Interventional catheters and blood pumping devices

Abstract

This application relates to the field of medical devices and discloses an interventional catheter and a blood pumping device. The interventional catheter includes a pumping tube and a detection assembly. The pumping tube comprises a distal segment, a middle segment, and a proximal segment arranged sequentially along the axial direction. The distal segment includes a distal pumping window, and the proximal segment includes a proximal pumping window. Both the distal and proximal pumping windows communicate with the lumen of the pumping tube. The middle segment is bendable. Driven by a power assembly, the pumping tube pumps fluid between the distal and proximal pumping windows. The detection assembly includes a distal detection element and a proximal detection element. The detection portion of the proximal detection element is recessed into the smooth transition outer surface of the proximal segment. This improves the positional accuracy of the interventional catheter during operation.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and in particular relates to an interventional catheter and a blood pumping device. Background Technology

[0002] Interventional catheters are tubular medical devices inserted into the body through natural cavities (such as blood vessels, the digestive tract, and the respiratory tract) or percutaneously for disease diagnosis, treatment, or to assist in the operation of other instruments. Their design typically includes specific diameters, lengths, flexibility, and functional structures (such as side holes, marking bands, and special tips), allowing for precise delivery to target sites within the body under the guidance of medical imaging equipment (such as DSA, CT, and ultrasound). Interventional catheters are widely used in various fields, including vascular intervention, non-vascular intervention, cardiac intervention, and neurointervention.

[0003] Taking ventricular assist devices (VADs) in the field of interventional cardiology as an example, interventional catheters are mainly used to assist or replace the heart's pumping function. They establish blood pathways through the catheter to achieve blood drainage, pumping, or circulatory support. Therefore, the positioning accuracy of each part of the interventional catheter within the heart is crucial, and improving this positioning accuracy is one of the important research topics currently requiring investigation. Utility Model Content

[0004] This application provides an interventional catheter and a blood pumping device, which can improve the positional accuracy of the interventional catheter in the working state.

[0005] On one hand, embodiments of this application provide an interventional catheter, including a pumping tube and a detection assembly. The pumping tube includes a distal segment, an intermediate segment, and a proximal segment arranged sequentially from distal to proximal along an axial direction. The distal segment includes a distal pumping window, and the proximal segment includes a proximal pumping window. The distal and proximal pumping windows communicate with the lumen of the pumping tube. The intermediate segment is bendable. Driven by a power assembly, the pumping tube pumps fluid between the distal and proximal pumping windows. The detection assembly includes a distal detection element and a proximal detection element. The detection portion of the proximal detection element is recessed on the outer peripheral surface of the proximal segment, and the detection portion of the distal detection element is recessed on the outer peripheral surface of the distal segment.

[0006] In some embodiments, the pumping tube includes a distal pumping housing, a spring tube, and a proximal pumping assembly connected sequentially along the axial direction. The spring tube is bendable and includes a first tube segment, an intermediate tube segment, and a second tube segment sequentially along the axial direction. The distal pumping window is opened in the distal pumping housing, and the proximal pumping window is opened in the proximal pumping assembly. The distal pumping housing and the first tube segment form the distal tube segment, and the proximal pumping assembly and the second tube segment form the proximal tube segment.

[0007] In some embodiments, the detection portion of the distal detection element is disposed on the distal pumping housing, and the detection portion of the proximal detection element is disposed on the proximal pumping assembly.

[0008] In some embodiments, the proximal pumping assembly includes a proximal pumping housing and a casing, the proximal pumping window is opened in the proximal pumping housing, the two ends of the proximal pumping housing are respectively connected to the spring tube and the casing, and the interventional catheter further includes a power assembly; the power assembly includes an impeller and a first motor body, the drive end of the first motor body is connected to the impeller, the impeller is placed inside the proximal pumping housing, and the first motor body is placed inside the casing; or, the power assembly includes an impeller, a transmission structure and a second motor body, the drive end of the second motor body is connected to the input end of the transmission structure, the output end of the transmission structure is connected to the impeller, the impeller is placed inside the proximal pumping housing, and a portion of the transmission structure is placed inside the casing.

[0009] In some embodiments, the detection portion of the proximal detection element is disposed on the proximal pump housing.

[0010] In some embodiments, the proximal pumping housing includes a main body and a plurality of extensions, the main body and the extensions being arranged sequentially along the axial direction, the plurality of extensions being spaced apart along the circumferential direction, a proximal pumping window being formed between two adjacent extensions, and the extensions being connected to the housing. The housing has two through holes along the axial direction, the two through holes being respectively arranged opposite to the two extensions, and the distal detection element and the proximal detection element extending into the housing through the through holes.

[0011] In some embodiments, the proximal pumping housing includes a main body and a plurality of extensions, the main body and the extensions being arranged sequentially along the axial direction, the plurality of extensions being spaced apart along the circumferential direction, a proximal pumping window being formed between two adjacent extensions, and the extensions being connected to the housing; the housing has two through holes, the two through holes being located between the extensions of two adjacent extensions along the axial direction, the spacing between the two through holes having a tendency to gradually decrease from the distal end to the proximal end, and the distal detection element and the proximal detection element extending into the housing through the through holes respectively.

[0012] In some embodiments, the housing includes a housing body and a second end portion sequentially from the distal end to the proximal end along the axial direction. The proximal end pump housing is connected to the outer peripheral surface of the housing body. The outer peripheral surface of the second end portion has a tendency to taper from the distal end to the proximal end. The detection portion of the proximal end detection element is disposed at the second end portion.

[0013] In some embodiments, the distal detection element includes a first detection portion and a first signal line connected together. The first detection portion is mounted on the outer peripheral surface of the distal pump housing. A portion of the first signal line is accommodated within the wall of the spring tube, and another portion extends axially and is disposed on the proximal pump assembly. The spring tube includes a first smooth transition inner surface and a first smooth transition outer surface disposed opposite each other along its own thickness direction. The centerline of the first smooth transition inner surface is eccentrically disposed with respect to the centerline of the first smooth transition outer surface. An axially extending mounting channel is provided at a first predetermined position between the first smooth transition inner surface and the first smooth transition outer surface. Within the same cross-section of the spring tube, the wall thickness at the first predetermined position is greater than the wall thickness at at least a portion of the other positions. The first signal line is accommodated within the mounting channel.

[0014] In some embodiments, along the radial direction of the interventional catheter, the spring tube includes a first polymer layer, a spring layer, and a second polymer layer stacked from the inside out along its own thickness direction. The center lines of the first polymer layer and the spring layer are concentrically arranged, and the side of the first polymer layer facing away from the spring layer forms a first smooth transition inner surface. The second polymer layer includes a second smooth transition inner surface and a first smooth transition outer surface. The center line of the second smooth transition inner surface is eccentrically arranged with respect to the center line of the first smooth transition outer surface. The center line of the second smooth transition inner surface is concentrically arranged with respect to the center line of the first polymer layer. The installation channel is located at a second predetermined position between the second smooth transition inner surface and the first smooth transition outer surface. Within the same cross-section of the second polymer layer, the wall thickness at the second predetermined position is at least greater than the wall thickness at at least a portion of the other positions.

[0015] In some embodiments, a first groove is formed on the outer peripheral surface of the proximal pumping assembly. The first groove extends along the axial direction and is located along the circumference of the interventional catheter. The first groove is located between two adjacent proximal pumping windows, and another portion of the first signal line is accommodated in the first groove.

[0016] In some embodiments, the proximal pumping housing includes a main body and a plurality of extensions, the main body and the extensions being arranged sequentially along the axial direction, the plurality of extensions being spaced apart along the circumferential direction, a proximal pumping window being formed between two adjacent extensions, and the extensions being connected to the housing; the proximal detection element includes a second detection part and a second signal line, the second detection part being mounted on the main body, the second signal line extending to the housing through one of the extensions, and the first signal line extending to the housing through the other extension.

[0017] In some embodiments, the proximal detection device includes a mounting base and a detection device body, the detection device body being mounted within the mounting base, and the mounting base being connected to the pumping tube; the mounting base includes a mounting wall and a mounting cavity enclosed by the mounting wall, the distal end of the mounting cavity being sealed, the mounting wall having a drainage channel extending radially through the interventional catheter, the drainage channel communicating with the mounting cavity, and the detection end of the detection device body being located on the side of the drainage channel opposite to the sealing of the mounting cavity.

[0018] In some embodiments, the mounting base includes a base, a sleeve, and a sealing element. The sleeve is connected to the pumping pipe through the base, and the sealing element seals one end of the sleeve. Along the radial direction, a recess is provided on the side of the base facing away from the pumping pipe, and the sleeve is connected to the recess. The base has a first hole through it. The sleeve includes a pipe wall that encloses to form the mounting cavity. The sleeve has a second hole and a third hole that communicate with the mounting cavity, respectively, along the radial direction. The second hole is opposite to the first hole, and the second hole and the third hole form the drainage channel.

[0019] On the other hand, embodiments of this application also provide a blood pumping device, including the above-mentioned interventional catheter and sheath, wherein the sheath is connected to the proximal end of the interventional catheter.

[0020] The interventional catheter and blood pumping device of this application embodiment have a detection part of the proximal detection element recessed on the outer peripheral surface of the proximal tube segment with a proximal pumping window, used to detect the fluid parameters flowing through the detection part of the proximal detection element. The detection part of the distal detection element is recessed on the outer peripheral surface of the distal tube segment with a distal pumping window, used to detect the fluid parameters flowing through the detection part of the distal detection element. The positions of the proximal pumping window and the distal pumping window are accurately located, improving the positional accuracy of each part of the interventional catheter in the working state. Attached Figure Description

[0021] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure of the interventional catheter according to some embodiments of this application;

[0023] Figure 2 Show Figure 1 Schematic diagram of the structure of the Bourdon tube;

[0024] Figure 3 Show Figure 2The three forms of cross-sectional views: (a), (b), and (c);

[0025] Figure 4 Show Figure 1 A schematic diagram of a mid-to-near end pumping assembly;

[0026] Figure 5 Show Figure 4 A schematic diagram of the longitudinal section;

[0027] Figure 6 Show Figure 1 Another structural schematic diagram of the mid-to-near end pumping assembly;

[0028] Figure 7 Show Figure 1 Schematic diagram of the structure of the mid-to-remote pump casing;

[0029] Figure 8 Show Figure 4 Schematic diagram of the near-end pump casing;

[0030] Figure 9 Show Figure 8 Cross-sectional view of the main body;

[0031] Figure 10 Show Figure 1 Another structural schematic diagram of the mid-to-near end pumping assembly;

[0032] Figure 11 This is a schematic diagram of the proximal detection element in the interventional catheter of some embodiments of this application;

[0033] Figure 12 Show Figure 11 A longitudinal section view;

[0034] Figure 13 This is an exploded view of the proximal detection element in an interventional catheter according to some embodiments of this application.

[0035] Figure label:

[0036] 100. Import tube;

[0037] 200. Pumping pipe; 201. Distal pipe section; 202. Intermediate pipe section; 203. Proximal pipe section; 210. Distal pumping housing; 211. Distal pumping window; 212. Second groove; 220. Spring tube; 221. First pipe section; 223. Second pipe section; 225. First polymer layer; 226. Spring layer; 227. Second polymer layer; 228. First smooth transition inner surface; 229. First smooth transition outer surface; 230. Proximal pumping assembly; 231. Proximal pumping window; 232. Housing; 232a. First end; 232b. Housing body; 232c. Second end; 233. Impeller; 234. Proximal pumping housing; 235. Main body; 236. Extension; 237. First groove; 238. Third groove; 239. Through hole;

[0038] 300. Detection component; 310. Remote detection component; 320. Proximal detection component; 301. Base; 302. Sleeve; 303. Sealing component; 304. First hole; 305. Second hole; 306. Third hole; 307. Vent hole; 308. Recess; 312. First signal line; 321. Second detection section; 322. Second signal line; 323. Mounting base; 324. Detection component body; 325. Drainage channel; 326. Mounting cavity;

[0039] 400, sheath; X, axial; Y, radial; Z, circumferential. Detailed Implementation

[0040] The embodiments of the technical solution of this application will now be described in detail with reference to the accompanying drawings. These embodiments are only used to more clearly illustrate the technical solution of this application and are therefore merely examples, and should not be used to limit the scope of protection of this application.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms “comprising” and “having”, and any variations thereof, in the specification, claims, and foregoing description of the drawings are intended to cover non-exclusive inclusion.

[0042] In the description of the embodiments of this application, technical terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly defined.

[0043] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0044] In the description of the embodiments in this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0045] In the description of the embodiments of this application, the term "multiple" refers to two or more (including two), similarly, "multiple sets" refers to two or more (including two sets), and "multiple pieces" refers to two or more (including two pieces).

[0046] In the description of the embodiments of this application, the technical terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0047] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0048] Interventional catheters are tubular medical devices inserted into the body through natural cavities (such as blood vessels, the digestive tract, and the respiratory tract) or percutaneously for disease diagnosis, treatment, or to assist in the operation of other instruments. Their design typically includes specific diameters, lengths, flexibility, and functional structures (such as side holes, marking bands, and special tips), allowing for precise delivery to target sites within the body under the guidance of medical imaging equipment (such as DSA, CT, and ultrasound). Interventional catheters are widely used in vascular interventions, non-vascular interventions, cardiac interventions, and neurointerventions. In vascular interventional applications, they can be used as pumping catheters for fluid delivery or thrombus aspiration catheters.

[0049] The following will take ventricular assist devices in the field of cardiac intervention as an example. Interventional catheters are mainly used to assist or replace the heart's pumping function. Blood access is established through interventional catheters to achieve blood drainage, pumping, or circulatory support.

[0050] In some scenarios, existing ventricular assist devices include interventional catheters that are inserted through the femoral, axillary, or carotid arteries. In these cases, the suction window of the catheter is located in the left ventricle, and the outflow window is located in the aorta. When the catheter is activated, it pumps blood from the left ventricle through the suction and outflow windows into the aorta, thus enabling the ventricular assist device to pump blood. Similarly, interventional catheters can be inserted through veins such as the femoral vein.

[0051] Currently, to determine whether the interventional catheter has accurately reached the designated position, the relevant technology uses a pressure sensor on the catheter on the outflow window side. The pressure sensor's blood flow pressure feedback determines whether the catheter has reached the designated position. However, since the pressure sensor is on the outflow window side, it can only determine the accuracy of the outflow window position and cannot determine the accuracy of the position on the aspiration window side. Furthermore, in the application of ventricular assist devices, if the aspiration window is located outside the left ventricle or on the boundary of the left ventricle, it will affect the pumping effect and may even cause other problems. For example, if the aspiration window is located in the left ventricle near the mitral valve orifice, it may lead to poor drainage or aspiration of valve tissue, affecting normal left ventricular filling; if it is located too low, close to the apex of the heart, myocardial contraction may compress the catheter, causing drainage obstruction.

[0052] Therefore, simply determining the location of the outflow window is insufficient to ensure the precise positioning of the interventional catheter at the designated location. Simultaneously and accurately locating both the aspiration and outflow windows of the interventional catheter during its operation remains a problem to be solved.

[0053] In view of this, this application provides an interventional catheter, in which the detection part of the proximal detection element is recessed on the outer peripheral surface of the proximal tube segment to detect the fluid parameters flowing through the detection part of the proximal detection element, and the detection part of the distal detection element is recessed on the outer peripheral surface of the distal tube segment to detect the fluid parameters flowing through the detection part of the distal detection element. This enables the simultaneous and precise positioning of the proximal and distal pumping windows of the interventional catheter during its operation.

[0054] To better illustrate this application, the following description uses an application scenario of a ventricular assist device as an example. In this application, the distal end is the end of the interventional catheter closer to the operator (doctor) or the external operating end. The proximal end is the end of the interventional catheter furthest from the operator (doctor) or the external operating end, and the proximal end enters the patient's body before the distal end. The axial direction of the interventional catheter refers to the direction parallel to the axis along the length of the interventional catheter (from proximal to distal or distal to proximal). The radial direction of the interventional catheter refers to the direction perpendicular to the axial direction, i.e., the radial direction from the center of the axis towards the outer wall of the interventional catheter (or vice versa). The circumferential direction of the interventional catheter refers to the circumferential direction around the axis, i.e., the direction of rotation along the outer wall or the perimeter of the lumen of the interventional catheter.

[0055] like Figures 1 to 13 As shown, some embodiments of this application provide an interventional catheter including a pumping tube 200 and a detection assembly 300. The pumping tube 200 is connected to an inlet tube 100. The pumping tube 200 includes a distal tube segment 201, an intermediate tube segment 202, and a proximal tube segment 203 arranged sequentially along the axial direction X. One end of the distal tube segment 201 facing away from the intermediate tube segment 202 is connected to the inlet tube 100. The distal tube segment 201 includes a distal pumping window 211, and the proximal tube segment 203 includes a proximal pumping window 231. The distal pumping window 211 and the proximal pumping window 231 are connected to the inlet tube 200. The cavity is connected, and the intermediate pipe section 202 is bendable; the pumping pipe 200 pumps fluid between the distal pumping window 211 and the proximal pumping window 231 under the drive of the power component; the detection component 300 includes a distal detection element 310 and a proximal detection element 320. The detection part of the proximal detection element 320 is recessed on the outer peripheral surface of the proximal pipe section 203 and is used to detect the fluid parameters flowing through the detection part of the proximal detection element 320. The detection part of the distal detection element 310 is recessed on the outer peripheral surface of the distal pipe section 201 and is used to detect the fluid parameters flowing through the detection part of the distal detection element 310.

[0056] In this application, the pumping pipe 200 includes a distal pipe section 201, an intermediate pipe section 202, and a proximal pipe section 203. The intermediate pipe section 202 is located between the distal pipe section 201 and the proximal pipe section 203. The distal end of the distal pipe section 201 is connected to the inlet pipe 100. The intermediate pipe section 202 is bendable. Exemplarily, the pumping pipe 200 can be formed by connecting one or more pipes, wherein each segment of the pumping pipe 200 can include one or more pipes.

[0057] The proximal segment 203 has a proximal pumping window 231, which can serve as either an outflow or inflow window. When the proximal pumping window 231 serves as an inflow window, the distal pumping window 211 serves as an outflow window, and vice versa. This application does not specifically limit the pumping direction of the interventional catheter.

[0058] In some applications, the interventional catheter is a blood-pumping catheter used to pump blood from the left ventricle into the aorta. For example, the proximal pumping window 231 is located in the proximal segment 203 of the pumping tube 200 (closer to the left ventricle). When the ventricular assist device is working, blood from the left ventricular cavity is drawn into the pumping tube 200 from the proximal pumping window 231.

[0059] In one example, the proximal pumping window 231 is an opening structure that penetrates the wall thickness of the pumping tube 200 mm, and there can be one or more proximal pumping windows 231. As an example, multiple proximal pumping windows 231 are arranged at Z-intervals along the circumferential direction of the interventional catheter.

[0060] The distal pipe section 201 is provided with a distal pumping window 211, which can be used as an outflow window or an inflow window.

[0061] For example, when the distal pumping window 211 is used as an outflow window, the distal pumping window 211 is located in the distal segment 201 of the pumping tube 200 (near the aorta side), and blood in the pumping tube 200 is transported to the ascending aorta via the distal pumping window 211.

[0062] In one example, the distal pumping window 211 is an opening structure that penetrates the wall thickness of the pumping tube 200 mm, and there can be one or more distal pumping windows 211. As an example, there are multiple distal pumping windows 211, and the multiple distal pumping windows 211 are arranged at Z-intervals along the circumferential direction of the interventional catheter.

[0063] In some examples, blood drawn from the left ventricular cavity through the proximal pumping window 231 is delivered to the ascending aorta via the intermediate tube segment 202 from the distal pumping window 211.

[0064] It is understood that a portion of the intermediate tube segment 202 is located at the aortic valve between the left ventricle and the aorta. In some embodiments of this application, there is an angle between the left ventricle and the aorta. The extension direction of the distal tube segment 201 after intervention has an angle with the extension direction of the proximal tube segment 203. In order to facilitate access and reduce damage to the aortic valve, the intermediate tube segment 202 is flexible and bendable.

[0065] Specifically, in some embodiments of this application, the extension direction of the intermediate tube segment 202 has a pre-bending angle, which can be achieved by heat setting, making it easier to turn during intervention and pass through the tortuous position of the blood vessel.

[0066] In some embodiments of this application, the interventional catheter can be driven either in vivo or externally. In some scenarios, "in vivo" refers to within human tissue, and "external" refers to outside human tissue.

[0067] The interventional catheter includes a detection component 300, which includes a distal detection element 310 and a proximal detection element 320 for achieving precise positioning of the dual windows. For example, the proximal detection element 320 determines whether the proximal pumping window 231 is located in the effective drainage area of ​​the left ventricle, and the distal detection element 310 determines whether the distal pumping window 211 is located at a suitable infusion position in the aorta.

[0068] For example, the fluid parameters detected by the distal detection element 310 and the proximal detection element 320 may be the same or different. The fluid parameters may include pressure, flow rate, temperature, etc. The distal detection element 310 and the proximal detection element 320 may be pressure sensors, flow rate sensors, temperature sensors, etc., respectively. In one example, both the distal detection element 310 and the proximal detection element 320 are used to detect the pressure of flowing blood. The pressure sensor may be a fiber optic pressure sensor, a piezoelectric pressure sensor, etc.

[0069] In some embodiments of this application, the proximal detection element 320 includes a detection section disposed on the outer peripheral surface of the proximal pipe section 203, facilitating installation and detection of fluid flowing through the proximal pipe section 203. Exemplarily, along the axial direction X, the proximal detection element 320 can be disposed on the proximal side or distal side of the proximal pumping window 231. In one example, based on different positioning methods, the detection section of the proximal detection element 320 can be located at any position between the intermediate pipe section 202 and the proximal pumping window 231.

[0070] A groove is recessed on the outer periphery of the proximal tube segment 203 in the axial direction. The detection part of the proximal detection element 320 can be placed in the groove, thereby avoiding the need to increase the extra interventional size of the interventional catheter, improving the smoothness of the outer periphery of the interventional catheter, reducing the difficulty of interventional catheterization, and reducing damage to blood vessels.

[0071] The distal sensing element 310 includes a sensing section disposed on the outer peripheral surface of the distal pipe section 201, facilitating installation and sensing of fluid flowing through the distal pipe section 201. Exemplarily, along the axial direction X, the distal sensing element 310 can be disposed on the proximal or distal side of the distal pumping window 211. In one example, based on different positioning methods, the sensing section of the distal sensing element 310 can be located at any position between the intermediate pipe section 202 and the distal pumping window 211.

[0072] A groove is recessed on the outer periphery of the distal tube segment 201 in the axial direction. The detection part of the distal detection element 310 can be placed in the groove, thereby avoiding the need to increase the extra interventional size of the interventional catheter, improving the smoothness of the outer periphery of the interventional catheter, reducing the difficulty of interventional catheterization, and reducing damage to blood vessels.

[0073] In the embodiments of this application, the detection portion of the proximal detection element 320 is recessed on the outer peripheral surface of the proximal tube segment 203 having a proximal pumping window 231 to detect the fluid parameters flowing through the detection portion of the proximal detection element 320, and the detection portion of the distal detection element 310 is recessed on the outer peripheral surface of the distal tube segment 201 having a distal pumping window 211 to detect the fluid parameters flowing through the detection portion of the distal detection element 310. The positions of the proximal pumping window 231 and the distal pumping window 211 are accurately located, thereby improving the positional accuracy of each part of the interventional catheter in the working state.

[0074] Some embodiments of this application provide an interventional catheter that also includes an inlet tube 100, which is used to guide the interventional catheter into a designated position, and the distal end of the catheter segment 201 facing away from the intermediate catheter segment 202 is connected to the inlet tube 100.

[0075] The inlet tube 100 is the leading-edge guiding structure of the interventional catheter, used to establish a pathway from outside the body to the target area inside the body, providing path support for the precise positioning of the subsequent pumping tube 200 and detection component 300. The inlet tube 100 is located at the distal end of the interventional catheter.

[0076] For example, the inlet tube 100 is a pigtail catheter. Exemplarily, the inlet tube 100 is shaped like a naturally curled pigtail, with the end of the tube spirally coiled. This structure not only effectively avoids sharp bends within the blood vessel, reducing mechanical stimulation to the vessel wall, but also allows for a more stable fit at the aortic root during procedures such as coronary angiography, thanks to the special curvature of the pigtail tip, ensuring uniform diffusion of the contrast agent and improving imaging clarity. Simultaneously, the coiled shape provides good compliance, naturally deforming with vascular pulsation and reducing hemodynamic interference.

[0077] In some examples, the main body material of the inlet catheter 100 may be medical-grade polyurethane (PU) or block polyetheramide (PEBAX), and a mesh support structure woven from nickel-titanium alloy superelastic wires may be embedded in the middle layer of the inlet catheter 100 to enable the inlet catheter 100 to maintain its shape memory capability in tortuous blood vessels. As an example, the surface of the inlet catheter 100 may be coated with a heparin coating to reduce the risk of thrombosis.

[0078] Furthermore, in some embodiments of this application, the pumping tube 200 includes a distal pumping housing 210, a spring tube 220, and a proximal pumping assembly 230 connected sequentially along the axial direction X. The spring tube 220 is bendable. A distal pumping window 211 is formed in the distal pumping housing 210, and a proximal pumping window 231 is formed in the proximal pumping assembly 230. The spring tube 220 is located between the distal pumping housing 210 and the proximal pumping assembly 230, and the distal end of the distal pumping housing 210 is connected to the inlet tube 100.

[0079] For example, the stiffness of the Bourdon tube 220 is less than that of the distal pumping housing 210 and the proximal pumping assembly 230. The stiffness of the distal pumping housing 210 is greater than that of the Bourdon tube 220, forming a "rigid anchor point-flexible joint" connection structure to ensure that the distal pumping window 211 maintains a stable orientation during aortic pulsation and a stable position within the left ventricle.

[0080] In some examples, the distal pump housing 210 may be made of medical-grade stainless steel (316LVM) or nickel-titanium alloy (NiTi55). The proximal pump assembly 230 may be made of polyurethane or polyethersulfone, medical-grade stainless steel 316L, or nickel-titanium alloy, offering both good fatigue resistance and biocompatibility.

[0081] Specifically, in one embodiment of this application, along the radial direction Y of the interventional catheter, the spring tube 220 includes a first polymer layer 225, a spring layer 226, and a second polymer layer 227 stacked from the inside out. In one example, the first polymer layer 225 is the inner layer that directly contacts the blood, possessing excellent anticoagulant properties and flexible substrate support capabilities. The first polymer layer 225 can be medical-grade silicone rubber or TPU (thermoplastic polyurethane elastomer), with anticoagulant properties enhanced by plasma grafting of phosphocholine groups. The first polymer layer 225 can also be block polyetheramide (PEBAX 7233), with a heparin coating on the surface to enhance anticoagulant properties.

[0082] In one example, the spring layer 226 serves as a support core, providing compressive stiffness to prevent lumen collapse and transmitting radial Y-force. Exemplarily, the spring layer 226 can be made of nickel-titanium alloy, 316L medical-grade stainless steel, or 304 stainless steel, and its structure can be a woven mesh, a spiral wound structure, or a metal tube laser-cut into a hypo tube shape.

[0083] In one example, the second polymer layer 227 is the outer layer that contacts the blood vessel wall, resisting external friction and compression, transmitting maneuvering force, and providing lubrication to reduce pushing resistance. The second polymer layer 227 can be polyurethane or polyethersulfone.

[0084] In one embodiment of this application, the spring tube 220 includes a first tube segment 221, an intermediate tube segment 202 and a second tube segment 223 in sequence along the axial direction X. The distal pumping housing 210 and the first tube segment 221 form the distal tube segment 201, and the proximal pumping assembly 230 and the second tube segment 223 form the proximal tube segment 203.

[0085] For example, the detection section of the remote detection element 310 may be disposed in either the remote pump housing 210 or the first pipe section 221. The detection section of the proximal detection element 320 may be disposed in either the proximal pump assembly 230 or the second pipe section 223.

[0086] In one example, the first pipe segment 221, the intermediate pipe segment 202, and the second pipe segment 223 may have the same or different stiffness along the axial direction X. As an example, the stiffness of the intermediate pipe segment 202 tends to increase in the direction of the first pipe segment 221 and the second pipe segment 223. The above embodiments of this application, while ensuring stiffness, facilitate the bending deformation of the intermediate pipe segment 202.

[0087] In one embodiment of this application, the detection part of the distal detection element 310 is disposed in the distal pumping housing 210, and the detection part of the proximal detection element 320 is disposed in the proximal pumping assembly 230.

[0088] The higher rigidity of the distal pump housing 210 facilitates the installation and fixation of the distal detection component 310, resulting in better stability of the distal detection component 310. Furthermore, the closer distance between the distal pump housing 210 and the distal pumping window 211 facilitates more precise positioning of the distal pumping window 211. Similarly, the higher rigidity of the proximal pumping assembly 230 facilitates the installation and fixation of the proximal detection component 320, resulting in better stability of the proximal detection component 320. Additionally, the closer distance between the proximal pumping assembly 230 and the proximal pumping window 231 facilitates more precise positioning of the proximal pumping window 231, and the closer proximity to the external body shortens the transmission distance, reducing wiring and data transmission length.

[0089] In some embodiments of this application, the proximal pumping assembly 230 includes a proximal pumping housing 234 and a housing 232. A proximal pumping window 231 is formed in the proximal pumping housing 234. The two ends of the proximal pumping housing 234 are respectively connected to a spring tube 220 and the housing 232. The interventional catheter also includes a power assembly; the power assembly includes an impeller 233 and a first motor body. The drive end of the first motor body is connected to the impeller 233. The impeller 233 is placed inside the proximal pumping housing 234, and the first motor body is placed inside the housing 232. It can be understood that the first motor body and the housing 232 combine to form a motor for the interventional catheter in the conventional sense.

[0090] For example, the detection section of the proximal detection element 320 may be disposed on the outer peripheral surface of the proximal pump housing 234 or the outer peripheral surface of the housing 232.

[0091] In some examples, the proximal pumping window 231 is located axially X-oriented between the impeller 233 and the housing 232. Alternatively, the proximal pumping window 231 is positioned opposite the impeller 233.

[0092] The first motor body drives the impeller 233 to rotate, thereby generating negative pressure to discharge the fluid in the spring tube 220 through the proximal pumping window 231. The first motor body is an internal motor.

[0093] In one embodiment of this application, the detection section of the proximal detection element 320 is disposed in the proximal pump housing 234.

[0094] For example, a groove is provided on the outer peripheral surface of the proximal pump housing 234 for mounting the proximal detection element 320, and a hole is provided in the groove to connect the groove with the inner cavity of the proximal pump housing 234, so that the fluid flowing through the proximal pump housing 234 is guided into the groove, which facilitates the detection by the proximal detection element 320.

[0095] The rigidity of the proximal pump housing 234 facilitates the installation and fixation of the proximal detection component 320. Furthermore, the closer proximity of the proximal pump housing 234 to the proximal pump window 231 makes it easier to accurately position the proximal pump window 231. Grooving the proximal pump housing 234 is convenient for processing and has low cost.

[0096] In some embodiments of this application, the proximal pumping assembly 230 includes a proximal pumping housing 234 and a housing 232. A proximal pumping window 231 is formed in the proximal pumping housing 234. The two ends of the proximal pumping housing 234 are respectively connected to the spring tube 220 and the housing 232. The interventional catheter also includes a power assembly. The power assembly includes an impeller 233, a transmission structure, and a second motor body. The drive end of the second motor body is connected to the input end of the transmission structure, and the output end of the transmission structure is connected to the impeller 233. The impeller 233 is placed inside the proximal pumping housing 234, and a part of the transmission structure is placed inside the housing 232.

[0097] For example, the transmission mechanism may include a flexible shaft, a rotating shaft, and bearings. The flexible shaft is connected to the rotating shaft, the output end of which is connected to the impeller 233, and the rotating shaft rotates relative to the housing 232 via the bearings. As an example, a portion of the flexible shaft is housed within the housing 232, and another portion of the flexible shaft is accommodated within the sheath 400.

[0098] The second motor body is located outside the body, and the impeller 233 is rotated by external drive. In one example, the second motor body can be covered by a second housing.

[0099] As an example, the detection section of the near-end detection element 320 can be disposed on the outer peripheral surface of the housing 232.

[0100] In one optional embodiment of this application, the proximal pumping assembly 230 includes a proximal pumping housing 234 and a casing 232. The power assembly includes an impeller 233 and a first motor body. The first motor body is connected to the impeller 233. The impeller 233 is placed inside the proximal pumping housing 234, and the first motor body is placed inside the casing 232. A proximal pumping window 231 is opened in the proximal pumping housing 234. The casing 232 includes a first end 232a, a casing body 232b, and a second end 232c along the axial direction X. The proximal pumping housing 234 is connected to the outer peripheral surface of the casing body 232b. The outer peripheral surface of the second end 232c has a tendency to taper from the first end 232a to the second end 232c.

[0101] In other words, the outer peripheral surface of the second end tends to taper from the distal end to the proximal end.

[0102] Exemplarily, the first end 232a is located within the proximal pump housing 234. In one example, the first end 232a has a tendency to gradually widen from the impeller 233 toward the housing body 232b. Fluid within the proximal pump housing 234 flows toward the housing body 232b via the first end 232a. The second end 232c has the opposite gradient tendency to the first end 232a.

[0103] In one example, the detection portion of the proximal detection element 320 can be disposed in one of the first end 232a, the shell body 232b, and the second end 232c. Specifically, the detection portion of the proximal detection element 320 is disposed within a groove on the outer peripheral surface of the shell body 232b to reduce the interference of the turbulent region on the detection accuracy of the proximal detection element 320.

[0104] In one embodiment of this application, the detection part of the proximal detection element 320 is disposed at the second end 232c.

[0105] For example, a groove is provided at the second end 232c, and the detection part of the proximal detection element 320 is installed in the groove.

[0106] In one example, the groove at the second end 232c has a tendency to gradually widen in the direction from the first end 232a to the second end 232c, which reduces the resistance to blood flowing out of the groove and reduces the risk of thrombus formation in the groove.

[0107] The fluid flowing out of the near-end pumping window 231 is turbulent, which affects the detection accuracy of the near-end detection element 320. By setting the detection part of the near-end detection element 320 at the second end 232c away from the turbulent flow, the fluid flowing through the detection part of the near-end detection element 320 becomes more stable, thereby improving the detection accuracy of the near-end detection element 320. Furthermore, the second end 232c is shorter than the shell body 232b in distance from the outside, which can shorten the transmission distance and wiring length of the near-end detection element 320.

[0108] In some embodiments of this application, the distal detection element 310 includes a first detection part (not shown in the figure) and a first signal line 312 connected together. The first detection part is installed on the outer peripheral surface of the distal pumping housing 210. A portion of the first signal line 312 is accommodated in the tube wall of the spring tube 220, and another portion extends along the axial direction X and is disposed in the proximal pumping assembly 230.

[0109] In some embodiments of this application, the first detection unit is used to detect fluid parameters flowing through it, and the first signal line 312 is a cable used to transmit the fluid parameters detected by the instrument detection unit.

[0110] In one example, the remote sensing element 310 can be a fiber optic pressure sensor, the first sensing part can be a fiber optic probe, and the first signal line 312 can be a fiber optic transmission line. In another example, the remote sensing element 310 can be a piezoelectric pressure sensor, the first sensing part can be a piezoelectric ceramic sheet, and the first signal line 312 can be an electrical conductor.

[0111] In one example, a second groove 212 is formed on the outer peripheral surface of the remote pump housing 210. The second groove 212 communicates with the inner cavity of the remote pump housing 210 through a hole and extends along the axial direction X. The first detection part is located in the second groove 212, and a portion of the first signal line 312 near the first detection part can be located in the second groove 212 and then connected to the spring tube 220.

[0112] In one example, a portion of the first signal line 312 extending from the Bourdon tube 220 is placed inside the proximal pumping assembly 230, and a portion is placed on the outer peripheral surface of the proximal pumping assembly 230.

[0113] The Bourdon tube 220 has excellent tensile, compressive, and bending resistance, providing physical protection for the first signal line 312 and preventing damage due to equipment movement, vibration, external impact, or pulling during installation. The Bourdon tube 220 can constrain the bending degree of the first signal line 312, preventing excessive bending (especially for transmission media sensitive to bending radius, such as optical fibers), thus preventing increased signal transmission loss or physical damage.

[0114] In one embodiment of this application, a first groove 237 is provided on the outer peripheral surface of the proximal pumping assembly 230. The first groove 237 extends along the axial direction X and along the circumferential direction Z of the interventional catheter. The first groove 237 is located between two adjacent proximal pumping windows 231. Another part of the first signal line 312 is accommodated in the first groove 237.

[0115] In one example, a first groove 237 is formed in the proximal pump housing 234, and a first signal line 312 drawn from the spring tube 220 extends along the first groove 237.

[0116] In another example, a first groove 237 is formed on the proximal pump housing 234 and housing 232, and a first signal line 312 drawn from the spring tube 220 extends along the first groove 237.

[0117] As an example, the first groove 237 is formed on the shell body 232b of the near-end pump housing 234 and the housing 232, and a through hole is formed on the shell body 232b to extend the first signal line 312 to the cavity corresponding to the second end 232c.

[0118] In this embodiment, a first groove 237 is provided on the outer periphery of the proximal pumping assembly 230 to facilitate the arrangement of the first signal line 312. The first groove 237 is located between two adjacent proximal pumping windows 231 to avoid affecting the blood pumping operation of the interventional catheter, affecting the outflow of blood, and to avoid the impact of blood on the first signal line 312, which would affect the lifespan and signal transmission effect of the first signal line 312.

[0119] In some other embodiments of this application, the spring tube 220 includes a first smooth transition inner surface 228 and a first smooth transition outer surface 229 disposed opposite to each other along its own thickness direction. The center line of the first smooth transition inner surface 228 is eccentrically disposed with respect to the center line of the first smooth transition outer surface 229. A portion of the first signal line 312 is embedded in the spring tube 220 between the first smooth transition inner surface 228 and the first smooth transition outer surface 229.

[0120] It is understood that the first smooth transition inner surface 228 and the first smooth transition outer surface 229 in this application can be circular or approximately circular, and deviations within a certain range are also within the protection scope of this application.

[0121] By pre-embedding a certain length of the first signal line 312, the axial dimension of the first signal line 312 exposed inside or outside the spring tube 220 is effectively shortened, reducing the outer diameter of the spring tube 220. Furthermore, part of the first signal line 312 is encased within the sidewall of the spring tube 220, improving the protective effect of the spring tube 220 on the first signal line 312. In addition, since both the inner and outer surfaces are smooth, the smoothness of the intervention process is improved, the difficulty of the intervention is reduced, and the probability of thrombus formation on the inner and outer surfaces is decreased.

[0122] Furthermore, in some embodiments of this application, the spring tube 220 includes a first smooth transition inner surface 228 and a first smooth transition outer surface 229 disposed opposite to each other along its own thickness direction. The centerline of the first smooth transition inner surface 228 is eccentrically disposed with respect to the centerline of the first smooth transition outer surface 229. An axially extending mounting channel is provided at a first preset position between the first smooth transition inner surface 228 and the first smooth transition outer surface 229. Within the same cross-section of the spring tube 220, the wall thickness at the first preset position is greater than the wall thickness at at least a portion of the other positions.

[0123] In one embodiment of this application, a mounting channel extending along the axial direction X is provided at the position of the maximum wall thickness of the spring tube 220 between the first smooth transition inner surface 228 and the first smooth transition outer surface 229; the first signal line 312 is accommodated in the mounting channel.

[0124] The thickness direction of the spring tube 220 is radial Y of the interventional catheter. Eccentric setting means that the geometric center line of the inner cavity of the spring tube 220 does not coincide with the geometric center line of the outer wall of the spring tube 220, and there is an offset distance (i.e., eccentricity) between them in space along the radial Y.

[0125] Due to the eccentric setting of the spring tube 220, the spring tube 220 has a maximum wall thickness position and a minimum wall thickness position along the circumferential Z direction. The maximum wall thickness position and the minimum wall thickness position are set opposite to each other along the radial Y direction, and the wall thickness has a gradual change trend from the maximum wall thickness position to the minimum wall thickness position.

[0126] For example, the mounting channel can be a hole structure or a pipe structure. In one example, the sidewalls of the mounting channel can be a single structure or a multi-layered structure.

[0127] For example, the location of the maximum wall thickness is within the range of a central angle greater than or equal to 1° and less than or equal to 180°.

[0128] In one example, within a cross-section perpendicular to the centerline, the mounting channel can be circular, elliptical, waist-shaped, crescent-shaped, or similar in form.

[0129] In one example, the remote pump housing 210 is stacked with the first smooth transition inner surface 228, the second groove 212 is disposed opposite to the mounting channel, and the first groove 237 is disposed opposite to the mounting channel.

[0130] The eccentric setting of the spring tube 220 ensures that there are no protrusions on the smooth transition outer surface of the spring tube 220, reducing the risk of thrombus formation on the first signal line 312 on the smooth transition outer surface of the spring tube 220 and reducing the impact on the pump blood flow.

[0131] Specifically, in one embodiment of this application, along the radial direction Y of the interventional catheter, the spring tube 220 includes a first polymer layer 225, a spring layer 226, and a second polymer layer 227 stacked along its own thickness direction. The center lines of the first polymer layer 225 and the spring layer 226 are concentrically arranged, and a first smooth transition inner surface 228 is formed on the side of the first polymer layer 225 facing away from the spring layer 226. The second polymer layer 227 includes a second smooth transition inner surface and a first smooth transition outer surface 229. The center line of the second smooth transition inner surface is eccentrically arranged with the center line of the first smooth transition outer surface 229, and the center line of the second smooth transition inner surface is concentrically arranged with the center line of the first polymer layer 225. The installation channel is located at a second preset position between the second smooth transition inner surface and the first smooth transition outer surface. In the same cross-section of the second polymer layer 227, the wall thickness at the second preset position is at least greater than at least part of the wall thickness at other positions.

[0132] In one embodiment, the mounting channel is located at the position of maximum wall thickness of the second polymer layer 227 between the second smooth transition inner surface and the first smooth transition outer surface 229.

[0133] Specifically, the first polymer layer 225 and the spring layer 226 can be bonded together, and the second polymer layer 227 is bonded together with the spring layer 226.

[0134] In one example, the first polymer layer 225 may include one or more layers. The second polymer layer 227 may include one or more layers.

[0135] The concentric arrangement of the center lines of the first polymer layer 225 and the spring layer 226 facilitates the placement of the spring layer 226, ensures the uniform winding of the spring layer 226 around the first polymer layer 225, and also facilitates the fixation of the spring layer 226. The eccentric arrangement of the second polymer layer 227 facilitates the setting of the installation channel and ensures that the installation channel is aligned with the first groove 237, and that the first signal line 312 is continuously and without bends.

[0136] Furthermore, in a specific embodiment of this application, the proximal pump housing 234 includes a main body 235 and a plurality of extensions 236. The main body 235 and the extensions 236 are arranged sequentially along the axial direction X, and the plurality of extensions 236 are distributed at intervals along the circumferential direction Z. A proximal pumping window 231 is formed between two adjacent extensions 236, and the extensions 236 are connected to the housing 232.

[0137] For example, the main body 235 is annular in the circumferential direction Z, and the main body 235 is connected to the spring tube 220. As an example, the end face of the main body 235 is bonded to the end face of the spring layer 226 and the first polymer layer 225.

[0138] In one example, the width of the extension 236 along the circumferential direction Z has a gradual trend, specifically the width of the extension 236 has a tendency to gradually decrease from the main body 235 toward the second end of the housing 232.

[0139] In another example, the proximal pump housing 234 includes two, three, four, or five extensions 236.

[0140] As an example, the extension 236 is connected to the housing body 232b of the housing 232.

[0141] In the embodiments of this application, the proximal pumping window 231 formed by the main body 235 and a plurality of extensions 236 facilitates the outflow of fluid from the proximal pumping housing 234.

[0142] In some embodiments of this application, the proximal detection element 320 includes a connected second detection part 321 and a second signal line 322. The second detection part 321 is mounted on the proximal pump housing 234, and a portion of the second signal line 322 is accommodated within the housing 232 or extends along the proximal pump housing 234.

[0143] In an embodiment of this application, the proximal detection element 320 includes a second detection part 321 and a second signal line 322. The second detection part 321 is mounted on the main body part 235, the second signal line 322 extends to the housing 232 through an extension part 236, and the first signal line 312 extends to the housing 232 through another extension part 236.

[0144] The first signal line 312 and the second signal line 322 are respectively opposite to the two extensions 236. Exemplarily, a first groove 237 is formed in one extension 236, and a third groove 238 is formed in the other extension 236. The first groove 237 is used to accommodate the first signal line 312, and the third groove 238 is used to accommodate the second signal line 322.

[0145] In one example, the two extensions 236 containing the first signal line 312 and the second signal line 322 may be adjacent or spaced apart. As an example, the included angle between the first signal line 312 and the second signal line 322 along the circumferential direction Z may range from 0° to 180°.

[0146] In another example, when the proximal detection element 320 is located at the second end 232c of the housing 232, the angle between the first signal line 312 and the second signal line 322 along the circumferential Z direction can be 0°. A first groove 237 is formed in the proximal pump housing 234, and a third groove 238 is formed in the second end 232c. The first signal line 312 is led out from the mounting channel to the first groove 237, and then through the first through hole in the housing body 232b of the housing 232 into the housing 232. The second signal line 322 is led into the housing 232 through the second through hole via the third groove 238.

[0147] The first signal line 312 and the second signal line 322 are respectively set in different extensions 236, which facilitates the independent routing of the near-end detection element 320 and the far-end detection element 310, is convenient for arrangement, and avoids the connection strength of the extension 236 being affected by excessively large slots.

[0148] In some embodiments of this application, the proximal pump housing 234 includes a main body 235 and a plurality of extensions 236. The main body 235 and the extensions 236 are arranged sequentially along the axial direction X, and the plurality of extensions 236 are distributed at intervals along the circumferential direction Z. A proximal pumping window 231 is formed between two adjacent extensions 236. The extensions 236 are connected to the housing 232. The housing 232 has two through holes 239 along the axial direction X. The two through holes 239 are respectively arranged opposite to the two extensions 236. The distal detection element 310 and the proximal detection element 320 extend into the housing 232 through the through holes 239.

[0149] In one example, the extension line of the extension 236 passes through the through hole 239. The two through holes 239 include a first through hole and a second through hole. This allows the first signal line 312 of the distal detection element 310 to extend in a straight line into the first through hole. The second signal line 322 of the proximal detection element 320 extends in a straight line into the second through hole. This reduces bending of the first signal line 312 and the second signal line 322, improving the detection stability and lifespan of both the distal and proximal detection elements 310 and 320. The dual through holes provide physically isolated independent channels for the two signal lines, preventing signal crosstalk and improving detection accuracy.

[0150] In another example, the two through holes 239 can be respectively opened on the shell body 232b or the second end 232c.

[0151] In some other embodiments of this application, the proximal pump housing 234 includes a main body 235 and a plurality of extensions 236. The main body 235 and the extensions 236 are arranged sequentially along the axial direction X. The plurality of extensions 236 are distributed at intervals along the circumferential direction Z. A proximal pumping window 231 is formed between two adjacent extensions 236. The extensions 236 are connected to the housing 232. The housing 232 has two through holes 239. The two through holes 239 are located between the extensions of two adjacent extensions 236 along the axial direction X. The distance between the two through holes 239 has a tendency to gradually decrease from the distal end to the proximal end. The distal detection element 310 and the proximal detection element 320 extend into the housing 232 through the through holes 239, respectively.

[0152] For example, two through holes 239 are arranged opposite to the proximal pumping window 231, and the first signal line 312 and the second signal line 322 extend from both sides of the proximal pumping window 231 towards the center of the proximal pumping window 231. Shortening the distance between the first signal line 312 and the second signal line 322 within the housing 232 facilitates their convergence within the housing 232, resulting in a more rational spatial layout and a more compact structure. The through holes can be produced by injection molding, which facilitates processing and improves processing efficiency.

[0153] The spacing between the two through holes 239 gradually decreases from the far end to the near end, which is beneficial for the convergence of the first signal line 312 and the second signal line 322. It also reduces the bending of the signal lines and improves the transition when the signal lines pass through the vias.

[0154] Furthermore, in one embodiment of this application, the proximal detection device 320 includes a mounting base 323 and a detection device body 324. The detection device body 324 is installed in the mounting base 323, and the mounting base 323 is connected to the pumping tube 200. The mounting base 323 includes a mounting wall and a mounting cavity 326 enclosed by the mounting wall. The mounting cavity 326 is blocked at one end of the inlet tube 100 along the axial direction X. The mounting wall is provided with a drainage channel 325 through the radial direction Y of the interventional catheter. The drainage channel 325 communicates with the mounting cavity 326. The detection end of the detection device body 324 is located on the side of the drainage channel 325 away from the blocked side of the mounting cavity 326.

[0155] In one example, the mounting base 323 is bonded to the pump pipe 200. As an example, the mounting base 323 is bonded within a groove on the smooth transition outer surface of the pump pipe 200.

[0156] In one example, the detection body 324 includes a detection terminal and a signal line. The detection terminal and a portion of the signal line are located within the mounting cavity 326.

[0157] Exemplarily, the drainage channel 325 may penetrate the mounting wall on one side or both sides of the mounting cavity 326 along the radial Y direction. In one example, when the proximal detection element 320 is mounted on the second end 232c, the drainage channel 325 may penetrate the mounting wall on the side of the mounting cavity 326 opposite to the pumping pipe 200 along the radial Y direction. In another example, when the proximal detection element 320 is mounted on the main body 235 of the proximal pumping housing 234, the drainage channel 325 may penetrate the mounting walls on both sides of the mounting cavity 326 along the radial Y direction.

[0158] In the embodiments of this application, the near-end detection element 320 is protected by placing it in the mounting base 323. Furthermore, the detection end of the detection element body 324 is located on the blocking side of the drainage channel 325 away from the mounting cavity 326 to prevent the fluid in the drainage channel 325 from impacting the detection end, which would cause human tissue in the fluid to directly contact the detection end and cause damage, thus affecting the service life and detection results of the near-end detection element 320.

[0159] In one example, the distal detection device 310 may also include a mounting base 323 and a detection device body 324. The detection device body 324 is installed in the mounting base 323, which is connected to the pumping tube 200. The mounting base 323 includes a mounting wall and a mounting cavity 326 enclosed by the mounting wall. The mounting cavity 326 is sealed at one end of the inlet tube 100 along the axial direction X. The mounting wall is provided with a drainage channel 325 through the radial direction Y of the interventional catheter. The drainage channel 325 communicates with the mounting cavity 326. The detection end of the detection device body 324 is located on the side of the drainage channel 325 away from the sealed side of the mounting cavity 326.

[0160] In some embodiments of this application, the mounting base 323 includes a base 301, a sleeve 302, and a sealing member 303. The sleeve 302 is connected to the pumping pipe 200 through the base 301, and the sealing member 303 seals one end of the sleeve 302. Along the radial direction Y, a recess 308 is provided on the side of the base 301 facing away from the pumping pipe 200, and the sleeve 302 is connected to the recess 308. The base 301 is provided with a first hole 304. The sleeve 302 includes a pipe wall, which encloses to form a mounting cavity 326. The sleeve 302 is provided with a second hole 305 and a third hole 306 communicating with the mounting cavity 326 along the radial direction Y. The second hole 305 is provided opposite to the first hole 304, and the second hole 305 and the third hole 306 form a drainage channel 325.

[0161] Exemplarily, the occlusion element 303 can be bonded or threaded to the sleeve 302. As an example, the occlusion element 303 has an arcuate surface to avoid damage to the blood vessel during the interventional procedure. The occlusion element 303 can be located outside the base 301 along the axial direction X. The occlusion element 303 can be made of polymer materials, metal, or silicone.

[0162] For example, the third hole 306 can be square, oblong, or circular.

[0163] In one example, an adhesive layer is provided to connect the inner wall of the sleeve 302 and the detection body 324.

[0164] For example, the cannula 302 is bonded or welded into the recess 308. In one example, the curvature of the recess 308 matches the curvature of the cannula 302, thereby ensuring a close fit between the recess 308 and the cannula 302, avoiding the formation of dead zones and reducing thrombus formation.

[0165] In another example, the sleeve 302 is provided with a vent 307 along the axial direction X. The vent 307 communicates with the mounting cavity 326 and is located on the side of the third hole 306 opposite to the sealing member 303.

[0166] For example, the bottom surface of the base 301 that fits against the pumping pipe 200 can be a plane. This facilitates laser welding between the base 301 and the pumping pipe 200, improving the fixing strength. As an example, the recess 308 has two upper surfaces on both sides along the circumferential direction Z, and the upper surfaces can be planes.

[0167] In some examples, the sleeve 302 can be made of metal or hard plastic, which can prevent the proximal detection element 320 from being compressed radially Y by tissue, thus solving the problem of long-term measurement accuracy degradation.

[0168] The mounting base 323 adopts a split structure, which facilitates processing in different positions, improves processing accuracy, and allows for the use of different materials to achieve different functions. For example, the sleeve 302 has a higher material rigidity than the base 301 and the sealing component 303, providing better support.

[0169] In one embodiment, the base 301 may be integrally connected to the distal pump housing 210 or the proximal pump housing 234 or be integrally formed.

[0170] Furthermore, in an embodiment of this application, the orthographic projection of the second hole 305 on the projection plane is placed within the orthographic projection of the third hole 306 on the projection plane, and the end face of the detection end is tangent to the third hole 306 in the orthographic projection of the projection plane, wherein the projection plane is perpendicular to the radial direction Y.

[0171] In one example, the first hole 304, the second hole 305, and the third hole 306 are of the same size, and their centers are collinear. In another example, the first hole 304 and the second hole 305 are of the same size, their centers are collinear and perpendicular to the centerline of the sleeve 302, and the third hole 306 is larger than the second hole 305. Fluid enters through the first hole 304, flows through the second hole 305, through the mounting cavity 326, and exits through the third hole 306.

[0172] The end face of the detection end of the detection body 324 is tangent to the third hole 306 in the orthographic projection of the projection plane, which is more conducive to detecting the fluid entering the mounting cavity 326 and reducing the risk of thrombosis.

[0173] This application also provides a blood pumping device, including the interventional catheter and sheath 400 described in the above embodiments, wherein the sheath 400 is connected to one end of the interventional catheter facing away from the inlet tube 100.

[0174] The above description is merely a specific implementation of this application. Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the systems, modules, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here. It should be understood that the protection scope of this application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in this application, and these modifications or substitutions should all be covered within the protection scope of this application.

Claims

1. An interventional catheter, characterized in that, include: A pumping pipe includes a distal pipe section, an intermediate pipe section, and a proximal pipe section arranged sequentially from the distal end to the proximal end along the axial direction. The distal pipe section includes a distal pumping window, and the proximal pipe section includes a proximal pumping window. The distal pumping window and the proximal pumping window are in communication with the lumen of the pumping pipe. The intermediate pipe section is bendable. The pumping pipe pumps fluid between the distal pumping window and the proximal pumping window under the drive of a power component. The detection assembly includes a distal detection element and a proximal detection element, wherein the detection portion of the proximal detection element is recessed on the outer peripheral surface of the proximal pipe segment, and the detection portion of the distal detection element is recessed on the outer peripheral surface of the distal pipe segment.

2. The interventional catheter according to claim 1, characterized in that, The pumping pipe includes a distal pumping housing, a spring tube, and a proximal pumping assembly connected sequentially along the axial direction. The spring tube is bendable and includes a first pipe section, an intermediate pipe section, and a second pipe section sequentially along the axial direction. The distal pumping window is located in the distal pumping housing, and the proximal pumping window is located in the proximal pumping assembly. The distal pumping housing and the first pipe segment form the distal pipe segment, and the proximal pumping assembly and the second pipe segment form the proximal pipe segment.

3. The interventional catheter according to claim 2, characterized in that, The detection part of the distal detection element is disposed on the distal pump housing, and the detection part of the proximal detection element is disposed on the proximal pump assembly.

4. The interventional catheter according to claim 3, characterized in that, The proximal pumping assembly includes a proximal pumping housing and a casing. The proximal pumping window is opened in the proximal pumping housing. The two ends of the proximal pumping housing are respectively connected to the spring tube and the casing. The interventional catheter also includes a power assembly. The power assembly includes an impeller and a first motor body. The drive end of the first motor body is connected to the impeller. The impeller is located within the proximal pump housing, and the first motor body is located within the housing; or The power assembly includes an impeller, a transmission structure, and a second motor body. The drive end of the second motor body is connected to the input end of the transmission structure, and the output end of the transmission structure is connected to the impeller. The impeller is placed inside the proximal pump housing, and a portion of the transmission structure is placed inside the housing.

5. The interventional catheter according to claim 4, characterized in that, The detection section of the proximal detection element is disposed in the proximal pump housing.

6. The interventional catheter according to claim 5, characterized in that, The proximal pumping housing includes a main body and a plurality of extensions. The main body and the extensions are arranged sequentially along the axial direction, and the plurality of extensions are distributed at intervals along the circumferential direction. A proximal pumping window is formed between two adjacent extensions, and the extensions are connected to the housing. The housing has two through holes along the axial direction, and the two through holes are respectively arranged opposite to the two extensions. The distal detection element and the proximal detection element extend into the housing through the through holes.

7. The interventional catheter according to claim 5, characterized in that, The proximal pump housing includes a main body and a plurality of extensions. The main body and the extensions are arranged sequentially along the axial direction. The plurality of extensions are distributed at intervals along the circumferential direction. The proximal pumping window is formed between two adjacent extensions. The extensions are connected to the housing. The housing has two through holes, which are located between the extension lines of two adjacent extensions along the axial direction. The distance between the two through holes tends to gradually decrease from the distal end to the proximal end. The distal detection element and the proximal detection element extend into the housing through the through holes.

8. The interventional catheter according to claim 4, characterized in that, The housing includes a housing body and a second end along the axial direction from the distal end to the proximal end. The proximal end pump housing is connected to the outer peripheral surface of the housing body. The outer peripheral surface of the second end has a tendency to taper from the distal end to the proximal end. The detection part of the proximal end detection element is disposed at the second end.

9. The interventional catheter according to claim 5, characterized in that, The distal detection component includes a first detection part and a first signal line connected together. The first detection part is installed on the outer peripheral surface of the distal pump housing. A portion of the first signal line is accommodated in the tube wall of the spring tube, and another portion extends along the axial direction and is disposed on the proximal pump assembly. The spring tube includes a first smooth transition inner surface and a first smooth transition outer surface arranged opposite to each other along its own thickness direction. The center line of the first smooth transition inner surface is eccentrically arranged with respect to the center line of the first smooth transition outer surface. An installation channel extending along the axial direction is provided at a first preset position between the first smooth transition inner surface and the first smooth transition outer surface. In the same cross-section of the spring tube, the wall thickness at the first preset position is greater than the wall thickness at at least some of the other positions. The first signal line is housed within the mounting channel.

10. The interventional catheter according to claim 9, characterized in that, Along the radial direction of the interventional catheter, the spring tube includes a first polymer layer, a spring layer and a second polymer layer stacked from the inside to the outside along its own thickness direction. The center lines of the first polymer layer and the spring layer are concentric. The side of the first polymer layer facing away from the spring layer forms the first smooth transition inner surface. The second polymer layer includes a second smooth transition inner surface and a first smooth transition outer surface. The centerline of the second smooth transition inner surface is eccentrically disposed with respect to the centerline of the first smooth transition outer surface. The centerline of the second smooth transition inner surface is concentrically disposed with respect to the centerline of the first polymer layer. The mounting channel is located at a second preset position between the second smooth transition inner surface and the first smooth transition outer surface. Within the same cross-section of the second polymer layer, the wall thickness at the second preset position is at least greater than the wall thickness at at least part of the other positions.

11. The interventional catheter according to claim 9, characterized in that, The outer peripheral surface of the proximal pumping assembly is provided with a first groove, which extends along the axial direction and along the circumference of the interventional catheter. The first groove is located between two adjacent proximal pumping windows, and another part of the first signal line is accommodated in the first groove.

12. The interventional catheter according to claim 9, characterized in that, The proximal pump housing includes a main body and a plurality of extensions. The main body and the extensions are arranged sequentially along the axial direction. The plurality of extensions are distributed at intervals along the circumferential direction. The proximal pumping window is formed between two adjacent extensions. The extensions are connected to the housing. The proximal detection element includes a second detection section and a second signal line. The second detection section is mounted on the main body. The second signal line extends to the housing through one of the extension sections. The first signal line extends to the housing through another of the extension sections.

13. The interventional catheter according to any one of claims 1 to 12, characterized in that, The proximal detection device includes a mounting base and a detection device body, the detection device body is installed in the mounting base, and the mounting base is connected to the pumping pipe; The mounting base includes a mounting wall and a mounting cavity enclosed by the mounting wall. The distal end of the mounting cavity is sealed. A drainage channel is provided through the mounting wall radially along the interventional catheter. The drainage channel communicates with the mounting cavity. The detection end of the detection element body is located on the side of the drainage channel opposite to the sealing side of the mounting cavity.

14. The interventional catheter according to claim 13, characterized in that, The mounting base includes a base, a sleeve, and a sealing element. The sleeve is connected to the pumping pipe through the base, and the sealing element seals one end of the sleeve. Along the radial direction, a recess is provided on the side of the base facing away from the pumping pipe, the sleeve is connected in the recess, and a first hole is provided through the base. The sleeve includes a tube wall that encloses the mounting cavity. The sleeve has a second hole and a third hole that communicate with the mounting cavity along the radial direction. The second hole is opposite to the first hole, and the second hole and the third hole form the drainage channel.

15. A blood pumping device, characterized in that, The invention includes the interventional catheter and sheath as described in any one of claims 1 to 14, wherein the sheath is connected to the proximal end of the interventional catheter.

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