WO2022077313A1 - 一种带加热功能的冷冻球囊导管 - Google Patents

一种带加热功能的冷冻球囊导管 Download PDF

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Publication number
WO2022077313A1
WO2022077313A1 PCT/CN2020/121059 CN2020121059W WO2022077313A1 WO 2022077313 A1 WO2022077313 A1 WO 2022077313A1 CN 2020121059 W CN2020121059 W CN 2020121059W WO 2022077313 A1 WO2022077313 A1 WO 2022077313A1
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Prior art keywords
catheter
cryoballoon
heating function
metal
braided mesh
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PCT/CN2020/121059
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English (en)
French (fr)
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肖家华
李恩光
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山前（珠海）医疗科技有限公司
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Priority to PCT/CN2020/121059 priority Critical patent/WO2022077313A1/zh
Publication of WO2022077313A1 publication Critical patent/WO2022077313A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques

Definitions

  • the present application relates to the technical field of cryoablation instruments, in particular to a cryoballoon catheter with a heating function.
  • cryoballoon catheters for interventional surgery currently have the following problems:
  • the catheter enters the human body through the blood vessels of the human body, and the outer diameter is generally 3-4 mm.
  • the tube wall will be very thin.
  • the temperature of the fluid entering the catheter is low enough (eg ⁇ -80°C), it will affect the blood flowing on the outer surface of the catheter, and even freeze the blood vessels and damage the human tissue. This will endanger the lives of surgical patients.
  • the purpose of this application is to provide a cryo-balloon catheter with a heating function, so as to solve the problem that when low-temperature fluid is introduced into the cryo-balloon catheter in the prior art, it will affect the blood flowing on the outer surface of the catheter, and even There is a problem of freezing blood vessels and freezing human tissue.
  • a freezing balloon catheter with heating function comprising a catheter and an external power source
  • the outer wall of the catheter comprises an inner layer, a middle layer and an outer layer sequentially arranged from the inside to the outside;
  • the middle layer comprises a metal braided mesh, and the The metal braided net is connected to the power supply circuit of the external power supply.
  • the metal braided mesh is a mesh-shaped metal wire braided mesh formed by interweaving a plurality of metal wires.
  • a temperature controller is also provided on the power supply circuit formed by the external power supply and the metal braided mesh.
  • the outer layer is made of block polyetheramide resin material.
  • the inner layer is made of block polyetheramide resin material.
  • thermostat is electrically connected with a thermocouple embedded in the outer wall of the conduit.
  • thermocouple is embedded in the conduit.
  • the metal wire braided mesh has a proximal end and a distal end, and the positive and negative electrodes of each metal wire in the metal wire braided mesh are drawn out from the proximal end.
  • the distal end of the wire braided mesh is provided with a conductive ring, and the positive and negative electrodes of each wire in the wire braided mesh are connected to the conductive ring at the distal end.
  • a deflection guide wire is provided on the outer side of the outer wall of the catheter, and the deflection guide wire, the metal braided mesh and the external power source constitute a power supply circuit.
  • the cryo-balloon catheter with heating function provided by this application is provided with a metal braided mesh with heat conduction function in the middle layer of the outer wall of the cryo-balloon catheter, and the metal braided mesh is connected to an external power supply. After the metal braided mesh is energized, It can generate heat to ensure that the temperature of the outer surface of the catheter is kept within the set temperature, which can not only ensure the effect of cryoablation, but also prevent the cryogenic fluid in the cryoballoon catheter from transferring cold energy to the outside of the catheter and causing human tissue to be frozen. bad question.
  • the cryoballoon catheter with heating function provided by this application is a mesh-shaped metal wire braided mesh formed by a plurality of metal wires intertwined with each other. , which can better ensure that the temperature of the outer surface of the catheter is kept within the required temperature range, and avoid the influence of uneven heating throughout the catheter on the human tissue outside the catheter.
  • the cryoballoon catheter with heating function provided by this application is provided with a thermostat on the power supply circuit composed of an external power source and a metal braided mesh. The temperature is controlled within the desired temperature range.
  • thermocouple connected to the thermostat is embedded in the middle layer of the catheter, which can measure the heating temperature of the metal braided mesh more closely and accurately, and measure the heating temperature of the metal braided mesh.
  • the measured temperature signal is fed back to the thermostat, and the thermostat can control the heating power of the metal braided mesh more timely and accurately, which is beneficial to keep the temperature of the outer wall of the catheter stably within the required temperature range for a long time.
  • the positive and negative electrodes of each metal wire in the wire braided mesh are drawn from the proximal end, and connected to the conductive ring at the distal end of the wire braided mesh, so that a plurality of metal wires are The wire forms a parallel circuit, which can increase the heat generation of the wire mesh.
  • a deflection guide wire is arranged on the outer wall of the catheter, and the deflection guide wire, the metal braided mesh and the external power supply can form a power supply loop, so that the heating capacity of the metal braided mesh can be fully utilized. , thereby reducing the heating voltage of the external power supply.
  • FIG. 1 is a schematic diagram of the connection structure of the cryoballoon catheter and an external power source in the first embodiment of the application;
  • FIG. 2 is a schematic structural diagram of a metal wire woven mesh in an embodiment of the application
  • FIG. 3 is a schematic diagram of the connection structure of the cryoballoon catheter and the external power source in the second embodiment of the application.
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • installed should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • a cryoballoon catheter with heating function is used in the field of cryogenic medical devices, and the temperature of the cryogenic fluid introduced into the cryoballoon catheter is usually below -80°C.
  • the cryoballoon catheter includes a catheter and an external power source 2.
  • the outer wall of the catheter includes an inner layer 101, a middle layer and an outer layer 103 arranged in sequence from the inside to the outside.
  • the inner layer 101 and the outer layer 103 are made of PEBAX (block polyetheramide resin). ) material; the middle layer is a metal woven mesh 102, and the metal woven mesh 102 is connected to the power supply loop of the external power supply 2.
  • a metal braided mesh 102 with heat conduction function is arranged on the middle layer of the outer wall of the cryoballoon catheter, and the metal braided mesh 102 is connected to the external power supply 2.
  • the metal braided mesh 102 is energized It can generate heat and ensure that the temperature of the outer surface of the catheter is kept within the set temperature (for example: 10 ⁇ 2°C), which can not only ensure the effect of cryoablation, but also solve the problem of low temperature when the cryoballoon catheter is introduced into the cryogenic fluid.
  • the fluid transfers cold energy to the outer surface of the cryo-balloon catheter, which causes a series of problems such as freezing of blood vessels outside the cryo-balloon catheter and freezing of human tissue.
  • the power supply circuit formed by the external power source 2 and the metal braided mesh 102 is further provided with a temperature controller 3, and the temperature controller 3 is electrically connected with a thermocouple 4 embedded in the middle layer of the conduit.
  • the thermocouple 4 connected to the thermostat 3 is embedded in the middle layer of the conduit, so that the heating temperature of the metal braided mesh 102 can be measured more closely and accurately, and the measured temperature signal can be fed back to the thermostat 3.
  • the temperature controller 3 can control the heating power of the metal braided mesh 102 more timely and accurately, which is beneficial to keep the temperature of the outer wall of the catheter stably within the required temperature range for a long time.
  • the metal woven mesh 102 is a mesh-shaped metal wire woven mesh formed by interweaving a plurality of metal wires, and is woven through a special weaving process.
  • the metal wire braided mesh has a proximal end and a distal end, the positive and negative electrodes of each metal wire in the metal wire braided mesh are drawn out from the proximal end, the distal end of the metal wire braided mesh is provided with a conductive ring 104, and each metal wire in the metal wire braided mesh is provided with a conductive ring 104.
  • the positive and negative ends of the wire are connected to the conductive ring 104 at the distal end.
  • This kind of mesh-shaped metal wire braided mesh consists of multiple metal wires forming a parallel circuit, which generates a large amount of heat after being energized, and can evenly generate heat on the outer wall of the catheter, which can better ensure that the temperature of the outer surface of the catheter is maintained at Within the required temperature range, the influence of uneven heating throughout the catheter on the human tissue outside the catheter can be avoided.
  • a cryoballoon catheter with heating function is different from the first embodiment in that a deflection guide wire 5 is arranged on the outer wall of the catheter, the deflection guide wire 5, the metal braided mesh 102, the temperature
  • the controller 3 and the external power supply 2 together form a power supply loop, the metal braided mesh 102 is connected to the positive pole of the external power supply 2, and the deflection guide wire 5 is connected to the negative pole of the external power supply 2.
  • the heating capacity of the metal woven mesh 102 can be fully utilized, thereby reducing the heating voltage of the external power supply 2 .

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Abstract

一种带加热功能的冷冻球囊导管，包括导管、温控器（3）和外部电源（2），导管的外壁包括自内而外依次设置的内层（101）、中间层和外层（103）；中间层包括金属编织网（102），金属编织网（102）、温控器（3）和外部电源（2）构成供电回路。这种带加热功能的冷冻球囊导管，在冷冻球囊导管外壁的中间层设置带有导热功能的金属编织网（102），并将金属编织网（102）连接到外部电源（2）上，金属编织网（102）通电后可以发热，保证导管外表面的温度保持在设定的温度内，这样既能保证冷冻消融的效果，又可以很好解决冷冻球囊导管通入低温流体时，低温流体将冷能传递到冷冻球囊导管外表面，而引起的冷冻球囊导管外的血管被冻住、人体组织被冻坏等一系列问题。

Description

一种带加热功能的冷冻球囊导管 技术领域
本申请涉及冷冻消融器械技术领域，具体涉及一种带加热功能的冷冻球囊导管。
背景技术
在医疗行业，介入手术用的冷冻球囊导管目前会存在下面这个问题：
导管通过人体的血管进入人体，外径尺寸一般都在3-4mm，为了保证足够的内径空间，管壁会很薄。当球囊导管通入低温流体时，由于管壁较薄，绝热效果不明显，就会把冷量从导管内传递到导管的外表面。当通入导管的流体温度足够低时(如<-80℃)，就会对导管外表面流动的血液产生影响，甚至出现冻住血管冻坏人体组织的现象。这样就会危害手术病人的生命安全。
因此，需要设计一种在保证冷冻消融效果的前提下，可以避免因导管外表面温度过低对人体组织产生破坏的冷冻球囊导管。
发明内容
有鉴于此，本申请的目的在于提供一种带加热功能的冷冻球囊导管，以解决现有技术中冷冻球囊导管内通入低温流体时，会对导管外表面流动的血液产生影响，甚至出现冻住血管冻坏人体组织的问题。
为解决上述技术问题，本申请的技术方案如下：
一种带加热功能的冷冻球囊导管，包括导管和外部电源，所述导管的外壁包括自内而外依次设置的内层、中间层和外层；所述中间层包括金属编织网，所述金属编织网连接在外部电源的供电回路上。
进一步地，所述金属编织网为由多根金属丝相互交织而成的网格状的金属丝编织网。
进一步地，所述外部电源和所述金属编织网构成的供电回路上还设有温控器。
进一步地，所述外层采用嵌段聚醚酰胺树脂材料制成。
进一步地，所述内层采用嵌段聚醚酰胺树脂材料制成。
进一步地，所述温控器电连接有嵌入所述导管外壁内的热电偶。
进一步地，所述热电偶嵌入所述导管的位置在所述导管的中间层。
进一步地，所述金属丝编织网具有近端和远端，所述金属丝编织网中每根金属丝的正极和负极从所述近端引出。
进一步地，所述金属丝编织网的远端设有导电环，所述金属丝编织网中每根金属丝的正极和负极在所述远端连接到所述导电环。
进一步地，所述导管外壁的外侧设有偏转导丝，所述偏转导丝、所述金属编织网和所述外部电源构成供电回路。
本申请技术方案，具有如下优点：
1.本申请提供的带加热功能的冷冻球囊导管，在冷冻球囊导管外壁的中间层设置带有导热功能的金属编织网，并将金属编织网连接到外部电源上，金属编织网通电后可以发热，保证导管外表面的温度保持在设定的温度内，这样既能保证冷冻消融的效果，又可以防止冷冻球囊导管内的低温流体将冷能传递到导管外而导致人体组织被冻坏的问题。
2.本申请提供的带加热功能的冷冻球囊导管，由多根金属丝相互交织而成的网格状的金属丝编织网，通电后的发热量大，而且可以在导管外壁各处均匀发热，可以更好地保证导管外表面各处的温度保持在所需的温度范围内，避免导管各处发热不均匀对导管外人体组织的影响。
3.本申请提供的带加热功能的冷冻球囊导管，在外部电源和金属编织网构成的供电回路上设置温控器，温控器可以控制金属编织网的发热功率，更好地 将导管外壁温度控制在所需的温度范围内。
4.本申请提供的带加热功能的冷冻球囊导管，与温控器连接的热电偶嵌入到导管的中间层内，可以更近距离、更精准地测量到金属编织网的发热温度，并将测量到的温度信号反馈到温控器，温控器可以更及时准确地控制金属编织网的发热功率，有利于导管外壁温度长期稳定地保持在所需的温度范围内。
5.本申请提供的带加热功能的冷冻球囊导管，金属丝编织网中每根金属丝的正极和负极从近端引出，并连接到金属丝编织网远端的导电环，这样多根金属丝构成并联电路，可以增大金属丝编织网的发热量。
6.本申请提供的带加热功能的冷冻球囊导管，在导管外壁设置偏转导丝，偏转导丝、金属编织网和外部电源可以构成供电回路，这样可以充分利用金属编织网的发热能力，进而减小外部电源的加热电压。
附图说明
为了更清楚地说明本申请具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请的一些实施方式，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他的附图。
图1为本申请实施例一中冷冻球囊导管和外部电源的连接结构示意图；
图2为本申请实施例中金属丝编织网的结构示意图；
图3为本申请实施例二中冷冻球囊导管和外部电源的连接结构示意图。
附图标记说明：101、内层；102、金属编织网；103、外层；104、导电环；2、外部电源；3、温控器；4、热电偶；5、偏转导丝。
具体实施方式
下面将结合附图对本申请的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实 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他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，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。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
实施例1
如图1和图2所示的一种带加热功能的冷冻球囊导管，应用于低温医疗器械领域，冷冻球囊导管内通入的低温流体的温度通常在-80℃以下。冷冻球囊导管包括导管和外部电源2，导管的外壁包括自内而外依次设置的内层101、中间层和外层103，内层101和外层103均采用PEBAX(嵌段聚醚酰胺树脂)材料制成；中间层为金属编织网102，金属编织网102连接在外部电源2的供电回路上。
这种带加热功能的冷冻球囊导管，在冷冻球囊导管外壁的中间层设置带有导热功能的金属编织网102，并将金属编织网102连接到外部电源2上，金属编织网102通电后可以发热，保证导管外表面的温度保持在设定的温度(例如：10±2℃)内，这样既能保证冷冻消融的效果，又可以很好解决冷冻球囊导管通入低温流体时，低温流体将冷能传递到冷冻球囊导管外表面，而引起的冷冻球囊导管外的血管被冻住、人体组织被冻坏等一系列问题。
在本实施例中，外部电源2和金属编织网102构成的供电回路上还设有温控器3，温控器3电连接有嵌入导管的中间层的热电偶4。与温控器3连接的热电偶4嵌入到导管的中间层内，可以更近距离、更精准地测量到金属编织网102的发热温度，并将测量到的温度信号反馈到温控器3，温控器3可以更及时准确地控制金属编织网102的发热功率，有利于导管外壁温度长期稳定地保持在所需的温度范围内。
如图2所示，金属编织网102为由多根金属丝相互交织而成的网格状的金属丝编织网，通过特殊的编织工艺编织而成。金属丝编织网具有近端和远端，金属丝编织网中每根金属丝的正极和负极从近端引出，金属丝编织网的远端设有导电环104，金属丝编织网中每根金属丝的正极和负极在远端连接到导电环104。这种网格状的金属丝编织网，多根金属丝构成并联电路，通电后的发热量大，而且可以在导管外壁各处均匀发热，可以更好地保证导管外表面各处的温度保持在所需的温度范围内，避免导管各处发热不均匀对导管外人体组织的影响。
实施例二
如图3所示的一种带加热功能的冷冻球囊导管，与实施例一的不同之处在于，在导管外壁设置有偏转导丝5，偏转导丝5、金属编织网102、温控器3和外部电源2共同构成供电回路，金属编织网102与外部电源2的正极相连，偏转导丝5与外部电源2的负极相连，这种方案与实施例一中金属编织网102的正极和负极从同一端引出并分别连接到外部电源2的正负极的方案相比，可以充分利用金属编织网102的发热能力，进而减小外部电源2的加热电压。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本申请的保护范围之中。

Claims (10)

  1. 一种带加热功能的冷冻球囊导管，其特征在于，包括导管和外部电源(2)，所述导管的外壁包括自内而外依次设置的内层(101)、中间层和外层(103)；所述中间层包括金属编织网(102)，所述金属编织网(102)连接在外部电源(2)的供电回路上。
  2. 根据权利要求1所述的带加热功能的冷冻球囊导管，其特征在于，所述金属编织网(102)为由多根金属丝相互交织而成的网格状的金属丝编织网。
  3. 根据权利要求1所述的带加热功能的冷冻球囊导管，其特征在于，所述外部电源(2)和所述金属编织网(102)构成的供电回路上还设有温控器(3)。
  4. 根据权利要求1所述的带加热功能的冷冻球囊导管，其特征在于，所述外层(103)采用嵌段聚醚酰胺树脂材料制成。
  5. 根据权利要求1所述的带加热功能的冷冻球囊导管，其特征在于，所述内层(101)采用嵌段聚醚酰胺树脂材料制成。
  6. 根据权利要求3所述的带加热功能的冷冻球囊导管，其特征在于，所述温控器(3)电连接有嵌入所述导管的外壁内的热电偶(4)。
  7. 根据权利要求6所述的带加热功能的冷冻球囊导管，其特征在于，所述热电偶(4)嵌入所述导管的位置在所述导管的中间层。
  8. 根据权利要求3或6所述的带加热功能的冷冻球囊导管，其特征在于，所述金属丝编织网具有近端和远端，所述金属丝编织网中每根金属丝的正极和负极从所述近端引出。
  9. 根据权利要求8所述的带加热功能的冷冻球囊导管，其特征在于，所述金属丝编织网的远端设有导电环(104)，所述金属丝编织网中每根金属丝的正极和负极在所述远端连接到所述导电环(104)。
  10. 根据权利要求1所述的带加热功能的冷冻球囊导管，其特征在于，所述导管的外壁的外侧设有偏转导丝(5)，所述偏转导丝(5)、所述金属编织网(102)和所述外部电源(2)构成供电回路。
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