CN115054318A - Composite balloon type shock wave generation system and directional medicine feeding method thereof - Google Patents
Composite balloon type shock wave generation system and directional medicine feeding method thereof Download PDFInfo
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- CN115054318A CN115054318A CN202210702966.4A CN202210702966A CN115054318A CN 115054318 A CN115054318 A CN 115054318A CN 202210702966 A CN202210702966 A CN 202210702966A CN 115054318 A CN115054318 A CN 115054318A
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- 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
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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
- A61B2017/22001—Angioplasty, e.g. PCTA
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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
- A61B2017/22005—Effects, e.g. on tissue
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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
- 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
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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
- 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
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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
- 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
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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
- 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
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Abstract
The invention discloses a composite balloon type shock wave generating system and a directional medicine feeding method thereof, and relates to the technical field of medical instruments. The device can effectively treat moderate and severe calcified pathological tissues of a vascular pathological part and reduce the incidence rate of adverse events generating interlayer; and the medicine is assisted to enter the vessel wall, so that the treatment effect of the shock wave saccule is enhanced.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a composite balloon type shock wave generation system and a directional medicine feeding method thereof.
Background
Coronary atherosclerotic heart disease is characterized by coronary artery angiogenesis and atherosclerotic lesion, resulting in stenosis or obstruction of blood vessel lumen, myocardial ischemia, anoxia or necrosis, also known as coronary heart disease. Generally, medication, intervention and surgery are used. The exploration and study of human coronary artery calcification has been known for about 100 years. As early as the 19 th century, the pathologist Rudolph Virchow first discovered vascular calcification, which was considered to be a passive degenerative phenomenon. With the ongoing and intensive research on vascular calcification, coronary calcification has proven to be an active, highly regulated biological process. Coronary sclerosis refers to the deposition of calcification in coronary artery tissue or atherosclerotic plaques by the mechanism of inflammatory cell necrosis and release of apoptotic bodies and necrotic residues as nucleation sites for calcium phosphate crystals.
Currently, coronary angiography indicates that the severity of calcified lesions can be classified into non-calcifications, mild calcifications, moderate calcifications, and severe calcifications. The diagnosis of the calcified structure by using the coronary artery OCT can clearly divide the calcified range and depth characteristics into annular calcifications, punctate calcifications, superficial calcifications, deep calcifications, eccentric calcifications, limited calcifications and concentric calcifications. Wherein the annular, superficial and deep calcifications are symmetrical structures, and the punctate, eccentric and limited calcifications are asymmetrical structures.
In 1977, Gruentzig successfully performed the first balloon angioplasty (PTCA) procedure in the world with a balloon catheter for a patient with a stenosis in the anterior descending proximal coronary artery, and initiated a new era of coronary intervention. In ten years, the saccule support technology is rapidly developed, becomes smaller in size and stronger in expansion force, and meanwhile, certain clinical experience is accumulated. The balloon technology is also continuously improved and developed, balloon designs with different functions are also brought forward, and a spinous process balloon, a chocolate balloon and the like are injected. However, these balloon techniques have many clinical drawbacks and cannot effectively treat moderately and heavily calcified tissues.
The spinous process saccule has a good effect of treating fibrosis lesion in blood vessels in intervention technology, and mild calcification, but for moderate or severe calcification lesion, the technical defect that contour collapse is generated due to the defect that the spinous process saccule has insufficient capability of marking when encountering severe calcification is often generated.
Disclosure of Invention
The invention aims to provide a composite balloon type shock wave generation system and a directional drug delivery method thereof, which are used for solving the problems in the prior art, can effectively treat moderate and severe calcified pathological tissues, reduce the incidence rate of adverse events generating interlayers, can directionally inject drugs into endothelial tissues and are more beneficial to improving the treatment effect.
In order to achieve the purpose, the invention provides the following scheme:
the invention provides a composite balloon type shock wave generating system which comprises a catheter, a balloon and a shock wave electric arc generator, wherein the catheter is provided with an elongated carrier, the balloon is hermetically surrounded at one part of the far end of the carrier, a fluid medium can be filled in the balloon, the outer surface of the balloon is provided with a spinous process, the outer surfaces of the balloon and the spinous process can be coated with coatings containing medicines, the shock wave electric arc generator is arranged in the balloon, the shock wave electric arc generator can generate electric arcs in the balloon, the electric arcs enable liquid in the balloon to be vaporized to generate tiny bubbles and shock waves, and shock wave energy can be transmitted to the top end of the spinous process through the fluid medium and transmitted to a blood vessel wall through the balloon and the spinous process.
Preferably, the spinous process is arranged on one side of the balloon, and the shock wave generated in the balloon by the shock wave arc generator is directed towards the spinous process.
Preferably, the shock wave arc generator comprises two or more shock wave sources distributed within the balloon, the shock wave arc generator being connected to an energy control system by which the output energy of the shock wave arc generator can be regulated.
Preferably, the shock wave source comprises a positive electrode and a counter electrode which are arranged at intervals, the energy control system comprises a high-voltage pulse power supply, the high-voltage pulse power supply is connected with the positive electrode and the counter electrode, when the high-voltage pulse power supply applies high-voltage pulses to the positive electrode and the counter electrode, an electric arc conducted through a fluid medium can be generated between the positive electrode and the counter electrode, and the output energy of the shock wave source is adjusted by changing the voltage applied by the high-voltage pulse power supply.
Preferably, one or more spinous processes are arranged on the outer surface of the balloon, the spinous processes extend along the length direction of the balloon, the shock wave sources corresponding to the spinous processes are arranged in the balloon, and the directions of the shock waves emitted by the shock wave sources face the tip directions of the spinous processes corresponding to the shock wave sources.
Preferably, the outer surface of the balloon is uniformly distributed with three spinous processes along the circumferential direction, and three shock wave sources respectively corresponding to the three spinous processes are arranged in the balloon.
Preferably, the shock wave sources are distributed longitudinally or circumferentially within the balloon and in non-contacting relation with the balloon inner wall.
Preferably, the spinous process is triangular in cross-section.
Preferably, the spinous processes are serrated.
The invention also provides a directional medicine delivery method based on the composite balloon type shock wave generation system, which comprises the following steps:
s1: coating a coating containing a drug on the surfaces of the balloon and the spinous process;
s2: inserting the balloon into a body so that the balloon is positioned adjacent to a blood vessel containing calcified lesions, inflating the balloon with a fluid medium to bring the balloon into contact with the blood vessel wall;
s3: the shock wave is generated in the saccule through the shock wave electric arc generator, the shock wave is transmitted to the side wall of the saccule and the spinous process through a fluid medium and then is transmitted to the blood vessel wall to impact and damage calcified tissues, the spinous process forms a fracture zone at a calcified lesion on the corresponding blood vessel wall, and meanwhile, the drugs on the surfaces of the saccule and the spinous process are promoted to be released and enter the blood vessel wall.
Compared with the prior art, the invention has the following technical effects:
according to the composite saccule type shock wave generating system and the directional medicine feeding method thereof, shock wave energy is generated by the shock wave electric arc generator and acts on the calcified tissue, after the shock wave energy is transmitted to the spinous process, the spinous process has stronger impact capability, the nicking capability of the spinous process on the calcified tissue is improved, and meanwhile, the shock wave is transmitted to the blood vessel wall through the spinous process to impact the calcified tissue, so that moderate and severe calcified pathological tissues can be effectively treated; due to the improvement of the notching capability of the spinous process, the shock wave with lower energy can be used in combination with the impact effect of the shock wave, so that the incidence rate of adverse events generating the interlayer is reduced; the balloon and the surface of the spinous process carry medicines, and the balloon and the surface of the spinous process carry medicines, have the functions of medicine conveying and releasing, and after the nicks of the spinous process penetrate calcified tissues, the medicine coating coated on the balloon and the spinous process can be instantaneously conveyed into vascular endothelial tissues behind the fractured layers of the calcified tissues by means of the energy of shock waves, so that the intervention process of a second medicine ball is avoided, the cost is low, the time is short, safety and effectiveness are realized, and the improvement of the treatment effect is facilitated;
furthermore, the output energy (such as high-low two-level output energy) of the shock wave electric arc generator can be adjusted through the energy control system, so that the composite balloon type shock wave generating system has the capability of adapting to the treatment of blood vessels with complex pathological conditions (including calcification, fibrosis and lipid pool).
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.
FIG. 1 is a schematic side view of a composite balloon-type shock wave generating system according to the present invention;
FIG. 2 is a schematic axial view of a composite balloon-type shock wave generation system for scoring calcified tissues under different conditions;
FIG. 3 is a schematic structural view of the composite balloon type shock wave generating system provided by the present invention when the balloon and the surface of the spinous process are provided with a drug coating;
FIG. 4 is a schematic structural view of the composite balloon type shock wave generating system provided by the present invention, wherein the balloon and the surface of the spinous process are provided with drug microspheres;
FIG. 5 is a schematic view of a balloon-based shock wave generation system of the present invention in which spinous processes are disposed on one side of the balloon to treat atheromatous calcified coronary vessels;
in the figure: 100-composite balloon type shock wave generating system, 1-catheter, 2-balloon, 3-spinous process, 4-coating containing medicine, 5-calcified tissue, 6-shock wave source, 7-medicine microsphere and 8-vessel wall.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The invention aims to provide a composite balloon type shock wave generation system and a directional drug delivery method thereof, which are used for solving the problems in the prior art, can effectively treat moderate and severe calcified pathological tissues, reduce the incidence rate of adverse events generating interlayers, can directionally inject drugs into endothelial tissues and are more beneficial to improving the treatment effect.
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in further detail below.
As shown in fig. 1-5, the present embodiment provides a composite balloon type shock wave generating system 100, which includes a catheter 1, a balloon 2 and a shock wave arc generator, wherein the catheter 1 has an elongated carrier, the balloon 2 is sealed and surrounded around a portion of a distal end of the carrier, a fluid medium can be filled in the balloon 2, a spinous process 3 is disposed on an outer surface of the balloon 2, a coating 4 containing a drug can be coated on outer surfaces of the balloon 2 and the spinous process 3, the shock wave arc generator is disposed in the balloon 2, the shock wave arc generator can generate an electric arc in the balloon 2, the electric arc vaporizes liquid in the balloon 2 to generate micro bubbles and shock waves, and shock wave energy can be transmitted to a top end of the spinous process 3 through the fluid medium and transmitted to a blood vessel wall through the balloon 2 and the spinous process 3.
Shock wave energy is generated by the shock wave electric arc generator to act on the calcified tissue 5, and after the shock wave energy is transmitted to the spinous process 3, the spinous process 3 has stronger impact capability, the nicking capability of the spinous process 3 on the calcified tissue 5 is improved, and moderate and severe calcified pathological tissues can be effectively treated by combining the impact effect of the shock wave; due to the improved notching capability of the spinous process 3, shock waves with lower energy can be used, thereby reducing the incidence of adverse events that produce the interlayer; the balloon 2 and the spinous process 3 are loaded with drugs (paclitaxel or rapamycin, derivatives and analogues thereof) on the surfaces and have drug delivery and release functions, wherein the drugs on the surfaces of the balloon 2 are arranged to be 0.5-3 mug/mm 2 The drug arrangement on the surface of the spinous process 3 is 1-10 mu g/mm 2 After the nicks of the spinous processes 3 penetrate through the calcified tissues 5, the medicine coating coated on the balloon 2 and the spinous processes 3 can be instantly conveyed into the vascular tissues behind the fractured layers of the calcified tissues 5 by means of the energy of shock waves, so that the medicine (paclitaxel or rapamycin or derivatives thereof) is directionally injected into the vascular walls, the use of a second medicine ball is avoided, the cost is low, the time is short, the medicine coating is safe and effective, and the treatment effect is better improved.
In some embodiments, the nylon balloon 2 is sized to have a diameter x length of 6mmx40 mm and a wall thickness of 0.05 mm. Pressurizing the sacculus 2 under low pressure, spraying a coating containing paclitaxel on a spraying machine, and continuously spraying for 3-6 times until the pressure reaches 1 microgram/mm 2 The drug coating concentration of (a). After drying, three coating layers are arranged on the surface of the balloon 2 and are coated with 3 mu g/mm 2 Nylon spinous process 3 of the drug; the balloon 2 with the drug coating and the spinous process 3 were folded with a balloon folder to have a diameter of 1.1mm through. During testing, the medicine-coated shock wave saccule is coated with lime ring to simulate calcified lesion and then placed in water bath at 37 ℃. Pressurizing the medicine-carrying spinous process shock wave sacculus to 4atm by using a handheld pressurizing pump containing 1:1 mixed developing solution and normal saline, expanding the sacculus to 6mm in diameter, switching on a power supply to emit pulses, and observing the shattering of calcified rings and the medicine from the surface of the sacculusAnd (4) releasing.
In some embodiments, the spinous process 3 is disposed on one side of the balloon 2, and the shock wave generated by the shock wave arc generator in the balloon 2 is directed toward the spinous process 3, as shown in fig. 5, if the calcified tissue 5 is formed only on one side of the blood vessel wall 8, by disposing the spinous process 3 on the outer surface of the balloon 2 corresponding to the calcified tissue 5 in the above area and directing the shock wave generated by the shock wave arc generator in the balloon 2 toward the spinous process 3, in this case, most of the shock wave is conducted in the direction of the spinous process 3, so as to reduce the impact on other non-calcified areas of the blood vessel wall 8 and improve the safety of the use thereof.
The shock wave arc generator comprises two or more shock wave sources 6 distributed in the saccule 2, the shock wave arc generator is connected with the energy control system, the output energy of the shock wave arc generator can be adjusted through the energy control system, and the composite saccule type shock wave generation system has the capability of adapting to the treatment of blood vessels with complex pathological changes (containing calcification, fibrosis and lipid pool) through different output energies, for example, the output energy of high and low gears can be set.
The shock wave source 6 comprises a positive electrode and a counter electrode which are arranged at intervals, the energy control system comprises a high-voltage pulse power supply, the high-voltage pulse power supply is connected with the positive electrode and the counter electrode, when the high-voltage pulse power supply applies high-voltage pulses to the positive electrode and the counter electrode, an electric arc conducted through a fluid medium can be generated between the positive electrode and the counter electrode, and the output energy of the shock wave source 6 is adjusted by changing the voltage applied by the high-voltage pulse power supply. By applying high voltage pulse between the positive electrode and the counter electrode, an electric arc effect is generated between the electrode pairs, so that surrounding liquid is rapidly vaporized and expanded, and shock waves are generated by a sound barrier effect generated after bubbles are broken.
The shock wave arc generator may include an elongated conductor and an insulator covering the elongated conductor, the insulator may have a plurality of discrete openings, each opening for exposing the elongated conductor to a fluid to form a plurality of positive electrodes. Insulated wire may be used to form the elongated conductor and the overlying insulator, the insulated wire may be wrapped around a carrier positioned within the balloon, a guidewire lumen may be disposed in the carrier, the insulated wire wrapped around the carrier to form electrode coil turns, and the shock wave arc generator further includes a conductor wire wrapped around the carrier positioned within the balloon and positioned between the electrode coil turns to form a counter electrode.
One or more spinous processes 3 are arranged on the outer surface of the balloon 2, the spinous processes 3 extend along the length direction of the balloon 2, shock wave sources 6 corresponding to the spinous processes 3 are arranged in the balloon 2, and the directions of shock waves emitted by the shock wave sources 6 face the tip directions of the corresponding spinous processes 3.
In some embodiments, the spinous processes 3 are uniformly distributed on the outer surface of the balloon 2 in the circumferential direction, as shown in fig. 2, three spinous processes 3 are uniformly distributed on the outer surface of the balloon 2 in the circumferential direction, three shock wave sources 6 corresponding to the three spinous processes 3 are arranged in the balloon 2, the directions of the shock waves emitted by the shock wave sources 6 respectively face the tip directions of the spinous processes 3 corresponding to the shock wave sources, and the three spinous processes are spaced by an included angle of 120 degrees, as shown in fig. 2(a), the shock waves facing the periphery of the balloon 2 can be generated by controlling the three shock wave sources 6 to continuously emit the shock waves, and the annular calcified tissue 5 is indented through the three spinous processes 3; as shown in fig. 2(b) and 2(c), when the calcified tissue 5 is asymmetric, after the balloon 2 is placed near the calcified tissue 5, the spinous process 3 corresponding to the calcified tissue 5 is determined, one or two of the three shock wave sources 6 corresponding to the spinous process 3 are controlled to continuously emit shock waves, and the emitted shock waves can score the asymmetric calcified tissue 5 through the spinous process 3, so that the accuracy of scoring the calcified tissue 5 is improved, and the use is safer; as shown in fig. 2(b), two shock wave sources 6 are controlled to continuously emit shock waves, so that the asymmetrical calcified tissue 5 is scored through the two corresponding spinous processes 3; as shown in fig. 2(c), one of the shock wave sources 6 is controlled to continuously emit shock waves, so that the asymmetrical calcified tissue 5 is scored through the corresponding spinous process 3. In other embodiments, the arrangement of the spinous processes 3 may be disordered.
The shock wave sources 6 are longitudinally or circumferentially distributed in the balloon 2 and are in non-contact relation with the inner wall of the balloon 2, so that direct impact on the balloon 2 is avoided.
The cross section of the spinous process 3 is triangular, but the spinous process is not limited to be triangular, and other spinous processes with a tip structure are also within the protection scope of the invention, and moderate and severe calcified pathological tissues can be treated by impacting the calcified tissues 5 through the tip of the spinous process 3 with lower shock wave energy.
The spinous process 3 may also be serrated, with the tip of the serration striking the calcified tissue 5.
A directional medicine delivery method based on the composite balloon type shock wave generation system 100 comprises the following steps:
s1: coating a coating 4 containing a medicament on the surfaces of the saccule 2 and the spinous process 3;
s2: inserting the balloon 2 into the body so that the balloon 2 is positioned adjacent to a blood vessel containing a calcified lesion, inflating the balloon 2 with a fluid medium to bring the balloon 2 into contact with calcified tissue 5;
s3: the shock wave is generated in the saccule 2 through the shock wave electric arc generator, the shock wave is transmitted to the side wall of the saccule 2 and the spinous process 3 through a fluid medium and is transmitted to the blood vessel wall to impact and damage the calcified tissue 5, the spinous process 3 forms a fracture zone at the corresponding calcified lesion on the blood vessel wall, and meanwhile, the medicine on the surfaces of the saccule 2 and the spinous process 3 is promoted to be released and enter the blood vessel wall 8.
As shown in fig. 2, after the calcified tissue 5 is damaged by the spinous process shock wave balloon technology, the drug coating coated on the surfaces of the balloon 2 and the spinous process 3 is also delivered to the vessel wall 8 by the shock wave, and the drug coating on the surface of the spinous process 3 enters the endothelial tissue of the vessel immediately after the peak of the spinous process is positioned at the calcified fracture layer. When the balloon 2 reaches the lesion site, the adherent drug is dissolved in blood or body fluid in the blood vessel, and a mixture of the drug and the blood is trapped between the balloon 2 and the vessel wall 8.
As shown in fig. 4, when the drug microspheres 7 are coated on the surface of the balloon 2, after the calcified tissues 5 in the blood vessel are destroyed by the balloon 2 and the spinous process 3 to generate a fracture zone, the drug microspheres 7 coated on the surface of the balloon 2 and the spinous process 3 can be delivered to the blood vessel wall 8, and when a shock wave occurs, the drug microspheres 7 on the surface of the balloon 2 are shattered to release the drug.
The composite balloon type shock wave generating system provided by the invention can generate shock wave energy, the shock wave energy is directly acted on calcified tissues through spinous processes, and meanwhile, the medicine on the surface of the balloon can be released and pushed to the wall of a blood vessel, so that after angioplasty is finished, the medicine for reducing restenosis in the blood vessel is applied at the same time, and the medicine can be directionally injected into endothelial tissues, thereby being more beneficial to improving the treatment effect.
The principle and the implementation mode of the invention are explained by applying a specific example, and the description of the embodiment is only used for helping to understand the method and the core idea of the invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, the specific embodiments and the application range may be changed. In view of the above, the present disclosure should not be construed as limiting the invention.
Claims (10)
1. A composite balloon type shock wave generation system is characterized in that: including pipe, sacculus and shock wave electric arc generator, the pipe has elongated carrier, the sacculus encircle in around the partly of carrier distal end, can fill fluid medium in the sacculus, the sacculus surface is equipped with the spinous process, the sacculus with the surface of spinous process can coat the coating that contains the medicine, shock wave electric arc generator set up in the sacculus, shock wave electric arc generator can be in produce electric arc in the sacculus, electric arc makes liquid vaporization in the sacculus produces tiny bubble and shock wave, and shock wave energy can be conducted extremely through fluid medium the top of spinous process, and the warp the sacculus with the spinous process passes to the vascular wall.
2. The composite balloon-based shock wave generating system of claim 1, wherein: the spinous process is arranged on one side of the balloon, and the direction of the shock wave generated in the balloon by the shock wave electric arc generator faces the direction of the spinous process.
3. The composite balloon-type shock wave generating system according to claim 1, wherein: the shock wave arc generator comprises two or more shock wave sources distributed in the saccule, and is connected with an energy control system, and the output energy of the shock wave arc generator can be adjusted through the energy control system.
4. The composite balloon shock wave generating system according to claim 3, wherein: the shock wave source comprises a positive electrode and a counter electrode which are arranged at intervals, the energy control system comprises a high-voltage pulse power supply, the high-voltage pulse power supply is connected with the positive electrode and the counter electrode, when the high-voltage pulse power supply applies high-voltage pulses to the positive electrode and the counter electrode, an electric arc conducted through a fluid medium can be generated between the positive electrode and the counter electrode, and the output energy of the shock wave source is adjusted by changing the voltage applied by the high-voltage pulse power supply.
5. The composite balloon shock wave generating system according to claim 3, wherein: one or more spinous processes are arranged on the outer surface of the balloon, the spinous processes extend along the length direction of the balloon, the shock wave sources corresponding to the spinous processes are arranged in the balloon, and the directions of the shock waves emitted by the shock wave sources face the tip directions of the spinous processes corresponding to the shock wave sources.
6. The composite balloon-type shock wave generating system according to claim 5, wherein: the outer surface of the balloon is uniformly distributed with three spinous processes along the circumferential direction, and three shock wave sources respectively corresponding to the three spinous processes are arranged in the balloon.
7. The composite balloon-based shock wave generating system of claim 1, wherein: the shock wave sources are longitudinally or circumferentially distributed in the balloon and are in non-contact relation with the inner wall of the balloon.
8. The composite balloon-based shock wave generating system of claim 1, wherein: the cross section of the spinous process is triangular.
9. The composite balloon-based shock wave generating system of claim 1, wherein: the spinous process is zigzag.
10. A directional medicine delivery method based on the composite balloon type shock wave generation system as claimed in any one of claims 1 to 9, characterized by comprising the following steps:
s1: coating a coating containing a drug on the surfaces of the balloon and the spinous process;
s2: inserting the balloon into a body so that the balloon is positioned adjacent to a blood vessel containing calcified lesions, inflating the balloon with a fluid medium to bring the balloon into contact with the blood vessel wall;
s3: the shock wave is generated in the saccule through the shock wave electric arc generator, the shock wave is transmitted to the side wall of the saccule and the spinous process through a fluid medium and is transmitted to the blood vessel wall to impact and damage calcified tissues, the spinous process forms a fracture zone at a calcified lesion on the corresponding blood vessel wall, and meanwhile, the medicine on the surfaces of the saccule and the spinous process is promoted to be released and enters the blood vessel wall.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210702966.4A CN115054318A (en) | 2022-06-21 | 2022-06-21 | Composite balloon type shock wave generation system and directional medicine feeding method thereof |
| PCT/CN2023/099776 WO2023246550A1 (en) | 2022-06-21 | 2023-06-13 | Composite balloon-type shockwave generation system and targeted drug delivery method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210702966.4A CN115054318A (en) | 2022-06-21 | 2022-06-21 | Composite balloon type shock wave generation system and directional medicine feeding method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115054318A true CN115054318A (en) | 2022-09-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210702966.4A Pending CN115054318A (en) | 2022-06-21 | 2022-06-21 | Composite balloon type shock wave generation system and directional medicine feeding method thereof |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN115054318A (en) |
| WO (1) | WO2023246550A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115245373A (en) * | 2022-09-26 | 2022-10-28 | 上海百心安生物技术股份有限公司 | Pulse sacculus expansion pipe of even fragmentation |
| WO2023246550A1 (en) * | 2022-06-21 | 2023-12-28 | 杭州天路医疗器械有限公司 | Composite balloon-type shockwave generation system and targeted drug delivery method thereof |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2003310762A (en) * | 2002-02-19 | 2003-11-05 | Kawasumi Lab Inc | Balloon adaptor and balloon catheter with the same |
| US20080300610A1 (en) * | 2007-05-31 | 2008-12-04 | Cook Incorporated | Device for treating hardened lesions and method of use thereof |
| JP6257625B2 (en) * | 2012-08-06 | 2018-01-10 | ショックウェーブ メディカル， インコーポレイテッド | Thin electrodes for shock wave catheters for angioplasty |
| CN205867283U (en) * | 2016-06-17 | 2017-01-11 | 张学民 | Medicine carrying cutting balloon dilation catheter |
| CA3040182A1 (en) * | 2016-10-20 | 2018-04-26 | Retrovascular, Inc. | Method and device for enhanced composition delivery |
| CN110811761B (en) * | 2019-05-17 | 2021-01-22 | 谱创医疗科技(上海)有限公司 | Shock wave generation system applied to angioplasty |
| CN113117220B (en) * | 2021-04-14 | 2023-03-21 | 深圳市赛禾医疗技术有限公司 | Medicine balloon catheter, medicine balloon catheter system and control method thereof |
| CN114098896A (en) * | 2021-11-04 | 2022-03-01 | 杭州天路医疗器械有限公司 | Balloon type shock wave generation system and directional medicine delivery method thereof |
| CN115054318A (en) * | 2022-06-21 | 2022-09-16 | 杭州天路医疗器械有限公司 | Composite balloon type shock wave generation system and directional medicine feeding method thereof |
| CN217744509U (en) * | 2022-06-21 | 2022-11-08 | 杭州天路医疗器械有限公司 | Composite balloon type shock wave generation system |
-
2022
- 2022-06-21 CN CN202210702966.4A patent/CN115054318A/en active Pending
-
2023
- 2023-06-13 WO PCT/CN2023/099776 patent/WO2023246550A1/en unknown
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023246550A1 (en) * | 2022-06-21 | 2023-12-28 | 杭州天路医疗器械有限公司 | Composite balloon-type shockwave generation system and targeted drug delivery method thereof |
| CN115245373A (en) * | 2022-09-26 | 2022-10-28 | 上海百心安生物技术股份有限公司 | Pulse sacculus expansion pipe of even fragmentation |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2023246550A1 (en) | 2023-12-28 |
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