Medical guide wire and medical system
By designing medical guidewire and ultrasonic transducer modules with an outer diameter of less than 2mm, the problem of the inability to ablate the sympathetic nerves of the renal artery above the second-level and the adjunctive artery in the prior art is solved, effective ablation of these parts and blood pressure reduction, and the safety and reliability of treatment are improved.
Patent Information
- Application Number
- CN202422145608.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-02
- Publication Date
- 2025-07-22
- Estimated Expiration
- 2034-09-02
AI Technical Summary
The existing ultrasound ablation catheter has a large outer diameter and cannot enter the secondary and secondary branches of the renal artery and the adjunctive artery, which makes it difficult for the sympathetic nerves in these areas to ablate and cannot effectively lower blood pressure.
A medical guide wire is designed, including a guide wire core and an ultrasonic transducer module. The ultrasonic transducer is arranged on the distal side wall of the guide wire core, with an outer diameter of less than 2mm, and can enter tiny blood vessels. Combined with the excitation system and imaging system, it realizes ablation of the sympathetic nerve and real-time vascular imaging.
Effective ablation of the sympathetic nerves near the secondary and secondary branches of the renal artery and the adjunctive artery is achieved, and the effect of lowering blood pressure is achieved, while improving the safety and reliability of treatment.
Smart Images

Figure CN223127109U_ABST
Abstract
Description
Technical Field
[0001] The utility model belongs to the technical field of medical devices, and particularly relates to a medical guide wire and a medical system. Background Art
[0002] For hypertension caused by overactive sympathetic nerves, ultrasound ablation catheter ablation of sympathetic nerves can be used for treatment. The treatment process includes: first, the distal end of the ultrasound ablation catheter is sent into the main renal artery, and then the ultrasound transducer at the distal end of the ultrasound ablation catheter is controlled to generate ultrasonic energy. When the ultrasonic energy acts on the sympathetic nerves outside the renal artery, the temperature of the sympathetic nerves rises and necrosis occurs, achieving the effect of reducing blood pressure. Compared with radiofrequency ablation, ultrasound ablation has the advantages of fast ablation speed and no damage to the blood vessel wall.
[0003] The outer diameter of the existing ultrasound ablation catheter is relatively large, and it only extends into the main renal artery with a diameter greater than or equal to 30 mm to ablate the sympathetic nerves near the main renal artery. For branches above the second level of the renal artery (with a diameter generally less than or equal to 5 mm), the ultrasound ablation catheter cannot enter due to its too large outer diameter. Therefore, the ultrasound ablation catheter cannot ablate the sympathetic nerves near the branches above the second level of the renal artery.
[0004] However, there are also a large number of sympathetic nerves near the branches above the second level of the renal artery, and the overactivity of these sympathetic nerves will also cause continuous increase in blood pressure. In addition, clinical findings show that the main renal artery of some patients is short (the length of the main renal artery is less than or equal to 20 mm). For such patients, only ablating the sympathetic nerves near the main renal artery is difficult to achieve the effect of effectively reducing blood pressure. Therefore, it is necessary to ablate the sympathetic nerves near the branches above the second level of the renal artery of such patients. Summary of the Utility Model
[0005] The purpose of the utility model is to provide a medical guide wire and a medical system, aiming to be able to ablate the sympathetic nerves near the branches above the second level of the renal artery and the accessory renal artery.
[0006] To achieve the above purpose, the utility model provides a medical guide wire, including: a guide wire core and an ultrasonic transducer module; the guide wire core includes a main body section; the ultrasonic transducer module has an energy emitting surface, the ultrasonic transducer is arranged on the distal side wall of the main body section, and the energy emitting surface is exposed outside the guide wire core.
[0007] Optionally, the outer diameter of the medical guide wire is 0.035 inch to 0.07 inch.
[0008] Optionally, engaging holes are formed in the distal side wall of the main body section, and the engaging holes penetrate the outer peripheral surface of the main body section; at least a part of the ultrasonic transducer module is disposed in the engaging holes; or,
[0009] the ultrasonic transducer module is disposed on the distal outer peripheral surface of the main body section.
[0010] Optionally, the ultrasonic transducer module includes a base, a backing layer, a transducer body, and a matching layer; the base is connected to the wire core, and the base, the backing layer, the transducer body, and the matching layer are arranged in sequence along a direction away from the axis of the wire core.
[0011] Optionally, the ultrasonic transducer module includes one transducer body, and the angle by which the transducer body extends circumferentially along the wire core is less than 360°.
[0012] Optionally, the ultrasonic transducer module includes one transducer body, and the transducer body is an annular structure extending 360° circumferentially along the wire core.
[0013] Optionally, the ultrasonic transducer module includes a plurality of transducer bodies, and the plurality of transducer bodies of the same ultrasonic transducer are arranged in sequence circumferentially along the wire core.
[0014] Optionally, the number of the ultrasonic transducer modules is multiple, and the multiple ultrasonic transducer modules are arranged in sequence axially along the wire core.
[0015] Optionally, a channel extending along its own axis is provided on the wire core; the medical wire further includes a cable, the distal end of the cable is connected to the ultrasonic transducer module, and the proximal end of the cable passes through the channel and extends to the proximal end of the wire core.
[0016] Optionally, a partition wall is provided in the channel, and the partition wall divides the channel into a first sub-channel and a second sub-channel arranged axially along the wire core, and the first sub-channel is located on the proximal side of the ultrasonic transducer module;
[0017] a wire passing hole extending axially through the partition wall is provided on the partition wall; a part of the cable is disposed in the wire passing hole;
[0018] a diversion hole is further provided on the side wall of the wire core, one end of the diversion hole communicates with the first sub-channel, and the other end penetrates the outer peripheral surface of the wire core and is located outside the ultrasonic transducer;
[0019] the medical wire further includes a sealing structure, and the sealing structure is disposed between the cable and the hole wall of the wire passing hole.
[0020] Optionally, the guide wire core further includes an introduction section, which is connected to the distal end of the main body section, and the outer diameter of the introduction section decreases in a direction away from the main body section;
[0021] The medical guide wire further includes a coil spring and a guide member. The coil spring is sleeved on the outer peripheral surface of the introduction section and is connected to the guide wire core; the guide member is connected to the distal end of the coil spring and / or the distal end of the guide wire core.
[0022] Optionally, the guide wire core includes a core body, a sheath, and a hydrophilic coating layer; the core body includes a proximal section and a distal section that are axially connected, and the outer diameter of the distal section gradually decreases in a direction away from the proximal section; the sheath is sleeved on the outer peripheral surface of the proximal section; the hydrophilic coating layer is coated on the outer peripheral surface of the sheath;
[0023] The introduction section includes the distal section of the core body; the main body section includes the proximal section of the core body, the sheath, and the hydrophilic coating layer.
[0024] To achieve the above object, the present invention further provides a medical system, including an excitation system and the medical guide wire as described above; the excitation system is electrically connected to the ultrasonic transducer module and outputs an excitation signal to the ultrasonic transducer to excite the ultrasonic transducer to generate ultrasonic energy.
[0025] Optionally, the medical system further includes an imaging system, which is communicatively connected to the ultrasonic transducer module and is configured to receive the ultrasonic signals reflected by tissues received by the ultrasonic transducer module and image based on the ultrasonic signals.
[0026] Optionally, a first sub-channel and a diversion hole are provided on the guide wire core; the first sub-channel extends along the axial direction of the guide wire core and is located on the proximal side of the ultrasonic transducer module; one end of the diversion hole is communicated with the first sub-channel, and the other end penetrates the outer surface of the guide wire core and is located on the outer periphery of the ultrasonic transducer;
[0027] The medical system further includes a perfusion system, which is communicated with the first sub-channel, and the perfusion system is configured to provide a coolant to the first sub-channel.
[0028] Compared with the prior art, the medical guide wire and the medical system of the present invention have the following advantages:
[0029] The aforementioned medical guidewire includes a guidewire core and an ultrasonic transducer module; the guidewire core includes a main body section; the ultrasonic transducer module is disposed on the distal sidewall of the main body section and is at least partially exposed. The outer diameter of the medical guidewire can be less than 2 mm and can enter into small blood vessels. Therefore, the medical guidewire can be used for ablating the sympathetic nerves near the branches above the second level of the renal artery and the accessory renal artery to achieve the effect of reducing blood pressure.
[0030] The aforementioned medical system includes the medical guidewire and an excitation system, and further includes an imaging system. The excitation system and the imaging system are respectively connected to the ultrasonic transducer module. Among them, the excitation system is configured to transmit an excitation signal to the ultrasonic transducer module so that the ultrasonic transducer module generates ultrasonic energy to ablate the sympathetic nerves. The imaging system is configured to receive the ultrasonic signals reflected by the blood vessel wall received by the ultrasonic transducer module and perform blood vessel imaging based on the ultrasonic signals, so that the operator can understand the condition of the blood vessels in real time, use it as a reference for the ablation effectiveness standard, and perform ablation operations based on the blood vessel state, which not only ensures the treatment effect but also improves the safety of the treatment process. BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The drawings are used to better understand the present invention and do not constitute an improper limitation to the present invention. Among them:
[0032] Figure 1 is a schematic diagram of the overall structure of the medical system provided by the present invention according to an embodiment;
[0033] Figure 2 is a schematic diagram of the structure of the medical guidewire of the medical system provided by the present invention according to an embodiment, and the cable is not shown in the figure;
[0034] Figure 3 is Figure 2 the A-A cross-sectional view of the medical guidewire of the medical system shown;
[0035] Figure 4 is a partial schematic diagram of the medical guidewire of the medical system provided by the present invention according to an embodiment;
[0036] Figure 5 is a partial schematic diagram of the guidewire core of the medical guidewire of the medical system provided by the present invention according to an embodiment, and the base and cable of the ultrasonic transducer module are also shown in the figure;
[0037] Figure 6 is a partial schematic diagram of the medical guidewire of the medical system provided by the present invention according to an embodiment, Figure 6 and Figure 4The difference is that the ultrasonic transducer module is arranged on the outer peripheral surface of the guide wire core, and the matching layer is not shown in the figure;
[0038] Figure 7 FIG. is a partial structural schematic diagram of a medical guide wire of a medical system according to an embodiment of the present invention; Figure 7 and Figure 6 The difference is that the outlet ends of some diversion holes are located on the distal side of the ultrasonic transducer module, and the matching layer is not shown in the figure;
[0039] Figure 8 FIG. is a partial structural schematic diagram of a medical guide wire of a medical system according to an embodiment of the present invention; Figure 8 and Figure 4 The difference is that the number of ultrasonic transducer modules is two, and the two ultrasonic transducer modules are arranged in sequence along the axial direction of the guide wire core, and the extending angle of the transducer body of each ultrasonic transducer in the circumferential direction of the guide wire core is less than 360°, and the matching layer is not shown in the figure;
[0040] Figure 9 FIG. is a partial structural schematic diagram of a medical guide wire of a medical system according to an embodiment of the present invention; Figure 9 and Figure 4 The difference is that the number of ultrasonic transducer modules is multiple, and the multiple ultrasonic transducer modules are arranged in sequence along the circumferential direction of the guide wire core, and the extending angle of the transducer body of each ultrasonic transducer in the circumferential direction of the guide wire core is less than 360°, and the matching layer is not shown in the figure;
[0041] Figure 10 FIG. is a partial structural schematic diagram of a medical guide wire of a medical system according to an embodiment of the present invention; Figure 10 and Figure 4 The difference is that the transducer body of the ultrasonic transducer module extends one circle in the circumferential direction of the guide wire core, the matching layer is not shown in the figure, and the transducer body coincides with the base;
[0042] Figure 11 FIG. is a partial structural schematic diagram of a medical guide wire of a medical system according to an embodiment of the present invention; Figure 11 and Figure 4 The difference is that the number of ultrasonic transducer modules is multiple, and the multiple ultrasonic transducer modules are arranged in sequence along the axial direction of the guide wire core, and the transducer body of each ultrasonic transducer module extends one circle in the circumferential direction of the guide wire core, the matching layer is not shown in the figure, and each transducer body coincides with the corresponding base;
[0043] Figure 12 FIG. is an anatomical schematic diagram of the renal artery;
[0044] Figure 13It is a flowchart when performing ultrasonic ablation using the medical system provided by the embodiments of the present invention.
[0045] [Explanation of the attached drawing reference numerals is as follows]:
[0046] 1 - Medical system, 10 - Medical guide wire, 100 - Guide wire core, 110 - Main body section, 120 - Insertion section, 130 - Core body, 131 - Proximal segment, 132 - Distal segment, 140 - Sheath, 150 - Hydrophilic coating layer, 160 - Partition wall, 101 - Channel, 1011 - First sub - channel, 1012 - Second sub - channel, 102 - Drainage hole, 200 - Ultrasonic transducer module, 210 - Base, 220 - Backing layer, 230 - Transducer body, 240 - Matching layer, 300 - Spring coil, 400 - Guide member, 500 - Cable, 20 - Excitation system, 30 - Imaging system, 40 - Perfusion system, 50 - Sheath, 01 - Second - level branch of renal artery, 02 - Accessory renal artery, 03 - Main trunk of renal artery, 04 - Abdominal aorta. Specific embodiments
[0047] The following uses specific specific examples to illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation manners. The details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the diagrams provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner. Therefore, only the components related to the present invention are shown in the diagrams, rather than being drawn according to the number, shape, and size of the components in actual implementation. The type, quantity, and ratio of each component in actual implementation can be arbitrarily changed, and the component layout type may also be more complex.
[0048] In addition, each of the following description embodiments has one or more technical features. However, this does not mean that those using the present invention must simultaneously implement all the technical features in any one embodiment, or can only separately implement some or all of the technical features in different embodiments. In other words, on the premise that implementation is possible, those skilled in the art can, according to the disclosure content of the present invention and depending on design specifications or implementation requirements, selectively implement some or all of the technical features in any one embodiment, or selectively implement the combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility when implementing the present invention.
[0049] As used in this specification, the singular forms "a", "an", and "the" include plural referents, and the plural form "pluralities" includes more than two referents, unless the context clearly dictates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or", unless the context clearly dictates otherwise, and the terms "mounted", "connected", "coupled" should be construed broadly. For example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and can be the communication inside two components or the interaction relationship between two components. The relational terms such as "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly specify the quantity of the indicated technical features. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.
[0050] The terms "proximal" and "distal" mentioned herein are described based on the relative positions and orientations of the components and elements of the medical device. Although non-limiting, generally, the "proximal" end is the end of the medical device that is closer to the operator during normal use, and the "distal" end is the end that first enters the patient's body.
[0051] The purpose of the present utility model is to provide a medical guide wire and a medical system, and the medical system includes the medical guide wire. The medical system can be used to ablate the sympathetic nerves near the renal artery to treat hypertension caused by overactive sympathetic nerves.
[0052] To make the purpose, advantages and features of the present utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the embodiments of the present utility model. The same or similar reference numerals in the drawings represent the same or similar components.
[0053] Figure 1 is a schematic diagram of the overall structure of the medical system 1 provided by the present utility model according to an embodiment. Figure 2 is a schematic diagram of the structure of the medical guide wire 10 of the medical system 1 provided by the present utility model according to an embodiment, Figures 6 to 11 is a partial schematic diagram of the medical guide wire 10 of the medical system 1 provided by other different embodiments of the present utility model.
[0054] As Figure 1 、 Figure 2 、Figures 6 to 11 As shown, the medical system 1 includes the medical guide wire 10 and the excitation system 20. The medical guide wire 10 includes a guide wire core 100 and an ultrasonic transducer module 200. The guide wire core 100 includes a main body section 110. The ultrasonic transducer module 200 is disposed on the distal side wall of the main body section 110. The ultrasonic transducer module 200 has an energy emitting surface, and the energy emitting surface is exposed outside the guide wire core 100. Thus, when the ultrasonic transducer 200 generates ultrasonic energy, the ultrasonic energy can be emitted to the outside of the guide wire core 100 via the energy emitting surface. The excitation system 20 is electrically connected to the ultrasonic transducer module 200 and is configured to output an excitation signal to the ultrasonic transducer module 200 to excite the ultrasonic transducer module 200 to generate ultrasonic energy.
[0055] The outer diameter of the distal end of the medical guide wire 10 is extremely small, which can be 0.035 inch to 0.07 inch, that is, about 0.889 mm to 1.778 mm. Therefore, the medical guide wire 10 can enter a blood vessel with a diameter less than 2 mm. In other words, the distal end of the medical guide wire 10 can extend into the secondary branch 01 of the renal artery or branches above the secondary branch of the renal artery or the accessory renal artery 02 as shown in Figure 12 and ablate the sympathetic nerves near these blood vessels to achieve the purpose of treating hypertension caused by overactive sympathetic nerves. Those skilled in the art know that the diameter of the secondary branch 01 of the renal artery and branches above the secondary branch of the renal artery is not greater than 5 mm, and the diameter of the accessory renal artery 02 is not greater than 2 mm.
[0056] Furthermore, please continue to refer to Figure 1 , the medical system 1 can also image the blood vessels, so that the operator can observe the blood vessel condition at any time before, during, and after ablation, and then determine whether to perform the ablation operation or stop the ablation operation to ensure the safety and reliability of the treatment process. Therefore, the medical system 1 further includes an imaging system 30. The imaging system 30 is communicatively connected to the ultrasonic transducer module 200 and is configured to receive the ultrasonic signals reflected by the blood vessel wall received by the ultrasonic transducer module 200 and perform blood vessel imaging based on the ultrasonic signals. The specific process of performing ablation treatment using the medical system 1 will be described in detail later.
[0057] Next, the specific configuration of the medical guide wire 10 will be introduced. It should be noted that only some optional configurations of the medical guide wire 10 are described below, but it cannot exhaust all possible configurations of the medical guide wire 10, so it should not constitute an improper limitation to the present invention.
[0058] As shown in Figures 4 - 5As shown, the guide wire core 100 includes the main body section 110 and an introduction section (not labeled in the figure) connected to the distal end of the main body section 110. The outer diameter of the introduction section gradually decreases in the direction away from the main body section 110 (i.e., from the proximal end to the distal end).
[0059] Please return for reference Figure 2 , the medical guide wire 10 further includes a spring coil 300 and a guide member 400. The spring coil 300 is sleeved on the outer peripheral surface of the introduction section and is connected to the guide wire core 100. The guide member 400 is located at the distal end of the guide wire core 100 and is connected to at least one of the guide wire core 100 and the spring coil 300. It can be understood that the outer diameter of the distal portion of the guide member 400 decreases in the direction from the proximal end to the distal end, so that the guide member 400 can play a guiding role during the process of the distal end of the medical guide wire 10 traveling in the blood vessel, reducing damage to the blood vessel wall. The purpose of setting the spring coil 300 is to maintain the flexibility of the distal end of the guide wire core 100, enable the distal end of the guide wire core 100 to smoothly pass through small and tortuous blood vessels, and at the same time improve the pushing performance of the distal end of the guide wire core 100, preventing the distal end of the guide wire core 100 from being folded. Both the spring coil 300 and the guide member 400 can be made of stainless steel.
[0060] Preferably, please refer to Figure 3 , the guide wire core 100 includes a core body 130, a sheath 140, and a hydrophilic coating layer 150. The core body 130 includes a proximal section 131 and a distal section 132 connected axially. The outer diameter of the distal section 132 gradually decreases in the direction away from the proximal section 131, and the distal section 132 constitutes the introduction section. The sheath 140 is sleeved on the outer peripheral surface of the proximal section 131 of the core body 130, and the hydrophilic coating layer 150 is coated on the outer peripheral surface of the sheath 140. Thus, the main body section 110 includes the sheath 140, the proximal section 131 of the core body 130, and the hydrophilic coating layer 150.
[0061] In the embodiments of the present utility model, the core body 130 is used as a support component of the medical guide wire 10, and it can be made of stainless steel or nitinol alloy. The sheath 140 is made of a polymer material and is connected to the core body 130 through a heat shrinkage process. Here, the polymer material for preparing the sheath 140 is, for example, block polyether amide (Pebax). The hydrophilic coating layer 150 is used to improve the surface lubricity of the medical guide wire 10, reduce the friction generated between the distal end of the medical guide wire 10 and the blood vessel wall when traveling in the blood vessel, and reduce the damage to the blood vessel wall. The hydrophilic coating layer 150 includes a hydrophilic polymer, and the optional hydrophilic polymers include but are not limited to at least one of Pro / Pel, Hydro-track, Hydro-coat, and M-Coat VR.
[0062] In some embodiments, please continue to refer to Figure 3 and in combination with Figure 2 and Figure 5 On the distal side wall of the main body section 110 on the guide wire core 100, there is a joining hole (not marked in the figure). The joining hole at least penetrates the outer surface of the main body section 110. The ultrasonic transducer module 200 is at least partially disposed in the joining hole. Preferably, the outer surface of the ultrasonic transducer module 200 does not protrude from the outer peripheral surface of the guide wire core 100, whereby the outer diameter of the medical guide wire 10 can be minimized.
[0063] In other embodiments, as Figures 6 to 11 shown, the ultrasonic transducer module 200 is disposed on the distal outer peripheral surface of the main body section 110 of the guide wire core 100. In such a case, the outer diameter of the medical guide wire 10 at the distal end of the main body section 110 can be reduced by minimizing the outer diameter of the guide wire core 100 itself.
[0064] As Figure 5 shown, when the ultrasonic transducer module 200 is at least partially disposed in the joining hole, the guide wire core 100 is specifically the core body 130 provided with a channel 101 extending along its own axial direction. The joining hole can also penetrate the inner surface of the guide wire core 100 (i.e., penetrate the inner surface of the core body 130) and communicate with the channel 101. As Figure 1 and Figure 5As shown, the medical guide wire 10 further includes a cable 500. The distal end of the cable 500 passes through the channel 101 and is connected to the ultrasonic transducer 200. The proximal end of the cable 500 passes through the channel 101 and extends to the proximal end of the guide wire core 100. The proximal end of the cable 500 is at least connected to the excitation system 20 so that the excitation signal generated by the excitation system 20 can be transmitted to the ultrasonic transducer module 200. The proximal end of the cable 500 can also be connected to the imaging system 30 to realize the communication connection between the imaging system 30 and the ultrasonic transducer module 200.
[0065] Alternatively, the engaging hole does not penetrate the inner surface of the guide wire core 100. At this time, a communication hole (not shown in the figure) is further provided on the side wall of the guide wire core 100. The communication hole communicates the engaging hole and the channel 101. The distal end of the cable 500 passes through the channel 101 and is connected to the ultrasonic transducer module 200 after passing through the communication hole.
[0066] Optionally, as Figure 3 shown, the ultrasonic transducer module 200 includes a base 210, a backing layer 220, a transducer body 230, and a matching layer 240. The base 210 is connected to the guide wire core 100 by welding or any other suitable method. The base 210, the backing layer 220, the transducer body 230, and the matching layer 240 are arranged in sequence along the direction away from the axis of the guide wire core 100.
[0067] The base 210 is electrically connected to the excitation system 20 through the cable 500. The base 210 receives the excitation signal emitted by the excitation system 20 and transmits the excitation signal to the transducer body 230. The transducer body 230 generates ultrasonic energy under the excitation of the excitation signal, and the ultrasonic energy is transmitted to the outside of the medical guide wire 10 after passing through the matching layer 240. Thus, the matching layer 240 can be regarded as the energy emitting surface of the ultrasonic transducer module 200.
[0068] The base 210 is also communicatively connected to the imaging system 30 through the cable 500. The transducer body 230 receives the ultrasonic signal reflected by the blood vessel wall and transmits the ultrasonic signal to the base 210. The base 210 transmits the ultrasonic signal to the imaging system 30 through the cable 500.
[0069] During the operation of the ultrasonic transducer module 200, the function of the backing layer 220 is to prevent the ultrasonic energy from diverging into the inside of the wire core 100 and to promote the divergence of the ultrasonic energy to the outside of the wire core 100, so as to ensure that enough ultrasonic energy can act on the sympathetic nerve. The matching layer 240 can balance the acoustic impedance, thereby reducing the energy attenuation of the ultrasonic energy. In an alternative embodiment, the backing layer 220 can be made of epoxy resin, and the matching layer 240 can also be made of epoxy resin.
[0070] The embodiments of the present utility model do not particularly limit the number of the ultrasonic transducer modules 200. In some embodiments, as Figure 2 , Figure 6 and Figure 7 shown, the number of the ultrasonic transducer modules 200 is one. In other embodiments, as Figure 8 and Figure 11 shown, the number of the ultrasonic transducer modules 200 is multiple, and the multiple ultrasonic transducer modules 200 are arranged in sequence along the axial direction of the wire core 100.
[0071] Each ultrasonic transducer module 200 may include one or more of the transducer bodies 230.
[0072] When the ultrasonic transducer module 200 includes one of the transducer bodies 230, as Figure 2 , Figures 6 to 8 shown, the angle at which the transducer body 230 extends in the circumferential direction of the wire core 100 may be less than 360°, that is, the transducer body 230 is a sheet-like structure. Those skilled in the art can understand that when the medical system 1 shown in Figure 2 , Figures 6 to 8 works, if it is necessary to image a blood vessel, it is necessary to control the rotation of the medical wire 10 to obtain ultrasonic signals reflected by the blood vessel in its entire circumference. Here, the rotation of the medical wire 10 can be controlled by a manual driving method or by a motor driving method. In other words, the medical system 1 may further include a driving motor (not shown in the figure), and the driving motor is connected to the proximal end of the medical wire 10 and is used to drive the rotation of the medical wire 10.
[0073] Alternatively, when the ultrasonic transducer module 200 includes one of the transducer bodies 230, as Figure 10 and Figure 11 shown, the transducer body 230 may be an annular structure extending 360° in the circumferential direction of the wire core 100. Thus, when performing blood vessel imaging, the medical wire 10 does not need to rotate.
[0074] Optionally, as Figure 9 shown, when the ultrasonic transducer module 200 includes a plurality of the transducer bodies 230, the plurality of the transducer bodies 230 of the same ultrasonic transducer 200 are arranged in sequence along the circumferential direction of the guide wire core 100. Thus, when performing vascular imaging, the medical guide wire 10 does not need to rotate.
[0075] In some embodiments, when the medical system 1 is working, the blood flow in the blood vessel is directly used to flush the ultrasonic transducer module 200 to cool the ultrasonic transducer module 200.
[0076] The blood flow in small blood vessels is also small and cannot effectively cool the ultrasonic transducer module 200. Therefore, in a preferred embodiment, please refer to Figure 5 , the guide wire core 100 further includes a partition wall 160. The partition wall 160 is disposed in the channel 101 and divides the channel 101 into a first sub-channel 1011 and a second sub-channel 1012 arranged along the axial direction of the guide wire core 100. The first sub-channel 1011 is located on the proximal side of the second sub-channel 1012. As Figure 2 , Figure 5 , Figures 6 to 8 , Figure 10 , Figure 11 shown, a diversion hole 102 is further provided on the side wall of the guide wire core 100. The diversion hole 102 has an inlet end and an outlet end that are axially opposite. The inlet end of the diversion hole 102 communicates with the first sub-channel 1011, and the outlet end of the diversion hole 102 penetrates through the outer peripheral surface of the guide wire core 100 and is located on the outer periphery of the ultrasonic transducer module 200. A threading hole (not marked in the figure) extending axially through the partition wall 160 is further provided on the partition wall 160. The cable 500 is partially disposed in the threading hole. The medical guide wire 10 further includes a sealing structure (not shown in the figure), and the sealing structure is disposed between the hole wall of the threading hole and the cable 500.
[0077] Thus, when coolant is introduced into the first sub-channel 1011, the coolant can flow out from the outlet end of the diversion hole 102 and flush the ultrasonic transducer module 200, so that the ultrasonic transducer module 200 is effectively cooled, avoiding adverse events such as thrombus formation caused by too high a temperature of the ultrasonic transducer module 200. Here, the coolant includes but is not limited to physiological saline.
[0078] It can be understood that by setting the sealing structure, the first sub-channel 1011 and the second sub-channel 1012 are isolated. Therefore, the coolant cannot enter the second sub-channel 1012 through the wire passing hole, and thus will not interfere with the conductive components of the ultrasonic transducer module 200, nor cause faults such as short circuits in the ultrasonic transducer module 200.
[0079] In the embodiment of the present invention, there is no particular limitation on the specific number of the diversion holes 102 and the specific position of the outlet end of the diversion holes 102, as long as the coolant flowing out of the diversion holes 102 can wash the ultrasonic transducer module 200. For example, as Figure 2 , Figure 4 and Figure 6 shown, the number of the diversion holes 102 is multiple, and the outlet ends of the multiple diversion holes 102 are all located on the proximal side of the ultrasonic transducer module 200. Another example is that, as Figure 7 , Figure 8 and Figure 10 shown, for any one of the ultrasonic transducer modules 200, the outlet ends of a part of the diversion holes 102 are located on the proximal side of the ultrasonic transducer module 200, and the outlet ends of another part of the diversion holes 102 are located on the distal side of the ultrasonic transducer module 200. Still another example is that the outlet ends of at least part of the diversion holes can also be arranged on at least one side (not shown in the figure) of the ultrasonic transducer in the circumferential direction of the guide wire core.
[0080] In the case where the medical guide wire 10 includes the diversion holes 102, the medical system 1 may further include a perfusion system 40, and the perfusion system 40 is communicated with the first sub-channel 1011 and supplies the coolant.
[0081] Next, taking the ablation of the sympathetic nerves near the secondary branch 01 of the renal artery as an example, the usage method of the medical system 1 provided by the embodiment of the present invention will be introduced. In a specific embodiment, the usage method of the medical system 1 is as Figure 13 shown and includes:
[0082] Step S1: Perform a puncture operation using a puncture sheath.
[0083] Step S2: Send the distal end of the medical guide wire 10 along the puncture sheath into the blood vessel and reach the target position, and the target position is, for example, the intersection of the abdominal aorta 04 and the main renal artery 03.
[0084] Step S3: Send the distal end of a sheath 50 (as Figure 1 shown) along the medical guide wire 10 into the target position. It can be understood that the sheath 50 is controllably bendable, and when the sheath 50 is bent, the medical guide wire 10 bends accordingly.
[0085] Step S4: Control the distal end of the medical guide wire 10 to enter the distal end of a secondary renal artery branch 01.
[0086] Step S5: Control the ultrasonic transducer module 200 to generate ultrasonic energy, and use the imaging system 30 to perform vascular imaging on the renal artery branch where the distal end of the medical guide wire 10 is currently located.
[0087] Step S6: The operator determines whether there are plaques in the renal artery branch where the distal end of the medical guide wire 10 is currently located according to the obtained image. If there are plaques, execute Step S7, and after Step S7 is completed, return to execute Step S4 and the subsequent steps. If there are no plaques, execute Steps S8 to S10.
[0088] Step S7: Withdraw the distal end of the medical guide wire 10 from the current secondary renal artery branch 01.
[0089] Step S8: Obtain the initial diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located.
[0090] Step S9: Control the ultrasonic transducer module 200 to generate ultrasonic energy to perform ultrasonic stimulation on the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located.
[0091] Step S10: Obtain target information.
[0092] Step S11: Based on the target information, determine whether the patient's elevated blood pressure is related to the overactivity of the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located. If not, execute Step S7, and after Step S7 is completed, return to execute Step S4. If so, execute Steps S12 and S13.
[0093] Step S12: Control the ultrasonic transducer module 200 to generate ultrasonic energy to ablate the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located. And use the imaging system 30 to perform vascular imaging on the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located.
[0094] Step S13: Obtain the current diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located according to the obtained vascular image.
[0095] Step S14: Determine whether severe spasm has occurred in the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located, based on the initial diameter and the current diameter of the secondary renal artery branch 01. If so, first execute Step S15, then execute Step S7 and the said Step S4. If not, execute Step S16.
[0096] Step S15: Inject glycerol through the sheath 50 into the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located to relieve the spasm.
[0097] Step S16: Determine whether the ablation of the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has been completed. If so, first execute the said Step S7, then execute the said Step S4 and the subsequent steps. If not, continue to execute the said Step S12 to the said Step S14.
[0098] Among them, in the said Step S6, if it is determined that there are plaques in the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located, the reason for not performing ablation on the sympathetic nerves near this secondary renal artery branch 01 is that, on the one hand, the plaques are very likely to fall off under ultrasonic stimulation and flow in the body with the blood, which may cause serious consequences such as embolism; on the other hand, it is difficult for ultrasonic energy to penetrate the plaques, resulting in low ablation efficiency.
[0099] The said target information in the said Step S10 is the patient's blood pressure value. The specific operation in Step S11 is to determine whether the patient's blood pressure value shows an upward trend compared to the baseline.
[0100] The "severe spasm" in the said Step S14 means that the current diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has decreased by more than 80% compared to the initial diameter, that is, the ratio of the current diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located to the initial diameter is less than 20%.
[0101] In the said Step S15, after the glycerol is ejected from the distal end of the sheath 50, it flows into the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located together with the blood.
[0102] In some examples, the operation of step S16 includes determining whether the blood pressure value of the patient shows an upward trend compared to the baseline. If not, it indicates that the ablation of the sympathetic nerves near the renal artery branch where the distal end of the medical guide wire 10 is currently located has been completed. If so, it is further determined whether the diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has changed significantly. If so, it indicates that the ablation of the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has been completed. If not, it indicates that the ablation of the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has not been completed.
[0103] In other examples, the operation of step S16 only includes determining whether the diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has changed significantly. If so, it indicates that the ablation of the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has been completed. If not, it indicates that the ablation of the sympathetic nerves near the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has not been completed.
[0104] A significant change in the diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located means that the ratio of the current diameter to the initial diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located is less than or equal to 50%. It should be understood that when performing step S16, it indicates that the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located has not experienced severe spasm, that is, the ratio of the current diameter to the initial diameter of the secondary renal artery branch 01 where the distal end of the medical guide wire 10 is currently located is greater than or equal to 20%.
[0105] The method of determining whether the ablation of the sympathetic nerves near the renal artery branch where the distal end of the medical guide wire 10 is currently located is completed only by judging whether the diameter of the renal artery branch where the distal end of the medical guide wire 10 is currently located has changed significantly is applicable to patients who are more sensitive to pain.
[0106] It should be noted that during the process of controlling the ultrasonic transducer module 200 to generate ultrasonic energy (that is, during the execution of step 5, step S9, and step S12), the operator can also perfusion the coolant into the first sub-channel 1011 through the perfusion system 40, so that the coolant can flow to the ultrasonic transducer module 200 through the diversion hole 102 to flush and cool the ultrasonic transducer 200.
[0107] It should be noted that although the ablation of the sympathetic nerves near the secondary branch 01 of the renal artery is taken as an example in the above text, it is not limited thereto. The medical system provided by the embodiments of the present invention can also be used to ablate the sympathetic nerves near blood vessels thinner than the secondary branch 01 of the renal artery, such as the tertiary branch of the renal artery (not marked in the figure), and can also ablate the sympathetic nerves near other blood vessels with a thickness equivalent to that of the secondary branch 01 of the renal artery, such as the accessory renal artery. Even more, it can ablate the sympathetic nerves near blood vessels slightly thicker than the secondary branch 01 of the renal artery. In practice, as long as the blood vessel meets the following Condition 1 and Condition 2, the medical system 1 can be used to ablate the sympathetic nerves near the blood vessel. The Condition 1 includes allowing the distal end of the medical guide wire 10 to enter; the Condition 2 includes that the medical guide wire 10 does not enter the renal pelvis.
[0108] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.
Claims
1. A medical guide wire, characterized in that, Comprising: A guide wire core and an ultrasonic transducer module; the guide wire core includes a main body section; the ultrasonic transducer module has an energy emitting surface, the ultrasonic transducer is disposed on the distal side wall of the main body section, and the energy emitting surface is exposed outside the guide wire core.
2. The medical guide wire according to claim 1, wherein, The outer diameter of the medical guide wire is 0.035 inch to 0.07 inch.
3. The medical guide wire according to claim 1 or 2, characterized in that, A joining hole is formed on the distal side wall of the main body section, the joining hole penetrates the outer peripheral surface of the main body section; at least a part of the ultrasonic transducer module is disposed in the joining hole; or, The ultrasonic transducer module is disposed on the distal outer peripheral surface of the main body section.
4. The medical guide wire according to claim 1, wherein The ultrasonic transducer module includes a base, a backing layer, a transducer body, and a matching layer; the base is connected to the guide wire core, and the base, the backing layer, the transducer body, and the matching layer are arranged in sequence along a direction away from the axis of the guide wire core.
5. The medical guide wire according to claim 4, wherein, The ultrasonic transducer module includes one transducer body, and the angle by which the transducer body extends circumferentially along the guide wire core is less than 360°.
6. The medical guide wire according to claim 4, characterized in that, The ultrasonic transducer module includes one transducer body, and the transducer body is an annular structure extending 360° circumferentially along the guide wire core.
7. The medical guide wire according to claim 4, characterized in that, The ultrasonic transducer module includes a plurality of transducer bodies, and the plurality of transducer bodies of the same ultrasonic transducer are arranged in sequence along the circumferential direction of the guide wire core.
8. The medical guide wire according to any one of claims 4-7, characterized in that, The number of the ultrasonic transducer modules is multiple, and the multiple ultrasonic transducer modules are arranged in sequence along the axial direction of the guide wire core.
9. The medical guide wire according to claim 1, characterized in that, A channel extending along its own axial direction is provided on the guide wire core; the medical guide wire further includes a cable, the distal end of the cable is connected to the ultrasonic transducer module, and the proximal end of the cable passes through the channel and extends to the proximal end of the guide wire core.
10. The medical guide wire according to claim 9, characterized in that, A partition wall is provided in the channel, the partition wall divides the channel into a first sub-channel and a second sub-channel arranged along the axial direction of the guide wire core, and the first sub-channel is located on the proximal side of the ultrasonic transducer module; A wire passing hole extending axially through the partition wall is provided on the partition wall; a part of the cable is disposed in the wire passing hole; A diversion hole is further provided on the side wall of the guide wire core, one end of the diversion hole communicates with the first sub-channel, and the other end penetrates the outer peripheral surface of the guide wire core and is located outside the ultrasonic transducer; The medical guide wire further includes a sealing structure, and the sealing structure is disposed between the cable and the hole wall of the wire passing hole.
11. The medical guide wire according to claim 1, characterized in that, The guide wire core further includes an introduction section, the introduction section is connected to the distal end of the main body section, and the outer diameter of the introduction section decreases in a direction away from the main body section; The medical guide wire further includes a spring coil and a guiding member, the spring coil is sleeved on the outer peripheral surface of the introduction section and is connected to the guide wire core; the guiding member is connected to the distal end of the spring coil and / or the distal end of the guide wire core.
12. The medical guide wire according to claim 11, characterized in that, The guide wire core includes a core body, a sheath, and a hydrophilic coating layer; the core body includes a proximal segment and a distal segment connected axially, and the outer diameter of the distal segment gradually decreases in a direction away from the proximal segment; the sheath is sleeved on the outer peripheral surface of the proximal segment; the hydrophilic coating layer is coated on the outer peripheral surface of the sheath; The introduction segment includes the distal segment of the core body; the main body segment includes the proximal segment of the core body, the sheath, and the hydrophilic coating layer.
13. A medical system, characterized in that, It includes an excitation system and a medical guide wire as described in any one of claims 1-12; the excitation system is electrically connected to the ultrasonic transducer module and outputs an excitation signal to the ultrasonic transducer to excite the ultrasonic transducer to generate ultrasonic energy.
14. The medical system according to claim 13, characterized in that, The medical system further includes an imaging system, the imaging system is communicatively connected to the ultrasonic transducer module, and is configured to receive the ultrasonic signal reflected by the tissue received by the ultrasonic transducer module and image based on the ultrasonic signal.
15. The medical system according to claim 13, characterized in that, A first sub-channel and a diversion hole are provided on the guide wire core; the first sub-channel extends along the axis of the guide wire core and is located on the proximal side of the ultrasonic transducer module; one end of the diversion hole communicates with the first sub-channel, and the other end penetrates the outer surface of the guide wire core and is located outside the ultrasonic transducer; The medical system further includes a perfusion system, the perfusion system is communicated with the first sub-channel, and the perfusion system is configured to provide a coolant to the first sub-channel.
