CN116831717A

CN116831717A - Cryoablation device

Info

Publication number: CN116831717A
Application number: CN202310882598.0A
Authority: CN
Inventors: 李培尚; 廖惠鹏; 方洋飞
Original assignee: Minder Medical Technology Group Co ltd
Current assignee: Minder Medical Technology Group Co ltd
Priority date: 2023-07-18
Filing date: 2023-07-18
Publication date: 2023-10-03

Abstract

The application relates to the technical field of cryoablation apparatuses, in particular to a cryoablation device, which comprises: the balloon assembly is connected with a mapping circuit chip on the outer surface of the balloon assembly, the mapping circuit chip is made of flexible materials, and a mapping electrode is arranged on the mapping circuit chip; and a catheter assembly in communication with the balloon assembly and adapted to deliver or remove fluid from the balloon assembly. In the process of performing an ablation operation by using the cryoablation device provided by the application, after marking measurement is performed by using the mapping electrode, the mapping electrode is not required to be withdrawn, the ablation operation can be immediately performed, the mapping can be immediately performed again after the ablation is finished to confirm the ablation effect, the position of the balloon component is unchanged in the mapping and ablation process, the mapping effect is stable because the deviation is not generated due to the entering and withdrawing of the catheter in the mapping position, the mapping effect in the cryoablation process can be greatly improved, and the success rate of the cryoablation operation is improved.

Description

Cryoablation device

Technical Field

The application relates to the technical field of cryoablation instruments, in particular to a cryoablation device.

Background

Atrial fibrillation is a disease that severely jeopardizes human health, and the risk of atrial fibrillation includes increasing the occurrence of stroke, congestive heart failure, and severely affecting the quality of life of the patient. Ablation therapy is one of the most effective therapeutic measures at present. Ablation energy includes radio frequency, cryogenics, lasers, and the like. Radio frequency catheter ablation is among the most common methods of treating atrial fibrillation. Balloon cryoablation is a new technique for treating paroxysmal atrial fibrillation. The principle is that the heat of the tissue is taken away through the endothermic evaporation of the liquid refrigerant, so that the temperature of the target ablation part is reduced, and the abnormal electrophysiological cell tissue is destroyed, thereby achieving the purpose of treating atrial fibrillation.

The cryoballoon ablation device in the prior art has the advantages that the ablation part is an ablation balloon, the ablation balloon can be expanded and contracted, the low temperature of the surface of the balloon is realized through the circulation of a freezing medium, the cryoablation is completed, the front end of the ablation part is a mapping part, and the ablation part is of a spiral structure and can be stretched into the ablation part. Before performing cryoablation, the mapping catheter is used for positioning the operation position in the human body, and then the mapping catheter is withdrawn from the blood vessel, and then the ablation catheter is used for performing the ablation operation. However, the patient usually does not have only one abnormal electrophysiological cell tissue, and multiple ablations in the body are required. Multiple mapping and positioning in the operation process, multiple ablation causes the operation process to be complex, and the operation time is long. And because the inner wall of the atrium and the inner wall of the connection part of the atrium and the pulmonary vein are irregular in shape and have strong contractility, the mapping catheter is used for mapping the position of the cell device, then the ablation catheter is introduced, the position of the ablation catheter in place and the actual mapping position possibly have deviation, the mapping effect is unstable, and the mapping effect is poor.

Disclosure of Invention

Therefore, the technical problem to be solved by the application is to overcome the defect of unstable marking effect in the cryoablation operation in the prior art, thereby providing a cryoablation device.

In order to solve the above technical problem, the present application provides a cryoablation apparatus, comprising:

the balloon assembly is connected with a mapping circuit chip on the outer surface of the balloon assembly, the mapping circuit chip is made of flexible materials, and a mapping electrode is arranged on the mapping circuit chip;

and a catheter assembly in communication with the balloon assembly and adapted to deliver or remove fluid from the balloon assembly.

Optionally, the balloon assembly comprises:

the inner balloon is fixedly connected with the catheter assembly, and the catheter assembly is suitable for introducing or discharging frozen fluid into the inner cavity of the inner balloon;

the outer balloon is sleeved outside the inner balloon, the mapping circuit chip is arranged on the outer surface of the outer balloon, the outer balloon is fixedly connected to the outer surface of the catheter assembly, and the catheter assembly is suitable for introducing or discharging inflation fluid into the outer balloon.

Optionally, the inner balloon is a non-compliant balloon and the outer balloon is a compliant balloon.

Optionally, the mapping circuit sheet extends from the head to the tail of the balloon assembly in a spiral shape.

Optionally, the catheter assembly comprises an inner catheter, a through-flow cavity is arranged on the side wall of the inner catheter, the through-flow cavity extends along the length direction of the inner catheter, one end of the through-flow cavity is communicated with the outside, the other end of the through-flow cavity is communicated with the balloon assembly, and the through-flow cavity is suitable for introducing or discharging the inflation fluid into the balloon assembly.

Optionally, the catheter assembly further comprises a filling tube extending along the outer side wall of the inner catheter, one end of the filling tube is communicated with the outside, the other end of the filling tube is communicated with the balloon assembly, and the filling tube is suitable for introducing or discharging frozen fluid into the balloon assembly.

Optionally, one end of the inflation tube, which is communicated with the balloon assembly, is wound on the inner catheter, and one end of the inflation tube, which is communicated with the balloon assembly, is provided with a plurality of diffusing holes.

Optionally, the catheter assembly further comprises an outer catheter sleeved and connected to the outer side of the inner catheter, and a flexible adjusting piece is installed on the outer catheter and used for adjusting the head direction of the catheter assembly.

Optionally, the flexible regulating member is symmetrically provided with at least one pair in the outer catheter.

Optionally, the outer catheter extends toward one end of the balloon assembly to connect with the balloon assembly.

The technical scheme of the application has the following advantages:

1. the present application provides a cryoablation device comprising: the balloon assembly is connected with a mapping circuit chip on the outer surface of the balloon assembly, the mapping circuit chip is made of flexible materials, and a mapping electrode is arranged on the mapping circuit chip; and a catheter assembly in communication with the balloon assembly and adapted to deliver or remove fluid from the balloon assembly.

By providing a flexible mapping circuit chip on the outer surface of the balloon assembly and providing mapping electrodes on the mapping circuit chip. When in operation, the balloon component enters the attachment of the heart and the pulmonary vein of the patient from the blood vessel under the drive of the catheter component, the electrical signals at different positions in the region are measured by using the mapping electrode, the region with the disorder of the electrical signals is marked, then frozen fluid is immediately introduced into the balloon component through the catheter component, and the cell tissues at the marked positions are frozen and ablated. And after the ablation is finished, the electrical signals at the corresponding positions can be measured again by using the mapping electrodes, if the electrical signals are stable, the ablation of the cell tissues at the positions is finished, and if the electrical signals are still disordered, the cryoablation can be continued. In the process of performing an ablation operation by using the cryoablation device provided by the application, after marking measurement is performed by using the mapping electrode, the mapping electrode is not required to be withdrawn, the ablation operation can be immediately performed, the mapping can be immediately performed again after the ablation is finished to confirm the ablation effect, the position of the balloon component is unchanged in the mapping and ablation process, the mapping effect is stable because the deviation is not generated due to the entering and withdrawing of the catheter in the mapping position, the mapping effect in the cryoablation process can be greatly improved, and the success rate of the cryoablation operation is improved.

2. The present application provides a cryoablation device, a balloon assembly comprising: the inner balloon is fixedly connected with the catheter assembly, and the catheter assembly is suitable for introducing or discharging frozen fluid into the inner cavity of the inner balloon; the outer balloon is sleeved outside the inner balloon, the mapping circuit chip is arranged on the outer surface of the outer balloon, the outer balloon is fixedly connected to the outer surface of the catheter assembly, and the catheter assembly is suitable for introducing or discharging inflation fluid into the outer balloon. Through setting up balloon subassembly into interior balloon and the outer balloon that mutually overlaps and establish, interior balloon is used for solution freezing fluid, and outer balloon is used for inflating inflation drive mapping electrode and the laminating of human internal cell tissue, promotes the mapping effect of mapping electrode.

3. The application provides a cryoablation device, which comprises an inner catheter, wherein a through-flow cavity is arranged on the side wall of the inner catheter, extends along the length direction of the inner catheter, one end of the through-flow cavity is communicated with the outside, the other end of the through-flow cavity is communicated with a balloon assembly, and the through-flow cavity is suitable for introducing or discharging an expansion fluid into the balloon assembly. Through arranging the through-flow cavity of the flowing expansion fluid on the side wall of the inner catheter, the number of the catheters sleeved with each other is reduced, the outer diameter of the catheter assembly can be reduced, and the smoothness of the catheter assembly moving in the blood vessel is improved.

4. The application provides a cryoablation device, the catheter assembly further comprises an outer catheter which is sleeved and connected with the outer side of the inner catheter, and a flexible adjusting piece is arranged on the outer catheter and used for adjusting the head direction of the catheter assembly. When the catheter assembly advances in the blood vessel, the head direction of the catheter assembly is adjusted by pulling or loosening the flexible regulator, so that the cryoablation device is driven to quickly and accurately reach the preset position in the patient.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present application, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic structural view of a cryoablation device provided in an embodiment of the present application.

Fig. 2 is a schematic view showing an external structure of an outer balloon provided in an embodiment of the present application.

Fig. 3 is a schematic structural view of a filler pipe according to an embodiment of the present application.

Fig. 4 is a schematic view showing an internal structure of an outer balloon provided in an embodiment of the present application.

Fig. 5 is a schematic structural view of an inner catheter tail provided in an embodiment of the present application.

Fig. 6 is a cross-sectional view of an innerduct provided in an embodiment of the application.

Fig. 7 is a schematic view of the outer balloon of fig. 4 after further inflation.

Fig. 8 is a schematic view of the outer balloon of fig. 7 after further inflation.

Fig. 9 is a schematic structural view of the outer balloon attached to the inner balloon after aspiration according to an embodiment of the present application.

Fig. 10 is a cross-sectional view of an outer catheter provided in an embodiment of the present application.

Fig. 11 is a schematic view of the structure of the catheter assembly head withdrawn into the balloon assembly provided in an embodiment of the present application.

Fig. 12 is a schematic view of the operation of a cryoablation device provided in an embodiment of the present application.

Fig. 13 is a cross-sectional view of an innerduct provided in another embodiment of the application.

Reference numerals illustrate: 1. an inner balloon; 2. an outer balloon; 3. mapping electrodes; 4. an inner catheter; 5. an outer conduit; 6. a filler tube; 7. a through-flow chamber; 8. a bending and wire pulling cavity is regulated; 9. a woven mesh; 10. a special-shaped cavity.

Detailed Description

The following description of the embodiments of the present application will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the application are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

In the description of the present application, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art.

In addition, the technical features of the different embodiments of the present application described below may be combined with each other as long as they do not collide with each other.

Fig. 1 to 12 show a cryoablation device according to the present embodiment, which includes a balloon assembly and a catheter assembly.

The outer surface of the balloon component is connected with a mapping circuit chip which is made of flexible materials, and the mapping circuit chip is provided with a mapping electrode 3. The catheter assembly is in communication with the balloon assembly and is adapted to deliver or remove fluid from the balloon assembly. The mapping electrode 3 is arranged on the outer surface of the balloon group price through a mapping circuit chip made of flexible materials, when in operation, the balloon component enters into the accessory of the joint of the heart and the pulmonary vein of a patient from the blood vessel under the drive of the catheter component, the mapping electrode 3 is utilized to measure electric signals at different positions in the region, the region with the electric signals being disordered is marked, then freezing fluid is immediately introduced into the balloon component through the catheter component, and the cell tissues at the marked positions are subjected to cryoablation. After the ablation is finished, the electrical signals at the corresponding positions can be measured again by using the mapping electrodes 3, if the electrical signals are stable, the ablation of the cell tissues at the positions is finished, and if the electrical signals are still disordered, the cryoablation can be continued.

Specifically, in the present embodiment, the balloon assembly includes an inner balloon 1 and an outer balloon 2, as shown in fig. 1. The inner balloon 1 is fixedly connected with a catheter assembly, and the catheter assembly is suitable for introducing or discharging frozen fluid into the inner cavity of the inner balloon 1. The outer balloon 2 is sleeved outside the inner balloon 1, and the mapping circuit chip is arranged on the outer surface of the outer balloon 2. The outer balloon 2 is fixedly connected to the outer surface of the catheter assembly, which is adapted to allow inflation fluid to pass into or out of the outer balloon 2. The inner balloon 1 is a non-compliant balloon, and the size of the inner balloon 1 cannot be changed along with the change of the air pressure in the inner balloon; the outer balloon 2 is a compliant balloon that will expand or contract depending on the magnitude of the internal air pressure. The non-compliant inner balloon 1 is made of materials such as polyethylene terephthalate, polyamide resin and the like, the inner balloon 1 is a storage cavity of a freezing medium, and the filling and emptying shrinkage of the inner cavity can be realized in a working state. The compliant outer balloon 2 is made of an elastomer material such as thermoplastic polyurethane rubber, and can increase in volume as the pressure of the medium filled in the balloon increases. And the filling and emptying shrinkage of the inner cavity can be realized under the working state.

The mapping circuit chip is a strip-shaped circuit chip and extends from the head to the tail of the balloon assembly in a spiral manner, as shown in fig. 2. The outer surface of the outer balloon 2 is provided with the spiral-distributed mapping electrodes 3, the mapping electrodes 3 are integrated on a strip-shaped mapping circuit chip substrate through a flexible circuit, and the mapping electrodes are fixed on the surface of the outer balloon 2 through processes such as bonding or hot melting; the flexible mapping circuit chip is designed into a spiral shape, and can change the length along with filling and shrinkage of the balloon, so that the balloon body is prevented from being pressed or torn in the process of deformation of the balloon. The mapping electrode 3 can adapt to the electrical signal mapping of the pulmonary vein related parts with different structures and sizes according to different shapes in the filling process of the outer balloon 2.

The catheter assembly comprises an inner catheter 4, a through-flow cavity 7 is arranged on the side wall of the inner catheter 4, the through-flow cavity 7 extends along the length direction of the inner catheter 4, one end of the through-flow cavity 7 is communicated with the outside, the other end of the through-flow cavity is communicated with the outer balloon 2 of the balloon assembly, and the through-flow cavity 7 is suitable for introducing or discharging inflation fluid into the outer balloon 2 of the balloon assembly. The intermediate lumen of the inner catheter 4 is used for the passage of a guiding wire during surgery. As shown in fig. 5 and 6, the wall of the inner catheter 4 is distributed with a plurality of through flow cavities 7 to realize gas circulation, and the wall openings at the position of the inner catheter 4 between the inner balloon 1 and the outer balloon 2 are communicated with the cavity of the through flow cavities 7 in the wall of the inner catheter, so that the inflation gas flows into or is discharged from the cavity of the through flow cavities 7 into the outer balloon 2 through small holes.

As shown in fig. 3, the catheter assembly further comprises a filling tube 6, wherein the filling tube 6 extends along the outer side wall of the inner catheter 4, one end of the filling tube 6 is communicated with the outside, the other end of the filling tube is communicated with the inner balloon 1 of the balloon assembly, and the filling tube 6 is suitable for introducing or discharging freezing fluid into the inner balloon 1 of the balloon assembly. One end of the inflation tube 6, which is communicated with the balloon assembly, is wound on the inner catheter 4, and one end of the inflation tube 6, which is communicated with the balloon assembly, is provided with a plurality of diffusing holes. The inner balloon 1 is filled with a medium such as frozen gas, nitrous oxide and the like, so that the balloon body reaches a low-temperature state, and the freezing treatment of tissues is realized by being abutted against the tissues; the frozen gas enters from the outside through the spirally wound filling pipe 6, the filling pipe 6 surrounds and is abutted against the outer ring of the inner pipe and is fixed at the position close to the front end in the inner balloon 1, and the surrounding part of the filling pipe 6 is uniformly distributed with dispersing holes, so that the frozen gas can be uniformly filled into the inner balloon 1.

As shown in fig. 4, the catheter assembly further comprises an outer catheter 5, the outer catheter 5 is sleeved and connected to the outer side of the inner catheter 4, and a flexible adjusting piece is installed on the outer catheter 5 and used for adjusting the head direction of the catheter assembly. The flexible regulating members are symmetrically provided with at least one pair in the outer guide tube 5. The outer catheter 5 extends towards one end of the balloon assembly to connect with the balloon assembly. The head of the catheter assembly is in a radian smooth design and is connected with the inner tube, one end of the outer balloon 2 is attached to the outer wall of the inner catheter 4 and is in sealing installation, two ends of the inner balloon 1 are attached to the outer wall of the inner catheter 4 and are in sealing installation, and the other section of the outer balloon 2 is attached to the outer wall of the outer catheter 5 and is in sealing installation. Thus, a closed interlayer space can be formed between the inner balloon 1 and the outer balloon 2. The connecting parts of the inner balloon 1, the outer balloon 2 and the inner catheter 4 are separated by a section at intervals, the wall of the inner catheter 4 of the section is provided with a plurality of small holes distributed circumferentially, and the small holes are communicated with the channels of a plurality of through-flow cavities 7 of the wall of the inner catheter 4, so that the outer balloon 2 can be inflated and exhausted through the channel of the wall of the inner catheter 4. As shown in fig. 7 and 8, the outer balloon 2 can be made to present different contour shapes to adapt to pulmonary vein abutment and mapping of different structures and sizes by filling the outer balloon 2 with gases of different pressures. After the mapping is completed, a freezing step is performed, at this time, the outer balloon 2 is completely attached to the inner balloon 1 by extracting the inflation gas from the outer balloon 2, and the inner balloon 1 is inflated with the freezing gas, as shown in fig. 9. The outer wall of the outer balloon 2 which is completely attached can also achieve a low-temperature effect through energy transmission so as to realize the cryotherapy by being attached to tissues. The outer catheter 5 is designed with symmetrically distributed bending-adjusting stay wire cavities 8, stay wires serving as flexible adjusting parts are arranged in the bending-adjusting stay wire cavities 8, and bidirectional bending adjustment of the outer catheter 5 can be achieved. As shown in fig. 10, the bending part of the outer catheter 5 can adopt a hypotube skeleton, a woven mesh 9 is built in the hypotube skeleton, and the outer catheter 5 is designed with an intermediate layer woven mesh 9 to improve the tensile property. A special-shaped cavity 10 is arranged in the side wall of the outer duct and is used for installing a lead of the mapping electrode 3 on the surface of the outer balloon 2. In order to adapt to the adhesion of the corresponding parts of pulmonary veins with different structural sizes and achieve the effect of complete adhesion, the head of the protruding catheter assembly sometimes becomes an obstacle for the adhesion, at this time, the inner tube can be moved by the operating handle so as to drive the head of the catheter assembly to move towards the inside of the balloon assembly, thereby realizing the retraction effect, and the balloon assembly can completely realize the adhesion tissue without blocking under the state, as shown in fig. 11.

As an alternative embodiment, as shown in fig. 13, the filling pipe 6 may be a filling channel built in the inner wall of the inner conduit 4, and the filling pipe 6 and the through-flow chamber 7 extend in parallel in the inner wall of the inner conduit 4.

It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the application.

Claims

1. A cryoablation apparatus comprising:

the balloon assembly is connected with a mapping circuit chip on the outer surface of the balloon assembly, the mapping circuit chip is made of flexible materials, and a mapping electrode (3) is arranged on the mapping circuit chip;

a catheter assembly in communication with the balloon assembly and adapted to deliver or remove fluid from the balloon assembly.

2. The cryoablation device of claim 1 wherein the balloon assembly comprises:

an inner balloon (1) fixedly connected with the catheter assembly, wherein the catheter assembly is suitable for introducing or discharging frozen fluid into the inner cavity of the inner balloon (1);

the outer balloon (2) is sleeved outside the inner balloon (1), the mapping circuit chip is mounted on the outer surface of the outer balloon (2), the outer balloon (2) is fixedly connected to the outer surface of the catheter assembly, and the catheter assembly is suitable for introducing or discharging inflation fluid into the outer balloon (2).

3. The cryoablation device according to claim 2, wherein the inner balloon (1) is a non-compliant balloon and the outer balloon (2) is a compliant balloon.

4. The cryoablation device of any of claims 1-3 wherein the mapping circuit sheet extends in a spiral from a head to a tail of the balloon assembly.

5. A cryoablation device according to any of claims 1 to 3 wherein the catheter assembly comprises an inner catheter (4) having a through lumen (7) disposed in a sidewall thereof, the through lumen (7) extending along a length of the inner catheter (4), the through lumen (7) having one end in communication with the outside and the other end in communication with the balloon assembly, the through lumen (7) being adapted to allow inflation fluid to pass into or out of the balloon assembly.

6. The cryoablation device of claim 5 wherein the catheter assembly further comprises a inflation tube (6), the inflation tube (6) extending along an outer sidewall of the inner catheter (4), the inflation tube (6) communicating at one end with the outside and at the other end with the balloon assembly, the inflation tube (6) being adapted to vent or expel a cryogenic fluid into the balloon assembly.

7. The cryoablation apparatus of claim 6 wherein an end of the inflation tube (6) in communication with the balloon assembly is wrapped around the inner catheter (4), the end of the inflation tube (6) in communication with the balloon assembly being provided with a plurality of diffusing holes.

8. The cryoablation apparatus of claim 5 wherein the catheter assembly further comprises an outer catheter (5) coupled to the outer side of the inner catheter (4), the outer catheter (5) having a flexible adjustment member mounted thereon for adjusting the head orientation of the catheter assembly.

9. Cryoablation apparatus according to claim 8, wherein the flexible regulating member is symmetrically arranged with at least one pair within the outer catheter (5).

10. The cryoablation device according to claim 8 or 9, wherein the outer catheter (5) extends towards one end of the balloon assembly to connect with the balloon assembly.