CN112401975A - Ultrasonic balloon with function of directionally breaking calcified plaque in cavity and preparation method thereof - Google Patents
Ultrasonic balloon with function of directionally breaking calcified plaque in cavity and preparation method thereof Download PDFInfo
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- CN112401975A CN112401975A CN202011373674.8A CN202011373674A CN112401975A CN 112401975 A CN112401975 A CN 112401975A CN 202011373674 A CN202011373674 A CN 202011373674A CN 112401975 A CN112401975 A CN 112401975A
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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
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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
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- 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
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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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
- A61B2017/22007—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
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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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- Life Sciences & Earth Sciences (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Orthopedic Medicine & Surgery (AREA)
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- Medical Informatics (AREA)
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- Anesthesiology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses an ultrasonic balloon with a function of directionally breaking calcified plaque in a cavity and a preparation method thereof. The ultrasonic balloon is arranged in an inner tube of the balloon expansion part and is provided with a micro mechanical ultrasonic transducer; the external surface of the expansion balloon section is coated with a preset air microbubble coating which is composed of sulfur hexafluoride air bubbles with ultrasonic response characteristics and a water-soluble adhesive. The coating may also contain thrombolytic, anti-inflammatory, anticoagulant or restenosis inhibiting agents. When in use, the ultrasonic balloon catheter is delivered to a diseased region and then is spread, so that the balloon is contacted with diseased tissues. Meanwhile, a power supply of the miniature ultrasonic transducer is turned on to apply ultrasonic interference to the sulfur hexafluoride air bubbles. Ultrasonic energy is emitted from the mechanical ultrasonic transducer and is transmitted to the sulfur hexafluoride air bubbles by a transmission medium (a liquid, such as a developer, injected when the balloon is inflated). The sulfur hexafluoride air bubbles generate cavitation effect under the action of the ultrasonic transducer, and the cavitation effect causes the air bubbles to explode and break calcified plaques on the inner wall of the blood vessel. By adjusting the characteristics of the drug-loaded micro-capsules, the ultrasonic characteristics and the sound pressure intensity, the control on the air bubbles of the sulfur hexafluoride can be realized, and the effect of the ultrasonic balloon catheter on treating calcified plaques is achieved.
Description
Technical Field
The present invention relates to the field of medical devices. In particular to an ultrasonic balloon with the function of directionally breaking calcified plaques in cavities and a preparation method thereof.
Background
Coronary atherosclerotic heart disease (coronary heart disease) can be treated by adopting medicines, intervention and surgical operations, wherein the intervention treatment has the advantages of obvious curative effect, small wound, less pain of patients, and the total curative effect which is the same as that of Coronary Artery Bypass Grafting (CABG), is obviously superior to that of pure medicine treatment, is increasingly favored by clinicians and patients, and becomes an important means in the treatment of coronary heart disease.
Since the inventor of Stones initiative of American scholars in 1958 first initiated the first coronary artery angiography and the inventor of GrUENTZIG of German scholars for interventional therapy in 1977 completed the 1 st Percutaneous Transluminal Coronary Angioplasty (PTCA), new instruments, new techniques and new strategies for coronary artery interventional therapy are continuously developed, clinical interventional experience is continuously accumulated, and interventional techniques are increasingly perfected; currently, the application of cardiovascular medical intervention has been far beyond CABG — more than 120 patients in the united states received percutaneous coronary intervention (PCl) treatment in 2006, while only 20 more than ten thousand CABG were received; in 2001, about 2 ten thousand patients in China receive PCl surgery, and more in 2006, 11 ten thousand patients, but only 6000 patients receive CABG. Intervention in coronary artery disease (atheromatous plaque, calcification, etc.) on the basis of catheters has been a prominent advance in the cardiovascular field in recent years. Therefore, it is important to understand the status and progress of PCI treatment.
The clinical application of the coronary artery stent in the 90 th of the 20 th century solves the problem of acute occlusive lesion after PTCA operation, and the incidence of long-term restenosis in a target vessel is reduced by 15 percent compared with that of simple balloon dilatation by improving the negative remodeling of the vessel, but the restenosis after PTCA operation cannot be fundamentally prevented and treated. After the naked stent is placed, the blood vessel wall injury, thrombosis and inflammatory reaction can be caused, so that the smooth muscle of the blood vessel is proliferated, and the excessive hyperplasia of the intima causes restenosis.
The current drug balloon is applied by drug passively diffusing when the balloon is propped open and is in transient contact with the vessel wall. Leading to the failure of precise control of the amount of drug entering the lesion (e.g. drug eluting balloon disclosed in patent CN101239216A directly coated with drug) and the loss of drug during the passage of the balloon through the blood circuit, and the failure of achieving the therapeutic effect for treating the lesion.
The appearance of the ultrasonic microbubble drug-loading technology provides a new idea for solving the problems. When ultrasonic waves are conducted in a liquid, an "ultrasonic cavitation" effect is produced, namely: the tiny bubbles (cavitation nuclei) existing in the liquid vibrate, grow and continuously gather the energy of a sound field under the action of an ultrasonic field, and when the energy reaches a certain threshold value, the cavitation bubbles are rapidly collapsed and closed. The research proves that: the liposome, degradable polymer and other materials are prepared into microbubbles with certain particle size and wall thickness characteristics, can be used as cavitation nuclei to promote the cavitation effect of ultrasound, and are broken after absorbing certain energy. If the medicine is carried in the cavity or the cavity wall of the micro-bubble to prepare the sulfur hexafluoride air bubble, the medicine carried in the sulfur hexafluoride air bubble is directly promoted to be released or accelerated to be released when the sulfur hexafluoride air bubble is broken under the action of the ultrasonic cavitation effect. The basic treatment process of the ultrasonic microbubble drug-loading technology comprises the following steps: the location of arrival of the sulfur hexafluoride air bubbles is determined by visualization of the microbubbles under ultrasound (originally used medically as an ultrasound contrast agent). Then ultrasonic wave with certain frequency is applied from the outside of the body to promote the micro-bubble carried with the therapeutic drug to be broken or the drug to be released in an accelerated way, thereby achieving the aim of targeted drug delivery and breaking calcified plaques on the inner wall of the blood vessel.
The problem of controlled release of the drug is solved by applying ultrasonic wave and ultrasonic wave to induce the micro-bubble to break in vitro. However, the ultrasonic waves penetrate different tissues (bones, muscles, blood, interstitial fluid and even cavities) of the human body from the outside of the body and are attenuated to different degrees at different distances; during treatment, individual differences among different patients and different application anatomical parts of the drug balloon (except coronary artery lesion, the drug balloon can also be used for peripheral blood vessels such as limb blood vessels, cerebral blood vessels, hepatic portal vein and the like) bring uncertainty to the efficiency of reaching sulfur hexafluoride air bubbles by ultrasonic energy and controlling drug release.
Disclosure of Invention
The invention aims to provide an ultrasonic balloon with a function of directionally breaking calcified plaques in cavities and a preparation method thereof.
The invention provides an ultrasonic balloon with an ultrasonic transducer, which comprises a naked balloon body with a mechanical ultrasonic transducer (comprising a lead and a near-end power supply interface) and two parts of preset air micro-bubbles which are coated outside the naked balloon and contain sulfur hexafluoride air bubbles.
The naked saccule can be a non-compliant saccule and a semi-compliant saccule which are made of high polymer materials such as nylon or mixed materials, and can be a quick exchange type saccule or a non-quick exchange type saccule. The capacitive micro-mechanical ultrasonic transducers are positioned on the outer wall of the inner tube corresponding to the balloon filling part, are distributed along the axial direction of the inner tube, are provided with a plurality of arrays, and can release ultrasonic waves to preset air micro-bubbles coated on the surface of the balloon filling part along the radial direction; the conducting wires for supplying power to the arrays extend to the proximal end interface of the balloon catheter along the inner cavity of the balloon catheter and are matched with power supply equipment at the proximal end of the balloon for use.
The preset air micro-bubbles are coated on the surface of the filling part of the balloon. The contained sulfur hexafluoride air bubbles are single-cavity microbubbles formed by degradable/absorptive materials (such as high polymers, proteins and liposomes such as PLGA, PLLA and PGA), the particle size range is 1-8 um, and the wall thickness is 10-5000 nm; the carried medicine can be one or more of paclitaxel, rapamycin, docetaxel or other antiproliferative medicines.
The invention also provides an ultrasonic balloon with the function of directionally breaking the calcified plaque in the cavity and a preparation method thereof. And adhering and fixing a mechanical ultrasonic transducer on the outer wall of the inner tube corresponding to the filling section of the bare balloon, and coating preset air micro-bubbles containing sulfur hexafluoride air bubbles on the outer surface of the filling section of the bare balloon.
The method comprises the following specific steps: 1. after passing through the tube wall from the inner tube cavity of the balloon catheter, a copper wire is welded with the micro mechanical ultrasonic transducer, and the micro mechanical ultrasonic transducer is fixed on the inner tube through adhesion; 2. welding components (an inner tube, an outer tube, a balloon tube and a hypotube) of the balloon catheter; 3. preparing sulfur hexafluoride air bubbles and preset air microbubble components; 4. coating the preset air microbubble component on the surface of the balloon filling section of the welded balloon catheter by adopting a spraying or dipping or spin coating method; 5. drying the coating, tabletting, rolling, packaging and sterilizing with ethylene oxide for later use.
The ultrasonic balloon catheter prepared by the method has the following advantages: 1. The surface of the balloon carries the medicine through sulfur hexafluoride air bubbles, and the medicine loss is less when the medicine passes through a blood passage; 2. The effective ultrasonic energy absorbed by the sulfur hexafluoride air bubbles is controllable and stable, and the interference factors are few: firstly, the ultrasonic transducer is positioned in the filling section of the balloon, the stroke of the ultrasonic transducer away from sulfur hexafluoride air bubbles is a fixed value (determined by the model of the balloon), and the influence of the anatomical position of a target lesion part on effective ultrasonic energy is avoided; secondly, the medium which is required to penetrate through the ultrasonic wave emitted by the ultrasonic transducer to take effect is balloon filling liquid (clinically common contrast agents such as iopromide and the like) and balloon body material (usually nylon or mixture thereof, which can be selected), so that the influence of penetrating through different tissues and the individual difference of patients on effective ultrasonic energy is avoided.
3. The drug release behavior can be controlled by ultrasonic wave form (pulse/continuous), ultrasonic energy and ultrasonic wavelength, the drug release characteristics of the balloon are controllable, and the release amount is stable and repeatable.
4. The particle size of the sulfur hexafluoride air bubbles is less than 8um, so that the blockage of blood vessels is not easy to occur; 5. The sulfur hexafluoride air bubble material can be degraded and does not remain in the organism or cause damage.
The specific implementation method comprises the following steps: the invention provides an ultrasonic balloon with a micro-mechanical ultrasonic transducer, which comprises a naked balloon main body with the micro-mechanical ultrasonic transducer (comprising a lead and a near-end power supply interface) and a preset air microbubble coated outside the naked balloon and containing sulfur hexafluoride air bubbles.
1. Bare balloon body with micro-mechanical ultrasound transducer (including wire and proximal power supply interface): firstly, a copper wire of a miniature ultrasonic transducer penetrates through the wall of a balloon inner tube; and (4) tightening the copper wire, bonding the micro ultrasonic transducer with the pipe wall of the inner pipe, and sealing the wall penetrating position. And then welding and assembling the naked balloon main body according to the general manufacturing process of the balloon catheter.
2. Pre-placed air micro-bubble coating containing "sulfur hexafluoride air bubbles": the sulfur hexafluoride air bubble is composed of a microcapsule material and a drug wrapped inside. The preset air microbubble material is a high polymer material with good biocompatibility or a completely degradable high polymer material, the physical structure design of the microbubble is required to have ultrasonic responsiveness, and the wall thickness of the preset air microbubble coating is required to be 10-10,000 nm; the sulfur hexafluoride air bubbles with thin wall thickness are relatively sensitive to the response of ultrasonic waves, are easy to break when being subjected to the ultrasonic action, and can be used for releasing medicaments instantly. The sulfur hexafluoride air bubbles with thicker wall thickness are not easy to break under the same ultrasonic action, and can be used for slowly releasing the medicine at the pathological change part.
3. After the sulfur hexafluoride air bubbles are prepared, the sulfur hexafluoride air bubbles are dispersed into a water-soluble dispersing agent with a specific formula to prepare a preset air microbubble coating material. The preset air microbubble coating material is fixed on the surface of the balloon in a dipping or spraying mode, and after drying under certain conditions, liquid components in the dispersing agent are volatilized, solute in the dispersing agent is used as an adhesive to adhere sulfur hexafluoride air bubbles on the surface of the balloon to form the preset air microbubble coating.
In conclusion, the invention has the creativity and the advancement that: the ultrasonic balloon with the micro mechanical ultrasonic transducer provided by the invention has the characteristics of large drug loading capacity, high drug loading efficiency and high drug absorption and utilization rate. More importantly, the device provided by the invention is provided with a capacitive micro-mechanical ultrasonic transducer which supplies ultrasonic energy from the inner tube of the balloon filling part, the path through which the energy is transmitted is fixed (determined by the type of the balloon), and the medium for energy transmission is controllable (developer), so that the possibility of more precise ultrasonic controlled-release process is provided.
The drug release process of the ultrasonic balloon catheter provided by the invention is controllable and directional: by controlling the structure of the microbubbles and combining the ultrasonic characteristics, the time, the position and the release amount of the released medicament can be controlled, so that the safety of the ultrasonic balloon catheter is ensured while the treatment effect of the ultrasonic balloon catheter is improved.
Compared with the method disclosed by CN 104841060A, the transmission process of the ultrasonic energy avoids the interference of human tissues and is more accurate and stable. Meanwhile, the ultrasonic controlled release technology is convenient to use on more human body parts.
Description of the drawings: FIG. 1 is a schematic diagram of a controlled drug release balloon with a micromechanical ultrasound transducer
1. A balloon filling section; 2. a drug; 3. drug-loaded microbubbles having ultrasound responsiveness; 4. a bare balloon.
Fig. 2 is a schematic diagram of the assembly process of the mechanical ultrasonic transducer in the inner tube of the balloon filling section (the micro mechanical ultrasonic transducer is shown in a shaded part).
FIG. 3 is a schematic view of a drug-loaded ultrasound microbubble structure
Fig. 4 is a schematic view of a balloon with a drug-loaded ultrasound microbubble coating.
Claims (4)
1. An ultrasonic balloon with the function of directionally breaking calcified plaques in a cavity and a preparation method thereof comprise a mechanical ultrasonic transducer positioned on the inner tube wall of an inflatable part of the balloon and sulfur hexafluoride air bubbles coated with an ultrasonic response preset air microbubble coating on the outer surface.
2. The ultrasonic balloon of claim 1, wherein: the wall of the inner tube of the balloon filling part is provided with a miniature capacitive mechanical ultrasonic transducer which can emit ultrasonic with very high energy at a specific frequency according to the requirement.
3. The ultrasonic balloon of claim 1, wherein: can be used to locally deliver various therapeutic agents to any intraluminal site or location within the body accessible using a guidewire/guiding catheter, such as the coronary arteries of the heart, the portal veins of the liver, etc.
4. The pre-existing air microbubble coating having ultrasound response properties of claim 1 comprising two parts: the sulfur hexafluoride air bubbles have hydrophilic adhesive and ultrasonic response characteristics; the physical structure design of the sulfur hexafluoride air bubbles should have ultrasonic responsiveness, and the air bubble part can be composed of specific sulfur hexafluoride air bubbles sensitive to certain characteristic ultrasonic waves, and can also be mixed with air bubbles with different sensitivities to certain characteristic ultrasonic waves according to a specific proportion, namely, the sulfur hexafluoride air bubbles with different sensitivities to certain characteristic ultrasonic waves are mixed in a certain intensity, frequency and different modes: under the action of pulse/continuous ultrasonic wave, the aim of controlling the instant/slow release/selective release of the medicine is achieved, and the air bubble material can be selected from liposome, protein and polymer; the sulfur hexafluoride air bubbles are fixed on the outer surface of the balloon part of the balloon catheter through a hydrophilic adhesive, and the coating can also contain thrombolytic, anti-inflammatory and anticoagulant drugs or restenosis inhibiting drugs.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011373674.8A CN112401975A (en) | 2020-11-30 | 2020-11-30 | Ultrasonic balloon with function of directionally breaking calcified plaque in cavity and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011373674.8A CN112401975A (en) | 2020-11-30 | 2020-11-30 | Ultrasonic balloon with function of directionally breaking calcified plaque in cavity and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114027926A (en) * | 2021-10-28 | 2022-02-11 | 嘉兴嘉创智医疗设备有限公司 | Intravascular calcified plaque impact fracture device |
| CN114682471A (en) * | 2022-03-08 | 2022-07-01 | 吉林大学 | Ultrasonic control device and detection system |
| WO2022217917A1 (en) * | 2021-04-14 | 2022-10-20 | 深圳市赛禾医疗技术有限公司 | Drug balloon catheter, and drug balloon catheter system and control method therefor |
-
2020
- 2020-11-30 CN CN202011373674.8A patent/CN112401975A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022217917A1 (en) * | 2021-04-14 | 2022-10-20 | 深圳市赛禾医疗技术有限公司 | Drug balloon catheter, and drug balloon catheter system and control method therefor |
| CN114027926A (en) * | 2021-10-28 | 2022-02-11 | 嘉兴嘉创智医疗设备有限公司 | Intravascular calcified plaque impact fracture device |
| WO2023071427A1 (en) * | 2021-10-28 | 2023-05-04 | 嘉兴嘉创智医疗设备有限公司 | Intravascular calcified plaque impact fracture device |
| CN114682471A (en) * | 2022-03-08 | 2022-07-01 | 吉林大学 | Ultrasonic control device and detection system |
| CN114682471B (en) * | 2022-03-08 | 2022-11-29 | 吉林大学 | Ultrasonic control device and detection system |
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Inventor after: Zhang Haijun Inventor after: Ge Junbo Inventor after: Zhou Chao Inventor after: Zhou Guangtai Inventor before: Zhang Haijun Inventor before: Ge Junbo Inventor before: Zhou Chao Inventor before: Lu Shoutao Inventor before: Zhou Guangtai |
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