CN220459404U

CN220459404U - Adjustable curved conduit

Info

Publication number: CN220459404U
Application number: CN202321493937.8U
Authority: CN
Inventors: 段超
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2023-06-12
Filing date: 2023-06-12
Publication date: 2024-02-09
Anticipated expiration: 2033-06-12

Abstract

The application provides an adjustable bending catheter, which comprises a catheter body and a bending section, wherein the proximal end of the bending section is connected with the distal end of the catheter body, the hardness of the bending section is smaller than that of the catheter body, and the bending section is used for mapping and/or ablating target tissues; the bending section is bent in advance relative to the pipe body, the bending section can form a second bending outside the first bending when being stressed and bent, the second bending is performed at a position point between the proximal end and the distal end of the bending section, and an included angle is formed between a plane where the first bending is located and a plane where the second bending is located. The utility model provides an adjustable curved pipe is to the curved target tissue that is difficult to get into in plane, can satisfy its entering requirement well, and more smooth and easy at the in-process that gets into target tissue, and then reduced the operation degree of difficulty of operation, improved operation efficiency.

Description

Adjustable curved conduit

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to an adjustable bent catheter.

Background

With the development of endocardial electrophysiology and ablation, physicians have long recognized that the Coronary Sinus (CS) has a dense and inseparable relationship with a variety of arrhythmias, mainly with unique anatomical locations and histological structures of the coronary sinus. The coronary sinus is a part of the blood circulation of the heart muscle and has the main function of pooling venous blood from the heart muscle and draining it back to the right atrium, which is located in the rear part of the heart, between the left atrium and the right atrium, with the coronary sinus opening in the right atrium.

Because of the specificity of the coronary sinus structure, the bending type of the current electrophysiology catheter is difficult to enter the coronary sinus orifice, thereby increasing the difficulty of heart operation and affecting the operation efficiency.

Disclosure of Invention

To the not enough that prior art exists, this application provides an adjustable curved pipe, can satisfy the entering requirement of the target tissue that the plane bending is difficult to get into well, and more smooth and easy at the in-process that gets into target tissue, and then reduced the operation degree of difficulty of operation, improved operation efficiency.

The application provides an adjustable bend catheter, comprising:

a pipe body; and

the proximal end of the bending section is connected with the distal end of the pipe body, the hardness of the bending section is smaller than that of the pipe body, and the bending section is used for mapping and/or ablating target tissues;

the bending section is bent in advance relative to the pipe body, the bending section can form a second bending outside the first bending when being stressed and bent, the second bending is performed at a position point between the proximal end and the distal end of the bending section, and an included angle is formed between a plane where the first bending is located and a plane where the second bending is located.

According to the adjustable bending catheter, on one hand, the distal end of the adjustable bending catheter can form the first bending and the second bending, the plane where the first bending is located and the plane where the second bending is located are two planes with included angles in a space structure, the space bending mode can meet the requirement of entering target tissues (target tissues which are difficult to enter by using plane bending, such as coronary sinus) with special structural forms, and the process of entering the target tissues is smoother, so that the operation difficulty of an operation is reduced, and the operation efficiency is improved; on the other hand, the adjustable bend catheter can be used as a mapping catheter and an ablation catheter, and also can be a catheter integrating an ablation function and a mapping function, so that the flexibility of the adjustable bend catheter in use is greatly improved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below. It is obvious that the drawings in the following description are only some implementations provided by way of example of the present application, and that other drawings may be obtained from these drawings by those of ordinary skill in the art without the inventive effort.

FIG. 1 is a schematic view of a structure of an adjustable bend conduit according to an embodiment of the present disclosure during a forming process;

FIG. 2 is a schematic view of an adjustable bend catheter according to an embodiment of the present disclosure in a first state;

FIG. 3 is a schematic view of an adjustable bend catheter according to an embodiment of the present disclosure in a second state;

FIG. 4 is a schematic view of a part of a bendable catheter according to an embodiment of the present disclosure in a first state;

FIG. 5 is a schematic view of a part of a flexible conduit according to an embodiment of the present disclosure in a second state;

FIG. 6 is a schematic cross-sectional view of a first handle according to one embodiment of the present application;

FIG. 7 is a schematic cross-sectional view of a first handle according to an embodiment of the present disclosure;

FIG. 8 is a schematic cross-sectional view of a second handle according to one embodiment of the present disclosure;

FIG. 9 is a schematic cross-sectional view of a second handle according to one embodiment of the present disclosure;

FIG. 10 is a schematic cross-sectional view of a distal end of a first adjustable bend conduit according to one embodiment of the present application;

FIG. 11 is a schematic cross-sectional view of a first bending section provided in an embodiment of the present application;

FIG. 12 is a schematic cross-sectional view of a first tubular body according to an embodiment of the present disclosure;

FIG. 13 is a schematic cross-sectional view of a second adjustable bend conduit distal end provided in accordance with one embodiment of the present application;

FIG. 14 is a schematic cross-sectional view of a second type of adjustable bend catheter distal end according to one embodiment of the present application;

FIG. 15 is a schematic cross-sectional view of a second bending section provided in an embodiment of the present application;

FIG. 16 is a schematic illustration of an adjustable bend catheter according to an embodiment of the present application applied to the coronary sinus.

The reference numerals are as follows:

the adjustable bending catheter-200, the bending section-10, the tube body-20, the handle-30, the traction piece-40, the protective sleeve-50, the gasket-60, the first locking head-70, the second locking head-80, the first electrode-90, the electric connector-100, the temperature sensor-110, the second electrode-120, the elastic tube-130, the elastic piece-140, the conduit-150, the traction tube-160, the first axial inner cavity-11, the second axial inner cavity-12, the third axial inner cavity-13, the three-cavity tube-14, the first woven mesh tube-15, the first coating layer-16, the inner film-17, the second woven mesh tube-18, the second coating layer-19, the positive electrode-121, the negative electrode-122, the first inner cavity-131, the second inner cavity-132, the first pipe cavity-21, the second pipe cavity-22, the third pipe cavity-23, the first bending-201, the second bending-202, the first bending angle-alpha, the second bending angle-beta, the push rod-31, the shell-32, the shell-311-312, the annular bending groove-313, the limiting groove-93-313, the connecting rod-and the boss.

Detailed Description

The technical solutions of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. It will be apparent that the described embodiments are only some, but not all, of the embodiments of the present application. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present disclosure.

The following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments that can be used to practice the present application. Directional terms referred to in the description of the present application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side wall", etc., are only directions referring to the attached drawings, and thus, directional terms are used for better, more clear description and understanding of the present application, rather than indicating or implying that the apparatus or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present application.

In the description of the present application, for example, "first", "second", "third", etc., are used merely to distinguish between the described objects and do not have any sequential or technical meaning. In the description of the present application, references to "connected" and "coupled" are intended to include both direct connection (coupling) and indirect connection (coupling), unless otherwise indicated.

For ease of description, in the field of endoluminal interventions, the proximal end refers to the end of the instrument that is close to the operator after the intervention, and the distal end refers to the end of the instrument that is far from the operator after the intervention. "proximal" and "distal" are non-limiting directional descriptions.

Referring to fig. 1, 2 and 3, the bendable catheter 200 provided in the present application can be used as a mapping catheter to perform potential mapping on target tissue, can be used as an ablation catheter to ablate target tissue, achieves the effect of electrical isolation, and can be a catheter integrating mapping function and ablation function. The target tissue may be a biological tissue such as the mitral isthmus, tricuspid isthmus, left atrial roof, any pulmonary vein ostium, coronary sinus, etc., which is not limited in this application.

The adjustable curved catheter 200 provided herein will be described in detail below with reference to the ablation and mapping of the coronary sinus by the adjustable curved catheter 200. The adjustable bend conduit 200 provided herein includes a bending section 10 and a tube body 20, wherein a proximal end of the bending section 10 is connected to a distal end of the tube body 20. The bending section 10 is used to deliver ablative energy to the coronary sinus to alter the electrical signal conduction of the coronary sinus (e.g., prevent abnormal electrical propagation and/or disrupt abnormal electrical conduction through the coronary sinus) and thereby effect ablation of the coronary sinus.

In this embodiment, the bending section 10 can be used not only for ablating the coronary sinus, but also for performing electrophysiological signal mapping (hereinafter referred to as mapping) on the coronary sinus, so that the adjustable bending catheter 200 integrates the ablation function and the mapping function, and thus, after the adjustable bending catheter 200 ablates the coronary sinus, mapping on the coronary sinus can be further implemented, so as to detect whether the effect of ablating the coronary sinus is expected or not, and further judge whether the coronary sinus needs to be ablated again, which is favorable for improving the quality of ablating the coronary sinus by the adjustable bending catheter 200.

In some other embodiments, the bending section 10 may be used only for ablating target tissue, or the bending section 10 may be used only for mapping target tissue, specifically selected according to the function that the adjustable bend catheter 200 is required to perform, which is not limited in this application.

In this embodiment, the hardness of the bending section 10 is smaller than that of the tube body 20, so that the bending performance of the bending section 10 is better, and the bending section 10 can be conveniently and smoothly introduced into the coronary sinus for ablation and mapping.

Referring to fig. 2, 3, 4 and 5, the bendable catheter 200 provided herein includes a first state and a second state, the bendable catheter 200 may be preformed in a thermoplastic shape to form the first state, and the bendable catheter 200 may be switched between the first state and the second state. In the first state, the bending section 10 forms a first bend 201 in advance relative to the pipe body 20, and a bending point of the first bend 201 is located at a joint between the bending section 10 and the pipe body 20, where the bending section 10 and the pipe body 20 are located on the same plane. In the second state, the bending section 10 is forced to bend to form a second bending 202, and the bending point of the second bending 202 is located between the distal end of the bending section 10 and the proximal end of the bending section 10, i.e. the bending point of the second bending 202 is different from the bending point of the first bending 201.

It should be understood that the plane in which the second bend 202 is located forms an included angle with the plane in which the first bend 201 is located, that is, the two planes intersect, and the included angle is an included angle between lines perpendicular to the same point on the intersection line of the two planes in each plane. In other words, the first bend 201 and the second bend 202 are not in the same plane, but are located in two planes of space, respectively, i.e., the distal end of the adjustable bend catheter 200 forms a spatial bend. In the ablation procedure, the adjustable bend catheter 200 enters from the input port of the inferior vena cava and then enters the coronary sinus from the output port of the inferior vena cava, however, the coronary sinus port is positioned at the side rear of the output port of the inferior vena cava, which determines that the planar bend is difficult to enter the coronary sinus, and because of the anatomical feature and the procedure entry path, the adjustable bend catheter 200 can enter the coronary sinus more easily after forming the spatial bend, which can reduce the complexity of the ablation procedure, is beneficial to reducing the preparation time before the ablation procedure, and further improves the efficiency of the ablation procedure.

In this embodiment, when the adjustable bend conduit 200 is in the first state, the first bend 201 forms a first bending angle α, which is an included angle between the bending section 10 and the pipe body 20, and the first bending angle α is an obtuse angle. When the adjustable catheter 200 is in the second state, the second bend 202 forms a second bending angle β, which is an included angle between a line between the distal end of the bending section 10 and the bending point at the second bend 202 and a line between the proximal end of the bending section 10 and the bending point at the second bend 202.

In some other embodiments, the second bending 202 may be an arc bending, which is not limited in this application, only to ensure that the plane of the portion between the second bending 202 and the distal end of the bending section 10 is inclined with respect to the plane of the portion between the first bending 201 and the second bending 202. On the one hand, due to the anatomical feature limitation of the coronary sinus, the spatially bent adjustable catheter 200 can be smoother in the process of entering the target tissue, so that the operation difficulty of the surgery can be reduced, and the ablation efficiency can be improved. On the other hand, the curved bending section 10 has an increased radial dimension compared to the straight bending section 10, and thus can better abut the coronary sinus, which is advantageous for improving the ablation and/or mapping effect of the adjustable bending catheter 200 on the target tissue.

Referring to fig. 2, 3, 6 and 7, the bendable catheter 200 provided in the present application further includes a handle 30 and a traction member 40, wherein the distal end of the handle 30 is connected to the proximal end of the tube body 20, the proximal end of the traction member 40 is connected to the handle 30, and the distal end of the traction member 40 is connected to the distal end of the bending section 10 after passing through the handle 30 and the tube body 20. When the adjustable bend conduit 200 is in the first state, the operator can drive the distal end of the traction element 40 to move proximally by the control handle 30, so that the bending section 10 is forced to bend to form the second bending 202, and the adjustable bend conduit 200 is in the second state. It will be appreciated that when the ablation procedure is completed, the adjustable bend catheter 200 is in the second state, at which point the operator may move the distal end of the retractor 40 distally by controlling the handle 30, thereby allowing the bending section 10 to resume its shape change, i.e., allowing the adjustable bend catheter 200 to resume its first state, so as to facilitate withdrawal of the adjustable bend catheter 200 from the coronary sinus.

Referring to fig. 2, 3, 4, 5, 6 and 7, the handle 30 provided in the present application includes a push rod 31 and a housing 32, wherein a distal end of the push rod 31 is fixedly sleeved on an outer side of a proximal end of the tube body 20, the housing 32 is sleeved on an outer side of the proximal end of the push rod 31, the housing 32 can slide along an axial direction of the housing 32 relative to the push rod 31, and a proximal end of the traction member 40 is fixedly connected with the housing 32.

When the adjustable bend conduit 200 is in the first state, the operator controls the handle 30 to move the housing 32 proximally relative to the push rod 31, the distal end of the traction member 40 is forced and moved proximally, and the bending section 10 is forced to bend to form the second bend 202, and the adjustable bend conduit 200 is switched from the first state to the second state.

When the adjustable bend conduit 200 is in the second state, the operator controls the handle 30 to move the housing 32 distally relative to the push rod 31, and the distal end of the traction member 40 moves distally and returns to the original state, so that the bending section 10 returns to the original state, and the adjustable bend conduit 200 is switched from the second state to the first state.

In this embodiment, the outer wall of the proximal end of the push rod 31 is provided with a glue injection hole 311, and the orthographic projection of the glue injection hole 311 on the pipe body 20 is completely located on the outer wall of the pipe body 20. The injecting hole 311 is used for injecting a connecting agent, such as resin, rubber, polymer, etc., so as to enhance the connection stability between the push rod 31 and the tube body 20, reduce the risk of falling off of the parts of the adjustable bending catheter 200, and further improve the safety of the ablation operation.

In this embodiment, the bendable catheter 200 further includes a protective sleeve 50, the protective sleeve 50 is sleeved on the outer side of the tube body 20, and the proximal end of the protective sleeve 50 extends into the distal end of the push rod 31 and is fixedly connected with the distal end of the push rod 31. Because the hardness of the pipe body 20 is smaller than that of the push rod 31, the connection part between the pipe body 20 and the push rod 31 is easy to bend, and normal use of the adjustable bend conduit 200 is affected. The utility model provides a connect between pipe shaft 20 and push rod 31 through protective sheath 50 to prevent that pipe shaft 20 from taking place to buckle at the junction of pipe shaft 20 and push rod 31, be favorable to improving the stability of adjustable curved pipe 200 in the use. When the operator controls the movement of the adjustable bend conduit 200, the synchronous movement between the pipe body 20 and the push rod 31 can be kept, and the pipe body 20 cannot bend relative to the push rod 31. Alternatively, the material of the protective sleeve 50 includes, but is not limited to, thermoplastic polyurethane (Thermoplastic urethanes, TPU), polypropylene (PP), polyethylene (PE), etc., and PP is preferred in this embodiment.

In a specific embodiment, the housing 32 includes a connecting rod 321 and a housing 322, the connecting rod 321 is slidably sleeved on the outer side of the push rod 31, the housing 322 is sleeved on the outer side of the connecting rod 321, and a distal end of the housing 322 is detachably connected with a distal end of the connecting rod 321. Optionally, the removable connection between the housing 322 and the connecting rod 321 includes, but is not limited to, a snap fit, a threaded connection, or the like. In this embodiment, the threaded connection is preferably a female thread provided on the housing 322, an male thread provided on the connecting rod 321, or a male thread provided on the housing 322, and a female thread provided on the connecting rod 321.

When the adjustable bend conduit 200 needs to be switched from the first state to the second state, the operator controls the handle 30 to move the connecting rod 321 and the housing 322 proximally relative to the push rod 31, so that the bending section 10 is forced to bend under the action of the traction element 40 to form the second bending 202. When the adjustable bend catheter 200 needs to be switched from the second state to the first state, the operator controls the handle 30 to move the connecting rod 321 and the housing 322 distally relative to the push rod 31, which in turn may cause the traction member 40 and the bending section 10 to return to the original state.

Further, the proximal end of the connecting rod 321 is provided with a clamping groove structure 3212, and the clamping groove structure 3212 is used for fixing the proximal end of the traction member 40. When the connecting rod 321 and the housing 322 are moved proximally relative to the push rod 31, the traction member 40 is forced distally and moved proximally, thereby causing the bending section 10 to bend under force to form the second bend 202, and the adjustable bend catheter 200 can be switched from the first state to the second state.

It will be appreciated that in other embodiments, the slot structure 3212 may be provided on the housing 322, and the proximal end of the traction member 40 is fixedly connected to the slot structure 3212, which is not limited in this application.

In this embodiment, the handle 30 further includes a spacer 60, an accommodating groove 312 is formed on an outer wall of the push rod 31, the spacer 60 is disposed in the accommodating groove 312 and contacts with an inner wall of the connecting rod 321, the spacer 60 is used for increasing resistance of the connecting rod 321 when sliding along an axial direction relative to the push rod 31, so that self-locking can be achieved when the adjustable bending catheter 200 is in the second state, and rebound of the bending section 10 after the second bending 202 occurs is prevented. This arrangement allows the position of the connecting rod 321 relative to the push rod 31 to be more controllable in the axial direction, which is advantageous for improving the accuracy of the control of the handle 30 by the operator.

Specifically, the accommodating groove 312 provided in the embodiment is annular, the gasket 60 is also annular, the assembly between the annular gasket 60 and the annular accommodating groove 312 is simple, and the annular gasket 60 can increase the contact area between the gasket 60 and the inner wall of the connecting rod 321, so as to increase the resistance of the connecting rod 321 relative to the push rod 31 during axial sliding.

It will be appreciated that in other embodiments, the number of shims 60 may be plural, the number of pockets 312 may be plural, and the plurality of pockets 312 may be spaced apart in the axial direction. The plurality of gaskets 60 are respectively disposed in the plurality of receiving grooves 312, so that the resistance of the connecting rod 321 when axially sliding relative to the push rod 31 can be further increased, and the stability of the connecting rod 321 when axially sliding relative to the push rod 31 can be further ensured. In some other embodiments, the number of the gaskets 60 is plural, the number of the receiving slots 312 is plural, the receiving slots 312 are sequentially arranged at intervals along the circumferential direction, and the plurality of gaskets 60 are respectively arranged in the plurality of receiving slots 312 arranged along the circumferential direction, which is not limited in this application.

In some other embodiments, the receiving groove 312 may be disposed on an inner wall of the connecting rod 321, and the gasket 60 is disposed in the receiving groove 312 and contacts with an outer wall of the push rod 31, so as to increase the resistance of the connecting rod 321 when sliding along the axial direction relative to the push rod 31, where the receiving groove 312 is disposed is not limited in the present application.

In this embodiment, the outer wall of the proximal end of the push rod 31 is provided with a limiting groove 313, the inner wall of the connecting rod 321 is provided with a limiting buckle 3211, and when the connecting rod 321 is sleeved on the proximal end of the push rod 31, the limiting buckle 3211 is matched with the limiting groove 313. When the limit button 3211 arranged on the inner wall of the connecting rod 321 is matched with the limit groove 313 arranged on the outer wall of the push rod 31, the distance of the connecting rod 321 along the axial sliding direction relative to the push rod 31 is smaller than or equal to the length of the limit groove 313 along the axial direction, so that the distance of the connecting rod 321 along the axial sliding direction relative to the push rod 31 can be limited, and the situation that the connecting rod 321 is separated from the push rod 31 is prevented.

Specifically, in order to ensure that the handle 30 can effectively control the bending section 10 to bend to form the second bending 202, the positions of the limiting groove 313 and the limiting buckle 3211 are required. The limit groove 313 and the limit buckle 3211 need to satisfy: when the retaining clip 3211 is located at the distal end of the retaining groove 313, the adjustable bend catheter 200 is in the first state. When the retaining clip 3211 is located at the proximal end of the retaining groove 313, the adjustable bend catheter 200 is in the second state. This ensures that the operator can control the switching of the tube of the adjustable bend section 10 between the first state and the second state via the handle 30.

In some other embodiments, the limiting groove 313 may be formed on an inner wall of the connecting rod 321, the limiting buckle 3211 may be disposed on an outer wall of the push rod 31, and when the connecting rod 321 is sleeved on a proximal end of the push rod 31, the limiting buckle 3211 is matched with the limiting groove 313, which is not limited in this application. It should be noted that, due to the assembly requirement, the limiting buckle 3211 disposed on the push rod 31 is an elastic buckle, so that the connecting rod 321 is sleeved on the proximal end of the push rod 31.

Referring to fig. 2, 3, 4, 5, 8 and 9, in some other embodiments, the limiting groove 313 may be omitted on the outer wall of the proximal end of the push rod 31, and the limiting button 3211 may be omitted on the inner wall of the connecting rod 321. The proximal end of the push rod 31 can be exposed from the proximal end of the connecting rod 321, with the outer wall of the proximal end of the push rod 31 being spaced from the inner wall of the housing 322. The handle 30 further includes a first locking head 70 and a second locking head 80, the first locking head 70 is detachably sleeved on the distal end of the push rod 31, the second locking head 80 is detachably sleeved on the proximal end of the push rod 31, and the second locking head 80 is used for limiting the axial sliding distance of the connecting rod 321 relative to the push rod 31.

Specifically, to ensure that the second locking head 80 can stably limit the distance that the connecting rod 321 slides axially relative to the push rod 31, the maximum outer diameter of the second locking head 80 is larger than the inner diameter of the proximal end of the connecting rod 321, so as to prevent the connecting rod 321 from being separated from the push rod 31 when the connecting rod 321 slides axially proximally relative to the push rod 31, thereby improving the stability of the adjustable bend catheter 200 when switching from the first state to the second state.

More specifically, to ensure that the handle 30 is able to effectively control the bending of the bending section 10 to form the second bend 202, a movable travel of the second locking head 80 within the housing 322 is required. The movable travel of the second locking head 80 in the housing 322 is required to satisfy: the adjustable bend conduit 200 is in the first state when the second locking head 80 is positioned near the proximal end of the housing 322. When the second locking head 80 is positioned near the proximal end of the connecting rod 321, the adjustable bend conduit 200 is in the second state. This ensures that the operator can control the switching of the tube of the adjustable bend section 10 between the first state and the second state via the handle 30.

Referring to fig. 2, 3, 6 and 10, the bendable catheter 200 provided herein further includes a first electrode 90 and an electrical connector 100, wherein the first electrode 90 is disposed at the distal-most end of the bending section 10, and the electrical connector 100 is disposed at the proximal end of the handle 30. The first electrode 90 is electrically connected to the electrical connector 100 via a lead a to enable the first electrode 90 to ablate or map the coronary sinus. The material of the first electrode 90 may be a medical metal or alloy such as platinum, iridium, gold, silver, etc. that can be used for interventional therapy. The electrical connector 100 is removably coupled to the proximal end of the housing 322 of the handle 30, preferably the electrical connector 100 is threadably coupled to the proximal end of the housing 322.

Specifically, the first electrode 90 includes a head 91 and a connecting portion 92, the head 91 is located at a distal end of the first electrode 90, the connecting portion 92 is located at a proximal end of the first electrode 90, the proximal end of the head 91 is connected to a distal end of the bending section 10, and the connecting portion 92 is disposed in the bending section 10 in a penetrating manner. In this embodiment, the head 91 at the distal end of the first electrode 90 is hemispherical, the connecting portion 92 at the proximal end of the first electrode 90 is cylindrical, and the diameter of the head 91 is larger than the outer diameter of the connecting portion 92. It will be appreciated that the head 91 may be semi-elliptical, as this application is not limited in this regard.

More specifically, the proximal end of the connecting portion 92 is provided with an annular boss 93 along the circumferential direction, and the annular boss 93 is used for contacting with the inner wall of the bending section 10, so as to enhance the connection strength between the first electrode 90 and the bending section 10, so as to prevent the first electrode 90 from falling off from the distal end of the bending section 10.

The adjustable bend conduit 200 provided herein further includes a temperature sensor 110, the temperature sensor 110 being disposed within the first electrode 90. The temperature sensor 110 is electrically connected to the electrical connector 100 through the lead B, so as to detect the temperature of the first electrode 90 when ablating the coronary sinus in real time, and prevent the matrix tissue from being damaged due to overhigh temperature.

Specifically, the head 91 has a hollow cavity, the connection portion 92 has a hollow cavity, the hollow cavity of the head 91 communicates with the hollow cavity of the connection portion 92, and the temperature sensor 110 enters the hollow cavity of the head 91 through the hollow cavity of the connection portion 92. The distal end of the wire B enters the hollow cavity of the head 91 through the hollow cavity of the connection portion 92, and the wire B is fixed in the hollow cavity of the connection portion 92 by welding, preferably soldering. The darkened portions in fig. 10 represent solder.

Specifically, the distal end of the lead a enters the hollow cavity of the head 91 through the hollow cavity of the connection portion 92, and the lead a is fixed in the hollow cavity of the connection portion 92 by welding, preferably soldering. The wire a is connected with the first electrode 90 through welding, which is beneficial to improving the stability of connection between the wire a and the first electrode 90, and further improving the stability of electrical connection between the first electrode 90 and the electrical connector 100.

Specifically, the distal end of the traction element 40 has a bent structure, and the traction element 40 is fixed in the hollow cavity of the connecting portion 92 by welding, preferably soldering. By providing the distal end of the traction member 40 in a bent configuration and by welding the traction member 40 to the connection portion 92 of the first electrode 90, the risk of the traction member 40 falling off the first electrode 90 can be reduced, thereby ensuring effective bending.

The tunable bending catheter 200 provided herein further includes a second electrode 120, the second electrode 120 being disposed on a peripheral sidewall of the tuning section 10. The second electrode 120 is electrically connected to the electrical connector 100 by a lead C to enable the second electrode 120 to ablate or map the coronary sinus. The material of the second electrode 120 may be a medical metal or alloy such as platinum, iridium, gold, silver, etc. that can be used for interventional therapy.

In some other embodiments, the adjustable bend catheter 200 may include only either the first electrode 90 or the second electrode 120, depending on the location of ablation and/or mapping, which is not limiting in this application.

Specifically, the second electrode 120 is an annular electrode, the value range of the inner diameter of the second electrode 120 is 1.6-3.0 mm, the value range of the outer diameter of the second electrode 120 is 1.65-3.05 mm, and the value range of the length of the second electrode 120 along the axial direction is 0.5-2.0 mm. The number of the second electrodes 120 is plural, and the second electrodes 120 include positive electrodes 121 and negative electrodes 122, and the positive electrodes 121 and the negative electrodes 122 are alternately arranged in order along the extending direction of the bending section 10. The positive electrode 121 is electrically connected to the electrical connector 100 through a positive electrode lead, and the negative electrode 122 is electrically connected to the electrical connector 100 through a negative electrode lead.

In this embodiment, all the electrodes (including the first electrode 90 and the second electrode 120) are sequentially from the distal end to the proximal end, that is, the first electrode 90, the negative electrode 122, the positive electrode 121, the negative electrode 122, the positive electrode 122, and the negative electrode 122, which are ten in number in this embodiment, it is understood that the number of electrodes may be any other suitable number, which is not limited in this application.

Since the electrode spacing is closely related to depth/precision and range, the smaller the electrode spacing is, the larger the ablation depth/mapping precision is, and the larger the electrode spacing is, the larger the electric field range/mapping range is. Therefore, in this embodiment, in order to meet the depth/precision and range requirements at the same time, the distance between two adjacent electrodes on the bending section 10 along the axial direction may include a small pitch and a large pitch, where the small pitch and the large pitch may be alternately arranged in sequence or may not be alternately arranged in sequence, and the small pitches may be equal or may not be equal, and the large pitches may be equal or may not be equal, but the small pitch is smaller than the large pitch. It will be appreciated that in other embodiments, there may be only one axial distance between two adjacent electrodes on the tuning section 10, which is not a limitation of the present application.

Referring to fig. 2, 3, 10 and 11, in the present embodiment, the bending section 10 of the bending catheter 200 has a three-cavity tube structure, i.e. the bending section 10 has a first axial cavity 11, a second axial cavity 12 and a third axial cavity 13 separated from each other, and the first axial cavity 11, the second axial cavity 12 and the third axial cavity 13 are all disposed parallel to the axis of the bending section 10. The bending section 10 is preferably a three-layer composite tube, and the bending section 10 sequentially comprises a three-cavity tube 14, a first woven mesh tube 15 and a first coating layer 16 from inside to outside, wherein the first axial inner cavity 11, the second axial inner cavity 12 and the third axial inner cavity 13 are all arranged in the three-cavity tube 14.

In this embodiment, the material of the triple lumen tube 14 is preferably Polytetrafluoroethylene (PTFE), the material of the first woven mesh tube 15 is preferably stainless steel, and the material of the first coating layer 16 is preferably polyether block amide (Polyether block amide, PEBAX).

Specifically, the distal end of the triple lumen tube 14 and the distal end of the first woven mesh tube 15 are disposed flush, and the distal end of the triple lumen tube 14 and the distal end of the first woven mesh tube 15 are housed within the first cladding layer 16, i.e., the distal end of the first cladding layer 16 exceeds the distal end of the triple lumen tube 14, and the distal end of the first cladding layer 16 exceeds the distal end of the first woven mesh tube 15. Preferably, the distal end of the first coating layer 16 exceeds the distal end of the triple lumen tube 14 by a distance ranging from 1.5 mm to 8.0mm, and the connecting portion 92 of the first electrode 90 is accommodated in the portion of the first coating layer 16 exceeding the distal end of the triple lumen tube 14, and the annular boss 93 is in contact with the inner wall of the portion of the first coating layer 16 exceeding the distal end of the triple lumen tube 14, so that the first electrode 90 is firmly connected to the distal end of the bending section 10. Moreover, the hollow cavity of the connecting portion 92 communicates with the first axial inner cavity 11 of the bending section 10, the hollow cavity of the connecting portion 92 also communicates with the second axial inner cavity 12 of the bending section 10, and the hollow cavity of the connecting portion 92 also communicates with the third axial inner cavity 13 of the bending section 10.

Referring to fig. 2, 3, 6, 10, 11 and 12, in the present embodiment, the tube body 20 of the bendable catheter 200 has a three-lumen structure, i.e. the tube body 20 has a first lumen 21, a second lumen 22 and a third lumen 23 penetrating along the axial direction thereof, and the first lumen 21, the second lumen 22 and the third lumen 23 are all parallel to and separated from the axis of the tube body 20. The pipe body 20 may be made of one or more of block polyether amide resin (Block polyether amide resin), polyurethane (Thermoplastic Urethane, TPU), block Polyamide (Polyether block amide, PEBA) or nylon (Polyamide, PA), which is not limited in this application. The outer diameter of the pipe body 20 is 1.5-2.9 mm, and the length of the pipe body 20 is 1050-1150 mm.

In this embodiment, when the proximal end of the bending section 10 is connected to the distal end of the tube body 20, the first lumen 21 and the first axial inner cavity 11 are mutually communicated to form a positive wire channel for accommodating the positive electrode wire of the positive electrode 121 and the wire a of the first electrode 90. The second lumen 22 communicates with the second axial lumen 12 to form a negative wire channel for receiving a negative electrode wire of the negative electrode 122. The third lumen 23 communicates with the third axial lumen 13 to form a traction channel for receiving the traction element 40.

Specifically, the distal end of the lead a is connected to the first electrode 90, and the proximal end of the first lead a sequentially penetrates through the hollow cavity of the first electrode 90, the first axial inner cavity 11 and the first lumen 21 to form a positive lead channel, and the inner cavity of the handle 30 (the inner cavity of the push rod 31) and is finally electrically connected to the electrical connector 100.

The distal end of the lead B is connected to the temperature sensor 110, and the proximal end of the lead B sequentially penetrates through the hollow cavity of the first electrode 90, the first axial inner cavity 11 and the first lumen 21 to form a positive lead channel, and the inner cavity of the handle 30 (the inner cavity of the push rod 31) and is finally electrically connected to the electrical connector 100. It is understood that the proximal end of the second wire B may also be electrically connected to the electrical connector 100 via a negative wire channel, which is not limited in this application.

The lead C includes a positive electrode lead and a negative electrode lead, the distal end of the positive electrode lead is connected to the positive electrode 121, and the proximal end of the positive electrode lead sequentially penetrates through the first axial inner cavity 11 and the first lumen 21 to form a positive lead channel, and the inner cavity (the inner cavity of the push rod 31) of the handle 30 is finally electrically connected to the electrical connector 100. The distal end of the negative electrode wire is connected to the negative electrode 122, and the proximal end of the negative electrode wire sequentially penetrates through the second axial inner cavity 12 and the second lumen 22 to form a negative wire channel, and the inner cavity of the handle 30 (the inner cavity of the push rod 31) is finally electrically connected to the electrical connector 100.

The distal end of the traction member 40 is connected with the first electrode 90, and the proximal end of the traction member 40 sequentially penetrates through a traction channel formed by the hollow cavity of the first electrode 90, the third axial inner cavity 13 and the third pipe cavity 23, and is finally fixedly connected with a clamping groove structure 3212 of the connecting rod 321 in the handle 30.

In this embodiment, an operator realizes in the switching process of the control handle 30 that the adjustable bend catheter 200 is in the first state and the second state, in order to prevent the occurrence of the phenomena of winding and knotting of the wire a, the wire B and the wire C, a hollow wire column 314 is disposed at the proximal end of the push rod 31, and the wire a, the wire B and the wire C pass through the hollow wire column 314 at the proximal end of the push rod 31 and are electrically connected with the electrical connector 100, so that the occurrence of the phenomena of winding and knotting of the wire a, the wire B and the wire C can be reduced, and the risk of breakage of the wire a, the wire B and the wire C can be further reduced.

Referring to fig. 2, 3, 4, 5, 6, 13, 14 and 15, in some other embodiments, the bending section 10 and the pipe body 20 are both single-lumen pipes, the bending section 10 has a hardness less than that of the pipe body 20, and when the operator pulls the traction element 40 through the control handle 30, the bending section 10 bends, and the adjustable bending catheter 200 is in the second state. When the operator releases the traction member 40 through the control handle 30, the bending section 10 resumes its shape change, and the bendable catheter 200 returns to the first state. The bending section 10 is a three-layer composite tube, and comprises an inner membrane 17, a second woven mesh tube 18 and a second coating layer 19 from inside to outside, wherein the inner membrane 17 is preferably made of Polytetrafluoroethylene (PTFE), the second woven mesh tube 18 is preferably made of stainless steel, and the second coating layer 19 is preferably made of polyether block amide (Polyether block amide, PEBAX).

Because the bending section 10 has smaller hardness, the bending section 10 cannot fully recover deformation after being bent without driving of external force. Thus, the bending-adjustable catheter 200 in the present embodiment includes the elastic tube 130, and the elastic tube 130 is inserted into the bending-adjustable section 10 and the tube body 20. The elastic tube 130 is a spring tube, the distal end of the elastic tube 130 abuts against the proximal end of the first electrode 90, and the proximal end of the elastic tube 130 is connected to the handle 30. When the adjustable bend conduit 200 is switched from the second state to the first state, the elastic tube 130 is used to provide an elastic force to the bending section 10 so that the bending section 10 can fully recover the deformation.

In this embodiment, the bendable catheter 200 further includes an elastic member 140, and when the bendable catheter 200 is switched from the first state to the second state, the elastic member 140 is used to make the bending section 10 always bend in a plane perpendicular to the axial direction of the elastic member 140, so that the distal end of the bendable catheter 200 is spatially bent. The elastic member 140 is accommodated in the elastic tube 130, the distal end of the elastic member 140 is fixedly connected to the proximal end of the first electrode 90, and the proximal end of the elastic member 140 is fixedly connected to the handle 30. The distal end of the elastic member 140 may be welded to the first electrode 90, and the elastic member 140 may be welded to the handle 30.

Specifically, the elastic member 140 is a spring plate, the cross-section of the elastic member 140 is rectangular, and the long side of the cross-section of the elastic member 140 is much larger than the short side of the elastic member 140, i.e. the elastic member 140 is in a sheet shape. The material of the elastic member 140 includes, but is not limited to, stainless steel, nickel-titanium alloy, etc., and preferably the material of the elastic member 140 is stainless steel.

In this embodiment, the elastic member 140 divides the inner cavity of the elastic tube 130 into a first inner cavity 131 and a second inner cavity 132. The adjustable bend catheter 200 further includes a guidewire tube 150, the guidewire tube 150 being received within the first lumen 131 of the flexible tube 130. The conduit 150 is configured to receive a wire a connected to the first electrode 90 and/or the conduit 150 is configured to receive a wire B connected to the temperature sensor 110 and/or the conduit 150 is configured to receive a wire C connected to the second electrode 120. Specifically, because of insulation requirements, the outer layers of the wires a, B and C are coated with a layer of insulation material, preferably Polytetrafluoroethylene (PTFE) heat shrink film.

Further, the bendable catheter 200 further includes a traction tube 160, wherein the traction tube 160 is received in the second lumen 132 of the elastic tube 130, i.e. the traction tube 160 and the conduit 150 are disposed on two opposite sides of the elastic member 140 along the radial direction thereof. The traction tube 160 is used for accommodating the traction element 40, the distal end of the traction element 40 is connected with the first electrode 90, and the proximal end of the traction element 40 is connected with the housing 32 of the handle 30.

Referring to fig. 3 and 16, the following steps of the embodiment of the adjustable catheter 200 for ablation and mapping of the coronary sinus are illustrated:

(1) Venipuncture

The adjustable bend catheter 200 is delivered to the right atrium under local anesthesia via a right femoral vein or subclavian vein puncture, under the direction of transluminal ultrasound.

(2) Insertion of adjustable bend catheters

The adjustable bend catheter 200 is delivered from the right atrium into the coronary sinus.

(3) Pre-ablation potential determination of coronary sinus

An intra-coronary sinus potential measurement is performed using the adjustable catheter 200 and the potential is recorded.

(4) Coronary sinus ablation

The adjustable bend catheter 200 is placed as closely as possible against the atrial side of the coronary sinus and then the coronary sinus is pulsed or radio frequency ablated using the first electrode 90 and/or the second electrode 120 on the adjustable bend catheter 200.

(5) Post-coronary sinus ablation potentiometry

And (3) carrying out potential measurement on the coronary sinus again by using the adjustable bending catheter 200 after ablation, judging an ablation effect according to the measurement result, and repeating the step (4) when the ablation is unsuccessful, and carrying out ablation on the coronary sinus again by using the adjustable bending catheter 200 until the coronary sinus is completely isolated.

(6) Retraction of adjustable bend catheter

After the ablation of the coronary sinus by the adjustable curved catheter 200 is completed, the adjustable curved catheter 200 is retracted and the sheath is completed.

The procedure is illustrated when the adjustable bend catheter 200 is applied only to the coronary sinus for ablation:

(1) Venipuncture

(2) Insertion of adjustable bend catheters

(3) Coronary sinus ablation

(4) Retraction of adjustable bend catheter

The procedure for mapping when the adjustable bend catheter 200 is applied only to the coronary sinus is illustrated:

(1) Venipuncture

(2) Insertion of adjustable bend catheters

(3) Coronary sinus potential measurement

(4) Retraction of adjustable bend catheter

After the coronary sinus mapping of the adjustable curved catheter 200 is completed, the adjustable curved catheter 200 is retracted and sheath retraction is completed.

The foregoing is a partial embodiment of the present application and it should be noted that, for a person skilled in the art, several improvements and modifications can be made without departing from the principle of the present application, and these improvements and modifications are also considered as the protection scope of the present application.

Claims

1. An adjustable bend catheter, comprising:

a pipe body; and

2. The adjustable bend catheter of claim 1, further comprising a handle and a pulling member, wherein the proximal end of the shaft is connected to the handle, the proximal end of the pulling member is connected to the handle, the distal end of the pulling member is connected to the bending section, and the handle is capable of driving the distal end of the pulling member to move proximally, thereby causing the bending section to bend under force.

3. The adjustable bend catheter of claim 2, wherein the handle comprises a push rod and a housing, wherein the distal end of the push rod is fixedly sleeved outside the tube body, the housing is sleeved at the proximal end of the push rod, and the proximal end of the traction member is fixedly connected with the housing; the shell can slide along the axial direction of the shell relative to the push rod, and when the shell moves towards the proximal end, the distal end of the traction piece is driven to move towards the proximal end, so that the bending section is stressed to bend.

4. The adjustable bend catheter of claim 3, wherein an outer wall of the proximal end of the push rod is provided with a glue injection hole for injecting a connecting agent to strengthen the connection between the push rod and the tube body.

5. The adjustable bend catheter of claim 3, further comprising a protective sleeve, wherein the protective sleeve is sleeved outside the shaft, and wherein a proximal end of the protective sleeve is connected to a distal end of the push rod.

6. The adjustable bend catheter of claim 3 wherein the housing comprises a connecting rod slidably disposed over the outer side of the push rod and a housing disposed over the outer side of the connecting rod, the distal end of the housing being removably connected to the distal end of the connecting rod.

7. The adjustable bend catheter of claim 6 wherein the handle further comprises a spacer, wherein the outer wall of the pushrod is provided with a receiving groove, the spacer is disposed in the receiving groove and contacts the inner wall of the connecting rod, and the spacer is used to increase the resistance of the connecting rod when the connecting rod slides axially relative to the pushrod.

8. The adjustable bend catheter of claim 6, wherein the outer wall of the proximal end of the push rod is provided with a limit groove, and the inner wall of the connecting rod is provided with a limit button, and when the connecting rod is sleeved on the proximal end of the push rod, the limit button is matched with the limit groove to limit the axial sliding distance of the connecting rod relative to the push rod.

9. The adjustable bend catheter of claim 6 wherein the proximal end of the push rod is provided with a hollow wire post.

10. The adjustable bend catheter of claim 6 wherein the proximal end of the connecting rod is provided with a detent structure for securing the proximal end of the pulling member.

11. The adjustable bend catheter of claim 6 wherein the handle further comprises a first locking head and a second locking head, the first locking head being removably sleeved on the distal end of the push rod, the second locking head being removably sleeved on the proximal end of the push rod, the second locking head being configured to limit the distance the connecting rod slides axially relative to the push rod.

12. The adjustable bend catheter of claim 2, further comprising a first electrode disposed at a distal-most end of the bending section, the first electrode for mapping and/or ablating target tissue.

13. The adjustable bend catheter of claim 2 or 12, further comprising a second electrode disposed on a peripheral sidewall of the bending section, the second electrode for mapping and/or ablating the target tissue.

14. The adjustable bend catheter according to claim 13, wherein the number of the second electrodes is plural, the second electrodes include positive electrodes and negative electrodes, the positive electrodes and the negative electrodes are alternately arranged in sequence along the extending direction of the bending section, the positive electrodes are electrically connected with a connector through positive electrode wires, the negative electrodes are electrically connected with the connector through negative electrode wires, and the connector is provided at the proximal end of the tube body.

15. The adjustable bend catheter of claim 14 wherein the tubular body has first and second spaced apart lumens extending axially therethrough, the bend section having first and second spaced apart axial lumens, the first lumen in communication with the first axial lumen to form a positive wire channel, the second lumen in communication with the second axial lumen to form a negative wire channel, the positive wire channel for receiving the positive electrode wire, the negative wire channel for receiving the negative electrode wire.

16. The adjustable bend conduit of claim 15 wherein the tubular body further has a third lumen extending axially therethrough, the third lumen being separate from the first lumen and the second lumen, the bend section further having a third axial lumen, the third lumen communicating with the third axial lumen to form a traction channel for receiving the traction element.

17. The adjustable bend catheter of claim 12 further comprising a sensor disposed within the first electrode for monitoring the temperature of the first electrode as it ablates in real time.

18. The adjustable bend catheter according to claim 12, wherein the first electrode comprises a head portion and a connecting portion connected to each other, wherein the proximal end of the head portion is connected to the distal end of the bending section, the connecting portion is disposed through the bending section, and the connecting portion is provided with an annular boss along the circumferential direction, the annular boss is in contact with the inner wall of the bending section, so as to enhance the connection strength between the first electrode and the bending section, and prevent the first electrode from falling off.

19. The adjustable bend catheter of claim 12, further comprising an elastic tube disposed through the shaft and the bending section, wherein a distal end of the elastic tube abuts against a proximal end of the first electrode, and wherein the elastic tube is configured to provide an elastic force to return the bending section to shape after the bending section is subjected to bending.

20. The adjustable bend catheter of claim 19 further comprising a resilient member received within the resilient tube, a distal end of the resilient member fixedly connected to the proximal end of the first electrode, the resilient member adapted to cause the bending section to bend in a plane generally perpendicular to the axis of the resilient member.

21. The adjustable bend conduit of claim 20 further comprising a conduit received within the flexible tube, the conduit for receiving a lead of the first electrode; or, the bending-adjustable catheter further comprises a second electrode arranged on the circumferential side wall of the bending-adjustable section, the second electrode is used for mapping and/or ablating the target tissue, and the wire conduit is used for accommodating the first electrode and the wires of the second electrode.

22. The adjustable bend conduit of claim 21, further comprising a pulling tube received within the elastic tube and disposed on opposite sides of the elastic member in a radial direction thereof, the pulling tube being configured to receive the pulling member.