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 surface of the balloon and 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 technical field of cardiovascular intervention, in particular to a small ball structure balloon catheter. BACKGROUND

[0002] Catheter ablation is a method of treating arrhythmia by introducing energy into the heart through a catheter to ablate the myocardial cells of a specific site to eliminate the lesion. It is a common method of treating arrhythmia, such as radiofrequency, electric field ablation, etc. When ablation is performed, three-dimensional mapping can clearly determine the anatomical structure of the heart, record the position of the catheter and the corresponding potential information, and the target point determination mechanism is more clear.

[0003] Therefore, the use of three-dimensional mapping and radiofrequency, electric field ablation has become more and more popular in the treatment of arrhythmia diseases. However, there is no catheter integrating mapping and ablation functions on the market. In actual treatment, at least one ablation catheter and one mapping catheter are needed to be used together. CONTENT OF THE INVENTION

[0004] The present application provides a balloon catheter which can realize the integration of ablation and high-precision mapping on one catheter. 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, and a plurality of electrodes are uniformly 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 led out from the other end of the catheter via the surface of the balloon and the inside of the catheter. Wherein, the electrode lead is used to transmit electrode signals to a mapping device so that the mapping device can perform three-dimensional mapping on a target object in contact with the balloon catheter according to the electrode signals, and receive energy released by an ablation device and transmit the energy to the electrodes for ablation.

[0005] Further, the end of the catheter close to the balloon is also provided with a ring electrode, the ring electrode is connected to a ring electrode lead, and the ring electrode lead is led out from the other end of the catheter via the inside of the catheter and connected to the mapping device.

[0006] Further, the end of the catheter close to the balloon is also provided with a magnetic sensor, the magnetic sensor is connected to a magnetic sensor lead, and the magnetic sensor lead is led out from the other end of the catheter via the inside of the catheter and connected to the mapping device, together with the ring electrode, to perform spatial and morphological position modeling and positioning of the balloon catheter.

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

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

[0009] Further, the balloon surface is distributed with a plurality of micro-perfusion holes connected to a perfusion interface through a perfusion channel in the catheter for isobaric perfusion.

[0010] Further, the balloon surface is distributed with a plurality of temperature sensors.

[0011] Further, the balloon material is a polymer material.

[0012] Further, the balloon diameter ranges from 5-30mm.

[0013] Further, the balloon catheter further comprises a bend control assembly and a handle, the bend control assembly extends from one end of the catheter close to the balloon through the catheter and further extends to the handle at the other end of the catheter, the catheter is twisted by the bend control assembly at the handle.

[0014] According to the above balloon catheter of the present application, by setting a balloon at the head end of the ablation catheter and uniformly 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, reducing the puncture points and puncture point diameters, reducing the patient's wound and blood dynamics, and reducing the risk of pericardial tamponade / perforation caused by instruments. In addition, the combination of diagnosis and treatment can judge the earliest excitation point and damage degree in real time. In addition, the surgical procedure is optimized, the operation time is reduced, and the X-ray exposure amount / time is reduced. For the balloon structure set at the head end of the ablation catheter in the embodiments of the present application, it can also be well attached to the local complex anatomical position to adapt to various types of diseases in the whole heart cavity. BRIEF DESCRIPTION OF DRAWINGS

[0015] The following drawings, which are part of the specification, illustrate embodiments of the present application and, together with the description, serve to explain the principles of the 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 of the electrode distribution on the 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] To make the objects, technical solutions and advantages of the embodiments of the present application clearer, the drawings and detailed descriptions will be used to clearly explain the spirits of the present application. Any person skilled in the art can make changes and modifications to the technology taught by the present application without departing from the spirits and scopes of the present application.

[0022] The schematic embodiments of the present application and the descriptions thereof are used to explain the present application but not as limitations of the present application. In addition, the same or similar reference signs of elements / components used in the drawings and embodiments are used to represent the same or similar parts.

[0023] As to "first", "second", and the like used herein, they do not mean to particularly refer to the order or sequence, nor to limit the present application. They are merely used to distinguish elements or operations described by the same technical terms.

[0024] As to "include", "comprise", "have", "contain", and the like used herein, they are open terms, i.e., meaning to include but not limited to.

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

[0026] As to "a plurality of" herein, it includes "two" and "more than two"; as to "a plurality of groups" herein, it includes "two groups" and "more than two groups".

[0027] Some words used to describe the present application will be discussed below or elsewhere in this specification to provide additional guidance to those skilled in the art on the description of the present application.

[0028] An embodiment of the present application provides a balloon catheter. As shown in Figure 1 , the balloon catheter includes a balloon 1 and a catheter 2.

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

[0030] The balloon 1 is uniformly distributed with a plurality of electrodes 3 on the surface. Each electrode is connected with an electrode lead, and the electrode lead is led out from the other end of the catheter via 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 constitute different loops independently. In an embodiment, as shown in Figure 1 , the electrode 3 is a circular electrode.

[0031] When the electrode lead is connected to the mapping device through the electrical interface 4, the mapping device can map the target (e.g. myocardial tissue) in contact with the balloon catheter in three dimensions according to the electrode signals transmitted by 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 electrodes via the electrode lead to perform ablation.

[0033] Specifically, when performing intracardiac ablation on a patient, the balloon catheter is first inserted into the patient's heart through the patient's blood vessels, and the position of the balloon catheter is mapped in three dimensions by the mapping device. When the balloon catheter is positioned in the appropriate position, energy is released to the electrodes on the balloon by the ablation device to ablate the lesion in the patient's heart. During the ablation process, the ablation effect can also be monitored by the mapping device.

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

[0035] As shown in Figure 1 , a handle 5 can also be connected to the catheter 2 to manipulate the catheter 2.

[0036] The various parts of the balloon catheter according to the embodiments of the present application will be described in more detail below.

[0037] In the present embodiment, a plurality of electrodes 3 are uniformly distributed on the surface of the balloon 1. The plurality of electrodes 3 can be electrodes of equal size. The distance between each two adjacent electrodes 3 is equal. The electrodes 3 are uniformly distributed on the entire balloon 1. Figure 2 A schematic diagram of the distribution of electrodes on the balloon according to the embodiments of the present application is shown. As shown in Figure 2 , the distance between all adjacent electrode pairs is constant and equal. The plurality of electrodes 3 are respectively connected to a plurality of electrode leads. In this way, on the one hand, by releasing energy to the plurality of electrode leads, the electrodes arranged at various positions on the balloon can be used to ablate the intracardiac tissue from various angles, and on the other hand, by the signals transmitted by the various electrode leads, the positions of the various electrodes 3 can be prepared to be positioned, so that the position of the balloon 1, as well as the state and orientation of the balloon 1, can be accurately positioned.

[0038] In one embodiment of the present application, during ablation, energy can be released to all electrodes, or only to part of the electrodes. For example, if the electrodes 1-20 are uniformly arranged on the surface of the balloon 1, and if a specific part is to be ablated, i.e. the tissue to which the electrodes 1-10 are attached, then energy can be directly released to the electrode leads to which the electrodes 1-10 are connected.

[0039] In one embodiment of the present application, the balloon is adhered to the inner surface of the catheter on the side of the catheter in contact with the balloon. The electrode leads can be arranged on the surface of the balloon and extend into the catheter along the surface of the balloon. The electrode material can be printed directly onto the balloon using electrode printing technology, and then optionally covered with a film or not covered with a film. In other embodiments, the electrodes can also be arranged on the balloon by means of double-layer film covering. In this way, each electrode lead includes two parts, the part printed on the surface of the balloon and the part inside the catheter, which can be connected by, for example, welding or the like.

[0040] In one embodiment of the present application, the balloon is a non-compliant balloon, i.e., a balloon with a fixed volume and shape. The material of the non-compliant balloon can be a high polymer material, such as polyamide (PA), polycarbonate (PC), polypropylene (PP), polyether block polyamide (PEBAX), polyurethane (PU), or urea-formaldehyde, etc. With the non-compliant balloon, the volume and shape of the balloon do not change, which can ensure that the positions of the electrodes arranged on the balloon and the distances between the electrodes are fixed, so as to facilitate the calculation of the positions and states of the electrodes by the electrode signal-related parameters at a 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. The balloon of this size can achieve good abutment and ablation for complex intracardiac anatomical positions and adapt to various types of diseases in the whole heart cavity.

[0042] In one embodiment of the present application, when the balloon and the catheter are placed in 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 of the human body, the balloon in the embodiment of the present application is a foldable balloon, and the electrodes are flexible electrodes. In this way, the balloon can be folded using a balloon folding device, and the size of the folded balloon is not greater than the diameter of the catheter. Then the folded balloon is placed in the controllable sheath, and the balloon and the catheter are guided into the heart through the controllable sheath, and then the balloon is unfolded, and then the subsequent mapping and ablation can be performed. In the process of folding the balloon, the electrodes are flexible, so the electrodes can also be folded, and the electrodes are unfolded after the balloon is unfolded.

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

[0044] In one embodiment of the present application, as shown in Figure 3As shown, a ring electrode 6 is also provided at the end of the catheter near the balloon, with a minimum of two ring electrodes. The ring electrode 6 is connected to a ring electrode lead, which extends from the other end of the catheter away from the balloon through the inside of the catheter and connects to a mapping device. This mapping device can be a three-dimensional mapping device. Specifically, the ring electrode 6 is connected to the ring electrode lead, which extends from the inside of the catheter to the other end and connects to the mapping device via an electrical interface 4. In three-dimensional space, two points define a straight line; therefore, the two ring electrodes can locate the position of the catheter.

[0045] In one embodiment of this application, such as Figure 3 As shown, a magnetic sensor 7 is also installed at the end of the catheter near the balloon. The magnetic sensor 7 is connected to a magnetic sensor lead, which extends from the other end of the catheter away from the balloon through the inside of the catheter and connects to a mapping device. Together with the ring electrode 6, it is used to model and locate the spatial and morphological position of the balloon catheter. Specifically, after the magnetic sensor 7 is connected to the mapping device through the magnetic sensor lead, the position of 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 combination of the two can quickly locate the position of the electrode and also achieve more accurate positioning.

[0046] In one embodiment of this application, such as Figure 4 As shown, the balloon surface has multiple micro-infusion holes 8. These multiple micro-infusion holes 8 are connected to the infusion interface (e.g., via infusion channels within the catheter) Figure 1 The perfusion interface 9 shown is used for isobaric perfusion. Specifically, the balloon surface has multiple micro-perfusion holes 8, and the catheter has a perfusion channel. The total cross-sectional area of ​​all micro-perfusion holes is no 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. During ablation on the patient, the balloon catheter is perfused with saline through the perfusion interface, allowing the saline to flow out through the micro-perfusion holes 8 on the balloon surface. By using saline as a medium, the contact resistance between the balloon and the myocardial tissue can be reduced, thus achieving better ablation.

[0047] In one embodiment of this application, temperature sensors 10 are also distributed on the surface of the balloon. For example... Figure 5 As shown, four temperature sensors 10 are distributed on the surface of the balloon, forming an isotropic tetrahedral structure. By placing temperature sensors on the surface of the balloon, the temperature of the tissues and organs in contact with the electrodes can be monitored in real time.

[0048] According to the embodiments of the present application, by setting a balloon at the head end of the ablation catheter and uniformly setting multiple electrodes on the balloon, the mapping function and the ablation function can be integrated on one balloon catheter, thereby reducing the number and types of instruments, reducing the puncture points and the puncture point diameters, reducing the patient's wound, reducing the hemodynamic impact, reducing the recovery time, reducing the pain, reducing the risk of thrombus and gas embolism, and reducing the risk of pericardial tamponade / perforation caused by the instrument. In addition, by combining diagnosis and treatment, the earliest excitation point and the damage degree can be judged in real time. In addition, the surgical procedure is optimized, the operation time is reduced, and the X-ray exposure amount / time is reduced. For the balloon structure set at the head end of the ablation catheter according to the embodiments of the present application, it can also be well attached to the local complex anatomical position to adapt to various types of diseases in the whole heart cavity.

[0049] The above description is merely illustrative of the embodiments of the present application, and any equivalent changes and modifications made by those skilled in the art without departing from the concept and principle of the present application shall fall within the scope of the present application.

Claims

1. A beaded balloon catheter, comprising: 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, the balloon surface is uniformly distributed with a plurality of electrodes, the distance between every two adjacent electrodes is equal, each electrode is connected with an electrode lead, the electrode lead is led out from the other end of the catheter via the balloon surface and the catheter interior, Wherein, the electrode lead is used to transmit electrode signals to a mapping device so that the mapping device performs three-dimensional mapping on a target object in contact with the balloon catheter according to the electrode signals, and receives energy released by an ablation device and transmits the energy to the electrodes for ablation.

2. The balloon catheter of claim 1, wherein, The catheter is also provided with a ring electrode near the balloon end, the ring electrode is connected to a ring electrode lead, the ring electrode lead is led out from the other end of the catheter via the catheter interior and connected to a mapping device.

3. The balloon catheter of claim 2, wherein, The catheter is also provided with a magnetic sensor near the balloon end, the magnetic sensor is connected to a magnetic sensor lead, the magnetic sensor lead is led out from the other end of the catheter via the catheter interior and connected to the mapping device, together with the ring electrode, to perform spatial and morphological position modeling and positioning of the balloon catheter.

4. The balloon catheter of claim 1, wherein, The balloon is a foldable balloon.

5. The balloon catheter of claim 1, wherein, The electrodes are flexible electrodes.

6. The balloon catheter of claim 1, wherein, The balloon surface is distributed with a plurality of micro-perfusion holes connected to a perfusion interface through a perfusion channel in the catheter for isobaric perfusion.

7. The balloon catheter of claim 1, wherein, The surface of the balloon is distributed with a plurality of temperature sensors.

8. The balloon catheter of claim 1, wherein, The material of the balloon is a high polymer material.

9. The balloon catheter of claim 1, wherein, The diameter of the balloon ranges from 5 to 30 mm.

10. The balloon catheter of claim 1, wherein, The balloon catheter further comprises a bend control assembly and a handle, the bend control assembly extends through the catheter from the end of the catheter near the balloon and further extends to the handle at the other end of the catheter, and the catheter is twisted by the bend control assembly at the handle.

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