Medical interventional catheters

Abstract

The present invention relates to a medical interventional catheter comprising a catheter body that integrates diagnostic and therapeutic functions. The catheter body includes a functional portion at a distal end, which is used for imaging and monitoring within a target lumen and for releasing a therapeutic source comprising therapeutic energy and / or a therapeutic substance to a target location within the target lumen. The medical interventional catheter of the present invention integrates diagnostic and therapeutic functions, enabling real-time imaging monitoring during treatment, thereby improving the accuracy and effectiveness of treatment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical interventional catheter integrating diagnosis and treatment. Background Art

[0002] Atherosclerosis is a syndrome that affects arterial blood vessels. Atherosclerosis causes a chronic inflammatory response in the walls of the arteries, which is largely due to the accumulation of lipids, macrophages, foam cells, and the formation of plaques in the arterial walls. Atherosclerosis is commonly referred to as arteriosclerosis, and the pathophysiology of the disease manifests in several different types of lesions, ranging from fibrosis to lipid-filled to calcification. Currently, the main established clinical treatments for atherosclerosis include medications, interventional therapy, and bypass surgery, but there are still problems such as long-term restenosis and thrombosis.

[0003] Thermal physical therapy has been widely used in clinical practice due to its relatively low cost, few side effects, and short treatment time. Thermal physical therapy is achieved through thermal ablation, and the energy generation methods for thermal ablation mainly include cryoballoons, focused ultrasound, lasers, and radiofrequency. Clinical studies have shown that radiofrequency ablation has advantages such as a certain safe frequency, controllable thermal energy output, and easier functional integration. During thermal physical therapy, in order to ensure the ablation effect, a certain range of tissue damage needs to be caused, but there is currently no relevant technical means to accurately monitor and control the ablation range of fibrous plaques.

[0004] Intravascular imaging is the primary monitoring method, and this technology primarily includes OCT (optical coherence tomography), IVUS (intravascular ultrasound), angioscopy, and intravascular MRI. Compared to other imaging technologies, OCT offers significant advantages in imaging resolution (better than 10μm), enabling the acquisition of high-definition images of biological tissue, which is highly beneficial for the precise imaging and identification of intravascular plaques. However, during treatment, imaging diagnosis and treatment are typically performed separately. This not only complicates the process but also makes it impossible to monitor treatment outcomes in real time, hindering timely treatment and, in some cases, leading to higher recurrence rates, while also increasing overall treatment costs. Summary of the Invention

[0005] The purpose of the present invention is to provide a medical interventional catheter that integrates diagnosis and treatment, which can realize real-time imaging monitoring during the treatment process and improve the accuracy and effectiveness of the treatment.

[0006] To achieve the above-mentioned objectives, the present invention provides a medical interventional catheter, which includes a catheter body that integrates diagnosis and treatment, and the catheter body includes a functional part located at the distal end, which is used for imaging monitoring within the target lumen and also for releasing a therapeutic source to a target position within the target lumen, wherein the therapeutic source includes therapeutic energy and / or therapeutic substance.

[0007] In one embodiment, the medical interventional catheter further comprises a head end, the distal end of the functional portion is connected to the proximal end of the head end via an elastic connecting portion, the connecting portion seals the distal end of the functional portion, and the head end is provided with a guidewire cavity.

[0008] In one embodiment, the functional part uses one or more imaging methods to achieve imaging monitoring of the target lumen.

[0009] In one embodiment, the functional part uses OCT imaging to achieve imaging monitoring of the target lumen.

[0010] In one embodiment, the functional portion includes an imaging probe, and the imaging probe is disposed at a transparent imaging window of the functional portion.

[0011] In one embodiment, the functional portion is capable of releasing one or more of the therapeutic energies.

[0012] In one embodiment, the functional portion is capable of releasing at least one therapeutic energy selected from the group consisting of radiofrequency, ultrasound, laser, and cryofluid.

[0013] In one embodiment, the functional portion releases the therapeutic substance to a target location in the target lumen using one or more methods.

[0014] In one embodiment, the therapeutic substance is a drug, and the functional portion releases the drug to a target location in the target lumen by at least one of a drug coating, a drug delivery hole, and a drug delivery microneedle.

[0015] In one embodiment, when the functional part adopts a drug delivery hole and / or a drug delivery microneedle, the catheter body also includes a tube body, the drug delivery hole and / or the drug delivery microneedle are arranged on the outer surface of the tube body, and a drug delivery channel is provided in the tube body, the drug delivery channel extends axially from the tube body of the functional part to the proximal end of the tube body, and the distal end of the drug delivery channel is connected to the drug delivery hole and / or the drug delivery microneedle.

[0016] In one embodiment, the functional part includes an imaging probe, an electrode and a temperature measuring component, the imaging probe is used for imaging monitoring, the electrode is used to release radio frequency, and the temperature measuring component is arranged on the electrode and is used to monitor the surface temperature of the electrode.

[0017] In one embodiment, the catheter body further comprises a tube body, the imaging probe is disposed in the tube body, and the electrodes are disposed on an outer surface of the tube body;

[0018] The tube body is provided with an independent imaging channel, an electrode wire channel, and a temperature control wire channel. The imaging channel, the electrode wire channel, and the temperature control wire channel all extend axially from the tube body of the functional portion to the proximal end of the tube body. The imaging channel is provided at the center of the tube body, and the electrode wire channel and the temperature control wire channel are arranged around the imaging channel.

[0019] An imaging transmission structure connected to the imaging probe is provided in the imaging channel, an electrode wire connected to the electrode is provided in the electrode wire channel, and a temperature control wire connected to the temperature measuring component is provided in the temperature control wire channel.

[0020] In one embodiment, a temperature-control fluid channel is further provided in the tube body. The temperature-control fluid channel is independently provided relative to the imaging channel, the electrode wire channel and the temperature-control wire channel, and is arranged on the periphery of the imaging channel. A temperature-control fluid output hole is provided on the electrode. The temperature-control fluid channel extends axially from the proximal end of the tube body and is connected to the temperature-control fluid output hole. The temperature-control fluid channel is used to transport the temperature-control fluid, and the temperature-control fluid is released to the target position through the temperature-control fluid output hole.

[0021] In one embodiment, the tube body is a single-lumen braided tube, and a temperature-controlled fluid tube, an imaging tube, an electrode wire tube, and a temperature-controlled wire tube are arranged in the single-lumen braided tube. The inner lumen of the temperature-controlled fluid tube forms the temperature-controlled fluid channel, the inner lumen of the imaging tube forms the imaging channel, the inner lumen of the electrode wire tube forms the electrode wire channel, and the inner lumen of the temperature-controlled wire tube forms the temperature-controlled wire channel. The wall thickness of the temperature-controlled fluid tube, the imaging tube, the electrode wire tube, and the temperature-controlled wire tube are all less than 0.2 mm.

[0022] In one embodiment, the temperature-controlled fluid tube, the imaging tube, the electrode wire tube, and the temperature-controlled wire tube are fixedly connected to each other.

[0023] In one embodiment, the outer diameter of the tube body is 1.0 mm to 3.0 mm, the diameter of the imaging channel does not exceed 1.0 mm, the diameter of the temperature control fluid channel does not exceed 0.5 mm, the diameter of the electrode wire channel is 0.1 mm to 0.5 mm, and the diameter of the temperature control wire channel is 0.1 mm to 0.5 mm.

[0024] In one embodiment, the temperature-control fluid output hole is a micropore, and the pore diameter of the micropore is 50 μm to 200 μm.

[0025] In one embodiment, there are multiple electrodes, and the multiple electrodes are arranged at intervals along the axial and / or circumferential direction of the catheter body. At least two of the multiple electrodes are annular electrodes, and at least two of the annular electrodes are arranged at intervals along the axial direction of the catheter body. The imaging probe is arranged between two adjacent annular electrodes.

[0026] In one embodiment, the medical interventional catheter further comprises an interface portion, the proximal end of the catheter body being connected to the interface portion, and the interface portion comprises:

[0027] an imaging interface connected to the proximal end of the imaging transmission structure;

[0028] a fluid perfusion interface connected to the proximal end of the temperature-controlled fluid channel; and

[0029] An electrical signal interface connected to the proximal ends of the electrode wire and the temperature control wire.

[0030] In one embodiment, the functional part includes an imaging probe, which is used for imaging monitoring. The catheter body also includes a tube body, and the imaging probe is arranged in the tube body. An imaging channel is provided in the tube body, and the imaging channel extends axially from the tube body of the functional part to the proximal end of the tube body. An imaging transmission structure connected to the imaging probe is provided in the imaging channel, and the imaging transmission structure is used to be driven by a driving device to drive the imaging probe to rotate circumferentially and / or move axially along the catheter body.

[0031] In one embodiment, the imaging transmission structure includes an imaging optical fiber, a protective tube and a torsion spring, the protective tube is sleeved on the imaging optical fiber, the torsion spring is arranged between the protective tube and the imaging optical fiber, one end of the imaging optical fiber is connected to the imaging probe, and the other end is used to connect to the driving device.

[0032] The medical interventional catheter provided by the present invention includes a functional portion at the distal end of the catheter body, which is used for imaging and monitoring the interior of a target lumen (e.g., a blood vessel) and for releasing a therapeutic source, including therapeutic energy and / or a therapeutic substance, to a target location within the target lumen. This configuration allows the medical interventional catheter of the present invention to function as both an imaging catheter and a therapeutic catheter, achieving integrated diagnosis and treatment. Therefore, when performing interventional treatment on a lesion, there is no need to replace the imaging and therapeutic catheters, thereby eliminating the need to swap catheters. This not only simplifies the surgical procedure but also avoids the difficulty of finding the treatment site after swapping different catheters, reducing surgical difficulty. Furthermore, during treatment, real-time imaging and monitoring of the treatment effect are possible, allowing for precise targeted treatment of the lesion, improving the accuracy and effectiveness of treatment, increasing the success rate of the procedure, and shortening the surgical time. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0034] Figure 1 1 is a schematic diagram of the overall structure of a medical interventional catheter in one embodiment of the present invention;

[0035] Figure 2 is a detailed structural diagram of a medical interventional catheter in one embodiment of the present invention;

[0036] Figure 3 1 is a detailed structural diagram of the medical interventional catheter in the first embodiment of the present invention when used as an ablation catheter;

[0037] Figure 4 yes Figure 3 A partial enlarged view of a TCM interventional catheter at position a;

[0038] Figure 5a yes Figure 4 Cross-section of the middle structure along line AA;

[0039] Figure 5b yes Figure 4 Cross-section of the middle structure along line BB;

[0040] Figure 5c yes Figure 4 Cross-section of the structure along the CC line. DETAILED DESCRIPTION

[0041] To make the objects, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are simplified and not drawn to scale, and are only used to facilitate and clearly illustrate the purpose of the embodiments of the present invention.

[0042] As used in this specification, the singular forms "a", "an" and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise. In the description of the present invention, unless otherwise stated, "multiple" means two or more, and "several" means that the quantity is not limited. In addition, in the description below, a large number of specific details are given in order to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features known in the art are not described.

[0043] In the following description, for the convenience of description, "distal" and "proximal", "axial" and "circumferential" are used; "distal" refers to the side away from the operator of the medical interventional catheter; "proximal" refers to the side close to the operator of the medical interventional catheter; "axial" refers to the direction along the central axis of the medical interventional catheter; "circumferential" refers to the direction around the central axis of the medical interventional catheter; "central axis" refers to the length direction of the medical interventional catheter.

[0044] The technical solution proposed by the present invention is further described below in conjunction with the accompanying drawings and preferred embodiments. In the absence of conflict, the following embodiments and features in the embodiments can complement or combine with each other.

[0045] like Figure 1 and Figure 2 As shown, one embodiment of the present invention provides a medical interventional catheter that integrates diagnosis and treatment. This medical interventional catheter is primarily used for coronary artery interventional treatment, such as the treatment of atherosclerosis. This medical interventional catheter enables real-time imaging monitoring during treatment, improving the accuracy and effectiveness of treatment.

[0046] The medical interventional catheter of the present embodiment includes a catheter body 2 that integrates diagnostic and therapeutic functions. The catheter body 2 includes a functional portion 210 at the distal end. Functional portion 210 is used for imaging and monitoring within a target lumen and for releasing a therapeutic source to a target location within the target lumen. The therapeutic source includes therapeutic energy and / or a therapeutic substance. The target lumen here refers to a blood vessel, preferably a coronary artery.

[0047] Functional unit 210 can implement imaging monitoring within the target lumen using one or more imaging modalities, such as at least one of optical imaging and ultrasound imaging, preferably optical coherence tomography (OCT). OCT offers the highest imaging resolution, facilitating the imaging and resolution of intravascular plaques.

[0048] The functional portion 210 can release one or more types of treatment energy, for example, the functional portion 210 can release at least one type of treatment energy selected from radio frequency, ultrasound, laser, and cryofluid.

[0049] Functional portion 210 can release therapeutic substances to the target location using one or more methods. The therapeutic substance is a therapeutic agent, which is a drug. The present invention does not limit the type of drug; the drug can be selected based on needs, such as anti-proliferative, anti-hyperplastic, anti-restenotic, anti-inflammatory, antibacterial, anti-tumor, anti-mitotic, anti-metastatic, anti-thrombotic, anti-osteoporotic, anti-angiogenic, cytostatic, and microtubule-inhibiting drugs. Functional portion 210 can release the drug to the target location using at least one of a drug coating, drug delivery holes, and drug delivery microneedles.

[0050] Therefore, the medical interventional catheter provided in the embodiment of the present application has the functions of both an imaging catheter and a treatment catheter, realizing the integration of diagnosis and treatment. When performing interventional treatment on the lesion site, there is no need to replace the imaging catheter and the treatment catheter, thereby eliminating the operation of exchanging catheters. This not only simplifies the surgical process, but also avoids the difficulty of finding the treatment site after exchanging different catheters, reduces the difficulty of the operation, and can monitor the treatment effect in real time during the treatment process, thereby improving the accuracy and effectiveness of the treatment, increasing the success rate of the operation, and shortening the operation time.

[0051] like Figure 1 and Figure 2 As shown, in one embodiment, the functional portion 210 includes a treatment component 211 and an imaging probe 212. The treatment component 211 is used to release a therapeutic source to a target location (including a lesion). The treatment component 211 can release at least one of radiofrequency, ultrasonic, laser, and cryofluid treatment energies, and / or utilize one or more structures to release therapeutic substances to the target location.

[0052] In one embodiment, the treatment component 211 includes an energy output structure for outputting therapeutic energy. The energy output structure may be at least one of an electrode, an ultrasonic transducer, a laser focusing lens, and a cryofluid channel. The electrode is configured to output radio frequency. The ultrasonic transducer is configured to generate ultrasonic waves. The laser focusing lens is configured to output laser light. The cryofluid channel is configured to be sealed within a medical interventional catheter and conduct energy for cryoablation.

[0053] In one embodiment, the therapeutic component 211 includes a therapeutic agent delivery structure for releasing the therapeutic agent to the target location. The therapeutic agent delivery structure can be any suitable structure, such as comprising at least one of a drug coating and a drug release structure. The drug release structure can include drug delivery holes and / or drug delivery microneedles. The drug delivery microneedles can be pre-stored with drugs or deliver drugs through drug delivery channels.

[0054] In a specific example, the catheter body 2 also includes a tube body, and the drug coating, drug delivery hole and / or drug delivery microneedle are arranged on the outer surface of the tube body, that is, the functional part 210 itself includes a tube body, and the drug coating, drug delivery hole and / or drug delivery microneedle are arranged on the outer surface of the tube body. The way in which the therapeutic agent output structure releases the therapeutic agent can be one or a combination of two or more, such as providing both a drug coating and a drug release structure. It should be noted that the energy output structure and the therapeutic agent output structure can be provided at the same time or one of them can be provided selectively. In addition, when the therapeutic agent output structure adopts a drug delivery hole and / or a drug delivery microneedle, a drug delivery channel is provided in the tube body, and the drug delivery channel extends axially from the tube body of the functional part 210 to the proximal end of the tube body, and the distal end of the drug delivery channel is connected to the drug delivery hole and / or the drug delivery microneedle.

[0055] The imaging probe 212 is used for imaging and monitoring within the vascular lumen, specifically for imaging and monitoring the lesion area. This facilitates identification of the lesion location and lesion components prior to treatment, monitoring the treatment effect or the extent of therapeutic agent release during treatment, and performing imaging scans to assess the treatment effect after treatment of the lesion area. This application does not limit the imaging method of the imaging probe 212. The imaging probe 212 can use optical imaging or ultrasonic imaging, preferably using OCT optical coherence tomography imaging. The imaging probe 212 can use at least one of a microlens (light focusing component), an ultrasonic probe, and a light reflector. That is, the imaging method of the imaging probe 212 can be one or a combination of two or more.

[0056] like Figure 2~Figure 3 、 Figure 4 、 Figure 5a and Figure 5b As shown, an imaging probe 212 is disposed within the catheter body, which is provided with an imaging channel 21. The imaging channel 21 extends axially from the tubular body of the functional portion 210 to the proximal end of the tubular body. An imaging transmission structure 213 connected to the imaging probe 212 is disposed within the imaging channel 21. Preferably, the imaging transmission structure 213 is driven by a driving device to cause the imaging probe 212 to rotate circumferentially and / or move axially along the catheter body 2, thereby adjusting the position and orientation of the imaging probe 212 and providing greater flexibility and convenience for intravascular imaging monitoring.

[0057] Specifically, one end of the imaging transmission structure 213 is connected to the imaging probe 212, and the other end extends through the imaging channel 21 to the proximal end of the catheter body 2. Optionally, the other end of the imaging transmission structure 213 is connected to the interface portion 1. The imaging transmission structure 213 is used to transmit the collected signals and energy for imaging. In one embodiment, the imaging probe 212 adopts optical imaging. In this case, the imaging transmission structure 213 includes an imaging optical fiber, and the imaging probe 212 is an optical probe. Preferably, the imaging transmission structure 213 also includes a protective tube and a torsion spring. The protective tube is sleeved on the imaging optical fiber. The torsion spring is arranged between the protective tube and the imaging optical fiber. One end of the imaging optical fiber is connected to the imaging probe 212, and the other end is used to connect to the driving device. The setting of the torsion spring can better transmit torsion so as to smoothly drive the imaging optical fiber and the imaging probe 212 to move.

[0058] In one embodiment, the imaging probe 212 employs OCT imaging, using an ultra-low propagation loss, very small diameter (e.g., 200 μm) imaging fiber as the light guide. A microlens is employed for collecting and transmitting optical signals, serving as a light focusing component. The light focusing component can be a spherical lens or a gradient index lens. Because optical fibers are glass fibers and are very fragile, they can easily break if not properly protected during use. Therefore, the entire transmission fiber is encapsulated in a protective tube to form a transmission cable. This prevents mechanical damage to the optical components and distal light focusing assembly during movement, and provides improved tensile and bending resistance. The protective tube can be transparent.

[0059] like Figure 2 and Figure 4 As shown, the functional part 210 includes a transparent imaging window 214. The imaging probe 212 is arranged at a position corresponding to the imaging window 214. The imaging window 214 facilitates the imaging probe 212 to transmit and receive light signals. The axial length of the imaging window 214 can be 2 mm to 100 mm, such as the length of the tube body extending from the proximal end to the distal end of the connecting part 4 is the axial length of the imaging window 214. The imaging window 214 can be understood as the tube body of the functional part 210 being set to be transparent. The transparent material can be transparent nylon. The portion of the tube body other than the imaging window 214 is mainly made of opaque material, such as polyamide and the like, and preferably, this portion is a braided tube.

[0060] like Figure 1 and Figure 2As shown, in one embodiment, the proximal end of the catheter body 2 is connected to the interface portion 1. Interface portion 1 serves as an interface for connecting to external devices and is used to input and output information. The information input and output by interface portion 1 includes at least energy and collected signals. The energy includes at least energy for imaging monitoring, and the collected signals include at least collected image signals. Interface portion 1 includes multiple interfaces, the number and type of which should be determined based on the functionality of the functional portion 210 itself.

[0061] In one embodiment, the interface portion 1 includes a fluid perfusion interface 11, an imaging interface 12, an electrical signal interface 13 (e.g., an electrical current interface), and a mechanical power transmission interface 14. The fluid perfusion interface 11 is used to connect to a fluid perfusion device to inject a temperature-control fluid, typically saline, into the medical interventional catheter. The imaging interface 12 is used to connect to an external imaging system, which outputs imaging energy (e.g., laser or electrical energy) to the medical interventional catheter and receives acquisition signals fed back from the catheter. The electrical signal interface 13 is used to connect to an external energy output device, which outputs electrical energy for treatment and temperature monitoring to the medical interventional catheter. The electrical signal interface 13 can also connect to an external control device, which receives temperature signals fed back from the catheter. The mechanical power transmission interface 14 is used to connect to a drive device, which drives the imaging probe 212 to rotate circumferentially and / or move axially around the catheter body 2. In one embodiment, the other end of the imaging transmission structure 213 is connected to the mechanical power transmission interface 14. The mechanical power transmission interface 14 can be integrated with the imaging interface 12. The driving device drives the imaging transmission structure 213 and the imaging probe 212 to move and rotate through the mechanical power transmission interface 14. The driving device can be a motor.

[0062] like Figure 4 As shown, combined with Figure 5a and Figure 5b In a preferred embodiment, the central axis of the imaging channel 21 coincides with the central axis of the tube body, i.e., the imaging channel 21 is located at the center of the tube body. Since the imaging channel 21 is the largest component within the entire medical interventional catheter, placing it in the center of the catheter facilitates overall catheter coaxiality and component layout. Specifically, this facilitates the placement of other functional channels around the periphery of the imaging channel 21, effectively utilizing the internal space of the tube body. This ensures sufficient strength of the catheter body 2 while avoiding increasing the outer diameter of the medical interventional catheter, facilitating interventional treatment in small blood vessels.

[0063] In addition to providing an imaging channel 21 for imaging monitoring, the tubular body of the catheter body 2, in some embodiments, also provides a channel for delivering therapeutic energy and / or therapeutic agents to the treatment component 211. The number of channels in the tubular body is set according to actual needs and is not limited in this application.

[0064] There are no specific requirements for the formation of the channels within the tube body. For example, the tube body can be a multi-lumen tube, with the lumens of the multi-lumen tube itself serving as the channels. Alternatively, the tube body can be a single-lumen tube with tubes positioned within the tube to form the channels. Regardless of the structure, the tube body should possess adequate strength to support the individual channels. The single-lumen tube is preferably a braided tube, which reduces the tube wall thickness while maintaining tube strength, ensuring effective integration space within the tube lumen.

[0065] In a preferred embodiment, the functional unit 210 includes an imaging probe 212, electrodes, and a temperature measurement component. In this case, the energy output structure includes the electrodes. The electrodes are used to deliver radiofrequency energy. The temperature measurement component is mounted on the electrodes and is used to monitor the surface temperature of the electrodes. To ensure the overall miniaturization of the medical interventional catheter, the imaging transmission structure 213 connected to the imaging probe 212, the temperature control wires connected to the temperature measurement component, and the electrode wires connected to the electrodes require a rational arrangement.

[0066] In one embodiment, the number of the electrodes is multiple, and the multiple electrodes are spaced apart along the axial and / or circumferential direction of the catheter body 2. The electrodes can be annular electrodes or non-annular electrodes. When the electrodes are annular, they are suitable for concentric diffuse plaque ablation. When the electrodes are non-annular, they are suitable for eccentric plaque ablation. The medical interventional catheter of the embodiment of the present application preferably integrates both annular electrodes and non-annular electrodes, so that the medical interventional catheter can perform conformal treatment on the treatment area, that is, adapt to the treatment of different lesion shapes to meet different clinical treatment needs.

[0067] The electrodes are attached to the outer surface of the tube body of the functional portion 210. The electrodes can be ring-shaped or strip-shaped, and can be fabricated into a sheet-like or mesh-like structure. The electrodes may or may not be developable, and this is not a requirement. This application does not specifically limit the material of the electrodes; for example, RF electrodes can be made of materials such as platinum-iridium alloy, platinum, copper, iron, or stainless steel. Furthermore, a certain insulation distance must exist between the electrodes, and this insulation distance should not be too small or too large. When a pulsed electric field is generated, the pulsed electric field is released as positive and negative electrode signals between the positive and negative electrodes. If the insulation distance between the electrodes is too small, sparking and low-temperature plasma effects are likely to occur. If the insulation distance is too large, the electric field strength will be affected. Therefore, the insulation distance between the electrodes cannot be set arbitrarily. The insulation distance should ensure the electric field energy intensity without generating ionization, ensuring energy and safety at the lesion site. In one embodiment, the insulation distance between the electrodes is 1 mm to 5 mm to precisely control the ablation range and avoid discharge caused by close proximity of the electrodes. The size of the electrodes can be set according to actual needs. In one embodiment, the electrode has an axial width of 2 mm to 10 mm along the medical interventional catheter, and a radial thickness of 0.05 mm to 0.5 mm. It should be understood that electrode size should be determined based on the size of the lesion. Generally, larger electrodes increase the ablation range. Given that plaques are typically around 1 mm in size, an axial electrode width of 2 mm to 10 mm can generally meet treatment requirements.

[0068] The temperature measuring component monitors the temperature at the target location during the treatment energy output process, thereby accurately controlling the intensity of the treatment energy output. The temperature measuring component can obtain more accurate temperature information of the lesion, thereby improving the treatment effect. The temperature measuring component can be any suitable structure, such as: a thermocouple, a thermistor, or a thermal signal acquisition lens. The temperature measuring component can use at least one of a thermocouple, a thermistor, and a thermal signal acquisition lens. In an embodiment of the present application, the temperature measuring component uses a thermocouple and directly monitors the surface temperature of the electrode to determine the temperature of the lesion site based on the surface temperature of the electrode.

[0069] Furthermore, the electrodes are arranged on the outer surface of the tube body. Figure 5a and Figure 5bAs shown, the tube body is provided with independent imaging channels 21, temperature control wire channels 23, and electrode wire channels 24. The imaging channel 21, electrode wire channels 24, and temperature control wire channels 23 all extend axially from the tube body of the functional portion 210 to the proximal end of the tube body. The imaging channel 21 is located at the center of the tube body. The electrode wire channels 24 and temperature control wire channels 23 are arranged around the imaging channel 21. An electrode wire 6 connected to the electrode is located within the electrode wire channel 24. A temperature control wire 5 connected to the temperature measuring component is located within the temperature control wire channel 23. In other embodiments, the temperature control wire 5 and electrode wire 6 may share a single wire channel. In this case, the two wires can be isolated from each other using an insulating coating to prevent mutual interference. Furthermore, there are multiple electrodes, and the number of electrodes corresponds to the number of temperature measuring components. Each electrode is connected to an electrode wire 6. One end of the electrode wire 6 is welded to the inner surface of the electrode, and the other end passes through the electrode wire channel 24 and is connected to the electrical signal interface 13. The material of the electrode wire 6 should be determined based on actual needs, such as by selecting the material of the electrode wire based on different length and impedance values. The temperature-measuring component is connected to a temperature-control wire 5. One end of the temperature-control wire 5 is connected to the temperature-measuring component, and the other end passes through the temperature-control wire channel 23 and is connected to the electrical signal interface 13. The electrode wire 6 and the temperature-control wire 5 can be connected to the same electrical signal interface 13 or different electrical signal interfaces 13. Preferably, the electrode wire 6 and the temperature-control wire 5 are made of a material in the hundreds of micrometers to reduce the difficulty of controlling the overall size of the catheter.

[0070] As a further improvement, a temperature-controlled fluid channel 22 is further provided within the tube body. The temperature-controlled fluid channel 22, the imaging channel 21, the temperature-controlled wire channel 23, and the electrode wire channel 24 are independently provided, that is, the channels are isolated from each other and do not interfere with each other. The temperature-controlled fluid channel 22 is arranged on the periphery of the imaging channel 21. Furthermore, a temperature-controlled fluid output hole 215 is provided on the electrode. The temperature-controlled fluid channel 22 extends axially from the proximal end of the tube body and is connected to the temperature-controlled fluid output hole 215. The temperature-controlled fluid channel 22 is used to transport the temperature-controlled fluid, and the temperature-controlled fluid is released to the target location through the temperature-controlled fluid output hole 215. Optionally, the proximal end of the temperature-controlled fluid channel 22 is connected to the interface portion 1, such as the fluid perfusion interface 11. The temperature-controlled fluid output hole 215 is used to release a temperature-controlled fluid (such as hot gas or cold saline) at a certain temperature to the target location (such as the ablation location) to reduce overheating or overcooling damage to the tissue. Therefore, during the energy treatment process, cold or hot fluid can be delivered to the target location with the help of the temperature-controlled fluid channel 22 to maintain the temperature of the contact surface between the medical interventional catheter and the target tissue within the normal body temperature range, thereby protecting the non-treatment area and increasing the safety of the treatment process.

[0071] The temperature-controlled fluid output hole 215 is preferably a micropore. If the aperture of the micropore is too large, it will affect the overall shape of the electrode and affect ablation; if the aperture of the micropore is too small, it will cause the problem that the fluid viscosity is too high and cannot flow out of the micropore. For this reason, the aperture of the micropore is preferably 50μm~200μm. The setting of the micropore can reduce the impact of the temperature-controlled fluid on the electrode during output. The temperature of the temperature-controlled fluid can be adjusted according to actual needs, for example, it can be 15℃~30℃. The temperature and energy output power of the temperature-controlled fluid can be adjusted at the same time to achieve a complete ablation effect of protecting the endothelium.

[0072] As one embodiment, the tube body is a single-lumen braided tube, and a temperature-controlled fluid tube, an imaging tube, an electrode wire tube, and a temperature-controlled wire tube are arranged in the single-lumen braided tube. The inner cavity of the temperature-controlled fluid tube forms a temperature-controlled fluid channel 22. The inner cavity of the imaging tube forms an imaging channel 21. The inner cavity of the electrode wire tube forms an electrode wire channel 24. The inner cavity of the temperature-controlled wire tube forms a temperature-controlled wire channel 23. The temperature-controlled fluid tube, imaging tube, electrode wire tube, and temperature-controlled wire tube in the single-lumen braided tube can be arranged at intervals from each other, or can be arranged close to each other without being connected, or can be fixed to each other, such as by gluing their outer surfaces. The wall thickness of the temperature-controlled fluid tube, imaging tube, electrode wire tube, and temperature-controlled wire tube is less than 0.2 mm, so as to reduce the overall size of the medical interventional catheter and reduce the difficulty of size control.

[0073] In a specific application scenario, the medical interventional catheter of this embodiment is used in coronary arteries. In this case, the outer diameter of the tube body is preferably 1.0 mm to 3.0 mm, preferably 1.8 mm to 2.0 mm. If the outer diameter of the tube body exceeds 3.0 mm, it is too large to allow coronary artery intervention. If the outer diameter of the tube body is less than 1.0 mm, it is difficult to integrate the various channels within it, increasing the process complexity. The wall thickness of the tube body can be 0.1 mm to 0.5 mm, ensuring the overall strength of the medical interventional catheter while also ensuring good flexibility. Furthermore, the diameter of the imaging channel 21 does not exceed 1.0 mm, the diameter of the temperature control fluid channel 22 does not exceed 0.5 mm, the diameter of the electrode wire channel 24 is 0.1 mm to 0.5 mm, and the diameter of the temperature control wire channel 23 is 0.1 mm to 0.5 mm. By controlling the diameter of each channel, while fully accommodating each component, it also reduces the mutual influence between the components, ensuring that each function can operate and be realized normally.

[0074] like Figure 3 and Figure 4 As shown, combined with Figure 5a to Figure 5c, using two electrodes as an example, the two electrodes are respectively a proximal electrode 216 and a distal electrode 217. Both electrodes are provided with a temperature-controlled fluid output hole 215. Preferably, at least the proximal electrode 216 is provided with a temperature-controlled fluid output hole 215. The temperature-controlled fluid is released through the temperature-controlled fluid output hole 215 on the proximal electrode 216, so that the temperature-controlled fluid fills the entire ablation zone. In the illustrated embodiment, the proximal electrode 216 and the distal electrode 217 are both annular electrodes, which are arranged at a certain distance in the axial direction, and the imaging probe 212 is disposed between the proximal electrode 216 and the distal electrode 217. The area between the proximal electrode 216 and the distal electrode 217 serves as the ablation zone, where radiofrequency ablation is performed on the lesion, while the imaging probe 212 monitors the treatment effect of the lesion in the ablation zone.

[0075] The outer diameter of the medical interventional catheter provided in the embodiment of the present application should be set in combination with the diameter of the blood vessel to be intervened. For example, the outer diameter of the medical interventional catheter can be 1.0 mm to 10.0 mm to accommodate systemic diseases. Preferably, the outer diameter of the medical interventional catheter provided in the embodiment of the present application does not exceed 2 mm to solve the problem of ablation plaque treatment at a smaller size. Here, it should be understood that the outer diameter of the medical interventional catheter mainly refers to the outer diameter of the catheter body 2 and the connecting portion 4 and the head end 3 in the following content. The outer diameters of the catheter body 2 and the connecting portion 4 are usually the same, and the proximal outer diameter of the head end 3 is the same as the outer diameter of the catheter body 2, that is, the part of the medical interventional catheter that enters the human body, and its outer surface is smooth and flat.

[0076] As a specific embodiment, Figure 4 ,as well as Figures 5a to 5c As shown, the catheter body 2 includes an imaging channel 21, a temperature-controlled fluid channel 22, and multiple wire channels. Taking two electrodes and two thermocouples as an example, the multiple wire channels are specifically four wire channels, two of which are temperature-controlled wire channels 23, which are used to lay the temperature-controlled wires 5 on the thermocouples, and the other two are electrode wire channels 24, which are used to lay the electrode wires 6. The temperature-controlled fluid channel 22, the temperature-controlled wire channel 23, and the electrode wire channel 24 are all arranged around the imaging channel 21, and the imaging channel 22 is set at the center of the medical interventional catheter. The two temperature-controlled wire channels 23 are symmetrically arranged relative to the imaging channel 21, and the two electrode wire channels 24 are also symmetrically arranged relative to the imaging channel 21, and the temperature-controlled fluid channel 22 is arranged in parallel with the imaging channel 21. This arrangement solves the problem of compatibility between light, electricity, and heat, and reduces the mutual influence and interference between the three.

[0077] like Figure 2As shown, in one embodiment, the medical interventional catheter further includes a head end 3, which is connected to the distal end of the functional part 210 through a connecting part 4. The connecting part 4 serves as a physical end seal and connects the functional part 210 and the head end 3. The connecting part 4 is a solid body, which can further seal the distal end of the functional part 210. Preferably, the connecting part 4 is an elastomer to reduce the risk of damage to the head end 3. The material for making the connecting part 4 can be polyurethane or silicone. The diameter of the connecting part 4 is consistent with the diameter of the catheter body 2. The length of the connecting part 4 should not be too long or too short; if it is too long, the bending radius of the entire distal end will increase, and the passing ability when encountering expected lesions will be reduced; if it is too short, the protection effect on the head end 3 is limited. For this reason, the axial length of the connecting part 4 is 1mm~10mm.

[0078] The head end 3 is usually soft and has a non-destructive structure, which can reduce damage to blood vessels or tissues. The head end 3 is preferably provided with a guide wire cavity 31 for the guide wire to pass through to achieve rapid exchange. By placing the guide wire cavity 31 in front, it is possible to more conveniently replace and operate the medical interventional catheter without affecting the overall size of the medical interventional catheter. The inner diameter of the guide wire cavity 31 can be set in combination with the diameter of the guide wire, such as the inner diameter of the guide wire cavity 31 is 0.1mm~2mm. The size of the head end 3 should not be too large, otherwise it will not be easy to pass through the stenosis lesion. Therefore, the size of the head end 3 is smaller. The head end 3 is a tapered head, and the head end 3 should not be too long. If it is too long, the head end 3 will be sharp and will damage the blood vessels or tissues. If the head end 3 is too short, it will affect the crossing performance. The axial length of the head end 3 can be 5.0mm~50mm, preferably 20mm.

[0079] In a non-limiting embodiment, the medical interventional catheter of the present invention may be used as follows, specifically comprising:

[0080] (1) Connect the imaging interface 12 to the imaging system, the electrical signal interface 13 to the energy output device, the fluid perfusion interface 11 to the fluid perfusion device, and the mechanical power transmission interface 14 to the drive device;

[0081] (2) The medical interventional catheter is delivered to the diseased vascular segment via the guide wire, and then the imaging system is turned on to image the diseased area to identify the location and components of the lesion;

[0082] (3) After the imaging diagnosis, the functional part 210 is delivered to the designated lesion location, and then the energy output device is turned on to release the therapeutic energy and / or therapeutic agent to the lesion location. During this period, the imaging system continues to work and continuously monitors the energy treatment effect or the degree of therapeutic agent release;

[0083] (4) After one lesion is treated, the medical interventional catheter is moved to the next lesion and the above process is repeated for treatment;

[0084] (5) After the lesion area is completely treated, the entire treated area is scanned to evaluate the treatment effect;

[0085] (6) Finally, the entire medical interventional catheter is withdrawn through the guide wire to complete the treatment process.

[0086] Next, the medical interventional catheter provided in the embodiment of the present application will be further described in conjunction with specific application scenarios.

[0087] In one application scenario, the medical interventional catheter provided in an embodiment of the present application is an ablation catheter, and uses OCT imaging and radiofrequency ablation, which is applied to the treatment of atherosclerotic plaques.

[0088] like Figure 3 、 Figure 4 as well as Figure 5a to Figure 5cAs shown, the ablation catheter includes an interface portion 1, a catheter body 2, a tip 3, and a connecting portion 4. The interface portion 1 includes a fluid perfusion interface 11, an imaging interface 12, and an electrical signal interface 13. The outer diameter of the tube body in the catheter body 2 is 1.8 mm and the wall thickness is 0.2 mm, which can be used for coronary atherosclerosis. The functional portion 210 includes a proximal electrode 216 and a distal electrode 217 spaced apart along the axial direction. The proximal electrode 216 and the distal electrode 217 are both annular and made of a platinum-iridium alloy. The proximal electrode 216 and the distal electrode 217 are used to output radiofrequency energy. The thickness of the proximal electrode 216 and the distal electrode 217 are both 0.1 mm, the axial width is 2.0 mm, and the diameter of the electrode wire 6 is 200 μm. The proximal electrode 216 and the distal electrode 217 are both provided with a temperature-controlled fluid output hole 215. The temperature-controlled fluid output holes 215 are evenly distributed along the circumference of the corresponding electrode. There are 12 temperature-control fluid output holes 215, each with a diameter of 90 μm. The tube body between the proximal electrode 216 and the distal electrode 217 is transparent and serves as the imaging window 214. Furthermore, a portion of the tube body proximal to the proximal electrode 216 also serves as the imaging window 214. The interior of the tube body comprises an imaging channel 21, a temperature-control fluid channel 22, two temperature-control wire channels 23, and two electrode wire channels 24, all independently arranged. The proximal and distal electrodes 216 and 217 are connected to two thermocouples in a one-to-one correspondence, and the temperature-control wires 5 have a diameter of 200 μm. The diameter of the imaging channel 21 is 0.5 mm. The imaging probe 212 utilizes a gradient refractive index (GRIN) lens, positioned between the proximal and distal electrodes 216 and 217, capable of receiving and transmitting optical signals through the imaging window 214. The imaging fiber moves axially and rotates within the imaging channel 21 in response to the drive mechanism, while simultaneously transmitting and collecting optical signals through the GRIN lens. The temperature-controlled fluid channel 22 is located on one side of the imaging channel 21. Its diameter is 0.3 mm. Cold saline enters the temperature-controlled fluid channel 22 from the fluid perfusion device via the fluid perfusion port 11. It then flows through the temperature-controlled fluid outlet port 215 on the electrode to the lesion, cooling it during the radiofrequency ablation process and protecting the endothelial cells. The flow rate of cold saline can be adjusted to meet different cooling requirements. Each electrode is welded with an electrode wire 6 and a temperature-controlled wire 5 for the thermocouple. The electrode wire 6 is made of a platinum-iridium alloy, and the temperature-controlled wire 5 is made of a copper-nickel alloy. The two temperature-controlled wires 5 and two electrode wires 6 are distributed within the corresponding wire channels, symmetrically arranged relative to the imaging channel 21 and the temperature-controlled fluid channel 22. The imaging port 12 and the mechanical power transmission port 14 are integrated into one, connecting this integrated port to the imaging system. The imaging probe 212 transmits laser light and collects light signals reflected from the blood vessels through a combination of an imaging fiber and a microlens. During the procedure, a guide wire is passed through the guidewire lumen 31 of the tip 3 to deliver the ablation catheter into the blood vessel.Tip 3 features a quick-exchange design. By placing the guidewire lumen 31 forward, it allows for rapid replacement of interventional instruments and reduces the overall size of the catheter. The inner diameter of the guidewire lumen 31 is 0.5 mm. The axial length of tip 3 is 20 mm.

[0089] In more detail, the ablation catheter of this embodiment involves: first, imaging the blood vessels using an OCT imaging system and analyzing the plaque morphology and composition; then, based on the imaging results, aligning the two ring electrodes (i.e., the proximal electrode 216 and the distal electrode 217) with the ablation site; turning on the radiofrequency system (energy output device) and applying radiofrequency current through the electrical signal interface 13 to generate impedance heat within the plaque, thereby ablating the vascular plaque. During this process, the imaging probe 212 continuously rotates to collect real-time signal imaging and monitor the degree of ablation. Thermocouples on the surfaces of the two ring electrodes monitor the ablation temperature in real time. Simultaneously, cold saline is continuously perfused from the temperature-controlled fluid outlet 215 to flush the electrodes and the ablated tissue surface, regulating the temperature and reducing endothelial cell damage. After ablation of one lesion is completed, the medical interventional catheter is moved to the next lesion for ablation. After treatment is complete, OCT imaging of the entire vascular segment is performed to assess the therapeutic effect. Finally, the catheter is withdrawn, completing the procedure.

[0090] It is particularly important to note that the ablation catheter of the embodiment of the present invention is not limited to being a radiofrequency ablation catheter, but can also be a cryoablation catheter. If it is a cryoablation catheter, it is necessary to set a cryofluid channel inside the tube body, and set an outlet at the distal end of the cryofluid channel, and use it to spray the cryofluid onto the inner surface of the balloon. In this case, a balloon can be placed over the functional part. It should also be understood that in the prior art, there is no radiofrequency ablation for atherosclerotic plaques under the guidance of intravascular imaging and temperature control. The outer diameter of the medical interventional catheter provided by the present invention can be no more than 2 mm. At this time, the problem of thermal ablation plaque treatment at a smaller size can be solved, and by effectively combining imaging, temperature monitoring and radiofrequency ablation, radiofrequency ablation can be made more precise and the ablation effect better.

[0091] The medical interventional catheter provided by the present invention can diagnose and treat vascular diseases, heart diseases, etc. in one or more ways, such as using OCT imaging to formulate a treatment plan before treatment, and using OCT imaging and temperature monitoring to provide real-time feedback on the treatment effect during treatment. After the treatment, the treatment effect is evaluated as a whole, effectively improving the treatment effect. In addition, when preparing the medical interventional catheter, the catheter is segmented and nested with functional blocks, which solves the technical problems of component distribution and function realization in a small physical space, realizes one tube with multiple functions and integrated diagnosis and treatment. After application, the catheter can effectively improve the expected clinical effect. The medical interventional catheter of the present invention can achieve precise location of the lesion and perform real-time monitoring and treatment, simplifying the treatment steps and facilitating the doctor's operation. At the same time, the medical interventional catheter of the present invention can be reused during the treatment process until the treatment is complete, saving material consumption, which is conducive to reducing the current incidence of complications after intervention, improving clinical treatment effects, reducing the rate of re-hospitalization, reducing the family burden and socioeconomic losses caused by the disease, and has good economic and ecological benefits.

[0092] While the present invention is disclosed above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to encompass such modifications and variations as long as they fall within the scope of the present invention and its equivalents.

Claims

1. A medical interventional catheter, characterized in that: The catheter comprises a tip and a catheter body that integrates diagnosis and treatment. The catheter body includes a functional portion at the distal end, the functional portion being used for imaging monitoring within a target lumen and for releasing a therapeutic source, including therapeutic energy and / or therapeutic substances, to a target location within the target lumen. The distal end of the functional portion is connected to the proximal end of the tip via an elastic connecting portion that seals the distal end of the functional portion. The tip is provided with a guidewire lumen. The functional part includes an imaging probe, an electrode, and a temperature measuring component. The imaging probe is used for imaging monitoring, and the electrode is used for releasing radio frequency. There are multiple electrodes, and the multiple electrodes are arranged at intervals along the axial direction and / or circumferential direction of the catheter body. At least two of the multiple electrodes are annular electrodes, and at least two of the annular electrodes are arranged at intervals along the axial direction of the catheter body. The imaging probe is arranged between two adjacent annular electrodes. The temperature measuring component is arranged on the electrode and is used to monitor the surface temperature of the electrode. The catheter body further includes a tube body, the imaging probe is disposed within the tube body, and the electrodes are disposed on the outer surface of the tube body; the tube body between two adjacent annular electrodes is a transparent structure and serves as an imaging window; the imaging probe receives and transmits light signals through the imaging window; the outer diameter of the tube body is 1.0 mm to 3.0 mm; An independent imaging channel, an electrode wire channel and a temperature control wire channel are provided in the tube body. The imaging channel, the electrode wire channel and the temperature control wire channel all extend axially from the tube body of the functional part to the proximal end of the tube body. The imaging channel is provided at the center of the tube body. The electrode wire channel and the temperature control wire channel are both arranged around the imaging channel. An imaging transmission structure connected to the imaging probe is provided in the imaging channel, an electrode wire connected to the electrode is provided in the electrode wire channel, and a temperature control wire connected to the temperature measuring component is provided in the temperature control wire channel.

2. The medical interventional catheter according to claim 1, characterized in that: The functional part adopts one or more imaging methods to realize imaging monitoring of the target lumen.

3. The medical interventional catheter according to claim 2, characterized in that: The functional part uses OCT imaging to achieve imaging monitoring of the target lumen.

4. The medical interventional catheter according to claim 1, characterized in that: The functional part is capable of releasing one or more of the therapeutic energies.

5. The medical interventional catheter according to claim 4, characterized in that: The functional part can also release at least one therapeutic energy selected from ultrasound, laser and cryofluid.

6. The medical interventional catheter according to claim 1, characterized in that: The functional part releases the therapeutic substance to a target position in the target lumen in one or more ways.

7. The medical interventional catheter according to claim 6, characterized in that: The therapeutic substance is a drug, and the functional part releases the drug to a target position in the target lumen by at least one of a drug coating, a drug delivery hole, and a drug delivery microneedle.

8. The medical interventional catheter according to claim 7, characterized in that: When the functional part adopts a dosing hole and / or a dosing microneedle, the dosing hole and / or the dosing microneedle are arranged on the outer surface of the tube body, and a dosing channel is provided in the tube body. The dosing channel extends axially from the tube body of the functional part to the proximal end of the tube body, and the distal end of the dosing channel is connected to the dosing hole and / or the dosing microneedle.

9. The medical interventional catheter according to claim 1, characterized in that: A temperature-control fluid channel is also provided in the tube body. The temperature-control fluid channel is independently provided relative to the imaging channel, the electrode wire channel and the temperature-control wire channel, and is arranged on the periphery of the imaging channel. A temperature-control fluid output hole is provided on the electrode. The temperature-control fluid channel extends axially from the proximal end of the tube body and is connected to the temperature-control fluid output hole. The temperature-control fluid channel is used to transport the temperature-control fluid, and the temperature-control fluid is released to the target position through the temperature-control fluid output hole.

10. The medical interventional catheter according to claim 9, characterized in that: The tube body is a single-lumen braided tube, in which a temperature-control fluid tube, an imaging tube, an electrode wire tube and a temperature-control wire tube are arranged. The inner lumen of the temperature-control fluid tube forms the temperature-control fluid channel, the inner lumen of the imaging tube forms the imaging channel, the inner lumen of the electrode wire tube forms the electrode wire channel, and the inner lumen of the temperature-control wire tube forms the temperature-control wire channel. The wall thickness of the temperature-control fluid tube, the imaging tube, the electrode wire tube and the temperature-control wire tube are all less than 0.2 mm.

11. The medical interventional catheter according to claim 10, characterized in that: The temperature control fluid tube, the imaging tube, the electrode wire tube and the temperature control wire tube are fixedly connected to each other.

12. The medical interventional catheter according to claim 9, characterized in that: The outer diameter of the tube body is 1.0mm~3.0mm, the diameter of the imaging channel does not exceed 1.0mm, the diameter of the temperature control fluid channel does not exceed 0.5mm, the diameter of the electrode wire channel is 0.1mm~0.5mm, and the diameter of the temperature control wire channel is 0.1mm~0.5mm.

13. The medical interventional catheter according to claim 9, characterized in that: The temperature control fluid output hole is a micropore, and the pore diameter of the micropore is 50 μm to 200 μm.

14. The medical interventional catheter according to claim 9, characterized in that: The catheter body further comprises an interface portion, to which the proximal end of the catheter body is connected, and the interface portion comprises: an imaging interface connected to the proximal end of the imaging transmission structure; a fluid perfusion interface connected to the proximal end of the temperature-controlled fluid channel; and An electrical signal interface connected to the proximal ends of the electrode wire and the temperature control wire.

15. The medical interventional catheter according to claim 1, characterized in that: The imaging transmission structure is configured to be driven by a driving device to drive the imaging probe to rotate along the circumferential direction of the catheter body and / or to move along the axial direction of the catheter body.

16. The medical interventional catheter according to claim 15, characterized in that: The imaging transmission structure includes an imaging optical fiber, a protective tube and a torsion spring. The protective tube is sleeved on the imaging optical fiber, and the torsion spring is arranged between the protective tube and the imaging optical fiber. One end of the imaging optical fiber is connected to the imaging probe, and the other end is used to connect to the driving device.

Images