CN115177363A

CN115177363A - Pulse ablation catheter

Info

Publication number: CN115177363A
Application number: CN202210536706.4A
Authority: CN
Inventors: 朱景秋; 张坤; 胡登脉; 王敏; 孙辉; 盛冬伟; 王辉
Original assignee: Shanghai Weiqi Medical Instrument Co ltd
Current assignee: Shanghai Weiqi Medical Instrument Co ltd
Priority date: 2022-05-17
Filing date: 2022-05-17
Publication date: 2022-10-14

Abstract

The embodiment of the specification provides a pulse ablation catheter which is arranged at the far end of a control handle and comprises an outer catheter, an inner catheter and an ablation assembly; the outer conduit is sleeved outside the inner conduit; the ablation assembly comprises an annular base, a plurality of bearing sections and a plurality of electrodes, wherein the annular base is fixed at the far end of the outer catheter, and the electrodes are arranged at preset positions of the bearing sections; the bearing section also comprises a first arc section and a second arc section which are connected with each other, the arc directions of the first arc section and the second arc section are opposite, the near end of the first arc section is connected with the annular base, and the far end of the second arc section is connected with the far end of the inner catheter; the shapes of the first arc section and the second arc section are adjusted by controlling the sliding distance of the inner catheter in the outer catheter, so that electrode regions in different shapes and sizes are formed, focus regions in different shapes and sizes are adapted, good adhesion with the focus regions is formed, the operation difficulty is reduced, and the operation time is shortened.

Description

Pulse ablation catheter

Technical Field

The specification relates to the technical field of medical equipment, in particular to a pulse ablation catheter.

Background

Atrial Fibrillation (AF, atrial Fibrillation) is one of the most common arrhythmia in clinic, and the total incidence rate of Atrial Fibrillation is about 2% as shown in many countries of clinical research, and the incidence rate of Atrial Fibrillation is gradually increased in recent years. Non-drug treatment of atrial fibrillation is a research hotspot in recent years, and the pulmonary veins are electrically isolated by adopting a catheter ablation technology, so that recurrence of atrial fibrillation can be effectively prevented and sinus rhythm can be maintained.

The pulse ablation catheter can release radio frequency energy, and pulse electric field energy forms irreversible micropores on a cell membrane through instant discharge to cause apoptosis so as to achieve the aim of non-thermal ablation, so that the ablation mode is also called irreversible electroporation ablation. In the process of an ablation operation, the ablation catheter enters human tissues and reaches a focus area, and the ablation catheter needs to have stretching capacity and can change the shape and size to be well attached to the focus areas in different shapes because different focus areas have different shapes.

Disclosure of Invention

In view of this, the embodiments of the present disclosure provide a pulse ablation catheter, which can be extended and retracted, has a discharge area with an adjustable area, provides a good contact with a lesion area, reduces the difficulty of surgical operation, and shortens the surgical time.

The embodiment of the specification provides the following technical scheme:

a pulse ablation catheter is arranged at the far end of a control handle and comprises an outer catheter, an inner catheter and an ablation assembly;

the outer catheter is sleeved outside the inner catheter;

the ablation assembly comprises an annular base, a plurality of bearing sections and a plurality of electrodes, wherein the annular base is fixed at the far end of the outer catheter, and the electrodes are arranged at preset positions of the bearing sections;

the bearing section also comprises a first arc section and a second arc section which are connected with each other, the arc directions of the first arc section and the second arc section are opposite, the near end of the first arc section is connected with the annular base, and the far end of the second arc section is connected with the far end of the inner catheter;

wherein the shapes of the first arc segment and the second arc segment are adjusted by controlling the sliding distance of the inner catheter in the outer catheter.

Above-mentioned pulse ablation catheter, through setting up first circular arc section and the second circular arc section that the circular arc direction is opposite, constitute the carrier segment jointly by first circular arc section and second circular arc section, the electrode is installed on the carrier segment, and the near-end of first circular arc section passes through annular base and fixes the distal end at outer catheter, and the distal end of second circular arc section is connected the distal end of inner catheter, when inner catheter is in the intraductal slip of outer catheter, through the sliding distance of control inner catheter, thereby the distal end of control inner catheter stretches out the length of the distal end of outer catheter, thereby the shape of control first circular arc section and second circular arc section constitutes shape and size changeable electrode area, in order to adapt to focus region of different shapes and sizes, form well with the focus region and lean on, reduce the operation degree of difficulty, shorten the operation time.

The invention also provides a scheme, and the radius of the first circular arc segment is the same as that of the second circular arc segment.

The invention also provides a scheme, and the radius of the first circular arc section and/or the second circular arc section is 70-80 mm.

The invention also provides a scheme, the bearing section further comprises a first straight line section and a second straight line section, the proximal end of the first circular arc section is connected with the annular base through the first straight line section, and the distal end of the second circular arc section is connected with the distal end of the inner catheter through the second straight line section.

The invention also provides a scheme that a fixing piece is arranged at the far end of the inner catheter, the fixing piece is provided with fixing holes with the same number as the bearing sections, and the fixing holes are used for correspondingly fixing the far end of the second straight-line section.

The invention also provides a scheme that the annular base and the bearing section are integrally formed.

The invention also provides a scheme, wherein the bearing section is provided with 2N electrodes, the distance between the adjacent electrodes is 4-8 mm, and N is a positive integer.

The invention also provides a scheme that the material of the outer catheter and/or the inner catheter comprises Pebax braided material.

The invention also provides a scheme, the control handle further comprises a push button, an elastic body, a reset plate and a first rack, wherein the elastic body, the reset plate and the first rack are arranged in the control handle;

the first rack is fixed on the inner wall of the control handle and is arranged opposite to the reset plate;

the first end of the push button is connected with the near end of the inner catheter and is connected with the reset plate in a sliding mode, a second rack is further arranged at the first end of the push button, and the second end of the push button is located on the outer side of the control handle;

the elastic body is connected with the reset plate and used for applying elastic force to the reset plate so as to enable the second rack to be meshed with the first rack;

when the second end of the push button approaches the control handle to a preset distance, the meshing state of the second rack and the meshing state of the first rack are released.

The invention also provides a scheme, the pulse ablation catheter further comprises a corrugated pipe, the far end of the corrugated pipe is connected with the near end of the outer catheter, and the near end of the corrugated pipe is connected with the first end of the push button.

Compared with the prior art, the beneficial effects that can be achieved by the at least one technical scheme adopted by the embodiment of the specification at least comprise: outer catheter is established through the outside cover of pipe including to set up between two sheathed tube distal ends and melt the subassembly, it is specific, melt the subassembly and include annular base, a plurality of carrier segment, a plurality of electrode, annular base is fixed in the distal end of outer catheter, and the electrode sets up in the preset position of carrier segment, and the carrier segment is provided with first circular arc section and second circular arc section that the circular arc opposite direction, and annular base is connected to the near-end of first circular arc section, and the distal end of interior catheter is connected to the distal end of second circular arc section, thereby can pass through control interior catheter is in the interior sliding distance of outer catheter, the adjustment first circular arc section with the shape of second circular arc section constitutes the electrode zone of different shapes and size to adapt to different shapes and the focus region of size, form well paste with the focus region and lean on, reduce the operation degree of difficulty, shorten operation time.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic perspective view of a pulse ablation catheter;

FIG. 2 is a schematic perspective view of the carrier section of the pulse ablation catheter in an extended state;

FIG. 3 is a schematic cross-sectional view of an outer catheter;

FIG. 4 is a perspective view of the ring base and the carrier section integrally formed;

FIG. 5 is a schematic top view of the load bearing segment;

FIG. 6 is a schematic cross-sectional view of the fastener;

FIG. 7 is a schematic view, partially in section, of the push button position of the control handle;

the reference numbers used in the drawings are as follows:

1. outer catheter, 101, first chamber of acting as go-between, 102, first wire chamber, 103, the second chamber of acting as go-between, 104, the second wire chamber, 2, inner catheter, 3, melt subassembly, 301, annular base, 302, the carrier segment, 3021, first straight-line segment, 3022, first circular arc segment, 3023, second circular arc segment, 3024, second straight-line segment, 4, control handle, 5, the mounting, 6, the spring, 7, first rack, 8, push knob, 81, the second rack, 82, reset plate, 9, the bellows.

Detailed Description

Embodiments of the present application are described in detail below with reference to the accompanying drawings.

The following description of the embodiments of the present application is provided by way of specific examples, and other advantages and effects of the present application will be readily apparent to those skilled in the art from the disclosure herein. It is to be understood that the embodiments described are only a few embodiments of the present application and not all embodiments. The present application is capable of other and different embodiments and its several details are capable of modifications and/or changes in various respects, all without departing from the spirit of the present application. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It is noted that various aspects of the embodiments are described below within the scope of the appended claims. It should be apparent that the aspects described herein may be embodied in a wide variety of forms and that any specific structure and/or function described herein is merely illustrative. Based on the present application, one skilled in the art should appreciate that one aspect described herein may be implemented independently of any other aspects and that two or more of these aspects may be combined in various ways. For example, an apparatus may be implemented and/or a method practiced using any number and aspects set forth herein. Additionally, such an apparatus may be implemented and/or such a method may be practiced using other structure and/or functionality in addition to one or more of the aspects set forth herein.

It should be noted that the drawings provided in the following embodiments are only for illustrating the basic idea of the present application, and the drawings only show the components related to the present application rather than the number, shape and size of the components in actual implementation, and the type, amount and ratio of the components in actual implementation may be changed arbitrarily, and the layout of the components may be more complicated.

It should be understood that in the present specification, the "proximal end" refers to the end near the operator during the operation, and the "distal end" refers to the end far from the operator during the operation. The term "connection of component A to component B" means that component A is directly connected in contact with component B or component A is indirectly connected to component B through another component. The terms of orientation of "upper", "lower", "inner", "outer", "side", and the like described in the exemplary embodiments of the present specification are described with respect to the angles shown in the drawings, and should not be construed as limiting the exemplary embodiments of the present specification.

In addition, in the following description, specific details are provided to facilitate a thorough understanding of the examples. However, it will be understood by those skilled in the art that the aspects may be practiced without these specific details.

Atrial Fibrillation (AF, atrial Fibrillation) is one of the most common clinical arrhythmias, and the total incidence rate of Atrial Fibrillation is about 2% as shown by multi-national clinical studies, and the incidence rate of Atrial Fibrillation is gradually increasing in recent years. Non-drug treatment of atrial fibrillation is a research hotspot in recent years, and the pulmonary veins are electrically isolated by adopting a catheter ablation technology, so that recurrence of atrial fibrillation can be effectively prevented and sinus rhythm can be maintained.

The pulse ablation operation is widely applied clinically as a minimally invasive treatment means with small damage and quick recovery. The pulse ablation catheter can release radio frequency energy, and pulse electric field energy forms irreversible micropores on a cell membrane through instant discharge to cause apoptosis so as to achieve the aim of non-thermal ablation, so that the ablation mode is also called irreversible electroporation ablation. Theoretically, irreversible electroporation ablation can damage target cells without heating tissues, has cell or tissue selectivity, and can effectively protect surrounding key structures, thereby reducing complications in the operative period and reducing the recurrence rate of diseases.

Ablation catheter access during ablation procedures

The inventors have made extensive and intensive studies to provide a pulse ablation catheter having both an expanded and a contracted state, the distal end of which is provided with a carrier section for mounting an electrode, and the carrier section has two circular arc sections connected to each other and having opposite circular arc directions, thereby constituting an S-shaped structure. The two ends of the S-shaped structure are respectively connected with the far end of the inner catheter and the far end of the outer catheter, and the inner catheter can move back and forth in the outer catheter, so that the S-shaped structure is driven to extend or contract. When the S-shaped structure is expanded, the S-shaped structure is expanded along the radial direction of the outer catheter to form expanded structures with different shapes and sizes, the power supply electrode performs attaching action, and when the S-shaped structure is contracted, the S-shaped structure is contracted along the radial direction of the outer catheter and is accommodated in the far end surface of the inner catheter. The size of the ablation area can be flexibly adjusted by adjusting the sliding distance of the inner catheter, so that the attaching effect of the focus area is improved.

The technical solutions provided by the embodiments of the present application are described below with reference to the accompanying drawings.

The pulse ablation catheter shown in fig. 1 and 2 is mounted to the distal end of the control handle 4 and includes: the ablation catheter comprises an outer catheter 1, an inner catheter 2 and an ablation assembly 3, wherein the outer catheter 1 is sleeved outside the inner catheter 2.

As shown in fig. 4 and 5, ablation assembly 3 includes an annular base 301, a plurality of carrier segments 302, and a plurality of electrodes (not shown). The annular base 301 is fixed to the distal end of the outer catheter 1, for example by gluing, in particular biocompatible glue, to the distal end of the outer catheter 1. The electrodes are disposed at predetermined positions of the carrier segment 302. The carrier section 302 further comprises a first circular arc section 3022 and a second circular arc section 3023 connected to each other, the circular arc direction of the first circular arc section 3022 is opposite to that of the second circular arc section 3023, the proximal end of the first circular arc section 3022 is connected to the annular base 301, and the distal end of the second circular arc section 3023 is connected to the distal end of the inner catheter 2.

It should be noted that the first circular arc segment 3022 and the second circular arc segment 3023 may be integrally formed, and may be two separate components connected together.

It should also be noted that the first circular arc segment 3022 and the annular base 301, and the second circular arc segment 3023 and the inner conduit 2 may be welded or bonded.

It should also be noted that the first arc segment 3022 and the annular base 301 may be integrally formed; similarly, the first circular arc segment 3022 and the second circular arc segment 3023 may be integrally formed with the annular base 301.

The inner catheter 2 can slide in the outer catheter 1, and the shapes of the first circular arc section 3022 and the second circular arc section 3023 can be adjusted by controlling the sliding distance of the inner catheter 2 in the outer catheter 1.

Specifically, when the inner catheter 2 slides inside the outer catheter 1, the following mechanical movements are achieved:

when the inner catheter 2 slides along the outer catheter 1 in a direction away from the operator, the first arc section 3022 and the second arc section 3023 are straightened, and contract inward in a radial direction of the outer sleeve, and finally adhere to the outer wall of the inner catheter 2. The ablation assembly is contracted to form a rod-shaped structure, so that the electrode device can conveniently move in the human tissue and reach a focus area;

when the inner catheter 2 is slid along the outer catheter 1 in a direction approaching the operator, the first arc section 3022 and the second arc section 3023 are compressed and spread outward in a radial direction of the outer sheath to form an expanded configuration, which forms an ablation treatment region of variable size, as shown in fig. 2.

The pulse ablation catheter of the structure improves the shape of an ablation contact area, so that the ablation contact area can be flexibly opened and closed, a structure which is convenient to adjust and extend and contract is formed, an ablation treatment area which can flexibly adjust the contact area is formed, the ablation treatment area is suitable for focus areas of different shapes and sizes, the focus areas are well attached to the focus areas, and energy is released through electrodes installed on a bearing area to perform ablation treatment.

In some embodiments, as shown in fig. 5, the first arc segment 3022 and the second arc segment 3023 have the same radius.

By arranging the first circular arc section 3022 and the second circular arc section 3023 having the same radius, when the two ends of the bearing structure composed of the first circular arc section 3022 and the second circular arc section 3023 receive the thrust from the outer catheter 1 and the inner catheter 2, the deformation degree of the first circular arc section 3022 is the same as that of the second circular arc section 3023.

In some embodiments, the first arc segment 3022 has a radius of 70 to 80mm.

In some embodiments, the second arc segment 3023 has a radius of 70 to 80mm.

In some embodiments, the material of the first arc segment 3022 and/or the second arc segment 3023 includes a memory alloy. In some preferred embodiments, the memory alloy comprises nitinol.

In some embodiments, as shown in fig. 5, the carrier section 302 further comprises a first straight segment 3021 and a second straight segment 3024, the proximal end of the first circular segment 3022 being connected to the annular base 301 by the first straight segment 3021, and the distal end of the second circular segment 3023 being connected to the distal end of the inner catheter 2 by the second straight segment 3024.

It should be noted that, as shown in fig. 5, the first straight line segment 3021, the first circular arc segment 3022, the second circular arc segment 3023, and the second straight line segment 3024 may be integrally formed; or may be separate components connected in series with each other. Likewise, the first linear segment 3021 may be integrally formed with the annular base 301.

It should be further noted that, as shown in fig. 5, a rounded transition is provided at a proximal end of the first straight line segment 3021, i.e. an end facing the annular base 301, so as to avoid stress concentration during deformation.

In some embodiments, as shown in fig. 2 and 6, the distal end of the inner catheter 2 is provided with a fixing member 5, and the fixing member 5 is provided with the same number of fixing holes as the number of the bearing segments 302, and the fixing holes are used for correspondingly fixing the distal end of the second linear segment 3024.

Taking 5 bearing segments as an example, the second straight segments 3024 are five segments, the second straight segments 3024 are numbered A2, B2, C2, D2, and E2 in sequence along the circumferential direction of the inner catheter 2, the five fixing holes of the fixing member 5 are numbered A1, B1, C1, D1, and E1 in sequence along the circumferential direction of the inner catheter 2, and the second straight segments 3024 and the fixing holes are fixed to each other in the order of A1 and A2, B1 and B2, C1 and C2, D1 and D2, and E1 and E2.

In some embodiments, the bearing segment 302 is not provided with the second straight segment 3024, and the second circular segment 3023 can be directly fixed in the fixing hole of the fixing member 5.

In some embodiments, the carrier section 302 is provided with 2N electrodes, and the distance between adjacent electrodes is 4 to 8mm, where N is a positive integer. Taking four electrodes as an example, the first electrode and the second electrode are separated by 4 to 5mm, the second electrode and the third electrode are separated by 7 to 8mm, and the third electrode and the fourth electrode are separated by 4 to 5mm.

In some embodiments, the material of the outer catheter 1 comprises a polyether block polyamide (Pebax) braided material.

In some embodiments, the material of the inner catheter 2 comprises a braided material comprising polyether block polyamide (Pebax).

In some embodiments, the outer catheter 1 has a Polytetrafluoroethylene (PTFE) coating on the inner wall to provide a slip effect as the inner catheter 2 slides.

In some embodiments, the carrier section 302 is wrapped with a heat shrink film. Preferably, the heat shrink film comprises TPU and Pebax materials.

In some embodiments, the number of bearer segments 302 is a positive odd number. Preferably, the number of load bearing segments 302 is 5-7.

In some embodiments, the number of electrodes is a positive integer. Preferably, the number of electrodes is 4 to 8.

In some embodiments, the outer catheter 1 is internally provided with a variety of cavities, including: at least one or a combination of a lumen at a central location, a guidewire lumen at an edge location, and a pull wire lumen at an edge location. Preferably, as shown in fig. 3, the first pull wire cavity 101 and the second pull wire cavity 103 are symmetrically arranged around the central axis of the outer catheter 1; the first guide wire lumen 102 and the second guide wire lumen 104 are symmetrically arranged around the central axis of the outer catheter 1.

In some embodiments, as shown in fig. 1 and 7, the control handle 4 further includes a push button 8, and an elastic body, a reset plate 82, and a first rack 7 are disposed inside the control handle. The elastic body may be a spring 6 (as shown in fig. 7) or an elastic rubber (not shown).

The first rack 7 is fixed on the inner wall of the control handle 4 and is arranged opposite to the reset plate 82.

The first end that pushes away button 8 is connected the near-end of inner catheter 2 to, the first end sliding connection that pushes away button 8 reset board 82, first end still is provided with second rack 81, and second rack 81 sets up with first rack relatively, and the second end that pushes away button 8 is located the outside of brake valve lever 4, the second end supplies operating personnel to control the use.

It should be noted that, a sliding plane may be disposed at the first end of the push button 8 to abut against and slide on the reset plate 82; a sliding block may be disposed at the first end of the push button 8, a sliding slot may be disposed on the reset plate 82, and the sliding block may be disposed in the sliding slot.

The elastic body is connected with the reset plate 82 and is used for applying an elastic force to the reset plate 82, the installation position of the elastic body and the reset plate 82 is not limited, and the elastic force may include an elastic pushing force or an elastic pulling force. The second rack 81 is engaged with the first rack 7 by an elastic force provided by the elastic body.

When the operator pushes the second end of the push button 8, and the second end approaches the control handle 4 to a preset distance, the engagement state of the second rack 81 and the first rack 7 is released, so that the first end of the push button 8 can freely slide on the reset plate 82, and the proximal end of the inner catheter 2 is driven to move, and the distal end of the inner catheter 2 moves along with the movement, so that the carrying section 302 performs an extending or contracting action.

When the operator releases the second end of the push button 8, the elastic force of the elastic body acts on the reset plate 82, the reset plate 82 pushes the first end of the push button 8, the second rack 81 on the first end is meshed with the first rack 7, so that the locking function is achieved, the inner catheter 2 is also locked, and the shape of the bearing section 302 is fixed.

In some embodiments, the impulse ablation catheter further comprises a bellows 9, a distal end of the bellows 9 is connected to a proximal end of the outer catheter 1, and a proximal end of the bellows 9 is connected to a first end of the push button 8. The two ends of the corrugated pipe 9 can be connected by bonding.

Preferably, the bellows 9 is arranged coaxially with the outer catheter 1.

By providing the bellows 9, the flexibility of the bellows 9 can be utilized to match the telescopic movement of the inner tube 2 in the outer tube 1, and a sealing structure can be formed between the inner tube 2 and the outer tube 1.

The embodiments in the present specification are described in a progressive manner, and the same and similar parts among the embodiments are referred to each other, and each embodiment focuses on differences from other embodiments. In particular, for the method embodiments described later, since they correspond to the system, the description is simple, and for relevant points, reference may be made to the partial description of the system embodiments.

The above description is only for the specific embodiments of the present application, but the scope of the present application is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present application should be covered within the scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. A pulse ablation catheter is arranged at the far end of a control handle and is characterized by comprising an outer catheter, an inner catheter and an ablation assembly;

the outer catheter is sleeved outside the inner catheter;

the ablation assembly comprises an annular base, a plurality of bearing sections and a plurality of electrodes, the annular base is fixed at the far end of the outer catheter, and the electrodes are arranged at preset positions of the bearing sections;

the bearing section also comprises a first circular arc section and a second circular arc section which are connected with each other, the circular arc directions of the first circular arc section and the second circular arc section are opposite, the near end of the first circular arc section is connected with the annular base, and the far end of the second circular arc section is connected with the far end of the inner catheter;

2. The pulse ablation catheter of claim 1, wherein the first circular arc segment and the second circular arc segment have the same radius.

3. The pulse ablation catheter of claim 1, wherein the radius of the first circular arc segment and/or the second circular arc segment is 70-80 mm.

4. The pulse ablation catheter of claim 1, wherein the carrier section further comprises a first linear segment through which a proximal end of the first circular segment is connected to the annular base and a second linear segment through which a distal end of the second circular segment is connected to a distal end of the inner catheter.

5. The pulse ablation catheter according to claim 4, wherein a fixing piece is arranged at the distal end of the inner catheter, the fixing piece is provided with fixing holes, the number of the fixing holes is the same as that of the bearing sections, and the fixing holes are used for correspondingly fixing the distal end of the second straight section.

6. The pulse ablation catheter of claim 1, wherein the annular base and the carrier section are integrally formed.

7. The pulse ablation catheter according to claim 1, wherein the bearing section is provided with 2N electrodes, and the distance between the adjacent electrodes is 4-8 mm, wherein N is a positive integer.

8. The pulse ablation catheter of claim 1, wherein the material of the outer and/or inner catheter comprises Pebax braided material.

9. The pulse ablation catheter according to claim 1, wherein the control handle further comprises a push button, and an elastomer, a reset plate, a first rack disposed inside the control handle;

10. The pulse ablation catheter according to claim 9, further comprising a bellows, a distal end of the bellows being connected to a proximal end of the outer catheter, a proximal end of the bellows being connected to the first end of the push button.