Electrophysiology mapping catheter

Abstract

The utility model relates to the field of medical instruments, in particular to an electrophysiology mapping catheter. Comprising a catheter body and an electrode branch used for mapping, the electrode branch is arranged at the tip of the far end of the catheter body, and the peripheral face, close to the far end, of the catheter body is sleeved with a first reference electrode; the first reference electrode can provide a reference potential for the electrode branch signal. Multi-directional cardiac cavity electric signal mapping within the same time is met, the operation time is shortened, and the operation efficiency is improved.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an electrophysiological mapping catheter. Background Art

[0002] In the field of electrophysiology surgery, an electrophysiology catheter is placed in the endocardial cavity, and the catheter electrical signal is transmitted to intuitively display the abnormal signal points and areas of the patient's endocardial cavity. However, in order to meet the mapping needs, this process not only increases the patient's pain during surgery, but also increases the operator's operating difficulty and learning curve; at the same time, the electrical signals collected by conventional mapping catheters are collected only by contact feedback with the endocardium, lacking accurate electrode signal reference, increasing the probability of misdiagnosis during surgery. Utility Model Content

[0003] In order to solve the problems existing in the prior art, the present application provides an electrophysiological mapping catheter.

[0004] The specific technical solutions of this application are as follows:

[0005] An electrophysiological mapping catheter, characterized in that it comprises a tube body and an electrode branch for mapping, wherein the electrode branch is arranged at the end of the distal end of the tube body.

[0006] A first reference electrode is sleeved on the outer peripheral surface of the tube body near the distal end;

[0007] The first reference electrode can provide a reference potential for the electrode branch signal.

[0008] In a specific embodiment, a magnetic induction module is provided at the distal end of the tube body; the magnetic induction module is used for positioning and navigation.

[0009] In a specific embodiment, the magnetic induction module is disposed at a proximal end of the first reference electrode.

[0010] In a specific embodiment, a second reference electrode capable of providing a reference potential for the electrode branch signal is provided at a position near the distal end of the tube body. Preferably, the second reference electrode is provided in the operator direction of the first reference electrode. Further preferably, the second reference electrode is 1-15 cm away from the first reference electrode.

[0011] In a specific embodiment, a plurality of electrode branches are provided.

[0012] In a specific embodiment, a plurality of ring electrodes for mapping are provided on each electrode branch.

[0013] In a specific embodiment, the proximal end of the electrode branch is fixedly connected to the distal end of the tube body.

[0014] In a specific embodiment, the electrode branches are evenly arranged along the circumference of the tube body; the tube body is a hollow structure at the distal end, and the electrode branches are fixedly connected to the tube wall of the tube body.

[0015] In a specific embodiment, the distal end of each electrode branch extends in a direction away from the central axis of the tube body.

[0016] Beneficial Effects

[0017] The electrophysiological mapping catheter of the present application has a soft claw-shaped electrode branch with multiple electrodes, which can locate more human tissues in a unit time, can meet the needs of rapid modeling of complex psychological anatomical structures, speed up the surgical process, shorten the operation time, and reduce operator fatigue. The catheter can improve surgical efficiency and can help accurately find complex arrhythmias, especially the lesions of persistent atrial fibrillation; in addition, in studying the occurrence mechanism of atrial fibrillation, the high-density electrodes of the catheter can also play a lot of basic research roles.

[0018] In the present application, the number of electrode branches and their lengths are reduced as much as possible while meeting the requirement of stable transmission of surgical electrical signals, which can effectively avoid errors caused by catheter surgery. For example, too many branches and poor structural flexibility may lead to protrusion of the endocardium and subsequent premature beats. By reasonably arranging the electrode density of the head end branches, the processing difficulty can be minimized while meeting the requirements of use.

[0019] In the present application, a single catheter is used in the surgical space to reduce the damage of the access wound to the patient during the postoperative recovery period; the multi-directional cardiac chamber electrical signal mapping can be achieved at the same time, shortening the operation time and improving the operation efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic diagram of the structure of the catheter of the present application;

[0021] Figure 2 This is another view of the structure of this application.

[0022] In the figure, 1. tube body; 2. electrode branch; 3. first reference electrode; 4. second reference electrode; 5. magnetic induction module; 6. ring electrode; 7. tissue. DETAILED DESCRIPTION

[0023] The present application is described in detail below. Although specific embodiments of the present application are shown, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0024] It should be noted that certain words are used in the specification and claims to refer to specific components. Those skilled in the art should understand that technicians may use different nouns to refer to the same component. This specification and claims do not use the difference in nouns as a way to distinguish components, but use the functional differences of components as the criterion for distinction. As mentioned throughout the specification and claims, "including" or "comprising" are open-ended terms and should be interpreted as "including but not limited to". The subsequent description of the specification is a preferred embodiment of the present application, but the description is based on the general principles of the specification and is not intended to limit the scope of the present application. The scope of protection of the present application shall be determined by the attached claims.

[0025] refer to Figure 1 The present application provides an electrophysiological mapping catheter, comprising a tube body 1 and an electrode branch 2 for mapping, wherein the electrode branch 2 is arranged at the distal end of the tube body 1.

[0026] A first reference electrode 3 is sleeved on the outer peripheral surface of the tube body 1 near the distal end;

[0027] The first reference electrode 3 can provide a reference potential for the electrode branch 2 signal.

[0028] In the field of interventional medicine, the end closer to the operator is defined as the "proximal end" and the end farther from the operator is defined as the "distal end". For long objects, the direction parallel to the direction of their length extension is defined as the "axial direction"; for objects with a circular cross-section, the direction around their axis is defined as the "circumferential direction". For cylindrical objects, their extension direction is defined as the "axial direction" and the radius direction of the circular cross-section is defined as the "radial direction".

[0029] refer to Figure 2 When performing interventional surgery on the human body, it is necessary to use the system to build a three-dimensional model of the anatomical structure of the human heart and other tissues, and then map and analyze the electrophysiological signals of the tissues in the surgical area to determine the pathological area.

[0030] refer to Figure 2 The electrophysiological mapping catheter and the supporting three-dimensional mapping system in this application are used to map the anatomical structure of human tissue 7 and establish a three-dimensional model. Therefore, when the electrophysiological catheter is used, it is necessary to enter the human body to map the anatomical structure of the tissue 7 that needs interventional surgery.

[0031] refer to Figure 2 The electrode branch 2 is used to map the anatomical structure of the tissue 7 in the human body. Specifically, the electrode branch 2 can construct the three-dimensional anatomical structure of the human tissue 7 and map the electrophysiological signals of various parts of the tissue 7 according to actual needs.

[0032] refer to Figure 1The tube body 1 is in the shape of a thin strip and is used to deliver the electrode branch 2 to the target tissue 7. The tube body 1 is made of a material with a certain strength, which can play a supporting role and thus deliver the electrode branch 2 to the target area. The electrode branch 2 is made of a relatively soft material, so that when the electrode branch 2 is in contact with the tissue 7, the possibility of the electrode branch 2 causing damage to the tissue 7 is reduced.

[0033] refer to Figure 2 When mapping tissue 7, in order to increase the mapping efficiency, the electrode branch 2 will be spread out along the axis of the tube body 1 in a direction away from the tissue 7, thereby increasing the range and area that the mapping electrode can map. Therefore, the first reference electrode 3 located on the tube body 1 is located exactly at the center of the electrode branch 2 when mapping.

[0034] refer to Figure 2 The first reference electrode 3 or the second reference electrode 4 provides a reference potential for the electrode signals of all electrode branches 2. The electrode signal on the electrode branch 2 is subtracted from the signal of the reference electrode 3 or the reference electrode 4 to obtain the so-called unipolar signal required for cardiac mapping. Compared with the traditional use of the virtual Wilson's Central Terminal (WCT) signal as a reference for the unipolar signal, the reference electrode 3 or the reference electrode 4 can provide better intracardiac electrophysiological signal quality, thereby being able to quickly and accurately locate the abnormal tissue 7 area. Accurate ablation treatment can be performed to improve the success rate of the operation.

[0035] refer to Figure 2 In the present application, the first reference electrode 3 is disposed at the distal end of the tube body 1, and when the electrode branch 2 is mapping the human tissue 7, it will extend outward along the axis of the tube body 1 close to the vertical direction to expand the mapping range. Therefore, the first reference electrode 3 is located at the center of the mapping range of the electrode branch 2. This enables the mapping of the electrode branch 2 in all directions to be referenced to the first reference electrode 3 for potential. In addition, the first reference electrode 3 located on the tube body 1 is not in contact with the human tissue 7, thereby reducing the damage of the first reference electrode 3 to the human body.

[0036] refer to Figure 1 A magnetic induction module 5 is provided at the distal end of the tube body 1; the magnetic induction module 5 is used for positioning and navigation.

[0037] When the tube body 1 delivers the electrode branch 2 into the human body, in order to enable the distal end of the tube body 1 to accurately move along the set route, the magnetic induction module 5 can be used to locate the tube body 1. In addition, during the process of entering the human body, after sensing the specific position of the magnetic induction module 5, the magnetic induction module 5 can also be used to navigate the tube body 1 so that the tube body 1 can move along the set route.

[0038] refer to Figure 1 A second reference electrode 4 capable of providing a reference potential for the electrode branch 2 signal is provided at a position near the distal end of the tube body 1. The second reference electrode 4 can also provide a reference potential for the electrode branch 2.

[0039] refer to Figure 1 The second reference electrode 4 is arranged at a position of the first reference electrode 3 close to the proximal end of the tube body 1 , and the first reference electrode 3 and the second reference electrode 4 are both arranged at one end position of the distal end of the tube body 1 .

[0040] refer to Figure 1 , and the electrode branch 2 is also arranged at the distal end of the tube body 1 , so the second reference electrode 4 can also be located at the center of the marking range of the electrode branch 2 , and the second reference electrode 4 can provide a reference potential for the electrode branch 2 .

[0041] refer to Figure 1 , the first reference electrode 3 and the second reference electrode 4 are used to provide a reference potential to the electrode branch 2 at the same time, and the electrical signals of the electrode branch 2 and the first reference electrode 3 and the second reference electrode 4 are compared with each other, thereby improving the accuracy of the electrode branch 2 in mapping the human tissue 7. Then, the abnormal signal mapped by the electrode branch 2 is displayed in real time, thereby prompting the user to accurately locate the signal excitation point and the reentry area. Then, the difficulty of subsequent ablation work and the error that may be generated during ablation are greatly reduced.

[0042] The magnetic induction module 5 is disposed at the proximal end of the first reference electrode 3. The second reference electrode 4 is preferably disposed in the operator direction of the first reference electrode 3, and further preferably, the distance between the second reference electrode 4 and the first reference electrode 3 is in the range of 1-15 cm.

[0043] The operator direction refers to the direction close to the user who performs surgery using the mapping catheter in the present application.

[0044] Setting the second reference electrode 4 closer to the first reference electrode 3 can provide a higher electrical signal reference. When the second reference electrode 4 is too close to the first reference electrode 3, the electrical signals of the first reference electrode 3 and the second reference electrode 4 are close. In the case of an error, the reference effect of the second reference electrode 4 is lost, and a good electrical signal reference effect cannot be obtained. Similarly, when the second reference electrode 4 is far away, the reference effect of the electrical signal will also be weakened.

[0045] Specifically, the distance between the second reference electrode and the first reference electrode is: 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, and 15 cm.

[0046] refer to Figure 1 The magnetic induction module 5 is arranged between the first reference electrode 3 and the second reference electrode 4, so that when the tube body 1 is positioned using the magnetic induction module 5, the positions of the first reference electrode 3 and the second reference electrode 4 can also be positioned, thereby making the first reference electrode 3 and the second reference electrode 4 be in a more appropriate position.

[0047] Preferably, the magnetic induction module 5 is located between the first reference electrode 3 and the second reference electrode 4 and close to the first reference electrode 3 .

[0048] refer to Figure 2 In the present application, the first reference electrode 3 plays a major role in providing a reference potential for the mapping of the electrode branch 2. Therefore, the magnetic induction module 5 is arranged close to the first reference electrode 3, so that the user can understand the precise position of the first reference electrode 3, so that the electrode branch 2 can map the anatomical structure of the human tissue 7 more accurately.

[0049] On the other hand, the first reference electrode 3 and the electrode branch 2 are both located near the distal end of the tube body 1, and the magnetic induction module 5 is used for positioning and navigation. In order to obtain more accurate positions of the electrode branch 2 and the first reference electrode 3, which are more important for mapping the anatomical structure of the tissue 7, the magnetic induction module 5 is set near the first reference electrode 3. In order to make the reference potential between the first reference electrode 3 and the electrode branch 2 more accurate, the first reference electrode 3 is set closer to the electrode branch 2.

[0050] refer to Figure 1 , a plurality of electrode branches 2 are provided.

[0051] Preferably, a plurality of electrode branches 2 are evenly arranged along the circumference of the tube body 1 .

[0052] Further preferably, the distal end of each electrode branch 2 extends in a direction away from the central axis of the tube body 1 .

[0053] refer to Figure 1 and Figure 2 , multiple electrode branches 2 are evenly arranged at the distal end of the tube body 1. When the electrode branches 2 are used to map the human body, the multiple electrode branches 2 are bent in a direction away from the tube body 1, so that the electrode branches 2 spread out. The multiple electrode branches 2 are in a circular shape, and then the electrode branches 2 are placed against the tissue 7, so that the electrode branches 2 can map the tissue 7 in the largest range, thereby improving the mapping efficiency of the electrode branches 2 on the tissue 7.

[0054] refer to Figure 1 , a plurality of ring electrodes 6 for marking are arranged on each electrode branch 2 .

[0055] refer to Figure 1 and Figure 2 , the ring electrode 6 is used to map the human tissue 7. That is, the ring electrode 6 can capture the endocardial electrical conduction signal, and then the ring electrode 6 can transmit the captured weak electrical signal of the tissue 7 to the multi-conductor or three-dimensional mapping system. The system compares the captured electrical signal with the electrical signal of the first reference electrode 3 or the second reference electrode 4, and then establishes an accurate three-dimensional model of the cardiac anatomical structure and an electrophysiological signal mapping map. The user can determine the exact location of the lesion based on the three-dimensional model and mapping map constructed by the system to facilitate subsequent ablation work.

[0056] refer to Figure 1 The proximal end of the electrode branch 2 is fixedly connected to the distal end of the tube body 1 .

[0057] refer to Figure 1 The proximal end of the electrode branch 2 is fixed on the tube body 1, and the distal end of the electrode branch 2 is a free end. The electrode branch 2 is a curved portion at a position close to the tube body 1. Therefore, after the electrode branch 2 is transported to the human body by the tube body 1, the electrode branch 2 will bend along the curved portion, so that the electrode branch 2 can be spread out in a circular shape, increasing the mapping area of ​​the electrode branch 2.

[0058] The electrode branches 2 are evenly arranged along the circumference of the tube body 1 ; the tube body 1 is a hollow structure at the distal end, and the electrode branches 2 are fixedly connected to the tube wall of the tube body 1 .

[0059] refer to Figure 1 When the electrode branch 2 is fixedly connected to the tube body 1, the electrode branch 2 is inserted into the tube wall of the tube body 1, thereby fixing the electrode branch 2 to the tube body 1. At the same time, when the electrode branch 2 is bent, it will bend along the root of the electrode branch 2 located on the outside of the tube body 1. Fixing the electrode branch 2 to the inside of the tube body 1 reduces the possibility that the root of the electrode branch 2 will be offset due to resistance when mapping the human tissue 7 after the electrode branch 2 is bent. Fixing the electrode branch 2 to the inside of the tube body 1 further improves the stability of the electrode branch 2 and improves the stability of the electrode branch 2 during mapping. It also has the effect of improving the mapping accuracy of the electrode branch 2.

[0060] In summary, the present application provides an electrophysiological mapping catheter, which, when used together with a matching three-dimensional mapping system, can be used to model and map the anatomical structure of tissue 7 in the human body, thereby accurately determining the location of the lesion.

[0061] When the electrophysiological mapping catheter is used, it needs to be used in conjunction with the sheath and the three-dimensional modeling system. The sheath is first inserted into the human body, and then the electrophysiological mapping catheter is inserted into the body through the sheath. Then the mapping data of the electrophysiological mapping catheter is transmitted to the three-dimensional modeling system, and the three-dimensional modeling system processes the mapping data to obtain an electrophysiological three-dimensional model of the human tissue 7. At the same time, the user determines the precise location of the lesion based on the electrophysiological three-dimensional model.

[0062] After the sheath tube penetrates deeply into the body, all the electrode branches 2 need to be retracted, so that the electrode branches 2 are transformed from the expanded state to the retracted state, and all the electrode branches 2 are placed in the sheath tube. Due to the restraining effect of the sheath tube, the electrode branches 2 will advance in the sheath tube in the retracted state, and then with the delivery of the tube body 1, the electrode branches 2 will finally be delivered to the target position of the human body. After the electrode branches 2 are discharged from the distal end of the sheath tube, under the elastic force of the electrode branches 2, the electrode branches 2 will bend in the circumferential direction away from the tube body 1, and the retracted state will be transformed into a dispersed state. Then, the tube body 1 is used to control the electrode branches 2 to be attached to the anatomical structure of the tissue 7 in the human body, and the ring electrodes 6 on the electrode branches 2 are used to capture the weak electrical signals of the tissue 7 in the human body and transmit them to the multi-channel instrument or three-dimensional mapping system. The system compares the captured electrical signals with the electrical signals of the first reference electrode 3 or the second reference electrode 4, and then establishes an accurate three-dimensional model of the cardiac anatomical structure and an electrophysiological signal mapping map. The user can determine the exact location of the lesion based on the three-dimensional model and mapping map constructed by the system.

[0063] Since the tube body 1 is located inside the sheath, the electrode branch 2 is located at the distal end of the tube body 1, and the root of the electrode branch 2 is connected to the tube body 1, when the tube body 1 is pulled back from the sheath, the electrode branch 2 will be transformed into a contracted state again under the action of the sheath and its root, and enter the sheath as the tube body 1 is pulled out of the human body.

[0064] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. An electrophysiological mapping catheter, characterized in that: It comprises a tube body and an electrode branch for mapping, wherein the electrode branch is arranged at the distal end of the tube body. A first reference electrode is sleeved on the outer peripheral surface of the tube body near the distal end; The first reference electrode can provide a reference potential for the electrode branch signal; A magnetic induction module is provided at the distal end of the tube body; the magnetic induction module is used for positioning and navigation; The magnetic induction module is arranged at the proximal end of the first reference electrode; A second reference electrode capable of providing a reference potential for the electrode branch signal is arranged at a position close to the distal end of the tube body.

2. The mapping catheter according to claim 1, characterized in that: The second reference electrode is arranged in the operator direction of the first reference electrode.

3. The mapping catheter according to claim 2, characterized in that: The second reference electrode is 1-15 cm away from the first reference electrode.

4. The mapping catheter according to claim 1, characterized in that: A plurality of electrode branches are provided.

5. The mapping catheter according to claim 1, characterized in that: A plurality of ring electrodes for mapping are arranged on each electrode branch.

6. The mapping catheter according to claim 1, characterized in that: The proximal end of the electrode branch is fixedly connected to the distal end of the tube body.

7. The mapping catheter according to any one of claims 1 to 6, characterized in that: The electrode branches are evenly arranged along the circumference of the tube body; the tube body is a hollow structure at the distal end, and the electrode branches are fixedly connected to the tube wall of the tube body.

8. The mapping catheter according to any one of claims 1 to 6, characterized in that: The distal end of each electrode branch extends in a direction away from the central axis of the tube body.

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