Medical intervention catheter and method of processing thereof

Abstract

The application relates to a medical intervention catheter and a processing method thereof. The medical intervention catheter comprises a catheter body and a shaping piece, the distal end of the shaping piece has a first shape and a second shape, the distal end of the shaping piece can extend into the catheter body in the first shape, when the distal end of the shaping piece reaches the distal end of the catheter body, the distal end of the shaping piece can be configured into the second shape so that the distal end of the catheter body is also in the second shape, wherein the bending angle of the distal end of the catheter body in the second shape is greater than the bending angle of the distal end of the catheter body in the first shape. The medical intervention catheter can select a suitable shaping piece according to the shape characteristics of a blood vessel (for example, a Marshall vein) where a target ablation position is located, so that the bending angle of the distal end of the catheter body is correspondingly adjusted by using the shaping piece, the requirement of Marshall veins with different opening positions and running angles can be met, and then the smooth positioning of the catheter body can be ensured.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a medical intervention catheter and a processing method thereof. BACKGROUND

[0002] In the field of treatment of tachyarrhythmia, when the effect of antiarrhythmic drugs cannot be achieved, catheter ablation is an important treatment method. The operator reaches the heart cavity through the blood vessels with a catheter with an electrode, collects and analyzes the intracardiac electrical signal, finds the abnormal part of the electrical signal, and then ablates the tissue to cut off the abnormal conduction of the heart electricity and terminate the arrhythmia. Among them, pulmonary vein isolation, referred to as PVI, is the most mature and widely used treatment method for atrial fibrillation so far.

[0003] However, as the number of cases of pulmonary vein isolation gradually increases, it is found that its long-term effect on complex or persistent atrial fibrillation is limited, and there is still about 20% recurrence rate within three months after the operation. In these recurrent populations, in addition to ectopic pacemaker in the pulmonary vein, other parts of abnormal electrical connection can also cause recurrent atrial fibrillation after PVI. Through anatomical and clinical research, it is found that the Marshall vein (vein of Marshall, VOM) is an important ectopic pacemaker outside the pulmonary vein. Its special running starts between the left upper and left lower pulmonary veins and injects into the proximal part of the coronary sinus at a certain angle. VOM is located in the epicardium and is connected with ligaments, ganglions, muscle bundles and the like, and has a complex structure, which can build a heart electrical conduction path to cause atrial fibrillation, and is a research hotspot for diagnosis and ablation of persistent atrial fibrillation in recent years.

[0004] In the related art, a distal end bendable medical intervention catheter is mainly used to enter the Marshall vein for ablation treatment. However, the bending angle of the distal end of the medical intervention catheter is not adjustable, which has certain requirements for the opening position and running angle of the Marshall vein of the patient, and it is difficult to cover various situations with one bending type. SUMMARY

[0005] Therefore, it is necessary to provide a medical intervention catheter and a processing method thereof aiming at the problem that the bending angle of the distal end of the existing medical intervention catheter is not adjustable.

[0006] The medical intervention catheter provided by the application comprises a catheter body and a shaping member, the distal end of the catheter body is provided with an electrode member, the distal end of the shaping member has a first shape and a second shape, the distal end of the shaping member can extend into the catheter body in the first shape, when the distal end of the shaping member reaches the distal end of the catheter body, the distal end of the shaping member is configured in the second shape so that the distal end of the catheter body is also in the second shape, wherein the bending angle of the distal end of the catheter body in the second shape is greater than the bending angle of the distal end of the catheter body in the first shape.

[0007] The distal end of the shaping member of the medical intervention catheter can extend into the catheter body and adjust the shape of the distal end of the catheter body by adjusting the shape of the distal end of the shaping member when reaching the distal end of the catheter body. It can be seen that the shaping member and the catheter body are relatively independent before the distal end of the shaping member reaches the distal end of the catheter body. A plurality of shaping members with different specifications of the distal end shape can be prepared in advance before the catheter body is delivered. Then, the appropriate shaping member can be selected according to the bending degree (i.e. the shape feature) of the blood vessel (such as Marshall vein) where the target ablation position is located. The distal end of the appropriate shaping member can be configured in the second shape so that the distal end of the catheter body is also in the second shape. In the second shape, the distal end of the catheter body is smoothly sent to the target ablation position and ablation is performed by using the electrode member.

[0008] In summary, the medical intervention catheter can select the appropriate shaping member according to the shape feature of the blood vessel (such as Marshall vein) where the target ablation position is located, so as to correspondingly adjust the bending angle of the distal end of the catheter body by using the shaping member. The requirement of Marshall vein with different opening positions and running angles can be met, and the smooth positioning of the catheter body can be ensured.

[0009] In one embodiment, the number of the shaping members is multiple, and the bending angles of the distal ends of the shaping members in the second shape are different.

[0010] In one embodiment, the shaping member is made of shape memory material, and the original shape of the distal end of the shaping member is the second shape.

[0011] In one embodiment, the diameters of the proximal end and the middle part of the shaping member are greater than the diameter of the distal end of the shaping member, and / or the diameter of the distal end of the shaping member gradually decreases along the direction close to the distal end of the catheter body.

[0012] In one embodiment, the distal end of the shaping member is provided with a protective part, and the outer surface of the protective part is smooth.

[0013] In one of the embodiments, the medical intervention catheter further comprises an inner sleeve arranged in the catheter body, a lumen of the inner sleeve is for the profiled member to pass through, an outer wall of the inner sleeve is formed with an electrically conductive layer, the electrically conductive layer is distributed along an axial direction of the inner sleeve, the electrode member is provided with an electrically conductive part, and the electrically conductive part is in electrically conductive contact with the electrically conductive layer through the catheter body.

[0014] In one of the embodiments, the outer wall of the inner sleeve has alternatingly distributed electrically conductive regions and non-electrically conductive regions in a circumferential direction, the electrically conductive regions are provided with the electrically conductive layer, and the non-electrically conductive regions are capable of being radially extruded until being tightly fitted with the inner wall of the catheter body.

[0015] In one of the embodiments, the number of the electrode members is multiple, the electrode members are annular and are distributed along an axial direction of the catheter body, the number of the electrically conductive layers is multiple, the electrically conductive layers are in electrically conductive contact with the electrically conductive parts on the corresponding electrode members, and the electrically conductive layers are distributed along a circumferential direction of the inner sleeve.

[0016] In one of the embodiments, a ratio of an inner diameter of the inner sleeve to a maximum outer diameter of the profiled member is 1:(0.85-0.95).

[0017] In one of the embodiments, the medical intervention catheter further comprises a handle arranged on a proximal end of the catheter body, the handle is provided with a profiled channel in communication with the lumen of the inner sleeve, and the profiled channel is for the distal end of the profiled member to pass through.

[0018] The application further provides a preparation method of the medical intervention catheter as described in any one of the above, the preparation method comprising:

[0019] providing a catheter body, an electrode member, an inner sleeve and multiple profiled members, wherein an electrically conductive part is arranged on an inner wall of the electrode member, and a bending angle of a distal end of each profiled member in a second form is different;

[0020] forming an electrically conductive layer on an outer wall of the inner sleeve along an axial direction, and punching a hole on a distal end side wall of the catheter body;

[0021] arranging the electrode member on an outer portion of the catheter body and making the electrically conductive part on the electrode member extend into the catheter body from the hole on the distal end side wall of the catheter body;

[0022] arranging the inner sleeve in the catheter body and making the electrically conductive layer on the inner sleeve in electrically conductive contact with the electrically conductive part, and radially extruding the inner sleeve until the inner sleeve is tightly fitted with the catheter body.

[0023] In one embodiment, the step of forming a conductive layer axially on the outer wall of the inner sleeve includes: coating a conductive material axially on the outer wall of the inner sleeve to form a plurality of conductive layers, the plurality of conductive layers being spaced apart circumferentially along the inner sleeve; and

[0024] The step of drilling holes in the distal sidewall of the catheter body includes: opening a plurality of holes spaced apart along the circumferential and axial directions of the catheter body in the distal sidewall of the catheter body;

[0025] The number of electrode components, conductive parts, and conductive layers are all multiple and are arranged in a one-to-one correspondence.

[0026] The medical interventional catheter manufacturing method provided in this embodiment offers a medical interventional catheter whose main body can be matched with any one of multiple distal shaping elements with different second morphologies. In use, the appropriate shaping element can be selected based on the curvature (i.e., course) of the blood vessel where the target ablation site is located (e.g., the Marshall vein). When the distal end of the matching shaping element is configured in the second morphology, the distal end of the catheter main body is also in the second morphology. In the second morphology, the distal end of the catheter main body is smoothly inserted to the target ablation site and ablated using electrodes. Furthermore, by forming a conductive layer on the outer wall of the inner cannula, the electrical signals collected and mapped by the electrodes can be transmitted to external devices using the cooperation between the conductive layer and the conductive part. This allows for the provision of a portion of the catheter main body's lumen for the shaping element without increasing the catheter main body size, enabling the medical interventional catheter to be applied to small blood vessels, such as the Marshall vein. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of a medical interventional catheter in which the distal end of the shaping element provided in some embodiments of this application extends into the distal end of the catheter body.

[0028] Figure 2 A schematic diagram showing the distal end of a medical interventional catheter being delivered to the Marshall vein, as provided in some embodiments of this application.

[0029] Figure 3 This is a partial structural diagram of the shaping component provided in some embodiments of this application in a second form.

[0030] Figure 4 for Figure 1 A cross-sectional view of one type of medical interventional catheter at point AA is provided.

[0031] Figure 5 for Figure 1 A cross-sectional view of another medical interventional catheter at the BB site is provided.

[0032] Figure 6 Partial perspective view of the inner sleeve according to some embodiments of the present application.

[0033] Figure 7 Transverse sectional view of the inner sleeve according to some embodiments of the present application.

[0034] Figure 8 Stress diagram of the inner sleeve according to some embodiments of the present application when being extruded.

[0035] In the drawings, the reference signs are explained as follows:

[0036] 10, medical intervention catheter; 100, catheter main body; 200, shaped member; 210, protection part; 300, electrode member; 310, conductive part; 320, wire; 400, inner sleeve; 410, conductive layer; 400a, conductive area; 400b, non-conductive area; 500, handle; 510, interface; A, Marshall vein; B, coronary sinus. DETAILED DESCRIPTION

[0037] In order to make the above objectives, features and advantages of the present application more clear and easily understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. In the following description, a lot of specific details are set forth in order to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, so the present application is not limited to the specific embodiments disclosed below.

[0038] In the description of the present application, it should be understood that if there are terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the device or member referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0039] In addition, the terms "first", "second", and the like, if any, are used herein for descriptive purposes only and should not be construed as indicating or implying relative importance or identifying the number of the indicated technical features. Thus, a feature limited to "first" or "second" can explicitly or implicitly include at least one of the features. In the description of the present application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0040] In the present application, unless otherwise explicitly specified and limited, if the terms "mounting", "connecting", "connecting", "fixing" and the like appear, these terms should be interpreted broadly. For example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two parts or the interaction relationship between two parts, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0041] In the present application, unless otherwise explicitly specified and limited, if the first feature is described as "on" or "under" the second feature, etc., it can mean that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature "above", "above" and "above" the second feature can be the first feature directly above or obliquely above the second feature, or only indicates that the first feature is higher than the second feature in horizontal height. The first feature "below", "below" and "below" the second feature can be the first feature directly below or obliquely below the second feature, or only indicates that the first feature is lower than the second feature in horizontal height.

[0042] It should be noted that if a part is referred to as "fixed to" or "provided on" another part, it can be directly on another part or there can be a middle part. If a part is considered to be "connected" to another part, it can be directly connected to another part or there can be a middle part. If present, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in the present application are only for illustrative purposes and do not represent the only implementation.

[0043] It should be noted that "distal" and "proximal" throughout the text are only for indicating relative positional relationship, the "distal" of a component refers to the end of the component that enters the patient's body first and / or is farther away from the operator during normal operation, while the "proximal" refers to the end that enters the patient's body later and / or is closer to the operator.

[0044] As Figure 1As shown, the embodiment provides a medical intervention catheter 10. The medical intervention catheter 10 can include a catheter body 100 and a shaped member 200, the distal end of the shaped member 200 having a first shape and a second shape, the distal end of the shaped member 200 being capable of extending into the catheter body 100 whose distal end is also in the first shape in the first shape (when the distal end of the shaped member 200 is constrained by external force), when the distal end of the shaped member 200 reaches the distal end of the catheter body 100, the distal end of the shaped member 200 can be configured into the second shape (when the distal end of the shaped member 200 is not constrained by any external force) so that the distal end of the catheter body 100 is also in the second shape, wherein the bending angle of the distal end of the catheter body 100 in the second shape is greater than the bending angle of the distal end of the catheter body 100 in the first shape.

[0045] It should be noted that, referring to Figure 2 , the bending angle of the distal end of the catheter body 100 is the included angle a between the distal end of the catheter body 100 and other parts of the catheter body 100 (i.e. the proximal end and the middle part of the catheter body 100), wherein the middle part of the catheter body 100 is the part between the proximal end and the distal end of the catheter body 100. Similarly, referring to Figure 3 , the bending angle of the distal end of the shaped member 200 is the included angle β between the distal end of the shaped member 200 and other parts of the shaped member 200 (i.e. the proximal end and the middle part of the shaped member 200), wherein the middle part of the shaped member 200 is the part between the proximal end and the distal end of the shaped member 200.

[0046] The above-mentioned medical intervention catheter 10 can be applied in various blood vessels, especially in rugged blood vessels with different anatomical shapes. The following describes the use process of the medical intervention catheter 10 in the Marshall vein A shown in Figure 2

[0047] ​When in use, a plurality of shaping members 200 can be provided, wherein the bending angle of the distal end of each shaping member 200 in the second configuration is different, for example, the bending angle can be 15°, 25°, 35°, etc. When the catheter body is delivered into the body, the opening position and the running angle a of the Marshall vein A are first determined, and the appropriate shaping member 200 is selected based on the running angle a of the Marshall vein A, for example, the shaping member 200 with a bending angle of the distal end in the second configuration greater than 30°; then, the distal end of the catheter body 100 is delivered to the proximal end of the coronary sinus B in the first configuration (for example, a straight configuration), and the distal end of the shaping member 200 is also inserted into the catheter body 100 in the first configuration; when the distal end of the shaping member 200 reaches the distal end of the catheter body 100, the distal end of the shaping member 200 is configured to the second configuration so that the distal end of the catheter body 100 is also in the second configuration, at this time, the bending angle of the distal end of the catheter body 100 is increased, and the distal end of the catheter body 100 can be smoothly sent into the Marshall vein A; finally, the distal end of the catheter body 100 is delivered into the Marshall vein A and the Marshall vein A is mapped and / or ablated by using the electrode member 300. It should be noted that the running angle of the Marshall vein A refers to the included angle between the Marshall vein A and the coronary sinus B.

[0048] The distal end of the shaping member 200 of the medical intervention catheter 10 provided by the embodiment can be inserted into the catheter body 100 and can adjust the configuration of the distal end of the catheter body 100 by adjusting the configuration of the distal end of the shaping member 200 when the distal end of the shaping member 200 reaches the distal end of the catheter body 100. It can be seen that the shaping member 200 and the catheter body 100 are relatively independent before the distal end of the shaping member 200 reaches the distal end of the catheter body 100. A plurality of shaping members 200 with different specifications of the distal end configuration can be prepared before the catheter body 100 is delivered. Then, the appropriate shaping member 200 can be selected according to the bending degree (i.e., the running feature) of the blood vessel (for example, the Marshall vein A) where the target ablation position is located. The distal end of the appropriate shaping member 200 can be configured to the second configuration so that the distal end of the catheter body 100 is also in the second configuration. In the second configuration, the distal end of the catheter body 100 is smoothly sent to the target ablation position and mapped and / or ablated by using the electrode member 300.

[0049] In summary, the medical intervention catheter 10 provided by the embodiment can select the appropriate shaping member 200 according to the running feature of the blood vessel (for example, the Marshall vein A) where the target ablation position is located, so as to correspondingly adjust the bending angle of the distal end of the catheter body 100 by using the shaping member 200. The requirement of the Marshall vein A with different opening positions and running angles can be met, and the smooth positioning of the catheter body 100 can be ensured.

[0050] In some embodiments of the present application, the number of the shaping members 200 is multiple, and the bending angles of the distal ends of the respective shaping members 200 in the second configuration are different. The appropriate shaping member 200 can be selected according to the bending degree (i.e., the shape feature) of the blood vessel in which the target ablation site (e.g., the Marshall vein A) is located, so as to ensure that the distal end of the catheter body 100 can be smoothly sent to the target ablation site. The bending angle of the distal end of the shaping member 200 in the second configuration can be 15°, 25°, 35°, etc.

[0051] In some embodiments of the present application, the proximal end port of the catheter body 100 is used for the distal end of the shaping member 200 to pass through, and the proximal end port of the catheter body 100 is closed. By closing the proximal end port of the catheter body 100, it can be ensured that the internal structure of the catheter body 100 does not contact the tissues in the patient's body.

[0052] In some embodiments of the present application, the material of the catheter body 100 can be a flexible material, such as PEBAX (polyether block polyamide) or other high polymer materials. The catheter body 100 made of such material has better flexibility, which facilitates the delivery of the catheter body 100 in rugged blood vessels.

[0053] In some embodiments of the present application, the shaping member 200 can be made of a shape memory material, such as a shape memory alloy material, which can be Nitinol or the like. The shaping member 200 made of such material can be heat treated during the forming process to have the ability to rebound to the original configuration after deformation. In order to realize the transformation of the distal end of the catheter body 100 and the shaping member 200 between the first configuration and the second configuration, the distal end of the catheter body 100 can be first delivered to the target area (e.g., the proximal end of the coronary sinus B) by using a guide sheath, which can be positioned by X-ray contrast or by using an electrode guide sheath with positioning function, and then the distal end of the shaping member 200 is inserted into the lumen of the catheter body 100 from the proximal end port of the catheter body 100; when the distal end of the shaping member 200 is delivered in the catheter body 100, the distal end of the shaping member 200 is configured to the first configuration due to the restraint of the guide sheath; when the distal end of the shaping member 200 reaches the distal end of the catheter body 100, the guide sheath is removed from the distal end of the catheter body 100, and since the shaping member 200 is released from the restraint of the guide sheath and the catheter body 100 is relatively soft, the distal end of the shaping member 200 rebounds to the original configuration (i.e., the second configuration) together with the distal end of the catheter body 100, thereby realizing the configuration of the catheter body 100 to the second configuration. As can be seen, the medical intervention catheter 10 of the present application utilizes the self-rebounding characteristics of the shaping member 200 to adjust the bending angle of the distal end of the catheter body 100 to realize the delivery of the catheter body 100 to the target position, without the need to use related guide instruments (such as a traction wire and a push button matched therewith), which can reduce the operation difficulty and the degree of dependence on the guide instruments during the delivery of the catheter body 100 to the target position.

[0054] In some embodiments of the present application, the diameter of the proximal end and the middle section of the shaping member 200 is larger than the diameter of the distal end of the shaping member 200. This can ensure the strength of the shaping member 200 and prevent the shaping member 200 from being bent during the pushing process.

[0055] In some embodiments of the present application, the diameter of the distal end of the shaping member 200 gradually decreases in the direction close to the distal end of the catheter body 100. The tapering of the distal end of the shaping member 200 facilitates the shaping of the distal end of the shaping member 200.

[0056] In some embodiments of the present application, referring to Figure 3 , the distal end of the shaping member 200 is provided with a protective portion 210. The protective portion 210 can prevent the distal end of the shaping member 200 from damaging the internal organs of the patient. Preferably, the outer surface of the protective portion 210 is smooth, for example Figure 3 spherical as shown. The material of the protective portion 210 can be the same as that of the shaping member 200, and the protective portion 210 can be integrally formed or welded on the distal end of the shaping member 200.

[0057] In some embodiments of the present application, referring to Figure 4 and Figure 5 , the medical intervention catheter 10 further comprises an inner sleeve 400 arranged in the catheter body 100, and the lumen of the inner sleeve 400 is used for the shaping member 200 to pass through. The inner sleeve 400 can prevent the shaping member 200 from contacting the catheter body 100, which can prevent the shaping member 200 from damaging the catheter body 100 during the sliding process in the catheter body 100, and can also prevent the shaping member 200 from electrically contacting the electrode member 300 on the catheter body 100, thereby avoiding the short circuit of the electrode member 300.

[0058] Based on the structure of the medical intervention catheter 10 described above, two ways of how the electrode member 300 transmits the collected and mapped electrical signals are given as follows:

[0059] The first way, referring to Figure 4 , the electrode member 300 is provided with a wire 320 for transmitting the electrical signals collected and mapped by the electrode member 300, and the wire 320 is arranged in the interlayer between the catheter body 100 and the inner sleeve 400. In this way, the structure of the medical intervention catheter 10 can be simplified, and the processing of the medical intervention catheter 10 is facilitated.

[0060] As for the number of wires 320, it is mainly related to the number of electrode members 300, for example, the number of wires 320 can be the same as the number of electrode members 300. Referring to Figure 4 , the plurality of wires 320 can be distributed along the circumference of the inner sleeve 400.

[0061] The second mode is as follows Figure 5 and Figure 6 The outer wall of the inner sleeve 400 can be formed with an electrically conductive layer 410 distributed along the axial direction of the inner sleeve 400. The electrode member 300 is provided with an electrically conductive part 310 in electrically conductive contact with the electrically conductive layer 410 through the catheter body 100. By forming the electrically conductive layer 410 on the outer wall of the inner sleeve 400, the electrically conductive layer 410 and the electrically conductive part 310 can be used to transmit the electrical signals collected and mapped by the electrode member 300 to an external device for analysis, visualization, and other processing. This mode can allow a portion of the lumen of the catheter body 100 to be given to the shaped member 200 without increasing the size of the catheter body 100, so that the medical intervention catheter 10 can be applied to small blood vessels, such as the Marshall vein A.

[0062] The ratio of the inner diameter of the inner sleeve 400 to the maximum outer diameter of the shaped member 200 can be 1:(0.85-0.95), such as 1:0.85, 1:0.86, 1:0.87, 1:0.88, 1:0.89, 1:0.90, 1:0.91, 1:0.92, 1:0.93, 1:0.94, 1:0.95, etc. In this way, the shaped member 200 can be prevented from being curled up in the lumen of the inner sleeve 400 and not properly shaped, ensuring that the shaped member 200 can freely slide in the inner sleeve 400.

[0063] The distal end port of the inner sleeve 400 can extend to and be connected to the distal end port of the catheter body 100, and both the distal end port of the inner sleeve 400 and the distal end port of the catheter body 100 are closed structures. In this way, the lumen of the inner sleeve 400 can be isolated from the patient's internal tissues. Of course, the distal end port of the inner sleeve 400 can also be independent of the distal end port of the catheter body 100 and directly provided as a closed structure.

[0064] The electrically conductive layer 410 can be coated on the outer wall of the inner sleeve 400 using a low-pressure cold spraying process or deposited on the outer wall of the inner sleeve 400 using a metal deposition method. Considering the risk of introducing harmful components in the metal deposition process, the electrically conductive layer 410 can be preferentially provided on the outer wall of the inner sleeve 400 using a low-pressure cold spraying process.

[0065] The electrically conductive layer 410 can be a metal material, such as pure copper. It should be noted that the copper content of the pure copper herein is greater than 99%.

[0066] The material of the conductive part 310 can be the same as that of the electrode member 300, and the conductive part 310 can be arranged on the electrode member 300 by welding, buckling, one-piece forming, or the like. The material of the electrode member 300 can be, but is not limited to, platinum-iridium, stainless steel, silver, or other metal conductive materials.

[0067] The conductive part 310 can be a rectangular, circular, or other shaped conductive sheet, and the shape of the conductive part 310 is not specifically limited in the present application, as long as it can effectively conduct electricity with the conductive layer 410.

[0068] Referring to Figure 1 , the number of electrode members 300 can be multiple, and the electrode members 300 are annular and spaced along the axial direction of the catheter body 100; referring to Figure 6 , the number of conductive layers 410 is multiple, and the conductive layers 410 are in conductive contact with the conductive parts 310 on the corresponding electrode members 300, and the conductive layers 410 are spaced along the circumferential direction of the inner sleeve 400. Considering that the outer diameter of the catheter body 100 can be as small as 1 mm, the annular electrode member 300 is easier to process than the sheet electrode member, and the conductive part 310 is preferably an arc-shaped sheet member or a block-shaped member with at least one outer surface consistent with the curvature of the electrode member 300; in addition, the multiple conductive parts 310 are spaced along the circumferential and axial directions of the inner sleeve 400, which can not only avoid conductive contact between the conductive parts 410, but also optimize the internal structure of the catheter body 100, and further reduce the outer diameter of the catheter body 100. It should be noted that, in order to clearly show the distribution of the conductive layer 410 on the inner sleeve 400, Figure 6 The inner sleeve 400 is processed to be transparent.

[0069] The number of conductive layers 410 is mainly related to the number of electrode members 300, for example, the number of conductive layers 410 can be the same as the number of electrode members 300. For example, Figure 1 The medical intervention catheter 10 shown is provided with eight annular electrode members 300; correspondingly, Figure 6 The outer wall of the inner sleeve 400 shown is uniformly and circumferentially provided with eight conductive layers 410.

[0070] The annular electrode member 300 can be assembled onto the catheter body 100 by nesting, pressing, or the like. During processing, a hole can be first punched on the distal end side wall of the catheter body 100; then the electrode member 300 provided with the conductive part 310 is nested on the catheter body 100, and the nesting of the electrode member 300 will cause the catheter body 100 to deform slightly, so that the conductive part 310 is clamped into the hole on the distal end side wall of the catheter body 100. It should be noted that the shape of the hole on the distal end side wall of the catheter body 100 can match the shape of the conductive part 310, and can be circular, rectangular, or other shapes.

[0071] Referring toFigure 7 The outer wall of the inner sleeve 400 has alternating conductive regions 400a and non-conductive regions 400b distributed circumferentially. The conductive regions 400a are provided with a conductive layer 410, and the non-conductive regions 400b can be radially compressed until they are tightly fitted to the inner wall of the catheter body 100. By radially compressing the non-conductive regions 400b of the inner sleeve 400, the connection strength between the inner sleeve 400 and the catheter body 100 can be improved, and more of the lumen of the catheter body 100 can be freed up from the given formwork 200. The direction of force on the inner sleeve 400 during compression is as follows: Figure 8 As shown. It should be noted that, Figure 8 The thick black straight arrow in the middle represents the direction of force on the inner sleeve 400 when it is being squeezed.

[0072] The inner sleeve 400 can be connected to the conduit body 100 by means of adhesive bonding or other methods.

[0073] The inner sleeve 400 can be made of an elastic insulating material, such as PU (polyurethane) or PET (polyethylene terephthalate). This type of inner sleeve 400 is more prone to deformation under pressure.

[0074] In some embodiments of this application, such as Figure 1 As shown, the medical interventional catheter 10 also includes a handle 500 disposed on the proximal end of the catheter body 100. The handle 500 has a shaping channel (not shown in the figure) communicating with the lumen of the inner sheath 400. The shaping channel is used for the distal end of the shaping element 200 to pass through. The handle 500 is designed to facilitate the operation of the medical interventional catheter 10.

[0075] The aforementioned handle 500 is a hollow shell structure formed by injection molding or other methods, and can be fixed to the outside of the conduit body 100 by welding, bonding, or other methods. This hollow shell structure has proximal and distal ports, both of which communicate with the shaping channel. See [link / reference] Figure 1 The handle 500 may have a connector 510 at its proximal port for the distal end of the shaping member 200 to pass through.

[0076] The inner shell of the handle 500 may be provided with a delivery tube (not shown in the attached drawings), and the lumen of the delivery tube forms a shaped channel. The delivery tube may extend from the proximal port of the handle 500 to the distal port, or it may extend from the proximal port of the handle 500 to the middle of the handle 500.

[0077] The aforementioned handle 500 also contains a circuit board (not shown in the attached drawings), which surrounds the shaping channel and is electrically connected to the conductive part 310 on the inner sleeve 400 via the output interface 510. The proximal port of the inner sleeve 400 can extend to the proximal port of the catheter body 100.

[0078] In some other embodiments of the present application, a method for using the medical intervention catheter 10 is also provided, and the method comprises:

[0079] In step S100, a plurality of shaping members 200 are provided, and a suitable shaping member 200 is selected based on the bending angle of the blood vessel where the target ablation position is located, wherein the bending angle of the distal end of each shaping member 200 in the second shape is different.

[0080] In step S200, the distal end of the catheter body 100 is delivered into the target region in the first shape, and then the distal end of the shaping member 200 is also extended into the catheter body 100 in the first shape, wherein the target region is adjacent to the target ablation position.

[0081] In step S300, when the distal end of the shaping member 200 reaches the distal end of the catheter body 100, the distal end of the shaping member 200 is configured to the second shape so that the distal end of the catheter body 100 is also in the second shape, and then the distal end of the catheter body 100 is delivered to the target ablation position and the target ablation position is mapped and / or ablated by the electrode member 300.

[0082] The method for using the medical intervention catheter 10 provided in this embodiment can prepare a plurality of shaping members 200 in advance before delivering the catheter body 100, and then a suitable shaping member 200 can be selected according to the bending degree (i.e., the shape feature) of the blood vessel (e.g., Marshall vein A) where the target ablation position is located. The distal end of the suitable shaping member 200 can be configured to the second shape so that the distal end of the catheter body 100 is also in the second shape. In the second shape, the distal end of the catheter body 100 can be smoothly delivered to the target ablation position and mapped and / or ablated by the electrode member 300.

[0083] In summary, the method for using the medical intervention catheter 10 provided in this embodiment can select a suitable shaping member 200 according to the shape feature of the blood vessel (e.g., Marshall vein A) where the target ablation position is located, so as to correspondingly adjust the bending angle of the distal end of the catheter body 100 by the shaping member 200, so as to meet the requirements of Marshall vein A with different opening positions and running angles, and thus the catheter body 100 can be smoothly positioned.

[0084] In step S100, the shaping member 200 can be made of a shape memory material, such as a shape memory alloy material, which can be a material such as Nitinol. The original shape of the distal end of the shaping member 200 is the second shape.

[0085] In step S200, the distal end of the catheter body 100 is delivered into a target region in a first configuration by using a guide sheath. When the use method is applied in the field of cardiac electrophysiology, specifically, the operator can first enter the inferior vena cava from the femoral vein approach of the patient by using the guide sheath, and then reach the coronary sinus B port of the right atrium to establish a channel for the medical intervention catheter 10 and perform angiography to find the Marshall vein A; and then deliver the distal end of the catheter body 100 along the guide sheath to the coronary sinus B.

[0086] In step S300, when the distal end of the shaping member 200 reaches the distal end of the catheter body 100, the distal end of the catheter body 100 is pushed out of the guide sheath so that the distal end of the shaping member 200 rebounds to the second configuration. The use method of the present application can adjust the bending angle of the distal end of the catheter body 100 by using the rebounding property of the shaping member 200 itself to achieve the delivery of the catheter body 100 in place, without using related guide instruments (such as a traction wire and a push button matched therewith), which can reduce the operation difficulty and the degree of dependence on guide instruments during the process of the catheter body 100 in place.

[0087] In some other embodiments of the present application, a preparation method of the medical intervention catheter 10 is also provided, which comprises:

[0088] Step S100, providing the catheter body 100, the electrode member 300, the inner sleeve 400 and a plurality of shaping members 200, wherein the inner wall of the electrode member 300 is provided with the conductive part 310, and the bending angle of the distal end of each shaping member 200 in the second configuration is different;

[0089] Step S200, forming the conductive layer 410 on the outer wall of the inner sleeve 400 in the axial direction, and punching a hole on the distal end side wall of the catheter body 100;

[0090] Step S300, arranging the electrode member 300 on the outside of the catheter body 100 and making the conductive part 310 on the electrode member 300 extend into the catheter body 100 from the hole on the distal end side wall of the catheter body 100;

[0091] Step S400, arranging the inner sleeve 400 in the catheter body 100 and making the conductive layer 410 on the inner sleeve 400 in conductive contact with the conductive part 310, and radially extruding the inner sleeve 400 until the inner sleeve 400 is tightly attached to the catheter body 100.

[0092] The medical intervention catheter 10 provided by the embodiment provides a medical intervention catheter 10, wherein the catheter body 100 can be matched with any one of the plurality of distal second-shaped shaping members 200, so that in use, the shaping member 200 can be selected according to the bending degree (i.e., the shape feature) of the blood vessel (e.g., Marshall vein A) where the target ablation position is located, the distal end of the matched shaping member 200 can be configured in the second shape so that the distal end of the catheter body 100 is also in the second shape, in the second shape, the distal end of the catheter body 100 is smoothly sent to the target ablation position and ablation is performed by using the electrode member 300; in addition, by forming the conductive layer 410 on the outer wall of the inner sleeve 400, the collected and mapped electrical signals of the electrode member 300 can be transmitted to the external device by using the cooperation of the conductive layer 410 and the conductive part 310, and the part of the lumen of the catheter body 100 can be left to the shaping member 200 without increasing the size of the catheter body 100, so that the medical intervention catheter 10 can be applied to small blood vessels, such as Marshall vein A.

[0093] In step S200, the conductive material can be coated on the outer wall of the inner sleeve 400 in the axial direction to form a plurality of conductive layers 410, and the plurality of conductive layers 410 are arranged along the circumference of the inner sleeve 400. Specifically, the conductive layer 410 can be coated on the outer wall of the inner sleeve 400 by using the process of low-pressure cold spraying. Of course, the conductive layer 410 can also be arranged on the outer wall of the inner sleeve 400 by using metal deposition and the like. Considering that the process of metal deposition has the risk of bringing harmful ingredients, the process of low-pressure cold spraying can be preferred to arrange the conductive layer 410 on the outer wall of the inner sleeve 400.

[0094] In step S200, a plurality of holes can be formed on the distal end side wall of the catheter body 100, and the plurality of holes are arranged along the circumference and the axial direction of the catheter body 100; wherein the number of the electrode member 300, the conductive part 310 and the conductive layer 410 is plural and arranged one by one.

[0095] The technical features of the above-mentioned embodiments can be combined arbitrarily, in order to make the description simple, not all possible combinations of the technical features in the above-mentioned embodiments are described, however, as long as the combinations of the technical features do not exist contradictory, it should be considered as the scope of the present application.

[0096] The above embodiments only express several implementation ways of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation to the patent scope of the application. It should be pointed out that for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, which all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A medical interventional catheter, characterized in that, The device includes a catheter body (100) and a shaping member (200). An electrode (300) is provided on the distal end of the catheter body (100). The distal end of the shaping member (200) has a first shape and a second shape. The distal end of the shaping member (200) can extend into the catheter body (100) in the first shape, where its distal end is also in the first shape. When the distal end of the shaping member (200) reaches the distal end of the catheter body (100), the distal end of the shaping member (200) is configured in the second shape so that the distal end of the catheter body (100) is also in the second shape. The bending angle of the distal end of the catheter body (100) in the second shape is greater than the bending angle of the distal end of the catheter body (100) in the first shape. The medical interventional catheter (10) further includes an inner sheath (400) disposed within the catheter body (100). The lumen of the inner sheath (400) is used for the insertion of the shaping member (200). A conductive layer (410) is formed on the outer wall of the inner sheath (400). The conductive layer (410) is distributed along the axial direction of the inner sheath (400). A conductive part (310) is disposed on the electrode member (300). The conductive part (310) passes through the catheter body (100) radially and makes conductive contact with the conductive layer (410). The outer wall of the inner sleeve (400) has alternating conductive regions (400a) and non-conductive regions (400b) distributed circumferentially. The conductive regions (400a) are provided with the conductive layer (410), and the non-conductive regions (400b) can be radially compressed until they are tightly fitted to the inner wall of the conduit body (100). The number of electrode elements (300) is multiple. The electrode elements (300) are annular and spaced apart along the axial direction of the conduit body (100). The number of conductive layers (410) is multiple. The conductive layers (410) are in conductive contact with the conductive portions (310) on the corresponding electrode elements (300). The conductive layers (410) are spaced apart along the circumferential direction of the inner sleeve (400).

2. The medical interventional catheter according to claim 1, characterized in that, The number of shaping parts (200) is multiple, and the bending angle of the distal end of each shaping part (200) is different in the second form.

3. The medical interventional catheter according to claim 1, characterized in that, The shaping component (200) is made of shape memory material, and the original shape of the far end of the shaping component (200) is the second shape.

4. The medical interventional catheter according to claim 1, characterized in that, The diameter of the proximal and middle portions of the shaping member (200) is greater than the diameter of the distal portion of the shaping member (200), and / or the diameter of the distal portion of the shaping member (200) gradually decreases along the direction closer to the distal portion of the catheter body (100).

5. The medical interventional catheter according to claim 1, characterized in that, The distal end of the shaping part (200) is provided with a protective part (210), and the outer surface of the protective part (210) is rounded.

6. The medical interventional catheter according to any one of claims 1 to 5, characterized in that, The ratio of the inner diameter of the inner sleeve (400) to the maximum outer diameter of the shaping part (200) is 1:(0.85~0.95).

7. The medical interventional catheter according to any one of claims 1 to 5, characterized in that, The medical interventional catheter (10) also includes a handle (500) disposed on the proximal end of the catheter body (100). The handle (500) has a shaping channel communicating with the lumen of the inner cannula (400). The shaping channel is used for the distal and middle parts of the shaping component (200) to pass through.

8. A method for preparing a medical interventional catheter as described in any one of claims 1 to 7, characterized in that, The preparation method includes: The device provides a catheter body (100), an electrode (300), an inner sleeve (400), and a plurality of shaping parts (200), wherein the inner wall of the electrode (300) is provided with a conductive part (310), and the distal end of each shaping part (200) has a different bending angle in the second form. A conductive layer (410) is formed axially on the outer wall of the inner sleeve (400), and a hole is punched on the distal side wall of the conduit body (100). The electrode (300) is disposed on the outside of the catheter body (100) and the conductive part (310) on the electrode (300) extends into the catheter body (100) from a hole on the distal side wall of the catheter body (100); The inner sleeve (400) is placed inside the catheter body (100) and the conductive layer (410) on the inner sleeve (400) is made into conductive contact with the conductive part (310). The inner sleeve (400) is radially squeezed until the inner sleeve (400) is tightly attached to the catheter body (100).

9. The method for preparing a medical interventional catheter according to claim 8, characterized in that, The step of forming a conductive layer (410) axially on the outer wall of the inner sleeve (400) includes: coating a conductive material axially on the outer wall of the inner sleeve (400) to form a plurality of the conductive layers (410), the plurality of the conductive layers (410) being spaced apart circumferentially along the inner sleeve (400); and The step of drilling holes in the distal sidewall of the catheter body (100) includes: opening a plurality of holes in the distal sidewall of the catheter body (100) spaced apart along the circumferential and axial directions of the catheter body (100); The number of electrode components (300), conductive parts (310) and conductive layers (410) are all multiple and are respectively arranged in a one-to-one correspondence.

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