CN112220526B - Pulse balloon and using method - Google Patents
Pulse balloon and using method Download PDFInfo
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- CN112220526B CN112220526B CN202011431329.5A CN202011431329A CN112220526B CN 112220526 B CN112220526 B CN 112220526B CN 202011431329 A CN202011431329 A CN 202011431329A CN 112220526 B CN112220526 B CN 112220526B
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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
- 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
-
- 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
- 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
Abstract
The invention relates to the field of medical instruments, in particular to a pulse balloon and a using method thereof. A pulse balloon comprises a catheter main body, wherein a guide wire cavity is arranged in the catheter main body, one end of the catheter main body is provided with a sealing tip, a first balloon is arranged at the sealing tip around the catheter main body, and the first balloon surrounds the catheter main body to form an annular channel; the first balloon is of a multilayer composite structure and at least comprises a first outer insulating layer, a first conducting layer and a first inner insulating layer from top to bottom in sequence. The product can enable the wave source between the anode and the cathode to be sufficiently close to the calcified position to be treated so as to achieve the purpose of enhancing the shock wave effect, and along with the enhancement of the shock wave effect, lower voltage (less than or equal to 1000V) can be further selected or the discharge frequency can be reduced, so that the safety of the operation is ensured, and the operation time is shortened, and the time of short-time ischemia of a patient caused by the sufficient saccule is shortened.
Description
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to a pulse balloon and a using method thereof.
Background
Aortic calcification, also known as aortic sclerosis, is the accumulation of calcium deposits on the aortic valve in the heart. This often results in heart murmurs that can be easily heard with a stethoscope placed over the heart. However, aortic calcification generally does not significantly affect the function of the aortic valve.
However, in some cases, the calcium deposits thicken and narrow the opening at the aortic valve. This reduces blood flow through the valve, causing chest pain or heart attack. Physicians refer to this stenosis as aortic stenosis.
Currently, there is no specific treatment for aortic calcification. General treatment includes monitoring the further progression of heart disease. Cholesterol levels are also examined to determine the need for drug therapy to lower cholesterol in hopes of preventing worsening of aortic calcification. Aortic valve replacement surgery may be necessary if the valve is severely narrowed.
The CN201380033808.3 patent discloses a shock wave balloon catheter having multiple shock wave sources, the apparatus comprising a balloon adapted to be positioned adjacent a calcified region of the body, a shock wave generator located within the balloon that generates shock waves that propagate through a liquid to impinge on the calcified region adjacent the balloon; the shock wave generator includes a plurality of shock wave sources distributed within the balloon. However, the anode and the cathode in the balloon catheter are wound on the inner tube, so that the wave source cannot be sufficiently close to the balloon wall, namely, cannot be sufficiently close to the calcification position, the effect of the shock wave is greatly damaged under the transmission of the electrolyte, if the treatment effect is required to be achieved, the discharge frequency is increased, or the effect of the shock wave is enhanced by improving the voltage so as to achieve the purpose of breaking the calcification by shaking, and the safety in the use process is reduced. On the other hand, the structure is a liquid filling structure with a single lumen, air at the far end of the balloon cannot be discharged in the liquid filling process, and the far end cannot generate effective shock waves under the condition that the far-end electrolyte cannot cover the electrodes, so that the effective treatment effect of the far end cannot be ensured.
Disclosure of Invention
In order to solve the technical problem, a first aspect of the present invention provides a pulse balloon, which includes a catheter main body 1, a guide wire cavity 2 is arranged in the catheter main body 1, a sealing tip portion 3 is arranged at one end of the catheter main body 1, a first balloon 4 is arranged around the catheter main body 1 at the sealing tip portion 3, and the first balloon 4 forms an annular channel 5 around the catheter main body 1; the first balloon 4 is of a multilayer composite structure and at least comprises a first outer insulating layer 6, a first conducting layer 7 and a first inner insulating layer 8 from top to bottom in sequence.
The guidewire lumen 2 can be used to insert a guidewire through which the pulsing balloon can be guided to a desired location for positioning in the area to be treated.
In a preferred or alternative embodiment, the annular channel 5 may be used to fill the electrolyte within the first balloon 4 to provide a conductive medium; a plurality of first annular notches 9 are circumferentially arranged on the first inner insulating layer 8 along the circumferential surface of the inner wall of the first inner insulating layer, and the first annular notches 9 enable the corresponding first conductive layers 7 to be exposed in the electrolyte for conducting.
The first annular cut 9 divides the first conductive layer 7 into a portion exposed to the electrolyte and a portion not exposed to the electrolyte, and a number of the first annular cuts 9 form a source point 10at the first conductive layer 7.
As shown in fig. 1-2, a second balloon 14 is further disposed on the inner side of the first balloon 4, and the second balloon 14 is a multilayer composite structure and at least includes a second inner insulating layer 15, a second conductive layer 16, and a second outer insulating layer 17 in sequence from top to bottom; a plurality of second annular notches 18 are circumferentially arranged on the second inner insulating layer 15 along the circumferential surface of the outer wall of the second inner insulating layer, so that the second conductive layer 16 on the second balloon 14 is exposed to the electrolyte to perform a conductive function.
In a preferred or alternative embodiment, the first annular incision 9 and the second annular incision 18 have the same width.
In a preferred or alternative embodiment, said at least one first annular incision 9 is arranged concentrically and coplanar with at least one second annular incision 18 along the longitudinal direction.
In a preferred or alternative embodiment, the cross section of the first annular notch 9 and the second annular notch 18 along the longitudinal section can be any one of square, rectangle, trapezoid and arc. Preferably, the cross section of the first annular notch 9 and the second annular notch 18 along the longitudinal section is square, the side length of the square is usually 0.2-2 mm, preferably 0.5-1mm, the shape and position of the cross section of the first annular notch 9 and the second annular notch 18 affect the shock wave efficiency, and when the cross section is square, the impact of the insulating layer on the shock wave is minimized for the first annular notch 9 and the second annular notch 18 with the same width, and even if the impact is minimized, the path of the shock wave is kept consistent, so the impact is negligible, thereby the shock wave generated near the wave source point is more stable, and the shock wave efficiency is improved.
In a preferred or alternative embodiment, each of the first ring-shaped cuts 9 has a corresponding second ring-shaped cut 18 disposed concentrically and coplanar with each other, and the distance between adjacent first ring-shaped cuts 9 or second ring-shaped cuts 18 is 0.5-2mm, preferably 0.1-1mm, and usually the number of first ring-shaped cuts 9 or second ring-shaped cuts 18 is the same, 2-8 respectively, and the generated wave source point provides an electric path through selecting the number and spacing of the first ring-shaped cuts 9 or second ring-shaped cuts 18, and the first conductive layer 7 and the second conductive layer 16 are applied with a high voltage pulse power supply to generate a suitable shock wave amplitude and duration.
In a preferred or alternative embodiment, an exchange port 19 is provided on one side of the second balloon 14 close to the sealed tip portion 3, and is used for circulation of electrolyte between the first balloon 4 and the second balloon 14, an electrolyte filling port is shown at a position a in fig. 1, and in the process of filling the balloons with electrolyte, original air inside the second balloon 14 can be discharged to the position of the first balloon 4 and then discharged into the catheter at the proximal end through the first balloon 4, so that no air exists inside the whole balloon, and the far-end shock wave effect of the balloon is ensured.
In a preferred or alternative embodiment, spiral flow conductors 21 are arranged on the exchange opening 19. The spiral flow guide body 21 is used for filling electrolyte from the inner layer to the outer layer, and original air in the balloon can be discharged in the filling process.
In a preferred or alternative embodiment, the spiral flow guide body 21 comprises a flow guide opening 22 and a spiral body 23 communicated with the flow guide opening 22, wherein the spiral body 23 is of a reducing inner hollow spiral structure; and the spiral bodies 23 are uniformly distributed on the circumference of the diversion port 22.
In a preferred or alternative embodiment, the spiral body 23 has a hollow passage 24 inside, and the shape of the hollow passage 24 is adjustable according to the shape of the diversion opening 22, such as, but not limited to: rectangular, square, triangular, circular, elliptical, irregular polygonal, etc., and the shape of the hollow passage 24 inside the corresponding spiral 23 may be a quadrangular prism, a triangular prism, a cylinder, an elliptic cylinder, an irregular cylinder, etc.; preferably, the diversion opening 22 is circular, and the inner diameter of the hollow passage 24 is gradually reduced from the direction away from the diversion opening 22.
In a preferred or alternative embodiment, the pitch of the spiral body 23 increases from the direction away from the diversion port 22, and the spiral body tail end is sealed. When the thread pitch is increased, the capacity of the electrolyte in the hollow pipeline is relatively increased, on one hand, the influence of the internal pressure difference caused by excessive injection on the stability of the pulse balloon is relieved, and on the other hand, the larger surface area enables the subsequent electrolyte exchange and exhaust to be more smooth.
In a preferred or alternative embodiment, the spiral body 23 is provided with a plurality of liquid outlet holes 25, and the shape of the liquid outlet holes 25 can be any shape, such as circular, oval, square, triangular, and the like. The diameter of the liquid outlet hole 25 is 0.1-0.5mm, and more preferably 0.1-0.3 mm. When setting up out liquid hole 25 on spirochaeta 23, when pouring into electrolyte from A department, electrolyte flow through second sacculus 14, rethread spiral baffle 21 that sets up on second sacculus 14 gets into first sacculus 4, and the effect that goes out liquid hole 25 this moment can be used to inside electrolyte pressure of dispersion, and makes the even slow inflow first sacculus 4 of electrolyte more, just can more effectively get rid of the bubble, and can not lead to making the phenomenon that the bubble increases on the contrary because pressure differential.
The spiral 23 may be made of any material that can be formed with a variable diameter and withstand a certain pressure, including, but not limited to, polyethylene, polypropylene, polydodecalactam, polyether block polyamide, polyimide, polytetrafluoroethylene, polyethylene terephthalate, fluorinated ethylene propylene copolymer, for example.
The sacculus and pipe link together through the welded mode, and outer sacculus and outer pipe connection, inlayer sacculus and middle level pipe connection, the intermediate layer between middle level pipe and the outer pipe is used for holding unnecessary air, and after the sacculus was squeezed into electrolyte, electrolyte made the sacculus sufficient, and unnecessary air is extruded in the intermediate layer between middle level pipe and the outer pipe, reaches the purpose of evacuation air between outer sacculus and inlayer sacculus.
In a preferred or alternative embodiment, the second conductive layer 16 in the second balloon 14 may be a cathode conductive layer, or an anode conductive layer, when the second conductive layer 16 is a cathode conductive layer, the corresponding first conductive layer 7 of the first balloon 4 is an anode conductive layer, the first conductive layer 7 and the second conductive layer 16 are attached to a high voltage pulse power source 20, and by applying a certain voltage, an arc is generated between the second annular notch 18 and the first annular notch 9, and a shock wave is generated in the electrolyte.
In a preferred or alternative embodiment, the diameter of the second balloon 14 is 0.5 to 0.9 times the diameter of the first balloon 4; and the first balloon 4 is semi-compliant or non-compliant; more preferably, the diameter of the second balloon 14 is 0.7 to 0.9 times the diameter of the first balloon 4. Since the exchange port 19 is provided on the second balloon 14 on the side close to the sealing tip 3, the diameter of the second balloon 14 does not change depending on the magnitude of the applied pressure, and the first balloon 4 is preferably a semi-compliant balloon or a non-compliant balloon.
The diameter of the first balloon 4 of the semi-compliant balloon is correspondingly increased along with the increase of the pressure, so that compared with the prior art, the wave source point is firstly close to the calcification position, and the shock wave efficiency is greatly improved; meanwhile, the wave source point is slightly far away from the outer wall of the first balloon 4 along with the pressure rise, so that the influence of shock waves on the first balloon 4 is reduced under the high-pressure condition, and the explosion condition of the first balloon 4 is avoided.
The non-compliant balloon has a smaller diameter change of the first balloon 4 with a change of pressure, and the voltage needs to be gradually decreased in inverse proportion to the pressure of the first balloon 4 as the pressure is increased in order to avoid the first balloon 4 from bursting by a shock wave.
The intensity of the shock wave can be controlled by controlling the magnitude of the voltage, current, duration and repetition rate of the high voltage pulse power supply. While the protection of the first outer insulating layer 6 protects the patient from electrical shock.
The voltage required to generate the arc is typically 100 to 3000 volts. The pulse duration also depends on the one hand on the surface area of the first anode conductive layer 12 and the first cathode conductive layer 11. The first anode conductive layer 12 or the first cathode conductive layer 11 in the first conductive layer 7 is thus dispersed by the first ring-shaped cut 9 into the wave source points 10 where more mechanical waves can be formed.
First and second conductive layers 7 and 16 may be made of any material capable of supporting the voltage necessary to generate a shock wave and resisting the force generated thereby. For example, the first conductive layer 7 and the second conductive layer 16 may be made of tungsten, nickel, iron, steel including stainless steel, copper, gold, or the like.
The first outer insulating layer 6, the first inner insulating layer 8, the second inner insulating layer 15, and the second outer insulating layer 17 may be made of any material having a breakdown voltage large enough to withstand a voltage generated during generation of a shock wave. For example, fluoropolymers (e.g., PTFE, FEP, etc.), polyethylene terephthalate (PET), polyimides (e.g., Kapton), polyamides, polyamide-block polyether copolymers, polyester-block copolymers, and the like.
Compared with the existing product, the pulse balloon shown in fig. 1 can enable the wave source between the anode and the cathode to be sufficiently close to the calcified position to be treated so as to achieve the purpose of enhancing the shock wave effect, and with the enhancement of the shock wave effect, lower voltage (less than or equal to 1000V) can be further selected or the discharge frequency can be reduced, so that the safety of the operation is ensured, and the operation time is shortened so as to reduce the occurrence time of short-time ischemia of a patient caused by the filling of the balloon.
In a second aspect, the present invention provides a method of using a pulsed balloon, comprising the steps of:
1) establishing a passage by subcutaneous puncture of a radial artery or a femoral artery and using a guide catheter and a guide wire;
2) the near end of the guide wire penetrates into the pulse saccule through the guide wire cavity, and the pulse saccule is sent into the body of a patient along one path of the guide wire to reach a lesion position;
3) electrolyte is filled into the balloon at the inner layer, and original air in the pulse balloon is discharged into the balloon near-end conduit in the filling process;
4) when the balloon pressure reaches 8-14 ATM, setting pulse voltage of 800-1000V and 1HZ for discharging for 10-100 times;
5) and (4) observing calcification conditions, selecting to continue pressurizing discharge or release pressure and withdraw the saccule, and pulsing the saccule to discharge 100 times at the maximum time.
More specifically, the method of using the pulse balloon specifically includes 2 methods, and the details of the two methods are described below.
The first use method comprises the following steps:
1. establishing a passage by subcutaneous puncture of a radial artery or a femoral artery and using a guide catheter and a guide wire;
2. selecting a semi-compliant balloon of appropriate diameter and length according to the patient's condition;
3. the near end of the guide wire penetrates into the pulse saccule through the guide wire cavity, and the pulse saccule is sent into the body of a patient along one path of the guide wire to reach a lesion position;
4. electrolyte is filled into the balloon at the inner layer, and original air in the pulse balloon is discharged into the balloon near-end conduit in the filling process;
5. when the balloon pressure reaches 8ATM, setting pulse voltage 800V and 1HZ to start discharging for 10-20 times;
6. further increasing the balloon pressure to 10ATM, setting pulse voltage 800V and 1HZ to start discharging for 10-20 times;
7. further increasing the balloon pressure to 12ATM, setting pulse voltage 800V and 1HZ to start discharging for 10-20 times;
8. further increasing the balloon pressure to 14ATM, setting pulse voltage 800V and 1HZ to start discharging for 10-20 times;
9. and (4) observing calcification conditions, selecting to continue pressurizing discharge or release pressure and withdraw the saccule, and pulsing the saccule to discharge 100 times at the maximum time.
The second use method comprises the following steps:
1. establishing a passage by subcutaneous puncture of a radial artery or a femoral artery and using a guide catheter and a guide wire;
2. selecting a non-compliant balloon of appropriate diameter and length according to the patient's condition;
3. the near end of the guide wire penetrates into the pulse saccule through the guide wire cavity, and the pulse saccule is sent into the body of a patient along one path of the guide wire to reach a lesion position;
4. electrolyte is filled into the balloon at the inner layer, and original air in the pulse balloon is discharged into the balloon near-end conduit in the filling process;
5. when the balloon pressure reaches 8ATM, setting pulse voltage 1000V and 1HZ to start discharging for 10-20 times;
6. further increasing the balloon pressure to 10ATM, setting pulse voltage 950V and 1HZ to start discharging for 10-20 times;
7. further increasing the balloon pressure to 12ATM, setting pulse voltage 900V and 1HZ to start discharging for 10-20 times;
8. further increasing the balloon pressure to 14ATM, setting pulse voltage 850V and 1HZ to start discharging for 10-20 times;
9. and (4) observing calcification conditions, selecting to continue pressurizing discharge or release pressure and withdraw the saccule, and pulsing the saccule to discharge 100 times at the maximum time.
Compared with the prior art, the invention has the following beneficial effects:
(1) the wave source point formed by the cathode and the anode is closer to the calcification position, and the shock wave efficiency is higher;
(2) the lower voltage (less than 1000V) can be adopted in the treatment process, so that the safety of the operation is ensured;
(3) the improvement of the shock wave efficiency greatly reduces the discharge times and shortens the operation time;
(4) the emptying design of the exchange port ensures the shock wave effect of the far end.
Drawings
In order to more clearly illustrate the technical solution of the present invention, the drawings used in the embodiments will be briefly described below, the drawings described below are only some embodiments of the present invention, and it is obvious to those skilled in the art that other drawings can be obtained based on the drawings without creative efforts.
Fig. 1 is a schematic structural view of a pulse balloon of embodiment 1 of the present invention;
fig. 2 is a partially enlarged structural schematic view of a pulse balloon in embodiment 1 of the present invention;
fig. 3 is a schematic plan view of a spiral flow conductor according to example 1 of the present invention;
the numbering in the figure is as follows:
1. a catheter body; 2. a guidewire lumen; 3. sealing the tip; 4. a first balloon; 5. an annular channel; 6. a first outer insulating layer; 7. a first conductive layer; 8. a first inner insulating layer; 9. a first annular incision; 10. a source point; 14. a second balloon; 15. a second inner insulating layer; 16. a second conductive layer; 17. a second outer insulating layer; 18. a second annular incision; 19. an exchange port; 20. a high voltage pulse power supply; 21. a spiral flow conductor; 22. a flow guide port; 23. a helical body; 24. a hollow channel; 25. and a liquid outlet hole.
Detailed Description
The technical features of the technical solutions provided by the present invention are further clearly and completely described below with reference to the specific embodiments, and the scope of protection is not limited thereto.
Example 1
As shown in fig. 1 to 3, embodiment 1 of the present invention provides another pulse balloon, which includes a catheter main body 1, a guidewire lumen 2 is provided in the catheter main body 1, a sealing tip portion 3 is provided at one end of the catheter main body 1, a first balloon 4 is provided around the catheter main body 1 at the sealing tip portion 3, and the first balloon 4 forms an annular channel 5 around the catheter main body 1; the first balloon 4 is of a multilayer composite structure and at least comprises a first outer insulating layer 6, a first conducting layer 7 and a first inner insulating layer 8 from top to bottom in sequence.
The guidewire lumen 2 can be used for insertion of a guidewire through which the pulsing balloon can be guided to a desired location for positioning in the area to be treated.
The annular channel 5 is filled with electrolyte to provide a conductive medium in the first balloon 4; the first inner insulating layer 8 is provided with a plurality of first annular cuts 9, and the first annular cuts 9 enable the corresponding first conductive layers 7 to be exposed in the electrolyte for conducting.
A second balloon 14 is further arranged on the inner side of the first balloon 4, the second balloon 14 is of a multilayer composite structure and at least comprises a second inner insulating layer 15, a second conducting layer 16 and a second outer insulating layer 17 from top to bottom in sequence; a plurality of second annular notches 18 are formed in the second inner insulating layer 15, the second annular notches 18 and the first annular notches 9 are axially symmetrical, and the second conducting layer 16 on the second balloon 14 and the first conducting layer 7 on the first balloon 4 are respectively exposed in the electrolyte to conduct electricity.
The first annular notch 9 and the second annular notch 18 have the same width; the cross sections of the first annular notch 9 and the second annular notch 18 along the longitudinal section are square, and the side length is about 1 mm; each first annular notch 9 is provided with a corresponding second annular notch 18 which is arranged concentrically and coplanar with the first annular notch, and the distance between the adjacent first annular notches 9 or second annular notches 18 is about 1 mm;
one side that is close to sealed point portion 3 on the second sacculus 14 is provided with exchange mouth 19 for electrolyte is in the circulation between first sacculus 4 and second sacculus 14, and in the catheter of the inside original air escape to the near-end of sacculus was sufficient to first sacculus 4 in-process to electrolyte, the inside air that does not exist of messenger's sacculus, guarantees sacculus distal end shock wave effect.
The exchange port 19 is provided with a spiral flow guide body 21, the spiral flow guide body 21 is used for filling electrolyte from the inner layer to the outer layer, and original air in the balloon can be discharged in the filling process. The spiral flow guide body 21 comprises a flow guide opening 22 and a spiral body 23 communicated with the flow guide opening 22, and the spiral body 23 is of a reducing hollow spiral structure; and the spiral bodies 23 are uniformly distributed on the circumference of the diversion port 22.
The spiral body 23 is internally provided with a hollow passage 24, the diversion port 22 is circular, and the inner diameter of the hollow passage 24 is gradually reduced from the direction far away from the diversion port 22; the screw pitch of the spiral body 23 is gradually increased from the direction far away from the flow guide port 22, and the tail end of the spiral body is sealed; the spiral body 23 is provided with a plurality of liquid outlet holes 25, and the liquid outlet holes 25 are circular.
The second conductive layer in the second balloon 14 is an anode conductive layer, the corresponding first conductive layer 7 of the first balloon 4 is a cathode conductive layer, the first conductive layer 7 and the second conductive layer 16 are attached to a high voltage pulse power source 20, and by applying a certain voltage, an electric arc is caused between the second annular notch 18 and the first annular notch 9, so that a shock wave is generated in the electrolyte.
The diameter of the second balloon 14 is 0.8 times the diameter of the first balloon 4; since the exchange port 19 is provided on the second balloon 14 on the side close to the sealed tip portion 3, the diameter of the second balloon 14 does not change depending on the magnitude of the applied pressure, and the first balloon 4 is a semi-compliant balloon.
The diameter of the first balloon 4 of the semi-compliant balloon is correspondingly increased along with the increase of the pressure, so that compared with the prior art, the wave source point is firstly close to the calcification position, and the shock wave efficiency is greatly improved; meanwhile, the wave source point is slightly far away from the outer wall of the first balloon 4 along with the pressure rise, so that the influence of shock waves on the first balloon 4 is reduced under the high-pressure condition, and the explosion condition of the first balloon 4 is avoided.
Claims (7)
1. A pulse balloon comprises a catheter main body, wherein a guide wire cavity is arranged in the catheter main body, and the pulse balloon is characterized in that a sealing tip is arranged at one end of the catheter main body, a first balloon is arranged at the sealing tip around the catheter main body, and the first balloon surrounds the catheter main body to form an annular channel; the first balloon is of a multilayer composite structure and at least comprises a first outer insulating layer, a first conducting layer and a first inner insulating layer from top to bottom in sequence; the annular channel can be used for injecting electrolyte into the first balloon to provide a conductive medium; a plurality of first annular notches are formed in the first inner insulating layer in an encircling manner along the circumferential surface of the inner wall of the first inner insulating layer, and the first annular notches enable the corresponding first conducting layers to be exposed in electrolyte to play a role in conducting electricity; a second balloon is arranged on the inner side of the first balloon, is of a multilayer composite structure and at least comprises a second inner insulating layer, a second conducting layer and a second outer insulating layer from top to bottom in sequence; a plurality of second annular notches are formed in the second inner insulating layer in an encircling mode along the circumferential surface of the outer wall of the second inner insulating layer, and therefore the second conducting layer on the second balloon is exposed in electrolyte to conduct electricity.
2. The pulsing balloon of claim 1, wherein the first and second annular cutouts have the same width.
3. The pulsing balloon of claim 1, wherein at least one of said first annular cutouts is longitudinally concentrically coplanar with at least one of said second annular cutouts.
4. The pulsing balloon of claim 3 wherein the second balloon is provided with an exchange port on a side thereof adjacent the sealing tip for electrolyte communication between the first balloon and the second balloon.
5. The pulsing balloon of claim 4 wherein a helical flow conductor is disposed over said exchange port.
6. The pulsing balloon of claim 5 wherein the second balloon diameter is 0.5 to 0.9 times the first balloon diameter; and the first balloon is semi-compliant or non-compliant.
7. The pulsing balloon of claim 6, wherein the first and second electrically conductive layers are attached to a high voltage pulse power source.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011431329.5A CN112220526B (en) | 2020-12-10 | 2020-12-10 | Pulse balloon and using method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011431329.5A CN112220526B (en) | 2020-12-10 | 2020-12-10 | Pulse balloon and using method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN112220526A CN112220526A (en) | 2021-01-15 |
| CN112220526B true CN112220526B (en) | 2021-04-02 |
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| CN113180822B (en) * | 2021-03-16 | 2022-02-08 | 哈尔滨医科大学 | Catheter integrating laser ablation and vascular shock wave forming |
| CN113317845B (en) * | 2021-03-23 | 2023-03-14 | 上海百心安生物技术股份有限公司 | Pulse saccule with grounding treatment on inner wall |
| CN112971915B (en) * | 2021-05-08 | 2021-08-20 | 上海百心安生物技术股份有限公司 | Pulse balloon and application thereof |
| CN113367768B (en) * | 2021-06-11 | 2023-03-21 | 南京欣科医疗器械有限公司 | Shock wave sacculus pipe with integrated electric field generating mechanism |
| CN113842190A (en) * | 2021-10-27 | 2021-12-28 | 上海微创旋律医疗科技有限公司 | Electrode balloon catheter |
| CN113855163B (en) * | 2021-11-09 | 2024-03-22 | 上海蓝帆博元医疗科技有限公司 | Shock wave electrode assembly, balloon catheter device and medical equipment |
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| CN103347456A (en) * | 2010-12-07 | 2013-10-09 | B·阿夫托尔 | Catheter systems for cardiac arrhythmia ablation |
| CN109303586A (en) * | 2017-07-26 | 2019-02-05 | 波士顿科学国际有限公司 | Blast wave generating apparatus |
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| AU2009257368B2 (en) * | 2008-06-13 | 2014-09-11 | Djt, Llc | Shockwave balloon catheter system |
| US20120203255A1 (en) * | 2011-02-04 | 2012-08-09 | Daniel Hawkins | High pressure balloon shockwave catheter and method |
| EP3870092A1 (en) * | 2018-10-24 | 2021-09-01 | Boston Scientific Scimed, Inc. | Photoacoustic pressure wave generation for intravascular calcification disruption |
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| US5609606A (en) * | 1993-02-05 | 1997-03-11 | Joe W. & Dorothy Dorsett Brown Foundation | Ultrasonic angioplasty balloon catheter |
| CN103347456A (en) * | 2010-12-07 | 2013-10-09 | B·阿夫托尔 | Catheter systems for cardiac arrhythmia ablation |
| CN109303586A (en) * | 2017-07-26 | 2019-02-05 | 波士顿科学国际有限公司 | Blast wave generating apparatus |
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