A medical catheter

Abstract

The present invention provides a medical catheter, comprising a tube assembly, a balloon and an electrode assembly; the balloon is arranged at the distal end of the tube assembly; the balloon comprises a first region and a second region arranged in a circumferential direction, the second region being located between adjacent first regions; the electrode assembly is arranged outside the balloon and connected to the tube assembly; the electrode assembly comprises an electrode unit extending along the axial direction of the tube assembly, at least a portion of which is located in the first region; the balloon has a contracted state and a working state, in which the balloon is close to the tube assembly in the contracted state; in the working state, the balloon expands radially outward along the tube assembly, so that at least a portion of the second region forms a concave portion, and at least a portion of the first region forms a convex portion, and the convex portion applies a supporting force to the corresponding electrode unit, so that the electrode unit contacts the target tissue. This design ensures that when the medical catheter performs electrophysiological treatment on the tissue, the electrode assembly can contact the tissue.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a medical catheter. Background Art

[0002] In the field of electrophysiological therapy, using medical catheters to transfer energy and perform tissue ablation is a common method. The basic principle is that after the distal end of the medical catheter reaches the corresponding treatment target in the human body, the electrode arranged at the distal end of the medical catheter is brought into contact with the tissue, and then the energy platform connected to the proximal end of the medical catheter is used to emit energy. The energy is transmitted to the tissue via the electrode to achieve ablation of the tissue.

[0003] A medical catheter generally includes an axially connected handle, a catheter shaft, and an electrode segment, wherein the electrode segment includes a substrate and an electrode fixed on the substrate. Currently, a mainstream electrode segment of a medical catheter is a basket mesh structure. The electrode segment of the basket mesh structure includes a plurality of petal portions, each of which is provided with an electrode 01 (such as Figure 1 In order to improve the expansion stability of the basket structure, a balloon 02 is also arranged on the inner side of the basket structure, and the filled balloon 02 is used to support each petal of the basket structure. However, it is found in practice that the medical catheter is prone to the following problems during application: Figure 1 In the situation shown, the part of the balloon 02 between two adjacent petals protrudes from the petals, resulting in the balloon 02 actually being in contact with the target tissue 00, while the electrode 01 on the petals cannot be in contact with the target tissue 00, and ablation cannot be achieved. In addition, there is also the problem that the electrode segment is easily displaced when the balloon is filled or not filled, and the electrode of the basket structure configured with the balloon in the prior art usually adopts an integrated electrode, the electrode size is large, and the ECG signal acquisition accuracy is low. Summary of the invention

[0004] The object of the present invention is to provide a medical catheter to solve the above problems.

[0005] To achieve the above object, the present invention provides a medical catheter, characterized in that it comprises:

[0006] Tube assemblies;

[0007] A balloon disposed at the distal end of the tube assembly; the balloon comprises a first region and a second region arranged along its own circumference, wherein the second region is located between adjacent first regions;

[0008] an electrode assembly, arranged outside the balloon and connected to the tube assembly; the electrode assembly comprises an electrode unit extending along the axial direction of the tube assembly and at least a portion of which is located in the first region;

[0009] The balloon has a contracted state and a working state. In the contracted state, the balloon is abutted against the tube assembly. In the working state, the balloon expands radially outward along the tube assembly so that at least a portion of the second region forms a recess and at least a portion of the first region forms a protrusion. The second region causes the protrusion to apply a radial supporting force to the corresponding electrode unit so that the electrode unit contacts the target tissue.

[0010] Optionally, the tube assembly comprises an inner shaft and an outer tube, wherein at least a portion of the inner shaft is disposed in the lumen of the outer tube, and a distal end of the inner shaft extends from a distal end of the outer tube; and an axial relative movement can be generated between the inner shaft and the outer tube;

[0011] The proximal end of the balloon is connected to the distal end section of the outer tube, and the distal end of the balloon is connected to the distal end section of the inner shaft;

[0012] The distal end of the electrode assembly is connected to the distal end section of the inner shaft, and the proximal end of the electrode assembly is connected to the distal end section of the outer tube;

[0013] The medical catheter also includes a longitudinal restriction member, which is arranged alternately with the electrode unit in the circumferential direction. In the working state, the maximum radial distance between the longitudinal restriction member and the tube assembly is smaller than the maximum radial distance between the electrode unit and the tube assembly, and the recess in the second area is generated under the action of the longitudinal restriction member.

[0014] Optionally, a conductive electrode is provided on the longitudinal limiting member.

[0015] Optionally, at least one of the proximal segment and the distal segment of the longitudinal restraint is connected to the tube assembly; in the working state, the longitudinal restraint applies radial pressure to the second region to generate the recess in the second region.

[0016] Optionally, the distal segment of the longitudinal restriction is connected to the distal segment of the inner shaft, and the proximal segment of the longitudinal restriction is connected to the distal segment of the outer tube; in the contracted state, the length of the longitudinal restriction between the two ends of the balloon is smaller than the length of the electrode unit between the two ends of the balloon.

[0017] Optionally, the distal end section of the longitudinal restraint is connected to the distal end section of the inner shaft, and the proximal end section of the longitudinal restraint is movable relative to the tube assembly.

[0018] Optionally, the medical catheter further comprises a circumferential limiter, wherein the circumferential limiter is connected to adjacent electrode units at a preset circumferential interval to ensure that adjacent electrode units are arranged at the preset circumferential interval in the working state.

[0019] Optionally, at least one of the proximal segment and the distal segment of the longitudinal limiting member is connected to the circumferential limiting member.

[0020] Optionally, the distal end section of the longitudinal restriction member is connected to the distal end section of the inner shaft, and the proximal end section of the longitudinal restriction member is connected to the circumferential limiter; or, the proximal end section of the longitudinal restriction member is connected to the distal end section of the outer tube, and the distal end section of the longitudinal restriction member is connected to the circumferential limiter;

[0021] The circumferential length of the circumferential limiter between adjacent electrode units is L C In the contracted state, the longitudinal extension length of the longitudinal restriction member located in the balloon region is L B1 The length of the electrode unit extending from the connection position of the electrode unit and the circumferential limiter to the connection position of the longitudinal limiter and the tube assembly in the balloon area is L E1 , where L B1 <L E1 ≤L B1 +L C / 2.

[0022] Optionally, the circumferential limiter comprises a first circumferential limiter and a second circumferential limiter which are axially spaced apart, one of the proximal end section and the distal end section of the longitudinal limiter is connected to the first circumferential limiter, and the other is connected to the second circumferential limiter;

[0023] The circumferential length of the first circumferential limiter between adjacent electrode units is L C1 The circumferential length of the second circumferential limiter between adjacent electrode units is L C2 In the contracted state, the longitudinal extension length of the longitudinal limiter between the first circumferential limiter and the second circumferential limiter in the balloon region is L B2 The extension length of the electrode unit from the connection position of the electrode unit and the first circumferential limiter to the connection position of the electrode unit and the second circumferential limiter is L E2 , where L B2 <L E2 ≤L B2 +(L C1 +L C2 ) / 2.

[0024] Optionally, the medical catheter further comprises a longitudinal extension member, a distal end section of the longitudinal extension member is connected to the longitudinal restriction member, and a proximal end section of the longitudinal extension member is movable relative to the tube assembly.

[0025] Optionally, the thickness of the indicating portion of the second region is greater than the thickness of the first region, and / or the elastic modulus of the indicating portion of the second region is greater than the elastic modulus of the first region.

[0026] Optionally, the electrode unit includes a main body and a first insulating layer; the main body includes a first section, a second section and a third section connected in sequence along the axial direction of the tube assembly; at least a portion of the second section constitutes at least a portion of the electrode; at least a portion of the outer surface of the first section and the second section is coated with the first insulating layer.

[0027] Optionally, the electrode unit further includes an inert metal layer, and the inert metal layer is coated on at least a portion of the outer surface of the second section; the electrode also includes at least a portion of the inert metal layer.

[0028] Optionally, the balloon comprises a flushing hole, and the flushing hole is capable of flushing a connecting area between the first segment and the second segment and / or a connecting area between the second segment and the third segment.

[0029] Optionally, the cross-section of at least a portion of the first segment is any one of a circle, an ellipse, and a regular polygon, and / or the cross-section of the third segment is any one of a circle, an ellipse, and a regular polygon; when the electrode assembly is in a contracted state, the electrode unit can be twisted and wound on the tube assembly.

[0030] Optionally, the electrode of the electrode unit is provided with an avoidance hole;

[0031] The electrode assembly further comprises a mapping electrode portion, wherein the mapping electrodes of the mapping electrode portion are capable of detecting electrical signals of the target tissue through the avoidance hole.

[0032] Optionally, the mapping electrode portion includes a first base layer, a first circuit layer and a second insulating layer arranged in sequence; the second insulating layer is arranged on the electrode unit and forms a first avoidance area, and the mapping electrode is electrically connected to the first circuit layer; the mapping electrode is at least partially arranged in the first avoidance area, and is visible to the outside through the first avoidance area and the avoidance hole.

[0033] Optionally, on a plane perpendicular to the axis of the avoidance hole, a projection of the first avoidance area is inside a projection of the avoidance hole; and the mapping electrode is arranged on a side of the first circuit layer away from the first substrate layer.

[0034] Optionally, the electrode assembly further includes a detection electrode portion, which is disposed on a side of the electrode unit facing the balloon to detect whether the balloon is effectively attached to the electrode assembly.

[0035] Optionally, the detection electrode portion includes a second base layer, a second circuit layer, a detection electrode and a third insulating layer; the second base layer, the second circuit layer, and the third insulating layer are arranged in sequence along the direction from the electrode unit to the balloon, and a second avoidance area is provided on the third insulating layer. In the working state, the second avoidance area is located at the maximum radial distance between the electrode assembly and the tube assembly; the detection electrode is electrically connected to the second circuit layer; the detection electrode is at least partially arranged at the second avoidance area and is visible to the outside through the second avoidance area.

[0036] Optionally, a filler inlet channel and a filler outlet channel connected to the balloon are formed on the tube assembly; the filler inlet channel and the filler outlet channel extend along the axial direction of the tube assembly, and the filler inlet channel and the filler outflow channel are isolated from each other.

[0037] Optionally, the electrode unit is at least partially bonded to the first region.

[0038] Optionally, in the contracted state, the balloon has folding wings, the folding wings have a first edge and a second edge in the radial direction of the tube assembly, the first edge is closer to the tube assembly than the second edge, and the electrode unit is arranged at the second edge.

[0039] Optionally, a longitudinal restriction of the medical catheter is provided at the first edge.

[0040] Optionally, the circumferential limiter is connected to the electrode unit by winding; or,

[0041] The electrode unit is provided with a connection hole, and the circumferential limiter passes through the connection hole to form a double-strand winding structure or a knotted structure, so that the circumferential limiter is connected to the electrode unit.

[0042] Optionally, the body is formed by a continuous elastic metal body.

[0043] Optionally, the longitudinal restraint comprises a reinforcement member.

[0044] To achieve the above object, the present invention further provides a medical electrode assembly, comprising:

[0045] An electrode unit, wherein the electrode of the electrode unit is provided with an avoidance hole;

[0046] A mapping electrode portion is provided on the electrode unit, and a mapping electrode of the mapping electrode portion can detect an electrical signal of a target tissue through the avoidance hole.

[0047] Optionally, the mapping electrode portion includes a first base layer, a first circuit layer and a second insulating layer arranged in sequence; the second insulating layer is arranged on the electrode unit and forms a first avoidance area, and the mapping electrode is electrically connected to the first circuit layer; the mapping electrode is at least partially arranged in the first avoidance area, and is visible to the outside through the first avoidance area and the avoidance hole.

[0048] Optionally, on a plane perpendicular to the axis of the avoidance hole, a projection of the first avoidance area is inside a projection of the avoidance hole; and the mapping electrode is arranged on a side of the first circuit layer away from the first substrate layer.

[0049] Optionally, the electrode assembly further includes a detection electrode portion, and the electrode unit, the mapping electrode portion and the detection electrode portion are arranged in sequence.

[0050] Optionally, the detection electrode portion includes a second circuit layer and a third insulating layer; the second circuit layer is arranged on the first base layer of the mapping electrode portion, or is arranged on the first base layer of the mapping electrode portion through the second base layer of the detection electrode portion; the third insulating layer is arranged on the second circuit layer and is provided with a second avoidance area; the detection electrode of the detection electrode portion is electrically connected to the second circuit layer, and is at least partially arranged at the second avoidance area, and is visible to the outside through the second avoidance area.

[0051] Optionally, the electrode unit includes a main body and a first insulating layer; the main body includes a first segment, a second segment and a third segment connected in sequence; at least a portion of the second segment constitutes at least a portion of the electrode of the electrode unit; at least a portion of the outer surfaces of the first segment and the second segment is covered with the first insulating layer.

[0052] Optionally, the electrode unit further includes an inert metal layer, and the inert metal layer is coated on at least a portion of the outer surface of the second segment; the electrode of the electrode unit further includes at least a portion of the inert metal layer.

[0053] Optionally, the cross-section of at least a portion of the first segment is any one of a circle, an ellipse, and a regular polygon, and / or the cross-section of the third segment is any one of a circle, an ellipse, and a regular polygon.

[0054] Optionally, the body is formed by a continuous elastic metal body.

[0055] To achieve the above object, the present invention further provides a medical catheter, comprising:

[0056] Tube assemblies;

[0057] An electrode assembly is provided at the distal end section of the tube assembly and includes a plurality of electrode units extending along the axial direction of the tube assembly; the electrode assembly includes a contracted state and a working state, in which the electrode units are close to the tube assembly; in which the electrode units are expanded away from the tube assembly;

[0058] A circumferential limiter is connected to adjacent electrode units at a preset circumferential interval to ensure that adjacent electrode units are arranged at the preset circumferential interval in the working state.

[0059] Optionally, the circumferential limiter comprises a first circumferential limiter and a second circumferential limiter which are axially spaced apart, and the first circumferential limiter and the second circumferential limiter are respectively connected to adjacent electrode units at a preset circumferential interval.

[0060] Optionally, the circumferential limiter is connected to the electrode unit by winding; or,

[0061] The electrode unit is provided with a connection hole, and the circumferential limiter passes through the connection hole to form a double-strand winding structure or a knotted structure, so that the circumferential limiter is connected to the electrode unit.

[0062] Compared with the prior art, the medical catheter of the present invention has the following advantages: the aforementioned medical catheter includes a tube assembly, a balloon and an electrode assembly; the balloon is arranged at the distal end section of the tube assembly; the balloon includes a first area and a second area arranged along its own circumference, and the second area is located between adjacent first areas; the electrode assembly is arranged outside the balloon and connected to the tube assembly; the electrode assembly includes an electrode unit extending along the axial direction of the tube assembly, at least a portion of which is located in the first area; the balloon has a contracted state and a working state, in which the balloon is attached to the tube assembly; in the working state, the balloon expands radially outward along the tube assembly, so that at least a portion of the second area forms a concave portion, and at least a portion of the first area forms a convex portion, and the second area causes the convex portion to apply a radial supporting force to the corresponding electrode unit, so that the electrode unit contacts the target tissue. This design can ensure that when the medical catheter is used to perform electrophysiological treatment on tissue, the electrode assembly can contact the tissue, and the balloon contacts the tissue while the electrode assembly does not contact the tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] The accompanying drawings are used to better understand the present invention and shall not constitute improper limitations of the present invention.

[0064] Figure 1 It is a schematic diagram of the application effect of the medical catheter in the prior art.

[0065] Figure 2 A schematic diagram of the partial structure of a medical catheter provided according to the first embodiment of the present invention.

[0066] Figure 3 is a partial structural schematic diagram of a medical catheter provided according to Embodiment 1 of the present invention, Figure 3 and Figure 2 The observation direction is different.

[0067] Figure 4 1 is a schematic diagram of the partial structure of a medical catheter provided according to the first embodiment of the present invention. The avoidance hole is not shown in the figure, but a circumferential limiter and a connecting hole are shown.

[0068] Figure 5 1 is a schematic diagram of the partial structure of the medical catheter provided according to the first embodiment of the present invention, and the figure mainly shows the folding wings of the balloon.

[0069] Figure 6 1 is a schematic diagram of a partial structure of a medical catheter provided according to the first embodiment of the present invention, and mainly shows the connection relationship between the circumferential limiter and the electrode unit.

[0070] Figure 7 It is a schematic diagram of the partial structure of the medical catheter provided according to the second embodiment of the present invention.

[0071] Figure 8 It is a schematic diagram of the structure of a medical catheter provided according to the third embodiment of the present invention.

[0072] Fig. 9 is a schematic structural diagram of a medical catheter provided according to Embodiment 3 of the present invention, Figure 7 and Figure 6 The difference lies in the different positions of the circumferential limiting members connected to the longitudinal limiting members.

[0073] Fig.10 It is a schematic structural diagram of a medical catheter provided according to a fourth embodiment of the present invention.

[0074] Fig.11 It is a schematic diagram of the structure of a medical catheter provided according to the fifth embodiment of the present invention.

[0075] Fig.12 is a schematic structural diagram of a medical catheter provided according to a fifth embodiment of the present invention, Fig.12 and Fig.11 The difference is that Fig.12 A longitudinal extension is shown in FIG.

[0076] Fig.13 It is a schematic diagram of the application effect of the medical catheter provided by an embodiment of the present invention.

[0077] Fig.14 It is a partial cross-sectional view of an electrode assembly of a medical catheter provided by an embodiment of the present invention.

[0078] [Description of reference numerals is as follows]: 00-target tissue, 01-electrode, 100-tube assembly, 110-outer tube, 120-inner shaft, 02, 200-balloon, 201-first region, 202-second region, 210-folding wing, 211-first edge, 212-second edge, 300-electrode assembly, 310-electrode unit, 311-electrode, 312-connecting hole, 313-first section, 314-second section, 315-third section, 316-avoidance hole , 320-marking electrode part, 321-first base layer, 322-first circuit layer, 323-marking electrode, 324-second insulating layer, 325-first avoidance area, 330-detection electrode part, 331-second base layer, 332-second circuit layer, 333-detection electrode, 334-third insulating layer, 335-second avoidance area, 400-longitudinal limiting member, 500-circumferential limiting member, 510-sub-limiting member, 501-via, 600-longitudinal extension member. DETAILED DESCRIPTION

[0079] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0080] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0081] As used in this specification, the singular forms "one", "an" and "the" include plural objects, and the plural form "multiple" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise, and the terms "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. Relational terms such as the terms "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. 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.

[0082] The terms "proximal end" and "distal end" used in this article are described based on the relative positions and orientations of the various elements and components of the medical device. Although non-restrictive, the "proximal end" is generally the end of the medical device that is closer to the operator during normal use, and the "distal end" is the end of the medical device that first enters the patient's body.

[0083] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0084] Figures 2 to 9 Schematic diagrams of medical catheters provided by different embodiments of the present invention are shown respectively. Figures 2 to 9 As shown, the medical catheter includes a tube assembly 100, a balloon 200 and an electrode assembly 300. The balloon 200 is arranged at the distal end of the tube assembly 100. The balloon 200 includes a first region 201 and a plurality of second regions 202 arranged along its own circumference, and the second regions 202 are located between adjacent first regions 201. Preferably, the first regions 201 and the second regions 202 are alternately arranged along the circumference of the balloon 200. The electrode assembly 300 is arranged outside the balloon 200 and connected to the tube assembly 100. The electrode assembly 300 includes an electrode unit 310 extending along the axial direction of the tube assembly 100, and at least a portion of the electrode unit 310 is located on one of the first regions 201.

[0085] In the medical catheter provided in the embodiment of the present invention, the balloon 200 has a contracted state and a working state. When the balloon 200 is in the contracted state, the balloon 200 is attached to the tube assembly 100. When the balloon 200 is in the working state, the balloon 200 expands radially outward along the tube assembly 100, and forms a concave portion in at least a portion of the second region 202, and forms a convex portion in at least a portion of the first region 201. The second region 202 causes the convex portion to apply a radial supporting force to the corresponding electrode unit 310, so that the electrode unit 310 is in contact with the target tissue 100 (such as Fig.13 shown) contacts.

[0086] On the same cross section, the maximum distance from the concave portion to the axis of the tube assembly 100 is smaller than the maximum distance from the convex portion to the axis of the tube assembly 100. Thus, on the same cross section, the maximum distance from the electrode unit 310 supported by the convex portion to the axis of the tube assembly 100 is larger than the maximum distance from the concave portion to the axis of the tube assembly 100. In this way, when the medical catheter is used to perform electrophysiological treatment to ablate the myocardium (i.e., the aforementioned target tissue 00), by controlling the balloon 200 to be in the working state, it can be ensured that the electrode unit 310 can contact the myocardium (e.g., Fig.13 As shown in the prior art, the portion of the balloon 200 between two adjacent electrode units 310 protrudes from the electrode unit 310, causing the portion of the balloon 200 between two adjacent electrode units 310 to contact the myocardium, while the electrode unit 310 does not contact the myocardium (that is, there will be no Figure 1 In other words, the medical catheter provided in the embodiment of the present invention can transmit the ablation energy to the myocardium through the electrode unit 310 to ensure the ablation effect.

[0087] The embodiment of the present invention does not limit the number of electrode units 310 included in the electrode assembly 300. In some embodiments, the electrode assembly 300 includes only one electrode unit 310. In other embodiments, the electrode assembly 300 includes more than two electrode units 310, and the more than two electrode units 310 are arranged at intervals along the circumference of the tube assembly 100. It should be understood that the number of the first regions 201 may be not less than the number of the electrode units 310, so that each of the electrode units 310 can be arranged corresponding to one of the first regions 201, so that each of the electrode units 310 is at least partially located at the corresponding first region 201.

[0088] In the embodiment of the present invention, the electrode unit 310 can be at least partially located in the first region 201 by any suitable method. For example, the electrode unit 310 can be at least partially bonded to the first region 201. In practice, the electrode unit 310 and the balloon 200 can be integrally formed to achieve the bonding of the electrode unit 310 and the first region 201, or the electrode unit 310 and the balloon 200 can be separately formed and then bonded together. For another example, when the electrode assembly 300 includes a plurality of electrode units 310 distributed at intervals along the circumference of the tube assembly 100, the position of the electrode unit 310 is constrained by setting a circumferential limiter 500, so that the electrode unit 310 is at least partially located in the corresponding first region 201.

[0089] Next, the configuration of the medical catheter is described in detail through specific embodiments. It is understood that the following only introduces some configurations of the medical catheter in an enumerated manner, and it is impossible to list all the configurations of the medical catheter, so the following description should not constitute an improper limitation on the present invention. In addition, in the following embodiments, the electrode assembly 300 includes a plurality of electrode units 310 arranged at intervals along the circumference of the tube assembly 100 as an example.

[0090] The structure of the medical catheter provided in the first embodiment of the present invention is as follows Figures 2 to 4 As shown, in this embodiment, the tube assembly 100 includes an inner shaft 120 and an outer tube 110, wherein the inner shaft 120 is partially disposed in the lumen of the outer tube 110, and the distal end of the inner shaft 120 extends out from the distal end of the outer tube 110. The inner shaft 120 can also generate axial relative movement with the outer tube 110.

[0091] When the balloon 200 is in the working state, the electrode assembly 300 bulges under the action of the convex part of the balloon 200 and is in the working state. When the balloon 200 is in the contracted state, if the outer tube 110 moves from the proximal end to the distal end relative to the inner shaft 120, the electrode assembly 300 can bulge with the movement of the outer tube 110 and can be switched to the working state. In addition, when the balloon 200 is in the contracted state, the electrode assembly 300 can also be in the contracted state.

[0092] Those skilled in the art know that the balloon 200 is a hollow structure with a filling cavity. A filling agent flow channel connected to the filling cavity of the balloon 200 is formed on the tube assembly 100. Therefore, the filling agent can enter the filling cavity of the balloon 200 from the filling agent flow channel, so that the balloon 200 is switched to the working state, and the filling agent can flow out from the filling agent flow channel, so that the balloon 200 is switched to the contracted state.

[0093] In some examples, the inner shaft 120 is formed with the filler flow channel, and the filler flow channel extends along the axial direction of the inner shaft 120. In a preferred embodiment, there are two filler flow channels formed on the inner shaft 120, one of which is a filler inlet channel, and the other is a filler outflow channel, and the filler inlet channel and the filler outflow channel are isolated from each other. During electrophysiological treatment, the external filler flows into the filling cavity of the balloon 200 along the filler inlet channel, and the filler in the filling cavity flows out of the filling cavity along the filler outflow channel. That is, during electrophysiological treatment, the operator can replace the filler in the balloon 200 in real time. The advantage of such a setting is that the balloon 200 can always be kept at a relatively low temperature to better cool the electrode 311. It can be understood that by reasonably controlling the inflow speed and outflow speed of the filler, it is possible to ensure that the balloon 200 always remains in a filled state during the electrophysiological treatment. In a specific embodiment, the filler inflow channel and the filler outflow channel are formed on the wall of the inner shaft 120. In an alternative embodiment, one of the filler inflow channel and the filler outflow channel is formed between the outer periphery of the inner shaft 120 and the inner periphery of the outer tube 110, and the other of the filler inflow channel and the filler outflow channel is formed in the wall of the inner shaft 120. In an alternative embodiment, the filler inflow channel and the filler outflow channel are formed on the wall of the outer tube 110. In other embodiments, the outer tube 110 includes a first sub-perfusion tube body and a second sub-perfusion tube body, wherein the first sub-perfusion tube body is sleeved on the outer circumference of the inner shaft 120, and the second sub-perfusion tube body is sleeved on the outer circumference of the first sub-perfusion tube body; thus, a first annular cylindrical cavity is formed between the inner circumference of the first sub-perfusion tube body and the outer circumference of the inner shaft 120, and a second annular cylindrical cavity is formed between the outer circumference of the first sub-perfusion tube body and the inner circumference of the second sub-perfusion tube body; one of the first annular cylindrical cavity and the second annular cylindrical cavity constitutes the filler inflow channel, and the other constitutes the filler outflow channel. Preferably, the inner shaft 120 includes a guide wire channel.

[0094] It should be noted that the electrode unit 310 is connected to a wire, and the wire extends along the axial direction of the tube assembly 100 to the proximal end of the tube assembly 100 to facilitate connection with an external power source. In practice, the wire can be arranged in any suitable manner so that during the application of the medical catheter, the wire is prevented from directly contacting the blood. In an optional embodiment, a wire channel is provided on the wall of the outer tube 110, and the wire extends along the wire channel (that is, the wire is buried in the wall of the outer tube 110). In another optional scheme, a tubular body can be arranged outside the outer tube 110 to form a cavity between the tubular body and the outer tube 110 to accommodate the wire. At this time, the distal end of the tubular body is sealed from the outer peripheral surface of the outer tube 110.

[0095] It should also be noted that the connection between the electrode assembly 300 and the tube assembly 100 mentioned above may be that the distal end of the electrode assembly 300 is connected to the distal end section of the inner shaft 120, and the proximal end of the electrode assembly 300 is connected to the distal end of the outer tube 110. The connection between the balloon 200 and the tube assembly 100 may be that the distal end of the balloon 200 is connected to the distal end section of the inner shaft 120, and the proximal end of the balloon 200 is connected to the distal end of the outer tube 110.

[0096] In addition, this embodiment has no special restrictions on the material and molding method of the tubes constituting the inner shaft 120 and the outer tube 110, but preferably a polymer braided tube known in the art is used so that the tube assembly 100 meets the requirements of pushing performance, bending performance, etc.

[0097] The balloon 200 may be a compliant balloon or a semi-compliant balloon. The material of the compliant balloon 200 is, for example, polyurethane, and the material of the semi-compliant balloon 200 is, for example, nylon. In this embodiment, each position of the balloon 200 may be made of the same material, and each position of the balloon 200 may have the same thickness. The specific positions of the first region 201 and the second region 202 are defined by the manufacturer according to actual conditions when producing the medical catheter.

[0098] Optionally, the outer diameter of the filled balloon 200 increases first and then decreases in the direction from the proximal end to the distal end, and the maximum outer diameter of the balloon 200 is approximately at 1 / 2 of its axial length. Such a balloon 200 has a smaller volume and a faster filling speed, which is conducive to shortening the operation time.

[0099] The medical catheter further includes a longitudinal restriction member 400, which extends along the axial direction of the tube assembly 100 and is located between adjacent first regions 201. Preferably, the longitudinal restriction member 400 and the electrode unit 310 are alternately arranged along the circumferential direction of the tube assembly 100. In this embodiment, the longitudinal restriction member 400 is at least connected to the tube assembly 100. Moreover, when the balloon 200 is in the working state, the maximum radial distance between the longitudinal restriction member 400 and the tube assembly 100 is less than the maximum radial distance between the electrode unit 310 and the tube assembly 100, so that the second region 202 at least partially forms the recess under the action of the longitudinal restriction member 400. Specifically, the longitudinal restriction member 400 is at least partially arranged at the second region 202, so that when the balloon 200 is in the working state, the longitudinal restriction member 400 can apply a radial extrusion force to the second region 202, so that the second region 202 at least partially forms the recess. Preferably, the recess is the only recess in the second region 202 .

[0100] In this embodiment, the distal end section of the longitudinal restriction member 400 is connected to the distal end section of the inner shaft 120, and the proximal end section of the longitudinal restriction member 400 is connected to the distal end section of the outer tube 110. When the balloon 200 is in the contracted state, the length of the longitudinal restriction member 400 between the axial ends of the balloon 200 is less than the length of the electrode unit 310 between the axial ends of the balloon 200.

[0101] It should be noted that, in this embodiment, when the balloon 200 is in the contracted state, the balloon 200 is stacked in the axial direction of the tube assembly 100, and the maximum radial distance between the electrode unit 310 of the electrode assembly 300 in the radial contracted state and the tube assembly 100 is also increased, thereby causing the outer diameter of the electrode assembly 300 in the radial contracted state to be slightly larger. As a result, when the medical catheter provided in this embodiment is used, a sheath tube with a slightly larger inner diameter needs to be used for delivery and withdrawal.

[0102] In some examples, the longitudinal restriction member 400 may be an elongated wire, thread or sheet, and its material may be a polymer material or a non-conductive non-polymer material. When the longitudinal restriction member 400 is made of a polymer material, the optional polymer materials include but are not limited to at least one of polyether block amide (Pebax), polyetheretherketone (PEEK), and thermoplastic polyurethane elastomer rubber (TPU).

[0103] Preferably, the longitudinal restraint 400 should have a certain rigidity so that it can correspond well to the second area 202 and enable the second area 202 to be at least partially formed into the concave portion. In practice, the longitudinal restraint 400 can be made to have a certain rigidity by increasing the size of the longitudinal restraint 400, or the longitudinal restraint 400 includes an inner core and a reinforcement, the inner core is made of a softer material, the reinforcement is sleeved on at least part of the outer surface of the inner core, for example, the outer surface of the inner core corresponding to the second area 202, and the reinforcement is, for example, a tubular structure with a certain rigidity. The material used to prepare the reinforcement includes, but is not limited to, nylon and polyurethane with a certain hardness, and can also be metal.

[0104] It should be noted that, for the filamentous or linear longitudinal restraining member 400, its cross section is generally circular, and the diameter of the longitudinal restraining member 400 should be appropriate. If the diameter of the longitudinal restraining member 400 is too small, on the one hand, it may not be strong enough and break when tightened, and on the other hand, it may also cause the pressure applied to the second area 202 of the balloon 200 to be too large, causing the balloon 200 to rupture due to stress concentration in the second area 202. In principle, the diameter of the longitudinal restraining member 400 is not less than 0.05 mm; when the diameter of the longitudinal restraining member 400 is too large, the concave portion formed by the second area 202 may be too large, resulting in the convex portion being too small, and then the convex portion cannot effectively support the electrode unit 310. The specific diameter of the longitudinal restraining member 400 is selected according to the material. For example, when the longitudinal restraining member 400 is a nylon line, the diameter of the longitudinal restraining member 400 can be between 0.1 mm and 0.3 mm.

[0105] Optionally, for the longitudinal limiting member 400, a conductive electrode (not shown in the figure) can also be set thereon, and the shape of the conductive electrode is, for example, ring-shaped, point-shaped, sheet-shaped, etc. The conductive electrode is used for mapping, such as detecting electrocardiogram signals during ablation, and then determining the ablation effect; and / or for discharge, such as ablation.

[0106] Specifically, taking the shape of the conductive electrode as a ring as an example, the conductive electrode can be directly or indirectly sleeved on the longitudinal restriction member 400. For example, if the longitudinal restriction member 400 is a filament or line structure with a small radial size, a sleeve can be firstly provided on the longitudinal restriction member 400, and then the ring electrode can be sleeved on the sleeve. The ring electrode can be used for ECG mapping or for discharge. It can be understood that the ring electrode is connected to a wire, and the wire can be provided in the sleeve.

[0107] In other examples, the longitudinal restraint 400 may be at least partially made of a conductive material, for example, the longitudinal restraint 400 includes a substrate made of an insulating material, on which conductive electrodes are arranged, and the conductive electrodes are shaped, for example, as dots or sheets, etc. In this way, the conductive electrodes of the longitudinal restraint 400 can be used for ECG mapping and / or discharge, etc.

[0108] In addition, when the balloon 200 is in a contracted state, Figure 5 As shown, the balloon 200 has a folding wing 210, and the folding wing 210 has a first edge 211 and a second edge 212 in the radial direction of the tube assembly 100, and the first edge 211 is closer to the tube assembly 100 than the second edge 212. Preferably, when the balloon 200 is in the contracted state, the longitudinal restriction member 400 is arranged at the first edge 211, and the electrode unit 310 is arranged at the second edge 212, so as to reduce the diameter of the medical catheter in the contracted state at the balloon 200 and the electrode assembly 300 as much as possible. Preferably, the electrode unit 310 is bonded to the second edge 212, based on which, in the contracted state, the electrode unit 310 can be wound on the tube assembly 100 with the balloon 200, which can simplify the operation of the catheter.

[0109] Preferably, the medical catheter also includes a circumferential limiter 500, which is connected to adjacent electrode units 310 at a preset circumferential interval to ensure that adjacent electrode units 310 are arranged at a preset circumferential interval in the working state, so that the electrode units 310 can be restricted to the corresponding first area 201.

[0110] Specifically, the circumferential stopper 500 includes a plurality of sub-stoppers 510, which are sequentially arranged along the circumference of the tube assembly 100, and each of the sub-stoppers 510 connects two adjacent electrode units 310 to limit the spacing between the two adjacent electrode units 310. It should be understood that when the medical catheter is in the working state, the sub-stoppers 510 are tightened to maintain a preset spacing between the corresponding two adjacent electrode units 310, so that each electrode unit 310 can always contact the corresponding convex portion of the first region 201 and receive the support force from the corresponding convex portion of the first region 201, so as to avoid misalignment between the electrode unit 310 and the first region 201.

[0111] In a preferred embodiment, all of the electrode units 310 are arranged at equal intervals in the circumferential direction of the tube assembly 100, and the sub-limiting members 510 of the same circumferential limiting member 500 are at the same position in the axial direction of the tube assembly 100. At this time, the lengths of all of the sub-limiting members 510 are the same.

[0112] There is at least one circumferential stopper 500. When there are multiple circumferential stoppers 500, the multiple circumferential stoppers 500 are arranged at intervals in the axial direction of the tube assembly 100 to circumferentially constrain the electrode unit 310 at different axial positions of the tube assembly 100.

[0113] The sub-limiting member 510 may be connected to the corresponding electrode unit 310 in any suitable manner. For example, each sub-limiting member 510 of the same circumferential limiting member 500 is an integrated structure, and the circumferential limiting member 500 is connected to the electrode unit 310 by winding; or, the electrode unit 310 is provided with a connecting hole 312, and the circumferential limiting member 500 is a double-strand structure (for example, two strands of wire or two strands of thread), wherein one strand of the double-strand structure passes through the connecting hole 312 (for example, two strands of wire or two strands of thread) on the electrode unit 310. Figure 4 As shown), and then the circumferential limiter 500 is entangled or knotted with the other strand of the double-strand structure, so as to realize the connection between the circumferential limiter 500 and the electrode unit 310 and prevent the circumferential limiter 500 from being separated from the electrode unit 310; it is also possible that the two strands of the double-strand structure cross through the connecting hole 312, and then the two strands are entangled or knotted. Preferably, the circumferential limiter 500 is knotted after passing through the connecting hole 312. The advantage of this is that when the balloon 200 is not filled, the circumferential limiter 500 is in a relaxed state, and a larger through hole 501 (as shown) that allows blood to flow through is formed between the two strands of the two-strand structure. Figure 6 as shown), and is less likely to form blood clots.

[0114] Preferably, the longitudinal limiting member 400 is also connected to the circumferential limiting member 500. Specifically, the longitudinal limiting member 400 and the sub-limiting member 510 corresponding to the same second area 202 are connected. For example, the middle part of the sub-limiting member 510 corresponding to the same second area 202 is connected to the longitudinal limiting member 400. The middle part here can be the 1 / 2 position of the sub-limiting member 510, or it can be slightly deviated from the 1 / 2 position, which is specifically set according to the position of the second area 202. In this way, the longitudinal limiting member 400 can be better restricted in the second area 202, avoiding the longitudinal limiting member 400 from being misaligned with the second area 202, thereby ensuring that the longitudinal limiting member 400 can apply radial pressure to the second area 202, so that the second area 202 at least partially forms the recess.

[0115] Further preferably, the longitudinal limiting member 400 and all the sub-limiting members 510 of the circumferential limiting member 500 are an integrated structure.

[0116] Under the premise that the electrode unit 310 is in close contact with the myocardium, the ablation effect of the medical catheter is related to the width of the electrode unit 310. Specifically, the larger the width of the electrode unit 310, the better the ablation effect of the medical catheter. In practice, the width of the electrode unit 310 is related to the number of the electrode units 310. That is, the larger the width of the electrode unit 310, the fewer the number of the electrode units 310, and the smaller the width of the electrode unit 310, the more the number of the electrode units 310. It can be understood that if the number of the electrode units 310 is too small, the number of sites that can be ablated by the medical catheter at one time is too small. In addition, the number of the electrode units 310 also has a certain influence on the pushing performance and bending performance of the medical catheter. In this way, when designing the electrode assembly 300, the width of the electrode unit 310, the number of the electrode units 310, and the pushing performance and bending performance of the medical catheter should be taken into account.

[0117] In a specific example, when the electrode units 310 are fully extended, all the electrode units 310 enclose a tube. When the outer diameter of the tube is 3 mm to 4 mm, preferably the number of the electrode units 310 is 6 to 12, so that the width of the electrode units 310 is about 1 mm to 1.8 mm. Further preferably, the number of the electrode units 310 is 8, and the width of the electrode units 310 is 1.2 mm to 1.5 mm.

[0118] In this embodiment, the electrode unit 310 includes a body (not shown in the figure) and a first insulating layer (not marked in the figure). The body is configured to have conductivity and includes a first section 313, a second section 314 and a third section 315 connected in sequence along the axial direction of the tube assembly 100, the first section 313 is located at the proximal end of the second section 314, and the third section 315 is located at the distal end of the second section 314. At least a portion of the second section 314 constitutes at least a portion of the electrode 311 of the electrode unit 310. The outer surfaces of the first section 313 and the third section 315 are both coated with the first insulating layer. Under the action of the first insulating layer, the first section 313 and the third section 315 cannot discharge in the blood. The body can be made of a metal with good conductivity and good biocompatibility.

[0119] Furthermore, the electrode unit 310 further includes an inert metal layer (not shown in the figure), and the inert metal layer is coated on the surface of the second segment 314. At least a portion of the inert metal layer also constitutes a portion of the electrode 311. In other words, the electrode 311 includes at least a portion of the second segment 314 and at least a portion of the inert metal layer. The provision of the inert metal layer can prevent the second segment 314 from being polarized when the electrode 311 is discharged.

[0120] In addition, under the action of the first insulating layer, when the electrode 311 discharges, the electric field is distorted at the intersection of the first section 313 and the second section 314, resulting in more heat generated at the intersection of the first section 313 and the second section 314. In order to better cool the intersection of the first section 313 and the second section 314, it is preferred that the balloon 200 is provided with a flushing hole (not shown in the figure) connected to the filling cavity corresponding to the intersection of the first section 313 and the second section 314 of each electrode unit 310, or near the intersection of the first section 313 and the second section 314, so that the low-temperature filling agent can flow from the flushing hole to the intersection of the first section 313 and the second section 314 to flush and cool the location. Similarly, the balloon 200 is also provided with a flushing hole connected to the filling cavity corresponding to the intersection area between the second section 314 and the third section 315 of each electrode unit 310, or near the intersection area between the second section 314 and the third section 315, so that the low-temperature filling agent can flow from the flushing hole to the intersection of the second section 314 and the third section 315 to flush and cool the location.

[0121] In a preferred example, when the electrode unit 310 is in a contracted state, the electrode unit 310 is twisted and wound around the outside of the balloon 200. The advantage of such a configuration is that the outer diameter of the electrode assembly 300 in the contracted state can be reduced, thereby reducing the outer diameter of the medical catheter, thereby facilitating the delivery and withdrawal of the medical catheter.

[0122] Optionally, the cross section of at least a portion of each of the first segments 313 is designed to be any one of a circle, an ellipse, and a regular polygon. And, the cross section of at least a portion of each of the third segments 315 is designed to be any one of a circle, an ellipse, and a regular polygon. Such a cross section facilitates the electrode unit 310 to be twisted and wound around the outside of the balloon 200. It should be noted that the regular polygon is at least a regular pentagon.

[0123] Furthermore, the electrode assembly 300 further includes: Fig.14 The mapping electrode portion 320 is shown so that the medical catheter also has a mapping function.

[0124] Specifically, the electrode 311 is provided with an avoidance hole 316 penetrating the electrode unit 310 , and the mapping electrode 323 of the mapping electrode part 320 can detect the electrocardiogram signal through the avoidance hole 316 .

[0125] More specifically, the mapping electrode unit 320 is disposed on a side of the electrode 311 close to the tube assembly 100, and includes a first base layer 321, a first circuit layer 322, a mapping electrode 323, and a second insulating layer 324. The first base layer 321, the first circuit layer 322, and the second insulating layer 324 are arranged in sequence along the direction from the tube assembly 100 to the electrode unit 310. The second insulating layer 324 is formed with a first avoidance area 325 at a position corresponding to the avoidance hole 316, and the mapping electrode 323 is electrically connected to the first circuit layer 322, and is at least partially disposed at the first avoidance area 325, and can be visible to the outside through the first avoidance area 325 and the avoidance hole 316. Furthermore, when the avoidance hole 316 and the first avoidance area 325 are both projected onto a plane perpendicular to the axis of the avoidance hole 316, the projection of the first avoidance area 325 is at least partially on the inner side of the projection of the avoidance hole 316, and preferably, the projection of the first avoidance area 325 is entirely on the inner side of the projection of the avoidance hole 316. When the electrode 311 is in contact with the myocardium, the mapping electrode 323 can receive the ECG signal through the avoidance hole 316 to realize the cardiac mapping function. Compared with the method of directly using the electrode 311 of the electrode unit 310 to detect the ECG signal, the exposed part of the mapping electrode 323 is smaller, and the myocardial range it covers is also small, and it will not be disturbed by the ECG activity of a large range of myocardium. Therefore, the obtained ECG signal is more accurate.

[0126] In a preferred embodiment, the mapping electrode 323 is disposed on a side of the first circuit layer 322 facing the electrode 311 , and is at least partially located in the first avoidance area 325 .

[0127] Furthermore, the electrode assembly 300 further includes: Fig.11 The detection electrode part 330 is shown. The detection electrode part 330 is arranged on a side of the electrode unit 310 close to the balloon 200. The purpose of setting the detection electrode part 330 is to detect whether the balloon 200 is effectively attached to the electrode assembly 300 during the use of the medical catheter.

[0128] Optionally, the detection electrode portion 330 includes a second base layer 331, a second circuit layer 332, a detection electrode 333 and a third insulating layer 334. The second base layer 331, the second circuit layer 332 and the third insulating layer 334 are arranged along the direction from the electrode unit 310 to the balloon 200, and a second avoidance area 335 is provided on the third insulating layer 334, and the second avoidance area 335 is located at the maximum diameter of the expanded electrode assembly 300. The detection electrode 333 is arranged on a side of the second circuit layer 332 away from the second base layer 331, and the detection electrode 333 is also electrically connected to the second circuit layer 332. And the detection electrode 333 is at least partially arranged at the second avoidance area 335, so that the detection electrode 333 is exposed outside the third insulating layer 334 at the second avoidance area 335, so that the detection electrode 333 is at least partially visible to the outside through the second avoidance area 335.

[0129] When the distal end of the medical catheter is located in the body and the balloon 200 is in the working state, if the balloon 200 is effectively attached to the electrode assembly 300, so that each of the protrusions applies a radial support force to the corresponding electrode unit 310, the balloon 200 blocks the second avoidance area 335, so that the detection electrode 333 is isolated or substantially isolated from body fluids (such as blood), so the impedance is large when power is applied to the detection electrode 333. If the balloon 200 is not effectively attached to the electrode assembly 300, resulting in each of the protrusions not applying a radial support force to the corresponding electrode unit 310, the balloon 200 cannot block the second avoidance area 335, so that the detection electrode 333 is in contact with the body fluid and conducts, so the impedance is small when power is applied to the detection electrode 333. Therefore, when the distal end of the medical catheter has entered the body, it is possible to determine whether the filled balloon 200 is effectively attached to the electrode assembly 300 based on the impedance when the detection electrode 333 is energized. That is, when the impedance when the detection electrode 333 is energized is small, it is determined that the balloon 200 is not effectively attached to the electrode assembly 300, and when the impedance when the detection electrode 333 is energized is large, it is determined that the balloon 200 is effectively attached to the electrode assembly 300.

[0130] In an optional embodiment, if Fig.11 As shown, the mapping electrode portion 320 and the detection electrode portion 330 share the same base layer, that is, the first base layer 321 and the second base layer 331 are the same structure.

[0131] Figure 7 FIG. 2 shows a partial structural schematic diagram of a medical catheter provided by Embodiment 2 of the present invention. Figure 7As shown, the difference between this embodiment and the first embodiment is that the proximal end of the longitudinal restriction member 400 is not connected to the distal end of the outer tube 110, but can move relative to the tube assembly 100. In this way, when the balloon 200 is in the working state, the operator can apply a pulling force to the proximal end of the longitudinal restriction member 400 in any appropriate manner, so that the proximal end of the longitudinal restriction member 400 moves from the distal end to the proximal end, so as to achieve the purpose of the longitudinal restriction member 400 applying radial pressure to the second area 202 of the filled balloon 200 and forming the concave portion in the second area 202. Preferably, the concave portion is the only concave portion in the second area 202.

[0132] In a preferred embodiment, the proximal end of the longitudinal restriction member 400 passes through the lumen of the outer tube 110 and extends to the outside of the proximal end of the outer tube 110 .

[0133] Compared with the first embodiment, the advantage of this embodiment is that, when the balloon 200 is in a contracted state and the operator cancels the tension applied to the proximal end of the longitudinal restriction member 400, the length of the portion of the longitudinal restriction member 400 located at the balloon 200 can be adapted to the natural length of the balloon 200 and the length of the electrode unit 310, thereby enabling the electrode assembly 300 to contract to a minimum radial dimension to allow the medical catheter to be delivered through a smaller delivery sheath.

[0134] Figure 8 and Fig. 9 FIG. 2 is a schematic diagram showing a partial structure of a medical catheter provided by Embodiment 3 of the present invention. Figure 8 and Fig. 9 As shown, the difference between this embodiment and embodiment 1 is that the proximal end of the longitudinal limiting member 400 is not connected to the distal end of the outer tube 110, but is connected to the circumferential limiting member 500, specifically, the longitudinal limiting member 400 corresponding to the two adjacent electrode units 310 in the same group is connected to the sub-limiting member 510.

[0135] Furthermore, the circumferential length of the portion of the circumferential stopper 500 between the adjacent electrode units 310 (ie, the sub-stopper 510 ) is L C When the balloon 200 is in the contracted state, the longitudinal extension length of the longitudinal restriction member 400 located in the balloon 200 area is L B1 The extension length of the electrode unit 310 between the connection position between the electrode unit 310 and the circumferential stopper 500 connected to the longitudinal stopper 400 and the connection position between the longitudinal stopper 400 and the tube assembly 100 is L. E1 .L C、 L B1、 LE1 Satisfaction: L B1 <L E1 ≤L B1 +L C / 2.

[0136] Compared with the first embodiment, the advantage of this embodiment is that after the balloon 200 is in the contracted state, the longitudinal restriction member 400 does not interfere with the retraction of the balloon 200, so that the balloon 200 can be restored to its natural length, and the electrode assembly 300 can be contracted to the minimum radial dimension to allow the medical catheter to be delivered through a smaller delivery sheath. Compared with the second embodiment, the advantage of this embodiment is that it is not necessary to control the proximal end of the longitudinal restriction member 400 to move from the distal end to the proximal end when the balloon 200 is in the working state.

[0137] It can be understood that the present embodiment has no special limitation on the specific position of the circumferential limiting member 500 connected to the longitudinal limiting member 400. Figure 8 As shown, the circumferential limiter 500 connected to the longitudinal limiter 400 is at the maximum diameter of the balloon 200 in the working state; or as shown Fig. 9 As shown, relative to the distal end of the electrode assembly 300, the connection between the longitudinal limiting member 400 and the circumferential limiting member 500 is closer to the proximal end of the electrode assembly 300, or the circumferential limiting member 500 connected to the longitudinal limiting member 400 deviates from the maximum diameter of the balloon 200 in a working state and is closer to the distal end of the outer tube 110.

[0138] Fig.10 FIG. 4 is a schematic diagram showing a partial structure of a medical catheter provided by Embodiment 4 of the present invention. Fig.10 As shown, the difference between this embodiment and the first embodiment is that the distal end of the longitudinal limiting member 400 is not connected to the distal end of the inner shaft 120, but is connected to the circumferential limiting member 500. In addition, the circumferential length of the portion of the circumferential limiting member 500 between the adjacent electrode units 310 (i.e., the sub-limiting member 510) is L. C When the balloon 200 is in the contracted state, the longitudinal extension length of the longitudinal restriction member 400 located in the balloon 200 area is L B1 The extension length of the electrode unit 310 between the connection position between the electrode unit 310 and the circumferential stopper 500 connected to the longitudinal stopper 400 and the connection position between the longitudinal stopper 400 and the tube assembly 100 is L. E1 .L C , L B1 , L E1 Satisfaction: L B1 <LE1 ≤L B1 +L C / 2. Further, relative to the proximal end of the electrode assembly 300, the connection between the longitudinal limiting member 400 and the circumferential limiting member 500 is closer to the distal end of the electrode assembly 300. The advantages of this embodiment are the same as those of the third embodiment, which will not be described in detail here.

[0139] Fig.11 FIG. 2 is a schematic diagram showing a partial structure of the medical catheter provided in Embodiment 5 of the present invention. Fig.11 As shown, the difference between this embodiment and the first embodiment is that the distal end of the longitudinal restriction member 400 is not connected to the distal end of the inner shaft 120 , and the proximal end of the longitudinal restriction member 400 is not connected to the distal end of the outer tube 110 .

[0140] In this embodiment, the medical catheter includes at least two circumferential limiters 500, one of which is connected to the distal end of the longitudinal limiter 400, and the other is connected to the proximal end of the longitudinal limiter 400.

[0141] For the convenience of description, in this embodiment, the circumferential limiter 500 connected to the proximal end of the longitudinal limiter 400 is referred to as the first circumferential limiter, and the circumferential limiter 500 connected to the distal end of the longitudinal limiter 400 is referred to as the second circumferential limiter.

[0142] The circumferential length of the portion of the first circumferential limiter located between the adjacent electrode units 310 (ie, the sub-limiter 510 of the first circumferential limiter) is L. C1 The circumferential length of the second circumferential limiter located between the adjacent electrode units 310 (ie, the sub-limiter 510 of the second circumferential limiter) is L C2 When the balloon 200 is in a contracted state, the longitudinal extension length of the longitudinal restriction member 400 located in the balloon 200 region and between the first circumferential restriction member and the second circumferential restriction member is L B2 The extension length of the portion from the connection position of the electrode unit 310 and the first circumferential limiter to the connection position of the electrode unit 310 and the second circumferential limiter is L E2 , L B2 , L E2 , L C1 , L C2 Satisfaction: L B2 <L E2 ≤L B2 +(L C1 + L C2 ) / 2.

[0143] Furthermore, relative to the distal end of the electrode assembly 300, the connection between the longitudinal restriction member 400 and the first circumferential restriction member is closer to the proximal end of the electrode assembly 300; relative to the proximal end of the electrode assembly 300, the connection between the longitudinal restriction member 400 and the second circumferential restriction member is closer to the distal end of the electrode assembly 300.

[0144] This embodiment has the same advantages as the third embodiment, which will not be described in detail here.

[0145] Furthermore, if Fig.12 As shown, the medical catheter further comprises a longitudinal extension member 600, the distal end of which is connected to the longitudinal restriction member 400, and the proximal end of which can move relative to the tube assembly 100. The advantage of providing the longitudinal extension member 600 is that, on the one hand, once the first circumferential stopper connected to the longitudinal restriction member 400 fails, the proximal end section of the longitudinal restriction member 400 can be controlled to move from the distal end to the proximal end by controlling the longitudinal extension member 600 to move relative to the tube assembly 100 from the distal end to the proximal end, so that the second region 202 can at least partially form the recess; on the other hand, even if the filling amount of the balloon 200 is small, the operator can control the longitudinal extension member 600 to move from the distal end to the proximal end to make the proximal end section of the longitudinal restriction member 400 move from the distal end to the proximal end, so that the longitudinal restriction member 400 applies a radial extrusion force to the second region 202, so that the second region 202 at least partially forms the recess.

[0146] The difference between the sixth embodiment of the present invention and the first embodiment is that, when the first region 201 and the second region 202 are made of the same material, the longitudinal restriction is achieved by the thickness of the second region 202 being greater than the thickness of the first region 201, that is, the longitudinal portion of the second region 202 that is thicker than the thickness of the first region 201 forms the longitudinal restriction, that is, this embodiment does not need to provide an additional longitudinal restriction independent of the balloon 200, and the effect of forming the concave portion and the convex portion on the filled balloon 200 is achieved through the characteristics of the balloon 200 itself. Further, the longitudinal restriction can be provided at the first edge of the folding wing of the balloon.

[0147] The difference between the seventh embodiment of the present invention and the first embodiment is that the first region 201 and the second region 202 are made of different materials, wherein the elastic modulus of at least a portion of the second region 202 in the longitudinal direction is greater than the elastic modulus of the first region 201. At least the portion in the longitudinal direction forms the longitudinal restriction member, that is, this embodiment does not need to provide an additional longitudinal restriction member independent of the balloon 200, and the effects of the concave portion and the convex portion are formed on the filled balloon 200 through the characteristics of the balloon 200 itself.

[0148] Further, the longitudinal restriction may be arranged at a first edge of the folding wing of the balloon.

[0149] Furthermore, the longitudinal limiting member may also be formed by a combination of materials and dimensions different from those of the first region 201 .

[0150] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A medical catheter, characterized in that: include: Tube assemblies; A balloon disposed at the distal end of the tube assembly; the balloon comprises a first region and a second region arranged along its own circumference, wherein the second region is located between adjacent first regions; an electrode assembly, disposed outside the balloon and connected to the tube assembly; the electrode assembly comprises an electrode unit extending along the axial direction of the tube assembly and at least a portion of which is located in the first region; and a longitudinal restriction member, located between adjacent first regions; The balloon has a contracted state and a working state. In the contracted state, the balloon is abutted against the tube assembly. In the working state, the balloon expands radially outward along the tube assembly, and the maximum radial distance between the longitudinal restriction and the tube assembly is smaller than the maximum radial distance between the electrode unit and the tube assembly, so that at least a portion of the second area forms a recess under the action of the longitudinal restriction, and at least a portion of the first area forms a convex portion, and the second area causes the convex portion to apply a radial supporting force to the corresponding electrode unit to bring the electrode unit into contact with the target tissue.

2. The medical catheter according to claim 1, characterized in that: The tube assembly comprises an inner shaft and an outer tube, wherein at least a portion of the inner shaft is inserted into the lumen of the outer tube, and a distal end of the inner shaft extends out from the distal end of the outer tube; and an axial relative movement can be generated between the inner shaft and the outer tube; The proximal end of the balloon is connected to the distal end section of the outer tube, and the distal end of the balloon is connected to the distal end section of the inner shaft; The distal end of the electrode assembly is connected to the distal end section of the inner shaft, and the proximal end of the electrode assembly is connected to the distal end section of the outer tube; The longitudinal restraining members and the electrode units are arranged alternately in the circumferential direction.

3. The medical catheter according to claim 2, characterized in that: At least one of the proximal section and the distal section of the longitudinal restraint is connected to the tube assembly; in the working state, the longitudinal restraint applies radial pressure to the second area to generate the recessed portion of the second area.

4. The medical catheter according to claim 3, characterized in that: The distal section of the longitudinal restriction member is connected to the distal section of the inner shaft, and the proximal section of the longitudinal restriction member is connected to the distal section of the outer tube; in the contracted state, the length of the longitudinal restriction member between the two ends of the balloon is smaller than the length of the electrode unit between the two ends of the balloon.

5. The medical catheter according to claim 3, characterized in that: The distal end section of the longitudinal restraint is connected to the distal end section of the inner shaft, and the proximal end section of the longitudinal restraint is movable relative to the tube assembly.

6. The medical catheter according to claim 2, characterized in that: The medical catheter further comprises a circumferential limiter, wherein the circumferential limiter is connected to adjacent electrode units at a preset circumferential interval to ensure that the adjacent electrode units are arranged at the preset circumferential interval in the working state.

7. The medical catheter according to claim 6, characterized in that At least one of the proximal end section and the distal end section of the longitudinal limiting member is connected to the circumferential limiting member.

8. The medical catheter according to claim 7, characterized in that: The distal end section of the longitudinal restriction member is connected to the distal end section of the inner shaft, and the proximal end section of the longitudinal restriction member is connected to the circumferential limit member; or, the proximal end section of the longitudinal restriction member is connected to the distal end section of the outer tube, and the distal end section of the longitudinal restriction member is connected to the circumferential limit member; The circumferential length of the circumferential limiter between adjacent electrode units is L C In the contracted state, the longitudinal extension length of the longitudinal restriction member located in the balloon region is L B1 The length of the electrode unit extending from the connection position of the electrode unit and the circumferential limiter to the connection position of the longitudinal limiter and the tube assembly in the balloon area is L E1 , where L B1 <L E1 ≤L B1 +L C / 2.

9. The medical catheter according to claim 7, characterized in that: The circumferential limiter comprises a first circumferential limiter and a second circumferential limiter which are axially spaced apart, one of the proximal end section and the distal end section of the longitudinal limiter is connected to the first circumferential limiter, and the other is connected to the second circumferential limiter; The circumferential length of the first circumferential limiter between adjacent electrode units is L C1 The circumferential length of the second circumferential limiter between adjacent electrode units is L C2 In the contracted state, the longitudinal extension length of the longitudinal limiter between the first circumferential limiter and the second circumferential limiter in the balloon region is L B2 The extension length of the electrode unit from the connection position of the electrode unit and the first circumferential limiter to the connection position of the electrode unit and the second circumferential limiter is L E2 , where L B2 <L E2 ≤L B2 +(L C1 +L C2 ) / 2.

10. The medical catheter according to claim 9, characterized in that The medical catheter further includes a longitudinal extension member, a distal end section of the longitudinal extension member being connected to the longitudinal restraint member, and a proximal end section of the longitudinal extension member being movable relative to the tube assembly.

11. The medical catheter according to any one of claims 1 to 10, characterized in that: The electrode unit includes a main body and a first insulating layer; the main body includes a first section, a second section and a third section connected in sequence along the axial direction of the tube assembly; at least a portion of the second section constitutes at least a portion of the electrode; at least a portion of the outer surface of the first section and the second section is covered with the first insulating layer.

12. The medical catheter according to claim 11, characterized in that The electrode unit further includes an inert metal layer, and the inert metal layer is coated on at least a portion of the outer surface of the second section; the electrode further includes at least a portion of the inert metal layer.

13. The medical catheter according to claim 11, characterized in that The balloon includes flushing holes, and the flushing holes are capable of flushing a connection area between the first segment and the second segment and / or a connection area between the second segment and the third segment.

14. The medical catheter according to claim 11, characterized in that The cross-section of at least a portion of the first segment is any one of a circle, an ellipse, and a regular polygon, and / or the cross-section of the third segment is any one of a circle, an ellipse, and a regular polygon; when the electrode assembly is in a contracted state, the electrode unit can be twisted and wound on the tube assembly.

15. The medical catheter according to any one of claims 1 to 10, characterized in that: The electrodes of the electrode unit are provided with avoidance holes; The electrode assembly further comprises a mapping electrode portion, wherein the mapping electrodes of the mapping electrode portion are capable of detecting electrical signals of the target tissue through the avoidance hole.

16. The medical catheter according to claim 15, characterized in that The mapping electrode portion includes a first base layer, a first circuit layer, and a second insulating layer which are arranged in sequence; the second insulating layer is arranged on the electrode unit and forms a first avoidance area, and the mapping electrode is electrically connected to the first circuit layer; the mapping electrode is at least partially arranged in the first avoidance area, and is visible to the outside through the first avoidance area and the avoidance hole.

17. The medical catheter according to claim 16, characterized in that On a plane perpendicular to the axis of the avoidance hole, a projection of the first avoidance area is inside a projection of the avoidance hole; and the mapping electrode is arranged on a side of the first circuit layer away from the first base layer.

18. The medical catheter according to any one of claims 1 to 10, characterized in that: The electrode assembly further includes a detection electrode portion, which is disposed on a side of the electrode unit facing the balloon to detect whether the balloon is effectively attached to the electrode assembly.

19. The medical catheter according to claim 18, characterized in that The detection electrode portion includes a second base layer, a second circuit layer, a detection electrode and a third insulating layer; the second base layer, the second circuit layer, and the third insulating layer are arranged in sequence along the direction from the electrode unit to the balloon, and a second avoidance area is provided on the third insulating layer. In the working state, the second avoidance area is located at the maximum radial distance between the electrode assembly and the tube assembly; the detection electrode is electrically connected to the second circuit layer; the detection electrode is at least partially arranged at the second avoidance area and is visible to the outside through the second avoidance area.

20. The medical catheter according to any one of claims 2 to 10, characterized in that: The tube assembly is formed with a filler inlet channel and a filler outlet channel connected to the balloon; the filler inlet channel and the filler outlet channel extend along the axial direction of the tube assembly, and the filler inlet channel and the filler outlet channel are isolated from each other.

21. The medical catheter according to any one of claims 1 to 10, characterized in that: The electrode unit is at least partially bonded to the first region.

22. The medical catheter according to claim 21, characterized in that In the deflated state, the balloon has a folded wing, the folded wing has a first edge and a second edge in a radial direction of the tube assembly, the first edge is closer to the tube assembly than the second edge, and the electrode unit is disposed at the second edge.

23. The medical catheter according to claim 22, characterized in that The longitudinal restriction of the medical tube is disposed at the first edge.

24. The medical catheter according to any one of claims 6 to 10, characterized in that: The circumferential limiter is connected to the electrode unit by winding; or, The electrode unit is provided with a connection hole, and the circumferential limiter passes through the connection hole to form a double-strand winding structure or a knotted structure, so that the circumferential limiter is connected to the electrode unit.

25. The medical catheter according to claim 11, characterized in that The main body is formed by a continuous elastic metal body.

26. The medical catheter according to any one of claims 2 to 10, characterized in that: The longitudinal restraint includes a reinforcement member.

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