 11, there is more space on the first wire 41 and the first electrode 11 for connection and fixation, assembly is easier, and welding or crimping is firmer.
Preferably, the fixing portion 113 is provided with a fixing groove along the first direction for fixing a portion of the first wire 41 in the first electrode 11, and the first wire 41 is fixed in the groove of the first electrode 11, so that the connection is more stable.
Preferably, the mounting tube 30 is assembled and fixed with the fixing portion 113, and the mounting tube 30 is sleeved on the fixing portion 113 and abuts against the step surface 114. It will be appreciated that the mounting tube has a multi-segment structure, and may be configured to have different lengths and different segments according to the number of the shock wave electrode assemblies 10 to be set, for example, two segments of mounting tubes 30 at two ends are provided corresponding to 1 shock wave electrode assembly 10; for 2 shock wave electrode assemblies 10, three segments of mounting tubes 30 may be provided. The number of shock wave electrode assemblies 10 is generally determined by the calcified plaque size and the intensity of the shock wave that is required to be generated.
Preferably, the fixing portion 113 is a cylinder with an outer diameter smaller than that of the middle portion, and is directly sleeved and fixed with the mounting tube 30; or the fixing portion 113 is a taper having an outer diameter gradually decreasing toward both sides in the first direction, and the maximum outer diameter of the fixing portion 113 is equal to the inner diameter of the mounting tube 30 and smaller than the outer diameter of the middle portion 112, so as to facilitate assembly and fixing.
The invention also includes a medical device comprising the balloon catheter described above and a shock wave generator connected to the balloon catheter for generating high voltage pulses. The distal ends of the second wire 42 and the first wire 41 are connected to the shock wave electrode assembly 10, and the proximal ends are connected to the shock wave generator, so that high voltage pulses generated by the shock wave generator can be applied to the shock wave electrode assembly 10 through the second wire 42 and the first wire 41 to generate shock waves.
The invention has the beneficial effects that: the first electrode 11 includes a hole 110 penetrating in a radial direction, and the second electrode 13 is assembled in the hole 110 in the radial direction and partially exposed to the hole 110, so that alignment assembly is not required, and the assembly process is simplified; the risk of displacement between the shock wave electrode assemblies 10 is reduced during the generation of shock waves; the insulating part 15 is coaxially assembled with the opening 110, and the second electrode 13 is coaxially assembled with the groove 152, so that the assembly process is simplified; at least two symmetrical openings 110 are provided to enlarge the treatment area.
It should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is for clarity only, and that the skilled artisan should recognize that the embodiments may be combined as appropriate to form other embodiments that will be understood by those skilled in the art.
The above list of detailed descriptions is only specific to practical embodiments of the present invention, and they are not intended to limit the scope of the present invention, and all equivalent embodiments or modifications that do not depart from the spirit of the present invention should be included in the scope of the present invention.

Claims (12)

1. A shock wave electrode assembly, comprising: the first electrode extends along a first direction and comprises an opening penetrating along a second direction perpendicular to the first direction, and the second electrode is assembled in the opening along the second direction and is partially exposed to the opening.
2. The shock wave electrode assembly according to claim 1, wherein the first electrode comprises at least one of the openings, the insulating portion is an insulator integrally formed of an insulating material and assembled to the opening in the second direction, the insulating portion is provided with a groove communicating with the opening on an outer surface of the opening exposed in the second direction, and the second electrode is fixed to and exposed to the groove.
3. The shock wave electrode assembly according to claim 2, wherein the first electrode comprises at least two of the openings, the two openings being symmetrical about the axis of the first electrode, the insulating portion extending in the second direction and fitting within the two openings in the second direction, the insulating portion being symmetrical about the axis of the first electrode.
4. The shock wave electrode assembly according to claim 3, wherein the first electrode comprises a first receiving hole extending in a first direction, the first receiving hole communicates with the opening, the insulating portion comprises a second receiving hole extending in the first direction, the second receiving hole communicates with the recess, and the first receiving hole and the second receiving hole are at least partially overlapped in a radial direction for a wire to pass through the first and second receiving holes and connect to the second electrode.
5. The shock wave electrode assembly according to claim 1, wherein the surface of the second electrode exposed to the opening is provided with grooves, and the surface of the second electrode is coated with an insulating layer except for the bottom surface of the grooves to form the insulating portion.
6. The shock wave electrode assembly according to claim 1, wherein an inner wall surface of the opening is coated with an insulating layer to form the insulating portion.
7. A balloon catheter, comprising: the shock wave electrode assembly, the wire connected to the shock wave electrode assembly and the balloon housing the shock wave electrode assembly according to any one of claims 1 to 6, wherein the first electrode comprises a first housing hole extending along a first direction, the first housing hole is communicated with the open hole, the wire comprises a first wire and a second wire which are arranged at intervals, the first wire extends to be electrically connected with the first electrode along the first direction, and the second wire extends to a corresponding open hole from the first housing hole and is electrically connected with the second electrode.
8. The balloon catheter of claim 7, wherein the first electrode comprises a middle portion and fixing portions at two ends of the middle portion along a first direction, wherein the fixing portions are provided with fixing grooves along the first direction for fixing a part of the first wire in the first electrode, and the opening penetrates through the outer surface of the middle portion along a second direction.
9. The balloon catheter of claim 7, wherein the first electrode comprises a middle portion and fixing portions located at two ends of the middle portion along the first direction, the middle portion is a cylinder and forms a transitional step surface with the fixing portions, the balloon catheter comprises a mounting tube assembled and fixed with the fixing portions, and the mounting tube is sleeved on the fixing portions and abutted to the step surface.
10. The balloon catheter of claim 9, wherein the fixation portion is a cylinder having an outer diameter less than the intermediate portion.
11. The balloon catheter of claim 9, wherein the fixation portion is a taper with an outer diameter that tapers in a first direction toward both sides, and wherein the fixation portion has a maximum outer diameter that is equal to the inner diameter of the mounting tube and less than the outer diameter of the intermediate portion.
12. A medical device comprising the balloon catheter of any one of claims 7-11 and a shock wave generator connected to the balloon catheter for generating high voltage pulses.
CN202310376065.5A 2023-04-10 2023-04-10 Shock wave electrode assembly, balloon catheter and medical equipment Pending CN116392200A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117281580A (en) * 2023-11-27 2023-12-26 沛嘉医疗科技(苏州)有限公司 Electrode device for treating tissue calcification and shock wave device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117281580A (en) * 2023-11-27 2023-12-26 沛嘉医疗科技(苏州)有限公司 Electrode device for treating tissue calcification and shock wave device
CN117281580B (en) * 2023-11-27 2024-03-15 沛嘉医疗科技(苏州)有限公司 Electrode device for treating tissue calcification and shock wave device

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