Medical catheter

Abstract

The present application relates to a kind of medical catheter, including catheter main body and control bending component, the catheter main body includes proximal end portion and the distal end portion at the distal end of catheter main body, the distal end portion is used for imaging monitoring, also for releasing treatment energy and / or therapeutic agent, the distal end portion is connected with control bending component, and it is used for bending relative to proximal end portion under the control of control bending component.The medical catheter of the present application is used, and treatment effect can be monitored in real time during treatment by imaging, and the bending angle of distal end portion can be adjusted at any time, so that distal end portion is closely attached to focus, to realize the precise target treatment of focus, improve treatment effect, improve operation success rate.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a medical catheter with diagnosis and treatment functions and controllable bending. BACKGROUND

[0002] Atherosclerosis is a syndrome affecting arterial blood vessels. Atherosclerosis leads to a chronic inflammatory response in the wall of an artery, mostly due to the accumulation of lipids, macrophages, foam cells and the formation of plaques in the arterial wall. Atherosclerosis is often referred to as arteriosclerosis, and the pathophysiology of the disease manifests several different types of lesions, ranging from fibrosis to lipid-laden to calcification. At present, the main mature treatment methods for atherosclerosis in clinical practice include drugs, intervention 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. The means of achieving thermal physical therapy is thermal ablation. The energy generation methods of thermal ablation mainly include cryoballoon, focused ultrasound, laser and radiofrequency, etc. Clinical studies have shown that radiofrequency ablation has the advantages of a certain safe frequency, controllable thermal energy output and easier functional integration. In thermal physical therapy, in order to ensure the ablation effect, a certain range of tissue damage needs to be caused, but there is no related technical means to accurately monitor and control the ablation range of fibrous plaques at present.

[0004] The current monitoring means is mainly intravascular imaging. Intravascular imaging techniques mainly include OCT (optical coherence tomography), IVUS (intravascular ultrasound imaging), angioscope and intravascular MRI, etc. Compared with other imaging techniques, the OCT technique has obvious advantages in imaging resolution (resolution better than 10 μm), and can obtain high-definition images of biological tissues, which is very beneficial to the accurate imaging and identification of intravascular plaques. However, in the treatment process, the diagnosis and treatment processes are usually separated, so the imaging catheter and the ablation catheter need to be frequently replaced, which not only increases the overall treatment cost, but also cannot provide timely treatment, and still has a high recurrence rate in some cases. In addition, during the treatment process, the ablation catheter will often fail to properly adhere to the tissue (lesion), resulting in poor treatment effect or even failure of the operation. SUMMARY

[0005] The purpose of the present application is to provide a medical catheter to solve the problem that the poor adhesion between the catheter and the target tissue during the treatment process in the prior art leads to poor treatment effect or even operation failure, and at the same time solve the problem caused by the separation of the diagnosis and treatment processes.

[0006] To achieve the above object, the present application provides a medical catheter, which comprises a catheter main body and a bending control component, the catheter main body comprises a proximal end portion and a distal end portion located at a distal end of the catheter main body, the distal end portion is used for imaging monitoring and releasing therapeutic energy and / or therapeutic agent, and is connected with the bending control component and used for bending relative to the proximal end portion under the control of the bending control component.

[0007] In an embodiment, the distal end portion further comprises a distal end tube body, and the proximal end portion comprises a proximal end tube body, the hardness of the distal end tube body is less than the hardness of the proximal end tube body.

[0008] In an embodiment, the bending control component comprises a bending control traction body and a bending control member, the bending control member is arranged at the proximal end of the catheter main body, the distal end of the bending control traction body is connected with the distal end portion, and the proximal end of the bending control traction body is connected with the bending control member after passing through the catheter main body, the bending control traction body is used for controlling the distal end portion to bend under the driving of the bending control member.

[0009] In an embodiment, the number of the bending control traction bodies is multiple, and the multiple bending control traction bodies are uniformly arranged along the circumferential direction around the central axis of the catheter main body.

[0010] In an embodiment, each of the bending control traction bodies is connected with at least one of the bending control members, and different bending control traction bodies are connected with different bending control members.

[0011] In an embodiment, the medical catheter further comprises an interface portion, the proximal end of the proximal end portion is connected with the interface portion, and the bending control member is movably arranged on the interface portion.

[0012] In an embodiment, the catheter main body further comprises a bending control channel arranged in the axial direction, and the bending control traction body passes through the bending control channel.

[0013] In an embodiment, the bending control component comprises a magnetic response deformation component and / or a light-induced deformation component, the magnetic response deformation component is made of a magnetic response material and can produce deformation under the action of a magnetic field, and the light-induced deformation component is made of a light response material and can produce light-induced deformation after absorbing light energy.

[0014] In an embodiment, the medical catheter further comprises an interface portion, the proximal end of the proximal end portion is connected with the interface portion, and the interface portion is used for connecting with a corresponding external device to input and output information.

[0015] In an embodiment, the distal end portion comprises an imaging diagnosis component and a treatment component, the imaging diagnosis component is used for imaging monitoring, and the treatment component is used for releasing therapeutic energy and / or therapeutic agent.

[0016] The imaging diagnostic component comprises an imaging probe, the catheter body further comprises an imaging channel arranged in axial extension, and an imaging transmission structure connected with the imaging probe is arranged in the imaging channel, and a central axis of the imaging channel coincides with a central axis of the catheter body.

[0017] In an embodiment, the distal end portion further comprises an imaging window, and the imaging probe is arranged at the imaging window.

[0018] In an embodiment, the imaging probe is an optical probe, the imaging transmission structure comprises an imaging optical fiber, a protection tube and a torsion spring, the protection tube is sleeved on the imaging optical fiber, the torsion spring is arranged between the protection tube and the imaging optical fiber, one end of the imaging optical fiber is connected with the imaging probe, and the other end of the imaging optical fiber extends along the imaging channel to a proximal end of the catheter body.

[0019] In an embodiment, the medical catheter further comprises an interface portion, a proximal end of the proximal end portion is connected with the interface portion, the interface portion comprises an imaging interface and a mechanical power transmission interface, the other end of the imaging optical fiber is connected with the mechanical power transmission interface and the imaging interface, and the imaging diagnostic component is used for rotating along a circumference of the catheter body and / or moving along an axial direction of the catheter body under the driving of a driving device.

[0020] In an embodiment, the treatment component comprises an energy output component capable of outputting at least one treatment energy of radio frequency, ultrasonic wave, laser and cryogenic fluid, and / or the treatment component comprises a treatment agent output component comprising at least one of a drug coating and a drug release structure, and the drug release structure comprises a drug delivery hole and / or a drug delivery microneedle.

[0021] In an embodiment, when the treatment component comprises the energy output component, the energy output component comprises an electrode, the distal end portion further comprises a temperature measurement component arranged on the electrode, and the temperature measurement component is used for acquiring a temperature of an electrode surface.

[0022] In an embodiment, the catheter body further comprises a temperature control fluid channel arranged in axial extension, the distal end portion further comprises a temperature control fluid output hole arranged on the electrode, a distal end of the temperature control fluid channel is connected with the temperature control fluid output hole, and the temperature control fluid channel is used for conveying a temperature control fluid.

[0023] In an embodiment, the catheter body further comprises an axially extending temperature control wire channel and an electrode wire channel, the temperature measuring component is connected to a distal end of the temperature control wire, a proximal end of the temperature control wire extends through the temperature control wire channel and to a proximal end of the catheter body; the electrode is connected to a distal end of the electrode wire, a proximal end of the electrode wire extends through the electrode wire channel and to a proximal end of the catheter body.

[0024] In an embodiment, the energy output component comprises an electrode for outputting radio frequency, the number of the electrodes is multiple and arranged in an axial and / or circumferential direction of the catheter body.

[0025] In an embodiment, a distal end of the distal end portion is connected to a head end through an elastic connecting portion, the head end is provided with a guide wire lumen.

[0026] Compared with the prior art, the medical catheter provided by the technical scheme has at least the following beneficial effects:

[0027] The medical catheter has a distal end portion, which can be used for imaging monitoring and releasing therapeutic energy and / or therapeutic agent, so that the medical catheter realizes the integration of diagnosis and treatment, and the distal end portion can be bent under the control of the bending control component. After being arranged in this way, the medical catheter provided by the present application does not need to replace the imaging catheter and the treatment catheter when performing interventional treatment on the lesion site, and the operation of frequently replacing the catheter is saved, which not only simplifies the operation process, but also avoids the difficulty of repositioning the catheter after replacing different catheters, and ensures the positioning accuracy of the catheter during the treatment process. In addition, the distal end portion can monitor the treatment effect in real time during the treatment process, which is conducive to accurately regulating the output of the therapeutic energy and / or the therapeutic agent, and in combination with the bending control function of the bending control component, the bending angle of the distal end portion can be adjusted at any time, so as to ensure that the distal end portion can be well attached to the lesion at all times, so as to achieve the purpose of accurately targeting the lesion, improve the treatment effect, and improve the success rate of the operation and shorten the operation time. Not only that, the bending control function of the medical catheter makes the catheter adaptable to the treatment of lesions of different shapes, and the use is more flexible and convenient, and the application range is wider. Therefore, the medical catheter can realize the accurate treatment of the lesion site, and the treatment steps are simplified, and the medical staff is facilitated to operate. Furthermore, the medical catheter can be repeatedly used until the treatment is completed during the treatment process, which saves material consumption, is conducive to reducing the incidence of current postoperative complications, improves the clinical treatment effect, reduces the rehospitalization rate, reduces the family burden and social and economic losses caused by diseases, has good economic benefits and ecological benefits. BRIEF DESCRIPTION OF DRAWINGS

[0028] Those skilled in the art will understand that the provided drawings are for better understanding of the present application, and do not constitute any limitation on the scope of the present application. In the drawings:

[0029] Figure 1 is a schematic diagram of the overall structure of a medical catheter in one embodiment of the present invention;

[0030] Figure 2 is a detailed structural diagram of a medical catheter in one embodiment of the present invention;

[0031] Figure 3 1 is a detailed structural diagram of a medical catheter provided with a bending control component in the first embodiment of the present invention;

[0032] Figure 4 yes Figure 3 A partial enlarged view of the TCM catheter at position a;

[0033] Figure 5a yes Figure 4 Cross-section of the middle structure along line AA;

[0034] Figure 5b yes Figure 4 Cross-section of the middle structure along line BB;

[0035] Figure 5c yes Figure 4 Cross-section of the middle structure along the CC line;

[0036] Figure 6 This is a diagram of a usage scenario in which a medical catheter according to one embodiment of the present invention is delivered to a blood vessel along a guide wire through a guide wire lumen on the tip;

[0037] Figure 7 This is a diagram of a usage scenario in which the distal end portion of a medical catheter in one embodiment of the present invention is bent relative to the proximal end portion so that the distal end portion is in contact with a lesion (fibrous plaque).

[0038] The description of the accompanying drawings is as follows:

[0039] 10-medical catheter; 1-interface; 11-fluid perfusion interface; 12-imaging interface; 13-electrical signal interface; 14-mechanical power transmission interface; 2-catheter body; 21-imaging channel; 22-temperature-controlled fluid channel; 23-temperature-controlled wire channel; 24-electrode wire channel; 25-bending control channel; 210-proximal part; 220-distal part; 221-treatment component; 222-imaging diagnostic component; 2221-imaging probe; 2222-imaging transmission structure; 223-imaging window; 224-temperature-controlled fluid output hole; 225-proximal electrode; 226-distal electrode; 3-head end; 31-guidewire cavity; 4-bending control component; 41-bending adjustment traction body; 42-bending control part; 5-connecting part; 6-temperature-controlled wire; 7-electrode wire; 20-fibrous plaque; 30-guide wire. DETAILED DESCRIPTION

[0040] The present invention will be described in more detail below with reference to schematic diagrams, which illustrate preferred embodiments of the present invention. It should be understood that those skilled in the art may modify the present invention as described herein while still achieving the advantageous effects of the present invention. Therefore, the following description should be understood as a general guide for those skilled in the art and not as a limitation of the present invention.

[0041] For the sake of clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not described in detail because they would clutter the invention with unnecessary details. It should be recognized that in the development of any actual embodiment, a large number of implementation details must be made to achieve the specific goals of the developer, such as changing from one embodiment to another according to the limitations of the relevant modules or relevant businesses. In addition, it should be recognized that such development work may be complex and time-consuming, but it is just routine work for those skilled in the art. The present invention is described in more detail by way of example with reference to the accompanying drawings in the following paragraphs. The advantages and features of the present invention will become clearer based on the following description. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0042] In addition, the terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms "a", "said" and "the" used in this application are also intended to include plural forms, unless the context clearly indicates otherwise. It should be understood that similar words such as "one" or "a" used in this application specification do not indicate a quantity limitation, but rather indicate the presence of at least one; "multiple" indicates a quantity of two or more. Unless otherwise indicated, similar words such as "distal end", "proximal end", "above" and / or "below" are only for ease of description and are not limited to one position or one spatial orientation. Similar words such as "include" or "comprising" mean that the elements or objects appearing before "include" or "comprising" include the elements or objects listed after "include" or "comprising" and their equivalents, and do not exclude other elements or objects. It should also be understood that "several" used in this application specification means an uncertain quantity.

[0043] In the following description, the terms "distal end" and "proximal end," "axial end," and "circumferential end" are used for ease of description; "distal end" refers to the side of the medical catheter that is away from the operator; "proximal end" refers to the side of the medical catheter that is closer to the operator; "axial end" refers to the direction along the central axis of the medical catheter; "circumferential end" refers to the direction around the central axis of the medical catheter; "central axis" refers to the length direction of the medical catheter; and "radial end" refers to the diameter direction of the medical catheter.

[0044] The application will be described in detail below with reference to the drawings and preferred embodiments, and the following embodiments and features in the embodiments can be complementary or combined with each other without conflict.

[0045] As shown in Figure 1 and Figure 2 , an embodiment of the present application provides a medical catheter 10 which integrates diagnosis and treatment, and the distal end of the medical catheter 10 can also be bent. The medical catheter 10 provided by the embodiment is not limited to intravascular intervention treatment, but can also be used for intervention treatment in esophagus, prostatic duct, intestinal tract and other non-vascular lumens. Preferably, the medical catheter 10 involved in the embodiment is used for intervention treatment in coronary vessels, such as treatment of atherosclerosis and the like, and has good treatment effect.

[0046] Specifically, the medical catheter 10 comprises a catheter main body 2. The catheter main body 2 comprises a proximal end portion 210 and a distal end portion 220 located at the distal end of the catheter main body 2. The distal end portion 220 can realize imaging monitoring in a target lumen, and can also release therapeutic energy and / or therapeutic agent to a target position in the target lumen. The target lumen refers to a blood vessel or a non-vascular lumen. The type of therapeutic energy is not limited, such as at least one of radio frequency, ultrasonic wave, laser and cryogenic fluid. The therapeutic agent refers to a therapeutic agent, which is mainly a drug. As shown in Figure 3 The medical catheter 10 of the embodiment of the present application further comprises a bending control component 4. The bending control component 4 is at least partially arranged in the catheter main body 2. The distal end portion 220 is connected with the bending control component 4 and is used for bending relative to the proximal end portion 210 under the control of the bending control component 4.

[0047] After being arranged in this way, the medical catheter 10 of the present application has the functions of both an imaging catheter and a treatment catheter, realizes the integration of diagnosis and treatment, and does not need to replace the imaging catheter and the treatment catheter when performing intervention treatment on a lesion site, thereby saving the operation process of exchanging catheters, simplifying the operation process, and avoiding the difficulty of re-finding the treatment site after exchanging different catheters. In addition, the distal end portion 220 can also monitor the treatment effect in real time during the treatment process, so as to accurately target the lesion and improve the accuracy and effectiveness of the treatment. At the same time, the bending control component 4 can adjust the bending angle of the distal end portion 220 at any time during the treatment process, so that the distal end portion 220 is always closely attached to the lesion, thereby accurately aiming at the lesion, and finally realizing accurate targeted treatment of the lesion, which will significantly improve the treatment effect and improve the success rate of the operation.

[0048] The present application does not limit the bending angle of the distal end portion 220, which can be less than or equal to 90° or greater than 90° and less than 180°. The bending angle of the distal end portion 220 can be set according to actual needs.

[0049] The distal portion 220 can be configured to image the target lumen using one or more imaging modalities, such as at least one of optical imaging and ultrasound imaging, and preferably OCT optical coherence tomography imaging. OCT imaging has the highest resolution and is advantageous for imaging and resolving intravascular plaques.

[0050] The distal portion 220 can be configured to deliver one or more therapeutic energies, such as at least one of radiofrequency, ultrasound, laser, and cryogenic fluid.

[0051] The distal portion 220 can be configured to deliver one or more therapeutic agents to the target site. The therapeutic agent is preferably a drug. The present application does not limit the type of drug, which can be selected as desired, such as an anti-proliferative, anti-proliferation, anti-restenotic, anti-inflammatory, anti-bacterial, anti-neoplastic, anti-mitotic, anti-metastatic, anti-thrombotic, anti-osteoporotic, anti-angiogenic, cytostatic, microtubule-inhibiting drug.

[0052] In one embodiment, the distal portion 220 includes a therapeutic component 221 and an imaging diagnostic component 222. The therapeutic component 221 is configured to deliver at least one of a therapeutic energy and a therapeutic agent to the target site, including a lesion such as a fibrous plaque. The therapeutic component 221 can output at least one of radiofrequency, ultrasound, laser, and cryogenic fluid, and / or the therapeutic component 221 can be configured to deliver the therapeutic agent in one or more ways. The imaging diagnostic component 222 is configured to image the lesioned region to facilitate identification of the lesion location and lesion composition prior to treatment, to facilitate monitoring of the treatment effect or monitoring of the therapeutic agent delivery during treatment, and to facilitate imaging scanning to evaluate the treatment effect after treatment of the lesioned region. The present application does not limit the imaging modality of the imaging diagnostic component 222. The imaging diagnostic component 222 can be optical imaging or ultrasound imaging, and preferably OCT imaging.

[0053] In the present embodiment, the distal portion 220 further includes a distal tube, and the proximal portion 210 includes a proximal tube. The therapeutic component 221 is disposed on the distal tube. The imaging diagnostic component 222 is disposed in the distal tube. If the therapeutic component 221 includes an electrode, the electrode is disposed on the outer circumferential surface of the distal tube. If the therapeutic component 221 includes a drug delivery hole, the drug delivery hole is disposed on the outer circumferential surface of the distal tube and penetrates the tube wall. If the therapeutic component 221 includes a drug coating, the drug coating is disposed on the outer circumferential surface of the distal tube. It is understood that the distal tube itself can form the therapeutic component 221, such as a drug delivery hole, a drug delivery microneedle, etc., so that the therapeutic component 221 and the distal tube are integrated, or the therapeutic component 31, such as an electrode, a drug coating, etc., can be additionally disposed on the distal tube.

[0054] It should be understood that the proximal tube body and the distal tube body can be independently processed and formed before assembly, or the proximal tube body and the distal tube body can be integrally processed and formed without the need for assembly. To facilitate bending control, preferably, the hardness of the distal tube body is less than that of the proximal tube body, so that the distal tube body as a whole is relatively soft, which is convenient for bending control, while the proximal tube body as a whole is relatively hard, which is convenient for pushing and manipulation. The distal end of the distal tube body and the proximal end of the proximal tube body can be connected in a split manner or in an integral manner. In a specific embodiment, the distal tube body and the proximal tube body are both made of polyamide materials such as nylon, PEBAX, etc., and the proximal tube body is set to a multi-layer tube structure, such as adding at least one metal layer (such as a braided tube or a spring tube) between the inner tube and the outer tube, thereby improving the strength or rigidity of the proximal part 210. However, in other embodiments of the present application, the proximal tube body and the distal tube body can also be made of materials with different hardness.

[0055] This application has no special restrictions on the structure of the bending control component 4. Figure 3 As shown, in one embodiment, the bending control component 4 includes a bending control body 41 and a bending control member 42. The bending control member 42 is disposed at the proximal end of the catheter body 2. The distal end of the bending control body 41 is connected to the distal portion 220, and the proximal end of the bending control body 41 passes through the catheter body 2 and is connected to the bending control member 42. The bending control body 41 is used to control the bending of the distal portion 220 under the drive of the bending control member 42.

[0056] The number of the bending adjustment traction bodies 41 can be one or more, usually more than one. When the number of the bending adjustment traction bodies 41 is more than one, it can be 2 or more than 2, and the number of the bending adjustment traction bodies 41 is mainly an even number, such as 2, 4, 6 or more. Preferably, the multiple bending adjustment traction bodies 41 are evenly arranged along the circumference around the central axis of the catheter body 2, so as to facilitate 360° all-round bending, make bending more flexible and convenient, and have a wider range of applications. Usually, the number of the bending adjustment traction bodies 41 is set to four or six, which can meet the actual diagnosis and treatment needs. The bending adjustment traction body 41 is preferably made of a material with long life, good resilience, high repeated bending accuracy, and high yield strength, such as metal materials such as nickel-titanium alloy and stainless steel. The bending adjustment traction body 41 can be any suitable structure such as a pull rope, a silk thread or a rod-shaped structure. The bending adjustment traction body 41 is preferably a wire, such as a round wire, and the diameter can be 0.01mm to 0.2mm. This diameter ensures that the wire will not be easily broken without increasing the overall size of the medical catheter.

[0057] Different bending adjustment traction bodies 41 are controlled by different bending control parts 42, but the number of bending control parts 42 and the number of bending adjustment traction bodies 41 may be consistent or inconsistent, such as one bending control part 42 may simultaneously control one bending adjustment traction body 42, or multiple bending control parts 42 may simultaneously control one bending adjustment traction body 42. In an embodiment of the present application, multiple bending control parts 42 are connected to multiple bending adjustment traction bodies 41 in a one-to-one correspondence, so that each bending adjustment traction body 41 is controlled by a corresponding bending control part 42. This arrangement can make the bending control operation more precise and reliable, reduce the difficulty of bending control, and has a simple structure and is easy to implement. The bending control part 42 can be a bending control knob or a bending control movable part, which can release or tighten the bending adjustment traction body 41 by rotating or moving.

[0058] like Figure 1 and Figure 2 As shown, as one embodiment, the medical catheter 10 further includes an interface portion 1, the proximal end of the proximal portion 210 being connected to the interface portion 1, and the bending control member 42 being movably disposed on the interface portion 1. Here, "movably disposed" means that the bending control member 62 is disposed on the interface portion 1 but can rotate or move relative to the interface portion 1. In other embodiments of the present application, the interface portion 1 may be omitted.

[0059] In other embodiments, the bending control component 4 can be a magnetically responsive deformation component disposed in the distal tube body. The magnetically responsive deformation component is made of a magnetically responsive material and can deform under the action of an external magnetic field to complete a bending motion, thereby causing the distal portion 220 to bend relative to the proximal portion 210. Moreover, after the magnetic field disappears, the magnetically responsive deformation component can return to its original shape, thereby causing the distal portion 220 to return to its original shape. In more detail, the magnetically responsive deformation component is made of a polymer material composited with magnetically responsive particles (such as ferroferric oxide or neodymium iron boron, etc.), can be made into a rod shape and placed near the middle position of the distal tube body, and the axial position is not limited. Driven by an external magnetic field, the magnetically responsive deformation component produces deformations in different directions and degrees, thereby driving the distal portion 220 to bend a certain angle.

[0060] In other embodiments, the bending control component 4 can be a photo-induced deformation component disposed in the distal tube body, which is made of a photo-responsive material and is capable of generating photo-induced deformation to complete the bending movement after absorbing light energy, so as to facilitate the bending of the distal portion 220 relative to the proximal portion 210. For example, the photo-induced deformation component is a strip-shaped photosensitive element, which is pasted in the distal tube body and facilitates the bending of the distal portion 220 relative to the proximal portion 210 through the photo-induced deformation of the strip-shaped photosensitive element. Moreover, the photo-induced deformation component can restore to the original state after the light disappears, so that the distal portion 220 restores to the original state. In more detail, the photo-induced deformation component is made of a photo-induced deformation material (such as azobenzene polymer, PLTZ ceramic) and has a strip-shaped structure, which is pasted in the distal tube body and generates deformation at a specific irradiation position under the irradiation of the light irradiation component in the medical catheter 10, thereby driving the distal portion 220 to bend by a certain angle.

[0061] Preferably, the bending control component 4 with a small occupied space is used to realize the bending of the distal portion 220. It should be noted that the bending control component 4 can be implemented in one or more of the above structures to control the bending. In addition, compared with other bending control modes, the bending control mode of the bending adjustment traction body 41 has a simpler structure, is relatively easy to implement in the process, and occupies a smaller space, which is beneficial to control the overall size of the medical catheter 10.

[0062] In the embodiments of the present application, when the distal portion 220 is delivered to a specified lesion position, the bending control component 42 is pulled to drive the bending adjustment traction body 41 to bend the distal portion 220 by a certain angle, so as to adapt to the topography of different lesions and improve the fitting degree and treatment effect. Alternatively, the bending control component 42 adjusts the distal portion 220 to form a bending angle of 0°-90°, so as to realize the purpose of conformal ablation of the lesion. Here, “conformal” refers to adjusting the bending angle according to the shape of the lesion site, so that the distal portion 220 is well attached to the lesion.

[0063] When the bending control component 4 uses the bending adjustment traction body 41 to control the bending, in some embodiments, a separate bending control channel 25 (see Figure 5a ) is arranged in the catheter body 2 for the bending adjustment traction body 41 to pass through. In other embodiments, the bending control channel 25 can be cancelled and shared with other channels to arrange the bending adjustment traction body 41, so as to reduce the number of channels and control the overall size of the medical catheter 10.

[0064] Taking four bending adjustment traction bodies 41 as an example, as shown in Figure 5a , in a specific example, four bending adjustment traction bodies 41 are correspondingly provided with four bending control channels 25, and the four bending control channels 25 are arranged at an interval of 90° around the central axis of the catheter body 2, and each bending control channel 25 is only for one bending adjustment traction body 41 to pass through.

[0065] The distal end of the bending-control traction member 41 is preferably positioned proximal to the imaging diagnostic component 222, specifically proximal to the imaging probe 2221 described below. This avoids the imaging probe 2221, minimizes interference with imaging, and ensures imaging quality. However, in practice, the connection location between the bending-control traction member 41 and the distal portion 220 can be determined based on the bending control angle.

[0066] like Figure 1 and Figure 2 As shown, in one embodiment, the proximal end of the proximal portion 210 is connected to an interface portion 1, which is used to connect to an external device for input and output of information. The external device may be an imaging system, an energy output system, a fluid perfusion device, a drive device, etc. The information input and output by the interface portion 1 includes at least energy, which includes at least energy for imaging, such as light energy or electrical energy. The interface portion 1 includes multiple interfaces, the number and type of which should be determined based on the function of the distal portion 220 itself.

[0067] like Figure 1 and Figure 2 As shown, in one embodiment, the distal end of the distal portion 220 is connected to the head end 3 via a connecting portion 5. The connecting portion 5 serves as a physical end cap and connects the distal portion 220 and the head end 3. The connecting portion 5 is a solid body, which can further seal the distal end of the distal tube body and realize the connection between the distal portion 220 and the head end 3. Preferably, the connecting portion 5 is an elastomer to reduce the risk of damage to the head end 3. The material for making the connecting portion 5 can be polyurethane or silicone. The diameter of the connecting portion 5 is consistent with the diameter of the catheter body 2. The length of the connecting portion 5 should not be too long or too short; if it is too long, it will reduce the pushing performance of the medical catheter 10; if it is too short, the protection effect on the head end 3 is limited. Preferably, the axial length of the connecting portion 5 is 1 mm to 10 mm.

[0068] The tip 3 is a conical head, which is usually soft and has a non-destructive structure, which can reduce damage to blood vessels or tissues. The tip 3 is preferably provided with a guidewire cavity 31 for the guide wire to pass through to achieve rapid exchange. The front position of the guidewire cavity 31 makes it more convenient to replace and operate the medical catheter 10 without affecting the overall size of the medical catheter 10. The diameter of the guidewire cavity 31 should be set in combination with the diameter of the guidewire, such as the diameter of the guidewire cavity 31 is 0.1mm to 2mm. In addition, the size of the tip 3 should not be too large, otherwise it will not be easy to pass through the stenosis lesion. Therefore, the size of the tip 3 is relatively small. The tip 3 should not be too long. If it is too long, the tip 3 will be sharp and will damage the blood vessels or tissues. If the tip 3 is too short, it will affect the crossing performance. Optionally, the axial length of the tip 3 is 5.0mm to 50mm, preferably 20mm.

[0069] In one embodiment, if Figure 2As shown, the imaging diagnostic component 222 comprises an imaging probe 2221 which transmits energy for imaging and collected signals through an imaging transmission structure 2222. Optionally, one end of the imaging transmission structure 2222 is connected to the imaging probe 2221, and the other end is connected to the interface portion 1 through the distal portion 220 and the proximal portion 210. The imaging probe 2221 comprises, but is not limited to, a micro-lens (light focusing component), an ultrasound probe, a light reflector, and the like. The imaging probe 2221 can employ at least one of a micro-lens, an ultrasound probe, and a light reflector. That is, the imaging mode of the imaging diagnostic component 222 can be one or a combination of two or more modes.

[0070] In an embodiment, the imaging diagnostic component 222 employs OCT imaging, employs an imaging optical fiber with ultra-low propagation loss and extremely low diameter (e.g., 200 μm) as a light guide medium, and employs a micro-lens at the distal end of the imaging optical fiber as the imaging probe 2221. The micro-lens can be a light focusing component. The light focusing component can be a spherical lens or a gradient refractive index lens. Since the optical fiber itself is a glass filament and is very fragile, it is easily broken if not protected during use. Therefore, the entire imaging optical fiber is encapsulated in a protective tube to form a light transmission cable to avoid mechanical damage to the optical element and the distal light focusing component during movement, and to provide better tensile and bending resistance. The protective tube can be a transparent tube.

[0071] As shown, the imaging diagnostic component 222 comprises an imaging probe 2221 which transmits energy for imaging and collected signals through an imaging transmission structure 2222. Optionally, one end of the imaging transmission structure 2222 is connected to the imaging probe 2221, and the other end is connected to the interface portion 1 through the distal portion 220 and the proximal portion 210. The imaging probe 2221 comprises, but is not limited to, a micro-lens (light focusing component), an ultrasound probe, a light reflector, and the like. The imaging probe 2221 can employ at least one of a micro-lens, an ultrasound probe, and a light reflector. That is, the imaging mode of the imaging diagnostic component 222 can be one or a combination of two or more modes. Figure 4 Figure 5a Figure 5b As shown, the catheter body 2 further comprises an imaging channel 21 for accommodating the imaging transmission structure 2222, which extends along the axial direction of the catheter body 2. The central axis of the imaging channel 21 is preferably coincident with the central axis of the catheter body 2, i.e., the imaging channel 21 is located at the center of the medical catheter 10. In this way, other functional channels can be arranged around the imaging channel 21, so that the internal space of the catheter body 2 is effectively utilized, while ensuring that the catheter body 2 has sufficient strength, and avoiding increasing the outer diameter of the medical catheter to facilitate interventional treatment in small blood vessels.

[0072] As shown, the catheter body 2 further comprises an imaging channel 21 for accommodating the imaging transmission structure 2222, which extends along the axial direction of the catheter body 2. The central axis of the imaging channel 21 is preferably coincident with the central axis of the catheter body 2, i.e., the imaging channel 21 is located at the center of the medical catheter 10. In this way, other functional channels can be arranged around the imaging channel 21, so that the internal space of the catheter body 2 is effectively utilized, while ensuring that the catheter body 2 has sufficient strength, and avoiding increasing the outer diameter of the medical catheter to facilitate interventional treatment in small blood vessels. Figure 2 Figure 4 ​​​As shown, the distal portion 220 further comprises an imaging window 223. The imaging probe 2221 is arranged at the imaging window 223. The imaging window 223 is preferably transparent. The imaging window 223 facilitates the imaging probe 2221 to emit and receive light beams. The axial length of the imaging window 223 can be equal to the axial length of the distal tube body, i.e. the whole distal tube body can be arranged as a transparent portion. Alternatively, the axial length of the distal tube body is greater than the axial length of the imaging window 223, i.e. only a portion of the distal tube body is arranged as a transparent portion. Optionally, the axial length of the imaging window 223 is 2mm to 100mm. The axial length of the imaging window 223 can be defined as the axial length extending from the proximal end of the connecting portion 5 towards the catheter body 2. The material for preparing the transparent portion in the distal tube body can be transparent nylon or the like. The proximal portion 210 is usually made of non-transparent material, such as polyamide or the like. It is noted that the imaging window 223 can be cancelled if optical imaging is not used.

[0073] In an embodiment, the imaging diagnostic component 222 employs optical imaging, in which case the imaging transmission structure 2222 comprises an imaging optical fiber and the imaging probe 2221 is an optical probe. Preferably, the imaging transmission structure 2222 further comprises a protection tube and a torsion spring. The protection tube is sleeved on the imaging optical fiber. The torsion spring is arranged between the protection tube and the imaging optical fiber. One end of the imaging optical fiber is connected to the imaging probe 321 and the other end is connected to the interface portion 1. The arrangement of the torsion spring can better conduct torsion so as to smoothly drive the imaging optical fiber and the imaging probe 2221 at the distal end of the imaging optical fiber to move.

[0074] In an embodiment, as shown in Figure 2 The interface portion 1 comprises an imaging interface 12 and a mechanical power transmission interface 14. The other end of the imaging optical fiber is connected to the mechanical power transmission interface 14 and the imaging interface 12, so that the imaging diagnostic component 32 is driven to rotate along the circumference of the catheter body 2 and / or move along the axial direction of the catheter body 2 under the driving of an external driving device. The mechanical power transmission interface 14 can be integrated with the imaging interface 12 or be separately arranged. The driving device drives the imaging transmission structure 2222 and the imaging probe 2221 to move and rotate through the mechanical power transmission interface 14. The driving device can be a motor.

[0075] In one embodiment, the treatment component 221 comprises an energy output component for outputting treatment energy. The energy output component is capable of outputting at least one of radio frequency, ultrasound, laser and cryogenic fluid. The energy output component can be at least one of an electrode, an ultrasound transducer, a laser focusing lens and a cryogenic fluid channel. That is, the treatment energy outputted by the energy output component can be one or a combination of two or more treatment energies. The electrode is used for outputting radio frequency. The ultrasound transducer is used for generating ultrasound. The laser focusing lens is used for outputting laser. The cryogenic fluid channel is used for sealing in the medical catheter 10 and cryoablation by conduction energy.

[0076] In one embodiment, the treatment component 221 comprises a treatment agent output component for releasing treatment agent to the target site. The treatment agent output component can be any suitable structure, such as the treatment agent output component comprising at least one of a drug coating and a drug release structure. The drug release structure comprises a drug delivery hole and / or a drug delivery microneedle. It is to be understood that the drug delivery microneedle is disposed on the outer circumferential surface of the distal tube body and can be pre-stored with drug or delivered through the drug delivery channel. The drug coating is disposed on the outer circumferential surface of the distal tube body. The drug delivery hole is disposed on the outer circumferential surface of the distal tube body and penetrates the tube wall to communicate with the drug delivery channel. The treatment agent output component can release treatment agent in one or a combination of two or more ways, such as both the drug coating and the drug release structure. It is to be noted that the energy output component and the treatment agent output component can be provided simultaneously or alternatively.

[0077] When the treatment component 221 comprises the energy output component, the distal portion 220 preferably further comprises a temperature measuring component (not shown) for obtaining the surface temperature of the target tissue (such as ablation tissue) during energy treatment, so as to ensure appropriate energy output. Since the temperature measuring component can obtain more accurate temperature information of the lesion, the treatment effect is improved. 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 adopt at least one of a thermocouple, a thermistor and a thermal signal acquisition lens. In the embodiment of the present application, the energy output component comprises an electrode, and the temperature measuring component is disposed on the electrode and directly monitors the surface temperature of the electrode to determine the surface temperature of the target tissue according to the surface temperature of the electrode.

[0078] As an improvement, as shown in Figure 5a and Figure 5b The catheter body 2 further comprises a temperature control fluid channel 22 extending axially and disposed separately from the imaging channel 21.

[0079] As shown in Figure 4As shown, in an embodiment, the distal portion 220 further comprises a temperature control fluid output hole 224 arranged on the electrode. The distal end of the temperature control fluid channel 22 is connected to the temperature control fluid output hole 224, and the proximal end extends to the proximal end of the catheter body 2, for example, the proximal end of the temperature control fluid channel 22 is connected to the interface portion 1. The temperature control fluid channel 22 is used to transport temperature control fluid. The temperature control fluid output hole 224 is used to release temperature control fluid (such as hot fluid or cold fluid) with a certain temperature to the target tissue (such as ablation tissue), so as to reduce the overheat damage or overcooling damage of the tissue. Therefore, during the energy treatment process, cold or hot fluid can be transported to the target tissue by means of the temperature control fluid channel 22, so as to maintain the temperature of the contact surface between the medical catheter 10 and the target tissue within the normal body temperature range, thereby protecting the non-treatment area and increasing the safety of the treatment process. If the pore size of the temperature control fluid output hole 224 is too large, it will affect the overall shape of the electrode and affect ablation; if the pore size of the temperature control fluid output hole 224 is too small, it will cause the problem that the fluid cannot flow out of the micropore due to too high viscosity. Preferably, the temperature control fluid output hole 224 is a micropore, and the pore size of the micropore is 50 μm to 200 μm. The arrangement of the micropore can reduce the influence on the electrode during the temperature control fluid output. The temperature of the temperature control fluid can be adjusted according to actual needs, for example, it can be 15°C to 30°C. The temperature of the temperature control fluid and the energy output power can be adjusted at the same time, so as to achieve the complete ablation effect of protecting the endothelium.

[0080] As an embodiment, as shown in Figure 5a and Figure 5b As shown, the catheter body 2 further comprises an axially extending temperature control wire channel 23 and an electrode wire channel 24, which are independently arranged. The temperature control wire channel 23 and the electrode wire channel 24 are arranged outside the imaging channel 21. In an embodiment, the imaging channel 21, the temperature control fluid channel 22, the temperature control wire channel 23, the electrode wire channel 24 and the control bending channel 25 are independently arranged separately, and do not interfere with each other and do not affect each other. The control bending channel 25, the temperature control wire channel 23, the electrode wire channel 24 and the temperature control fluid channel 22 can be arranged on the same circumference, that is, the centers of these channels are on the same circumference, and they are all arranged around the imaging channel 21. The control bending channel 25, the temperature control wire channel 23, the electrode wire channel 24 and the temperature control fluid channel 22 can also be arranged on different circumferences, which are not limited.

[0081] The temperature measuring component is connected to the distal end of the temperature control wire 6, and the proximal end of the temperature control wire 6 extends through the temperature control wire channel 23 and extends to the proximal end of the catheter body 2, for example, is connected to the interface portion 1, and specifically is connected to the electrical signal interface 13 in the interface portion 1. The electrode is connected to the distal end of the electrode wire 7, and the proximal end of the electrode wire 7 extends through the electrode wire channel 24 and extends to the proximal end of the catheter body 2, for example, is connected to the interface portion 1, and specifically can be connected to the electrical signal interface 13.

[0082] In addition, when the treatment component 211 comprises a therapeutic agent output component, the catheter body 2 further comprises an axially extending drug delivery channel (not shown). The drug delivery channel is disposed outside the imaging channel 21. The distal end of the drug delivery channel is connected to a drug release structure, and the proximal end is connected to the interface 1. At this time, the drug delivery channel is used to deliver drugs, and the drug release structure comprises a drug delivery hole and / or a drug delivery microneedle, and is used to release drugs to the target tissue.

[0083] The present application does not make special requirements for the formation of each channel in the catheter body 2. In an implementation, the catheter body 2 can be a multi-lumen tube, and each lumen is directly used as a channel. Alternatively, the catheter body 2 is a single-lumen tube, and several partitions in the catheter body 2 isolate several channels from each other. Alternatively, the catheter body 2 is a single-lumen tube, and several small tubes are wrapped in the catheter body 2 as channels. Regardless of the structure, the catheter body 2 should have adequate strength to support each channel. All channels in the catheter body 2 can be arranged separately, or can be arranged next to each other, or can be arranged next to each other and fixedly connected to each other.

[0084] In a specific embodiment, as shown in Figure 2 The interface 1 comprises a fluid infusion interface 11, an imaging interface 12, an electrical signal interface 13 (including a current interface), and a mechanical power transmission interface 14. The fluid infusion interface 11 is used to connect with a fluid infusion device to inject temperature-controlled fluid, generally physiological saline such as cold saline, into the medical catheter 10. The imaging interface 12 is used to connect with an imaging system, which outputs energy for imaging to the medical catheter 10, and receives the acquisition signal fed back from the medical catheter 10 to obtain an image and can be displayed. The electrical signal interface 13 is used to connect with an energy output system, such as a radio frequency system, which outputs therapeutic energy, such as radio frequency energy, to the medical catheter 10. The electrical signal interface 13 can also output electrical energy for temperature monitoring to the medical catheter 10. The electrical signal interface 13 can also be connected with an external control system, which receives the temperature signal fed back from the medical catheter 10. The mechanical power transmission interface 14 is used to connect with a driving device, which drives the imaging and diagnosis component 222 to rotate and move, so as to adjust the position and orientation of the imaging probe 2221, thereby imaging the target site to be monitored.

[0085] In an embodiment, the energy output component comprises electrodes for outputting radio frequency energy to achieve radio frequency ablation. The electrodes can be one or more. The number of electrodes is preferably multiple, and the multiple electrodes are arranged in an axial and / or circumferential direction of the catheter body 2. The electrodes can be ring electrodes or non-ring electrodes. When the electrodes are ring electrodes, they can be suitable for concentric diffuse plaque ablation. When the electrodes are non-ring electrodes, they can be suitable for eccentric plaque ablation. The medical catheter 10 provided by the embodiments of the present application preferably integrates both ring electrodes and non-ring electrodes, so that the medical catheter 10 can treat lesions at different positions to meet different clinical treatment needs.

[0086] The electrodes can be ring-shaped or strip-shaped, and can be prepared into a sheet structure or a mesh structure. The electrodes can be radiopaque or non-radiopaque, and no requirement is made in this regard. The material of the electrodes is not particularly limited in the present application, and materials such as platinum-iridium alloy, platinum-gold, copper, iron or stainless steel can be used to make the radio frequency electrodes. In addition, a certain insulation distance is required between the electrodes, and the insulation distance should not be too small or too large. When a pulse electric field is generated, the pulse electric field is released between the positive and negative electrodes in the form of positive and negative electrode signals. At this time, if the insulation distance between the electrodes is too small, electric spark phenomenon and low-temperature plasma effect are easy to occur, and if the insulation distance is too large, the electric field strength will be affected. Therefore, the insulation distance between the electrodes cannot be set at will, and the insulation distance should ensure the electric field energy intensity and not produce ionization, so as to ensure the energy and safety acting on the lesion. In an embodiment, the insulation distance between the electrodes is 1 mm to 5 mm, so as to accurately control the ablation range and avoid the discharge phenomenon caused by too close distance between the electrodes. The size of the electrodes can be set according to actual needs. In an embodiment, the width of the electrodes in the axial direction of the medical catheter 10 is 2 mm to 10 mm, and the thickness of the electrodes in the radial direction of the medical catheter can be 0.05 mm to 0.5 mm. It should be understood that the size of the electrodes should be set according to the size of the lesion site. Generally, the larger the size of the electrodes, the larger the ablation range. Since the size of the plaque is usually about 1 mm, the axial width of the electrodes is set to 2 mm to 10 mm, which basically meets the treatment needs.

[0087] As shown in Figure 3 and Figure 4 , and in combination with Figures 5a to 5cThe temperature control fluid output hole 224 is arranged on the proximal electrode 225 and / or the distal electrode 226. Preferably, the temperature control fluid output hole 224 is arranged on the proximal electrode 225 first, and the temperature control fluid is released through the temperature control fluid output hole 224 on the proximal electrode 225 to fill the entire ablation zone between the proximal electrode 225 and the distal electrode 226 with the temperature control fluid. In the illustrated embodiment, the proximal electrode 225 and the distal electrode 226 are both ring electrodes, which are arranged at a distance in the axial direction and the imaging probe 2221 is arranged between the proximal electrode 225 and the distal electrode 226. The area between the proximal electrode 225 and the distal electrode 226 serves as an ablation zone to perform radiofrequency ablation on the lesion, while the imaging probe 2221 monitors the treatment effect of the lesion in the ablation zone. In an embodiment, the distal end of the bending and pulling body 41 is connected to the distal tube body at a position corresponding to the proximal end of the proximal electrode 225.

[0088] An electrode lead wire 7 is welded on each electrode, specifically on the inner surface of the electrode, and the distal end of the electrode lead wire 7 can pass through the tube wall and be connected to the inner surface of the electrode. The material of the electrode lead wire 7 should be set according to the requirements, such as selecting the material of the electrode lead wire 7 according to the impedance value of different lengths. The electrode lead wire 7 and the temperature control lead wire 6 can share the same electrical signal interface 13, or they can use two independent electrical signal interfaces 13.

[0089] The outer diameter of the medical catheter 10 should be set according to the pipe diameter of the intervened lumen. Optionally, the outer diameter of the medical catheter 10 can be 1.0mm-10.0mm to adapt to systemic diseases. Further, the outer diameter of the medical catheter 10 is not more than 2mm to solve the problem of treating plaque ablation in smaller sizes. It should be understood that the outer diameter of the medical catheter 10 mainly guides the outer diameter of the tube body 2, the connecting part 5 and the head end 3. The outer diameters of the catheter body 2 and the connecting part 5 are usually the same, and the outer diameter of the proximal end of the head end 3 is also the same as that of the catheter body 2.

[0090] In a specific application scenario, the medical catheter 10 is applied to a coronary blood vessel, and the outer diameter of the catheter body 2 is 1.0 mm to 3.0 mm, preferably 1.8 mm to 2.0 mm. If the outer diameter of the catheter body 2 exceeds 3.0 mm, the size is too large to be inserted into the coronary blood vessel, and if the outer diameter of the catheter body 2 is less than 1.0 mm, it is difficult to integrate various channels inside, increasing the process difficulty. The wall thickness of the catheter body 2 can be 0.1 mm to 0.5 mm, which not only ensures the overall strength of the medical catheter 10, but also ensures better flexibility of the medical catheter 10. Further, the diameter of the imaging channel 21 is not more than 1.0 mm, the diameter of the temperature control fluid channel 22 is not more than 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, the mutual influence between each part is reduced when each part can be fully accommodated, ensuring that each function can operate normally and be implemented.

[0091] As a specific embodiment, as shown in FIG. 1, the medical catheter 10 comprises a catheter body 2 and a catheter head 1. The catheter body 2 is a hollow tube, and the catheter head 1 is arranged at one end of the catheter body 2. The catheter body 2 is provided with an imaging channel 21, a temperature control fluid channel 22, a temperature control wire channel 23, an electrode wire channel 24, and a guide wire channel 25. Figures 3 to 4 and Figures 5a to 5cAs shown, the medical catheter 10 is used as an ablation catheter, and adopts OCT imaging and radio frequency ablation, which is applied to conformal treatment of atherosclerotic plaque. In this embodiment, the outer diameter of the catheter body 2 is 2.0 mm, and the catheter body 2 is provided with one imaging channel 21, one temperature control fluid channel 22, two temperature control wire channels 23, two electrode wire channels 24 and four bending control channels 25. The temperature measuring component is a thermocouple, the electrodes are ring electrodes and the number of the electrodes is two, the two ring electrodes are arranged along the axial direction of the catheter body 2, the two ring electrodes are made of platinum-iridium alloy, the thickness of each ring electrode is 0.1 mm, the axial width of each ring electrode is 2.0 mm, and the transparent imaging window 223 is arranged between the two ring electrodes, the total length of the imaging window 223 is 50 mm, and the imaging probe 2221 is arranged between the two ring electrodes. The temperature control wire 6 and the electrode wire 7 are welded on each ring electrode, the temperature control wire 6 is made of copper-nickel alloy, the electrode wire 7 is made of platinum-iridium alloy, the two temperature control wires 6 and the two electrode wires 7 are distributed around the imaging channel 21 and symmetrically distributed with respect to the imaging channel 21, the temperature control fluid output hole 224 is arranged on each ring electrode, the number of the temperature control fluid output hole 224 is 12, the hole diameter is 90 μm, and the temperature control fluid output hole 224 is uniformly arranged along the circumferential direction of the electrode, the number of the bending control traction body 41 is four, the four bending control traction bodies 41 are arranged in one-to-one correspondence with the four bending control channels 25, the proximal ends of the four bending control traction bodies 41 are connected to the four bending control members 42 respectively, and the distal ends are connected to the positions corresponding to the proximal ends of the proximal electrodes 225 on the distal tube body. The temperature control fluid channel 22, the two temperature control wire channels 23, the two electrode wire channels 24 and the four bending control channels 25 are arranged around the imaging channel 21, the imaging channel 21 is arranged at the center position of the medical catheter 10, the temperature control fluid channel 22, the two temperature control wire channels 23, the two electrode wire channels 24 and the four bending control channels 25 are arranged on the same circumference, so as to reduce the overall outer diameter of the catheter, the diameter of the imaging channel 21 is 0.5 mm, the diameter of the temperature control fluid channel 22 is 0.3 mm, the two temperature control wire channels 23 are symmetrically arranged with respect to the imaging channel 21, and the two electrode wire channels 24 are also symmetrically arranged with respect to the imaging channel 21. In this way, the integration and compatibility of light, electricity and heat on the medical catheter 10 can be better solved, and the mutual influence and mutual interference between these structures are reduced.

[0092] In addition, during the operation, the guide wire is transported into the blood vessel via the guide wire lumen 31 of the head end 3. The head end 3 is designed for quick exchange, and the guide wire lumen 31 is arranged in front to facilitate the replacement of the interventional instrument and reduce the overall design size of the catheter. The diameter of the guide wire lumen 31 is 0.5 mm, and the axial length of the head end 3 is 30 mm. The head end 3 is connected to the distal end part 220 through the connecting part 5 made of polyurethane, such as adhesive connection. The outer diameter of the connecting part 5 is 2.0 mm, and the axial length is 20 mm. In addition, during the ablation treatment, the imaging interface 12 and the mechanical power transmission interface 14 are integrated, the integrated interface is connected to the imaging system, the imaging diagnostic part 222 emits laser and collects blood vessel reflection light signals through the combination of the imaging optical fiber and the gradient refractive index lens, and the treatment process of radiofrequency ablation is monitored; the imaging probe 2221 selects a gradient refractive index (GRIN) lens, the gradient refractive index lens is arranged between the two ring electrodes, and the light beam can be received and emitted through the imaging window 223; the imaging optical fiber moves axially and rotates in the imaging channel 21 along with the driving device, and emits and collects light signals through the gradient refractive index lens. During the ablation treatment, cold saline enters the temperature control fluid channel 22 through the fluid perfusion interface 11 from the fluid perfusion device, passes through the temperature control fluid output hole 224 on the electrode, flows to the lesion, and cools down during the radiofrequency ablation process to protect the endothelial cells; the flow rate of the cold saline can be adjusted to meet different cooling requirements.

[0093] The medical catheter 10 of the embodiment can be used in the following manner, specifically including:

[0094] (1) The imaging interface 12 is connected to the imaging system, the electrical signal interface 13 is connected to the energy output system, the fluid perfusion interface 11 is connected to the fluid perfusion device, and the mechanical power transmission interface 14 is connected to the driving device;

[0095] (2) The whole medical catheter 10 is transported to the diseased blood vessel segment via the guide wire, then the imaging system is turned on to image the lesion area to determine the lesion position and lesion composition;

[0096] (3) After the imaging diagnosis, the distal end part 220 is transported to the specified lesion position, then the temperature control part 4 is adjusted to make the distal end part 220 have a certain angle and direction relative to the proximal end part 210, so that the distal end part 220 closely contacts the lesion;

[0097] (4) After the distal end part 220 closely contacts the lesion, the energy output system is turned on to release the treatment energy or the treatment agent to the lesion site, and during this period, the imaging probe 2221 continuously monitors the treatment effect or the release degree of the treatment agent at the specified site through the imaging window 223;

[0098] (5) After the treatment of one lesion is completed, the distal portion 220 is released, the distal portion 220 is restored to its original shape, and then the medical catheter 10 is moved to the next lesion to repeat the above process for treatment;

[0099] (6) After the treatment of the entire lesion area is completed, the treatment area is imaged and scanned again to evaluate the treatment effect;

[0100] (7) Finally, the medical catheter 10 is withdrawn through the guide wire, and the treatment process is completed.

[0101] In more detail, referring to Figure 6 and Figure 7 , before the operation, each interface in the interface portion 1 is connected with the corresponding imaging system, radio frequency system and fluid perfusion device. Then, the medical catheter 10 is delivered into the blood vessel through the guide wire 30 along the guide wire lumen 31 of the head portion 3, and the imaging optical fiber and the imaging probe 2221 are moved and rotated in the imaging channel 21 by mechanical force control, the imaging probe 2221 emits laser and collects the light signal reflected by the blood vessel, and the imaging system uses OCT analysis to image the blood vessel and analyze the morphology and composition of the plaque 20; then, according to the imaging result, the electrode is aligned with the ablation site; the bending control member 42 is pulled to adjust the bending angle of the distal portion 220, so that the distal portion 220 closely fits the fibrous plaque 20, as shown in Figure 7 ; then, the radio frequency system is turned on, the radio frequency current is applied through the electrical signal interface 13, the impedance heat is generated in the plaque 20, and the blood vessel plaque is ablated, in the process, the imaging optical fiber continuously rotates to collect real-time signal imaging, monitors the ablation degree, and the thermocouple on the surface of the electrode monitors the ablation temperature in real time, while the cold saline is continuously perfused from the temperature control fluid output hole 224 to flush the surface of the electrode and the ablated tissue, to adjust the temperature and reduce the damage to the endothelial cells. After the ablation of one place is completed, the distal portion 220 is released (see Figure 6 ), the medical catheter 10 is moved to the next lesion for the same ablation treatment. After the treatment is completed, the entire blood vessel is imaged and scanned by OCT to evaluate the treatment effect. Finally, the catheter is withdrawn, and the operation is completed.

[0102] It is particularly pointed out that the ablation catheter of the embodiments of the present application is not limited to a radiofrequency ablation catheter, but can also be a cryoablation catheter. If it is a cryoablation catheter, a cryogenic fluid channel needs to be arranged inside the catheter body 2, the distal end of the cryogenic fluid channel is provided with an outlet, and is used to spray cryogenic liquid to the inner surface of the balloon, at this time, the balloon can be sleeved on the distal end portion 220. It should also be understood that in the prior art, there is no radiofrequency ablation of atherosclerotic plaques under the guidance of intravascular imaging and temperature control. The outer diameter of the medical catheter provided by the present application can be not greater than 2mm, at this time, the problem of thermal ablation of plaques in smaller sizes can be solved, and the imaging, temperature monitoring and radiofrequency ablation are effectively combined, so that the radiofrequency ablation is more accurate and the ablation effect is better. Especially in the medical catheter with an outer diameter of less than 10mm, especially 2mm or less, the bending control function is added, the purpose of conforming to the shape of the lesion space is achieved, the target therapy can be more accurate, and the treatment effect is improved.

[0103] In summary, the medical catheter provided by the present application can diagnose and treat vascular diseases, heart diseases and the like in one or more ways, such as using OCT imaging to make a treatment plan before treatment, using OCT imaging and temperature monitoring to feed back the treatment effect in real time during treatment, and evaluating the treatment effect as a whole after treatment, so as to effectively improve the treatment effect. And when preparing the medical catheter, the catheter is segmented and arranged and the nested function part is used, so as to solve the technical problems of component distribution and function realization in a small physical space, realize one-tube multi-function and diagnosis and treatment integration. The medical catheter can effectively improve the expected clinical effect after application.

[0104] Although the present application has been disclosed as above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the present application and its equivalent technology, the present application also intends to include these modifications and variations.

Claims

1. A medical catheter, characterized in that: The catheter comprises a catheter body and a bending control component, wherein the catheter body comprises a proximal portion and a distal portion located at the distal end of the catheter body, the distal portion being used for imaging monitoring and for releasing therapeutic energy and / or therapeutic agent, the distal portion being connected to the bending control component and being used to bend relative to the proximal portion under the control of the bending control component; The catheter body is provided with an axially extending and separately arranged imaging channel, a temperature control fluid channel, a temperature control wire channel, an electrode wire channel, and a bending control channel. The temperature control fluid channel, the temperature control wire channel, the electrode wire channel, and the bending control channel are all arranged on the periphery of the imaging channel and arranged around the imaging channel. The outer diameter of the catheter body is 1.0-3.0 mm, and the wall thickness of the catheter body is 0.1-0.5 mm. The distal part includes an electrode and a temperature measuring component and a temperature control fluid output hole arranged on the electrode; the electrode is used to output radio frequency; the temperature measuring component is used to obtain the surface temperature of the electrode and is connected to the distal end of the temperature control wire, the proximal end of the temperature control wire passes through the temperature control wire channel and extends to the proximal end of the catheter body; the temperature control fluid channel is used to transport the temperature control fluid; the distal end of the temperature control fluid channel is connected to the temperature control fluid output hole; the electrode is connected to the distal end of the electrode wire, the proximal end of the electrode wire passes through the electrode wire channel and extends to the proximal end of the catheter body; the distal part also includes an imaging probe and a transparent imaging window, the imaging probe is arranged at the imaging window to transmit and receive light beams using the imaging window; an imaging transmission structure connected to the imaging probe is provided in the imaging channel; the bending control channel is provided with a bending adjustment traction body of the bending control component; the distal end of the distal part is connected to the head end through an elastic connecting part, and the head end is provided with a guide wire cavity.

2. The medical catheter according to claim 1, wherein The distal portion includes a distal tubular body, and the proximal portion includes a proximal tubular body. The hardness of the distal tubular body is less than that of the proximal tubular body.

3. The medical catheter according to claim 1 or 2, characterized in that The bending control component includes a bending adjustment traction body and a bending control piece. The bending control piece is arranged at the proximal end of the catheter body. The distal end of the bending adjustment traction body is connected to the distal part. The proximal end of the bending adjustment traction body passes through the catheter body and is connected to the bending control piece. The bending adjustment traction body is used to control the bending of the distal part under the drive of the bending control piece.

4. The medical catheter according to claim 3, wherein There are multiple bending adjustment traction bodies, and the multiple bending adjustment traction bodies are evenly distributed along the circumferential direction around the central axis of the catheter body.

5. The medical catheter according to claim 4, characterized in that Each of the bending adjustment traction bodies is connected to at least one bending control member, and different bending adjustment traction bodies are connected to different bending control members.

6. The medical catheter according to claim 3, wherein It also includes an interface portion, the proximal end of the proximal part is connected to the interface portion, and the bending control piece is movably arranged on the interface portion.

7. The medical catheter according to claim 1 or 2, characterized in that: The bending control component includes a magnetically responsive deformation component and / or a photo-induced deformation component. The magnetically responsive deformation component is made of a magnetically responsive material and can be deformed under the action of a magnetic field. The photo-induced deformation component is made of a photo-responsive material and can be photo-induced deformed after absorbing light energy.

8. The medical catheter according to claim 1 or 2, characterized in that The device further comprises an interface portion, to which the proximal end of the proximal portion is connected, and the interface portion is used to connect with a corresponding external device to input and output information.

9. The medical catheter according to claim 1 or 2, characterized in that: The distal portion includes a therapeutic component for releasing therapeutic energy and / or therapeutic agent; The central axis of the imaging channel coincides with the central axis of the catheter body.

10. The medical catheter according to claim 1 or 2, characterized in that The imaging probe is an optical probe, and 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 extends along the imaging channel to the proximal end of the catheter body.

11. The medical catheter according to claim 10, wherein The catheter also includes an interface portion, the proximal end of the proximal part is connected to the interface portion, the interface portion includes an imaging interface and a mechanical power transmission interface, the other end of the imaging optical fiber is connected to the mechanical power transmission interface and the imaging interface, and the imaging probe is used to rotate circumferentially along the catheter body and / or move axially along the catheter body under the drive of a driving device.

12. The medical catheter according to claim 9, wherein The therapeutic component includes a therapeutic agent output component, the therapeutic agent output component includes at least one of a drug coating and a drug release structure, and the drug release structure includes a drug delivery hole and / or a drug delivery microneedle.

13. The medical catheter according to claim 1 or 2, characterized in that There are multiple electrodes, which are spaced apart along the axial direction and / or circumferential direction of the catheter body.

14. The medical catheter according to claim 1 or 2, characterized in that 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.

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