CN219110541U - Medical catheter - Google Patents

Abstract

The present utility model relates to a medical catheter comprising a catheter body and a bend controlling member, the catheter body comprising a proximal portion and a distal portion at the distal end of the catheter body, the distal portion being for imaging monitoring and also for releasing therapeutic energy and/or therapeutic agents, the distal portion being connected to the bend controlling member and being adapted to bend relative to the proximal portion under control of the bend controlling member. After the medical catheter is used, the treatment effect can be monitored by real-time imaging in the treatment process, and the bending angle of the distal end part can be adjusted at any time, so that the distal end part is closely attached to a focus, thereby realizing the accurate targeted treatment of the focus, improving the treatment effect and improving the success rate of the operation.

Description

Medical catheter

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a medical catheter which is integrated with diagnosis and treatment and can be bent controllably.

Background

Atherosclerosis is a syndrome affecting arterial blood vessels. Atherosclerosis leads to a chronic inflammatory response in the wall of the artery, which is largely due to accumulation of lipids, macrophages, foam cells and plaque formation in the arterial wall. Atherosclerosis is commonly referred to as arteriosclerosis, and the pathophysiology of the disease manifests several different types of lesions, ranging from fibrosis to lipid-filled to calcification. At present, the main mature treatment means for atherosclerosis clinically comprise medicines, intervention and bypass operations, but the problems of long-term restenosis, thrombosis and the like still exist.

Thermophysical therapy has been widely used in clinic due to its relatively low cost, few side effects, and short treatment time. The means for achieving thermophysical therapy is thermal ablation. The energy generation modes of the thermal ablation mainly comprise a freezing saccule, focused ultrasound, laser, radio frequency and the like. Clinical studies show that the radio frequency ablation has the advantages of definite safety frequency, controllable heat energy output, easier function integration and the like. In the thermal physical therapy, a certain tissue damage range needs to be caused in order to ensure an ablation effect, but no related technical means are available at present for accurately monitoring and controlling the fiber plaque ablation range.

Current monitoring means are mainly intravascular imaging. Intravascular imaging techniques mainly include OCT (optical coherence tomography), IVUS (intravascular ultrasound imaging), angioscope, intravascular MRI, and the like. Compared with other imaging technologies, the OCT technology has obvious advantages (the resolution is better than 10 mu m) in terms of imaging resolution, can obtain high-definition images of biological tissues, and is very favorable for accurate imaging and identification of intravascular plaques. However, during treatment, the diagnostic and therapeutic procedures are often separate, and therefore, frequent replacement of the imaging catheter and ablation catheter is required, not only increasing the overall cost of the treatment, but also failing to provide timely treatment, in some cases with a high recurrence rate. In addition, ablation catheters often suffer from poor or even failure of treatment due to poor adhesion to tissue (lesions) during treatment.

Disclosure of Invention

The utility model aims to provide a medical catheter, which solves the problems of poor treatment effect and even operation failure caused by poor adhesion between the catheter and target tissues in the treatment process in the prior art, and simultaneously solves the problems caused by separation of diagnosis and treatment processes.

To achieve the above object, the present utility model provides a medical catheter comprising a catheter body and a bending control member, the catheter body comprising a proximal portion and a distal portion at a distal end of the catheter body, the distal portion for imaging monitoring and for releasing therapeutic energy and/or therapeutic agent, the distal portion being connected to the bending control member and being adapted to bend relative to the proximal portion under control of the bending control member.

In one embodiment, the distal portion further comprises a distal tube and the proximal portion comprises a proximal tube, the distal tube having a hardness less than the proximal tube.

In an embodiment, the bending control component comprises a bending control traction body and a bending control piece, the bending control piece 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, the proximal end of the bending control traction body penetrates through the catheter main body and then is connected with the bending control piece, and the bending control traction body is used for controlling the bending of the distal end portion under the driving of the bending control piece.

In an embodiment, the number of the bending traction bodies is plural, and the plural bending traction bodies are uniformly distributed around the central axis of the catheter body along the circumferential direction.

In an embodiment, each bending traction body is connected with at least one bending control piece, and different bending traction bodies are connected with different bending control pieces.

In one embodiment, the medical catheter further comprises an interface portion, a proximal end of the proximal portion being connected to the interface portion, the bend control member being movably disposed on the interface portion.

In one embodiment, the catheter body further comprises an axially extending bend control passage through which the bend adjustment traction body passes.

In one embodiment, the bending control component comprises a magnetically responsive deformation component and/or a photo-deformable component, wherein the magnetically responsive deformation component is made of a magnetically responsive material and is capable of deforming under the action of a magnetic field, and the photo-deformable component is made of a photo-responsive material and is capable of photo-deforming after absorbing light energy.

In an embodiment, the medical catheter further comprises an interface portion, a proximal end of the proximal portion being connected to the interface portion, the interface portion being for connection with a corresponding external device for inputting and outputting information.

In an embodiment, the distal portion comprises an imaging diagnostic component for imaging monitoring and a therapeutic component for releasing therapeutic energy and/or therapeutic agents;

the imaging diagnosis component comprises an imaging probe, the catheter main body further comprises an imaging channel which is axially extended, an imaging transmission structure connected with the imaging probe is arranged in the imaging channel, and the central axis of the imaging channel coincides with the central axis of the catheter main body.

In an embodiment, the distal end portion further comprises an imaging window, the imaging probe being disposed at the imaging window.

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 to the proximal end of the catheter body along the imaging channel.

In an embodiment, the medical catheter further comprises an interface portion, a proximal end of the proximal end portion being connected to the interface portion, the interface portion comprising an imaging interface and a mechanical power transmission interface, the other end of the imaging fiber being connected to the mechanical power transmission interface and the imaging interface, the imaging diagnostic component being adapted to be driven by a driving device to rotate in a circumferential direction of the catheter body and/or to move in an axial direction of the catheter body.

In an embodiment, the therapeutic component comprises an energy output component capable of outputting at least one therapeutic energy of radio frequency, ultrasound, laser, and chilled fluid, and/or the therapeutic component comprises a therapeutic agent output component comprising at least one of a drug coating and a drug release structure comprising drug delivery pores and/or drug delivery microneedles.

In an embodiment, when the treatment member comprises the energy output member, the energy output member comprises an electrode, and the distal portion further comprises a temperature measuring member disposed on the electrode for acquiring the electrode surface temperature.

In an embodiment, the catheter body further comprises a temperature-control fluid channel extending axially, the distal end portion further comprises a temperature-control fluid output hole, the temperature-control fluid output hole is arranged on the electrode, the 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 temperature-control fluid.

In an embodiment, the catheter body further comprises a temperature control wire channel and an electrode wire channel which are axially extended, the temperature measuring component is connected with the distal end of the temperature control wire, and 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 electrode is connected to a distal end of an electrode lead, a proximal end of which passes through the electrode lead passageway and extends to a proximal end of the catheter body.

In an embodiment, the energy output component comprises electrodes for outputting radio frequency, the number of the electrodes being plural and being arranged at intervals along the axial direction and/or the circumferential direction of the catheter body.

In one embodiment, the distal end of the distal portion is connected to a head end by an elastic connection, the head end being provided with a guidewire lumen.

Compared with the prior art, the medical catheter provided by the technical scheme of the utility model has at least the following beneficial effects:

the medical catheter of the present utility model has a distal portion that can be used for both imaging monitoring and for releasing therapeutic energy and/or therapeutic agents, enabling the medical catheter to be integrated for diagnosis and therapy, and that can be bent under the control of a bending control member. After the device is arranged, when interventional therapy is carried out on the focus part, the imaging catheter and the therapeutic catheter do not need to be replaced, the operation of frequently replacing the catheter is omitted, the operation process is simplified, the difficulty of repositioning the catheter after replacing different catheters is avoided, and the positioning precision of the catheter in the therapeutic process is ensured. In addition, in the treatment process, the far-end part can monitor the treatment effect in real time, is favorable for accurately regulating and controlling the output of treatment energy and/or therapeutic agent, combines the bending control function of the bending control part, can adjust the bending angle of the far-end part at any time, ensures that the far-end part can be well attached to a focus all the time, finally achieves the aim of accurately targeting the treatment focus, improves the treatment effect, improves the success rate of surgery and shortens the surgery time. Not only this, the curved function of accuse of medical catheter makes the catheter adaptable to the focus treatment of different shapes, and it is more nimble and convenient to use, and the range of application is wider. Therefore, the medical catheter can realize accurate treatment of focus positions, simplifies treatment steps and is convenient for medical staff to operate. Furthermore, the medical catheter can be reused in the treatment process until the treatment is complete, so that the material consumption is saved, the occurrence rate of complications after the current interventional operation is reduced, the clinical treatment effect is improved, the re-hospitalization rate is reduced, the family burden and the social and economic losses caused by diseases are reduced, and the medical catheter has good economic and ecological benefits.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present utility model and do not constitute any limitation on the scope of the present utility model. In the accompanying drawings:

FIG. 1 is a schematic view of the overall structure of a medical catheter according to an embodiment of the present utility model;

FIG. 2 is a detailed schematic of the structure of a medical catheter in an embodiment of the utility model;

FIG. 3 is a detailed schematic view of the medical catheter according to the first embodiment of the present utility model, in which a bend controlling member is provided;

FIG. 4 is an enlarged view of a portion of the medical catheter of FIG. 3 in position a;

FIG. 5a is a cross-sectional view of the structure of FIG. 4 taken along line A-A;

FIG. 5B is a cross-sectional view of the structure of FIG. 4 taken along line B-B;

FIG. 5C is a cross-sectional view of the structure of FIG. 4 taken along line C-C;

FIG. 6 is a view of a medical catheter according to an embodiment of the present utility model being delivered to a blood vessel along a guidewire through a guidewire lumen on a head end;

fig. 7 is a view of a use scenario in which a distal portion of a medical catheter according to an embodiment of the present utility model is bent relative to a proximal portion such that the distal portion abuts a lesion (fibrous plaque).

Wherein reference numerals are as follows:

10-a medical catheter; 1-an interface part; 11-a fluid priming interface; 12-an imaging interface; 13-an electrical signal interface; 14-a mechanical power transmission interface; 2-a catheter body; 21-an imaging channel; 22-a temperature-controlled fluid passage; 23-temperature control wire channels; 24-electrode lead channels; 25-controlling a bending channel; 210-proximal portion; 220-a distal portion; 221-a treatment component; 222-imaging diagnostic component; 2221-imaging probe; 2222-imaging transmission structure; 223-imaging window; 224—a temperature-controlled fluid outlet port; 225-a proximal electrode; 226-a distal electrode; 3-headend; 31-a guidewire lumen; 4-a bending control component; 41-bending traction body; 42-controlling bending piece; a 5-connection; 6-a temperature control wire; 7-electrode leads; 20-fibrous plaque; 30-guiding a guide wire.

Detailed Description

The present utility model will be described in more detail below with reference to the drawings, in which preferred embodiments of the utility model are shown, it being understood that one skilled in the art can modify the utility model described herein while still achieving the advantageous effects of the utility model. Accordingly, the following description is to be construed as broadly known to those skilled in the art and not as limiting the utility model.

In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions or constructions are not described in detail since they would obscure the utility model in unnecessary detail. It should be appreciated that in the development of any such actual embodiment, numerous implementation details must be made to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. In addition, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art. The utility model is more particularly described by way of example in the following paragraphs with reference to the drawings. The advantages and features of the present utility model will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the utility model.

Furthermore, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be understood that the use of the terms "a" or "an" and the like in this specification do not denote a limitation of quantity, but rather denote the presence of at least one; "plurality" means two and more than two. Unless otherwise indicated, the terms "distal," "proximal," "above," and/or "below" and the like are merely for convenience of description and are not limited to one location or one spatial orientation. The word "comprising" or "comprises", and the like, means that elements or items appearing before "comprising" or "comprising" are encompassed by the element or item recited after "comprising" or "comprising" and equivalents thereof, and that other elements or items are not excluded. It should also be understood that the use of "a number" in the present specification means an indefinite number.

In the following description, for ease of description, "distal" and "proximal", "axial", and "circumferential" are used; "distal" is the side of the operator distal from the medical catheter; "proximal" is the side near the operator of the medical catheter; "axial" refers to a direction along the central axis of the medical catheter; "circumferential" refers to a direction about the central axis of the medical catheter; "central axis" refers to the length of the medical catheter; "radial" refers to the diameter of a medical catheter.

The present application will be described in detail with reference to the drawings and the preferred embodiments, and the following embodiments and features of the embodiments may be mutually complemented or combined without conflict.

As shown in fig. 1 and 2, an embodiment of the present utility model provides a medical catheter 10 that integrates diagnosis and treatment into one medical catheter 10, and the distal end of the medical catheter 10 is also capable of being bent. The medical catheter 10 provided in this embodiment is not limited to intravascular intervention, and may be used for treatment in non-vascular lumens such as the esophagus, prostate, and intestinal tracts. Preferably, the medical catheter 10 according to the present embodiment is used for interventional coronary treatment, such as treatment of atherosclerosis, with good therapeutic effects.

Specifically, the medical catheter 10 includes a catheter body 2. The catheter body 2 includes a proximal portion 210 and a distal portion 220 at the distal end of the catheter body 2. Distal portion 220 may enable imaging monitoring within a target lumen and may also release therapeutic energy and/or therapeutic agents within the target lumen to a target location. The target lumen refers to a vascular or non-vascular lumen. The type of therapeutic energy is not limited, and may be at least one of radio frequency, ultrasonic, laser, and cryogenic fluid, for example. The therapeutic agent refers to a therapeutic agent, which is mainly a drug. As shown in fig. 3, the medical catheter 10 of the embodiment of the present application further comprises a bend control component 4. The bending control member 4 is at least partially disposed in the catheter body 2. The distal portion 220 is connected to the bending control member 4 and is adapted to bend relative to the proximal portion 210 under the control of the bending control member 4.

After the arrangement, the medical catheter 10 of the utility model has the functions of the imaging catheter and the treatment catheter, realizes the integration of diagnosis and treatment, and does not need to replace the imaging catheter and the treatment catheter when interventional treatment is carried out on a focus part, thereby omitting the operation process of exchanging the catheter, simplifying the operation process and avoiding the difficulty of searching the treatment site again after exchanging different catheters. In addition, during treatment, the distal portion 220 may also monitor the treatment effect in real time, so as to precisely target the treatment focus, and improve the accuracy and effectiveness of the treatment. Meanwhile, in the treatment process, the bending angle of the distal end part 220 can be adjusted at any time by the bending control part 4, so that the distal end part 220 is always closely attached to a focus, the focus is accurately aligned, the accurate targeted treatment of the focus is finally realized, the treatment effect is obviously improved, and the success rate of the operation is improved.

The bending angle of the distal portion 220 is not limited in this application, and may be, for example, less than or equal to 90 ° or greater than 90 ° and less than 180 °. The bending angle of the distal portion 220 may be set according to actual requirements.

The distal portion 220 can employ one or more imaging modalities to effect imaging monitoring of the target lumen, such as at least one of optical imaging and ultrasound imaging, preferably OCT optical coherence tomography. The imaging resolution of OCT is highest, which is beneficial to imaging and resolving plaque in blood vessel.

The distal portion 220 is capable of releasing one or more therapeutic energies, such as at least one of radio frequency, ultrasound, laser, and cryogenic fluids.

Distal portion 220 may release the therapeutic agent to the target site in one or more ways. The therapeutic agent is preferably a drug. The present utility model is not limited in the kind of drugs, and the drugs may be selected according to the need, such as antiproliferative, antirestins, anti-inflammatory, antibacterial, antitumor, antimitotic, antimetastatic, antithrombotic, antiosteoporosis, antiangiogenic, cytostatic, microtubule inhibitory drugs.

In one embodiment, distal portion 220 includes a treatment component 221 and an imaging diagnostic component 222. The treatment component 221 is configured to deliver at least one of therapeutic energy and a therapeutic agent to a target site (including lesions such as fibrous plaque). The treatment component 221 can output at least one of radiofrequency, ultrasound, laser, and cryogenic fluid treatment energy, and/or the treatment component 221 can employ one or more structures to release a therapeutic agent to a target site. The imaging diagnostic component 222 is used to image a lesion area, to facilitate discrimination of lesion location and lesion composition prior to treatment, to facilitate monitoring of treatment efficacy or monitoring of the extent of release of a therapeutic agent during treatment, and to facilitate evaluation of treatment efficacy by imaging scans after treatment of the lesion area is completed. The imaging method of the imaging diagnosis section 222 is not limited in this application. The imaging diagnostic component 222 may be optical imaging or ultrasound imaging, preferably OCT imaging.

In this embodiment, distal portion 220 further comprises a distal tube and proximal portion 210 comprises a proximal tube. A treatment member 221 is disposed on the distal tube. An imaging diagnostic component 222 is disposed in the distal tube. If the treatment member 221 includes an electrode, the electrode is disposed on the outer peripheral surface of the distal tube body. If the treatment member 221 includes an administration hole, the administration hole is provided on the outer circumferential surface of the distal tube body and penetrates the tube wall. In another example, where the treatment member 221 includes a drug coating, the drug coating overlies the outer peripheral surface of the distal tube body. It will be appreciated that the distal tube body itself may be formed with the treatment member 221, such as a drug delivery port, a drug delivery microneedle, etc., such that the treatment member 221 and the distal tube body are integrated, or the treatment member 31, such as an electrode, a drug coating, etc., may be additionally provided on the distal tube body.

It should be understood that the proximal and distal tubes may be assembled after being formed by separate processes, or the proximal and distal tubes may be formed integrally without assembly. In order to facilitate the control of the bending, preferably, the hardness of the distal tube body is smaller than that of the proximal tube body, so that the whole distal tube body is softer and is convenient for controlling the bending, and the whole proximal tube body is harder and is convenient for pushing and controlling. The distal end of the distal tube body and the proximal end of the proximal tube body can be connected in a split type or an integral type. In one embodiment, the distal and proximal tubes are each made of a polyamide-based material such as nylon, PEBAX, etc., and the proximal tube is provided in a multi-layered tube structure, such as by adding at least one metal layer (e.g., a braided tube or a coiled tube) between the inner and outer tubes, thereby increasing the strength or rigidity of the proximal portion 210. However, in other embodiments of the present application, the proximal and distal tubes may be made of materials of different hardness.

The structure of the bending control member 4 is not particularly limited in this application. As shown in fig. 3, in one embodiment, the bending control member 4 includes a bending adjustment traction body 41 and a bending control member 42. A bending control member 42 is provided at the proximal end of the catheter body 2. The distal end of the bending traction body 41 is connected to the distal end portion 220, and the proximal end of the bending traction body 41 passes through the catheter body 2 and is connected to the bending control member 42. The bending traction body 41 is used for controlling the bending of the distal end portion 220 under the driving of the bending control member 42.

The number of bending traction bodies 41 may be one or more, typically a plurality. When the number of the bending traction bodies 41 is plural, it may be 2 or more than 2, and the number of the bending traction bodies 41 is mainly an even number, such as 2, 4, 6 or more. Preferably, the plurality of bending traction bodies 41 are uniformly distributed around the central axis of the catheter main body 2 along the circumferential direction, so that 360-degree omnibearing bending is realized, bending is more flexible and convenient, and the application range is wider. Typically, the number of bending traction bodies 41 is set to four or six, which is already sufficient for practical diagnostic and therapeutic needs. The bending traction body 41 is preferably made of a material having a long life, good recovery, high repeated bending accuracy, and high yield strength, such as a metal material of nickel-titanium alloy, stainless steel, or the like. The bending traction body 41 may be such as: any suitable structure such as a drawstring, wire, or rod-like structure. The bend-adjusting traction body 41 is preferably a wire, such as a circular wire, which may be 0.01mm to 0.2mm in diameter, without increasing the overall size of the medical catheter while ensuring that the wire is not easily broken.

The different bending traction bodies 41 are controlled by different bending control members 42, but the number of the bending control members 42 and the number of the bending traction bodies 41 may be identical or not, for example, one bending traction body 42 may be controlled by one bending control member 42 at the same time, or one bending traction body 42 may be controlled by a plurality of bending control members 42 at the same time. In this embodiment of the present application, a plurality of accuse curved pieces 42 are connected with a plurality of accent curved traction body 41 one-to-one, make each accent curved traction body 41 by a accuse curved piece 42 that corresponds control, set up like this, can make accuse curved operation more accurate and reliable, accuse curved degree of difficulty also reduces, simple structure easily realizes moreover. The bending control member 42 may be a bending control knob or a bending control moving member, and the bending adjustment traction body 41 may be released or tightened by rotating or moving.

As shown in fig. 1 and 2, as an embodiment, the medical catheter 10 further includes an interface portion 1, the proximal end of the proximal portion 210 is connected to the interface portion 1, and the bending control member 42 is movably disposed on the interface portion 1. Here, "movably provided" means that the bending control member 62 is provided on the interface section 1 but is rotatable or movable with respect to the interface section 1. In other embodiments of the present application, the interface section 1 may be omitted.

In other embodiments, the bend controlling member 4 may be a magnetically responsive deformation member disposed in the distal tube body, the magnetically responsive deformation member being made of a magnetically responsive material capable of deforming under an external magnetic field to complete the bending motion, thereby causing the distal portion 220 to bend relative to the proximal portion 210. And after the magnetic field is removed, the magnetically responsive deformation member may be allowed to revert, which in turn allows the distal portion 220 to revert. In more detail, the magnetically responsive deformation member is made of polymer material compounded with magnetically responsive particles (such as ferroferric oxide or neodymium iron boron, etc.), and can be made into a rod shape and placed near the middle position of the distal tube body, the axial position is not limited, and the magnetically responsive deformation member deforms in different directions and different degrees under the driving of an external magnetic field, so that the distal end portion 220 is driven to bend by a certain angle.

In other embodiments, the bend controlling member 4 may be a photo-deformable member disposed in the distal tube body, the photo-deformable member being made of a photo-responsive material capable of undergoing photo-deformation upon absorption of light energy to effect bending movement, thereby causing bending of the distal portion 220 relative to the proximal portion 210. For example, the optically deformable member may be a strip-shaped photosensitive element, which is glued into the distal tube, and the distal portion 220 is caused to bend relative to the proximal portion 210 by the optical deformation of the strip-shaped photosensitive element. And after the light is lost, the optically deformable element may be restored to its original shape, thereby restoring the distal portion 220. In more detail, the photo-deformable member is made of photo-deformable material (such as azobenzene polymer, PLTZ ceramic) and is formed in a strip shape, and is attached to the distal tube body, and is deformed at a specific irradiation position under irradiation of the light irradiation member in the medical catheter 10, thereby driving the distal portion 220 to bend at a certain angle.

Preferably, the bending of the distal portion 220 is achieved with a small space-consuming bending control member 4. It should be noted that the bending control component 4 may adopt one or more of the above structures to realize bending control. In addition, compared with other bending control modes, the bending control mode of the bending control traction body 41 is simpler in structure, relatively easy to realize in terms of technology, occupies smaller space and is beneficial to controlling the overall size of the medical catheter 10.

In this embodiment, when the distal end portion 220 is delivered to the designated lesion position, the bending control member 42 is pulled, so that the bending adjustment traction body 41 can be pulled to drive the distal end portion 220 to bend at a certain angle, so as to adapt to the morphology of different lesions, and improve the fitting degree and the treatment effect. Optionally, the bend control member 42 adjusts the distal portion 220 to form a bend angle of 0-90 to achieve a conformal fit of the ablation lesion. The term "conformal" as used herein refers to the adjustment of the bending angle according to the shape of the lesion site, so that the distal end portion 220 is well abutted against the lesion.

When the bend controlling component 4 uses the bend adjusting traction body 41 for controlling bending, in some embodiments, a separate bend controlling channel 25 (see fig. 5 a) is provided in the catheter main body 2 for the bend adjusting traction body 41 to pass through. In other embodiments, the bend control channels 25 may be eliminated and used in combination with other channels to deploy the bend-adjusting traction body 41, thereby reducing the number of channels and controlling the overall size of the medical catheter 10.

Taking four bending traction bodies 41 as an example, as shown in fig. 5a, in a specific example, four bending traction bodies 41 are correspondingly provided with four bending control channels 25, the four bending control channels 25 are staggered by 90 ° around the central axis of the catheter main body 2, and each bending control channel 25 only allows one bending traction body 41 to pass through.

The distal end of the bending traction body 41 is preferably disposed on the proximal end side of the imaging diagnosis section 222, specifically on the proximal end side of an imaging probe 2221 described below, so as to avoid the imaging probe 2221, reduce the influence on imaging, and ensure imaging quality. In practice, however, the location at which the bend-adjusting traction body 41 is connected to the distal end portion 220 may be set according to the bending angle.

As shown in fig. 1 and 2, in an embodiment, a proximal end of the proximal portion 210 is connected to an interface part 1, and the interface part 1 is used for connection with an external device to input and output information. The external device may be an imaging system, an energy output system, a fluid infusion device, a driving device, etc. The information input and output by the interface section 1 includes at least energy including at least energy for image formation, such as light energy or electric energy. The interface section 1 comprises several interfaces, the number and kind of which should be set according to the function of the distal end portion 220 itself.

As shown in fig. 1 and 2, in one embodiment, the distal end of distal portion 220 is connected to head end 3 by a connection 5. The connection 5 functions as a physical termination and connects the distal portion 220 and the head end 3. The connection 5 is solid and may further seal the distal end of the distal tube and provide a connection between the distal portion 220 and the head end 3. Preferably, the connection 5 is an elastomer to reduce the risk of damage to the head end 3. The material from which the connection 5 is made may be polyurethane or silicone. The diameter of the connection part 5 corresponds to the diameter of the catheter body 2. The length of the connecting part 5 is not too long or too short; if too long, the pushing performance of the medical catheter 10 is lowered; if too short, the protecting effect on the head end 3 is limited. Preferably, the axial length of the connecting portion 5 is 1mm to 10mm.

The head end 3 is a conical head, generally soft and atraumatic structure, which reduces damage to blood vessels or tissue. The head end 3 is preferably provided with a guidewire lumen 31 for guiding a guidewire therethrough for rapid exchange. The prepositioning of the guide wire cavity 31 makes the replacement and operation of the medical catheter 10 more convenient without affecting the overall size of the medical catheter 10. The diameter of the guidewire lumen 31 should be set in combination with the diameter of the guidewire, such as a guidewire lumen 31 diameter of 0.1mm to 2mm. Furthermore, the size of the head end 3 is not too large, otherwise it is not easy to pass through stenosis, and thus the head end 3 is small in size. The head end 3 is not easy to be overlong, if the head end 3 is overlong, the head end 3 is relatively sharp, blood vessels or tissues can be damaged, and if the head end 3 is too short, the traversing performance can be affected. Alternatively, the axial length of the head end 3 is between 5.0mm and 50mm, preferably 20mm.

In one embodiment, as shown in fig. 2, imaging diagnostic component 222 includes an imaging probe 2221, imaging probe 2221 transmitting imaging energy and acquired signals via an imaging transmission structure 2222. Optionally, the imaging transmission structure 322 has one end connected to the imaging probe 2221 and the other end connected to the interface 1 after passing through the distal end portion 220 and the proximal end portion 210. Imaging probe 2221 includes, but is not limited to, micro-lenses (light collection assemblies), ultrasound probes, and light reflectors. The imaging probe 2221 may employ at least one of a microlens, an ultrasonic probe, and a light mirror. That is, the imaging manner of the imaging diagnosis section 222 may be one kind or a combination of two or more kinds.

In one embodiment, imaging diagnostic component 2222 uses OCT imaging, which uses an ultra-low propagation loss, very low diameter (e.g., 200 μm) imaging fiber as the light guiding medium, and a microlens at the distal end of the imaging fiber as imaging probe 2221. The microlenses may be light focusing components. The light focusing assembly may be a ball lens or a gradient index lens. Because the optical fiber is a glass fiber and is very fragile, if the optical fiber is not protected during use, the whole imaging optical fiber is packaged in a protection tube to form a conductive optical cable, so that mechanical damage in the movement process of an optical element and a far-end light focusing assembly is avoided, and the tensile and bending resistance performance is better. The protective tube may be a transparent tube.

As shown in fig. 4, and in combination with fig. 5a and 5b, the catheter body 2 further comprises an imaging channel 21 for accommodating the imaging transmission structure 2222, the imaging channel 21 being arranged along the axial extension of the catheter body 2. The central axis of the imaging channel 21 preferably coincides with the central axis of the catheter body 2, i.e. the imaging channel 21 is in the central position of the medical catheter 10. By this arrangement, it is convenient to arrange channels of other functions at the periphery of the imaging channel 21, so that the inner space of the catheter main body 2 is effectively utilized, and the outer diameter of the medical catheter is prevented from being enlarged while ensuring sufficient strength of the catheter main body 2, so that the treatment in a minute blood vessel can be facilitated.

As shown in fig. 2 and 4, distal portion 220 further includes an imaging window 223. The imaging probe 2221 is disposed at the imaging window 223. The imaging window 223 is preferably transparent. The imaging window 223 facilitates the transmission and reception of a light beam by the imaging probe 2221. The axial length of the imaging window 223 and the axial length of the distal tube may be equal, i.e., the entire distal tube may be set as a transparent portion. Alternatively, the axial length of the distal tube is greater than the axial length of the imaging window 223, i.e., the distal tube portion is provided as a transparent portion. Alternatively, the imaging window 223 has an axial length of 2mm to 100mm. The axial length of the imaging window 223 may be defined as an axial length extending from the proximal end of the connection portion 5 toward the catheter body 2. The material of which the transparent portion of the distal tube is made may be transparent nylon or the like. The proximal portion 210 is typically made of an opaque material, such as polyamide or the like. It should be noted that, if optical imaging is not used, the imaging window 223 may be omitted.

In one embodiment, imaging diagnostic component 222 employs optical imaging, where imaging transport structure 2222 includes imaging fibers, imaging probe 2221 is an optical probe. Preferably, the imaging transport structure 2222 further includes a protective tube and a torsion spring. The protective tube is sleeved on the imaging optical fiber. The torsion spring is disposed between the protective tube and the imaging fiber. One end of the imaging optical fiber is connected with the imaging probe 321, and the other end is connected with the interface part 1. The torsion spring is provided to better conduct torsion force 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.

In an embodiment, as shown in fig. 2, the interface part 1 includes an imaging interface 12 and a mechanical power transmission interface 14, and 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 diagnosis part 32 rotates along the circumferential direction of the catheter body 2 and/or moves along the axial direction of the catheter body 2 under the drive of an external driving device. The mechanical power conducting interface 14 may be integral with the imaging interface 12 or separate and independent of both. The drive device moves and rotates the imaging transmission structure 2222 and imaging probe 2221 via the mechanical power conduction interface 14. The driving device can be a motor.

In an embodiment, the treatment component 221 includes an energy output component for outputting treatment energy. The energy output component is capable of outputting at least one therapeutic energy of radio frequency, ultrasound, laser, and cryogenic fluid. The energy output component may be at least one of an electrode, an ultrasonic transducer, a laser focusing lens, and a chilled fluid channel. That is, the therapeutic energy output by the energy output component may be one or a combination of two or more therapeutic energies. The electrode is used for outputting radio frequency. The ultrasonic transducer is used for generating ultrasonic waves. The laser focusing lens is used for outputting laser. The cryofluid channel is used to seal in the medical catheter 10 and conduct cryoablation by conduction of energy.

In one embodiment, the treatment component 221 includes a therapeutic agent delivery component for delivering a therapeutic agent to a target site. The therapeutic agent delivery member may be of any suitable construction, such as a therapeutic agent delivery member comprising at least one of a drug coating and a drug release structure. The drug release structure includes drug delivery pores and/or drug delivery microneedles. It should be understood that the administration microneedle is disposed on the outer circumferential surface of the distal tube body, and may be used for storing a drug in advance or may be used for administration through an administration channel. The drug coating is disposed on the outer peripheral surface of the distal tube body. The drug delivery hole is arranged on the outer peripheral surface of the distal tube body and penetrates through the tube wall to be communicated with the drug delivery channel. The therapeutic agent delivery member may release the therapeutic agent in one or a combination of two or more such as providing both a drug coating and a drug release structure. The energy output member and the therapeutic agent output member may be provided simultaneously or alternatively.

When the treatment member 221 includes an energy output member, the distal portion 220 preferably further includes a thermometry member (not shown) for acquiring the surface temperature of the target tissue (e.g., ablated tissue) during the energy treatment to ensure proper energy output. Because the temperature measuring component can obtain more accurate temperature information of the focus, the treatment effect is improved. The temperature measuring component may be of any suitable construction, such as: a thermocouple, a thermistor, or a thermal signal acquisition lens. The temperature measuring component can adopt at least one structure of a thermocouple, a thermistor and a thermal signal acquisition lens. In an embodiment of the present application, the energy output component includes an electrode, and the temperature measurement component is disposed on the electrode and directly monitors the electrode surface temperature to determine the target tissue surface temperature from the electrode surface temperature.

As a modification, as shown in fig. 5a and 5b, the catheter main body 2 further includes a temperature-controlling fluid passage 22 extending in the axial direction, and the temperature-controlling fluid passage 22 and the imaging passage 21 are provided separately.

As shown in fig. 4, in one embodiment, the distal portion 220 further includes a temperature-controlled fluid output aperture 224, the temperature-controlled fluid output aperture 224 being disposed on the electrode. The distal end of the temperature-controlled fluid passage 22 is connected to the temperature-controlled 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-controlled fluid passage 22 is connected to the interface portion 1. The temperature-control fluid passage 22 is used for conveying a temperature-control fluid. The temperature-controlled fluid output hole 224 is used to release a temperature-controlled fluid (e.g., hot fluid or cold fluid) having a certain temperature to a target tissue (e.g., ablated tissue) so as to reduce overheating damage or supercooling damage of the tissue. Thus, during energy treatment, cold or hot fluid may be delivered to the target tissue by means of the temperature-controlled fluid passage 22 to maintain the temperature of the interface of the medical catheter 10 with the target tissue within the normothermic range, thereby protecting non-treated areas and increasing the safety of the treatment process. If the aperture of the temperature-control fluid output hole 224 is too large, the overall shape of the electrode is affected to affect ablation; if the pore diameter of the temperature-controlled fluid output hole 224 is too small, the problem of the fluid viscosity being too high to flow out of the micropores may result. Preferably, the temperature-controlled fluid output holes 224 are micro-holes having a pore diameter of 50 μm to 200 μm. The arrangement of the micropores can reduce the influence on the electrode when the temperature control fluid is output. The temperature of the temperature control fluid can be adjusted according to actual needs, for example, the temperature can be 15-30 ℃. The temperature of the temperature control fluid and the energy output power can be adjusted simultaneously, so that the complete ablation effect of protecting the endothelium is achieved.

As an embodiment, as shown in fig. 5a and 5b, the catheter body 2 further includes a temperature control wire channel 23 and an electrode wire channel 24, which are axially extended and independently provided. The temperature control wire passage 23 and the electrode wire passage 24 are both provided outside the imaging passage 21. In one embodiment, the imaging channel 21, the temperature-control fluid channel 22, the temperature-control wire channel 23, the electrode wire channel 24, and the bend-control channel 25 are each independently provided separately, without interfering with each other and without affecting each other. The bend control channels 25, the temperature control wire channels 23, the electrode wire channels 24, and the temperature control fluid channels 22 may be disposed on the same circumference, that is, the centers of these channels are on the same circumference and all are routed around the imaging channel 21. The bend control passage 25, the temperature control wire passage 23, the electrode wire passage 24, and the temperature control fluid passage 22 may be provided on different circumferences, which is not limited thereto.

The temperature measuring member is connected to the distal end of the temperature control wire 6, and the proximal end of the temperature control wire 6 passes through the temperature control wire passage 23 and extends to the proximal end of the catheter body 2, for example, to the interface part 1, in particular to the electrical signal interface 13 in the interface part 1. The electrode is connected to the distal end of the electrode lead 7, and the proximal end of the electrode lead 7 passes through the electrode lead passageway 24 and extends to the proximal end of the catheter body 2, for example to the interface portion 1, and in particular to the electrical signal interface 13.

In addition, when the treatment member 211 includes a therapeutic agent output member, the catheter main body 2 further includes an axially extending administration channel (not shown). The administration channel is provided outside the imaging channel 21. The distal end of the administration channel is connected to the drug release structure and the proximal end is connected to the mouthpiece portion 1. At this time, the drug delivery channel is used for delivering a drug, and the drug release structure includes drug delivery holes and/or drug delivery microneedles and is used for releasing the drug to the target tissue.

The manner in which the individual channels in the catheter body 2 are formed is not particularly critical. In one implementation, the catheter body 2 may be a multi-lumen tube directly, with each lumen being used directly as a channel. Or the catheter main body 2 is a single-cavity tube, and a plurality of channels are mutually isolated by a plurality of clapboards in the interior of the catheter main body 2. Or the catheter main body 2 is a single-cavity tube, and a plurality of small tubes are wrapped in the catheter main body 2 to be used as channels. Whatever the construction, the catheter body 2 should be provided with adequate strength to support the individual channels. All channels in the catheter body 2 may be arranged at a distance from each other, may be arranged next to each other, or may be fixedly connected to each other when arranged next to each other.

In a specific embodiment, as shown in fig. 2, the interface portion 1 includes a fluid infusion interface 11, an imaging interface 12, an electrical signal interface 13 (including a current interface), and a mechanical power conduction interface 14. The fluid infusion interface 11 is adapted to connect with a fluid infusion device for infusing a temperature-controlling fluid, typically a physiological saline, such as cold saline, into the medical catheter 10. The imaging interface 12 is used to connect with an imaging system that outputs imaging energy to the medical catheter 10 and receives acquisition signals fed back from the medical catheter 10 to acquire images and display them. The electrical signal interface 13 is adapted to be coupled to 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 may also output electrical energy for temperature monitoring to the medical catheter 10. The electrical signal interface 13 may also be connected to an external control system that receives temperature signals fed back from the medical catheter 10. The mechanically-powered conductive interface 14 is adapted to be coupled to a drive device that drives the imaging diagnostic component 222 in rotation and movement to adjust the position and orientation of the imaging probe 2221 to image a target site to be monitored.

In one embodiment, the energy output component includes an electrode for outputting radio frequency energy to effect radio frequency ablation. The electrode may be one or more. The number of electrodes is preferably plural, and the plural electrodes are arranged at intervals in the axial direction and/or the circumferential direction of the catheter main body 2. The electrode may be a ring electrode or a non-ring electrode. When the electrode is annular, it is applicable to concentric diffuse plaque ablation. When the electrode is non-annular, it is suitable for eccentric plaque ablation. The medical catheter 10 provided in the embodiments of the present application preferably integrates both annular electrodes and non-annular electrodes, so that the medical catheter 10 can treat lesions at different locations to meet different clinical treatment requirements.

The electrode may be ring-shaped or strip-shaped, and may be prepared in a sheet-like structure or a mesh-like structure. The electrode may or may not be developable, which is not required. The material of the electrode is not particularly limited, and for example, a radio frequency electrode can be made of platinum iridium alloy, platinum, copper, iron or stainless steel. In addition, a certain insulation distance is required between the electrodes, and the insulation distance is not suitable to be too small or too large. When a pulse electric field is generated, the pulse electric field is released between the positive electrode and the negative electrode by positive and negative electrode signals, at this time, if the insulation distance between the electrodes is too small, an electric spark phenomenon and a low-temperature plasma effect are easily generated, and if the insulation distance is too large, the electric field strength is influenced. For this reason, the insulation distance between the electrodes cannot be set arbitrarily, and the insulation distance should ensure the electric field energy intensity and not generate ionization, ensuring the energy and safety of the affected part. In one embodiment, the insulation distance between the electrodes is 1mm to 5mm in order to precisely control the ablation range and to avoid discharge phenomena occurring due to the electrode distance being too close. The size of the electrode can be set according to actual requirements. In one embodiment, the width of the electrode along the axial direction of the medical catheter 10 is 2mm to 10mm, and the thickness of the electrode along the radial direction of the medical catheter may be 0.05mm to 0.5mm. It should be understood that the electrode size should be set according to the size of the lesion site, and generally, the larger the electrode size, the larger the ablation range. Since plaque size is usually about 1mm, the axial width of the electrode is set to 2mm to 10mm, which can basically meet the treatment requirement.

As shown in fig. 3 and 4, and referring to fig. 5a to 5c, two electrodes are illustrated, wherein the two electrodes are a proximal electrode 225 and a distal electrode 226, and a temperature-controlled fluid output hole 224 is provided on the proximal electrode 225 and/or the distal electrode 226. Preferably, the temperature-controlling fluid output hole 224 is first provided on the proximal electrode 225, and the temperature-controlling fluid is released through the temperature-controlling fluid output hole 224 on the proximal electrode 225, so that the temperature-controlling fluid fills the entire ablation zone between the proximal electrode 225 and the distal electrode 226. In the illustrated embodiment, the proximal electrode 225 and the distal electrode 226 are ring electrodes, which are disposed at a distance apart in the axial direction, and the imaging probe 2221 is disposed 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 for rf ablation of the lesion, while the imaging probe 2221 monitors the treatment effect of the lesion at the ablation zone. In one embodiment, the distal end of the buckle traction body 41 is connected to a proximal position of the distal tube body corresponding to the proximal electrode 225.

Electrode wires 7 are welded on each electrode, the electrode wires 7 are welded on the inner surface of the electrode, and the distal ends of the electrode wires 7 can penetrate through the pipe wall to be connected with the inner surface of the electrode. The material of the electrode lead 7 should be set according to the requirements, such as selecting the material of the electrode lead 7 according to different length resistance values. The electrode wire 7 and the temperature control wire 6 may share the same electrical signal interface 13, or both may use two independent electrical signal interfaces 13.

The outer diameter of the medical catheter 10 should be set according to the tube diameter of the lumen being accessed. Alternatively, the outer diameter of the medical catheter 10 may be 1.0mm to 10.0mm to accommodate systemic disease. Further, the outer diameter of the medical catheter 10 does not exceed 2mm to address the problem of ablation plaque treatment at smaller sizes. It should be understood that the outer diameter of the medical catheter 10 primarily directs the outer diameters of the catheter body 2, the connector 5, and the head end 3, with the outer diameters of the catheter body 2 and the connector 5 being generally the same, as is the proximal outer diameter of the head end 3.

In a specific application scenario, the medical catheter 10 according to the present embodiment is applied to a coronary vessel, and the outer diameter of the catheter body 2 is 1.0mm to 3.0mm, preferably 1.8mm to 2.0mm. If the outer diameter of the catheter body 2 exceeds 3.0mm, the size is too large, it is difficult to access the coronary blood vessel, and if the outer diameter of the catheter body 2 is less than 1.0mm, it is difficult to integrate the respective channels inside thereof, increasing the difficulty of the process. The wall thickness of the catheter body 2 may be 0.1mm to 0.5mm, ensuring the overall strength of the medical catheter 10, and also ensuring good flexibility of the medical catheter 10. Further, the diameter of the imaging channel 21 is not more than 1.0mm, the diameter of the temperature-control fluid channel 22 is not more than 0.5mm, the diameter of the electrode lead channel 24 is 0.1 mm-0.5 mm, and the diameter of the temperature-control lead channel 23 is 0.1 mm-0.5 mm; by controlling the diameter of each channel, when each part of structure can be fully accommodated, the mutual influence among the part of structures is reduced, and each function can be ensured to be normally operated and realized.

As a specific example, as shown in fig. 3-4 and 5 a-5 c, the medical catheter 10 is used as an ablation catheter and OCT imaging and radio frequency ablation are used for conformal treatment of atherosclerotic plaques. In this embodiment, the outer diameter of the catheter body 2 is 2.0mm, an imaging channel 21, a temperature-controlling fluid channel 22, two temperature-controlling wire channels 23, two electrode wire channels 24 and four bending-controlling channels 25 are arranged in the catheter body 2, the temperature measuring component is a thermocouple, the electrodes are ring-shaped electrodes, the two ring-shaped electrodes are distributed at intervals along the axial direction of the catheter body 2, the two ring-shaped electrodes are made of platinum iridium alloy, the thickness is 0.1mm, the axial width is 2.0mm, a transparent imaging window 223 is arranged between the two ring-shaped electrodes, the total length of the imaging window 223 is 50mm, the imaging probe 2221 is arranged between the two ring-shaped electrodes, an electrode wire 7 and a temperature-controlling wire 6 are welded on each ring-shaped electrode, the temperature-controlling wire 6 is made of copper-nickel alloy, the electrode wire 7 is made of platinum iridium alloy, the two paths of temperature-controlling wires 6 and the two paths of electrode wires 7 are distributed around the imaging channel 21, the four bending traction bodies 41 are arranged in a one-to-one correspondence with the four bending control channels 25, the near ends of the four bending traction bodies 41 are respectively connected with the four bending control members 42, the far ends are connected to the positions of the far-end tube body corresponding to the near ends of the near-end electrodes 225, the temperature control fluid channel 22, the two temperature control lead channels 23, the two electrode lead channels 24 and the four bending control channels 25 are arranged around the imaging channel 21, the imaging channel 21 is arranged at the central position of the medical catheter 10, the temperature control fluid channel 22, the two temperature control lead channels 23, two electrode wire channels 24 and four bend control channels 25 are provided on the same circumference to reduce the overall outer diameter of the catheter, the diameter of the imaging channel 21 is 0.5mm, the diameter of the temperature control fluid channel 22 is 0.3mm, two temperature control wire channels 23 are symmetrically provided with respect to the imaging channel 21, and two electrode wire channels 24 are also symmetrically provided with respect to the imaging channel 21. With this arrangement, the problem of optical, electrical and thermal compatibility with the medical catheter 10 is better addressed, and interactions and interference between these structures are reduced.

In addition, during surgery, the guide wire delivers the ablation catheter into the blood vessel via the guide wire lumen 31 of the head end 3. The head end 3 is of a quick exchange type design, and the replacement of the interventional instrument and the reduction of the overall design size of the catheter can be quickly realized by leading the guide wire cavity 31. The diameter of the guidewire lumen 31 is 0.5mm; the axial length of the head end 3 is 30mm. The head end 3 is connected, such as adhesively connected, to the distal portion 220 by a polyurethane-made connection 5. The outer diameter of the connecting portion 5 is 2.0mm and the axial length is 20mm. In addition, during the ablation treatment process, the imaging interface 12 and the mechanical power transmission interface 14 are integrated, the integrated interface is connected into an imaging system, and the imaging diagnosis component 222 emits laser and collects vascular reflection light signals through the combination of the imaging optical fiber and the gradient refractive index lens to monitor the treatment process of radio frequency ablation; imaging probe 2221 is a gradient index (GRIN) lens disposed between two ring electrodes that receives and transmits light beams through imaging window 223; the imaging fiber moves and rotates axially with the drive device within the imaging channel 21 while the emission and collection of the optical signal is performed by the gradient index lens. During the ablation treatment, cold saline enters the temperature-control fluid channel 22 from the fluid infusion device through the fluid infusion interface 11, flows to the focus through the temperature-control fluid output hole 224 on the electrode, and is cooled during the radio frequency ablation process, so as to protect endothelial cells; the cold brine can be subjected to flow regulation and control so as to meet different cooling requirements.

The medical catheter 10 of the present embodiment can be used in accordance with the following manner, and specifically includes:

(1) The imaging interface 12 is connected with an imaging system, the electric signal interface 13 is connected with an energy output system, the fluid filling interface 11 is connected with fluid filling equipment, and the mechanical power transmission interface 14 is connected with driving equipment;

(2) The whole medical catheter 10 is conveyed to a lesion blood vessel section through a guide wire, and then an imaging system is started to image a lesion region to distinguish focus positions and focus components;

(3) After imaging diagnosis, the distal end portion 220 is conveyed to a designated focus position, and then the bending control component 4 is adjusted to enable the distal end portion 220 to generate a certain angle and direction relative to the proximal end portion 210, so that the distal end portion 220 is tightly attached to the focus;

(4) After the distal portion 220 is in close proximity to the lesion, the energy delivery system is turned on to target delivery of therapeutic energy or therapeutic agent to the lesion site, during which time the imaging probe 2221 continuously monitors the therapeutic effect or extent of therapeutic agent delivery at the designated site through the imaging window 223;

(5) After treatment of one lesion is completed, releasing the distal portion 220, allowing the distal portion 220 to recover, and then moving the medical catheter 10 to the next site to repeat the above procedure for treatment;

(6) After the treatment of the lesion area is completed, carrying out whole-section imaging scanning on the treatment area section to evaluate the treatment effect;

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

In more detail, referring to fig. 6 and 7, each interface in the interface section 1 is connected with a corresponding imaging system, radio frequency system and fluid infusion device prior to surgery. The medical catheter 10 is then delivered into the blood vessel along the guidewire lumen 31 of the head end 3 via the guidewire 30 and the imaging fiber and imaging probe 2221 are controlled to move and rotate in the imaging channel 21 by mechanical force, the imaging probe 2221 emits laser light and collects the optical signals reflected back from the blood vessel, the imaging system uses OCT analysis to image the blood vessel and analyze plaque 20 morphology and composition; then, aligning the electrode to the part to be ablated according to the imaging result; pulling the bend control 42 adjusts the bending angle of the distal portion 220 so that the distal portion 220 fits snugly against the fibrous plaque 20, see fig. 7; then, the radio frequency system is opened, radio frequency current is applied through the electric signal interface 13, heat resistance is generated in the plaque 20, the vascular plaque is ablated, in the process, the imaging optical fiber continuously rotates to collect real-time signal imaging, the ablation degree is monitored, a thermocouple on the surface of the electrode monitors the ablation temperature in real time, meanwhile, cold saline is continuously poured into the temperature control fluid output hole 224 to wash the electrode and ablate the surface of tissue, the temperature is adjusted, and the damage of endothelial cells is reduced. After ablation is completed, distal portion 220 is released (see fig. 6), and medical catheter 10 is moved to the next lesion for the same ablation process. After the treatment is finished, OCT imaging is carried out on the whole blood vessel to evaluate the treatment effect. Finally, the catheter is retracted, and the operation is completed.

It should be noted that the ablation catheter according to the embodiment of the present utility model is not limited to a radiofrequency ablation catheter, but may be a cryoablation catheter. In the case of a cryoablation catheter, it is desirable to provide a cryofluid channel within the catheter body 2, with the distal end of the cryofluid channel provided with an outlet and for injecting a cryofluid against the inner surface of the balloon, in which case the balloon may be sheathed on the distal portion 220. It is also understood that in the prior art, there is no radiofrequency ablation for atherosclerotic plaques under intravascular imaging and temperature control guidance. The outer diameter of the medical catheter provided by the utility model can be not more than 2mm, at the moment, the problem of thermal ablation plaque treatment under smaller size can be solved, and the imaging, the temperature monitoring and the radio frequency ablation are effectively combined, so that the radio frequency ablation is more accurate, and the ablation effect is better. Especially, the bending control function is added in the medical catheter with the outer diameter smaller than 10mm, especially smaller than 2mm, so that the aim of matching the treatment with the shape of the focus space is fulfilled, the targeted treatment can be more accurate, and the treatment effect is improved.

In summary, the medical catheter provided by the utility model can diagnose and treat vascular diseases, heart diseases and the like in one or more modes, for example, an OCT imaging is used to make a treatment plan before treatment, in the treatment process, the treatment effect is fed back in real time by the OCT imaging and temperature monitoring, and the treatment effect is estimated as a whole after the treatment is finished, so that the treatment effect is effectively improved. And when the medical catheter is prepared, the catheter is arranged in sections and the nesting of the functional parts is utilized, so that the technical problems of component distribution and function realization in a narrow physical space are solved, and the multifunctional and diagnosis and treatment integrated one-tube catheter is realized. The medical catheter can effectively improve the expected clinical effect after being applied.

Although the present utility model is disclosed above, it is not limited thereto. Various modifications and alterations of this utility model may be made by those skilled in the art without departing from the spirit and scope of this utility model. Thus, if such modifications and variations of the present utility model fall within the scope of the present utility model and the equivalent techniques thereof, the present utility model is also intended to include such modifications and variations.

Claims (19)

1. A medical catheter comprising a catheter body and a bend controlling member, the catheter body comprising a proximal portion and a distal portion at a distal end of the catheter body, the distal portion for imaging monitoring and also for releasing therapeutic energy and/or therapeutic agents, the distal portion being connected to the bend controlling member and adapted to bend relative to the proximal portion under control of the bend controlling member.

2. The medical catheter of claim 1, wherein the distal portion comprises a distal tube and the proximal portion comprises a proximal tube, the distal tube having a hardness that is less than a hardness of the proximal tube.

3. The medical catheter according to claim 1 or 2, wherein the bending control member comprises a bending adjustment traction body and a bending control member, the bending control member being provided at a proximal end of the catheter body, a distal end of the bending adjustment traction body being connected to the distal end portion, the proximal end of the bending adjustment traction body being connected to the bending control member after passing through the catheter body, the bending adjustment traction body being adapted to control bending of the distal end portion under the drive of the bending control member.

4. The medical catheter of claim 3, wherein the number of bending traction bodies is plural, and the plural bending traction bodies are uniformly distributed circumferentially around the central axis of the catheter body.

5. The medical catheter of claim 4, wherein each bend-adjusting traction body is connected to at least one of the bend-controlling members, different ones of the bend-adjusting traction bodies being connected to different ones of the bend-controlling members.

6. A medical catheter according to claim 3, further comprising an interface portion, a proximal end of the proximal portion being connected to the interface portion, the bend control element being movably disposed on the interface portion.

7. A medical catheter according to claim 3, wherein the catheter body further comprises an axially extending bend control passage through which the bend-modifying traction body passes.

8. The medical catheter according to claim 1 or 2, wherein the bend controlling member comprises a magnetically responsive deformation member made of magnetically responsive material capable of deforming under the influence of a magnetic field and/or a photo-deformable member made of photo-responsive material capable of photo-deforming upon absorption of light energy.

9. The medical catheter of claim 1 or 2, further comprising an interface portion, a proximal end of the proximal portion being connected to the interface portion, the interface portion being for connection with a corresponding external device for inputting and outputting information.

10. The medical catheter of claim 1 or 2, wherein the distal portion comprises an imaging diagnostic component for imaging monitoring and a therapeutic component for releasing therapeutic energy and/or therapeutic agents;

the imaging diagnosis component comprises an imaging probe, the catheter main body further comprises an imaging channel which is axially extended, an imaging transmission structure connected with the imaging probe is arranged in the imaging channel, and the central axis of the imaging channel coincides with the central axis of the catheter main body.

11. The medical catheter of claim 10, wherein the distal portion further comprises an imaging window, the imaging probe being disposed at the imaging window.

12. The medical catheter of claim 10, wherein the imaging probe is an optical probe, the imaging transmission structure comprises 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 with the imaging probe, and the other end of the imaging optical fiber extends to the proximal end of the catheter body along the imaging channel.

13. The medical catheter of claim 12, further comprising an interface portion to which a proximal end of the proximal end portion is connected, the interface portion including an imaging interface and a mechanical power transmission interface, the other end of the imaging optical fiber being connected to the mechanical power transmission interface and the imaging interface, the imaging diagnostic component being configured to be rotated in a circumferential direction of the catheter body and/or moved in an axial direction of the catheter body under a drive of a drive device.

14. The medical catheter of claim 10, wherein the treatment component comprises an energy output component capable of outputting at least one of radiofrequency, ultrasound, laser, and cryogenic fluid treatment energy, and/or wherein the treatment component comprises a therapeutic agent output component comprising at least one of a drug coating and a drug release structure comprising drug delivery pores and/or drug delivery microneedles.

15. The medical catheter of claim 14, wherein when the treatment member comprises the energy output member, the energy output member comprises an electrode, the distal end portion further comprising a thermometry member disposed on the electrode, the thermometry member for acquiring electrode surface temperature.

16. The medical catheter of claim 15, wherein the catheter body further comprises an axially extending temperature-control fluid passage, the distal portion further comprising a temperature-control fluid output aperture disposed on the electrode, the temperature-control fluid passage having a distal end connected to the temperature-control fluid output aperture, the temperature-control fluid passage for delivering a temperature-control fluid.

17. The medical catheter of claim 15, wherein the catheter body further comprises a temperature control wire channel and an electrode wire channel extending axially, the temperature measurement component being connected to a distal end of a temperature control wire, a proximal end of the temperature control wire passing through the temperature control wire channel and extending to a proximal end of the catheter body; the electrode is connected to a distal end of an electrode lead, a proximal end of which passes through the electrode lead passageway and extends to a proximal end of the catheter body.

18. The medical catheter of claim 14, wherein the energy output component comprises electrodes for outputting radio frequency, the number of electrodes being a plurality and being spaced apart along the axial and/or circumferential direction of the catheter body.

19. The medical catheter according to claim 1 or 2, wherein the distal end of the distal end portion is connected to a head end by an elastic connection, the head end being provided with a guidewire lumen.

Images