Water-driven intrusive miniature ultrasonic catheter

Abstract

The invention provides a water-driven intrusive miniature ultrasonic catheter which sequentially comprises an imaging / treatment section, a bending control section and a connecting section, a power assembly of the imaging / treatment section rotates under the pushing of water flow and drives an ultrasonic reflecting element connected with the power assembly to rotate, and catheter axial ultrasound emitted by a fixed ultrasonic transducer is converted into circumferential ultrasound, so that the ultrasonic effect is achieved. Therefore, ultrasonic circumferential imaging or treatment is realized. The problem of non-uniform rotation of a guide pipe entering a bent complex pipeline can be effectively solved; the catheter can be effectively and autonomously bent to guide the catheter to enter an area to be observed and treated; the treatment catheter driven by water flow can effectively take away heat generated in the transducer, so that the transducer works stably; the anti-interference capability of water flow driving is high, electromagnetic radiation is avoided, interference to weak ultrasonic signals is avoided, and the safety performance is good; and high-cost flexible shaft driving is replaced by turbine rotation, so that good economical efficiency and wider application range are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a water-driven interventional micro ultrasonic catheter. Background Art

[0002] A micro-invasive ultrasound catheter is an ultrasound device that uses the body's natural channels or tiny incisions to enter the body's lesions for imaging diagnosis and treatment. Existing invasive ultrasound imaging devices such as intravascular ultrasound (IVUS) and endobronchial ultrasound (EBUS) are widely used in frontline clinical settings. Interventional therapeutic ultrasound catheters use catheters made of miniature ultrasound probes, which can directly position ultrasound energy at or near the target area through the body's natural cavities or interventional methods. After reaching the treatment area, fewer operations are required, treatment time is shorter, and efficiency is higher.

[0003] At present, common ultrasonic catheter products include two types: phased array and mechanical rotation. Among them, the main working principle of the mechanical rotation catheter is to use a metal steel wire ring of about 2 meters as a flexible shaft, and use a motor to drive the flexible shaft at the end outside the body to drive the single-element transducer at the other end to rotate 360 ​​degrees. At the same time, the outer layer uses a rubber catheter sleeve to constrain the entire flexible shaft and prevent rotation from causing tissue wear.

[0004] Due to the complex structure and dynamic characteristics of the internal lumen of the human body, when an interventional catheter works in a curved and narrow lumen organ or a sharp turn tissue (such as the intestine), the endoscope axis will encounter uneven friction and resistance during rotation, which hinders the smooth transmission of the motor torque, resulting in an unstable rotation speed of the head transducer along the circumference of the organ, resulting in non-uniform rotation distortion (NURD), which leads to the appearance of image artifacts and seriously affects the doctor's judgment. For catheters used for treatment, it will cause uneven distribution of energy, resulting in deviations in the treatment area and affecting the treatment effect. Therefore, there is a real need to develop an interventional ultrasound catheter that can be used for curved and narrow lumen tissues.

[0005] Existing methods for solving non-uniform rotation imaging include the following two categories:

[0006] 1. The imaging probe driven by a flexible shaft uses two identical back-to-back transducers to work simultaneously. When the NURD area does not exceed 180°, the 180° phase difference of the back-to-back transducers can be used for software replacement and dynamic replacement. This method requires a two-channel ultrasound imaging device, which is less economical and practical. In addition, the size of the ultrasound imaging catheter will also increase due to the two transducers.

[0007] 2. For example, the Chinese invention patent with application number CN202310075463.3 discloses the use of contactless magnetic drive to replace the traditional end motor drive flexible shaft to achieve stability during imaging. This method adds a magnet module around the outside of the human body, and when the external magnet module is working, the internal magnetic response rotation module needs to be accurately positioned to rotate normally. This requires high operational difficulty and a large spatial position, and for the operating room, there must be no ferromagnetic materials or equipment that affects the magnetic field, which is more limited in practical applications.

[0008] Therefore, it is necessary and meaningful to further develop and design new methods to solve the non-uniform rotational distortion of interventional ultrasound catheters.

[0009] Another important aspect is that traditional ultrasound catheters are mostly guided by guidewires to enter narrow lumens, such as intravascular imaging ultrasound. The disadvantages of using guidewires to enter blood vessels include that the guidewires may cause vascular damage, bleeding, or increased risk of infection. In addition, guidewire guidance mainly relies on the doctor's feel, and the operator is also required to be very demanding. In addition, the guidewire will block a part of the area during operation, affecting the quality of the ultrasound image and limiting the doctor's field of vision and judgment. These factors may affect the accuracy of diagnosis and the safety of treatment. Therefore, it is also of great significance to further develop the design of catheters that can be autonomously driven to achieve bending on the existing basis. Summary of the invention

[0010] In order to achieve the above-mentioned purpose and other advantages of the present invention, the first purpose of the present invention is to provide a water-driven interventional micro-ultrasonic catheter, which comprises an imaging / treatment section, a bending control section, and a connecting section in sequence, wherein the imaging / treatment section, the bending control section, and the connecting section all comprise an inner tube and an outer tube for water flow, wherein the inner tube is placed inside the outer tube, and the imaging / treatment section further comprises an ultrasonic transducer assembly, a power assembly, and an ultrasonic reflection element, wherein the ultrasonic transducer assembly, the power assembly, and the ultrasonic reflection element are installed inside the inner tube, wherein the power assembly is connected to the ultrasonic reflection element, and the connecting section further comprises a water flow control assembly, wherein the water flow control assembly is used to control the water flow rate;

[0011] The power assembly rotates under the impetus of the water flow, driving the ultrasonic reflective element connected thereto to rotate, thereby converting the axial ultrasound of the catheter emitted by the fixed ultrasonic transducer assembly into a circumferential direction, thereby realizing circumferential ultrasonic imaging or treatment.

[0012] Furthermore, the ultrasonic transducer assembly includes an ultrasonic transducer and a fixed support member through which water can flow, and the ultrasonic transducer is fixedly installed in the inner tube through the fixed support member.

[0013] Furthermore, the power assembly includes a turbine and a stop assembly through which water can flow, and the turbine is axially stopped by the stop assembly.

[0014] Furthermore, the stop assembly includes a stop support, and any one of a stop ball, a stop cylindrical ejector pin, and a stop conical ejector pin.

[0015] Furthermore, the ultrasonic transducer assembly is installed close to the bending control section, and the power assembly and the ultrasonic reflective element are installed away from the bending control section.

[0016] Furthermore, the stop assembly adopts a stop ring.

[0017] Furthermore, the ultrasonic transducer assembly is installed far away from the bending control section, and the power assembly and the ultrasonic reflective element are installed close to the bending control section.

[0018] Furthermore, the ultrasonic reflective element is an ultrasonic reflective mirror.

[0019] Furthermore, the ultrasonic reflector adopts a cylindrical structure with one side beveled.

[0020] Furthermore, the inclined surface angle of the cylinder is 40° to 50°.

[0021] Furthermore, the outer tube of the bending control section is made of a material that bends under pressure, and the bending coefficient of the outer tube of the bending control section is different, so that the catheter bending function is achieved.

[0022] Furthermore, the water flow direction of the micro ultrasonic catheter is flowing in from the inner tube and flowing out from the outer tube, or flowing in from the outer tube and flowing out from the inner tube.

[0023] Furthermore, the water flow control assembly includes a water pump and a control valve body, and the water flow rate is controlled by the input and output control valve body and the water pump.

[0024] Furthermore, when the micro-ultrasound catheter is an imaging catheter, the ultrasound emission of the imaging catheter adopts a pulse repetition mode;

[0025] When the micro ultrasonic catheter is a therapeutic catheter, the ultrasonic emission of the therapeutic catheter adopts a continuous wave or PWM mode.

[0026] Furthermore, the outer tube is connected to a water bag material with elasticity at the farthest end, and the opening and contraction of the water bag are achieved by controlling the water pressure.

[0027] Compared with the prior art, the embodiments of the present invention have the following beneficial effects:

[0028] The present invention proposes a water pressure driven interventional ultrasound microcatheter to achieve imaging or treatment. The main advantages are: it can effectively solve the problem of uneven rotation of the catheter entering a curved and complex pipeline; it can effectively achieve autonomous bending of the catheter to guide the catheter into the desired observation and treatment area; the water flow driven treatment catheter can effectively take away the heat generated inside the transducer, so that the transducer can work stably; the water flow drive has strong anti-interference ability, no electromagnetic radiation, no interference with weak ultrasonic signals, and good safety performance; the turbine rotation replaces the high-cost soft shaft drive, so it has good economy and a wider range of applications.

[0029] The above description is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention and implement it according to the contents of the specification, the following is a detailed description of the preferred embodiments of the present invention in conjunction with the accompanying drawings. The specific implementation of the present invention is given in detail by the following embodiments and their accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The drawings described herein are used to provide a further understanding of the present invention and constitute a part of this application. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0031] Figure 1 Schematic diagram of water-driven invasive micro-ultrasound catheter Figure 1 ;

[0032] Figure 2 Schematic diagram of water-driven invasive micro-ultrasound catheter Figure 2 ;

[0033] Figure 3 It is a schematic diagram of the imaging / treatment segment;

[0034] Figure 4 Schematic diagram of imaging / treatment;

[0035] Figure 5 A schematic diagram of a stop support member;

[0036] Figure 6 is a schematic diagram of a fixed support member;

[0037] Figure 7 This is a schematic diagram of the combined structure after installing the ultrasonic transducer;

[0038] Figure 8 is a schematic diagram of a turbine and an ultrasonic reflector;

[0039] Fig. 9 It is a schematic diagram of the bending control section;

[0040] Fig.10 Schematic diagram of water flow direction;

[0041] Fig.11 Schematic diagram of the catheter with the water bag connected to the distal end of the outer tube. DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] In the drawings, the shapes and dimensions may be exaggerated for clarity, and the same reference numerals will be used throughout to designate the same or like components.

[0044] In the following description, words such as center, thickness, height, length, front, back, rear, left, right, top, bottom, upper, lower, etc. are defined relative to the structure shown in the drawings. In particular, "height" is equivalent to the dimension from top to bottom, "width" is equivalent to the dimension from left to right, and "depth" is equivalent to the dimension from front to back. They are relative concepts and may change accordingly according to their different positions and different usage states. Therefore, these or other directions should not be interpreted as restrictive terms.

[0045] Terms related to attachment, coupling, and the like (eg, "connected" and "attached") refer to either a fixed or attached relationship between structures, either directly or indirectly, and either movable or rigid attachments or relationships, unless expressly stated otherwise, of the structures to one another through intermediate structures.

[0046] Example 1

[0047] A water-driven invasive micro-ultrasound catheter uses water pressure to drive the internal components of the catheter to achieve 360° ultrasound imaging or treatment, and can autonomously control the bending angle. Figure 1 As shown, the water-driven interventional micro-ultrasound catheter includes an imaging / treatment section, a bending control section, and a connecting section in sequence. Figure 2 As shown, the imaging / treatment section, the bending control section, and the connecting section all include an inner tube 2 and an outer tube 1 for water flow, the inner tube 2 is placed in the outer tube 1, the outer tube 1 is connected to the first tube port 3, and the inner tube 2 is connected to the second tube port 4, the imaging / treatment section also includes an ultrasonic transducer assembly, a power assembly, and an ultrasonic reflection element, the ultrasonic transducer assembly, the power assembly, and the ultrasonic reflection element are installed in the inner tube 2, the power assembly is connected to the ultrasonic reflection element, and the connecting section also includes a water flow control assembly, and the water flow control assembly is used to control the water flow rate;

[0048] The power assembly rotates under the impetus of the water flow, driving the ultrasonic reflective element connected thereto to rotate, thereby converting the axial ultrasound of the catheter emitted by the fixed ultrasonic transducer assembly into a circumferential direction, thereby realizing circumferential ultrasonic imaging or treatment.

[0049] This embodiment provides a solution that can allow the catheter to be bent autonomously through changes in water pressure. When entering complex luminal tissues, the angle of entry of the catheter head can be autonomously adjusted, providing high flexibility, which can replace the traditional guidewire guidance method, reduce risks and provide better imaging field of view and quality.

[0050] In some embodiments, Figure 3-Figure 4 , Figure 6-Figure 8 As shown, the ultrasonic transducer assembly includes an ultrasonic transducer 7 and a fixed support member 8 that can pass through water flow. The fixed support member 8 preferably has a structure as shown in Figure 6 As shown in (a) and (b), the ultrasonic transducer 7 is fixedly installed in the inner tube 2 through the fixed support 8, and the ultrasonic transducer 7 is connected to the transducer cable 11. Figure 7 (a) and (b) are schematic diagrams of the combined structure after the ultrasonic transducer 7 is installed on the fixed support 8.

[0051] In some embodiments, Figure 3-Figure 5 , Figure 8 As shown, the power assembly includes a turbine 5 and a stop assembly that can pass water flow. The turbine 5 Figure 3 , Figure 4 The water flow will flow in the direction of the water flow under the impact, so axial stop is required. The turbine 5 is axially stopped by the stop assembly.

[0052] This embodiment provides two typical positions, one of which is: the ultrasonic transducer assembly is installed close to the bending control section, and the power assembly and the ultrasonic reflective element are installed away from the bending control section, such as Figure 3 As shown in (a), (b) and (c).

[0053] Alternatively, if Figure 3-Figure 5 , Figure 8 As shown, the stop assembly includes a stop support 9, and any one of a stop ball 10, a stop cylindrical ejector pin 12, and a stop conical ejector pin 13. The stop support 9 preferably has a structure as follows: Figure 5 As shown in (a) and (b).

[0054] Another position is: the ultrasonic transducer assembly is installed far away from the bending control section, and the power assembly and the ultrasonic reflective element are installed close to the bending control section. Figure 3 As shown in (d).

[0055] Alternatively, if Figure 3 As shown in (d), the stop assembly adopts a stop ring 14.

[0056] This embodiment provides the above four stopping methods, namely, including Figure 3 In (a), a stop ball 10 is used to achieve point contact stop. Figure 3 In (b), the stopper is provided by a cylindrical ejector pin 12. Figure 3 In (c), a stop cone ejector pin 13 is used for stopping. Figure 3 In (d), a stop ring 14 is used for stopping.

[0057] In some embodiments, Figure 3 , Figure 4 , Figure 8 As shown, the ultrasonic reflective element is an ultrasonic reflector 6. Preferably, the ultrasonic reflector is a cylindrical structure with one side beveled, wherein the angle of the inclined surface of the cylinder is 40° to 50°, and the typical value of the inclined surface angle is preferably 45°.

[0058] Imaging / treatment segment Figure 3 , Figure 4 As shown, the water flow drives the turbine 5 to rotate, thereby driving the ultrasonic reflector 6 connected to the turbine 5 to rotate, so that the axial ultrasound of the catheter emitted by the fixed ultrasonic transducer 7 is converted into the circumferential direction, thereby realizing the circumferential imaging or treatment of ultrasound.

[0059] In some embodiments, Fig. 9 As shown, the outer tube of the bending control section is made of a material that bends under pressure, and the bending coefficient of the outer tube of the bending control section is different to achieve the function of catheter bending. Fig. 9 (a) is the cross-sectional view of the bending control section. Fig. 9 (b) is a schematic diagram of the bending control section in the unbent state. Fig. 9 As shown in (c), when the pressure is greater, the bending angle is greater, so by controlling the pressure value of the input and output water flow of the pressure pump at the outer end of the catheter, the catheter bending can be freely controlled.

[0060] like Fig.10 As shown in (a), the water flow direction of the micro ultrasonic catheter is to flow in from the inner tube and out from the outer tube; or Fig.10 As shown in (b), the water flows in from the outer tube and flows out from the inner tube. It is preferred to adopt the flow direction of the water flowing in from the inner tube and flowing out from the outer tube. When the water flows in from the outer tube and flows out from the inner tube, the corresponding turbine stop assembly needs to be changed. The specific method includes adopting Figure 3 The stopping cylindrical ejector pin 12 shown in (d) is stopped near the bending control section.

[0061] In some embodiments, the water flow control assembly includes a water pump and a control valve body, and the water flow rate is controlled by the input and output of the control valve body and the water pump.

[0062] In this embodiment, the liquid driving the turbine to rotate is water, or physiological saline, or other liquids with low viscosity, low sound attenuation, and harmless to the human body. The water flow rate is controlled by the input and output control valve bodies, namely the pressure valve and the water pump.

[0063] The water-driven catheter of this embodiment includes an imaging catheter and a treatment catheter. The ultrasound emission of the imaging catheter usually adopts a pulse repetition mode, while the treatment catheter usually adopts a continuous wave or PWM mode. Among them, as a treatment catheter, since the treatment requires a large output power, a large amount of heat is generated inside the ultrasonic transducer, which will lead to the risk of degradation of the performance of the ultrasonic transducer or even failure. The catheter provided in this embodiment also plays a good role in the heat dissipation of the ultrasonic transducer by rotating driven by water flow. The ultrasonic transducer and water exchange heat, and the flow of water takes away the heat accumulated inside the ultrasonic transducer, so that the treatment transducer can work stably.

[0064] Since invasive ultrasound catheters usually need to work in a liquid environment, ultrasound can be transmitted well. Fig.11 As shown, this embodiment also provides a catheter that does not need to be bent but needs a distal water bag by replacing the outer tube, and works in a gas-filled lumen such as a bronchus. By connecting the distal end of the outer tube to a water bag material with good elasticity, the water bag can be opened and contracted by controlling the water pressure. Fig.11 (a) is a schematic diagram of the state without water flow. Fig.11 (b) is a schematic diagram of the water flow state. In this way, the outer tube can be easily replaced without changing the components of the inner tube.

[0065] This embodiment provides a water-driven invasive micro-ultrasound catheter, which uses water pressure to drive the micro-turbine to rotate, thereby driving the rotation of the reflective acoustic mirror, thereby achieving 360° rotation imaging or treatment of ultrasound. This water-driven rotation can replace the traditional end motor driving the flexible shaft, thereby improving the rotation stability during imaging and the uniformity during treatment.

[0066] The number of devices and processing scales described here are used to simplify the description of the present invention. Applications, modifications and variations of the present invention will be obvious to those skilled in the art.

[0067] Although the embodiments of the present invention have been disclosed as above, they are not limited to the applications listed in the specification and implementation modes. They can be fully applied to various fields suitable for the present invention. For those familiar with the art, additional modifications can be easily implemented. Therefore, without departing from the general concept defined by the claims and the scope of equivalents, the present invention is not limited to the specific details and the illustrations shown and described herein.

[0068] It should also be noted that the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, commodity or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, commodity or device. In the absence of more restrictions, the elements defined by the sentence "comprises a ..." do not exclude the existence of other identical elements in the process, method, commodity or device including the elements.

[0069] Each embodiment in this specification is described in a progressive manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the system embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0070] The above description is only an embodiment of this specification and is not intended to limit one or more embodiments of this specification. For those skilled in the art, one or more embodiments of this specification may have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of one or more embodiments of this specification shall be included in the scope of the claims of one or more embodiments of this specification.

Claims

1. A water-driven invasive micro-ultrasonic catheter, characterized in that: The imaging / treatment section, the bending control section, and the connecting section are sequentially included. The imaging / treatment section, the bending control section, and the connecting section all include an inner tube and an outer tube for water flow, and the inner tube is placed inside the outer tube. The imaging / treatment section also includes an ultrasonic transducer assembly, a power assembly, and an ultrasonic reflection element. The ultrasonic transducer assembly, the power assembly, and the ultrasonic reflection element are installed inside the inner tube, and the power assembly is connected to the ultrasonic reflection element. The connecting section also includes a water flow control assembly, and the water flow control assembly is used to control the water flow rate. The power assembly rotates under the impetus of the water flow, driving the ultrasonic reflective element connected thereto to rotate, thereby converting the axial ultrasound of the catheter emitted by the fixed ultrasonic transducer assembly into a circumferential direction, thereby realizing circumferential ultrasonic imaging or treatment.

2. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: The ultrasonic transducer assembly comprises an ultrasonic transducer and a fixed support member through which water can flow. The ultrasonic transducer is fixedly installed in the inner tube through the fixed support member.

3. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: The power assembly comprises a turbine and a stop assembly through which water can flow, and the turbine is axially stopped by the stop assembly.

4. The water-driven invasive micro-ultrasonic catheter according to claim 3, characterized in that: The stop assembly comprises a stop support and any one of a stop ball, a stop cylindrical ejector pin and a stop conical ejector pin.

5. The water-driven invasive micro-ultrasonic catheter according to claim 4, characterized in that: The ultrasonic transducer assembly is installed near the bending control section, and the power assembly and the ultrasonic reflective element are installed away from the bending control section.

6. The water-driven invasive micro-ultrasonic catheter according to claim 3, characterized in that: The stop assembly adopts a stop ring.

7. The water-driven invasive micro-ultrasonic catheter according to claim 6, characterized in that: The ultrasonic transducer assembly is installed far away from the bending control section, and the power assembly and the ultrasonic reflective element are installed close to the bending control section.

8. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: The ultrasonic reflective element is an ultrasonic reflective mirror.

9. The water-driven invasive micro-ultrasonic catheter according to claim 8, characterized in that: The ultrasonic reflector adopts a cylindrical structure with one side beveled.

10. The water-driven invasive micro-ultrasonic catheter according to claim 9, characterized in that: The angle of the inclined surface of the cylinder is 40° to 50°.

11. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: The outer tube of the bending control section is made of a material that bends under pressure, and the bending coefficient of the outer tube of the bending control section is different, so that the catheter bending function is achieved.

12. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: The water flow direction of the micro ultrasonic catheter is to flow in from the inner tube and flow out from the outer tube, or to flow in from the outer tube and flow out from the inner tube.

13. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: The water flow control assembly includes a water pump and a control valve body, and the water flow rate is controlled by the input and output control valve body and the water pump.

14. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: When the micro-ultrasound catheter is an imaging catheter, the ultrasound emission of the imaging catheter adopts a pulse repetition mode; When the micro ultrasonic catheter is a therapeutic catheter, the ultrasonic emission of the therapeutic catheter adopts a continuous wave or PWM mode.

15. The water-driven invasive micro-ultrasonic catheter according to claim 1, characterized in that: The outer tube is connected to a water bag material with elasticity at the farthest end, and the opening and contraction of the water bag are achieved by controlling the water pressure.

Images