Balloon catheter with small ball structure

Abstract

A balloon catheter with a small ball structure comprises a balloon and a catheter body, the balloon is arranged at one end of the catheter body, the balloon is a non-compliant balloon, a plurality of electrodes are evenly distributed on the surface of the balloon, the distance between every two adjacent electrodes is equal, each electrode is connected with an electrode lead, and the electrode lead is connected with the catheter body. And the electrode lead is led out from the other end of the catheter through the inside of the catheter. Wherein the electrode lead is used for transmitting an electrode signal to mapping equipment, so that the mapping equipment performs three-dimensional mapping on a target object in contact with the balloon catheter according to the electrode signal, receives energy released by ablation equipment and transmits the energy to the electrode for ablation. According to the balloon catheter with the small ball structure, high-precision mapping and ablation can be integrated on one balloon catheter.

Description

Technical Field

[0001] The present application relates to the field of cardiovascular intervention technology, and in particular to a balloon catheter with a small ball structure. Background Art

[0002] Catheter ablation is a common method for treating arrhythmias, which involves introducing energy into the heart through a catheter to ablate myocardial cells in specific locations and eliminate lesions, such as radiofrequency and electric field ablation. During ablation, three-dimensional mapping can clarify the anatomical structure of the heart, record the location of the catheter and the corresponding potential information, and make the target judgment mechanism clearer.

[0003] Therefore, the combination of three-dimensional mapping and radiofrequency and electric field ablation has become increasingly popular in the treatment of arrhythmias. However, there is currently no catheter that integrates mapping and ablation functions on the market. In actual treatment, at least one ablation catheter and one mapping catheter are required to be used together. Summary of the invention

[0004] The present application provides a balloon catheter that can realize the integration of ablation and high-precision mapping on a single catheter. The balloon catheter includes a balloon and a catheter. The balloon is arranged at one end of the catheter, and the balloon is a non-compliant balloon. A plurality of electrodes are evenly distributed on the surface of the balloon, and the distance between every two adjacent electrodes is equal. Each electrode is connected to an electrode lead, and the electrode lead is led out from the other end of the catheter through the inside of the catheter. The electrode lead is used to transmit an electrode signal to a mapping device so that the mapping device can perform three-dimensional mapping of a target object in contact with the balloon catheter according to the electrode signal, and receive energy released by an ablation device and transmit the energy to the electrode for ablation.

[0005] Furthermore, a ring electrode is provided at one end of the catheter close to the balloon, and the ring electrode is connected to a ring electrode lead wire, and the ring electrode lead wire is led out from the other end of the catheter through the inside of the catheter and connected to a mapping device.

[0006] Furthermore, a magnetic sensor is provided at one end of the catheter close to the balloon, and the magnetic sensor is connected to a magnetic sensor lead. The magnetic sensor lead is led out from the other end of the catheter through the inside of the catheter and connected to the mapping device, and together with the ring electrode, the spatial and morphological position modeling and positioning of the balloon catheter are performed.

[0007] Furthermore, the balloon is a foldable balloon.

[0008] Furthermore, the electrode is a flexible electrode.

[0009] Furthermore, a plurality of micro-perfusion holes are distributed on the surface of the balloon, and the plurality of micro-perfusion holes are connected to a perfusion interface through a perfusion channel in the catheter to perform isobaric perfusion.

[0010] Furthermore, a plurality of temperature sensors are distributed on the surface of the balloon.

[0011] Furthermore, the material of the balloon is a polymer material.

[0012] Furthermore, the diameter of the balloon is in the range of 5-30 mm.

[0013] Furthermore, the balloon catheter also includes a bending control assembly and a handle, wherein the bending control assembly extends from one end of the catheter close to the balloon, passes through the catheter and further extends to the handle located at the other end of the catheter, and the catheter is controlled to twist at the handle through the bending control assembly.

[0014] According to the above-mentioned balloon catheter of the present application, by setting a balloon at the head end of the ablation catheter and evenly setting multiple electrodes on the balloon, the mapping function and the ablation function can be integrated into one balloon catheter, thereby reducing the number and types of instruments used, reducing the puncture points and the diameter of the puncture points, and the patient has small and few wounds, less impact on hemodynamics, faster recovery, less pain, and reduced risks of thrombosis and air embolism, and can also reduce the risk of pericardial tamponade / perforation caused by the instrument. In addition, by combining diagnosis with treatment, the earliest excitation point and the degree of damage can be determined in real time. In addition, the surgical process is optimized, the operation time is reduced, and the X-ray exposure / time is reduced. For the embodiment of the present application, the balloon structure is set at the head end of the ablation catheter, which can also be well attached to the local complex anatomical position to adapt to multiple types of diseases in the entire heart cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The attached drawings below are part of the specification of the present application, which illustrate embodiments of the present application. The attached drawings together with the description of the specification are used to explain the principles of the present application.

[0016] Figure 1 A schematic diagram of a balloon catheter according to an embodiment of the present application is shown.

[0017] Figure 2 A schematic diagram showing the distribution of electrodes on a balloon according to an embodiment of the present application is shown.

[0018] Figure 3 A schematic diagram of a ring electrode and a magnetic sensor according to an embodiment of the present application is shown.

[0019] Figure 4 A schematic diagram of a micro-perfusion hole according to an embodiment of the present application is shown.

[0020] Figure 5A schematic diagram of a temperature sensor according to an embodiment of the present application is shown. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solutions and advantages of the embodiments of the present application more clearly understood, the spirit of the contents disclosed in the present application will be clearly explained with the accompanying drawings and detailed descriptions below. After understanding the embodiments of the contents of the present application, any technician in the relevant technical field can change and modify them according to the techniques taught by the contents of the present application without departing from the spirit and scope of the contents of the present application.

[0022] The exemplary embodiments and descriptions of the present application are used to explain the present application, but are not intended to limit the present application. In addition, elements / components with the same or similar reference numerals used in the drawings and embodiments are used to represent the same or similar parts.

[0023] The terms “first”, “second”, etc. used in this document do not particularly refer to an order or sequence, nor are they used to limit this application. They are only used to distinguish elements or operations described with the same technical terms.

[0024] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0025] As used herein, "and / or" includes any or all combinations of the items described.

[0026] As used herein, “plurality” includes “two” and “more than two”; as used herein, “plurality of groups” includes “two groups” and “more than two groups”.

[0027] Certain terms used to describe the present application are discussed below or elsewhere in this specification to provide additional guidance to those skilled in the art regarding the description of the present application.

[0028] The present application embodiment provides a balloon catheter. Figure 1 As shown, the balloon catheter comprises a balloon 1 and a catheter 2 .

[0029] The balloon 1 is arranged at one end of the catheter 2 .

[0030] A plurality of electrodes 3 are evenly distributed on the surface of the balloon 1. Each electrode is connected to an electrode lead, which is led out from the other end of the catheter through the inside of the catheter and connected to an external device through an electrical interface 4. The external device can be a mapping device or an ablation device. Here, the electrode lead and the electrode are in a one-to-one correspondence, and each electrode, the electrode lead connected to the electrode, and the external device all constitute independent and different circuits. In one embodiment, as Figure 1 As shown, the electrode 3 is a circular electrode.

[0031] When the electrode lead is connected to the mapping device via the electrical interface 4 , the mapping device can perform three-dimensional mapping of the target object (eg, myocardial tissue) in contact with the balloon catheter based on the electrode signal transmitted from the electrode lead.

[0032] When the electrode lead is connected to the ablation device through the electrical interface 4, the ablation device can release energy to the electrode via the electrode lead to perform ablation.

[0033] Specifically, when performing intracardiac ablation on a patient, one end of a catheter with a balloon is first inserted into the patient's heart through the patient's blood vessels, and the position of the balloon catheter is three-dimensionally mapped using a mapping device. When the balloon catheter is positioned at a suitable position, the ablation device releases energy to the electrodes on the balloon to ablate the lesions in the patient's heart. During the ablation process, the ablation effect can also be monitored using the mapping device.

[0034] In one embodiment, the electrical interface 4 can be connected to any number (1, 2, 3, ...) of external devices.

[0035] like Figure 1 As shown, a handle 5 may also be connected to the catheter 2 to facilitate manipulation of the catheter 2 .

[0036] The various parts of the balloon catheter according to the embodiment of the present application are introduced in more detail below.

[0037] In this embodiment, a plurality of electrodes 3 are evenly distributed on the surface of the balloon 1. The plurality of electrodes 3 may be electrodes of equal size. The distance between each two adjacent electrodes 3 is equal. The electrodes 3 are evenly distributed on the entire balloon 1. Figure 2 FIG. 4 is a schematic diagram showing the distribution of electrodes on a balloon according to an embodiment of the present application. Figure 2 As shown, the distances between all the nearest electrode pairs are constant and equal. Multiple electrodes 3 are connected to multiple electrode leads respectively. In this way, on the one hand, by releasing energy to the multiple electrode leads, the intracardiac tissue can be ablated from various angles through the electrodes arranged at various positions on the balloon. On the other hand, the position of each electrode 3 can be precisely located through the signals transmitted by each electrode lead, so that the position of the balloon 1, as well as the state and orientation of the balloon 1 can be accurately located.

[0038] In one embodiment of the present application, during ablation, energy can be released to all electrodes, or only to some electrodes. For example, electrodes No. 1-20 are evenly arranged on the surface of the balloon 1. If a specific part, i.e., the tissue to which electrodes No. 1-10 are attached, is to be ablated, energy can be directly released to the electrode leads connected to electrodes No. 1-10.

[0039] In one embodiment of the present application, the outer surface of the balloon on the side in contact with the catheter is pasted to the inner surface of the catheter on the side in contact with the balloon. The electrode lead can be arranged on the balloon surface and extend to the inside of the catheter along the balloon surface. Electrode printing technology can be used to print the electrode material directly on the balloon, and then optionally coated or not coated. In other embodiments, the electrode can also be arranged on the balloon by means of a double-layer coating. In this way, each electrode lead includes two parts, namely, a part printed on the balloon surface and a part in the catheter, and the two parts can be connected by, for example, welding.

[0040] In one embodiment of the present application, the balloon is a non-compliant balloon, that is, a balloon with a fixed volume and shape. The material of the non-compliant balloon can be a polymer material, such as polyamide (PA), polycarbonate (PC), polypropylene (PP), polyether block polyamide (PEBAX), polyurethane (PU), or urea-formaldehyde. By using a non-compliant balloon, the volume and shape of the balloon will not change, and the position of the electrodes set on the balloon and the distance between the electrodes can be guaranteed to be fixed, so as to facilitate the calculation of the position and state of the electrodes through the electrode signal related parameters in the later stage.

[0041] In one embodiment of the present application, the diameter of the balloon ranges from 5 to 30 mm. Preferably, the diameter of the balloon is 8 to 9 mm. A balloon of this size can achieve good adhesion and ablation for complex intracardiac anatomical locations and is suitable for multiple types of diseases in the entire cardiac cavity.

[0042] In one embodiment of the present application, when the balloon and the catheter are placed into the patient's heart through the patient's blood vessels, the balloon and the catheter can be guided into the heart through a controllable sheath. In view of the narrow blood vessels in the human body, the balloon in the embodiment of the present application is a foldable balloon, and the electrode is a flexible electrode. In this way, the balloon can be folded using a balloon folding device first, and the size of the folded balloon is not larger than the diameter of the catheter. The folded balloon is then placed in a controllable sheath, and after the balloon and the catheter are guided into the heart through the controllable sheath, the balloon is unfolded, and subsequent mapping and ablation can be performed. During the balloon folding process, since the electrode is flexible, the electrode can also be folded accordingly, and after the balloon is unfolded, the electrode is also unfolded accordingly.

[0043] In one embodiment of the present application, the balloon catheter also includes a bending control assembly, which extends from one end of the catheter close to the balloon, through the catheter and further extends to the handle. The bending control assembly is used to control the catheter to twist at the handle, thereby realizing the bending control function, so as to smoothly introduce the balloon catheter into the patient's heart, find the target and stick to it in the heart, and perform mapping and ablation.

[0044] In one embodiment of the present application, Figure 3As shown, a ring electrode 6 is also provided at one end of the catheter close to the balloon, wherein at least two ring electrodes are arranged. The ring electrode 6 is connected to a ring electrode lead, which is led out from the other end of the catheter away from the balloon through the inside of the catheter and connected to a mapping device. The mapping device can be a three-dimensional mapping device. Specifically, the ring electrode 6 is connected to a ring electrode lead, which extends to the other end of the catheter through the inside of the catheter and is connected to the mapping device through an electrical interface 4. In three-dimensional space, two points define a straight line, so two ring electrodes can locate the position of the catheter.

[0045] In one embodiment of the present application, Figure 3 As shown, a magnetic sensor 7 is also provided at one end of the catheter close to the balloon. The magnetic sensor 7 is connected to the magnetic sensor lead, which is led out from the other end of the catheter away from the balloon through the inside of the catheter and connected to the mapping device, and together with the ring electrode 6, the space and morphological position modeling and positioning of the balloon catheter are performed. Specifically, after the magnetic sensor 7 is connected to the mapping device through the magnetic sensor lead, the position of the electrode 3 relative to the magnetic sensor 7 can be obtained through the magnetic signal of the magnetic sensor. In this way, the absolute position is located by the electric field of the ring electrode, and the relative position is located by the magnetic field of the magnetic sensor. The cooperation of the two can quickly locate the position of the electrode, and can also locate it more accurately.

[0046] In one embodiment of the present application, Figure 4 As shown, a plurality of micro perfusion holes 8 are distributed on the surface of the balloon. The plurality of micro perfusion holes 8 are connected to the perfusion interface (such as Figure 1 The perfusion interface 9 shown in the figure) is used for isobaric perfusion. Specifically, a plurality of micro-perfusion holes 8 are provided on the surface of the balloon, and a perfusion channel is provided in the catheter, and the sum of the cross-sectional areas of all the micro-perfusion holes is not greater than the cross-sectional area of ​​the perfusion channel. One end of the perfusion channel is connected to the inside of the balloon, and the other end is connected to the perfusion interface at the other end of the catheter away from the balloon. When ablation is performed on a patient, the balloon catheter is filled with saline through the perfusion interface, so that the saline flows out through the micro-perfusion holes 8 on the surface of the balloon. In this way, the contact impedance between the balloon and the myocardial tissue can be reduced by using saline as a medium, so as to better achieve ablation.

[0047] In one embodiment of the present application, temperature sensors 10 are also distributed on the surface of the balloon. Figure 5 As shown, four temperature sensors 10 are distributed on the surface of the balloon to form an iso-regular tetrahedron structure. By arranging temperature sensors on the surface of the balloon, the temperature of the tissue and organ to which the balloon and the electrode are attached can be monitored in real time.

[0048] According to the embodiment of the present application, by setting a balloon at the tip of the ablation catheter and evenly setting a plurality of electrodes on the balloon, the mapping function and the ablation function can be integrated into one balloon catheter, thereby reducing the number and types of instruments used, reducing the puncture points and the diameter of the puncture points, and providing patients with small and fewer wounds, less impact on hemodynamics, faster recovery, less pain, and reduced risks of thrombosis and air embolism, as well as the risk of pericardial tamponade / perforation caused by the instrument. In addition, by combining diagnosis with treatment, the earliest excitation point and the degree of damage can be determined in real time. In addition, the surgical process is optimized, the operation time is reduced, and the X-ray exposure / time is reduced. For the embodiment of the present application, a balloon structure is set at the tip of the ablation catheter, which can also be well attached to the local complex anatomical position to adapt to multiple types of diseases in the entire heart cavity.

[0049] The above description is only an illustrative specific implementation manner of the present application. Without departing from the concept and principle of the present application, any equivalent changes and modifications made by any technician in the field should fall within the scope of protection of the present application.

Claims

1. A small ball structure balloon catheter, characterized in that: The balloon catheter comprises a balloon and a catheter. The balloon is arranged at one end of the catheter. The balloon is a non-compliant balloon. A plurality of electrodes are evenly distributed on the surface of the balloon. The distance between every two adjacent electrodes is equal. Each electrode is connected to an electrode lead. The electrode lead is led out from the other end of the catheter through the inside of the catheter. The electrode lead is used to transmit electrode signals to the mapping device so that the mapping device can perform three-dimensional mapping of the target object in contact with the balloon catheter according to the electrode signals, and receive energy released by the ablation device and transfer the energy to the electrode for ablation.

2. The balloon catheter according to claim 1, characterized in that: A ring electrode is also provided at one end of the catheter close to the balloon. The ring electrode is connected to a ring electrode lead. The ring electrode lead is led out from the other end of the catheter through the inside of the catheter and connected to a mapping device.

3. The balloon catheter according to claim 2, characterized in that: A magnetic sensor is also provided at one end of the catheter close to the balloon, and the magnetic sensor is connected to a magnetic sensor lead. The magnetic sensor lead is led out from the other end of the catheter through the inside of the catheter and connected to the mapping device, and together with the ring electrode, the spatial and morphological position modeling and positioning of the balloon catheter are performed.

4. The balloon catheter according to claim 1, characterized in that: The balloon is a foldable balloon.

5. The balloon catheter according to claim 1, characterized in that: The electrodes are flexible electrodes.

6. The balloon catheter according to claim 1, characterized in that: A plurality of micro-perfusion holes are distributed on the surface of the balloon, and the plurality of micro-perfusion holes are connected to the perfusion interface through the perfusion channel in the catheter to perform isobaric perfusion.

7. The balloon catheter according to claim 1, characterized in that: A plurality of temperature sensors are distributed on the surface of the balloon.

8. The balloon catheter according to claim 1, characterized in that: The material of the balloon is a polymer material.

9. The balloon catheter according to claim 1, characterized in that: The diameter of the balloon ranges from 5 to 30 mm.

10. The balloon catheter according to claim 1, characterized in that: The balloon catheter also includes a bending control assembly and a handle. The bending control assembly extends from one end of the catheter close to the balloon, through the catheter and further extends to the handle located at the other end of the catheter. The bending control assembly is used at the handle to control the catheter to twist.

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