WO2022242546A1 - 一种医用导管及医用装置 - Google Patents

一种医用导管及医用装置 Download PDF

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Publication number
WO2022242546A1
WO2022242546A1 PCT/CN2022/092523 CN2022092523W WO2022242546A1 WO 2022242546 A1 WO2022242546 A1 WO 2022242546A1 CN 2022092523 W CN2022092523 W CN 2022092523W WO 2022242546 A1 WO2022242546 A1 WO 2022242546A1
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WIPO (PCT)
Prior art keywords
medical catheter
tube
shaped
tube body
support rod
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PCT/CN2022/092523
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English (en)
French (fr)
Inventor
岳斌
常兆华
贾婧玮
聂京闽
桂宝珠
Original Assignee
上海微创心通医疗科技有限公司
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Application filed by 上海微创心通医疗科技有限公司 filed Critical 上海微创心通医疗科技有限公司
Priority to ES202390190A priority Critical patent/ES2957905A2/es
Publication of WO2022242546A1 publication Critical patent/WO2022242546A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave

Definitions

  • the invention relates to the technical field of medical devices, in particular to a medical catheter and a medical device.
  • Aortic valve calcification is the ectopic accumulation of calcium nodules on the surface of the aortic valve, which can lead to thickening and functional stenosis of the aortic valve.
  • Degenerative calcific aortic stenosis is a degenerative change of the aortic valve with age, such as fibrosis, calcification, and eventually dysfunctional heart valve disease.
  • CAS is currently the most common heart valve disease in the elderly.
  • China gradually enters an aging society coupled with the improvement of people's quality of life and the extension of average life expectancy, the incidence and prevalence of calcific aortic stenosis in China are increasing year by year. rise.
  • Surgical treatment is currently an effective treatment for CAS, including surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).
  • SAVR surgical aortic valve replacement
  • TAVR transcatheter aortic valve replacement
  • both SAVR and TAVR have strict indications and contraindications, are more suitable for patients with severe stenosis, and have certain requirements for the anatomical structure of the aortic valve.
  • SAVR surgical aortic valve replacement
  • TAVR transcatheter aortic valve replacement
  • the purpose of the present invention is to provide a medical catheter and a medical device, which can effectively treat calcified lesions without surgery.
  • the present invention provides a medical catheter, including a loading part and an electrode;
  • the loading part has an inner cavity, and the electrode is arranged in the inner cavity, and the electrode is used to generate a shock wave;
  • the The inner cavity is also used to accommodate a conductive medium, which is used to transmit the shock wave;
  • the medical catheter is configured such that the distance from the electrode to the axis of the medical catheter increases when the medical catheter is switched from the first state to the second state.
  • the medical catheter includes a first tube body, a first balloon and a support rod, the first balloon is sleeved on the outer surface of the distal end of the first tube body and constitutes the loading part;
  • the support rod is arranged inside the first balloon, and the support rod has a first end and a second end opposite to each other, wherein the first end is connected to the first tube body, and the second end connected to the electrodes;
  • the medical catheter is configured such that when the medical catheter is in the first state, the second end of the support rod is close to the axis of the first tube, and the electrode is close to the first tube axis; when the medical catheter is in the second state, the second end of the support rod is away from the axis of the first tube, and the electrode is away from the axis of the first tube.
  • the support rod is a self-expanding structure, and includes a first part and a second part connected at an angle, the second part has the first end and the second end, and the first end connected to the first pipe body through the first part; or,
  • the free ends of the first part and the second part respectively constitute a first end and are connected to the first pipe body, and the junction of the first part and the second part constitutes the second end.
  • it also includes a second tube body, which is used to movably fit on the outside of the first tube body and the balloon;
  • the medical catheter is configured such that when the second tubular body is sleeved on the outside of the balloon, the second tubular body applies radial pressure to the support rod, and the medical catheter is positioned at the first position. state; when the second tubular body moves in the direction from the distal end to the proximal end, and releases the radial pressure applied to the support rod, the support rod expands radially outward, so that the support rod The second end of the rod is far away from the first tubular body and makes the medical catheter in the second state.
  • the support rod is an elastic member;
  • the medical catheter further includes a control pull rope, and the distal end of the control pull rope is connected to the support rod;
  • the medical catheter is configured such that the control pull cord is used to apply tension to the support rod and drive the second end of the support rod to move away from the first tube body, so that the medical catheter is in the In the second state, the support rod stores elastic potential energy; when the pulling force is canceled, the support rod releases the elastic potential energy and drives the second end of the support rod to move closer to the first pipe body to move the medical catheter back to the first state.
  • the medical catheter further includes a push piece and a positioning piece; the distal end of the push piece is connected to the support rod, and the push piece is used to drive the first end of the support rod along the Axial movement of the pipe body; the locating piece is connected to the pushing piece and also connected to the first pipe body; the locating piece is used to fix the pushing piece on the first pipe body ;
  • the pushing member pushes the support rod in the direction from the proximal end to the distal end, the second end of the support rod moves away from the first tube body, so that the medical catheter is switched to the the second state; when the push rod moves in the direction from the distal end to the proximal end, the second end of the support rod moves in a direction close to the first tube body, so that the medical catheter is switched to the first state.
  • the medical catheter includes a third tube body and an inner tube assembly;
  • the inner tube assembly includes a pre-shaped tube body and a fourth tube body, and the fourth tube body is partially disposed on the third tube
  • the pre-shaped tube body is a self-expanding structure, at least part of the tube section of the pre-shaped tube body constitutes the loading part;
  • the proximal end of the pre-shaped tube body is connected to the third tube
  • the distal end of the pre-shaped pipe section is connected to the fourth pipe body;
  • the medical catheter is configured such that when the fourth tubular body moves in a proximal-to-distal direction relative to the third tubular body, the pre-shaped tubular body shrinks radially, so that the medical catheter When the catheter is in the first state, when the fourth tubular body moves in the direction from the distal end to the proximal end relative to the third tubular body, the pre-shaped tubular body expands radially outward, and makes The medical catheter is in the second state.
  • the distal end of the pre-shaped tubular body is at least partially in a three-dimensional helical structure
  • the distal end of the pre-shaped tubular body is at least partially in an arc-shaped structure, and the concave side of the arc-shaped structure faces the fourth tubular body.
  • a first sheath tube is also included, and the first sheath tube is used to be movably fitted on the outside of the third tube body and the pre-shaped tube body.
  • the medical catheter includes a second sheath tube and an inner tube assembly, and the second sheath tube is movably sleeved on the outside of the inner tube assembly;
  • the inner tube assembly includes a pre-shaped tube body and a first inner tube assembly.
  • Four tubes, the distal end of the pre-shaped tube is connected to the fourth tube;
  • the medical catheter is configured such that when the second sheath is sleeved on the inner tube assembly and covers the pre-shaped tubular body, the second sheath applies a radial force to the pre-shaped tubular body. pressure to radially compress the pre-shaped tubular body, and make the medical catheter in the first state; when the second sheath moves along the direction from the distal end to the proximal end, and make the pre-shaped When at least part of the tube section of the shaped tube protrudes from the distal end of the second sheath, the tube section of the pre-shaped tube protruding from the distal end of the second sheath can at least partially radially expanding outward, and placing the medical catheter in the second state.
  • the pre-shaped tubular body includes a third part and a fourth part connected to each other, the proximal end of the third part is connected to the fourth tubular body and communicated with the fourth tubular body, Or at least part of the outer surface of the third part is connected to the fourth tubular body, and the proximal end of the third part extends along the axial direction of the fourth tubular body; the distal end of the fourth part is a free end, and the fourth portion constitutes the loading portion;
  • the pre-shaped tubular body When the medical catheter is in the first state, the pre-shaped tubular body is attached to the outer surface of the fourth tubular body; when the medical catheter is in the second state, the fourth The part is bent radially outwards to expand the pre-shaped tube body to form a V-shaped structure or a U-shaped structure.
  • the inner tube assembly further includes an anchor connected to the fourth tube;
  • the anchor includes a branch tube and a second balloon, and the number of the branch tubes is multiple
  • a plurality of branch tubes are arranged at intervals along the circumference of the fourth tube, and the outer surface of each branch tube is covered with the second balloon.
  • the pre-shaped tubular body is at least partially in a three-dimensional helical structure
  • the pre-shaped tube body is at least partially in an arc-shaped structure, and the concave side of the arc-shaped structure faces the fourth tube body.
  • the medical catheter includes an inner tube assembly;
  • the inner tube assembly includes a fourth tube body and a controllable bend body;
  • the controllable bend body includes a straight pipe section, a controllable bend section and a control pull cord;
  • the proximal end of the straight pipe section is connected to the fourth pipe body and communicates with the fourth pipe body, or the proximal outer surface of the straight pipe section is at least partially connected to the fourth pipe body;
  • the proximal end of the controllable bend section is connected to the far end of the straight pipe section, the far end of the controllable bend section is a free end, and the controllable bend section constitutes the loading part;
  • the control pull cord is used for controlling bending or straightening of the controllable bend segment;
  • the medical catheter is configured such that when the medical catheter is in the first state, the controllable bendable body is in a straight line and abuts against the outer surface of the fourth tubular body; when the control pull When the rope exerts a pulling force on the controllable bending section, the controllable bending section bends radially outward so that the distal end of the controllable bending tube body expands to form a V-shaped structure or a U-shaped structure.
  • the medical catheter further includes a second sheath tube, and the second sheath tube is used to be movably sleeved on the outside of the inner tube assembly.
  • the medical catheter also includes an anchor, which is arranged on the fourth tubular body; the anchor includes a branch catheter and a second balloon, and the number of the branch catheters is multiple, and a plurality of The branch catheters are arranged at intervals along the circumference of the fourth tubular body, and the outer surface of each branch catheter is sleeved with the second balloon.
  • an anchor which is arranged on the fourth tubular body; the anchor includes a branch catheter and a second balloon, and the number of the branch catheters is multiple, and a plurality of The branch catheters are arranged at intervals along the circumference of the fourth tubular body, and the outer surface of each branch catheter is sleeved with the second balloon.
  • the present invention also provides a medical device, comprising a shock wave generator and the medical catheter as described in any one of the preceding items, the shock wave generator is used to electrically connect with the electrodes, and make the electrodes generate The shock wave.
  • the medical catheter and the medical device of the present invention have the following advantages:
  • the aforementioned medical device includes a medical catheter and a shock wave generator
  • the medical catheter includes a loading part and an electrode
  • the loading part has an inner cavity
  • the electrode is arranged in the inner cavity
  • the electrode is connected to the shock wave generator.
  • the inner cavity is also used to accommodate a conductive medium, and the conductive medium is used to transmit the shock waves;
  • the medical catheter is configured to be used when the medical When the catheter switches from the first state to the second state, the distance from the electrode to the axis of the medical catheter increases.
  • the medical catheter When using the medical device to treat calcified lesions, the medical catheter is in the second state, thereby reducing the distance from the electrodes to the calcified lesions, achieving better therapeutic effects, and avoiding the The longer the distance, the lower the shock wave energy transmitted to the calcified lesion, and the calcified area cannot be effectively softened.
  • Fig. 1 is a schematic structural view of the medical device provided by the present invention according to Embodiment 1 to Embodiment 3, showing that the Chinese medical catheter is in the second state;
  • Fig. 2 is a partial structural schematic diagram of the medical device shown in Fig. 1;
  • Fig. 3 is a schematic structural diagram of a medical device in an alternative implementation
  • Fig. 4 is a schematic structural diagram of a medical device in an alternative implementation, showing a perfusion tube
  • Fig. 5 is A-A sectional view of the medical device shown in Fig. 2;
  • Fig. 6 is a partial structural schematic diagram of the medical device provided by the present invention according to the first to the third embodiment, showing that the Chinese medical catheter is in the first state;
  • Fig. 7 is a schematic structural view of the medical device provided according to the fourth embodiment of the present invention, which shows that the medical catheter is in the first state, and only part of the third tube is shown in the diagram;
  • Fig. 8 is a schematic structural view of the medical device provided according to Embodiment 4 of the present invention, showing that the Chinese medical catheter is in the second state;
  • Fig. 9 is a partial structural schematic diagram of the medical device provided by the present invention according to Example 4, showing that the Chinese medical catheter is in the second state;
  • Fig. 10 is a partial structural schematic diagram of the medical device provided according to the sixth embodiment of the present invention, showing that the Chinese medical catheter is in the second state;
  • Fig. 11 is a partial structural schematic diagram of the medical device provided by the present invention according to Embodiment 7;
  • Fig. 12 is a partial structural schematic diagram of the medical device provided by the seventh embodiment of the present invention, and the viewing directions of Fig. 12 and Fig. 11 are different;
  • Fig. 13 is a schematic structural diagram of the medical device provided according to the eighth embodiment of the present invention, showing that the medical catheter is in the second state;
  • Fig. 14 is a partial structural schematic diagram of the medical device provided according to the eighth embodiment of the present invention, showing that the Chinese medical catheter is in the second state;
  • FIG. 15 is a schematic diagram of a partial structure of a medical device according to Embodiment 8 of the present invention, and FIG. 13 is viewed in a different direction from FIG. 13 and FIG. 14 .
  • each embodiment of the content described below has one or more technical features respectively, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless the content clearly states otherwise.
  • the term “or” is generally used in the sense including “and/or”, unless the content clearly indicates otherwise, and the terms “install”, “connect” and “connect” should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
  • proximal refers to the relative orientation, relative position, direction of elements or actions relative to each other from the perspective of a doctor using the medical device, although “proximal”, “distal ” is not limiting, but “proximal” generally refers to the end of the medical device that is closest to the practitioner during normal operation, and “distal” generally refers to the end that enters the patient first.
  • the purpose of the present invention is to provide a medical catheter and a medical device including the medical catheter, the medical device can treat calcified lesions of blood vessels or aortic valves by utilizing the electro-hydraulic effect.
  • the medical device includes a shock wave generator 10 and a medical catheter 20
  • the medical catheter 20 includes a loading portion and an electrode 201 .
  • the loading part has an inner cavity, and the electrode 201 is arranged in the inner cavity, and the proximal end of the electrode 201 is used for connecting with the shock wave generator 10 and used for the function of the shock wave generator 10. A shock wave is generated.
  • the inner cavity is also used to accommodate a conductive medium, and the conductive medium is used to immerse the electrode 201 and transmit the shock wave.
  • the medical catheter 20 has a first state and a second state, and when the medical catheter 20 switches from the first state to the second state, the distance from the electrode 201 to the axis of the medical catheter 20 increases. big.
  • the loading part is first introduced into the lesion, and then the medical catheter 20 is switched to the second state for treatment, so that the electrodes 201 and the lesion Closer can increase the energy of the shock wave transmitted to the lesion area, avoiding insufficient energy transmitted to the lesion area due to the long distance between the electrode 201 and the lesion area, thus preventing effective softening of the calcified area.
  • the medical catheter 20 in this embodiment includes a first tube body 210 , a first balloon 220 and a support rod 230 .
  • the first balloon 220 is sleeved on the outer surface of the distal end of the first tube body 210 and constitutes the loading part, and the electrode 201 is disposed inside the first balloon 220 .
  • the support rod 230 is also disposed inside the first balloon 220, and the support rod 230 has opposite first and second ends, the first end is connected to the first tube body 210, so The second end is connected to the electrode 201.
  • the medical catheter 20 is configured such that when the medical catheter 20 is in the first state, the second end of the support rod 230 is close to the axis of the first tube body 210, so that the electrode 201 is also close to the axis of the first tube body 210. the axis of the first tube body 210; when the medical catheter 20 is in the second state, the second end of the support rod 230 is far away from the axis of the first tube body 210, so that the electrode 201 It is far away from the axis of the first tube body 210 .
  • the support rod 230 is a self-expanding structural member, and is pre-shaped into a "V"-shaped structure.
  • the support rod 230 includes a first portion 231 and a second portion 232 connected at an angle.
  • the second part 232 has the first end and the second end, and the first end is connected to the first end through the first part 231. on the tube body 210 .
  • the medical catheter 20 further includes a second tube body 240 , and the second tube body 240 is used to be movably fitted on the outside of the first tube body 210 and the first balloon 220 .
  • the second tube body 240 When the second tube body 240 is sleeved on the outside of the first balloon 220, the second tube body 240 exerts radial pressure on the second part of the support rod 230, so that the second Partially abuts (or substantially abuts) on the first tube body 210, so that the medical catheter 20 is in the first state.
  • the second tube body 240 moves along the direction from the distal end to the proximal end of the first tube body 240 and releases the radial pressure exerted on the second part, the second part moves radially Expanding outward makes the second end of the support rod 230 away from the first tube body 210 , so that the medical catheter 20 switches to the second state.
  • the self-expanding structural member mentioned in this article means that the structural member itself has high elasticity, and it will deform when it is under pressure, and once the pressure is removed, it can return to its original shape under the action of its own elasticity , usually the self-expanding structure can be made of shape memory alloy.
  • the support rod 230 is a V-shaped self-expanding structure, and the free end of the first part 231 and the free end of the second part 232 respectively constitute two The two first ends are respectively connected to the first pipe body 210, and the junction of the first part 231 and the second part 232 constitutes the second end (so that each of the The first end is opposite to the second end), and connected to the electrode 201 (as shown in FIG. 3 ).
  • the number of the electrodes 201 is multiple, and the multiple electrodes 201 are uniformly arranged along the circumferential direction of the first tube body 210 .
  • the number of the electrodes 201 can be three, so that the three electrodes 201 The combination can achieve 360° coverage of the shock wave in the circumferential direction.
  • the number of the electrodes 201 can be selected from 1 to 6.
  • the first tube body 210 and the second tube body 240 are arranged coaxially, so the axis of the first tube body 210 is the axis of the medical catheter 20 .
  • the second tube body 240 moves along the axial direction of the first tube body 210 until the distal end of the second tube body 240 is on the proximal end side of the first balloon 220 , and When the first balloon 220 has not been inflated, the second portion of the support rod 230 has expanded, and exerts a radial support force on the first balloon 220 . Since the first balloon 220 is made of elastic polymer material, it will not be damaged by the support rod 230 .
  • the medical catheter 20 further includes a developing element 202 for indicating the position of the first balloon 220 in the patient's body.
  • the developing element 202 can be arranged at the distal end of the first tube 210 and inside the first balloon 220 , or, the developing element 202 can also be arranged near the first balloon 220 . terminal and/or remote.
  • the first balloon 220 is delivered to the position where the calcified lesion occurs in the body.
  • the second tubular body 240 is retracted to expand the second portion of the support rod 230 .
  • the conductive medium is perfused into the first balloon 220 to fill the first balloon 220 and immerse the electrode 201 .
  • the conductive medium may be, for example, a mixture of physiological saline and contrast agent, and the ratio of physiological saline to contrast agent may be 1:1 ⁇ 4:1.
  • the shock wave generator is used to make the electrode 201 generate a shock wave, and the shock wave is transmitted to the calcified lesion area by the conductive medium.
  • the user can push the second tube body 240 along the direction from the proximal end to the distal end of the first tube body 210, so that the second tube body 240 is set in the second tube body 210 again. on the first balloon 220 and apply radial pressure to the support rod 230 to switch the medical catheter 20 to the first state.
  • each component of the medical catheter 20 can be selected according to actual needs. Taking the use of the medical device to treat aortic valve calcification as an example, the diameter of the first balloon 220 matches the size of the valve, which can be 8 mm to 10 mm. 32mm, the axial length can be 20mm ⁇ 50mm. The outer diameter of the second tube body 240 may be 2mm ⁇ 6mm.
  • the distance from the second end of the support rod 230 to the axis of the first tube 210 (that is, the axis of the medical catheter 20 ) is 0.5-1.5mm In this way, while improving the treatment effect, it is also possible to avoid shock wave burns to the valve due to the excessive distance between the electrode 201 and the axis of the first tubular body 210 causing the electrode 201 to be too close to the valve.
  • the tube wall of the first tube body 210 is opened with a liquid flow channel extending along its axial direction. channel, and the side of the tube body 210 is also provided with a perfusion hole for communicating the liquid channel and the inner cavity of the first balloon 220 .
  • the medical catheter further includes a perfusion tube 221, the perfusion tube 221 is sleeved on the outside of the first tube body 210, and the distal end of the perfusion tube 221 It is connected with the proximal end of the first balloon 220 and also communicates with the lumen of the first balloon 220 .
  • the user injects filling agent at the proximal end of the perfusion tube 221 , and the filling agent flows into the lumen of the first balloon 220 along the gap between the perfusion tube 221 and the first tube body 210 .
  • the second tube body 240 is sleeved on the outside of the perfusion tube 221 .
  • the support rod 230 may be a linear structure and an elastic member, and the first end of the support rod 230 is connected to the first pipe body 210, and the first end of the support rod 230 is connected to the first pipe body 210, The two ends are connected with the electrodes 201 .
  • the medical catheter 20 further includes a control pull cord (not shown in the figure), through which the user switches the medical catheter 20 from the first state to the second state.
  • the elastic parts described here can be made of shape memory alloys, or other elastic metals or polymer materials, as long as they can store elastic potential energy when subjected to external force and deform, and release the elastic energy when the external force is canceled.
  • the elastic potential energy is enough, which is not limited in this embodiment.
  • the axis of the medical catheter 20 refers to the axis of the first tube body 210 .
  • the proximal end of the control pull cord extends to the proximal end of the first tube body 210 to facilitate the user's operation, and the distal end of the control pull cord is connected to the support rod 230 (preferably with the support rod 230 The second end of the support rod 230) is connected.
  • the support rod 230 abuts (or substantially abuts) on the first tube body 210 , at this time, the control pull cord and the support rod 230 There is no interaction between them.
  • the second end of the support rod 230 can be driven to move away from the first tube body 210 along the direction.
  • the direction of a tube body 210 moves, and increases the distance from the electrode 201 to the axis of the medical catheter 20 (that is, drives the medical catheter to switch to the second state), during which the support rod 230 stores elastic potential energy.
  • the support rod 230 releases the elastic potential energy and drives the second end of the support rod 230 to move in a direction close to the first tube body 210 , so that the medical catheter 20 switch to the first state.
  • the medical catheter 20 may also include the second tube body 240 .
  • the second tube body 240 When the medical catheter 20 is delivered into the body and the medical catheter 20 is withdrawn from the body, the second tube body 240 is sleeved on the outer surface of the first tube body 210 and the first balloon 220 superior. That is, the second tube body 240 only serves as a delivery sheath.
  • the support rod 230 is preferably a linear structure, the first end of the support rod 230 is movably connected to the first pipe body 210, and can be moved along Axial movement of the first tube body 210 .
  • the medical catheter 20 also includes a pushing part (not shown in the figure) and a positioning part (not shown in the figure).
  • the proximal end of the pusher extends to the proximal end of the first tube body 210 to facilitate user operation, and the distal end of the pusher is connected to the support rod 230, preferably to the first end of the support rod 230. Connected at one end.
  • the positioning element is connected to the proximal end of the pushing element and connected to the first tube body 210 for fixing the pushing element on the first tube body 210 .
  • the control pusher when the medical catheter 20 is in the first state, applies a pulling force to the support rod 230 along the distal end of the first tube body 210 toward the proximal end, so that The support rod 230 is arranged parallel to (or substantially parallel to) the first tube body 210 , and at the same time, the positioning member fixes the control pushing member at the first position.
  • the user releases the fixation of the positioning member to the control pusher, and pushes the control pusher along the direction from the proximal end to the distal end, so as to drive the
  • the first end of the support rod 230 moves in a direction close to the distal end of the first tube body 210, while the second end of the support rod 230 moves in a direction away from the first tube body 210, so that the The medical catheter 20 is switched to the second state, and then the positioning member is used to fix the control pushing member at the second position.
  • the user can apply a force along the first end of the support rod 230 through the control pusher.
  • the distal end of the first tube 210 is pulled toward the proximal end, so that the medical catheter 20 switches back to the first state.
  • the balloon catheter also includes an electrode wire with an insulating layer, the proximal end of the electrode wire is used to electrically connect with the shock wave generator 10, and the electrode wire is along the first tubular body. 210 extends axially, and the distal end of the electrode wire extends into the balloon 220 and is electrically connected to the electrode 201 .
  • the electrode wire can be integrally formed with the electrode 201. In actual production, the electrode 201 is formed by removing part of the insulating layer at the distal end of the electrode wire to partially expose the conductor of the electrode wire. .
  • the electrode wire has a certain rigidity, so as to prevent the electrode wire from being deformed and causing the support rod 230 to be deformed when the proximal end of the support rod 230 moves in a direction close to the proximal end of the first tube body 210 under the action of tension.
  • the second end of the rod 230 moves synchronously with the first end.
  • the axis of the medical catheter 20 in this embodiment is the axis of the first tube body 210 .
  • the medical catheter 20 includes a third tube body 250 and an inner tube assembly.
  • the inner tube assembly may include a fourth tube body 260 and a pre-shaped tube body 270, the pre-shaped tube body 270 is a self-expanding structural member, and its distal end may be connected to the fourth tube body 260, Its proximal end can be connected to the distal end of the third tube 250 .
  • the pre-shaped tube body 270 constitutes the loading part, that is, the electrode 201 is disposed in the inner cavity of the pre-shaped tube body 270 .
  • the third tube body 250 is sleeved on the outside of the fourth tube body 260, and the inner tube assembly can move axially relative to the third tube body 250, when the fourth tube body 260 is relatively
  • the pre-shaped tube body 270 can be expanded in the radial direction to be in the second state; otherwise, when the fourth tube body
  • the third tube body 250 applies a pulling force to the pre-shaped tube body 270 along the direction from the distal end to the proximal end, And the pre-shaped tube body 270 is stretched in the axial direction, and at the same time shrunk in the radial direction to the first state.
  • the axis of the medical catheter 20 is the axis of the fourth tube 260 .
  • the pre-shaped tube body 270 may at least partially assume a three-dimensional helical structure in a natural state.
  • the so-called natural state refers to a state in which the pre-shaped tube body 270 is not subjected to external pressure.
  • the pre-shaped tubular body 270 may include a proximal connection section 271 , a main body section 272 and a distal connection section 273 , and the main body section 272 has a three-dimensional helical structure in the natural state.
  • the main body section 272 is helically wound on the outer surface of the fourth tube body 260 , and the main body section 272 has a larger pitch.
  • the main body section 272 expands radially outward, so that the distance between the main body section 272 and the fourth tubular body 260 increases, and the main body Section 272 is also axially retracted so that the pitch of the body section 272 is reduced.
  • the using method of the medical catheter 20 provided by the present embodiment is as follows:
  • the user pours a conductive medium into the pre-shaped tube body 270.
  • the conductive medium can be mixed with physiological saline and a developer.
  • the pre-shaped tube body 270 can be directly developed during delivery. , and determine its position in the patient's body.
  • the distal end of the medical catheter 20 is then delivered to the calcified lesion in the patient.
  • the main body section 272 of the tubular body 270 is at least partially expanded.
  • the main body section 272 of the pre-shaped tubular body 270 is at least partially expanded.
  • shock wave generator is used to make the electrode 201 generate shock waves for treatment.
  • the main body section 272 of the pre-shaped tubular body 270 is still at least partially expanded due to the withdrawal of the fourth tubular body 260 through the previous operation. Pushing the fourth tube body 260 can switch the medical catheter 20 back to the first state, and then the medical catheter 20 can be withdrawn from the body.
  • the medical catheter 20 in this embodiment is expanded to the second state, it can be directly anchored to the lesion by using the main body section 272, without setting a balloon or other anchors, and also It will not block blood flow, avoid rapid pacing and other complications caused by balloon inflation.
  • the user can also adjust the expansion degree of the pre-shaped tube body 270 by adjusting the retracted length of the fourth tube body 260, so as to adapt to the area of calcified lesions.
  • the medical device is especially suitable for patients with early aortic calcification. Since the aortic calcification is concentrated at the root, the appearance of clinical symptoms can be effectively delayed after early calcification is eliminated.
  • the electrodes 201 are specifically arranged inside the main body section 272 of the pre-shaped tubular body 270, preferably the number of the electrodes 201 is 2-6, and the electrodes 201 can be arranged along the The axial direction of the pre-shaped tube body 270 is arranged sequentially.
  • the outer diameter of the third tubular body 250 may be 2 mm to 6 mm, and the outer diameter of the three-dimensional helical structure formed by the expansion of the main body segment 272 may be 8mm ⁇ 32mm.
  • the medical catheter 20 also includes a first sheath that is movably sleeved on the outside of the third tube body 250, the fourth tube body 260, and the pre-shaped tube body 270 (in the figure not shown), the first sheath is used to deliver the third tubular body 250, the fourth tubular body 260, and the pre-shaped tubular body 270 to the lesion site.
  • the medical catheter does not have the third tube body, but has a second sheath tube, and the second sheath tube is used to be movably fitted on the inner tube assembly of the exterior.
  • the medical catheter is configured such that when the second sheath is sleeved on the inner tube assembly and covers the pre-shaped tubular body, the second sheath applies a radial force to the pre-shaped tubular body. pressure to radially compress the pre-shaped tubular body and keep the medical catheter in the first state.
  • the second sheath moves in a direction from the distal end to the proximal end of the fourth tubular body so that at least a part of the pre-shaped tubular body protrudes from the distal end of the second sheath
  • the distal end of the pre-shaped tubular body moves proximally along the axial direction of the fourth tubular body 260, and enables the section of the pre-shaped tubular body protruding from the distal end of the second sheath tube to be at least Partially radially outwardly expanded such that the medical catheter is in the second state.
  • the pre-shaped tubular body may also include a proximal connecting section, a main body section and a distal connecting section.
  • the proximal connection section is connected to the fourth tube body, and preferably communicates with the fourth tube body, so that the user can use the fourth tube body to pour the pre-shaped tube into the conductive medium, and use the fourth pipe body 260 to discharge the conductive medium.
  • the proximal connecting section can also extend along the axial direction of the fourth tube body, and be directly used for connecting with an external perfusion mechanism.
  • the distal connecting section is movably connected to the fourth tube body.
  • the body segment is pre-shaped into a three-dimensional helical structure.
  • the distal connecting section is configured to keep relatively stationary with the fourth tubular body in the circumferential direction.
  • the main body section When the medical catheter is in the first state, the main body section is helically wound on the outer surface of the fourth tubular body under the extrusion of the third tubular body, and the main body section has a larger pitch.
  • the main body section When the medical catheter is in the second state, the main body section expands radially outward, so that the distance between the main body section and the fourth tubular body increases, and at the same time, the main body section also expands along the axis retract to reduce the pitch of the body section.
  • the distal connecting section can move either in the axial direction of the fourth tubular body or in the circumferential direction of the fourth tubular body.
  • the main body section can be in a straight line under the extrusion of the third tube body and lean against the outer surface of the fourth tube body, while when the medical catheter is switched to the second state, the main body segment expands radially and retracts axially, so as to recover to a three-dimensional helical structure.
  • the method of use is as follows:
  • the user pours a conductive medium into the pre-shaped tube body through the fourth tube body.
  • the conductive medium can be mixed with physiological saline and developer.
  • the pre-shaped tube body can be directly processed during delivery.
  • the tube body is visualized and its position in the patient's body is judged.
  • the distal end of the medical catheter is then delivered to the calcified lesion in the patient.
  • the second sheath is then retracted and the main body section of the pre-shaped tubular body is at least partially expanded.
  • shock wave generator is used to make the electrodes generate shock waves for treatment.
  • the user can push the second sheath to the distal end of the fourth tube to switch the medical catheter back to the first state, and then withdraw the medical catheter from the body.
  • the axis of the medical catheter is the axis of the fourth tube.
  • each pre-shaped tube body 270 is pre-shaped into an arc-shaped structure, preferably the The whole pre-shaped tube body 270 is pre-shaped into an arc-shaped structure, and the concave side of the arc-shaped structure faces the fourth tube body 260 .
  • the number of the pre-shaped tube body 270 is preferably multiple, such as 3-8, and the multiple pre-shaped tube bodies 270 are arranged around the circumference of the fourth tube body 260, so that the inner The pipe assembly is arranged coaxially with the third pipe body 250 .
  • each pre-shaped tubular body 270 is connected to the fourth tubular body, and the proximal end is connected to the third tubular body 250, and the third tubular body 250 can be relative to the fourth tubular body.
  • the fourth tube body 260 moves axially.
  • the third tube body 250 applies a pulling force from the distal end to the proximal end to the pre-shaped tube body 270 and makes the pre-shaped tube 270 in a straight line state
  • the pulling force is gradually canceled, and the pre-shaped tube body 270 can be Dilation to the lantern configuration is performed to switch the medical catheter 20 to the second state.
  • the pulling force will also be gradually canceled.
  • the expanded pre-shaped tube body 270 can be used to anchor the lesion, and the relative movement distance between the third tube body 250 and the fourth tube body 260 can be adjusted to adjust the The degree of expansion of the pre-shaped tubular body 270 is adapted to the anatomical structure of the lesion.
  • the axis of the medical catheter 20 is the axis of the fourth tube 260 .
  • the medical catheter does not include the third tube body, but includes a second sheath tube 290 .
  • the distal end of the pre-shaped tube body 270 is movably connected to the fourth tube body 260 and can move along the axial direction of the fourth tube body 260 .
  • the distal ends of the plurality of pre-shaped tubes 270 are all set on an annular connecting piece, and then connected to the fourth tube body 260 through the annular connecting piece.
  • the proximal end of the pre-shaped tube 270 extends along the proximal end of the fourth tube 260 and is used for connecting with an external injection device.
  • the second sheath tube 290 is used to be movably sleeved on the outside of the pre-shaped tube body 270 .
  • the second sheath 290 is covered on the outside of the pre-shaped tube 270, and at this time the pre-shaped tube 270 is in the second
  • the sheath tube 290 is in a straight shape under extrusion and leans against the outer surface of the fourth tube body 260 .
  • the distal end of the pre-shaped tube 270 gradually moves from the second sheath 290
  • the distal end of the sheath protrudes, and also moves on the fourth tubular body 260 along the direction from the distal end to the proximal end, so that the pre-shaped tubular body 270 extends from the distal end of the second sheath tube 290
  • the resulting pipe section is at least partially expanded into an arc shape, so that the expanded portions of the plurality of pre-shaped pipe bodies 270 are jointly formed into a lantern shape (as shown in FIGS. 11 and 12 ).
  • each of the pre-shaped tubes 270 is provided with a plurality of electrodes 201 sequentially arranged along the axial direction of the pre-shaped tube 270 .
  • the outer diameter of each pre-shaped tube body 270 may be 0.5mm ⁇ 2mm.
  • a developing element 202 may also be provided on the distal end of the fourth tube body 260 for displaying the position of the distal end of the inner tube assembly in the patient's body.
  • the axis of the medical catheter 20 is the axis of the fourth tube 260 .
  • the distal end of the pre-shaped tube body 270 is pre-shaped into a V-shaped structure or a U-shaped structure, and includes interconnected Third part 274 and fourth part 275 .
  • the proximal end of the third part 274 can be connected to the fourth tube body 260, or the proximal end of the third part 274 extends along the axial direction of the fourth tube body 260 and is used to communicate with an external injection device. connect.
  • the fourth portion 275 is located on a side of the third portion 274 away from the fourth tube 260 and constitutes the loading portion, and the distal end of the fourth portion 275 is a free end.
  • the multiple pre-shaped tube bodies 270 are arranged in sequence along the circumference of the fourth tube body 260, so that the fourth tube body 260 may be arranged coaxially with said second sheath 290 .
  • the axis of the fourth tube 260 is the axis of the medical catheter 20 .
  • the pre-shaped tubular body 270 is stretched in a straight line under the extrusion of the second sheath tube 290 (that is, the third part 274 and the The fourth part 275 is arranged along the axial direction of the fourth tube body 260 ), and abuts against the outer surface of the four tube body 260 .
  • the fourth portion 275 fully protrudes from the distal end of the third tube body 250 and is bent radially outward, so that the pre-shaped tube
  • the distal expansion of the body 270 is V-shaped or U-shaped.
  • the third portion 274 protrudes by the The section of the second sheath tube 290 can also expand radially outwards so that there is a gap between it and the outer surface of the fourth tube body 260 .
  • the inner tube assembly further includes an anchor 280 , and the third tube 250 can be used to cover the anchor 280 .
  • the anchor 280 is connected to the fourth tube 260 and is preferably located on the distal side of the pre-shaped tube 270, and is used for positioning the inner tube assembly at a predetermined position in the patient's body. , and keep the fourth part 275 of the pre-shaped tubular body 270 at the position of the calcified lesion.
  • the anchor 280 includes a plurality of branch tubes 281 and a plurality of second balloons 282, the plurality of branch tubes 281 are preferably arranged at intervals along the circumference of the fourth tube 260, the branch tubes Both the proximal end and the distal end of 281 are connected to the fourth tube body 260 , and one second balloon 282 is disposed on the outer surface of each branch tube body 281 .
  • the second balloon 282 is preferably a compliant balloon.
  • the medical catheter 20 in the first state is transported into the body, and the distal end of the pre-shaped tube body 270 of the inner tube assembly is The end reaches the calcified lesion, and the anchor 280 is at the distal end of the calcified lesion.
  • the third tubular body 250 is withdrawn, so that the anchoring member 280 and the distal end of the pre-shaped tubular body 270 protrude from the distal end of the third tubular body 250 .
  • fill the second balloon 282 with a filling agent, so that the second balloon 282 is filled and the medical catheter 20 is anchored and fixed, and then a conductive medium can be poured into the pre-shaped tube 270 and performed treat.
  • the third tube 250 may not cover the anchor 280, and when delivered to the lesion site, fill the second balloon 282 with filling agent to make the second balloon 282 inflated Perform anchoring and positioning, and then withdraw the second sheath tube 290, so that the distal end of the pre-shaped tubular body 270 protrudes from the distal end of the second sheath tube 290, and then the pre-shaped tube can be Body 270 is perfused with a conductive medium and treated.
  • the second sheath tube 290 may also be fixed, and the pre-shaped tubular body 270 is operated to move axially to protrude from the second sheath tube 290 .
  • the anchoring member 280 including a plurality of second balloons 282 for anchoring and positioning, the contact area between the second balloons 282 and the leaflet is large, the anchoring effect is better, and there is no damage to the leaflet. Not only that, there are gaps between the plurality of second balloons 282 for blood circulation, avoiding rapid pacing and other complications caused by blocking blood flow.
  • the medical catheter includes an inner tube assembly, and the inner tube assembly includes a fourth tube body and a controllable bend tube body.
  • the number of the controllable bending pipe bodies is preferably multiple, and the plurality of controllable bending pipe bodies are arranged in sequence along the circumference of the fourth pipe body.
  • Each of the controllable bending pipe bodies includes a straight pipe section, a controllable bending section and a control pull cord.
  • the proximal end of the straight pipe section is connected to the fourth pipe body and communicated with the fourth pipe body, so that the user can pour a conductive medium into the controllable bend pipe body through the fourth pipe body, or the At least part of the outer surface of the straight tube section is connected to the fourth tube body, and the proximal end of the straight tube section extends along the axial direction of the fourth tube body and is used for connecting with an external injection device.
  • the proximal end of the controllable bending section is connected to the straight pipe section, the distal end of the controllable bending section is a free end, and the controllable bending section constitutes the loading part; the control pull cord is used to control The controllable bend bends or straightens
  • the medical catheter is configured such that when the medical catheter is in the first state, the controllable bending section is in a straight shape and fits on the outer surface of the fourth tubular body.
  • the control pull cord applies a pulling force directed from the distal end of the fourth tubular body to the proximal end on the controllable bending section, the controllable bending section bends radially outward so that the controllable bending section
  • the distal expansion of the tube body is in a V-shaped or U-shaped structure.
  • the medical catheter further includes a second sheath, and the second sheath is used to be movably sleeved on the outside of the inner tube assembly.
  • the second sheath can cover the inner tube assembly, and before switching the medical catheter to the second state, the second sheath can be retracted by withdrawing the first Two sheath tubes allow the controllable bend section to protrude from the distal end of the second sheath tube, and then the controllable bend tube body can be pulled to expand by controlling the pull cord.
  • the medical catheter described in this embodiment also includes an anchor, and the structure of the anchor can refer to the anchor in Embodiment 8, which will not be repeated here.
  • the axis of the delivery medical catheter is the axis of the fourth tube.

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Abstract

一种医用导管及医用装置,医用装置包括医用导管(20),医用导管(20)包括装载部和电极(201);装载部具有一内腔,内腔中设置有电极(201),电极(201)用于产生冲击波;内腔还用于容纳导电介质,导电介质用于传递冲击波;医用导管(20)被配置为当医用导管(20)由第一状态切换至第二状态时,电极(201)到医用导管(20)之轴线的距离增大。医用装置可对钙化病变进行治疗,并可使电极(201)与病变区域的距离较近,以提高冲击波传递至病变区域的能量,改善治疗效果。

Description

一种医用导管及医用装置 技术领域
本发明涉及医疗器械技术领域,具体涉及一种医用导管及医用装置。
背景技术
钙化病变具有多种类型,例如主动脉瓣钙化(CAVD),主动脉钙化是钙结节在主动脉瓣膜表面的异位蓄积,会导致主动脉瓣膜增厚及功能性狭窄。退行性钙化性主动脉瓣狭窄(CAS)是主动脉瓣随年龄增长发生的退行性变例如纤维化、钙化,并最终出现功能障碍性的心脏瓣膜病。CAS是目前老年人中最为常见的心脏瓣膜病,随着中国渐入老龄化社会,加之人们生活质量的提高和平均寿命的延长,钙化性主动脉瓣狭窄在中国的发病率及患病率逐年上升。
目前手术治疗是CAS较为有效的治疗方法,其包括了外科主动脉瓣置换术(SAVR)及经导管主动脉瓣置换术(TAVR),其中,SAVR创伤大、恢复时间长,近年来正逐渐被TAVR替代。但不论是SAVR还是TAVR都有较为严格的适应症和禁忌症,更适用于重度狭窄患者,且对主动脉瓣的解剖结构有一定的要求。针对早期的轻中度主动脉瓣钙化,目前临床上尚无较好的治疗方法。其他类型的钙化病变的治疗也存在类似的问题。
发明内容
本发明的目的在于提供一种医用导管及医用装置,可在不进行手术的情况下对钙化病变进行有效治疗。
为实现上述目的,本发明提供了一种医用导管,包括装载部和电极;所述装载部具有一内腔,所述内腔中设置有所述电极,所述电极用于产生冲击波;所述内腔还用于容纳导电介质,所述导电介质用于传递所述冲击波;
所述医用导管被配置为当所述医用导管由第一状态切换至第二状态时,所述电极到所述医用导管之轴线的距离增大。
可选地,所述医用导管包括第一管体、第一球囊和支撑杆,所述第一球 囊套装在所述第一管体的远端外表面上并构成所述装载部;所述支撑杆设置在所述第一球囊内部,且所述支撑杆具有相对的第一端和第二端,其中,所述第一端与所述第一管体连接,所述第二端与所述电极连接;
所述医用导管被配置为当所述医用导管处于所述第一状态时,所述支撑杆的第二端靠近所述第一管体的轴线,并使所述电极靠近所述第一管体的轴线;当所述医用导管处于所述第二状态时,所述支撑杆的第二端远离所述第一管体的轴线,并使所述电极远离所述第一管体的轴线。
可选地,所述支撑杆为自膨式结构,并包括成角度连接的第一部分和第二部分,所述第二部分具有所述第一端和所述第二端,所述第一端通过所述第一部分连接于所述第一管体上;或者,
所述第一部分和所述第二部分的自由端分别构成一个所述第一端并连接于所述第一管体上,所述第一部分和所述第二部分的连接处构成所述第二端。
可选地,还包括第二管体,用于可活动地套装在所述第一管体及所述球囊的外部;
所述医用导管被配置为当所述第二管体套装在所述球囊外部时,所述第二管体向所述支撑杆施加径向压力,并使所述医用导管处于所述第一状态;当所述第二管体沿远端向近端的方向移动,并解除施加在所述支撑杆上的径向压力时,所述支撑杆沿径向向外扩张,以使所述支撑杆的第二端远离所述第一管体,并使得所述医用导管处于所述第二状态。
可选地,所述支撑杆为弹性件;所述医用导管还包括控制拉绳,所述控制拉绳的远端与所述支撑杆连接;
所述医用导管被配置为所述控制拉绳用于向所述支撑杆施加拉力并驱使所述支撑杆的第二端沿远离所述第一管体的方向移动,以使得所述医用导管处于所述第二状态,且所述支撑杆存储弹性势能;当所述拉力被取消时,所述支撑杆释放所述弹性势能并驱使所述支撑杆的第二端沿靠近所述第一管体的方向运动,以使所述医用导管恢复至所述第一状态。
可选地,所述医用导管还包括推送件和定位件;所述推送件的远端与所述支撑杆连接,所述推送件用于驱使所述支撑杆的所述第一端沿所述管体的 轴向移动;所述定位件与所述推送件连接,并还连接于所述第一管体上;所述定位件用于将所述推送件固定在所述第一管体上;
当所述推送件沿由近端向远端的方向推送所述支撑杆时,所述支撑杆的第二端沿远离所述第一管体的方向移动,以使所述医用导管切换至所述第二状态;当所述推送杆沿由远端向近端的方向移动时,所述支撑杆的第二端沿靠近所述第一管体的方向移动,以使所述医用导管切换至所述第一状态。
可选地,所述医用导管包括第三管体和内管组件;所述内管组件包括预塑形管体和第四管体,所述第四管体部分地设置在所述第三管体内部,所述预塑形管体为自膨式结构,所述预塑形管体的至少部分管段构成所述装载部;所述预塑形管体的近端连接于所述第三管体的远端上,所述预塑形管段远端连接于所述第四管体上;
所述医用导管被配置为当所述第四管体相对于所述第三管体沿近端向远端的方向移动时,所述预塑形管体沿径向收缩,以使所述医用导管处于所述第一状态,当所述第四管体相对于所述第三管体沿远端向近端的方向移动时,所述预塑形管体沿径向向外扩张,并使所述医用导管处于所述第二状态。
可选地,当所述医用导管处于所述第二状态时,所述预塑形管体的远端至少部分地呈三维螺旋结构;
或者,所述预塑形管体的远端至少部分地呈弧形结构,且所述弧形结构的凹侧朝向所述第四管体。
可选地,还包括第一鞘管,所述第一鞘管用于可活动地套装在第三管体及所述预塑形管体的外部。
可选地,所述医用导管包括第二鞘管和内管组件,所述第二鞘管可活动地套装在所述内管组件的外部;所述内管组件包括预塑形管体和第四管体,所述预塑形管体的远端连接于所述第四管体上;
所述医用导管被配置为当所述第二鞘管套装在所述内管组件上并覆盖所述预塑形管体时,所述第二鞘管向所述预塑形管体施加径向压力以沿径向压缩所述预塑形管体,并使所述医用导管处于所述第一状态;当所述第二鞘管沿由远端向近端的方向移动,并使所述预塑形管体的至少部分管段从所述第 二鞘管的远端伸出时,所述预塑形管体从所述第二鞘管的远端伸出的管段能够至少部分地沿径向向外扩张,并使所述医用导管处于所述第二状态。
可选地,所述预塑形管体包括相互连接的第三部分和第四部分,所述第三部分的近端连接于所述第四管体上并与所述第四管体连通,或者所述第三部分的至少部分外表面与所述第四管体连接,且所述第三部分的近端沿所述第四管体的轴向延伸;所述第四部分的远端为自由端,且所述第四部分构成所述装载部;
当所述医用导管处于所述第一状态时,所述预塑形管体贴靠在所述第四管体的外表面上;当所述医用导管处于所述第二状态时,所述第四部分沿径向向外弯折并使所述预塑形管体扩张呈V型结构或U型结构。
可选地,所述内管组件还包括锚定件,连接于所述第四管体上;所述锚定件包括分支管体和第二球囊,所述分支管体的数量为多个,多个所述分支管体沿所述第四管体的周向间隔布置,且每个所述分支管体的外表面上均套装有所述第二球囊。
可选地,当所述医用导管处于所述第二状态时,所述预塑形管体至少部分地呈三维螺旋结构;
或者,所述预塑形管体至少部分地呈弧形结构,且所述弧形结构的凹侧朝向所述第四管体。
可选地,所述医用导管包括内管组件;所述内管组件包括第四管体和可控弯管体;所述可控弯管体包括直管段、可控弯段和控制拉绳;所述直管段的近端连接于所述第四管体上,并与所述第四管体连通,或者所述直管段的近端外表面至少部分地与所述第四管体连接;所述可控弯段的近端与所述直管段的远端连接,所述可控弯段的远端为自由端,且所述可控弯段构成所述装载部;所述控制拉绳用于控制所述可控弯段弯曲或伸直;
所述医用导管被配置为当所述医用导管处于所述第一状态时,所述可控弯管体呈直线形态并贴靠在所述第四管体的外表面上;当所述控制拉绳向所述可控弯段施加拉力时,所述可控弯段沿径向向外弯曲以使所述可控弯管体的远端扩张形成V型结构或U型结构。
可选地,所述医用导管还包括第二鞘管,所述第二鞘管用于可活动地套装在所述内管组件的外部。
可选地,所述医用导管还包括锚定件,设置在所述第四管体上;所述锚定件包括分支导管和第二球囊,所述分支导管的数量为多个,多个所述分支导管沿所述第四管体的周向间隔布置,且每个所述分支导管的外表面上均套装有所述第二球囊。
为实现上述目的,本发明还提供了一种医用装置,包括冲击波发生器和如前任一项所述的医用导管,所述冲击波发生器用于与所述电极电性连接,并使所述电极产生所述冲击波。
与现有技术相比,本发明的医用导管及医用装置具有如下优点:
前述的医用装置包括医用导管和冲击波发生器,所述医用导管包括装载部和电极,所述装载部具有一内腔,所述内腔中设置有所述电极,所述电极与所冲击波发生器电性连接,并在所述冲击波发生器的作用下产生冲击波,所述内腔还用于容纳导电介质,所述导电介质用于传递所述冲击波;所述医用导管被配置为当所述医用导管由第一状态切换至第二状态时,所述电极到所述医用导管之轴线的距离增大。利用所述医用装置对钙化病变进行治疗时,所述医用导管处于所述第二状态,从而可减小所述电极到钙化病变位置的距离,实现较好的治疗效果,避免因电极到钙化病变的距离较远而导致传递至钙化病变处的冲击波能量降低,不能有效软化钙化区域。
附图说明
附图用于更好地理解本发明,不构成对本发明的不当限定。其中:
图1是本发明根据实施例一至实施例三所提供的医用装置的结构示意图,图示中医用导管处于第二状态;
图2是图1所示的医用装置的局部结构示意图;
图3是替代性的实现方式中的医用装置的结构示意图;
图4是替代性的实现方式中的医用装置的结构示意图,图中示出灌注管;
图5是图2所示的医用装置的A-A剖视图;
图6是本发明根据实施例一至实施例三所提供的医用装置的局部结构示意图,图示中医用导管处于第一状态;
图7是本发明根据实施例四所提供的医用装置的结构示意图,图示中医用导管处于第一状态,且图示中仅示出部分第三管体;
图8是本发明根据实施例四所提供的医用装置的结构示意图,图示中医用导管处于第二状态;
图9是本发明根据实例四所提供的医用装置的局部结构示意图,图示中医用导管处于第二状态;
图10是本发明根据实施例六所提供的医用装置的局部结构示意图,图示中医用导管处于第二状态;
图11是本发明根据实施例七所提供的医用装置的局部结构示意图;
图12是本发明根据实施例七所提供的医用装置的局部结构示意图,图12与图11的观察方位不同;
图13是本发明根据实施例八所提供的医用装置的结构示意图,图示中医用导管处于第二状态;
图14是本发明根据实施例八所提供的医用装置的局部结构示意图,图示中医用导管处于第二状态;
图15是本发明根据实施例八所提供的医用装置的局部结构示意图,图13与图13及图14的观察方位不同。
具体实施方式
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。需要说明的是,本实施例中所提供的图示仅以示意方式说明本发明的基本构想,遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制,其实际实施时各组件的型态、数量及比例可为一种随意的 改变,且其组件布局型态也可能更为复杂。
另外,以下说明内容的各个实施例分别具有一或多个技术特征,然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征,或仅能分开实施不同实施例中的一部或全部技术特征。换句话说,在实施为可能的前提下,本领域技术人员可依据本发明的公开内容,并视设计规范或实作需求,选择性地实施任一实施例中部分或全部的技术特征,或者选择性地实施多个实施例中部分或全部的技术特征的组合,借此增加本发明实施时的弹性。
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,复数形式“多个”包括两个以上的对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行使用的,除非内容另外明确指出外,以及术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接。可以是机械连接,也可以是电连接。可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
为使本发明的目的、优点和特征更加清楚,以下结合附图对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。
在本文中,术语“近端”、“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向,尽管“近端”、“远端”并非是限制性的,但是“近端”通常指该医疗设备在正常操作过程中靠近医生的一端,而“远端”通常是指首先进入患者体内的一端。
本发明的目的在于提供一种医用导管及包括所述医用导管的医用装置,该医用装置可利用液电效应来治疗血管的钙化病变或主动脉瓣的钙化病变。请参考图1、图4、图5及图6,所述医用装置包括冲击波发生器10和医用导管20,所述医用导管20包括装载部和电极201。所述装载部具有一内腔,所 述内腔中设置有所述电极201,所述电极201的近端用于与所述冲击波发生器10连接,并用于在所述冲击波发生器10的作用下产生冲击波。所述内腔还用于容纳导电介质,所述导电介质用于浸没所述电极201,并传递所述冲击波。所述医用导管20具有第一状态和第二状态,当所述医用导管20从所述第一状态切换至所述第二状态时,所述电极201到所述医用导管20之轴线的距离增大。在利用所述医用装置进行钙化病变的治疗时,首先将所述装载部导入病变部位,然后使所述医用导管20切换至所述第二状态以进行治疗,如此,所述电极201与病变区域较近,可提高传递至所述病变区域的冲击波的能量,避免因电极201与病变区域距离较远导致的传递至病变区域的能量不足而无法有效软化钙化区域。
以下结合具体实施例说明所述医用装置之医用导管20的结构。需要说明的是,以下仅以列举的方式说明书所述医用装置的可选结构,不应对本发明构成限制。
<实施例一>
请参考图1至图6,本实施例中的所述医用导管20包括第一管体210、第一球囊220和支撑杆230。所述第一球囊220套装在所述第一管体210的远端外表面上,并构成所述装载部,所述电极201设置在所述第一球囊220的内部。所述支撑杆230也设置在所述第一球囊220内部,且所述支撑杆230具有相对的第一端和第二端,所述第一端与所述第一管体210连接,所述第二端与所述电极201连接。所述医用导管20被配置为当所述医用导管20处于所述第一状态时,所述支撑杆230的第二端靠近所述第一管体210的轴线,从而所述电极201亦靠近所述第一管体210的轴线;当所述医用导管20处于所述第二状态时,所述支撑杆230的第二端远离所述第一管体210的轴线,以使所述电极201随之远离所述第一管体210的轴线。
具体地,所述支撑杆230为自膨式结构件,并预塑形呈“V”型结构。换句话说,所述支撑杆230包括成角度地连接的第一部分231和第二部分232。请继续参考图1,在一个非限制性的实现方式中,所述第二部分232具有所述第一端和所述第二端,所述第一端通过所述第一部分231连接于第一管体210 上。所述医用导管20还包括第二管体240,所述第二管体240用于可活动地套装在所述第一管体210及所述第一球囊220的外部。当所述第二管体240套装在所述第一球囊220外部时,所述第二管体240向所述支撑杆230的所述第二部分施加径向压力,以使所述第二部分贴靠(或基本贴靠)在所述第一管体210上,使得所述医用导管20处于所述第一状态。当所述第二管体240沿所述第一管体240的远端向近端的方向移动并解除施加在所述第二部分上的径向压力时,所述第二部分沿径向向外扩张以使所述支撑杆230的第二端远离所述第一管体210,从而所述医用导管20切换至所述第二状态。可理解,本文所述及的自膨式结构件是指所述该结构件自身具有高弹性,当其受到压力会发生变形,而一旦压力被取消,其可在自身的弹性作用下恢复至原状,通常自膨式结构件可采用形状记忆合金制造。
在替代性的实现方式中,所述支撑杆230为被预塑形成V型的自膨式结构,且所述第一部分231的自由端和所述第二部分232的自由端分别构成两个所述第一端,两个所述第一端分别与所述第一管体210连接,所述第一部分231和所述第二部分232的相接处构成所述第二端(如此每一个所述第一端均与所述第二端相对设置),并与所述电极201连接(如图3所示)。
所述电极201的数量为多个,多个所述电极201沿所述第一管体210的周向均匀布置。例如,当每个所述电极201所产生的冲击波在所述第一管体210的周向上的覆盖范围为120°时,所述电极201的数量可以是三个,以使三个电极201的组合可以实现冲击波在周向上360°的覆盖。根据实际情况,所述电极201的数量可在1~6个中选择。在此,所述第一管体210与所述第二管体240同轴布置,故而所述第一管体210的轴线即为所述医用导管20的轴线。
需要说明的是,在所述第二管体240沿所述第一管体210的轴向移动至所述第二管体240的远端处于所述第一球囊220的近端侧,且所述第一球囊220尚未被充盈时,所述支撑杆230的所述第二部分已经扩张,并向所述第一球囊220施加径向支撑力。由于所述第一球囊220采用弹性的高分子材料制作,其不会被所述支撑杆230损坏。
此外,本实施例中,所述医用导管20还包括显影元件202,用于指示所述第一球囊220在患者体内的位置。所述显影元件202可设置在所述第一管体210的远端,并位于所述第一球囊220内部,或者,所述显影元件202也可以设置在所述第一球囊220的近端和/或远端。
本实施例所提供的医疗装置的使用过程可以如下:
首先将所述第一球囊220输送至体内发生钙化病变的位置。
然后回撤所述第二管体240,以使所述支撑杆230的所述第二部分扩张。
接着向所述第一球囊220灌注导电介质,以使所述第一球囊220充盈,并浸没所述电极201。所述导电介质例如可以是生理盐水与造影剂混合而成,生理盐水与造影剂的配比可以是1:1~4:1。
最后利用所述冲击波发生器使所述电极201产生冲击波,该冲击波被所述导电介质传递至钙化病变区域。
回撤所述医用导管20时,使用者可沿所述第一管体210的从近端到远端的方向推送所述第二管体240,以使所述第二管体240再次套装在所述第一球囊220上,并向所述支撑杆230施加径向压力,以使所述医用导管20切换至所述第一状态。
所述医用导管20的各个部件的尺寸可根据实际需要选择,以利用所述医用装置治疗主动脉瓣钙化病变为例,所述第一球囊220的直径与瓣膜尺寸相匹配,可为8mm~32mm,轴向长度可为20mm~50mm。所述第二管体240的外径可以是2mm~6mm。当所述医用导管20处于所述第二状态时,所述支撑杆230的第二端到所述第一管体210的轴线(即所述医用导管20的轴线)的距离为0.5~1.5mm,如此在提高治疗效果的同时,还避免因电极201与所述第一管体210的轴线间的距离过大造成电极201过于靠近瓣膜而导致冲击波灼伤瓣膜。
本领域技术人员可理解,为实现向所述第一球囊220灌注充盈剂的目的,在一些实现方式中,所述第一管体210的管壁上开设有沿其轴向延伸的液体流道,且所述管体210的侧面上还开设有用于连通所述液体流道和所述第一球囊220之内腔的灌注孔。在替代性的实现方案中,请参考图4,所述医用导 管还包括一灌注管221,所述灌注管221套装在所述第一管体210的外部,且所述灌注管221的远端与所述第一球囊220的近端连接,并还与所述第一球囊220的内腔连通。使用者在所述灌注管221的近端灌注充盈剂,所述充盈剂沿所述灌注管221与所述第一管体210之间的空隙流入所述第一球囊220的内腔中。在此情况下,所述第二管体240套装在所述灌注管221的外部。
<实施例二>
本实施例与实施例一的区别之处在于,所述支撑杆230可以是直线型结构,并为弹性件,且所述支撑杆230的第一端与所述第一管体210连接,第二端与所述电极201连接。所述医用导管20还包括控制拉绳(图中未示出),使用者通过控制拉绳使所述医用导管20从所述第一状态切换至所述第二状态。此处所述的弹性件可采用形状记忆合金制作,也可以采用其他具有弹性的金属或高分子材料制作,只要其在受到外力且发生变形时能够存储弹性势能,并在外力取消后释放所述弹性势能即可,本实施例对此不作限定。此外,本实施例中,所述医用导管20的轴线是指所述第一管体210的轴线。
详细地,所述控制拉绳的近端延伸至所述第一管体210的近端,以方便使用者进行操作,所述控制拉绳的远端与所述支撑杆230(优选与所述支撑杆230的第二端)连接。当所述医用导管20处于所述第一状态时,所述支撑杆230贴靠(或基本贴靠)在所述第一管体210上,此时所述控制拉绳与所述支撑杆230之间没有相互作用力。当使用者通过所述控制拉绳向所述支撑杆230施加沿所述第一管体210的远端指向近端的拉力时,可驱使所述支撑杆230的第二端沿远离所述第一管体210的方向移动,并使所述电极201到所述医用导管20的轴线的距离增大(也即驱使所述医用导管切换至所述第二状态),此过程中所述支撑杆230存储弹性势能。当使用者取消所述拉力时,所述支撑杆230释放所述弹性势能并驱使所述支撑杆230的第二端沿靠近所述第一管体210的方向移动,以使所述医用导管20切换至所述第一状态。
此外,本实施例中,所述医用导管20也可以包括所述第二管体240。在将所述医用导管20输送至体内及将所述医用导管20从体外撤出时,所述第 二管体240套装在所述第一管体210及所述第一球囊220的外表面上。也即,所述第二管体240仅起到输送鞘管的作用。
<实施例三>
本实施例与实施例一的区别之处在于,所述支撑杆230优选为直线型结构,所述支撑杆230的第一端可活动地连接在所述第一管体210上,并能够沿所述第一管体210的轴向移动。所述医用导管20还包括推送件(图中未示出)和定位件(图中未示出)。所述推送件的近端延伸至所述第一管体210的近端,以方便使用者操作,所述推送件的远端与所述支撑杆230连接,优选与所述支撑杆230的第一端连接。所述定位件与推送件的近端相连,并连接于所述第一管体210上,用于将所述推送件固定在所述第一管体210上。
本实施例中,当所述医用导管20处于所述第一状态时,所述控制推送件向所述支撑杆230施加沿所述第一管体210的远端指向近端的拉力,以使所述支撑杆230平行于(或基本平行于)所述第一管体210布置,同时将定位件将所述控制推送件固定在第一位置。当所述第一球囊220被递送到病变位置时,使用者解除定位件对所述控制推送件的固定,并沿由近端向远端的方向推动所述控制推送件,以驱使所述支撑杆230的第一端沿靠近所述第一管体210的远端的方向移动,同时所述支撑杆230的第二端沿远离所述第一管体210的方向移动,以使所述医用导管20切换至所述第二状态,之后利用所述定位件将所述控制推送件固定在第二位置。
在利用本实施例所提供的医用装置进行钙化治疗后,在将所述医用导管20撤出体外时,使用者可通过所述控制推送件向所述支撑杆230的第一端施加沿所述第一管体210的远端指向近端的拉力,以使医用导管20切换回所述第一状态。
需要说明的是,所述球囊导管还包括具有绝缘层的电极线,所述电极线的近端用于与所述冲击波发生器10电性连接,所述电极线沿所述第一管体210的轴向延伸,且所述电极线的远端伸入所述球囊220内部并与所述电极201电性连接。通常所述电极线可与所述电极201一体成型,在实际生产中,通 过在所述电极线的远端去除部分所述绝缘层而使电极线的导电体部分地裸露而形成所述电极201。所述电极线具有一定的刚度,以避免所述支撑杆230的近端在拉力的作用下沿靠近第一管体210的近端的方向移动时,所述电极线发生变形并导致所述支撑杆230的第二端随第一端同步移动。还需要说明的是,本实施例中所述医用导管20的轴线是所述第一管体210的轴线。
<实施例四>
请参考图7至图9,本实施例中,所述医用导管20包括第三管体250和内管组件。所述内管组件可包括第四管体260和预塑形管体270,所述预塑形管体270为自膨式结构件,其远端可连接于所述第四管体260上,其近端可连接于所述第三管体250的远端。本实施例中,所述预塑形管体270构成所述装载部,也就是说,所述电极201设置在所述预塑形管体270的内腔中。所述第三管体250套设在所述第四管体260的外部,且所述内管组件可相对所述第三管体250做轴向移动,当所述第四管体260相对于所述第三管体250沿由远端向近端的方向移动时,可使所述预塑形管体270在径向上扩张开而处于所述第二状态;反之,当所述第四管体260相对于所述第三管体250沿由近端向远端的方向移动时,所述第三管体250向所述预塑形管体270施加沿由远端指向近端的拉力,并使所述预塑形管体270沿轴向被拉伸,同时沿径向收缩至所述第一状态。本实施例中,所述医用导管20的轴线为所述第四管体260的轴线。
本实施例中,所述预塑形管体270在自然状态下可至少部分地呈三维螺旋结构,所谓自然状态是指所述预塑形管体270未受到外界压力的状态。更为详细地,所述预塑形管体270可包括近端连接段271、主体段272及远端连接段273,所述主体段272在所述自然状态下呈三维螺旋结构。当所述医用导管20处于所第一状态时,所述主体段272螺旋盘绕在所述第四管体260的外表面上,且所述主体段272具有较大的螺距。当所述医用导管20处于所述第二状态时,所述主体段272沿径向向外扩张,以使所述主体段272到所述第四管体260的距离增大,同时所述主体段272还沿轴向回缩,以使所述主体 段272的螺距减小。
本实施例所提供的医用导管20的使用方法如下:
首先使用者通过向所述预塑形管体270灌注导电介质,所述导电介质可由生理盐水与显影剂混合而成,如此,在输送过程中可直接对所述预塑形管体270进行显影,并判断其在患者体内的位置。
接着将所述医用导管20的远端输送至患者体内的钙化病变区域。
接着回撤所述第四管体260(即,使所述第三管体250保持静止,并使所述第四管体260沿远端向近端的方向移动),并使所述预塑形管体270的主体段272至少部分地扩张。替代性地,也可以通过推送所述第三管体250(即,使所述第四管体260保持静止,并使所述第三管体沿由近端向远端的方向移动)来使所述预塑形管体270的主体段272至少部分地扩张。
最后利用所述冲击波发生器使所述电极201产生冲击波进行治疗。
治疗结束后,由于此时所述第四管体260经过之前操作进行了撤回而导致所述预塑形管体270的主体段272仍至少部分地扩张,在此情况下,使用者向远端推送所述第四管体260便可使所述医用导管20切换回所述第一状态,之后可将所述医用导管20撤出体外。
与实施例一至实施例三相比,本实施例所述医用导管20扩张至所述第二状态后,可直接利用所述主体段272锚固在病变部位,无需设置球囊或其他锚固件,也不会阻塞血流,避免球囊充盈时的快速起搏及其引发的其他并发症。不仅如此,使用者还可以通过调节所述第四管体260回撤的长度来调节所述预塑形管体270的扩张程度,以适应于钙化病变的区域。该医疗装置尤其适应于早期的主动脉钙化患者,由于主动脉钙化集中在根部,早期钙化消除后可有效延缓临床症状的出现时间。
应理解的是,本实施例中,所述电极201具体设置在所述预塑形管体270的所述主体段272内部,优选所述电极201的数量为2~6个,并可沿所述预塑形管体270的轴向依次布置。此外,当所述医用装置用于治疗主动脉瓣的钙化病变时,所述第三管体250的外径可为2mm~6mm,所述主体段272扩张形成的三维螺旋结构的外径可为8mm~32mm。
在其他实施方式中,医用导管20还包括可活动地套装在所述第三管体250、所述第四管体260、及所述预塑形管体270外部的第一鞘管(图中未示),所述第一鞘管用于将所述第三管体250、所述第四管体260、及所述预塑形管体270输送至病变位置。
<实施例五>
本实施例与实施例四的区别之处在于所述医用导管不具有所述第三管体,而具有一第二鞘管,所述第二鞘管用于可活动地套装在所述内管组件的外部。所述医用导管被配置为当所述第二鞘管套装在所述内管组件上并覆盖所述预塑形管体时,所述第二鞘管向所述预塑形管体施加径向压力以沿径向压缩所述预塑形管体,并使所述医用导管处于所述第一状态。当所述第二鞘管沿所述第四管体的远端向近端的方向移动以使所述预塑形管体的至少部分管段从所述第二鞘管的远端伸出时,所述预塑形管体的远端沿所述第四管体260的轴向向近端移动,并使所述预塑形管体从所述第二鞘管远端伸出的管段能够至少部分地沿径向向外扩张,以使得所述医用导管处于所述第二状态。
本实施例中,所述预塑形管体同样可包括近端连接段、主体段及远端连接段。所述近端连接段连接于所述第四管体上,并优选与所述第四管体连通,以使使用者可利用所述第四管体向所述预塑形管体内灌注所述导电介质,以及利用所述第四管体260将所述导电介质排出。替代性地,所述近端连接段还可沿所述第四管体的轴向延伸,并直接用于与外部的灌注机构连接。所述远端连接段可活动地连接于所述第四管体上。所述主体段被预塑形为三维螺旋结构。
可选地,所述远端连接段被配置为与所述第四管体在周向上保持相对静止。当所述医用导管处于所第一状态时,所述主体段在所述第三管体的挤压下螺旋盘绕在所述第四管体的外表面上,且所述主体段具有较大的螺距。当所述医用导管处于所述第二状态时,所述主体段沿径向向外扩张,以使所述主体段到所述第四管体的距离增大,同时所述主体段还沿轴向回缩,以使所述主体段的螺距减小。
或者,所述远端连接段既可以沿所述第四管体的轴向移动,也可以沿所述第四管体的周向移动。如此,当所述导管处于所述第一状态时,所述主体段在所述第三管体的挤压下可呈直线形态并贴靠在所述第四管体的外表面上,而当所述医用导管切换至所述第二状态时,所述主体段径向扩张并轴向回缩,以恢复至三维螺旋结构。
利用本实施例所提供的医用装置进行钙化病变的治疗时,其使用方法如下:
首先使用者通过所述第四管体向所述预塑形管体灌注导电介质,所述导电介质可由生理盐水与显影剂混合而成,如此,在输送过程中可直接对所述预塑形管体进行显影,并判断其在患者体内的位置。
接着将所述医用导管的远端输送至患者体内的钙化病变区域。
接着回撤所述第二鞘管,并使所述预塑形管体的主体段至少部分地扩张。
最后利用所述冲击波发生器使所述电极产生冲击波进行治疗。
治疗结束后,使用者向所述第四管体的远端推送所述第二鞘管便可使所述医用导管切换回所述第一状态,之后可将所述医用导管撤出体外。
本实施例中,所述医用导管的轴线为所述第四管体的轴线。
<实施例六>
请参考图10,本实施例与实施例四的区别之处在于,每个所述预塑形管体270的至少部分管段(例如远端管段)被预塑形为弧形结构,优选所述预塑形管体270整体被预塑形为弧形结构,且所述弧形结构的凹侧朝向所述第四管体260。所述预塑形管体270的数量优选为多个,例如3~8个,且多个所述预塑形管体270绕所述第四管体260的周向布置,以使所述内管组件与所述第三管体250同轴布置。
每个所述预塑形管体270的远端端部连接在所述第四管体上,近端连接在所述第三管体250上,且所述第三管体250能够相对于所述第四管体260做轴向移动。当所述医用导管处于所述第一状态时,所述第三管体250向所述预塑形管体270施加远端指向近端的拉力并可使所述预塑形管270呈直线 状态,当所述第四管体260保持静止,且所述第三管体250沿由近端向远端的方向移动时,所述拉力被逐步取消,并可使所述预塑形管体270进行扩张至所述灯笼形态,以使所述医用导管20切换至所述第二状态。替代性地,当所述第三管体250保持静止,所述第四管体260沿由远端向近端的方向移动时,所述拉力也会被逐步取消。
本实施例中可利用扩张后的所述预塑形管体270锚固在病变位置,且可通过调节所述第三管体250及所述第四管体260的相对移动的距离来调节所述预塑形管体270的扩张程度,以适应于病变处的解剖结构。此外,本实施例中,所述医用导管20的轴线为所述第四管体260的轴线。
<实施例七>
请参考图11,本实施例与实施例六的区别之处在于,所述医用导管不包括所述第三管体,但包括一第二鞘管290。所述预塑形管体270的远端端部可活动地连接在所述第四管体260上,并可沿所述第四管体260的轴向移动。较佳地,多个所述预塑形管270的远端可均设置在一环形连接件上,然后通过所述环形连接件连接至所述第四管体260上。所述预塑形管体270的近端沿所述第四管体260的近端延伸并用于与外部的注射装置连接。所述第二鞘管290用于可活动地套装在所述预塑形管体270的外部。
当所述医用导管20处于所述第一状态时,所述第二鞘管290包覆在所述预塑形管体270的外部,此时所述预塑形管体270在所述第二鞘管290的挤压下呈直线形态并贴靠在所述第四管体260的外表面上。当所述第二鞘管290相对于所述第四管体260沿由远端向近端的方向移动时,所述预塑形管体270的远端逐步地从所述第二鞘管290的远端伸出,并还在所述第四管体260上沿由远端向近端的方向移动,以使所述预塑形管体270从所述第二鞘管290的远端伸出的管段至少部分地扩张呈弧形结构,以使多个所述预塑形管体270的扩张部分共同形成为灯笼形态(如图11及12所示)。
此外,每个所述预塑形管体270中均设有沿预塑形管体270的轴向依次布置的多个所述电极201。每个所述预塑形管体270的外径可为0.5mm~2mm。 以及,所述第四管体260的远端上还可设置显影元件202,用于显示所述内管组件的远端在患者体内的位置。以及,所述医用导管20的轴线为所述第四管体260的轴线。
<实施例八>
请参考图13至图15,本实施例与实施例七的区别之处在于,所述预塑形管体270的远端被预塑形为V型结构或U型结构,并包括相互连接的第三部分274和第四部分275。所述第三部分274的近端可连接于所述第四管体260上,或者所述第三部分274的近端沿所述第四管体260的轴向延伸并用于与外部的注射装置连接。所述第四部分275位于所述第三部分274远离所述第四管体260的一侧,并构成所述装载部,且所述第四部分275的远端为自由端。本实施例中,所述预塑形管体270的数量为多个,多个所述预塑形管体270沿所述第四管体260的周向依次布置,如此所述第四管体260可与所述第二鞘管290同轴布置。所述第四管体260的轴线即为所述医用导管20的轴线。
当所述医用导管20处于所述第一状态时,所述预塑形管体270在所述第二鞘管290的挤压下被拉伸呈直线状态(即所述第三部分274和所述第四部分275沿所述第四管体260的轴向布置),并贴靠在所述四管体260的外表面上。当所述医用导管20处于所述第二状态时,所述第四部分275完全伸出所述第三管体250的远端并沿径向向外弯折,以使所述预塑形管体270的远端扩张呈V型结构或U型结构。
进一步地,当所述医用导管20处于所述第二状态,且所述第三部分274至少部分地从所述第二鞘管290的远端伸出时,所述第三部分274伸出所述第二鞘管290的节段也可沿径向向外地扩张,以使其与所述第四管体260的外表面之间具有间隙。
再进一步地,所述内管组件还包括锚定件280,且所述第三管体250可用于覆盖所述锚定件280。所述锚定件280连接于所述第四管体260上,并优选位于所述预塑形管体270的远端侧,其用于将所述内管组件定位在患者体内的预定位置处,并使所述预塑形管体270的第四部分275保持在钙化病变的 位置。所述锚定件280包括多个分支管体281和多个第二球囊282,多个所述分支管体281优选沿所述第四管体260的周向间隔布置,所述分支管体281的近端与远端均与所述第四管体260连接,且每个所述分支管体281的外表面上均设置有一个所述第二球囊282。所述第二球囊282优选为顺应性球囊。
利用本实施例所提供的医用装置对主动脉瓣的钙化病变进行治疗时,首先将处于第一状态的医用导管20输送至体内,并使所述内管组件的预塑形管体270的远端抵达钙化病变处,且使所述锚定件280处于钙化病变的远端。然后回撤所述第三管体250,使得所述锚定件280及所述预塑形管体270的远端从所述第三管体250的远端伸出。接着向所述第二球囊282灌注充盈剂,以使所述第二球囊282充盈并对所述医用导管20进行锚固定位,之后可向所述预塑形管体270灌注导电介质并进行治疗。
在替代方案中,所述第三管体250可不覆盖所述锚定件280,当输送到病变位置时,向所述第二球囊282灌注充盈剂,以使所述第二球囊282充盈进行锚固定位,再回撤所述第二鞘管290,使得所述预塑形管体270的远端从所述第二鞘管290的远端伸出,之后可向所述预塑形管体270灌注导电介质并进行治疗。当然也可采用所述第二鞘管290固定不动,操作所述预塑形管体270轴向移动至伸出所述第二鞘管290。
利用包括多个第二球囊282的锚定件280进行锚固定位,第二球囊282与瓣叶的接触面积大,锚固效果更好,且对瓣叶无损伤。不仅如此,多个第二球囊282之间存在间隙,可供血液流通,避免阻塞血流而引起快速起搏和其他并发症。
<实施例九>
本实施例中,所述医用导管包括内管组件,所述内管组件包括第四管体和可控弯管体。所述可控弯管体的数量优选为多个,多个所述可控弯管体沿所述第四管体的周向依次布置。每个所述可控弯管体均包括直管段、可控弯段和控制拉绳。所述直管段的近端连接在所述第四管体上并与所述第四管体连通,以使使用者可通过第四管体向所述可控弯管体灌注导电介质,或者所 述直管段的至少部分外表面与所述第四管体连接,且所述直管段的近端沿所述第四管体的轴向延伸并用于与外部的注射装置连接。所述可控弯段的近端与所述直管段连接,所述可控弯段的远端为自由端,且所述可控弯段构成所述装载部;所述控制拉绳用于控制所述可控弯段弯曲或伸直
所述医用导管被配置为当当所述医用导管处于所述第一状态时,所述可控弯段呈直线形态并贴合在所述第四管体的外表面上。当所述控制拉绳向所述可控弯段施加从所述第四管体的远端指向近端的拉力时,所述可控弯段沿径向向外弯曲以使所述可控弯管体的远端扩张呈V型结构或U型结构。
优选地,所述医用导管还包括第二鞘管,所述第二鞘管用于可活动地套装在所述内管组件的外部。当所述医用导管处于所述第一状态时,所述第二鞘管可包覆所述内管组件,在将所述医用导管切换至所述第二状态之前,可通过回撤所述第二鞘管以使所述可控弯段从所述第二鞘管的远端伸出,之后可通过控制拉绳拉动所述可控弯管体扩张。
进一步地,本实施例所述的医用导管也包括锚定件,所述锚定件的结构可参考实施例八中的锚定件,此处不再赘述。
本实施例中,输送医用导管的轴线为所述第四管体的轴线。
虽然本发明披露如上,但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。

Claims (17)

  1. 一种医用导管,其特征在于,包括装载部和电极;所述装载部具有一内腔,所述内腔中设置有所述电极,所述电极用于产生冲击波;所述内腔还用于容纳导电介质,所述导电介质用于传递所述冲击波;
    所述医用导管被配置为当所述医用导管由第一状态切换至第二状态时,所述电极到所述医用导管之轴线的距离增大。
  2. 根据权利要求1所述的医用导管,其特征在于,所述医用导管包括第一管体、第一球囊和支撑杆,所述第一球囊套装在所述第一管体的远端外表面上并构成所述装载部;所述支撑杆设置在所述第一球囊内部,且所述支撑杆具有相对的第一端和第二端,其中,所述第一端与所述第一管体连接,所述第二端与所述电极连接;
    所述医用导管被配置为当所述医用导管处于所述第一状态时,所述支撑杆的第二端靠近所述第一管体的轴线,并使所述电极靠近所述第一管体的轴线;当所述医用导管处于所述第二状态时,所述支撑杆的第二端远离所述第一管体的轴线,并使所述电极远离所述第一管体的轴线。
  3. 根据权利要求2所述的医用导管,其特征在于,所述支撑杆为自膨式结构,并包括成角度连接的第一部分和第二部分,所述第二部分具有所述第一端和所述第二端,所述第一端通过所述第一部分连接于所述第一管体上;或者,
    所述第一部分和所述第二部分的自由端分别构成一个所述第一端并连接于所述第一管体上,所述第一部分和所述第二部分的连接处构成所述第二端。
  4. 根据权利要求3所述的医用导管,其特征在于,所述医用导管还包括第二管体,用于可活动地套装在所述第一管体及所述球囊的外部;
    所述医用导管被配置为当所述第二管体套装在所述球囊外部时,所述第二管体向所述支撑杆施加径向压力,并使所述医用导管处于所述第一状态;当所述第二管体沿由远端向近端的方向移动,并解除施加在所述支撑杆上的径向压力时,所述支撑杆沿径向向外扩张,以使所述支撑杆的第二端远离所 述第一管体,并使得所述医用导管处于所述第二状态。
  5. 根据权利要求2所述的医用导管,其特征在于,所述支撑杆为弹性件;所述医用导管还包括控制拉绳,所述控制拉绳的远端与所述支撑杆连接;
    所述医用导管被配置为所述控制拉绳用于向所述支撑杆施加拉力并驱使所述支撑杆的第二端沿远离所述第一管体的方向移动,以使得所述医用导管处于所述第二状态,且所述支撑杆存储弹性势能;当所述拉力被取消时,所述支撑杆释放所述弹性势能并驱使所述支撑杆的第二端沿靠近所述第一管体的方向运动,以使所述医用导管恢复至所述第一状态。
  6. 根据权利要求2所述的医用导管,其特征在于,所述医用导管还包括推送件和定位件;所述推送件的远端与所述支撑杆连接,所述推送件用于驱使所述支撑杆的所述第一端沿所述管体的轴向移动;所述定位件与所述推送件连接,并还连接于所述第一管体上;所述定位件用于将所述推送件固定在所述第一管体上;
    当所述推送件沿由近端向远端的方向推送所述支撑杆时,所述支撑杆的第二端沿远离所述第一管体的方向移动,以使所述医用导管切换至所述第二状态;当所述推送杆沿由远端向近端的方向移动时,所述支撑杆的第二端沿靠近所述第一管体的方向移动,以使所述医用导管切换至所述第一状态。
  7. 根据权利要求1所述的医用导管,其特征在于,所述医用导管包括第三管体和内管组件;所述内管组件包括预塑形管体和第四管体,所述第四管体部分地设置在所述第三管体内部,所述预塑形管体为自膨式结构,所述预塑形管体的至少部分管段构成所述装载部;所述预塑形管体的近端连接于所述第三管体的远端上,所述预塑形管段远端连接于所述第四管体上;
    所述医用导管被配置为当所述第四管体相对于所述第三管体沿由近端向远端的方向移动时,所述预塑形管体沿径向收缩,以使所述医用导管处于所述第一状态,当所述第四管体相对于所述第三管体沿远端向近端的方向移动时,所述预塑形管体沿径向向外扩张,并使所述医用导管处于所述第二状态。
  8. 根据权利要求7所述的医用导管,其特征在于,当所述医用导管处于所述第二状态时,所述预塑形管体的远端至少部分地呈三维螺旋结构;
    或者,所述预塑形管体的远端至少部分地呈弧形结构,且所述弧形结构的凹侧朝向所述第四管体。
  9. 根据权利要求7或8所述的医用导管,其特征在于,还包括第一鞘管,所述第一鞘管用于可活动地套装在第三管体及所述预塑形管体的外部。
  10. 根据权利要求1所述的医用导管,其特征在于,所述医用导管包括第二鞘管和内管组件,所述第二鞘管可活动地套装在所述内管组件的外部;所述内管组件包括预塑形管体和第四管体,所述预塑形管体的远端连接于所述第四管体上;
    所述医用导管被配置为当所述第二鞘管套装在所述内管组件上并覆盖所述预塑形管体时,所述第二鞘管向所述预塑形管体施加径向压力以沿径向压缩所述预塑形管体,并使所述医用导管处于所述第一状态;当所述第二鞘管沿由远端向近端的方向移动,并使所述预塑形管体的至少部分管段从所述第二鞘管的远端伸出时,所述预塑形管体从所述第二鞘管的远端伸出的管段能够至少部分地沿径向向外扩张,并使所述医用导管处于所述第二状态。
  11. 根据权利要求10所述的医用导管,其特征在于,所述预塑形管体包括相互连接的第三部分和第四部分,所述第三部分的近端连接于所述第四管体上并与所述第四管体连通,或者所述第三部分的至少部分外表面与所述第四管体连接,且所述第三部分的近端沿所述第四管体的轴向延伸;所述第四部分的远端为自由端,且所述第四部分构成所述装载部;
    当所述医用导管处于所述第一状态时,所述预塑形管体贴靠在所述第四管体的外表面上;当所述医用导管处于所述第二状态时,所述第四部分沿径向向外弯折并使所述预塑形管体扩张呈V型结构或U型结构。
  12. 根据权利要求11所述的医用导管,其特征在于,所述内管组件还包括锚定件,连接于所述第四管体上;所述锚定件包括分支管体和第二球囊,所述分支管体的数量为多个,多个所述分支管体沿所述第四管体的周向间隔布置,且每个所述分支管体的外表面上均套装有所述第二球囊。
  13. 根据权利要求11所述的医用导管,其特征在于,当所述医用导管处于所述第二状态时,所述预塑形管体至少部分地呈三维螺旋结构;
    或者,所述预塑形管体至少部分地呈弧形结构,且所述弧形结构的凹侧朝向所述第四管体。
  14. 根据权利要求1所述的医用导管,其特征在于,所述医用导管包括内管组件;所述内管组件包括第四管体和可控弯管体;所述可控弯管体包括直管段、可控弯段和控制拉绳;所述直管段的近端连接于所述第四管体上,并与所述第四管体连通,或者所述直管段的近端外表面至少部分地与所述第四管体连接;所述可控弯段的近端与所述直管段的远端连接,所述可控弯段的远端为自由端,且所述可控弯段构成所述装载部;所述控制拉绳用于控制所述可控弯段弯曲或伸直;
    所述医用导管被配置为当所述医用导管处于所述第一状态时,所述可控弯管体呈直线形态并贴靠在所述第四管体的外表面上;当所述控制拉绳向所述可控弯段施加拉力时,所述可控弯段沿径向向外弯曲以使所述可控弯管体的远端扩张形成V型结构或U型结构。
  15. 根据权利要求14所述的医用导管,其特征在于,所述医用导管还包括第二鞘管,所述第二鞘管用于可活动地套装在所述内管组件的外部。
  16. 根据权利要求14所述的医用导管,其特征在于,所述医用导管还包括锚定件,设置在所述第四管体上;所述锚定件包括分支导管和第二球囊,所述分支导管的数量为多个,多个所述分支导管沿所述第四管体的周向间隔布置,且每个所述分支导管的外表面上均套装有所述第二球囊。
  17. 一种医用装置,其特征在于,包括冲击波发生器和如权利要求1-16中任一项所述的医用导管,所述冲击波发生器用于与所述电极电性连接,并使所述电极产生所述冲击波。
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