WO2024017280A1

WO2024017280A1 - Medical catheter

Info

Publication number: WO2024017280A1
Application number: PCT/CN2023/108068
Authority: WO
Inventors: 曾金; 赵丽; 林航; 梁波; 黄双红
Original assignee: 上海微创电生理医疗科技股份有限公司
Priority date: 2022-07-20
Filing date: 2023-07-19
Publication date: 2024-01-25
Also published as: CN117462137A

Abstract

A medical catheter, comprising: a catheter body (1), a driving wire (2) penetrating through the catheter body (1), and a bending control core (3) penetrating through the catheter body (1) in the axial direction of the catheter body (1). The driving wire (2) is connected to the distal end of the bending control core (3). The cross section of the bending control core (3) has a first axis passing through the centroid thereof and a second axis perpendicular to the first axis. Driven by the driving wire (2), the bending control core (3) can bend in the direction of the first axis and is restricted to bending in the direction of the second axis. The bending control core (3) comprises a torsion section (31). The first axis at the cross section of the proximal end of the torsion section (31) and the first axis at the cross section of the distal end of the torsion section (31) are arranged at an angle. With such a configuration, the medical catheter can self-deflect during bending control to better fit the target area and thus can smoothly arrive and operate at different sites at the same time, solving the problem in the prior art that it is difficult for a medical catheter to arrive at multiple sites at the same time.

Description

medical catheter

Technical field

The present invention relates to the technical field of medical devices, and in particular to a medical catheter.

Background technique

Arrhythmia is a serious challenge facing the field of cardiovascular disease in the 21st century, and atrial fibrillation is one of the most common clinical arrhythmia diseases. Catheter ablation therapy is currently one of the effective methods for treating atrial fibrillation. Mapping catheters are an important tool for surgeons to determine the source of lesions and determine treatment plans.

Mapping catheter is an interventional medical device that collects intracardiac biological signals and is widely used in cardiac electrophysiological examinations and radiofrequency ablation of arrhythmias. Mapping catheters are usually punctured through the femoral vein and superior vena cava and placed at the site that needs to be mapped for signal extraction. Currently, the mapping catheters commonly used in domestic clinical practice have four-pole/deca-pole specifications. Usually, during the operation, different surgeries need to be mapped. Generally, at least two mapping catheters must be placed at each location. The placement of multiple mapping catheters will not only increase the operation time and increase the surgical X-ray exposure, but also increase the number of surgical wounds for the patient.

Contents of the invention

The object of the present invention is to provide a medical catheter to solve the problem that existing medical catheters are difficult to reach multiple locations at the same time.

In order to solve the above technical problems, the present invention provides a medical catheter, which includes: a catheter body, a driving wire penetrated in the catheter body, and a control wire penetrated in the catheter body along the axial direction of the catheter body. Bend core;

The driving wire is connected to the distal end of the bending control core;

The cross section of the bending control core has a first axis passing through its own centroid and a second axis perpendicular to the first axis; driven by the driving wire, the bending control core can move along the first axis. The direction of the axis is curved and is restricted from bending along the direction of the second axis;

The bending control core includes a torsion segment, and the first axis at the proximal cross-section of the torsion segment is aligned with The first axis at the distal cross-section of the torsion section is angled.

Optionally, the moment of inertia of the cross section of the bending control core with respect to the first axis is smaller than the moment of inertia of the cross section of the bending control core with respect to the second axis.

Optionally, the bending control core is in the shape of a flat sheet, and the thickness direction of the sheet is arranged along the first axis; the bending control core has self-restoring elasticity.

Optionally, the bending control core includes a straight section connected to the torsion section in the axial direction, and the first axes at each cross section of the straight section are parallel to each other and parallel to the The first axis at the end cross-section of the torsion section connected to the straight section; wherein at least the distal end of the torsion section is connected to the straight section.

Optionally, the bending control core includes two or more straight sections, and the distal end and the proximal end of the torsion section are respectively connected to one straight section.

Optionally, the medical catheter further includes an electrode group, the electrode group includes a plurality of electrodes arranged at intervals along the axial direction of the catheter body, and the electrodes are arranged on the outer peripheral wall of the catheter body; The arrangement range of the electrode group along the axial direction of the catheter body does not exceed the axial extension range of the straight section.

Optionally, the catheter body includes a limiting cavity, and the bending control core is accommodated in the limiting cavity; the limiting cavity is used to limit the position of the bending control core in the catheter body.

Optionally, in the cross section of the catheter body, the length of the limiting cavity along the direction of the second axis is greater than the length along the direction of the first axis; the catheter body further includes a first container. The first accommodation cavity is at least used to accommodate the driving wire, and the first accommodation cavity is located on one side of the limiting cavity along the direction of the first axis.

Optionally, the medical catheter includes an electrode lead; the catheter body further includes a second accommodation cavity for accommodating the electrode lead, and the first accommodation cavity and the second accommodation cavity are located along the The directions of the first axis are respectively located on both sides of the limiting cavity; and the first accommodating cavity and the second accommodating cavity are both connected to the limiting cavity.

Optionally, the centroid of the limiting cavity is located on the central axis of the catheter body, and the first accommodating cavity and the second accommodating cavity are symmetrically arranged with respect to the limiting cavity.

Optionally, in the cross section of the catheter body, the limiting cavity is along the direction of the second axis Both ends of the accommodating cavity are arc-shaped, and the end of the accommodation cavity away from the limiting cavity is arc-shaped.

Optionally, the catheter body includes an outer tube and a limiting structure, the bending control core and the limiting structure are accommodated in the outer tube; at least a part of the bending control core is connected to the limiting structure through the limiting structure. The outer tube is fixedly connected.

Optionally, the bending control core includes a fixed section located at the proximal end, and the limiting structure includes a gel injected, and the gel injected is filled between the fixed section and the outer tube.

Optionally, the medical catheter includes a first sheath tube, the first sheath tube is inserted into the outer tube, the driving wire is inserted into the first sheath tube, and the injection tube is inserted into the outer tube. The colloid is filled between the first sheath tube and the outer tube.

Optionally, the medical catheter includes an electrode lead and a second sheath tube, the electrode lead is passed through the second sheath tube, and the first sheath tube and the second sheath tube are arranged along the The direction of the first axis is arranged on both sides of the fixed section.

Optionally, the bending control core includes a connecting section located at the distal end and a main body section connected to the proximal end of the connecting section; the cross-sectional profile of the connecting section is smaller than the distal cross-sectional profile of the main body section; The driving wire is connected to the connecting section.

Optionally, the driving wire and the connecting section are welded along the direction of the first axis.

Optionally, the medical catheter includes a press-fitting component that is press-fitted outside the welding point between the drive wire and the connecting section.

Optionally, the medical catheter further includes a handle and a driving member provided on the handle; the handle is connected to the proximal end of the catheter body, and the driving member is connected to the driving wire; the driving member It is used to drive the driving wire to move along the axial direction to drive the catheter body to bend.

To sum up, the medical catheter provided by the present invention includes: a catheter body, a driving wire penetrated in the catheter body, and a bending control core penetrated in the catheter body along the axial direction of the catheter body; The driving wire is connected to the distal end of the bending control core; the cross section of the bending control core has a first axis passing through its own centroid and a second axis perpendicular to the first axis; at the end of the driving wire When driven, the bending control core can bend in the direction of the first axis and is restricted to bend in the direction of the second axis; the bending control core includes a torsion section, and the proximal cross section of the torsion section The first axis at and the The first axis at the distal cross-section of the torsion section is arranged at an angle.

In this configuration, based on the setting of the torsion section, the medical catheter can generate self-deflection when controlling the bend, so that the medical catheter can better fit the structure of the target area (such as the heart), so that the medical catheter can smoothly reach different locations at the same time. work (such as mapping or ablation, etc.), which solves the problem in the existing technology that medical catheters are difficult to reach multiple locations at the same time. It has efficient placement performance and adhesion performance, reduces the placement time, and can also reduce the difficulty of the operator's operation. ,Improve efficiency.

Description of drawings

Those of ordinary skill in the art will understand that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. in:

Figure 1 is a schematic diagram of a medical catheter according to an embodiment of the present invention;

Figure 2 is a schematic cross-sectional view of a catheter body according to an embodiment of the present invention;

Figure 3 is a schematic cross-sectional view of a medical catheter according to an embodiment of the present invention;

Figure 4 is a schematic diagram of the torsion section of the embodiment of the present invention;

Figure 5 is a schematic diagram of a bending control core according to an embodiment of the present invention;

Figure 6 is a schematic diagram of the medical catheter in a controlled bending state according to an embodiment of the present invention;

Figure 7 is a schematic diagram of the medical catheter in another direction in a controlled bending state according to the embodiment of the present invention;

Figure 8 is an enlarged schematic diagram of the distal part of Figure 7;

Figure 9 is a schematic cross-sectional view of another preferred example of a medical catheter according to an embodiment of the present invention;

Figure 10 is a schematic diagram of another preferred example of the bending control core according to the embodiment of the present invention;

Figure 11 is a schematic diagram of the combination of the bending control core and the driving wire according to the embodiment of the present invention.

In the attached picture:

1-catheter body; 11-bend control section; 12-main body section; 13-limiting cavity; 131-first area; 132-second area; 133-third area; 14-first accommodation cavity; 15-second accommodation cavity; 16-outer tube; 17-limiting structure; 18-first sheath tube; 19-second sheath tube; 2-driving wire; 3-bending control core; 30-main section ;31-twisting section; 32-straight section; 33-connecting section; 34-pressed part; 35-fixed section; 4-handle; 41-driving part; 5-electrode group; 51-electrode; 52-electrode wire; 53-head electrode.

Detailed ways

In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions.

As used in this invention, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in its sense including "and/or", and the term "several" The term "at least two" is usually used in a meaning including "at least one", and the term "at least two" is usually used in a meaning including "two or more". In addition, the terms "first" and "th "Second" and "third" are used for descriptive purposes only and cannot be understood as indicating or implying the relative importance or implicitly indicating the quantity of the technical features indicated. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of these features, "one end" and "other end" and "proximal end" and "Remote" usually refers to the two corresponding parts, which includes not only the endpoint. The terms "proximal end" and "distal end" are defined herein with respect to a medical catheter having one end for insertion into the human body and a manipulation end extending outside the body. The term "proximal end" refers to the position of the component closer to the control end of the medical catheter that extends outside the body, and the term "distal end" refers to the position of the component closer to the end of the medical catheter inserted into the human body and therefore further away from the control end of the medical catheter. . Optionally, in manual or hand-operated applications, the terms "proximal" and "distal" are defined herein with respect to an operator such as a surgeon or clinician. The term "proximal" refers to the location of the element closer to the operator, and the term "distal" refers to the location of the element closer to the medical catheter and therefore farther from the operator. In addition, as used in the present invention, "mounted", "connected", "connected", one element is "disposed" on another element, should be interpreted broadly, and usually only mean that there is a connection, coupling, or connection between the two elements. Cooperation or transmission relationship, and the connection, coupling, cooperation or transmission between the two elements can be directly or indirectly through an intermediate element, and cannot be understood It is interpreted as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any position inside, outside, above, below or to one side of another element, unless the content clearly indicates otherwise. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. Furthermore, directional terms such as above, below, up, down, up, down, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upward direction being toward the top of the corresponding figure, The downward or downward direction is towards the bottom of the corresponding figure.

The object of the present invention is to provide a medical catheter to solve the problem that existing medical catheters are difficult to reach multiple locations at the same time. Description will be made below with reference to the drawings.

The inventor's research found that it is difficult for existing medical catheters to meet the need to reach multiple locations at the same time. Taking mapping catheters as an example, when the mapping catheter is passed through blood vessels to the heart, due to the specific curvature of the human heart structure shape, and the bending control direction of the mapping catheter itself is limited (often can only bend in one direction), so it is difficult to push conventional mapping catheters to different mapping sites at one time. For example, in one application scenario, when mapping the coronary sinus and right atrium at the same time, if a conventional mapping catheter needs to enter the coronary sinus from the right atrium control curve, the operator needs to repeatedly rotate the mapping catheter to enter the sinus ostium. This is very difficult, so more than two different mapping catheters are often used to reach different mapping sites through different blood vessel paths for mapping.

Based on the above research, please refer to Figures 1 to 8. The present invention provides a medical catheter. It should be noted that the medical catheter provided by the present invention is not limited to mapping catheters. It can also be used for ablation catheters and other other devices that need to reach multiple locations at the same time. Site catheter. The medical catheter includes: a catheter body 1, a driving wire 2 penetrated in the catheter body 1, and a bending control core 3 penetrated in the catheter body 1 along the axial direction of the catheter body 1; The driving wire 2 is connected to the distal end of the bending control core 3; the cross section of the bending control core 3 has a first axis A1 passing through its own centroid and a second axis A2 perpendicular to the first axis A1 (see Figure 3); driven by the driving wire 2, the bending control core 3 can bend in the direction of the first axis A1, and is restricted from bending in the direction of the second axis A2 (the control bending core 3 During bending, it is mainly bent along the direction of the first axis A1. It is easier to bend along the direction of the first axis A1 than along the direction of the second axis A2. Therefore, the bending core 3 is generally controlled to be mainly along the direction of the first axis A1. Bending, but in some application scenarios, the bending control core 3 may be forced to bend in the direction of the second axis A2, which should be regarded as being restricted to bend in the direction of the second axis A2); as shown in Figure 4 and Figure As shown in 5, the bending control core 3 includes a torsion section 31, the first axis A1 at the proximal cross section of the torsion section 31 and the first axis A1 at the distal cross section of the torsion section 31. The axis A1 is arranged at an angle. Preferably, along the axial direction (that is, the length direction) of the torsion section 31, the first axis A1 at each cross section gradually rotates around the central axis of the torsion section 31, that is, the first axis A1 at each cross section along the axial direction It rotates uniformly through a certain circumferential angle, that is, the torsion section 31 twists uniformly along the axial direction, rather than suddenly.

Further, the medical catheter also includes a handle 4 and a driving member 41 provided on the handle (see Figure 1); the handle 4 is connected to the proximal end of the catheter body 1, and the driving member 41 is connected to the proximal end of the catheter body 1. The driving wire 2 is connected; the driving member 41 is used to drive the driving wire 2 to move in the axial direction to drive the catheter body 1 to bend. The handle 4 is located at the proximal end of the catheter body 1, and is left outside the human body after the catheter body 1 is inserted into the human body for the operator to operate. Optionally, the catheter body 1 includes a bending control section 11 at the distal end and a main body section 12 connected to the proximal end of the bending control section 11 along the axial direction. The bending control section 11 and the main body section 12 can pass through Connect by glue or welding. The bending control core 3 is mainly located in the bending control section 11. Preferably, a part of the proximal end of the bending control core 3 can be extended into the main body section 12 to facilitate transition connection, and the driving wire 2 passes through the bending control section 11. The main body section 12 extends to the proximal handle 4 and is connected with the driving member. As shown in FIG. 6 , it can be understood that since the driving wire 2 is connected to the distal end of the bending control core 3 , when the bending control wire 2 is pulled toward the proximal end by the driving member, the bending control core 3 will be driven to generate a wave along the first axis A1 The bending control section 11 then bends in the direction. For the convenience of description, the angle between the extension direction of the distal end of the bending control section 11 and the extension direction of the main body section 12 is called the bending control angle, that is, the head of the initial state of the bending control section 11 when the bending control section 11 is not controlled. The angle between the end direction and the head end direction after the bending is controlled. It can be understood that the bending control angle will change with the changes of the driving member 41 and the driving wire 2. In the example shown in Figure 6, the bending control angle expressed by the dotted line is approximately is 270°.

As shown in Figures 7 and 8, due to the arrangement of the torsion section 31, the catheter body 1 will not bend in the same plane during bending control, but will produce a certain self-deflection, that is, the catheter body 1 will rotate along the axis of the torsion section 31. The controlled bending to both sides is not in the same plane, so that the controlled bending of the catheter body 1 forms a three-dimensional bend in space. form. Such a configuration allows the medical catheter to better fit the heart structure, so that the medical catheter can smoothly reach different mapping sites for mapping at the same time (mapping sites such as the coronary sinus and high right atrium, etc.), solving the existing problem of The technology solves the problem of needing to place multiple medical catheters separately. It has efficient placement performance and adhesion performance, reduces placement time, and can also reduce the operator's operating difficulty and improve mapping efficiency.

As shown in FIG. 4 , for convenience of description, the angle between the second axis A2 at the proximal cross section of the torsion section 31 and the second axis A2 at the distal cross section of the torsion section 31 is called the torsion of the torsion section 31 Angle θ; the radial distance between the distal end of the bending control section 11 and the main body section 12 (the central axis) after the bending is controlled is called the offset distance e. It should be noted that the radial spacing means that a perpendicular line perpendicular to the main body section 12 is drawn at the distal end of the bending control section 11 and the central axis of the distal end of the bending control section 11 and the main body section 12 is along this line. The distance of the vertical line is the offset distance e. Further, as shown in Figure 4, in Figure 4, the proximal end is inward and the distal end is outward. The torsion section 31 is twisted in a counterclockwise direction from the proximal end to the distal end, adapting to the anatomy of the human heart. The structure facilitates clinical operation and avoids unnecessary resistance during operation. Optionally, the twist angle θ of the twist section 31 can be selected between 10° and 40°. In practice, the corresponding twist angle θ can be set according to different mapping positions. Preferably, the twist angle θ is 25°. With this configuration, when the bending angle is between 180° and 360°, the offset distance e is between 10mm and 15mm. Preferably, when the bending angle is between 180° and 270°, the offset distance e is between 10mm and 15mm, which is more conducive to the placement of the medical catheter. Of course, in some other application scenarios, the twisting section 31 can also be twisted in the clockwise direction from the proximal end to the distal end, and this embodiment is not limited to this.

Optionally, the moment of inertia of the cross section of the bending control core 3 with respect to the first axis A1 is smaller than the moment of inertia of the cross section of the bending control core 3 with respect to the second axis A2. Such a configuration can ensure control. When the bending core 3 is pulled by the driving wire 2, it bends along the direction of the first axis A1. It can be understood that this embodiment does not specifically limit the shape of the cross-section of the bending control core 3. The cross-sections of various shapes can be satisfied as long as the moment of inertia of the first axis A1 is smaller than the moment of inertia of the second axis A2. Optionally, as shown in Figures 3 and 4, the bending control core 3 is in the shape of a flat sheet, and the thickness direction of the sheet is arranged along the first axis A1. In an example, the cross section of the bending control core 3 is an oblong rectangle, and its length along the second axis A2 is greater than the length along the first axis A1. According to the calculation formula of the moment of inertia of the rectangular cross section, it is obvious that Its moment of inertia along the first axis A1 is smaller than that along the second axis A2. The moment of inertia in the direction also makes the ability of the bending control core 3 to resist bending in the direction of the first axis A1 smaller than the ability of the bending control core 3 to resist bending in the direction of the second axis A2. When subjected to bending stress (such as When pulled by the driving wire 2 or guided by the vascular tissue), the bending control core 3 will bend in the direction of the first axis A1. It can be understood that the rectangular cross-section is only an example of the cross-sectional shape of the bending control core 3 and is not a limitation on the cross-sectional shape of the bending control core 3 . In other embodiments, the cross-sectional shape of the bending control core 3 can also be any suitable shape such as a rounded rectangle, an oblong shape, an oblong oval, or a fan-ring shape, and the present invention is not limited thereto. Of course, using the moment of inertia to make the bending control core 3 easier to bend along the first axis A1 is only an example. In other embodiments, the cross section of the bending control core 3 can also be circular, polygonal, or polygonal. Ring-shaped and other cross-sections with the same moment of inertia in the direction of the first axis A1 and the second axis A2. In this case, the density distribution and material distribution of the bending control core 3 along the cross section can be adjusted to make it easier to control the bending core 3 Curved along the direction of the first axis A1, those skilled in the art can adjust this according to the existing technology, and the present invention is not limited to this.

Please refer to Figure 5. Optionally, the bending control core 3 includes a straight section 32 connected to the torsion section 31 in the axial direction. The first axis at each cross section of the straight section 32 A1 are parallel to each other and parallel to the first axis A1 at the end cross-section of the torsion section 31 connected to the straight section 32; wherein at least the distal end of the torsion section 31 is in contact with the Straight sections 32 are connected. The first axes A1 at each cross-section of the straight section 32 are parallel to each other, that is, the straight section 32 remains axially without twisting, and therefore, the straight section 32 will remain in the same plane when bent. For the straight section 32 located on the distal side of the torsion section 31 , the end cross section of the torsion section 31 connected thereto refers to the distal cross section of the torsion section 31 , that is, the flat section located on the distal side of the torsion section 31 The first axis A1 at each cross section of the straight section 32 is parallel to the first axis A1 at the distal cross section of the torsion section 31 . Since at least the distal end of the torsion section 31 is connected to the straight section 32, it is ensured that when the bending control core 3 is controlled to bend, the bending control of the distal straight section 32 can be relatively deflected. Preferably, the bending control core 3 includes more than two straight sections 32 , and the distal end and the proximal end of the torsion section 31 are respectively connected to one straight section 32 . This embodiment does not limit the number of torsion segments 31. If the bending control core 3 only includes one torsion segment 31, then preferably, the bending control core 3 includes two straight segments 32, which are respectively located in the axial direction of the torsion segment 31. both sides. And if the bending control core 3 includes a larger number of torsion segments 31, correspondingly, one can pass between each torsion segment 31. Straight sections 32 are connected. The number of twisted segments 31, the angle of twist, the length of the straight segments 32, the number of the straight segments 32, etc. can be configured according to different application scenarios.

Preferably, the bending control core 3 has self-restoring elasticity, and bends under the pull of the driving wire 2. When the pulling force of the driving wire 2 is reduced or removed, the bending control core 3 can return to its original state based on its self-restoring elasticity. The original shape is linear in the axial direction. In an alternative example, the bending control core 3 includes a metal elastic piece made of a metal with certain resistance to deformation, such as nickel-titanium alloy or stainless steel. In practice, the twisted segment 31 with a specific twist angle θ can be formed by twisting and shaping the metal elastic piece at a predetermined position. In one embodiment, the material of the metal spring is a nickel-titanium alloy with certain supporting properties and memory properties, which can cause the metal spring to undergo thermoelastic martensitic transformation through heat treatment to produce a memory effect and achieve shaping. Preferably, the bending control core 3 also includes an insulating lubricating coating covering the outside of the metal elastic piece, so that the entire bending control core 3 remains insulated from the catheter body 1 .

Optionally, the medical catheter also includes an electrode group 5. The electrode group 5 includes a plurality of electrodes 51 arranged at intervals along the axial direction of the catheter body 1. The electrodes 51 are provided on the catheter body 1. On the outer peripheral wall; the arrangement range of the electrode group 5 along the axial direction of the catheter body 1 does not exceed the axial extension range of the straight section 32 . It should be noted that here, the arrangement range of the electrode group 5 along the axial direction of the catheter body 1 does not exceed the axial extension range of the straight section 32. This means that for a certain electrode group 5, the arrangement range of several electrodes 51 it contains along the axial direction. The cloth area should fall within the axial extension range of the same straight section 32 and should not span the twisted section 31 and fall within the axial extension range of different straight sections 32 .

Furthermore, the axial arrangement spacing between the plurality of electrodes 51 in each electrode group 5 may be equal or unequal. The electrode 51 may be a ring electrode. In one example, the electrode 51 may be a metal electrode, and its material may be platinum-iridium alloy or gold. The medical catheter further includes an electrode lead 52 , which may be threaded through the catheter body 1 . The electrode 51 conducts electrical signals to the proximal handle 4 through the electrode wire 52, and is further connected to the corresponding mapping equipment.

Optionally, the medical catheter includes more than two electrode sets 5 . It should be noted that the number of electrodes 51 included in each different electrode group 5 may be the same or different, and the axial arrangement spacing of the electrodes 51 included in each different electrode group 5 may be the same or different. Preferably, each electrode group 5 corresponds to a straight section 32 . In an alternative example, the bending core 3 includes two flat Straight section 32. Correspondingly, the medical catheter includes two electrode groups 5. The axial distance between the two electrode groups 5 (referring to the axial distance between the two closest electrodes 51 of the two electrode groups 5) is 35mm～70mm to adapt to different people’s heart sizes. Preferably, the axial distance between the two electrode groups 5 is 50 mm to 60 mm, which is generally suitable for the anatomical structure of the adult heart. For patients with a larger right atrium, the axial distance between the two electrode groups 5 can be expanded to 70 mm. In particular, the axial distance between the two electrode groups 5 does not represent the axial length of the torsion section 31 , and the axial length of the torsion section 31 may be equal to or less than the axial distance between the two electrode groups 5 . Preferably, the axial spacing between the electrodes 51 in each electrode group 5 is smaller than the axial spacing between adjacent electrode groups 5, which is beneficial to improving mapping accuracy and mapping efficiency.

Optionally, the medical catheter also includes a head electrode 53 , which is disposed at the distal end of the catheter body 1 . Preferably, the head electrode 53 is connected to the bending control core 3 and to the driving wire 2 . In one embodiment, the driving wire 2 and the distal end of the bending control core 3 are connected by welding (including but not limited to soldering, laser welding or resistance welding, etc.). Preferably, the driving wire 2 is welded to one side of the bending control core 3 along the direction of the first axis A1 of the bending control core 3 . Furthermore, the distal end of the driving wire 2 also extends beyond the distal end of the bending control core 3 and is connected to the head electrode 53 . The driving wire 2 is not only used to drive the bending control core 3 to bend, but is also used to transmit electrical signals of the head electrode 53 .

Please refer to FIG. 10 . In another embodiment, the bending control core 3 includes a connecting section 33 at the distal end and a main body section 30 connected to the proximal end of the connecting section 33 . The main body section 30 includes the aforementioned straight section. 32 and torsion section 31; the cross-sectional profile of the connecting section 33 is smaller than the distal cross-sectional profile of the main body section 30; the driving wire 2 is connected to the connecting section 33. Preferably, the driving wire 2 and the connecting section 33 are welded along the direction of the first axis A1. Optionally, the axial length of the connecting section 33 is 5 mm to 10 mm, and the axial length of the connecting section 33 is adapted to the length of the welding area between the driving wire 2 and the connecting section 33 . By adjusting the cross-sectional profile of the connecting section 33 (such as adjusting the width or thickness), the increase in hardness caused by the welding of the driving wire 2 can be balanced to ensure that the hardness of the welded part of the connecting section 33 is not significantly different from the hardness of the main section 30 .

Further, in some embodiments, please refer to FIG. 11 , the medical catheter includes a pressing member 34 , and the pressing member 34 is pressed outside the welding point of the driving wire 2 and the connecting section 33 . In an example, the pressing member 34 can be a stainless steel pipe. After the driving wire 2 and the connecting section 33 are welded, the pressing member 34 can be pressed. The joint 34 can further improve the connection strength between the driving wire 2 and the connecting section 33 . In another embodiment, the head electrode 53 has a connection hole open toward the proximal end, and the connection section 33 of the bending core 3 and the driving wire 2 can be buried together in the connection hole of the head electrode 53 to further improve the connection. The connection strength between segment 33 and drive wire 2.

Please refer to Figures 2 and 3. Optionally, the catheter body 1 includes a limiting cavity 13, and the bending control core 3 is accommodated in the limiting cavity 13; the limiting cavity 13 is used to limit the The position of the bending core 3 in the catheter body 1 is controlled. It should be noted that in some embodiments, the cross-sectional shape of the limiting cavity 13 can be slightly larger than the cross-sectional shape of the bending control core 3, and the bending control core 3 can be easily penetrated from the proximal end of the limiting cavity 13, and can There is slight mobility in the area of the limiting chamber 13 . Of course, in other embodiments, the cross-section of the limiting cavity 13 can also be adapted to the cross-sectional shape of the bending control core 3 to reliably limit the movement of the bending control core 3 .

Preferably, as shown in FIGS. 2 and 3 , in the cross-section of the catheter body 1 , the length of the limiting cavity 13 along the direction of the second axis A2 is greater than the length along the direction of the first axis A1 length; in an alternative embodiment, the cross-section of the limiting cavity 13 is generally a flat rectangle, and the second axis A2 of the bending control core 3 is arranged along the long side direction of the limiting cavity 13, and the limiting cavity 13 Both ends along the direction of the second axis A2 are arc-shaped (that is, the short side of the cross section of the limiting cavity 13 is arc-shaped). Preferably, the length of the cross section of the limiting cavity 13 along the direction of the first axis A1 is greater than the length of the bending control core 3 in the direction of the first axis A1. In this way, the bending control core 3 can move slightly in the limiting cavity 13 to adapt to the bending and torsion of the bending control section 11 . However, the approximate position of the bending control core 3 is determined in the limiting cavity 13 and will not affect the driving wire 2 and the electrode lead 52 .

Furthermore, the catheter body 1 further includes a first accommodation cavity 14, which is at least used to accommodate the drive wire 2, and the first accommodation cavity 14 is located along the first The direction of axis A1 is located on one side of the limiting cavity 13 . In an alternative embodiment, the cross-section of the first accommodation cavity 14 is generally rectangular, with one side communicating with the limiting cavity 13 and an arc-shaped side away from the communicating side with the limiting cavity 13 . Of course, in other embodiments, the first accommodation cavity 14 can also be provided separately from the limiting cavity 13 . Since the first accommodating cavity 14 is located on one side of the limiting cavity 13 along the direction of the first axis A1, it can be ensured that the drive wire 2 inserted in the first accommodating cavity 14 is always positioned at the control bending position along the direction of the first axis A1. core 3 one side, ensuring the relative position of the driving wire 2 can ensure the effectiveness of the bending control, avoid the bending control of the driving wire 2 being blocked due to winding and other reasons, and ensure that after the driving wire 2 exerts a pulling force on the bending control core 3, the bending control core 3 faces the first The direction of axis A1 is curved.

Furthermore, the catheter body 1 further includes a second accommodation cavity 15 for accommodating the electrode lead 52 , and the first accommodation cavity 14 and the second accommodation cavity 15 are arranged along the first The direction of the axis A1 is located on both sides of the limiting cavity 13 respectively; and the first accommodating cavity 14 and the second accommodating cavity 15 are both connected to the limiting cavity 13 . In an alternative embodiment, the cross-section of the second accommodation cavity 15 is generally rectangular, with one side communicating with the limiting cavity 13 and an arc-shaped side away from the communicating side with the limiting cavity 13 . Of course, in other embodiments, the second accommodation cavity 15 can also be provided separately from the limiting cavity 13 . The arrangement of the second accommodating cavity 15 can separate the electrode wire 52 and the driving wire 2 to avoid entanglement with each other. As shown in Figures 2 and 3, in a preferred example, the centroid of the limiting cavity 13 is located on the central axis of the catheter body 1, and the first accommodating cavity 14 and the second accommodating cavity are The cavity 15 is arranged symmetrically with respect to the limiting cavity 13. Preferably, the first accommodating cavity 14, the second accommodating cavity 15 and the limiting cavity 13 are connected with each other to form a flower-shaped cavity. It should be noted that since the number of electrode wires 52 may be large, in the solution where the second accommodating cavity 15 is connected to the limiting cavity 13 , the second accommodating cavity 15 is used to accommodate the electrode wires 52 and does not limit the electrode wires 52 to only the electrode wires 52 . It can be inserted into the second accommodation cavity 15, and a part of the electrode wire 52 can also be arranged in the limiting cavity 13. After the bending control core 3 penetrates into the limiting cavity 13, the electrode wire 52 is blocked by the bending control core 3. Being separated from the driving wire 2 can also achieve the effect of avoiding mutual entanglement.

More preferably, the two sides of the first accommodating cavity 14 are perpendicular to the limiting cavity 13 , and the two sides of the second accommodating cavity 15 are also perpendicular to the limiting cavity 13 . For the convenience of description, the limiting cavity 13 is divided into a first area 131, a second area 132 and a third area 133 connected in sequence, where the second area 132 is adjacent to the first accommodating cavity 14 and the second accommodating cavity 15. area, the first area 131 and the third area 133 are located on both sides of the second area 132. Preferably, the cross-sectional area of the first region 131 is equal to the cross-sectional area of the third region 133 and smaller than the cross-sectional area of the first accommodating cavity 14 and the cross-sectional area of the second accommodating cavity 15 .

Such a configuration can avoid the entanglement of the internal structures such as the bending control core 3, the electrode wire 52 and the driving wire 2, and ensure the strength and support of the bending control section 11 itself, while obtaining the largest possible inner cavity capacity; while ensuring When the inner cavity volume remains unchanged, the diameter of the bending control section 11 is further reduced. And the first accommodation The flower-shaped cavity formed by the cavity 14, the second accommodation cavity 15 and the limiting cavity 13 is approximately in the center of the bending control section 11; since the direction of the second axis A2 of the bending control core 3 is approximately arranged along the long side of the limiting cavity 13 , the cross-sectional area of the first accommodating cavity 14 and the cross-sectional area of the second accommodating cavity 15 are larger, that is, the moment of inertia of the cross-section of the bending control section 11 with respect to the direction of the first axis A1 is reduced, It is also advantageous for the bending control section 11 to bend in the direction of the first axis A1.

It should be noted that the first accommodation cavity 14 , the second accommodation cavity 15 and the limiting cavity 13 extend at least in the entire axial direction of the bending control section 11 , and optionally can also extend to part or all of the main body section 12 , this embodiment is not limited to this. In the axial direction of the bending control section 11, the flower-shaped cavity composed of the first accommodating cavity 14, the second accommodating cavity 15 and the limiting cavity 13 should adapt to the axial torsion of the bending control core 3, that is, In the axial section corresponding to the torsion section 31, the flower-shaped cavity is also twisted accordingly, so that after the bending control core 3 is inserted into the limiting cavity 13, the catheter body 1 and the bending control core 3 will not twist each other. In an alternative example, the catheter body 1 is made of medical polymer materials, such as polyurethane and pebax. It can be formed by processes such as extrusion molding or hot blowing (reflow). The catheter body 1 has a certain degree of flexibility, which facilitates the insertion of the bending core 3 and facilitates intervention into the blood vessels of the human body.

Please refer to Figures 9 to 11. In another preferred example, the catheter body 1 includes an outer tube 16 and a limiting structure 17, and the bending control core 3 and the limiting structure 17 are accommodated in the outer tube. 16; at least part of the bending control core 3 is fixedly connected to the outer tube 16 through the limiting structure 17. Since the preparation of a tube with a flower-shaped cavity is relatively complicated, in this preferred example, the catheter body 1 can be a single-lumen tube that is easier to process, that is, the catheter body 1 includes an outer tube 16 , and the bending control core 3 passes through an additional limiting structure 17 It is fixed with the outer tube 16 to limit the relative position of the bending control core 3 and the outer tube 16 .

Optionally, the bending control core 3 includes a fixing section 35 located at the proximal end, and the limiting structure 17 includes a glue injection material filled between the fixation section 35 and the outer tube 16 . In an alternative example, the axial length of the fixing section 35 is 3 mm to 8 mm, and its cross-sectional profile is smaller than the proximal cross-sectional profile of the main body section 30 . The colloid can be solidified after being injected with glue. With this configuration, the fixed section 35 of the bending control core 3 and the outer tube 16 form a fixed connection. Of course, in some other embodiments, the limiting structure 17 is not limited to including glue injection, and may also be other components such as clamping parts. It should be noted that the axial extension length of the colloid injection body only needs to be slightly larger than the axial length of the fixed section 35. The entire outer tube 16 is packed along its entire axial length.

Further, the medical catheter includes a first sheath tube 18 , the first sheath tube 18 is inserted into the outer tube 16 , and the driving wire 2 is inserted into the first sheath tube 18 . , the injection gel is filled between the first sheath tube 18 and the outer tube 16 . Since the driving wire 2 needs to move along the axial direction, in order to prevent the driving wire 2 from being fixed by injecting colloid, a first sheathing tube 18 can be set inside the outer tube 16 and the driving wire 2 can be inserted into the first sheathing tube 18, so that The injected colloid is not in direct contact with the driving wire 2, which can ensure the free movement of the driving wire 2 in the outer tube 16. In some embodiments, the electrode wire 52 may also be inserted into the first sheath tube 18 . Of course, preferably, in other embodiments, the medical catheter includes a second sheath tube 19 , the electrode lead 52 is passed through the second sheath tube 19 , and the first sheath tube 18 The second sheath tube 19 is arranged on both sides of the fixing section 35 along the direction of the first axis A1. The first sheath tube 18 and the second sheath tube 19 are arranged separately to avoid entanglement between the electrode wire 52 and the driving wire 2 . The first sheath tube 18 and the second sheath tube 19 are arranged on both sides of the fixed section 35 along the direction of the first axis A1, which can ensure that the driving wire 2 is always located on the bending control core 3 along the direction of the first axis A1. On one side, ensure the relative position of the drive wire 2 to ensure the effectiveness of bending control.

To sum up, the medical catheter provided by the present invention includes: a catheter body, a driving wire penetrated in the catheter body, and a bending control core penetrated in the catheter body along the axial direction of the catheter body; The driving wire is connected to the distal end of the bending control core; the cross section of the bending control core has a first axis passing through its own centroid and a second axis perpendicular to the first axis; at the end of the driving wire When driven, the bending control core can bend in the direction of the first axis and is restricted to bend in the direction of the second axis; the bending control core includes a torsion section, and the proximal cross section of the torsion section The first axis at is arranged at an angle to the first axis at the distal cross-section of the torsion section. In this configuration, based on the setting of the torsion section, the medical catheter can generate self-deflection when controlling the bend, so that the medical catheter can better fit the structure of the target area (such as the heart), so that the medical catheter can smoothly reach different locations at the same time. work (such as mapping or ablation, etc.), which solves the problem in the existing technology that medical catheters are difficult to reach multiple locations at the same time. It has efficient placement performance and adhesion performance, reduces the placement time, and can also reduce the difficulty of the operator's operation. ,Improve efficiency.

It should be noted that the above-mentioned embodiments can be combined with each other. The above description is only a comparative view of the present invention. The description of the preferred embodiments does not limit the scope of the present invention in any way. Any changes or modifications made by those of ordinary skill in the field of the present invention based on the above disclosure shall fall within the protection scope of the claims.

Claims

A medical catheter, characterized in that it includes: a catheter body, a driving wire penetrated in the catheter body, and a bending control core penetrated in the catheter body along the axial direction of the catheter body;

The driving wire is connected to the distal end of the bending control core;

The cross section of the bending control core has a first axis passing through its own centroid and a second axis perpendicular to the first axis; driven by the driving wire, the bending control core can move along the first axis. The direction of the axis is curved and is restricted from bending along the direction of the second axis;

The bend control core includes a torsion segment, the first axis at a proximal cross-section of the torsion segment being arranged at an angle to the first axis at a distal cross-section of the torsion segment.
The medical catheter according to claim 1, wherein the moment of inertia of the cross section of the bending control core with respect to the first axis is smaller than the moment of inertia of the cross section of the bending control core with respect to the second axis.
The medical catheter according to claim 2, wherein the bending control core is in the shape of a flat sheet, and the thickness direction of the sheet is arranged along the first axis; the bending control core has self-restoring elasticity.
The medical catheter according to claim 1, wherein the bending control core includes a straight section connected to the torsion section in the axial direction, and the first first section at each cross section of the straight section The axes are parallel to each other and parallel to the first axis at the end cross-section of the torsion segment connected to the straight segment; wherein at least the distal end of the torsion segment is connected to the straight segment .
The medical catheter according to claim 4, wherein the bending control core includes two or more straight sections, and the distal end and the proximal end of the torsion section are respectively connected to one straight section.
The medical catheter according to claim 4 or 5, characterized in that the medical catheter further includes an electrode group, the electrode group includes a plurality of electrodes arranged at intervals along the axial direction of the catheter body, and the electrodes are arranged On the outer peripheral wall of the catheter body; the arrangement range of the electrode group along the axial direction of the catheter body does not exceed the axial extension range of the straight section.
The medical catheter according to claim 1, wherein the catheter body includes a limiting cavity, and the bending control core is accommodated in the limiting cavity; the limiting cavity is used to limit the bending control core. The core is where Describe the location in the catheter body.
The medical catheter according to claim 7, wherein in the cross-section of the catheter body, the length of the limiting cavity along the direction of the second axis is greater than the length along the direction of the first axis. ; The catheter body also includes a first accommodation cavity, the first accommodation cavity is at least used to accommodate the drive wire, and the first accommodation cavity is located at the limit along the direction of the first axis. one side of the cavity.
The medical catheter according to claim 8, wherein the medical catheter includes an electrode lead; the catheter body further includes a second accommodation cavity for accommodating the electrode lead, and the first accommodation cavity and the second accommodating cavity are respectively located on both sides of the limiting cavity along the direction of the first axis; and the first accommodating cavity and the second accommodating cavity are both connected to the limiting cavity. Connected.
The medical catheter according to claim 9, characterized in that the centroid of the limiting cavity is located on the central axis of the catheter body, and the first accommodating cavity and the second accommodating cavity are relative to the The limiting cavities are symmetrically arranged.
The medical catheter according to claim 1, wherein the catheter body includes an outer tube and a limiting structure, the bending control core and the limiting structure are accommodated in the outer tube; the bending control core At least a part of the outer tube is fixedly connected to the outer tube through the limiting structure; the bending control core includes a fixed section located at the proximal end, the limiting structure includes an injection gel, and the injection gel is filled in the fixed section and the outer tube. between the outer tubes.
The medical catheter according to claim 11, wherein the medical catheter includes a first sheath tube, the first sheath tube is inserted into the outer tube, and the driving wire is inserted into the outer tube. In the first sheath tube, the colloid is filled between the first sheath tube and the outer tube; the medical catheter includes an electrode lead and a second sheath tube, and the electrode lead is passed through the In the second sheathing tube, the first sheathing tube and the second sheathing tube are arranged on both sides of the fixed section along the direction of the first axis.
The medical catheter according to claim 1, wherein the bending control core includes a connecting section located at the distal end and a main body section connected to the proximal end of the connecting section; the cross-sectional profile of the connecting section is smaller than the The distal cross-sectional profile of the main body section; the driving wire is connected to the connecting section.
The medical catheter according to claim 1, further comprising a handle and a driving member provided on the handle; the handle is connected to the proximal end of the catheter body, and the driving member is connected to the proximal end of the catheter body. The driving wire is connected; the driving member is used to drive the driving wire to move in the axial direction to drive the catheter body to bend.