[go: up one dir, main page]

WO2021022849A1 - 用于治疗心脏瓣膜或血管钙化的装置和方法 - Google Patents

用于治疗心脏瓣膜或血管钙化的装置和方法 Download PDF

Info

Publication number
WO2021022849A1
WO2021022849A1 PCT/CN2020/088393 CN2020088393W WO2021022849A1 WO 2021022849 A1 WO2021022849 A1 WO 2021022849A1 CN 2020088393 W CN2020088393 W CN 2020088393W WO 2021022849 A1 WO2021022849 A1 WO 2021022849A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
shock wave
balloons
expansion member
present
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2020/088393
Other languages
English (en)
French (fr)
Inventor
陈剑锋
张一�
潘孔荣
陈茂
吴永健
郭克
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Peijia Medical (suzhou) Co Ltd
Original Assignee
Peijia Medical (suzhou) Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Peijia Medical (suzhou) Co Ltd filed Critical Peijia Medical (suzhou) Co Ltd
Priority to EP20851172.5A priority Critical patent/EP4011304B1/en
Priority to CN202080005866.5A priority patent/CN113194855B/zh
Priority to US17/633,085 priority patent/US20220287731A1/en
Priority to JP2022507707A priority patent/JP7479449B2/ja
Priority to ES20851172T priority patent/ES3014427T3/es
Publication of WO2021022849A1 publication Critical patent/WO2021022849A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
    • A61B17/2202—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 the ultrasound transducer being inside patient's body at the distal end of the catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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 inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22055—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with three or more balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22098—Decalcification of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the invention belongs to the field of medical technology, and specifically relates to a device for treating heart valve or blood vessel calcification and a method for treating animal heart valve or blood vessel calcification.
  • Heart valve calcification is the main pathological manifestation of heart valve stenosis and regurgitation, which usually occurs in the elderly; vascular calcification is a common common cause of atherosclerosis, hypertension, diabetic vascular disease, vascular damage, chronic kidney disease, and aging. Pathological manifestations.
  • the prior art shock wave device 900 for treating heart valve calcification includes a shock wave transmitter 920 and a balloon 910.
  • the shock wave transmitter 920 includes an electrode cable and an electrode probe 922.
  • the electrode cable receives and conducts voltage/current pulses.
  • the electrode probe 922 is electrically connected to the electrode cable for receiving voltage/current pulses to generate shock waves.
  • the balloon 910 is wrapped around the shock wave launcher 920 and has the properties of retractable, foldable and insulating.
  • the balloon 910 also has a through hole for liquid to flow in, so that the inside of the balloon 910 is filled with liquid.
  • the balloon 910 When the interior of the balloon 910 is filled with liquid, the balloon 910 is filled so that at least a part of the outer surface of the balloon 910 is in contact with the heart valve or blood vessel with calcification disease (hereinafter sometimes referred to as "calcification disease” or “calcification disease heart” Valves or blood vessels") contact.
  • calcification disease or “calcification disease heart” Valves or blood vessels
  • the shock wave generated by the electrode probe 922 is radially conducted to the surface of the balloon 910 via the liquid inside the balloon 910, and then is conducted to the calcified lesion via the surface of the balloon.
  • the shock wave When the shock wave is transmitted to the calcified lesion, the compressive stress of the shock wave will cause the calcified tissue in the calcified lesion to break.
  • the shock wave of proper strength can destroy the calcified tissue without causing additional burden on the soft tissue around the calcified tissue.
  • the intensity of the shock wave is rapidly attenuated as the transmission distance increases during the radial transmission from the electrode probe 922.
  • tissue with a large inner diameter such as the mitral valve or tricuspid valve
  • the shock wave is transmitted from the electrode probe 922 located in the center of the balloon 910 to the outer surface of the balloon 910 that is in contact with the calcified lesion of the heart valve ,
  • the shock wave is greatly attenuated, making it difficult to obtain the ideal therapeutic effect.
  • Fig. 2 shows another shock wave device 800 of the prior art.
  • the shock wave device 800 includes a plurality of balloons 810, and each balloon 810 is provided with a shock wave transmitter.
  • the plurality of balloons 810 may be spaced apart (dispersed) from each other in the radial direction at a specific angle, so that the plurality of balloons 810 can respectively contact the concave parts of the plurality of valves.
  • the operation of the shock wave device 800 shown in FIG. 2 during the operation is relatively complicated, and it is especially difficult to accurately position each balloon 810 at each calcification lesion. Therefore, there is a high requirement for the proficiency of the operator, and the operation time is too long, which increases the burden on the treatment target, and thereby reduces the success rate of the operation.
  • the present invention provides a shock wave device for treating heart valve or blood vessel calcification.
  • the shock wave device is simple to operate, can effectively reduce the attenuation of shock wave, and achieve a satisfactory therapeutic effect on heart valve or blood vessel calcification.
  • a shock wave device for treating heart valve or blood vessel calcification including:
  • a guide head end and a plurality of balloons at least two balloons of the plurality of balloons are connected to the guide head end, wherein,
  • At least one balloon of the plurality of balloons includes:
  • At least one balloon body At least one balloon body
  • At least one shock wave transmitter which includes at least one electrode cable and at least one electrode probe, and is used to receive voltage/current pulses to generate shock waves.
  • the guiding head end is provided at the distal end of the shock wave device, and the distal ends of the plurality of balloons are all connected to the guiding head end.
  • the device according to one aspect of the embodiment of the present invention further includes at least one expansion member,
  • the expansion member includes at least one main body and at least one through hole, and fluid is injected into the expansion member through the through hole to fill the expansion member, and
  • the plurality of balloons are distributed on the outer periphery of the expansion member around the expansion member.
  • the diameter of the expansion member is 6-12 mm.
  • the device further includes at least one core wire, the core wire is provided inside and in the entire at least one balloon body of the balloon. Extend lengthwise, and
  • the electrode probe of the shock wave transmitter is fixed to the core wire.
  • the electrode probe includes an inner electrode and an outer electrode composed of a conductor, and the inner electrode and the outer electrode are coaxially arranged and insulated from each other.
  • the inner electrode and the outer electrode are arranged on the outer circumference of the core wire in a coaxial manner with the core wire.
  • the device further includes at least one developing device including a developing member, and the developing member is provided on the electrode probe, the end of the balloon, and the core wire At least one of them.
  • each of the core wires is provided with the developing member, and the developing members arranged on the different core wires have different positions, shapes, lengths or numbers. .
  • the device includes a plurality of wires, and each wire of the plurality of wires is respectively connected to more than one of the electrode cables for transmitting to the shock wave transmitter Voltage/current pulse.
  • a conductive system is connected to the through hole so that the liquid circulates in the conductive system and the balloon.
  • the device according to one aspect of the embodiment of the present invention further includes a plurality of passages, the passages are located inside the conduction system, and
  • Each of the multiple passages respectively communicates with the through holes of more than one balloon.
  • At least one of the plurality of passages communicates with the through hole of the expansion member.
  • the device according to one aspect of the embodiment of the present invention further includes a protective umbrella having an umbrella-like structure that opens toward the balloon.
  • a method for treating calcification of an animal heart valve or blood vessel comprising
  • the shock wave transmitter is made to generate shock waves to treat the calcified diseased blood vessel wall or valve.
  • the method according to one aspect of the embodiment of the present invention further includes filling the at least one expansion member of the shock wave device so that the balloon body of the balloon is close to the blood vessel wall of the calcified lesion or valve.
  • the shock wave emitters of the multiple balloons of the shock wave device are caused to generate shock waves of at least two different intensities.
  • the shock wave transmitters of the multiple balloons of the shock wave device are sequentially triggered to generate shock waves.
  • At least one of the shock wave transmitters generates shock waves of different intensities during the operation.
  • the plurality of balloons and/or the at least one expansion member of the shock wave device have at least two different filling degrees.
  • At least one of the balloons has at least two different filling degrees during the operation.
  • At least one of the expansion members has at least two different filling degrees during the operation.
  • a specific balloon is selected according to at least one of the position, the shape, the length, and the number of the developing member on the core wire, To control the selected balloon to have a specific filling degree or to control the shock wave transmitter in the selected balloon to generate a shock wave of a specific intensity.
  • the animal is a human.
  • a shock wave device for treating calcification of a heart valve or blood vessel can be provided.
  • the shock wave device can not only effectively reduce the attenuation of the shock wave in the conduction process, but also can eliminate the hidden surgical hazards caused by the balloon damage or the leaking fluid of the leak, so as to safely and reliably achieve a satisfactory treatment effect.
  • the shock wave device of the present invention is simple to operate, and the requirements for the operator’s proficiency are significantly reduced, so that the operation time can be significantly shortened, the burden on the treated object can be reduced, and the success rate of the operation can be improved, and the operation process can be effectively reduced.
  • Various risks are possible to be applied to the shock wave device of the present invention.
  • Fig. 1 is a schematic structural diagram of a shock wave device in the prior art
  • Figure 2 is a schematic diagram of the structure of a shock wave device in the prior art
  • FIG. 3 is a schematic structural diagram of an embodiment of the shock wave device of the present invention.
  • Fig. 4 is a schematic diagram of the use state of an embodiment of the shock wave device of the present invention.
  • FIG. 5 is a schematic cross-sectional view of the balloon portion of the shock wave device shown in FIG. 4;
  • Figure 6 is a schematic structural view of an embodiment of the shock wave device of the present invention.
  • FIG. 7A and 7B are schematic cross-sectional views of the balloon portion of an embodiment of the shock wave device of the present invention.
  • FIGS. 8A, 8B and 8C are schematic cross-sectional views of an embodiment of the shock wave device of the present invention.
  • Fig. 9 is a schematic diagram of the conduction system part of an embodiment of the shock wave device of the present invention.
  • FIG. 10 is a schematic structural diagram of an embodiment of the shock wave device of the present invention.
  • Fig. 11 is a schematic structural diagram of an embodiment of the shock wave device of the present invention.
  • shock wave is a general term for various forms of waves (such as pressure waves, etc.) that can be generated by the counter electrode probe during discharge, and is not used to limit specific wave forms.
  • the "distal" of the shock wave device or its components refers to the end toward the tip of the wire that enters the body of the subject during surgery, and the “distal” of the shock wave device or its components refers to the end that remains during the operation. The end of the handle outside the body of the subject.
  • a plurality of refers to two or more than two. In view of this, “a plurality of” may also be understood as “at least two” in the embodiments of the present invention.
  • “And/or” describes the association relationship of the associated objects, indicating that there can be three types of relationships, for example, A and/or B, which can mean: A alone exists, A and B exist at the same time, and B exists alone.
  • the character "/”, unless otherwise specified, generally indicates that the associated objects before and after are in an "or" relationship.
  • heart valve and “valve” are collective names for valves including mitral valve, tricuspid valve, and aortic valve.
  • the heart valve and blood vessel with calcification disease is sometimes referred to simply as “the heart valve and blood vessel with calcification disease” or “calcification disease.”
  • the shock wave device 100 includes a plurality of balloons 10. At least one of the plurality of balloons 10 has at least one balloon body.
  • the balloon body of the balloon 10 is cylindrical after being filled.
  • the shape of the two ends of the balloon 10 in the longitudinal direction is not specifically limited.
  • the cylindrical balloon bodies of the balloon 10 are parallel to each other in the length direction.
  • the axes of the cylindrical balloon main bodies of the balloon 10 are parallel to each other in the longitudinal direction.
  • the balloon 10 of the shock wave device of the present invention may also have other shapes.
  • the balloon 10 may have a plurality of balloon bodies, and these balloon bodies may have the same shape, such as a cylinder, after being filled with liquid, and the balloon bodies are mutually Connected so that liquid can flow between these balloon bodies.
  • the balloon 10 may be formed of a polymer material as a semi-compliant or non-compliant balloon, and has stretchable, foldable and insulating properties. There is no specific limitation on the material forming the balloon 10, and for example, it may be nylon, polyether block amide (PEBA) or polyethylene terephthalate (PET).
  • the balloon 10 also has at least one through hole, which communicates with the connecting tube A14, and is used to inject liquid into the balloon 10 to fill the balloon 10. When the inside of the balloon 10 is filled with liquid, the balloon 10 is filled so that at least a part of the outer surface of the balloon 10 is in contact with the calcified heart valve or blood vessel (calcified lesion).
  • At least one shock wave transmitter 20 is provided inside the balloon 10, and the shock wave transmitter 20 is used to receive voltage/current pulses and generate shock waves.
  • each balloon body of the balloon 10 is provided with at least one shock wave transmitter 20.
  • the shock wave transmitter 20 includes at least one electrode cable 21 and at least one electrode probe 22.
  • the electrode cable 21 receives and conducts voltage/current pulses.
  • the electrode probe 22 is electrically connected to the electrode cable 21 for receiving voltage/current pulses.
  • the shock wave generated by the electrode probe 22 is radially conducted to the surface of the balloon 10 via the liquid inside the balloon 10, and then is conducted to the calcified lesion via the surface of the balloon.
  • the balloon 10 of the shock wave device 100 is positioned at the position of the heart valve.
  • the position of the electrode probe 22 in the balloon 10 corresponds to the calcification lesion, so that the distance between the electrode probe 22 and the calcification lesion is the shortest.
  • FIG. 5 shows a schematic cross-sectional view of the balloon part of the shock wave device 100 shown in FIG. 4 in a working state (after being filled).
  • each balloon 10 includes a shock wave launcher 20 arranged inside the balloon body. Therefore, with respect to the prior art shock wave device 900 shown in FIG. 1, in the use state of the shock wave device 100 of an embodiment of the present invention, the electrode probe 22 of the shock wave transmitter 20 that generates the shock wave to the balloon 10 The distance between the outer surface of the part in contact with the calcified lesion is significantly shortened. Therefore, even if the shock wave generated by the lower voltage/current pulse is transmitted to the calcified lesion, it can maintain sufficient strength to obtain a satisfactory therapeutic effect.
  • the shock wave device 100 of the present invention has the above-mentioned structure, that is, the cylindrical balloon bodies of the balloons 10 in the shock wave device 100 are parallel to each other. Therefore, during the operation, when the balloon contacts the calcified lesion , The balloon is not easy to be displaced due to the slight squeezing of the valve, and therefore, medical personnel only need to perform a simple positioning operation to obtain a satisfactory treatment effect. Therefore, compared with the prior art shock wave device 800 shown in FIG. 2, the shock wave device 100 of an embodiment of the present invention significantly reduces the operator's operational proficiency requirements, so that operators with general interventional surgery experience can be proficient The shock wave device 100 of the present invention is operated. Therefore, the operation time can be significantly shortened, the burden on the target to be treated can be reduced, the success rate of the operation can be increased, and various risks during the operation can be reduced.
  • the shock wave device 100 is provided with three balloons 10, but in other embodiments of the present invention, the number of balloons 10 may be two, four or more.
  • the shock wave device 100 further includes at least one expansion member 16.
  • the expansion member 16 has at least one main body.
  • the main body of the expansion member 16 is cylindrical after being filled.
  • the shape of the two ends of the expansion member 16 in the longitudinal direction is not specifically limited.
  • the expansion member 16 is provided inside the plurality of balloons 10, and when the expansion member 10 and the plurality of balloons 10 are in an inflated state, the outer surface of the balloon 10 is in close contact with the expansion member 16 The outer surface.
  • the material forming the expansion member 16 There is no specific limitation on the material forming the expansion member 16.
  • the expansion member 16 can be formed into a semi-compliant or non-compliant balloon using the same material as the balloon 10, and has the properties of stretchability, foldability and insulation. There is no shock wave transmitter inside the expansion part 16.
  • the expansion member 16 has at least one through hole that communicates with the connecting tube B15 and is used to allow fluid to flow into the expansion member 16 to fill the expansion member 16.
  • the fluid used to inflate the expansion member 16 and the liquid used to inflate the balloon 10 may be the same or different, but it is preferable that the fluid used to inflate the expansion member 16 is the same as the liquid used to inflate the balloon 10.
  • the balloon 10 may be evenly distributed around the expansion member 16 on the outer periphery of the expansion member 16.
  • this article when describing the balloon distribution on the periphery of the expansion member, it refers to the distribution of the balloon after inflation on the periphery of the expansion member after inflation.
  • a plurality of balloons 10 may be evenly distributed on the entire periphery of the expansion member 16.
  • a plurality of balloons 10 may be distributed at intervals on the outer circumference of the expansion member 16. Therefore, when only part of the valve of the target is calcified, the calcified lesions can be treated more specifically, and the burden on the tissues that have not been calcified can be reduced. And, as shown in FIGS. 7A and 7B, by arranging a plurality of balloons 10 at intervals on the outer circumference of the expansion member 16, the gap between the balloons (including the balloon 10 and the expansion member 16) can be further increased, thereby further ensuring The blood was unobstructed during the operation.
  • the shock wave device 100 may have a plurality of expansion members 16.
  • the plurality of expansion members 16 are arranged inside the plurality of balloons 10, and the plurality of expansion members 16 may be arranged to have a regular shape or an irregular shape in cross section in the length direction.
  • the plurality of balloons 10 are arranged on the outer periphery of the regular or irregular cross-sectional shape of the plurality of expansion members 16. According to this structure, it is possible to more effectively treat an irregularly shaped valve (for example, a mitral valve).
  • each balloon 10 is provided with an electrode probe 22.
  • multiple electrode probes 22 may be provided in the balloon 10.
  • the shock wave device of the present invention further includes at least one core wire 12.
  • the core wire 12 is provided inside each balloon body of the balloon 10 and extends in the length direction of the balloon body and penetrates the balloon body.
  • the core wire 12 may be made of materials such as stainless steel, nickel titanium alloy, or polymer.
  • the two ends of the core wire 12 are respectively connected to the two ends of the balloon 10 from the inside of the balloon 10.
  • the core wire 12 is used to fix the shock wave transmitter 20 provided inside the balloon 10.
  • the electrode cable 21 and the electrode probe 22 of the shock wave transmitter 20 are both arranged along the core wire 12 and fixed to the core wire 12.
  • the shock wave emitter 20 can be fixed to the core wire 12 by means of adhesive, heat shrinkable tube or welding.
  • the electrode probe 22 may include at least a pair of coaxially arranged conductors composed of ends, namely, an outer electrode 221 and an inner electrode 222.
  • the outer electrode 221 and the inner electrode 222 are made of a conductive body such as copper, stainless steel, or conductive polymer, and are separated by an insulating layer.
  • the outer electrode 221 and the inner electrode 222 may have a ring shape or an arc shape.
  • the outer electrode 221 and the inner electrode 222 are arranged on the outer circumference of the core wire 12 coaxially with the core wire 12.
  • the shock wave transmitter 20 especially the electrode probe 22 in the balloon body of each balloon 10 is relatively far from the surface of the balloon. short. Moreover, when the expansion member 16 is provided, the distance between the electrode probe 22 and the balloon surface will be further shortened.
  • the shock wave transmitter 20 along the core wire 12 and fixing it to the structure of the core wire 12, it can be ensured that the electrode probe 22 does not contact the inner surface of the balloon 10, thereby avoiding the external electrode 221 of the electrode probe 22 and the inner surface of the balloon 10 during the operation.
  • the electric spark generated between the inner electrodes 222 due to the discharge causes the problem of damage to the balloon 10.
  • the end of the electrode tip 22 can be bent at a certain angle, so that the electrode tip The distance from the calcified lesion is further shortened, which can further reduce the attenuation of the shock wave.
  • the diameter of the main body portion of the balloon 10 is 2-12 mm.
  • the diameter of the balloon 10 is preferably 6-10 mm, more preferably 8-10 mm.
  • the diameter of the balloon is greater than 12 mm, the distance between the electrode probe 22 and the calcified lesion increases, and there is shock wave Risk of excessive intensity attenuation.
  • the length of the body portion of the balloon 10 is 20-60 mm, for example, 20 mm, 35 mm, 40 mm, 55 mm, or 60 mm.
  • the length of the balloon 10 is too long, there is a possibility of causing damage to the heart tissue during the operation, and it is too difficult to bend when the shock wave device is delivered during the interventional operation.
  • the length of the balloon 10 is too short, it will increase the difficulty of positioning the shock wave device during the operation.
  • the diameter of the main body portion of the expansion member 16 of the shock wave device of the present invention is preferably 6-12 mm, preferably 8-10 mm.
  • the diameter of the main body portion of the balloon 10 arranged on the outer periphery of the expansion member 16 is 2-8 mm, preferably 4-6 mm.
  • the diameters of the multiple balloons 10 may be different from each other.
  • the diameter of the balloon 10 can make the intensity of the shock wave finally transmitted to the calcified lesion different. Therefore, when there are differences in the calcification of different parts of the valve of the subject to be treated, the above-mentioned structure of the shock wave device 100 of the present invention can be targeted when the shock wave intensity emitted by each shock wave transmitter 20 is the same. The intensity of shock waves reaching different parts of the calcified lesions is different.
  • a balloon with a smaller diameter can be placed in a site with a more severe calcification lesion, so that the shock wave reaching the calcification lesion retains greater intensity.
  • a balloon with a larger diameter can be placed on a site with a lighter calcification lesion, so that the intensity of the shock wave reaching the calcification lesion is lower, and therefore, the burden on the subject during surgery can be further reduced.
  • the liquid injected into the balloon 10 used in the shock wave device 100 of the present invention is not specifically limited.
  • the liquid may be an electrolyte liquid, such as physiological saline, etc., or the liquid may also be a non-electrolyte liquid, such as glycerin.
  • the fluid injected into the expansion member 16 may be an electrolyte fluid, such as physiological saline, or the fluid may also be a non-electrolyte fluid, such as glycerin.
  • the fluid injected into the balloon 10 and the fluid injected into the expansion member 16 are the same.
  • the balloon 10 of the shock wave device 100 of the present invention can be designed as a disposable consumable or a reusable consumable. When it is a reusable consumable, it needs to be sterilized before use. Moreover, since the shock wave device 100 of the present invention has multiple independent balloons 10, when one balloon is damaged, only the damaged balloon can be replaced, without the need to discard the entire shock wave device, thereby significantly reducing the maintenance of the shock wave device. Cost.
  • the shock wave device 100 further includes a developing device, which can help the doctor accurately position the shock wave device 100 and ensure that the shock wave transmitter 20 and/or the balloon 10 are treated in the target area to be treated.
  • the developing device can observe its position in the body of the subject under the action of an external developing device (such as an X-ray imaging device, etc.).
  • the developing device includes a developing member.
  • the developing member may be provided on the electrode probe 22.
  • the electrode probe 22 may include a material with a developing function, so that it can be developed under the action of X-ray imaging equipment and the like to help doctors locate the shock wave device 100.
  • the electrode probe 22 itself can be used as a developing part.
  • the developing device may further include developing members 11 arranged at both ends of the balloon 10.
  • the developing device may include a plurality of developing members 19 arranged on the core wire 12.
  • the specific position of the developing member 19 on the core line is not particularly limited, and can be adjusted according to different surgical positions (for example, aortic valve, mitral valve, or tricuspid valve).
  • aortic valve for example, aortic valve, mitral valve, or tricuspid valve.
  • material of the developing part for example, aortic valve, mitral valve, or tricuspid valve.
  • it can better help the doctor to accurately position the shock wave device 100 and ensure that the shock wave emitter 20 and/or the balloon 10 are performed in the target area to be treated. Treat it.
  • the shape of the developing member and it may be manufactured in a ring shape, and may also be manufactured in other shapes, such as a ring member fixed on the balloon 10 and the like.
  • the specific positions of the developing members 19 respectively disposed on the core wires in different balloons on the respective core wires 12 are different.
  • the developing member 19 may be provided at the end of the core wire 12 in the length direction, or the developing member 19 may be provided at the middle portion of the core wire 12.
  • the respective developing members 19 may have mutually different shapes, lengths or numbers.
  • the developing members 19 provided on different core wires 12 may have different shapes such as a circle, a rectangle, a square, and a triangle.
  • the calcification of the various parts of the valve when the calcification of the various parts of the valve is not completely the same, it can be realized according to the different positions on the core wire 12 in each balloon 10 or the developing parts 19 having different shapes, lengths or numbers.
  • the precise positioning of each balloon 10 during the operation so as to apply different intensities of voltage/current pulses to the shock wave transmitter 20 in the corresponding balloon according to the different degree of calcification to generate shock waves of different intensities.
  • the diameter of the capsule 10 is the same, the effect of applying shock waves of different intensities to different parts of the calcified lesion is achieved.
  • the developing device includes a developer, and the developer is mixed in the liquid injected into the balloon 10.
  • the imaging agent may be an imaging agent commonly used in the current medical technology field, which can be developed in an X-ray imaging device or a blood vessel imaging device DSA.
  • the vascular imaging device can monitor the amount of liquid in the balloon 10 through the developer.
  • the balloon 10 expands under the liquid filling and closes to the calcified lesion, it stops to The balloon 10 is filled with liquid. In this way, on the one hand, the balloon 10 can be as close as possible to the calcification lesion, and on the other hand, it can prevent the balloon 10 from being overfilled with fluid, thereby causing damage to the valve or blood vessel wall.
  • the shock wave device 100 further includes a pulse generator 40, a conduction system 30 and a wire 60.
  • the conductive system 30 includes a connecting tube A14 connected to the through holes of each balloon 10 and a connecting tube B15 connected to the through holes of the expansion member 16, so that the conductive system 30 communicates with the inside of the balloon 10 and the expansion member 16 and forms Seal the cavity.
  • the conduction system 30 is provided with a first hole in a part outside the body of the subject during the operation, and external liquid can flow into the conduction system 30 through the first hole, and then be injected into the balloon 10 and the expansion member 16. In the above case, the fluid injected into the balloon 10 and the fluid injected into the expansion member 16 are the same.
  • a plurality of wires 60 may be provided inside the conductive system 30.
  • the pulse generator 40 is connected to an external power source to generate voltage/current pulses.
  • a plurality of wires 60 are located inside the conductive system 30, one end of which is electrically connected to the pulse generator 40, and the other end is electrically connected to the electrode cable 21 of the shock wave transmitter 20 to connect the pulse generator 40 The generated voltage/current pulse is conducted to the shock wave transmitter 20.
  • a wire 60 may be separately electrically connected to a shock wave launcher 20 in the balloon 10 for respectively conducting voltage/current pulses to each shock wave launcher.
  • one of the plurality of wires 60 may be electrically connected to two or more shock wave transmitters 20 arranged in the same balloon, or one of the plurality of wires 60 may be connected to the one arranged in a different balloon.
  • Two or more shock wave emitters are electrically connected to conduct voltage/current pulses to the two or more shock wave emitters.
  • the shock wave device 100 of the present invention can control multiple wires 60 to respectively conduct voltage/current pulses of different intensities to the shock wave transmitters 20 inside the multiple balloons 10.
  • the calcification lesions of some treatment targets may only occur at individual positions of the valve or the calcifications at different positions of the treatment target valve are not completely the same.
  • the needle can deliver voltage/current pulses of different intensities to the shock wave emitters corresponding to each calcification part according to different degrees of calcification.
  • a higher-intensity voltage/current pulse is sent to a shock wave transmitter corresponding to a lesion with a more severe degree of calcification to generate a higher intensity shock wave, and to a shock wave transmitter corresponding to a lesion with a lesser degree of calcification Transmit a low-intensity voltage/current pulse to produce a low-intensity shock wave. Therefore, shock waves of different intensities can be applied to lesions with different calcifications in a targeted manner, thereby further reducing the burden on the subject.
  • a certain one/more balloons 10 or one or more balloon bodies of a balloon 10 when a certain one/more balloons 10 or one or more balloon bodies of a balloon 10 does not have calcified lesions, it can be delivered to the corresponding balloon/ The voltage/current pulse of the balloon body is reduced to zero, so that it does not generate shock waves, thereby further reducing the burden on the subject.
  • multiple wires 60 can be controlled separately so that the electrode probes 22 of the shock wave transmitter 20 in the multiple balloons 10 are cyclically triggered. That is to avoid the shock wave transmitters in all or multiple balloons from generating shock waves at the same time, thereby further reducing the burden on the subject during the operation.
  • multiple passages may be provided inside the conduction system 30.
  • the passageway may include a connecting tube A14 that communicates with the through hole of each balloon 10 and a connecting tube B15 that communicates with the through hole of the expansion member 16 for connecting to each balloon 10 respectively.
  • the liquid is delivered and the fluid is delivered to the expansion member 16.
  • the proximal end of each passage of the plurality of passages can be communicated with the first hole for injecting liquid/fluid into the plurality of passages from the outside.
  • One of the multiple passages can be connected to the through holes of more than one balloon 10 through the connecting tube A, and is used to deliver liquid to the more than one balloon.
  • At least one of the plurality of passages may be connected to the through hole of the expansion member 16 through the connecting tube B, and is used to deliver fluid to the expansion member 16.
  • the multiple passages are formed of a flexible material, which is stretchable, foldable, and insulating.
  • the shock wave device 100 of the present invention can control multiple passages respectively, so that each balloon 10 and/or the expansion member 16 can have different filling degrees.
  • "filling degree” refers to the volume of liquid or fluid actually filled inside the balloon 10 or the expansion member 16 and the maximum fillable volume inside the balloon 10 or the expansion member 16 (the maximum volume of the balloon 10 or the expansion member 16) Liquid/fluid capacity) ratio.
  • the balloon 10 when the volume of liquid actually filled inside the balloon 10 is the same as the maximum liquid capacity of the balloon 10, that is, the balloon is completely filled with liquid and the shape of the balloon reaches a critical state (when the critical state is exceeded, When the balloon will rupture), the inflation of the balloon is 100%.
  • the volume of the liquid actually filled in the balloon 10 is less than the maximum liquid capacity of the balloon 10, the filling degree is less than 100%.
  • the lower limit of the balloon filling degree is to ensure that the electrode probe generating the shock wave is surrounded by liquid and the electrode probe does not contact the balloon wall, and the electrode probe and the balloon surface contacting the calcified lesion are filled with liquid.
  • the upper limit of the filling degree of the expansion member 16 is 100%.
  • the lower limit of the filling degree of the expansion member is that the expansion member 16 can support the balloon 10 distributed on its outer periphery.
  • the valve of the subject to be treated will squeeze the balloon 10.
  • the highly filled balloon can ensure that the distance between the electrode probe inside the balloon and the inner surface of the balloon is close to or reaches the radius of the balloon. ;
  • the low-filling balloon will deform slightly under squeezing, causing the distance between the electrode probe and the inner surface of the balloon to be smaller than the balloon diameter, which can shorten the distance between the electrode probe and the calcified lesion, thereby further reducing Attenuation of shock waves. Therefore, when the calcifications of various parts of the valve of the subject to be treated are different, the balloon 10 can have different filling degrees for different calcification parts, so as to achieve the effect of applying shock waves of different intensities to different calcification lesions.
  • the filling degree of the balloon 10 can be effectively and selectively controlled according to the different positions, shapes, lengths, or numbers of the developing members 19 provided on the core wire 12 in the balloon 10. In order to achieve the above effects.
  • the shock wave emitters 20 in the multiple balloons 10 can be controlled separately during the operation to generate shock waves with different intensities; or multiple shock waves can be controlled separately.
  • the filling degree of the balloon 10 and/or at least one expansion member 16 is used to control the intensity of shock waves transmitted to calcified lesions with different degrees of calcification; or a combination of the two can also be used to target calcified lesions with different degrees of calcification. Generate/deliver shock waves of different intensities.
  • the calcified tissue in the calcified lesion is crushed or decomposed under the action of the shock wave, so that the calcification in the calcified lesion is alleviated.
  • the intensity of the shock wave applied to the calcified lesion can be reduced, that is, the subsequent treatment of the calcified lesion can be continued with a lower intensity shock wave.
  • the voltage/current pulses delivered to different shock wave emitters can be continuously adjusted at different stages of the operation according to the treatment of the calcified lesion during the operation, so that the same shock wave can be emitted.
  • the device generates shock waves of different intensities at different stages of the operation.
  • the amount of liquid and/or fluid delivered to different balloons and/or expansion components can be adjusted at different stages of the operation, so that the same balloon has different filling degrees at different stages of the operation, thereby The different stages of the shock wave applied to the same location of the calcified lesion have different intensities.
  • the burden on the subject can be further reduced.
  • the corresponding passage can be controlled so as not to deliver liquid to the balloon, so that the balloon remains compressed.
  • the corresponding wire 60 is controlled not to deliver voltage/current pulses to the shock wave transmitter 20 of the balloon 10.
  • a pipeline 33 may be provided at the first hole, and the pipeline 33 may be located only outside the conductive system 30 and communicate with the first hole, or the pipeline 33 It can extend from the outside of the conduction system 30 along the first hole into the inside of the conduction system 30, and communicate with multiple passages inside the conduction system.
  • the liquid/fluid in the balloon 10 and the expansion member 16 can also flow out after passing through the conductive system 30 (or multiple passages) and the first hole.
  • a second hole may be provided on the conductive system 30, and the second hole is connected to the connecting pipe B15 provided with the through hole connected to the expansion member 16.
  • the passage is connected, and is used to separately deliver fluid to the inside of the expansion component or to make the fluid in the expansion component flow out through the hole.
  • the second hole may be provided with a pipeline 34 located outside the conductive system 30 and communicating with the second hole.
  • the conductive system 30 and the passage may be formed of a flexible material, which is stretchable, foldable, and has insulating properties.
  • the surface of the conduction system 30 is arc-shaped.
  • the outer shape of the conduction system 30 may be a sphere, such as a sphere, an ellipsoid, a convex sphere with a curvature, and the like.
  • the shock wave device 100 further includes a control valve 32, which is arranged on the liquid/fluid delivery path and is used to control the on/off of the liquid/fluid.
  • the control valve can be arranged on the above-mentioned pipeline 33 to facilitate the control by medical personnel.
  • the shock wave device 100 further includes a guiding head end 70, and the guiding head end 70 is located at the distal end of the shock wave device 100 away from the conductive system 30.
  • the guiding tip 70 plays a guiding role, facilitating part of the balloon 10 to enter the blood vessel or valve position.
  • the guiding head end 70 has a conical shape, and the end of the conical shape is rounded without sharp corners, so as to avoid scratching blood vessels and valves during the operation.
  • the guide tip 70 is made of a flexible material, so that it has a certain deformability, and can be bent with the shape of the blood vessel, which is convenient for the shock wave device to bend during the transportation process.
  • the distal ends of at least two of the balloons 10 of the shock wave device 100 are connected to each other.
  • the distal ends of the multiple balloons 10 are all connected to the guide tip 70.
  • the balloon 10 and the distal end of the expansion member 16 are both connected to the guide tip 70.
  • the shock wave device 100 of the present invention further includes a reserved channel 80.
  • the reserved channel 80 is inside the shock wave device 100 and extends from the handle part through the conduction system 30 and the balloon part to the guide tip 70.
  • an external metal wire or other matching instruments can pass through the reserved channel 80. After the external metal wire enters the reserved channel 80, the forward direction of the shock wave device 100 can be guided.
  • the reserved channel 80 may be provided at the gap C in the inner region of the multiple balloons 10 as shown in FIG. 5.
  • the reserved channel 80 may be provided inside the expansion member 16 and pass through the expansion member 16 in the length direction of the expansion member 16.
  • the reserved channel 80 may be arranged inside the connecting tube B15 of the expansion component 16 so as to enter the inside of the expansion component through the connecting tube B15.
  • the reserved channel 80 may be provided at the gap inside the two or more expansion members 16, or may also be provided inside a certain expansion member.
  • the shock wave device 100 further includes a protective umbrella.
  • the protective umbrella is made of super-elastic materials.
  • the protective umbrella can be arranged on the outer circumference of the conductive system 30, and has two states of opening and contraction. During the operation, the distal end of the protective umbrella expands toward the balloon 10, and the proximal end of the protective umbrella remains at the outer surface of the conductive system 30, so that the protective umbrella 23 changes from a contracted state to an umbrella-like structure that opens toward the balloon 10 The open state.
  • the protective umbrella can prevent free biological tissue fragments from passing through during the operation, thereby preventing these tissue fragments from entering the blood vessel.
  • the shock wave device 100 further includes a handle 90, which is suitable for interventional therapy.
  • a handheld shockwave device can be designed.
  • the handle 90 may be connected to the end of the conduction system 30 in the direction away from the balloon 10 (the proximal direction).
  • the connection between the handle 90 and the conductive system 30 is not specifically limited, for example, it can be connected by screwing or snapping.
  • the handle 90 is held by the operating doctor, and the handle 90 can be designed in an arc shape or other shape that is convenient for the operating doctor to hold.
  • a concave-convex structure may be provided on the outside of the handle 90 or the roughness of the outer surface of the handle 90 may be increased to increase the contact area and the friction between the handle 90 and the human hand.
  • the handle 90 is also connected to a connection joint 31, and the connection joint 31 is electrically connected to the wire 60 and is used to connect the pulse generator, thereby connecting the pulse generator and the shock wave transmitter 20.
  • the handle 90 or the pulse generator 40 is also provided with a control switch system for adjusting the output of different currents according to the degree of calcification of the target area (for example, valve, leaflet, blood vessel, etc.) of the subject to be treated /Voltage pulse intensity, repetition frequency, duration.
  • a light source may be provided at the handle 90, and the LED light source can be used for illumination during the operation.
  • shock wave device of the present invention mainly by taking the calcification of the heart valve of the subject as an example.
  • the above description is also applicable to the treatment of vascular calcification of the subject.
  • the balloon 10 is driven into the human body by the guide tip 70, which plays a guiding role; the medical staff can use imaging equipment (for example, X-ray imaging equipment, etc.) Observe the position of the imaging device, and then position the balloon 10 of the shock wave device 100 in the target area to be treated.
  • imaging equipment for example, X-ray imaging equipment, etc.
  • Liquid and/or fluid enters the balloon 10 and/or the expansion member 16 through the conduction system 30 or passage to fill the balloon 10 and/or the expansion member 16 so that the balloon body of the balloon 10 is close to the heart with calcification Valves or vessel walls.
  • the pulse generator 40 generates voltage/current pulses
  • the wire 60 conducts the voltage/current pulses to the shock wave transmitter 20, the shock wave transmitter 20 emits shock waves, and the liquid conducts the shock waves to the target area to be treated.
  • the fluid flows out of the balloon 10 and the fluid flows out of the expansion member 16, and the shock wave device 100 is withdrawn from the human body.
  • the shock wave device 100 used to treat heart valve and vascular calcification is first sent by the delivery system through the hemostatic valve, along the path of the pathway product, and sent to the human body with the assistance of the imaging device.
  • the target area to be treated is first sent by the delivery system through the hemostatic valve, along the path of the pathway product, and sent to the human body with the assistance of the imaging device. The target area to be treated.
  • physiological saline containing imaging agent is injected into the balloon 10 through the first hole, and physiological saline containing no imaging agent is injected into the expansion member 16 through the second hole, so that the balloon 10 and the expansion member 16 is filled, so that the balloon body of the balloon 10 is close to the calcified heart valve or blood vessel wall;
  • the control switch system is turned on, the parameters are adjusted, and the shock wave transmitter 20 starts working to emit shock waves to treat the target area to be treated; the treatment is completed Afterwards, the physiological saline containing the imaging agent flows out of the balloon 10 and flows to the outside of the shock wave device through the first hole, while the physiological saline containing no imaging agent flows out of the expansion member 16 and flows to the outside of the shock wave device through the second hole to remove
  • the balloon 10 and the expansion member 16 are pressure-relieved; the shock wave device 100 is withdrawn through the access product to complete the treatment process.
  • the balloon 10 and the expansion member 16 are filled, so that the balloon body of the balloon 10 is close to the heart valve or blood vessel wall with calcification disease; the control switch system is turned on, the parameters are adjusted, and the shock wave transmitter 20 starts to work and emit shock waves, Treat the target area to be treated; after the treatment, the physiological saline containing the imaging agent flows out of the balloon 10 and through the first hole to the outside of the shock wave device, and at the same time, the physiological saline containing no imaging agent flows out of the expansion member 16 and passes through the second The hole flows to the outside of the shock wave device to relieve the pressure of the balloon 10 and the expansion member 16; the shock wave device 100 is withdrawn through the access product to complete the treatment process.
  • the treatment target of the shock wave device of the present invention is not limited to humans, and may be other animals.
  • the patent object of the shock wave device of the present invention can be pets such as cats and dogs, large animals such as cows and horses, and rare wild animals such as pandas.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Dentistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明提供一种用于治疗心脏瓣膜或血管钙化的冲击波装置，包括：导向头端和多个球囊，所述多个球囊中的至少两个球囊连接至所述导向头端，其中，所述多个球囊中的至少一个球囊包括：至少一个球囊主体；至少一个通孔，通过该通孔将用于传导冲击波的液体注入所述球囊，以使所述球囊被充盈；以及至少一个冲击波发射器，该冲击波发射器包括至少一个电极线缆和至少一个电极探头，且用于接收电压/电流脉冲以产生冲击波。本发明的冲击波装置操作简单，并且能够有效地降低冲击波在传导过程中的衰减。本发明还提供一种用于治疗动物心脏瓣膜或血管钙化的方法。

Description

用于治疗心脏瓣膜或血管钙化的装置和方法 技术领域
本发明属于医疗技术领域，具体涉及一种治疗心脏瓣膜或血管钙化的装置以及一种用于治疗动物心脏瓣膜或血管钙化的方法。
背景技术
心脏瓣膜钙化是心脏瓣膜狭窄和返流等主要的病理表现，通常发生于老年人群；血管钙化是动脉粥样硬化、高血压、糖尿病血管病变、血管损伤、慢性肾病和衰老等普遍存在的共同的病理表现。
目前，由于具有容易操作及球囊预扩的优点，冲击波球囊技术已被用于治疗心脏瓣膜或血管钙化。如图1所示，现有技术的治疗心脏瓣膜钙化的冲击波装置900，包括冲击波发射器920和球囊910。冲击波发射器920包括电极线缆和电极探头922，电极线缆接收并传导电压/电流脉冲，电极探头922与电极线缆电性连接，用于接收电压/电流脉冲以产生冲击波。球囊910包裹于冲击波发射器920外部，并具有可伸缩、可折叠和绝缘性能。球囊910还具有供液体流入的通孔，用于使球囊910内部被注满液体。当球囊910内部被注满液体后，球囊910充盈使得球囊910的外表面的至少一部分与存在钙化病变的心脏瓣膜或血管(以下有时简称为“钙化病变处”或“钙化病变的心脏瓣膜或血管”)相接触。电极探头922所产生的冲击波经由球囊910内部的液体被径向传导至球囊910表面，进而经球囊的表面被传导至钙化病变处。当冲击波被传导至钙化病变处时，冲击波的压缩应力会导致钙化病变处的钙化组织断裂。适当强度的冲击波能够满足即破坏钙化组织而又不会对于钙化组织周围的软组织产生额外负担。
然而，冲击波的强度从电极探头922径向传导的过程中，随着传 导距离的增加而迅速衰减。特别是在二尖瓣或三尖瓣等内径较大的组织处，当冲击波从位于球囊910的中心的电极探头922传导至与心脏瓣膜的钙化病变处相接触的球囊910的外表面时，冲击波大幅衰减，导致难以获得理想的治疗效果。
图2示出了现有技术的另一种冲击波装置800。如图2所示，冲击波装置800包括多个球囊810，每个球囊810内均设置有冲击波发射器。在手术过程中，多个球囊810可以以特定角度在径向方向上相互远离(分散)，从而使多个球囊810能够分别接触多个瓣膜的凹入部位。然而，图2所示的冲击波装置800在手术过程中的操作较为繁琐，尤其是难以将各个球囊810准确定位于各钙化病变处。因此对于操作者的熟练程度具有较高要求，并且导致手术时间过长，增加治疗对象负担，进而降低手术成功率。
发明内容
本发明提供一种治疗心脏瓣膜或血管钙化的冲击波装置，该冲击波装置操作简单，并且能够有效地降低冲击波的衰减，对心脏瓣膜或血管钙化实现令人满意的治疗效果。
为解决上述技术问题，本发明的实施例的一个方面提供一种用于治疗心脏瓣膜或血管钙化的冲击波装置，包括：
导向头端和多个球囊，所述多个球囊中的至少两个球囊连接至所述导向头端，其中，
所述多个球囊中的至少一个球囊包括：
至少一个球囊主体；
至少一个通孔，通过该通孔将用于传导冲击波的液体注入所述球囊，以使所述球囊被充盈；以及
至少一个冲击波发射器，该冲击波发射器包括至少一个电极线缆和至少一个电极探头，且用于接收电压/电流脉冲以产生冲击波。
根据本发明的实施例的一个方面的装置，所述导向头端设置于所述冲击波装置的远端处，并且所述多个球囊的远端均连接于所述导向头端。
根据本发明的实施例的一个方面的装置，还包括至少一个扩张部件，
所述扩张部件包括至少一个主体和至少一个通孔，通过所述通孔将流体注入所述扩张部件以使所述扩张部件被充盈，并且
所述多个球囊围绕所述扩张部件分布于所述扩张部件的外周。
根据本发明的实施例的一个方面的装置，所述扩张部件的直径为6-12mm。
根据本发明的实施例的一个方面的装置，所述装置还包括至少一个芯线，所述芯线设置在所述球囊的至少一个球囊主体内部并在所述至少一个球囊主体的整个长度方向上延伸，并且
所述冲击波发射器的所述电极探头固定至所述芯线。
根据本发明的实施例的一个方面的装置，所述电极探头包括由导电体构成的内电极和外电极，并且所述内电极和所述外电极同轴设置并且相互绝缘。
根据本发明的实施例的一个方面的装置，所述内电极和所述外电极以与所述芯线同轴的方式设置于所述芯线的外周。
根据本发明的实施例的一个方面的装置，还包括至少一个显影装置，该显影装置包括显影件，并且所述显影件设置于所述电极探头、所述球囊的端部和所述芯线中的至少一个上。
根据本发明的实施例的一个方面的装置，每个所述芯线上均设置 有所述显影件，并且设置于不同的所述芯线上的显影件具有各自不同位置、形状、长度或数量。
根据本发明的实施例的一个方面的装置，所述装置包括多个导线，所述多个导线中的每个导线分别连接至一个以上所述电极线缆，用于向所述冲击波发射器输送电压/电流脉冲。
根据本发明的实施例的一个方面的装置，还包括：
传导系统，该传导系统连接于所述通孔，使得所述液体在所述传导系统和所述球囊内流通。
根据本发明的实施例的一个方面的装置，还包括多个通路，所述通路位于所述传导系统内部，并且
所述多个通路中的每个通路分别与一个以上所述球囊的所述通孔相连通。
根据本发明的实施例的一个方面的装置，所述多个通路中的至少一个通路与所述扩张部件的通孔相连通。
根据本发明的实施例的一个方面的装置，还包括保护伞，该保护伞具有朝向所述球囊张开的伞状结构。
根据本发明的一个方面，还提供一种用于治疗动物心脏瓣膜或血管钙化的方法，该方法包括
将本发明的冲击波装置输送至待治疗的目标区域；
使所述冲击波装置的所述多个球囊充盈，以使所述多个球囊的所述球囊主体紧贴钙化病变的血管壁或瓣膜；以及
使所述冲击波发射器产生冲击波以对所述钙化病变的血管壁或瓣膜进行治疗。
根据本发明的实施例的一个方面的方法，还包括使所述冲击波装置的所述至少一个扩张部件充盈，以使所述球囊的所述球囊主体紧贴所述钙化病变的血管壁或瓣膜。
根据本发明的实施例的一个方面的方法，使所述冲击波装置的所述多个球囊的所述冲击波发射器产生至少两种不同强度的冲击波。
根据本发明的实施例的一个方面的方法，使所述冲击波装置的所述多个球囊的所述冲击波发射器被依次触发，以产生冲击波。
根据本发明的实施例的一个方面的方法，使至少一个所述冲击波发射器在手术过程中产生不同强度的冲击波。
根据本发明的实施例的一个方面的方法，使所述冲击波装置的所述多个球囊和/或所述至少一个扩张部件具有至少两种不同的充盈度。
根据本发明的实施例的一个方面的方法，使至少一个所述球囊在手术过程中具有至少两种不同的充盈度。
根据本发明的实施例的一个方面的方法，使至少一个所述扩张部件在手术过程中具有至少两种不同的充盈度。
根据本发明的实施例的一个方面的方法，根据所述芯线上的所述显影件的所述位置、所述形状、所述长度和所述数量中的至少一种来选择特定球囊，以控制所选择的球囊具有特定的充盈度或控制所选择的球囊中的所述冲击波发射器产生特定强度的冲击波。
根据本发明的实施例的一个方面的方法，所述动物为人。
根据本发明的一个实施例，能够提供一种治疗心脏瓣膜或血管钙 化的冲击波装置。该冲击波装置不仅能够有效地降低冲击波在传导过程中的衰减，而且可以消除因球囊破损或密封不严漏液带来的手术隐患，从而安全可靠地实现令人满意的治疗效果。此外，本发明的冲击波装置操作简单，对操作者的操作熟练地的要求显著降低，从而能够显著地缩短手术时间，减轻治疗对象的负担，进而提高手术成功率，并有效地减少手术过程中的各种风险。
附图说明
为了更清楚地说明本发明实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它的附图，其中：
图1是现有技术的冲击波装置的结构示意图；
图2是现有技术的冲击波装置的结构示意图；
图3是本发明的冲击波装置的一个实施例的结构示意图；
图4是本发明的冲击波装置的一个实施例的使用状态示意图；
图5是图4所示的冲击波装置的球囊部分的剖面示意图；
图6是本发明的冲击波装置的一个实施例的结构示意图；
图7A和图7B是本发明的冲击波装置的一个实施例的球囊部分的剖面示意图；
图8A、图8B和图8C是本发明的冲击波装置的实施例的剖面示意图；
图9是本发明的冲击波装置的一个实施例的传导系统部分的示意图；
图10是本发明的冲击波装置的一个实施例的结构示意图；
图11是本发明的冲击波装置的一个实施例的结构示意图。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方 案进行清楚、完整地描述，显然，所描述的实施例仅是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例，都属于本发明保护的范围。
在本申请中，“冲击波”是对电极探头在放电时所能够产生的各种形式波(诸如压力波等)的统称，而非用于限定具体波形式。
在本申请中，冲击波装置或其部件的“远端”是指朝向在手术过程中进入治疗对象体内的导线头端的一端，而冲击波装置或其部件的“远端”是指在手术过程中留在治疗对象体外的手柄一端。
在本申请中，“多个”是指两个或两个以上，鉴于此，本发明实施例中也可以将“多个”理解为“至少两个”。“和/或”，描述关联对象的关联关系，表示可以存在三种关系，例如，A和/或B，可以表示：单独存在A，同时存在A和B，单独存在B这三种情况。另外，字符“/”，如无特殊说明，一般表示前后关联对象是一种“或”的关系。
在本申请中，“心脏瓣膜”和“瓣膜”是对包括二尖瓣、三尖瓣和主动脉瓣在内的瓣膜的统称。在本申请中，“存在钙化病变的心脏瓣膜和血管”有时被简称为“钙化病变的心脏瓣膜和血管”或“钙化病变处”。
如图3所示，本发明的一个实施例的冲击波装置100，包括多个的球囊10。多个球囊10中的至少一个球囊具有至少一个球囊主体。优选的，球囊10的球囊主体在充盈后为圆柱状。只要球囊10充盈后的球囊主体为圆柱状即可，对于球囊10在长度方向上两个端部的形状并未具体限定。更优选的，球囊10的圆柱状球囊主体在长度方向上相互平行。具体而言，球囊10的圆柱状球囊主体的各自长度方向上轴线相 互平行。本发明的冲击波装置的球囊10的也可以具有其他形状。例如，在本发明的一个实施例中，球囊10可以具有多个球囊主体，这些球囊主体在被液体充盈后可以具有相同的形状，例如圆柱体，并且这些球囊主体之间是相互连通的，使得液体可以在这些球囊主体之间流动。
球囊10可以由聚合物材料形成为半顺应性或非顺应性球囊，并具有可伸缩、可折叠和绝缘性能。对形成球囊10的材料没有具体限制，例如可以是尼龙、聚醚嵌段酰胺(PEBA)或聚对苯二甲酸乙二酯(PET)等。球囊10还具有至少一个通孔，该至少一个通孔与连接管A14相连通，用于将液体注入球囊10内部，使球囊10充盈。当球囊10内部被注满液体后，球囊10充盈使得球囊10的外表面的至少一部分与钙化病变的心脏瓣膜或血管(钙化病变处)相接触。
球囊10内部设置有至少一个冲击波发射器20，冲击波发射器20用于接收电压/电流脉冲并产生冲击波。优选的，如图8C所示，球囊10的每个球囊主体内均设置有至少一个冲击波发射器20。冲击波发射器20包括至少一个电极线缆21和至少一个电极探头22，电极线缆21接收并传导电压/电流脉冲，电极探头22与电极线缆21电性连接，用于接收电压/电流脉冲以产生冲击波。电极探头22所产生的冲击波经由球囊10内部的液体被径向传导至球囊10表面，进而经球囊的表面被传导至钙化病变处。
如图4所示，在手术过程中，将冲击波装置100的球囊10定位于心脏瓣膜位置处。优选的，使球囊10内的电极探头22的位置对应于钙化病变处，从而使电极探头22与钙化病变处的距离最短。
图5示出了图4所示的冲击波装置100的球囊部分在工作状态下(充盈后)的剖面示意图。如图5所示，由于每个球囊10均包括设置在其球囊主体内部的冲击波发射器20。因此，相对于图1所示的现有技术的冲击波装置900，在本发明的一个实施例的冲击波装置100的使 用状态下，由产生冲击波的冲击波发射器20的电极探头22至球囊10的与钙化病变处相接触的部分外表面的距离显著缩短。因此，即使采用较低的电压/电流脉冲所产生的冲击波在被传导至钙化病变处时，也能够保持足够的强度，进而获得满意的治疗效果。
另一方面，由于本发明的冲击波装置100具有上述结构，即冲击波装置100中的各个球囊10的圆柱状球囊主体相互平行，因此，在手术过程中，在球囊与钙化病变处接触时，球囊不容易由于瓣膜的轻微挤压而造成位移，并且因此医护人员只需进行简单的定位操作，即可获得满意的治疗效果。因此，相对于图2所示的现有技术的冲击波装置800，本发明的一个实施例的冲击波装置100对操作者的操作熟练度要求显著减低，使得具有普通介入手术经验的操作者即可熟练操作本发明的冲击波装置100。因此，能够显著地缩短手术时间，减低治疗对象的负担，进而提高手术成功率，并且减少手术过程中的各种风险。
另一方面，在本发明的一个实施例中，由于设置有多个球囊10，各个球囊10间存在供血液通过的间隙，可保证在血液畅通的情况下手术，从而减轻手术对治疗对象带来的负担。具体而言，如图5所示，多个球囊10(图中为3个)在充盈后，球囊外侧区域和球囊内侧区域均保留有足够的间隙。在图5所示的本发明的实施例中，冲击波装置100设置有三个球囊10，但在本发明的其他实施例中，球囊10的数量可以为两个、四个或者更多。
在本发明的一个实施例中，冲击波装置100还包括至少一个扩张部件16。扩张部件16具有至少一个主体。优选的，扩张部件16的主体在充盈后为圆柱状。只要扩张部件16充盈后的主体为圆柱状即可，对于扩张部件16在长度方向上两个端部的形状并未具体限定。如图6和7所示，扩张部件16设置于多个球囊10内侧，并且在扩张部件10和多个球囊10处于充盈状态的情况下，球囊10的外表面紧贴扩张部件16的外表面。对形成扩张部件16的材料没有具体限制，例如可以 采用与球囊10相同的材料将扩张部件16形成为半顺应性或非顺应性球囊，并具有可伸缩、可折叠和绝缘性能。扩张部件16内部不设置冲击波发射器。扩张部件16具有至少一个通孔，该至少一个通孔与连接管B15相连通，用于使流体流入扩张部件16内部，以使扩张部件16充盈。用于使扩张部件16充盈的流体与用于使球囊10扩张的液体可以相同或不同，但优选的是，用于使扩张部件16充盈的流体与用于使球囊10扩张的液体相同。在本申请中，“液体”与“流体”之间并无上下位关系，仅仅是为了便于区分分别注入球囊10和扩张部件16内部并使其充盈的物质。根据上述结构，由于设置有扩张部件16，因此，能够进一步减小球囊10的直径，进而进一步缩短电极探头与钙化病变处之间的距离。并且因此能够进一步降低冲击波在传输过程中的衰减。
在本发明的一个实施例中，球囊10可以围绕扩张部件16在扩张部件16的外周均匀分布。在本文中，当描述球囊在扩张部件的外周分布时，是指充盈后的球囊在充盈后的扩张部件的外周分布。如图8A所示，多个球囊10可以在扩张部件16的整个外周均匀分布。
或者，如图8B和8C所示，多个球囊10可以在扩张部件16的外周间隔地分布。因此，当治疗对象仅有部分瓣膜发生钙化时，可以更有针对性地对钙化病变处进行治疗，并且减轻对未发生钙化的组织的负担。并且，如图7A和图7B所示，通过在扩张部件16的外周间隔地设置多个球囊10，可以进一步增加球囊(包括球囊10和扩张部件16)之间的间隙，从而进一步保证手术时血液通畅。
在本发明的一个实施例中，冲击波装置100可以具有多个扩张部件16。该多个扩张部件16设置于多个球囊10内侧，并且该多个扩张部件16可以布置为其长度方向上截面呈规则形状或不规则形状。并且多个球囊10布置在多个扩张部件16的规则或不规则截面形状的外周。根据该结构，能够更加有效地对不规则形状的瓣膜(例如二尖瓣)进行治疗。
另外，在本发明的一个实施例中，每个球囊10内设置有一个电极探头22。而在本发明的其他实施例中，球囊10内还可以设置多个电极探头22。
优选的，如6所示，本发明的冲击波装置还包括至少一个芯线12。优选的，芯线12设置在球囊10的每个球囊主体内部并且在球囊主体的长度方向上延伸并贯穿球囊主体。芯线12可以由不锈钢、镍钛合金或聚合物等材料制成。芯线12的两端分别由球囊10内侧连接至球囊10的两端。芯线12用于固定设置在球囊10内部的冲击波发射器20。在本发明的一个实施例中，在球囊10内部，冲击波发射器20的电极线缆21和电极探头22均沿着芯线12设置并且被固定至芯线12。在本发明的一个实施例中，可以采用粘合剂、热收缩管或焊接等方式对将冲击波发射器20固定于芯线12。如图6所示，在本发明的一个实施例中，电极探头22可以包括至少一对同轴设置的导电体构成的端头，即，外电极221和内电极222。外电极221和内电极222由诸如铜、不锈钢或导电聚合物等导电体制成，并且二者之间由绝缘层隔开。在本发明的一个实施例中，外电极221和内电极222可以具有环形或弧形的形状。在本发明的一个实施例中，外电极221和内电极222与芯线12同轴地设置在芯线12的外周。
在本发明的冲击波装置中，设置有多个球囊10，因此，在充盈状态下，各个球囊10的球囊主体中的冲击波发射器20、尤其是电极探头22距离球囊表面的距离较短。并且，当设置扩张部件16时，电极探头22距离球囊表面的距离将进一步缩短。通过将冲击波发射器20沿芯线12设置并固定于芯线12的结构，能够确保电极探头22不与球囊10的内表面接触，从而避免在手术过程中，电极探头22的外电极221与内电极222之间由于放电而产生的电火花导致球囊10损坏的问题。
在本发明的一个实施例中，在确保电极探头22的内电极与外电极 之间的放电火花不会损坏球囊10的情况下，电极端头22的末端可以以一定角度弯曲，使电极末端与钙化病变处之间的距离进一步缩短，从而能够进一步降低冲击波的衰减。
在本发明的一个实施例的冲击波装置100中，球囊10的主体部分直径为2-12mm。当不设置扩张部件16时，球囊10的直径优选为6-10mm，更优选为8-10mm当球囊直径大于12mm时，电极探头22与钙化病变处之间的距离增大，存在冲击波的强度过度衰减的风险。
球囊10的主体部分的长度为20-60mm，例如20mm、35mm、40mm、55mm或者60mm。当球囊10的长度过长时，手术过程中存在对心脏组织造成损伤的可能性，并且介入手术过程中冲击波装置的输送时过弯难度过大。另一方面，当球囊10的长度过短时，则会增加手术过程中对冲击波装置进行定位的操作的难度。
本发明的冲击波装置的扩张部件16的主体部分的直径优选为6～12mm，优选为8～10mm。在设置扩张部件16的情况下，布置在扩张部件16外周的球囊10的主体部分的直径为2-8mm，优选为4-6mm。
在本发明的一个实施例中，多个的球囊10的直径可以相互不同。在向各个球囊内部的冲击波发射器输送的电压/电流脉冲相同的情况下，球囊10的直径不同可以使最终传导至钙化病变处的冲击波的强度也不相同。因此，当治疗对象的瓣膜的不同部位的钙化情况存在差异时，通过本发明的冲击波装置100的上述结构，在各个冲击波发射器20所发射的冲击波强度均相同的情况下，可以有针对性的使到达钙化病变情况不同的部位的冲击波强度产生差异。具体而言，在手术过程中，可以将直径较小的球囊设置在钙化病变情况较为严重的部位，从而使达到钙化病变处的冲击波保留更大的强度。另一方面，可以将直径较大的球囊设置在钙化病变情况较轻的部位，从而使达到钙化病变处的冲击波的强度较低，因此，能够进一步减轻手术期间治疗对象的 负担。
对本发明的冲击波装置100中所使用的注入球囊10内部的液体没有具体限定。该液体可以是电解质液体，例如生理盐水等，或者该液体也可以是非电解质液体，例如甘油等。同样地，注入扩张部件16的流体可以是电解质流体，例如生理盐水等，或者该流体也可以是非电解质流体，例如甘油等。优选地，注入球囊10内部的液体与注入扩张部件16的流体是相同的。
本发明的冲击波装置100的球囊10可设计为一次性耗材或者重复使用耗材，当其为重复使用耗材时，使用之前需要进行消毒灭菌。并且，由于本发明的冲击波装置100具有多个独立的球囊10，因此，当一个球囊损坏后，可以仅仅替换损坏的球囊，而无需将整个冲击波装置废弃，从而显著降低冲击波装置的维护费成本。
在本发明的一个实施例中，冲击波装置100中还包括显影装置，该显影装置能够帮助医生精准定位冲击波装置100，确保冲击波发射器20和/或球囊10在待治疗目标区域进行治疗。在本发明的一个实施例中，显影装置可在外部显影设备(例如X光成像设备等)作用下观察到其在治疗对象体内的位置。
在本发明的一个实施例中，显影装置包括显影件。在本发明的一个实施例中，显影件可以设置在电极探头22上。优选地，电极探头22可以包括具有显影作用的材料，从而可以在X光成像设备等作用下显影，帮助医生定位冲击波装置100，此时，电极探头22本身即可被用作显影件。在本发明的一个实施例中，显影装置还可以包括设置于球囊10两端的显影件11。在本发明的一个实施例中，如图6所示，显影装置可以包括多个设置于芯线12上的显影件19。对显影件19在芯线上的具体位置没有特别限定，可以根据不同的手术位置(例如主动脉瓣、二尖瓣或三尖瓣)进行调整。对显影件的材料没有具体限制，只 要其可在X光成像设备等作用下显影，更好地帮助医生精准定位冲击波装置100，确保冲击波发射器20和/或球囊10在待治疗目标区域进行治疗即可。对显影件形状并无具体限制，其可以被制造为环状，并且也可以被制造为其他形状，例如固定在球囊10上的环状件等。
在本发明的一个实施例中，如图6所示，分别设置于不同球囊内的芯线上的显影件19在各自的芯线12上的具体位置不同。例如，在一个芯线12上，显影件19可以设置在芯线12的长度方向上的端部，或者显影件19可以设置在芯线12的中部。或者各个显影件19可以具有相互不同的形状、长度或数量。例如，在显影设备的显影下，设置在不同的芯线12上的显影件19可以具有圆形、长方形、正方形和三角形等不同的形状。根据该结构，当瓣膜的各个部位的钙化情况不完全相同时，可以根据分别设置在各个球囊10内的芯线12上的不同位置处或具有不同形状、长度或数量的显影件19来实现各个球囊10在手术过程中的准确定位，从而根据钙化程度的不同针对性地对相应球囊内的冲击波发射器20施加不同强度的电压/电流脉冲，以产生不同强度的冲击波，从而在球囊10的直径相同的情况下，达到对钙化病变情况不同部位施加强度不同的冲击波的效果。
在本发明的一个实施例中，显影装置包括显影剂，显影剂混合于注入球囊10内部的液体内。显影剂可以是现有医疗技术领域常用的显影剂，其可在X光显影设备或血管成像设备DSA显影。当球囊10内充盈含有显影剂的液体时，血管成像设备可以通过显影剂监控球囊10内的液体的量，当球囊10在液体的充盈下扩张并紧贴钙化病变处时，停止向球囊10内充盈液体。通过这种方式，一方面可以使球囊10尽可能贴近钙化病变处，另一方面，可以避免球囊10中的液体充盈过量，进而对瓣膜或血管壁产生损伤。
在本发明的一个实施例中，如图9所示，冲击波装置100还包括脉冲发生器40、传导系统30和导线60。传导系统30包括分别连接至 各个球囊10的通孔的连接管A14和连接至扩张部件16的通孔的连接管B15，从而使传导系统30与球囊10和扩张部件16的内部连通且形成密封腔体。传导系统30在手术过程中位于治疗对象体外的部分设置第一孔洞，外部液体可经该第一孔洞流入传导系统30，进而注入球囊10和扩张部件16。在上述情况下，注入球囊10内部的液体与注入扩张部件16内部的流体是相同的。
在本发明的一个实施例中，如图10所示，可以在传导系统30内部设置多个导线60。脉冲发生器40连接外部电源，以产生电压/电流脉冲。如图10所示，多个导线60位于传导系统30的内部，其一端与脉冲发生器40电性连接、另一端与冲击波发射器20的电极线缆21电性连接，以将脉冲发生器40产生的电压/电流脉冲传导至冲击波发射器20。在本发明的一个实施例中，一个导线60可以单独与球囊10内的一个冲击波发射器20电性连接，用于分别向各个冲击波发射器传导电压/电流脉冲。或者，多个导线60中的一个导线可以与设置于同一个球囊内的两个以上的冲击波发射器20电性连接，或者多个导线60中的一个导线可以与设置于不同球囊内的两个以上冲击波发射器电性连接，用于向上述两个以上冲击波发射器传导电压/电流脉冲。根据上述结构，本发明的冲击波装置100可以分别控制多个导线60，向多个球囊10内部的冲击波发射器20分别传导不同强度的电压/电流脉冲。
在实际手术中，某些治疗对象的钙化病变可能只发生在瓣膜的个别位置处或者治疗对象瓣膜的不同位置处的钙化情况不完全相同。此时，如果对球囊内的全部冲击波发射器20输送相同强度的电压/电流脉冲，使全部冲击波发射器均产生相同强度的冲击波，则存在使未发生钙化或钙化情况较低的部位承受不必要的负担的风险。根据本发明的冲击波装置的上述结构，能够实现针根据不同的钙化程度分别向与各个钙化部位相对应的冲击波发射器输送不同强度的电压/电流脉冲。例如，向对应于钙化程度较严重的病变处的冲击波发射器输送较高强度的电压/电流脉冲，使其产生强度较高的冲击波，而向对应于钙化程度 较轻的病变处的冲击波发射器输送强度较低的电压/电流脉冲，使其产生强度较低的冲击波。因此，能够有针对性地对钙化情况不同的病变处施加不同强度的冲击波，从而进一步降低治疗对象的负担。
在本发明的一个实施例中，当某一个/多个球囊10或一个球囊10的一个/多个球囊主体所接触的部位并未发生钙化病变时，可以将输送至相应球囊/球囊主体的电压/电流脉冲降低为零，使其不产生冲击波，从而进一步减轻治疗对象负担。
在本发明的一个实施例中，可以分别控制多个导线60，使多个球囊10中的冲击波发射器20的电极探头22被循环触发。即避免全部或多个球囊中的冲击波发射器同时产生冲击波，从而进一步减轻手术过程中治疗对象的负担。
在本发明的一个实施例中，可以根据设置于球囊10内的芯线12上的具有不同的位置、形状、长度或数量的显影件19来有效地选择性控制球囊10中的冲击波发射器，从而实现上述效果。
在本发明的一个实施例中，可以在传导系统30内部设置多个通路。在本发明的一个实施例中，通路可以包括分别与各个球囊10的通孔相连通的连接管A14和与扩张部件16的通孔相连通的连接管B15，用于分别向各个球囊10输送液体并向扩张部件16输送流体。并且该多个通路的每个通路的近端可以与第一孔洞相连通，用于将液体/流体从外部注入多个通路中。多个通路中的一个通路可以通过连接管A与一个以上球囊10的通孔相连通，用于向该一个以上球囊输送液体。多个通路中的至少一个通路可以通过连接管B与扩张部件16的通孔相连通，用于向扩张部件16输送流体。多个通路由柔性材料形成，其可伸缩、折叠并且具有绝缘性。根据上述结构，本发明的冲击波装置100可以分别控制多个通路，从而能够使各个球囊10和/或扩张部件16分别具有不同的充盈度。在本发明中，“充盈度”是指球囊10或扩张部 件16内部实际填充的液体或流体的体积与球囊10或扩张部件16内部最大可填充体积(球囊10或扩张部件16的最大液体/流体容量)的比值。以球囊10为例，当球囊10内部实际填充的液体的体积与球囊10的最大液体容量相同，即球囊被液体完全填充并球囊的形状达到临界状态(超过该临界状态时，球囊将会破裂)时，该球囊的充盈度为100％。而当球囊10内部实际填充的液体的体积小于球囊10的最大液体容量时，充盈度低于100％。在本发明中，球囊充盈度的下限为能够确保产生冲击波的电极探头被液体包围且该电极探头不与球囊壁接触，并且电极探头与接触钙化病变处的球囊表面之间充满液体，以确保能够有效地将冲击波由电极探头传送至钙化病变处。类似地，在本发明中，扩张部件16的充盈度的上限为100％。另一方面，扩张部件的充盈度下限为扩张部件16能够对分布在其外周的球囊10起到支撑作用。
在手术过程中，治疗对象的瓣膜会对球囊10造成挤压，此时充盈度高的球囊能够确保球囊内部的电极探头与球囊内表面之间的距离接近或达到球囊的半径；而充盈度低的球囊在挤压下会轻微变形，导致电极探头与球囊内表面之间的距离小于球囊直径，即能够缩短电极探头与钙化病变处之间的距离，从而进一步降低冲击波的衰减。因此，当治疗对象的瓣膜的各个部位的钙化情况不同时，可以针对不同的钙化部位使球囊10具有相应的不同充盈度，从而实现对不同钙化病变处施加不同强度的冲击波的效果。
在本发明的一个实施例中，可以根据设置于球囊10内的芯线12上的具有不同的位置、形状、长度或数量的显影件19来有效地选择性控制球囊10的充盈度，从而实现上述效果。
在本发明的一个实施例中，可以根据治疗对象的实际情况，在手术过程中可以分别控制多个球囊10中的冲击波发射器20，以分别产生强度不同的冲击波；也可以分别控制多个球囊10和/或至少一个扩张部件16的充盈度，以分别控制传输至钙化程度不同的钙化病变处的冲击 波强度；或者也可以采用二者相结合的方式，针对钙化程度不同的钙化病变处产生/输送强度不同的冲击波。
在手术开始阶段，由于钙化病变处钙化情况较为严重，因此需要施加较强的冲击波进行治疗。随着手术的进行，钙化病变处的钙化组织在冲击波的作用下被粉碎或分解，使得钙化病变处的钙化情况得到缓解。此时，可以降低施加至该钙化病变处的冲击波强度，即以强度较低的冲击波对该钙化病变处继续进行后续治疗。因此，在本发明的一个实施例中，可以根据手术过程中钙化病变处的治疗情况，在手术不同阶段不断地调整输送至不同的冲击波发射器的电压/电流脉冲，以使同一个的冲击波发射器在手术的不同阶段产生强度不同的冲击波。或者，可以在手术的不同阶段调整输送至不同的球囊和/或扩张部件的液体和/或流体的量，从而使，同一个球囊在手术的不同阶段具有不同的充盈度，从而在手术的不同阶段使施加至相同位置的钙化病变处的冲击波强度有所不同。根据本发明的上述实施例，能够进一步降低治疗对象的负担。
在本发明的一个实施例中，对于贴近无钙化病变的瓣膜组织处的球囊10来说，可以控制相应的通路，不向该球囊输送液体，使该球囊保持压缩状态。此时，相应地，控制相应的导线60不向该球囊10的冲击波发射器20输送电压/电流脉冲。通过上述配置，能够达到仅对钙化的瓣膜进行治疗的目的，因此能够进一步减轻手术过程中治疗对象的负担。
如图9所示，在本发明的一个实施例中，第一孔洞处可以设置管路33，该管路33可以仅位于传导系统30外部，且与第一孔洞连通，或者，该管路33可以从传导系统30外部沿第一孔洞延伸入传导系统30内部，并在传导系统内部与多个通路相连通。同样地，球囊10和扩张部件16内的液体/流体也可经传导系统30(或多个通路)、第一孔洞后流出。优选地，在本方发明的一个实施例中，如图11所示，传导 系统30上可以设置第二孔洞，该第二孔洞经与设置有连接至扩张部件16的通孔的连接管B15的通路相连通，用于单独向扩张部件内部输送流体或使扩张部件内的流体经该孔洞流出。优选地，该第二孔洞处可以设置位于传导系统30外部并与第二孔洞相连通的管路34。传导系统30和通路可由柔性材料形成，其可伸缩、折叠并且具有绝缘性。传导系统30的表面为弧形，例如，传导系统30的外形可以是球状体，例如，球体、椭圆体、有弧度的突起球体等。
在本发明的一个实施例的冲击波装置100还包括控制阀32，控制阀32设置于液体/流体的输送路径上，用于控制液体/流体的通断。具体地，控制阀可以设置于上述的管路33上，从而方便医护人员控制。
在本发明的一个实施例中，如图3所示，冲击波装置100还包括导向头端70，导向头端70位于冲击波装置100的远离传导系统30的远端处。导向头端70起到引导作用，便于球囊10部分进入血管或瓣膜位置。优选的，导向头端70具有圆锥形状，并且该圆锥形状的末端圆滑，无尖角，以避免在手术过程中对血管和瓣膜造成划伤。进一步地，导向头端70为柔性材料，从而具有一定的可变形能力，可随血管形状进行弯曲，便于冲击波装置在输送过程中过弯。
在本发明的一个实施例中，冲击波装置100的多个球囊10中的至少两个球囊的远端相互连接。优选的，在本发明的一个实施例的冲击波装置100中，多个球囊10的远端均连接于导向端头70。进一步优选的，在本发明的一个实施例的冲击波装置100中，球囊10和扩张部件16的远端均连接于导向端头70。根据该结构，能够在手术过程中避免由于多个球囊10的远端的分散所可能导致的对血管、瓣膜和心脏组织的损伤。
本发明的冲击波装置100还包括预留通道80。预留通道80在冲击波装置100内部，由手柄部位经传导系统30和球囊部分延伸至导向 头端70。在手术过程中，预留通道80内可供外部金属线或其他配合器械通过，外部金属线进入该预留通道80内后，可引导该冲击波装置100的前进方向。
在本发明的具有多个球囊10的冲击波装置100中，预留通道80可以设置在如图5所示的多个球囊10的内侧区域的间隙C处。当本发明的冲击波装置设置有扩张部件16时，预留通道80可以设置于扩张部件16内部并在扩张部件16的长度方向穿过扩张部件16。优选地，预留通道80可以设置在扩张部件16的连接管B15内部，从而经连接管B15进入扩张部件内部。优选地，当本发明的冲击波装置100设置有两个以上扩张部件16时，预留通道80可以设置在两个以上扩张部件16内侧的间隙处，或者也可设置在某一个扩张部件的内部。
在本发明的一个实施例中，冲击波装置100还包括保护伞。该保护伞由具有超弹性的材料制成。保护伞可以设置于传导系统30的外周，并且具有打开和收缩两种状态。在手术过程中，保护伞的远端朝向球囊10张开，并且保护伞的近端保持在传导系统30的外表面处，使得保护伞23由收缩状态变为呈现朝向球囊10张开的伞状结构的打开状态。根据上述结构，在手术过程中，保护伞能够防止游离的生物组织碎片通过，从而避免这些组织碎片进入血管。
如图9所示，本发明的一个实施例的冲击波装置100还包括手柄90，从而适用于介入治疗方式。另一方面，当治疗对象需要采用外科手术方式进行治疗时，可设计出手持式冲击波装置。具体地，手柄90可连接于传导系统30的远离球囊10的方向(近端方向)上的末端。对手柄90与传导系统30之间的连接方式没有具体限定，例如可通过螺旋旋紧或者卡合的方式连接。
在手术过程中，手柄90由操作医生把持，手柄90可以设计成弧形等利于操作医生把持的形状。而为了降低手柄90滑脱的可能性，还 可以在手柄90的外部设置凹凸结构或者增加手柄90外表面粗糙度，以增大接触面积和手柄90与人手之间的摩擦力。手柄90处还连接有连接接头31，连接接头31与导线60电连接，并用于连接脉冲发生器，从而连接脉冲发生器与冲击波发射器20。
在一个实施例中，手柄90或脉冲发生器40上还设置有控制开关系统，用于根据治疗对象待治疗目标区域(例如，瓣膜处、瓣叶、血管等)的钙化程度，调节输出不同电流/电压脉冲强度、重复频率、持续次数。进一步地，手柄90处可能还设置有光源，该LED光源可在手术过程中用于照明。
以上主要以治疗对象的心脏瓣膜钙化为例描述了本发明的冲击波装置。但能够理解的是，以上描述同样适用于对治疗对象的血管钙化进行治疗。
以下将描述本发明的冲击波装置的使用方法。
具体而言，在手术过程中，使用本发明的冲击波装置100时，通过导向头端70带动球囊10进入人体，起到引导作用；医护人员可通过显影设备(例如，X光显影设备等)观察显影装置的位置，进而将冲击波装置100的球囊10定位在待治疗目标区域。
液体和/或流体经传导系统30或通路进入球囊10和/或扩张部件16，以使球囊10和/或扩张部件16充盈，从而使球囊10的球囊主体紧贴钙化病变的心脏瓣膜或血管壁。随后脉冲发生器40产生电压/电流脉冲，导线60将电压/电流脉冲传导至冲击波发射器20，冲击波发射器20发射冲击波，液体将冲击波传导至待治疗目标区域。治疗结束后，使液体流出球囊10并且使流体流出扩张部件16，冲击波装置100撤出人体。
具体而言，在介入手术的情况下，首先将用于治疗心脏瓣膜和血 管钙化的冲击波装置100由输送系统通过止血阀，沿通路产品的路径进入人体，并在显影装置的辅助下被送到待治疗目标区域。随后，在血管成像设备DSA作用下，经第一孔洞将含有显影剂的生理盐水注入球囊10并经第二孔洞将不含显影剂的生理盐水注入扩张部件16，使球囊10和扩张部件16被充盈，从而使球囊10的球囊主体紧贴钙化病变的心脏瓣膜或血管壁；打开控制开关系统，调节参数，冲击波发射器20开始工作发射冲击波，对待治疗目标区域进行治疗；治疗完毕后，使含有显影剂的生理盐水流出球囊10并经第一孔洞流至冲击波装置外部，同时使不含显影剂的生理盐水流出扩张部件16并经第二孔洞流至冲击波装置外部，以将球囊10和扩张部件16泄压；通过通路产品将冲击波装置100撤回，完成治疗过程。另一方面，在外科手术的情况下，操作者借助外科手术对治疗对象进行开胸后，在心尖上切口，医护人员手持该冲击波装置100沿着预先建立的通路路径进入心脏内，并在显影件11的作用下到达待治疗目标区域；在血管成像设备DSA作用下，经第一孔洞将含有显影剂的生理盐水注入球囊10并经第二孔洞将不含显影剂的生理盐水注入扩张部件16，使球囊10和扩张部件16被充盈，从而使球囊10的球囊主体紧贴钙化病变的心脏瓣膜或血管壁；打开控制开关系统，调节参数，冲击波发射器20开始工作发射冲击波，对待治疗目标区域进行治疗；治疗完毕后，使含有显影剂的生理盐水流出球囊10并经第一孔洞流至冲击波装置外部，同时使不含显影剂的生理盐水流出扩张部件16并经第二孔洞流至冲击波装置外部，以将球囊10和扩张部件16泄压；通过通路产品将冲击波装置100撤回，完成治疗过程。
尽管本发明的上述实施例以人为治疗对象，描述了本发明的冲击波装置的结构和用法。但本发明的冲击波装置的治疗对象不限于人，也可以是其它动物。例如，本发明的冲击波装置的专利对象可以是猫、狗等宠物，也可以是牛、马等大型动物，并且也可是熊猫等珍稀野生动物。
以上所述仅为本发明的实施例，并非因此限制本发明的专利范围，凡是利用本发明说明书及附图内容所作的等效结构或等效流程变换，或直接或间接运用在其它相关的技术领域，均同理包括在本发明的专利保护范围内。

Claims (24)

  1. 一种用于治疗心脏瓣膜或血管钙化的冲击波装置，其特征在于，包括：
    导向头端和多个球囊，所述多个球囊中的至少两个球囊连接至所述导向头端，其中，
    所述多个球囊中的至少一个球囊包括：
    至少一个球囊主体；
    至少一个通孔，通过该通孔将用于传导冲击波的液体注入所述球囊，以使所述球囊被充盈；以及
    至少一个冲击波发射器，该冲击波发射器包括至少一个电极线缆和至少一个电极探头，且用于接收电压/电流脉冲以产生冲击波。
  2. 根据权利要求1所述的装置，其特征在于，
    所述导向头端设置于所述冲击波装置的远端处，并且所述多个球囊的远端均连接于所述导向头端。
  3. 根据权利要求1或2所述的装置，其特征在于，还包括至少一个扩张部件，
    所述扩张部件包括至少一个主体和至少一个通孔，通过所述通孔将流体注入所述扩张部件以使所述扩张部件被充盈，并且
    所述多个球囊围绕所述扩张部件分布于所述扩张部件的外周。
  4. 根据权利要求3所述的装置，其特征在于，所述扩张部件的直径为6-12mm。
  5. 根据权利要求1～4任意一项所述的装置，其特征在于，所述装置还包括至少一个芯线，所述芯线设置在所述球囊的至少一个球囊主体内部并在所述至少一个球囊主体的整个长度方向上延伸，并且
    所述冲击波发射器的所述电极探头固定至所述芯线。
  6. 根据权利要求1～5任意一项所述的装置，其特征在于，所述电极探头包括由导电体构成的内电极和外电极，并且所述内电极和所述外电极同轴设置并且相互绝缘。
  7. 根据权利要求6所述的装置，其特征在于，所述内电极和所述外电极以与所述芯线同轴的方式设置于所述芯线的外周。
  8. 根据权利要求1-7中任一项所述的装置，其特征在于，还包括至少一个显影装置，该显影装置包括显影件，并且所述显影件设置于所述电极探头、所述球囊的端部和所述芯线中的至少一个上。
  9. 根据权利要求8所述的装置，其特征在于，每个所述芯线上均设置有所述显影件，并且设置于不同的所述芯线上的显影件具有各自不同位置、形状、长度或数量。
  10. 根据权利要求1～9任意一项所述的装置，其特征在于，所述装置包括多个导线，所述多个导线中的每个导线分别连接至一个以上所述电极线缆，用于向所述冲击波发射器输送电压/电流脉冲。
  11. 根据权利要求1-10任意一项所述的装置，其特征在于，还包括：
    传导系统，该传导系统连接于所述通孔，使得所述液体在所述传导系统和所述球囊内流通。
  12. 根据权利要求11所述的装置，其特征在于，还包括多个通路，所述通路位于所述传导系统内部，并且
    所述多个通路中的每个通路分别与一个以上所述球囊的所述通孔相连通。
  13. 根据权利要求11所述的装置，其特征在于，所述多个通路中的至少一个通路与所述扩张部件的通孔相连通。
  14. 根据权利要求1～13所述的装置，其特征在于，还包括保护伞，该保护伞具有朝向所述球囊张开的伞状结构。
  15. 一种用于治疗动物心脏瓣膜或血管钙化的方法，其特征在于，该方法包括
    将权利要求1～14任意一项所述的冲击波装置输送至待治疗的目标区域；
    使所述冲击波装置的所述多个球囊充盈，以使所述多个球囊的所述球囊主体紧贴钙化病变的心脏瓣膜或血管壁；以及
    使所述冲击波发射器产生冲击波以对所述钙化病变的心脏瓣膜或血管进行治疗。
  16. 根据权利要求15所述的方法，其特征在于，还包括使所述冲击波装置的所述至少一个扩张部件充盈，以使所述球囊的所述球囊主体紧贴所述钙化病变的心脏瓣膜或血管壁。
  17. 根据权利要求15或16所述的方法，其特征在于，使所述冲击波装置的所述多个球囊的所述冲击波发射器产生至少两种不同强度的冲击波。
  18. 根据权利要求15～17任意一项所述的方法，其特征在于，使所述冲击波装置的所述多个球囊的所述冲击波发射器被依次触发，以产生冲击波。
  19. 根据权利要求15～18任意一项所述的方法，其特征在于，使至少一个所述冲击波发射器在手术过程中产生不同强度的冲击波。
  20. 根据权利要求15～19任意一项所述的方法，其特征在于，使所述冲击波装置的所述多个球囊和/或所述至少一个扩张部件具有至少两种不同的充盈度。
  21. 根据权利要求15～20任意一项所述的方法，其特征在于，使至少一个所述球囊在手术过程中具有至少两种不同的充盈度。
  22. 根据权利要求16～21中任意一项所述的方法，其特征在于，使至少一个所述扩张部件在手术过程中具有至少两种不同的充盈度。
  23. 根据权利要求15～22中任意一项所述的方法，其特征在于，根据所述芯线上的所述显影件的所述位置、所述形状、所述长度和所述数量中的至少一种来选择特定球囊，以控制所选择的球囊具有特定的充盈度或控制所选择的球囊中的所述冲击波发射器产生特定强度的冲击波。
  24. 根据权利要求15～23中任意一项所述的方法，其特征在于，所述动物为人。
PCT/CN2020/088393 2019-08-06 2020-04-30 用于治疗心脏瓣膜或血管钙化的装置和方法 Ceased WO2021022849A1 (zh)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP20851172.5A EP4011304B1 (en) 2019-08-06 2020-04-30 Device for treating heart valve or vascular calcification
CN202080005866.5A CN113194855B (zh) 2019-08-06 2020-04-30 用于治疗心脏瓣膜或血管钙化的装置
US17/633,085 US20220287731A1 (en) 2019-08-06 2020-04-30 Device and method for treating heart valve or vascular calcification
JP2022507707A JP7479449B2 (ja) 2019-08-06 2020-04-30 心臓弁又は血管の石灰化を治療するための装置及び方法
ES20851172T ES3014427T3 (en) 2019-08-06 2020-04-30 Device for treating heart valve or vascular calcification

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910720924.1 2019-08-06
CN201910720924.1A CN110604607A (zh) 2019-08-06 2019-08-06 一种治疗心脏瓣膜钙化的冲击波装置

Publications (1)

Publication Number Publication Date
WO2021022849A1 true WO2021022849A1 (zh) 2021-02-11

Family

ID=68890998

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2020/088393 Ceased WO2021022849A1 (zh) 2019-08-06 2020-04-30 用于治疗心脏瓣膜或血管钙化的装置和方法

Country Status (6)

Country Link
US (1) US20220287731A1 (zh)
EP (1) EP4011304B1 (zh)
JP (1) JP7479449B2 (zh)
CN (3) CN110604607A (zh)
ES (1) ES3014427T3 (zh)
WO (1) WO2021022849A1 (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113633345A (zh) * 2021-08-24 2021-11-12 江苏朴芃医疗科技有限公司 一种用于血管内钙化斑块治疗的支架系统
WO2023015295A1 (en) * 2021-08-05 2023-02-09 Nextern Innovation, Llc Intravascular lithoplasty balloon systems, devices and methods

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110604607A (zh) * 2019-08-06 2019-12-24 沛嘉医疗科技(苏州)有限公司 一种治疗心脏瓣膜钙化的冲击波装置
JP7510184B2 (ja) * 2019-09-17 2024-07-03 国立大学法人大阪大学 大動脈弁形成術用カテーテル
ES3009524T3 (en) 2019-09-24 2025-03-27 Shockwave Medical Inc Lesion crossing shock wave catheter
CN118750097A (zh) * 2020-07-31 2024-10-11 深圳市赛禾医疗技术有限公司 一种压力波球囊导管
US12016610B2 (en) * 2020-12-11 2024-06-25 Bolt Medical, Inc. Catheter system for valvuloplasty procedure
WO2022127507A1 (zh) * 2020-12-16 2022-06-23 深圳市赛禾医疗技术有限公司 一种压力波球囊导管及医疗器械
CN112842324A (zh) * 2021-01-07 2021-05-28 复旦大学 一种球囊式心脏瓣膜在体测量装置
CN114869401B (zh) * 2021-02-05 2023-09-22 沛嘉医疗科技(苏州)有限公司 冲击波装置
CN114869400B (zh) * 2021-02-05 2025-02-18 沛嘉医疗科技(苏州)有限公司 用于治疗心脏瓣膜或血管钙化的冲击波装置用电极和冲击波装置
CN114869399B (zh) * 2021-02-05 2025-03-07 沛嘉医疗科技(苏州)有限公司 电极组件和使用该电极组件的冲击波装置
CN112971915B (zh) * 2021-05-08 2021-08-20 上海百心安生物技术股份有限公司 一种脉冲球囊及其应用
CN115363689A (zh) * 2021-05-21 2022-11-22 上海微创心通医疗科技有限公司 一种医用导管及医用装置
CN113367769B (zh) * 2021-06-11 2024-04-02 南京欣科医疗器械有限公司 高压脉冲输出装置及使用该装置的冲击波球囊导管系统
CN113367767B (zh) * 2021-06-11 2023-01-24 南京欣科医疗器械有限公司 一种微孔诱导冲击波球囊导管及系统
CN113769284A (zh) * 2021-10-27 2021-12-10 华中科技大学同济医学院附属协和医院 一种超声主动脉瓣成形装置
CN113855162B (zh) * 2021-11-03 2024-10-29 上海精诚医疗科技有限公司 能产生冲击波的体内介入的小电极装置
CN114098897A (zh) * 2021-11-04 2022-03-01 杭州天路医疗器械有限公司 能够进行能量控制的球囊式冲击波发生系统及其控制方法
CN116269628A (zh) * 2021-12-20 2023-06-23 上海微创心通医疗科技有限公司 一种医用装置及系统
CN115127714A (zh) * 2022-07-13 2022-09-30 上海佳沐垚医疗科技有限公司 冲击波能量检测系统及方法
CN115530918A (zh) * 2022-09-14 2022-12-30 苏州心岭迈德医疗科技有限公司 一种钙化病灶去除装置
CN120477876A (zh) * 2022-09-30 2025-08-15 沛嘉医疗科技(苏州)有限公司 一种冲击波系统
WO2024088366A1 (zh) * 2022-10-27 2024-05-02 上海蓝帆博奥医疗科技有限公司 用于冲击波医用装置的球囊装置和冲击波医用装置
CN115737061A (zh) * 2022-11-14 2023-03-07 杭州诺纳生物医疗科技有限公司 冲击波装置
CN115624367B (zh) * 2022-11-18 2023-03-10 乐普（北京）医疗器械股份有限公司 一种治疗血管钙化的辅助装置
CN115778487A (zh) * 2023-02-02 2023-03-14 上海佳沐垚医疗科技有限公司 一种可用于靶向治疗的冲击波球囊导管及导管系统
WO2024235189A1 (zh) * 2023-05-17 2024-11-21 为泰医疗器械（深圳）)有限公司 冲击波球囊扩张导管及用于三尖瓣开口处的冲击波球囊扩张导管
CN117045293B (zh) * 2023-10-09 2024-02-06 北京心祐医疗科技有限公司 膜缝合系统
CN117481617B (zh) * 2023-11-15 2024-04-26 苏州心岭迈德医疗科技有限公司 一种震波球囊装置
CN117898794B (zh) * 2024-02-07 2025-11-04 深圳英美达医疗技术有限公司 冲击波系统及冲击波控制方法
US12396742B1 (en) 2024-02-08 2025-08-26 IV-X Medical, LLC Intravascular lithotripsy system
US12433620B2 (en) * 2024-02-23 2025-10-07 Shockwave Medical, Inc. Locus emitter shock wave catheter devices with increased longevity and higher sonic output
CN118402858A (zh) * 2024-04-18 2024-07-30 江苏瑞诺兹医疗科技有限公司 一种瓣膜冲击波系统
CN120436773B (zh) * 2025-07-10 2025-10-17 上海爱声生物医疗科技有限公司 一种轴对称诊治装置及其控制方法、计算机程序

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5863284A (en) * 1995-11-13 1999-01-26 Localmed, Inc. Devices and methods for radiation treatment of an internal body organ
US6117064A (en) * 1997-01-06 2000-09-12 Apple; Marc G. Catheter system
CN104519809A (zh) * 2012-08-08 2015-04-15 冲击波医疗公司 具有多个球囊的冲击波瓣膜成形术
US20160135828A1 (en) * 2014-11-14 2016-05-19 Shockwave Medical, Inc. Shock wave valvuloplasty device and methods
CN109223100A (zh) * 2018-09-03 2019-01-18 沛嘉医疗科技(苏州)有限公司 一种用于治疗心脏瓣膜和血管钙化的装置及其使用方法
WO2019034778A1 (en) * 2017-08-17 2019-02-21 Koninklijke Philips N.V. TEMPORARY BALLOON OCCLUSION DEVICES, SYSTEMS AND METHODS FOR PREVENTING FLOW THROUGH VASCULAR PERFORATION
CN110604607A (zh) * 2019-08-06 2019-12-24 沛嘉医疗科技(苏州)有限公司 一种治疗心脏瓣膜钙化的冲击波装置

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4986830A (en) * 1989-09-22 1991-01-22 Schneider (U.S.A.) Inc. Valvuloplasty catheter with balloon which remains stable during inflation
US9795442B2 (en) * 2008-11-11 2017-10-24 Shifamed Holdings, Llc Ablation catheters
ES2610134T3 (es) 2009-07-08 2017-04-26 Sanuwave, Inc. Uso de ondas de choque de presión extracorpóreas e intracorpóreas en medicina
CN102858272B (zh) * 2009-12-15 2015-07-15 爱德华兹生命科学公司 治疗脉管通道的膨胀设备
WO2012064404A1 (en) * 2010-11-09 2012-05-18 Daniel Hawkins Shockwave valvuloplasty device with guidewire and debris basket
US20120209375A1 (en) * 2011-02-11 2012-08-16 Gilbert Madrid Stability device for use with percutaneous delivery systems
US20130150881A1 (en) 2011-12-13 2013-06-13 Boston Scientific Scimed, Inc. Valvuloplasty device
CN104582621B (zh) * 2012-08-06 2017-04-12 冲击波医疗公司 用于血管成形冲击波导管的低剖面电极
WO2014104075A1 (ja) * 2012-12-26 2014-07-03 国立大学法人東北大学 衝撃波収束装置、衝撃波発生装置及び衝撃波アブレーションシステム
BR112015013364B1 (pt) * 2012-12-31 2021-04-20 Clearstream Technologies Limited aparelho para tratar uma área de tratamento em uma vasculatura e método de montagem de um conjunto que inclui um cateter que inclui um balão
EP3240603B1 (en) * 2014-12-30 2019-05-01 The Spectranetics Corporation Laser-induced fluid filled balloon catheter
WO2016141195A1 (en) 2015-03-04 2016-09-09 Transmed7, Llc Steerable, conformable, drug eluting balloon catheter
US11179169B2 (en) * 2016-11-04 2021-11-23 Les Solutions Medicales Soundbite Inc. Device for delivering mechanical waves through a balloon catheter
DE102016013480A1 (de) * 2016-11-11 2018-05-17 Peter Osypka Stiftung Vorrichtung zur Ballondilatation einer verengten Herzklappe

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5863284A (en) * 1995-11-13 1999-01-26 Localmed, Inc. Devices and methods for radiation treatment of an internal body organ
US6117064A (en) * 1997-01-06 2000-09-12 Apple; Marc G. Catheter system
CN104519809A (zh) * 2012-08-08 2015-04-15 冲击波医疗公司 具有多个球囊的冲击波瓣膜成形术
US20160135828A1 (en) * 2014-11-14 2016-05-19 Shockwave Medical, Inc. Shock wave valvuloplasty device and methods
WO2019034778A1 (en) * 2017-08-17 2019-02-21 Koninklijke Philips N.V. TEMPORARY BALLOON OCCLUSION DEVICES, SYSTEMS AND METHODS FOR PREVENTING FLOW THROUGH VASCULAR PERFORATION
CN109223100A (zh) * 2018-09-03 2019-01-18 沛嘉医疗科技(苏州)有限公司 一种用于治疗心脏瓣膜和血管钙化的装置及其使用方法
CN110604607A (zh) * 2019-08-06 2019-12-24 沛嘉医疗科技(苏州)有限公司 一种治疗心脏瓣膜钙化的冲击波装置

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4011304A4 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023015295A1 (en) * 2021-08-05 2023-02-09 Nextern Innovation, Llc Intravascular lithoplasty balloon systems, devices and methods
US20240307081A1 (en) * 2021-08-05 2024-09-19 Nextern Innovation, Llc Intravascular lithoplasty balloon systems, devices and methods
CN113633345A (zh) * 2021-08-24 2021-11-12 江苏朴芃医疗科技有限公司 一种用于血管内钙化斑块治疗的支架系统

Also Published As

Publication number Publication date
JP7479449B2 (ja) 2024-05-08
EP4011304B1 (en) 2025-01-01
EP4011304A4 (en) 2023-09-13
JP2022544651A (ja) 2022-10-20
CN212490066U (zh) 2021-02-09
CN113194855A (zh) 2021-07-30
CN113194855B (zh) 2022-11-08
EP4011304A1 (en) 2022-06-15
CN110604607A (zh) 2019-12-24
ES3014427T3 (en) 2025-04-22
US20220287731A1 (en) 2022-09-15

Similar Documents

Publication Publication Date Title
CN113194855B (zh) 用于治疗心脏瓣膜或血管钙化的装置
WO2020048274A1 (zh) 一种用于治疗心脏瓣膜和血管钙化的装置及其使用方法
US8634929B2 (en) Method for treatment of neoplastic cells in the prostate of a patient
RU2539988C9 (ru) Способ и система для облегчения прохождения проволочного проводника через закупоренные протоки
US7306591B2 (en) Apparatus and methods for treating female urinary incontinence
US7449026B2 (en) Intra-cavity catheters and methods of use
US7004940B2 (en) Devices for performing thermal ablation having movable ultrasound transducers
US9888962B2 (en) Apparatus and method of use for treating blood vessels
WO2023072154A1 (zh) 电极球囊导管
US20100022944A1 (en) Method and apparatus for treating an acute myocardial infarction
JP2018083080A (ja) ローブを形成する内側バルーンを有する二重バルーンカテーテル
CN107427226A (zh) 用于识别治疗部位的方法和装置
US20110098564A1 (en) Method and apparatus for diagnosing and treating vascular disease
CN114869400B (zh) 用于治疗心脏瓣膜或血管钙化的冲击波装置用电极和冲击波装置
US20180042459A1 (en) Medical tool with image enhancing features
US12471939B2 (en) Shock wave catheter with retractable enclosure
CN116115320A (zh) 一种脉冲消融装置
CN101912301B (zh) 利用高压纳秒脉冲治疗人体肝脏肿瘤的手术治疗仪器
CN211094508U (zh) 一种治疗心脏瓣膜钙化的冲击波装置
WO2005058411A1 (ja) 神経刺激デバイス用キット
CN116392199A (zh) 一种冲击波球囊导管及其反馈系统

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20851172

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2022507707

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2020851172

Country of ref document: EP

Effective date: 20220307