A non-invasive penetrating radiofrequency diagnostic and therapeutic device and its catheter

Abstract

A non-invasive penetrating radiofrequency diagnosis and treatment device and its catheter. The catheter includes a tube body, an intermediate film layer and a radiofrequency electrode array. The tube body has a retractable cavity. The intermediate film layer is attached to the outer surface of the retractable cavity. The intermediate film layer includes a first part and a second part. Under the same external force, the deformation degree of the first part is less than that of the second part. The radiofrequency electrode array is attached to the first part of the intermediate film layer. The retractable cavity has a smaller contraction state and a larger expansion state. The second part can absorb most of the deformation caused by the expansion activity of the retractable cavity, while the first part will not be significantly deformed. When the retractable cavity is in a contracted state, the radiofrequency electrode array can remain flat with the inner wall of the organ during the process of inserting the catheter into the organ or withdrawing the catheter from the organ, thereby effectively preventing the radiofrequency electrode array from scratching the inner wall of the organ.

Description

Technical Field

[0001] The present invention relates to the field of medical electronic devices, and in particular to a device attached to a body surface or in a cavity for radio frequency treatment, and more particularly to a non-invasive penetrating radio frequency diagnosis and treatment device and a catheter thereof. Background Art

[0002] Radiofrequency therapy has many cutting-edge applications in medicine, where radiofrequency power is applied through radiofrequency electrodes attached to the surface of tissues. Generally speaking, radiofrequency therapy does not require surgery, is simple and convenient, and has a short treatment time. This method has been widely used in kidney and heart treatment, but it is mainly used to treat tumor cancer. Radiofrequency therapy is rarely used in large cavities, such as the bladder, uterus, etc. Taking the treatment of the bladder as an example, the treatment device used must be inserted through the tiny urethral opening and then penetrate into the bladder. The aperture of the urethra is very narrow, but the volume of the bladder is very large after being filled with water. The treatment device must accommodate a considerable volume change. However, the tensile deformation of the metal electrode is very limited. Existing radiofrequency equipment is difficult to use on organs with huge internal cavity volumes such as the bladder, which brings challenges to the research and development and production of the device.

[0003] One example of treating large cavity diseases is overactive bladder (OAB), which is caused by oversensitive bladder nerves. This disease can cause great inconvenience in life, especially for women aged 45-60. OAB is usually caused by spasms of the bladder muscles, which is mainly a problem with the bladder nerves and muscles. The detrusor is one of the main muscles of the bladder, and it contracts to urinate when the bladder is full of urine. The contraction and relaxation of the detrusor is regulated by the nervous system. Due to various abnormalities, oversensitive nerves lead to OAB. There are many ways to treat OAB, including behavioral therapy, drug therapy, surgical treatment and radiofrequency treatment. Many patients tend to adopt an attitude of indifference and tolerance, mainly because the existing treatment methods are not ideal. The effect of behavioral therapy is closely related to whether the patient persists. It is often ineffective because the patient finds it difficult to persist. Drug therapy, such as anticholinergics, has a certain effect, but it is not effective for everyone, and it is often accompanied by great side effects. The method of injecting neurotoxins has a certain effect, but most patients will not choose surgical treatment, but still hope to use radiofrequency treatment, a non-invasive and safer treatment method. It should be known that urination or sensing urine pressure is completed through the nerve fibers of the inner wall of the bladder. The basic principle of radio frequency treatment of OAB is to reduce the sensitivity of the bladder by killing some nerves, thereby normalizing the function of the bladder. As mentioned above, there is a huge potential market for radio frequency treatment, but there are also great technical obstacles. Only by overcoming the existing technical difficulties can radio frequency treatment give full play to its potential value in treating bladder OAB. Non-invasive penetrating radio frequency diagnostic and treatment equipment usually includes a radio frequency power supply, an intelligent controller and a catheter. During the treatment process, the catheter needs to be inserted into the patient's organ so that the radio frequency electrode array arranged on the outside of the catheter and the inner wall of the organ form a good contact, so that the radio frequency power can smoothly penetrate deep into the inner wall of the organ and reach the nerve area, thereby achieving treatment, and the catheter is pulled out after the treatment is completed. The current problem is that in the process of inserting the catheter into the patient's organ and pulling the catheter out of the patient's organ, the radio frequency electrode array arranged on the outside of the catheter is easy to scratch the inner wall of the organ. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a catheter for non-invasive penetrating radiofrequency diagnosis and treatment equipment which can reduce the risk of scratching the inner wall of an organ.

[0005] Another technical problem to be solved by the present invention is to provide a non-invasive penetrating radiofrequency diagnostic and therapeutic device having the catheter as described above.

[0006] In order to solve the above technical problems, the technical solution adopted by the invention is to provide a catheter for non-invasive penetrating radio frequency diagnostic and treatment equipment, wherein the catheter includes a tube body, an intermediate film layer and a radio frequency electrode array, the tube body has a retractable cavity, the intermediate film layer is adhered to the outer surface of the retractable cavity, the intermediate film layer includes a first part and a second part that are connected, and under the same external force, the deformation degree of the first part is less than the deformation degree of the second part, the radio frequency electrode array is attached to the first part of the intermediate film layer, and the retractable cavity has a smaller volume contracted state and a larger volume expanded state.

[0007] By adopting the catheter of the above technical solution, the intermediate film layer includes a first part and a second part connected to each other, and the deformation degree of the first part is less than the deformation degree of the second part under the same external force, that is, the deformation resistance of the first part is stronger than that of the second part. It can be understood that when the telescopic cavity expands to the expanded state, the second part can absorb most of the deformation caused by the expansion activity of the telescopic cavity, and the first part will not be significantly deformed, so that the radio frequency electrode array attached to the first part will not be violently bifurcated or even cracked, and the radio frequency electrode array is always kept in close contact with the first part of the intermediate film layer, so that when the telescopic cavity shrinks from the expanded state to the contracted state, the radio frequency electrode array still remains flat and attached to the intermediate film layer of the catheter, so that when the telescopic cavity is in the contracted state, the catheter is inserted into the organ or the catheter is withdrawn from the organ, the radio frequency electrode array can remain flat with the inner wall of the organ, thereby effectively preventing the radio frequency electrode array from scratching the inner wall of the organ.

[0008] In the catheter provided by the present invention, the first part and the second part are made of the same material, and the thickness of the first part is greater than the thickness of the second part. In this way, since the first part and the second part are designed to be made of the same material, the manufacturing process of the intermediate film layer can be simplified. By increasing the thickness of the first part, the deformation resistance of the first part can be enhanced, and by reducing the thickness of the second part, the second part can be more easily deformed and better absorb deformation. In this way, after the retractable cavity is repeatedly expanded and contracted, the first part of the intermediate film layer can still maintain a very small deformation amount, thereby ensuring that the radio frequency electrode array can always remain flat with the intermediate film layer, ensuring that when the retractable cavity retracts to the contracted state, the radio frequency electrode array will not bifurcate, preventing the radio frequency electrode array from scratching the inner wall of the organ.

[0009] In the catheter provided by the present invention, the first part and the second part are made of different materials, and the hardness of the first part is greater than that of the second part. Here, by selecting a material with higher hardness to make the first part and selecting a material with lower hardness to make the second part, it can be made that when the thickness of the first part and the second part are the same, the first part has a stronger anti-deformation ability than the second part, so that when the retractable cavity expands, the second part is more likely to deform and thus better absorbs the deformation, while the first part will not deform significantly, so that after the retractable cavity expands and contracts repeatedly, the first part of the intermediate film layer can still maintain a very small deformation amount, thereby ensuring that the radio frequency electrode array can always remain flat with the intermediate film layer, ensuring that when the retractable cavity retracts to the contracted state, the radio frequency electrode array will not bifurcate, and prevent the radio frequency electrode array from scratching the inner wall of the organ.

[0010] In the catheter provided by the present invention, the material and thickness of the first part and the second part are the same, and the second part is pierced with a plurality of through holes. Here, since the first part and the second part are designed to be made of the same material and have the same thickness, the manufacturing process of the intermediate film layer can be further simplified. By punching holes in the second part to form a plurality of through holes on the second part, the second part is more likely to deform and better absorb deformation, so that the first part of the intermediate film layer can still maintain a very small deformation after the retractable cavity is repeatedly expanded and contracted, thereby ensuring that the radio frequency electrode array can always remain flat with the intermediate film layer, and ensuring that when the retractable cavity retracts to the contracted state, the radio frequency electrode array will not bifurcate, thereby preventing the radio frequency electrode array from scratching the inner wall of the organ.

[0011] In the catheter provided by the present invention, the intermediate membrane layer is made of a material selected from the group consisting of silicone, polyurethane, silica gel, latex, polyethylene, cross-linked polyethylene, conductive silicone, polyethylene terephthalate, latex, semipermeable membrane, carbon fiber and nylon.

[0012] In the catheter provided by the present invention, the radio frequency electrode array uses a flexible film as a carrier, and the flexible film is completely attached to the first part of the intermediate membrane layer. In this way, during the expansion and contraction of the retractable cavity, the radio frequency electrode array can rise and fall with the expansion and contraction of the retractable cavity. It can be understood that after the catheter is inserted into the organ, the retractable cavity can be expanded from the contracted state to the expanded state, so that the radio frequency electrode array moves toward the inner wall of the organ driven by the retractable cavity, and by regulating the expansion degree of the retractable cavity, the radio frequency electrode array can be made to contact the tissue surface of the inner wall of the organ and maintain close contact with the tissue surface under the pressure of the retractable cavity, forming a good electrical contact.

[0013] In the catheter provided by the present invention, the opposite ends of the catheter are respectively provided with a first body fluid input and output port and a second body fluid input and output port that are interconnected, and the retractable cavity is located between the first body fluid input and output port and the second body fluid input and output port and close to the second body fluid input and output port; a refrigerant injection port is connected to one end close to the first body fluid input and output port, and the refrigerant injection port runs through the catheter and is connected to the retractable cavity, and the retractable cavity is filled with refrigerant. In this way, the refrigerant can be injected into or extracted from the retractable cavity through the refrigerant injection port to achieve the expansion and contraction of the retractable cavity. In addition, the radio frequency electrode array in contact with the retractable cavity can always maintain a low temperature, effectively protecting the mucosal tissue on the inner wall surface of the organ from burning.

[0014] In the catheter provided by the present invention, the intermediate film layer is detachably attached to the outer surface of the telescopic cavity. With such a design, when the intermediate film layer is damaged, the intermediate film layer can be replaced separately, which is conducive to reducing the maintenance cost of the catheter.

[0015] In the catheter provided by the present invention, the intermediate film layer can be omitted, that is, the radio frequency electrode array uses a flexible film as a carrier, and the flexible film is directly and completely attached to the catheter. As the retractable cavity of the tube body expands and contracts, the radio frequency electrode array can rise and fall with the expansion and contraction of the retractable cavity. The material and structure of the tube body of the catheter can be selected and designed in accordance with the above intermediate film layer.

[0016] To solve the other technical problem mentioned above, the technical solution adopted by the invention is to provide a non-invasive penetrating radio frequency diagnostic and treatment device, which includes a radio frequency power supply, an intelligent controller and the catheter as described above, and the radio frequency power supply is electrically connected to the radio frequency electrode array through the intelligent controller.

[0017] When the non-invasive penetrating radiofrequency diagnosis and treatment device of the above technical solution is used for treatment, after the catheter is inserted into the organ when the retractable cavity is in the contracted state, refrigerant is injected into the retractable cavity through the refrigerant injection port to expand the retractable cavity to the expanded state, at which time the radiofrequency electrodes of the radiofrequency electrode array are in contact with the inner wall of the organ; then the radiofrequency power supply is turned on, and the parameters of radiofrequency treatment (including radiofrequency power, treatment time, pulse period and width) are automatically controlled by the intelligent controller to allow the radiofrequency electrode array to treat the organ; after the treatment is completed, the refrigerant in the retractable cavity is extracted from the refrigerant injection port to retract the retractable cavity to the contracted state, and then the catheter is extracted from the organ. At this point, intelligent radiofrequency treatment of the organ is achieved to obtain the best treatment effect.

[0018] The non-invasive penetrating radio frequency diagnosis and treatment device provided by the present invention also includes a signal detector and a signal source; when the diagnosis and treatment device is used, the signal detector is arranged outside the organ, and the catheter is integrated with a radio frequency electrode array or a signal transmitter, and the signal detector is used to detect the signal emitted by the signal transmitter, and three-dimensionally locate or diagnose the lesion according to the signal. In this way, positioning treatment is achieved through the signal transmitter and the signal detector.

[0019] The implementation of the present invention can achieve at least the following beneficial effects:

[0020] 1. When the retractable cavity expands to the expanded state, the second part can absorb most of the deformation caused by the expansion activity of the retractable cavity, and the first part will not be significantly deformed, so that the radio frequency electrode array attached to the first part will not be violently bifurcated or even cracked, and the radio frequency electrode array is always kept in close contact with the first part of the intermediate film layer, so that when the retractable cavity shrinks from the expanded state to the contracted state, the radio frequency electrode array still remains flatly attached to the intermediate film layer of the catheter. Then, when the catheter is inserted into the organ or the catheter is withdrawn from the organ when the retractable cavity is in the contracted state, the radio frequency electrode array can remain flat with the inner wall of the organ, thereby effectively preventing the radio frequency electrode array from scratching the inner wall of the organ;

[0021] 2. Since the first part and the second part are designed to be made of the same material, the manufacturing process of the intermediate film layer can be simplified. By increasing the thickness of the first part, the deformation resistance of the first part can be enhanced, and by reducing the thickness of the second part, the second part can be more easily deformed and better absorb deformation. In this way, after the retractable cavity is repeatedly expanded and contracted, the first part of the intermediate film layer can still maintain a very small deformation, thereby ensuring that the RF electrode array can always remain flat with the intermediate film layer, and ensuring that when the retractable cavity retracts to the contracted state, the RF electrode array will not bifurcate, preventing the RF electrode array from scratching the inner wall of the organ;

[0022] 3. By selecting a material with higher hardness to make the first part and a material with lower hardness to make the second part, when the thickness of the first part and the second part are the same, the first part can have a stronger deformation resistance than the second part. In this way, when the retractable cavity expands, the second part is more likely to deform and thus better absorbs the deformation, while the first part will not deform significantly. In this way, after the retractable cavity is repeatedly expanded and contracted, the first part of the intermediate membrane layer can still maintain a very small deformation, thereby ensuring that the RF electrode array can always remain flat with the intermediate membrane layer, and ensuring that when the retractable cavity retracts to the contracted state, the RF electrode array will not bifurcate, thereby preventing the RF electrode array from scratching the inner wall of the organ. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below. Obviously, the drawings in the following description are only embodiments of the invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without creative work:

[0024] Figure 1 A schematic diagram of the structure of the non-invasive penetrating radiofrequency diagnostic and therapeutic device provided in Example 1;

[0025] Figure 2 A schematic diagram of the structure of the catheter provided in Example 1 when the retractable cavity is in an expanded state;

[0026] Figure 3 A schematic diagram of the structure of the catheter provided in the second embodiment when the retractable cavity is in a retracted state;

[0027] Figure 4 This is a schematic diagram of the structure of the catheter provided in Example 2 when the retractable cavity is in an expanded state.

[0028] Description of the accompanying drawings in the specific implementation manner:

[0029] catheter 1 RF Power 2 Intelligent Controller 3 tube body 11 Radiofrequency electrode array 12 Intermediate film layer 13 First body fluid input and output port 111 Second body fluid input and output port 112 Refrigerant injection port 113 Retractable cavity 114 Part I 131 Part 2 132 DETAILED DESCRIPTION

[0030] In order to facilitate understanding of the invention, the invention will be described more fully below with reference to the relevant drawings. Typical embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the invention more thorough and comprehensive.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which the invention belongs. The terms used in the specification of the invention herein are only for the purpose of describing specific embodiments and are not intended to limit the invention.

[0032] Embodiment 1

[0033] This embodiment provides a non-invasive penetrating radiofrequency diagnosis and treatment device. Figure 1 , Figure 1 The schematic diagram of the structure of the non-invasive penetrating radiofrequency diagnostic and therapeutic device provided in this embodiment is as follows: Figure 1 As shown, the non-invasive penetrating radio frequency diagnosis and treatment device includes a radio frequency power supply 2, an intelligent controller 3 and a catheter 1, and the radio frequency power supply 2 is electrically connected to the radio frequency electrode array 12 through the intelligent controller 3. The catheter 1 includes a tube body 11, an intermediate film layer 13 and a radio frequency electrode array 12. Figure 1It can be seen that the two opposite ends of the catheter 1 are respectively provided with a first body fluid input and output port 111 and a second body fluid input and output port 112 which are interconnected, and the position of the tube body 11 between the first body fluid input and output port 111 and the second body fluid input and output port 112 is provided with a refrigerant injection port 113 and a retractable cavity 114, the refrigerant injection port 113 is close to the first body fluid input and output port 111, the retractable cavity 114 is close to the second body fluid input and output port 112, the refrigerant injection port 113 runs through the catheter 1 and is connected to the retractable cavity 114, and the retractable cavity 114 is filled with refrigerant. It can be understood that the refrigerant can be injected into or extracted from the retractable cavity 114 through the refrigerant injection port 113 to achieve the expansion and contraction of the retractable cavity 114. Since the retractable cavity 114 is filled with refrigerant, the RF electrode array 12 in contact with the retractable cavity 114 can always maintain a low temperature, effectively protecting the mucosal tissue on the inner wall surface of the organ from burning. The intermediate film layer 13 is attached to the outer surface of the retractable cavity 114, and the intermediate film layer 13 includes a first part 131 and a second part 132 connected to each other. Under the same external force, the deformation degree of the first part 131 is less than that of the second part 132. The retractable cavity 114 has a contracted state with a smaller volume and an expanded state with a larger volume. The RF electrode array 12 is attached to the first part 131 of the intermediate film layer 13. In this embodiment, the RF electrode array 12 uses a flexible film as a carrier, and the flexible film is completely attached to the first part 131 of the intermediate film layer 13. In this way, during the expansion and contraction of the retractable cavity 114, the RF electrode array 12 can rise and fall with the expansion and contraction of the retractable cavity 114. In this embodiment, the first part 131 and the second part 132 are made of the same material. Here, the material of the first part 131 and the second part 132 can be selected from one of silicone, polyurethane, silicone, latex, polyethylene, cross-linked polyethylene, conductive silicone, polyethylene terephthalate, latex, semi-permeable membrane, carbon fiber and nylon. Figure 1As shown, the thickness of the first part 131 is greater than the thickness of the second part 132. It should be understood that since the first part 131 and the second part 132 are designed to be made of the same material, the manufacturing process of the intermediate film layer 13 can be simplified. By increasing the thickness of the first part 131, the deformation resistance of the first part 131 can be enhanced, and by reducing the thickness of the second part 132, the second part 132 can be more easily deformed and better absorb deformation. In this way, after the retractable cavity 114 repeatedly expands and contracts, the first part 131 of the intermediate film layer 13 can still maintain a very small deformation, thereby ensuring that the RF electrode array 12 can always remain flat with the intermediate film layer 13, and ensuring that when the retractable cavity 114 retracts to the contracted state, the RF electrode array 12 will not bifurcate, preventing the RF electrode array 12 from scratching the inner wall of the organ. In this embodiment, the intelligent controller 3 includes an information display unit, a logic control unit, a communication module and a radio frequency controller. The specific structure and working principle of the intelligent controller 3 are disclosed in the Chinese invention patent application number 201610753065.2.

[0034] As can be seen from the above, when the above-mentioned non-invasive penetrating radiofrequency diagnosis and treatment equipment is used for treatment, after the catheter 1 is inserted into the organ when the retractable cavity 114 is in the contracted state, the refrigerant is injected into the retractable cavity 114 through the refrigerant injection port 113, so that the retractable cavity 114 expands to the expanded state, at which time the radiofrequency electrodes of the radiofrequency electrode array 12 are in contact with the inner wall of the organ; then the radiofrequency power supply 2 is turned on, and the parameters of the radiofrequency treatment (including radiofrequency power, treatment time, pulse period and width) are automatically controlled by the intelligent controller 3, so that the radiofrequency electrode array 12 treats the organ; after the treatment is completed, the refrigerant in the retractable cavity 114 is extracted from the refrigerant injection port 113, so that the retractable cavity 114 retracts to the contracted state, and then the catheter 1 is extracted from the organ. At this point, intelligent radiofrequency treatment of the organ is achieved to obtain the best treatment effect.

[0035] The most important thing is that, since the intermediate film layer 13 is designed to include a first portion 131 and a second portion 132 connected to each other, and the first portion 131 has a stronger anti-deformation capability than the second portion 132. It can be understood that, see Figure 2 , Figure 2 The schematic diagram of the structure of the catheter 1 provided in this embodiment when the telescopic cavity 114 is in an expanded state is as shown in FIG. Figure 2As shown, when the retractable cavity 114 expands to the expanded state, the second portion 132 can absorb most of the deformation caused by the expansion activity of the retractable cavity 114, and the first portion 131 will not be significantly deformed, so that the RF electrode array 12 attached to the first portion 131 will not be violently bifurcated or even cracked, and the RF electrode array 12 is always kept in close contact with the first portion 131 of the intermediate film layer 13, which makes the retractable cavity 114 shrink from the expanded state to the contracted state (see Figure 1 , Figure 1 When the retractable cavity 114 is in the contracted state, the RF electrode array 12 still remains flatly attached to the middle membrane layer 13 of the catheter 1. Then, when the catheter 1 is inserted into an organ or withdrawn from an organ when the retractable cavity 114 is in the contracted state, the RF electrode array 12 can remain flatly attached to the inner wall of the organ, thereby effectively preventing the RF electrode array 12 from scratching the inner wall of the organ.

[0036] In addition, after the catheter 1 is inserted into the organ, the retractable cavity 114 can be expanded from the contracted state to the expanded state, so that the RF electrode array 12 moves toward the inner wall of the organ driven by the retractable cavity 114. By adjusting the expansion degree of the retractable cavity 114, the RF electrode array 12 can be made to contact the tissue surface of the inner wall of the organ and maintain close contact with the tissue surface under the pressure of the retractable cavity 114, thereby forming good electrical contact.

[0037] Furthermore, in this embodiment, the intermediate film layer 13 is detachably attached to the outer surface of the retractable cavity 114. In this way, when the intermediate film layer 13 is damaged, the intermediate film layer 13 can be replaced separately, which is conducive to reducing the maintenance cost of the catheter 1.

[0038] In some other embodiments, the intermediate film layer 13 can be omitted, that is, the RF electrode array 12 uses a flexible film as a carrier, and the flexible film is directly and completely attached to the catheter. As the retractable cavity 114 of the catheter body expands and contracts, the RF electrode array 12 can rise and fall with the expansion and contraction of the retractable cavity 114. The material and structure of the catheter body can be selected and designed in accordance with the above intermediate film layer.

[0039] Embodiment 2

[0040] This embodiment provides a non-invasive penetrating radio frequency diagnosis and treatment device. The difference between the non-invasive penetrating radio frequency diagnosis and treatment device provided in this embodiment and the embodiment 1 is that the design of the intermediate film layer 13 is different. Figure 3 and Figure 4 , Figure 3 This is a schematic diagram of the structure of the catheter 1 provided in this embodiment when the retractable cavity 114 is in a retracted state. Figure 4 The schematic diagram of the structure of the catheter 1 provided in this embodiment when the telescopic cavity 114 is in an expanded state is as shown in FIG. Figure 3 and Figure 4 As shown, the first part 131 and the second part 132 are made of different materials, and the hardness of the first part 131 is greater than that of the second part 132. Here, by selecting a material with higher hardness to make the first part 131 and selecting a material with lower hardness to make the second part 132, when the thickness of the first part 131 and the second part 132 are the same, the first part 131 has a stronger anti-deformation ability than the second part 132. In this way, when the telescopic cavity 114 expands, the second part 132 is more likely to deform and better absorb the deformation, while the first part 131 will not deform significantly. In this way, after the telescopic cavity 114 repeatedly expands and contracts, the first part 131 of the intermediate film layer 13 can still maintain a very small deformation amount, thereby ensuring that the radio frequency electrode array 12 can always remain flat with the intermediate film layer 13, and ensuring that when the telescopic cavity 114 retracts to the contracted state, the radio frequency electrode array 12 will not bifurcate, thereby preventing the radio frequency electrode array 12 from scratching the inner wall of the organ.

[0041] In some other embodiments, the intermediate film layer 13 can be omitted, that is, the RF electrode array 12 uses a flexible film as a carrier, and the flexible film is directly and completely attached to the catheter. As the retractable cavity 114 of the catheter body expands and contracts, the RF electrode array 12 can rise and fall with the expansion and contraction of the retractable cavity 114. The material and structure of the catheter body can be selected and designed in accordance with the above intermediate film layer.

[0042] Embodiment 3

[0043] This embodiment provides a non-invasive penetrating radio frequency diagnosis and treatment device. The difference between the non-invasive penetrating radio frequency diagnosis and treatment device provided in this embodiment and the embodiment 1 is that the non-invasive penetrating radio frequency diagnosis and treatment device provided in this embodiment also includes a signal detector and a signal source; when the diagnosis and treatment device is used, the signal detector is arranged outside the organ, and the catheter 1 is integrated with a radio frequency electrode array 12 or a signal transmitter, and the signal detector is used to detect the signal emitted by the signal transmitter, and three-dimensionally locate or diagnose the lesion according to the signal. In this way, positioning treatment is achieved by the signal transmitter and the signal detector. Here, the radio frequency electrode array 12 and the signal transmitter are separated structures or integrated structures, and the signal transmitter and the signal source are separated structures or integrated structures. Specifically, the radio frequency electrode integrated in the catheter 1 can be used as a signal transmitter. Of course, a signal transmitter can also be additionally integrated on the flexible film. The signal strength received by the signal detector outside the body is related to the distance and angle between the two. In addition, the pathological tissue and the normal tissue will also be different. Using this principle, we can use it to locate the position of the radio frequency electrode and diagnose the pathological changes of the tissue.

[0044] Embodiment 4

[0045] This embodiment provides a non-invasive penetrating radio frequency diagnosis and treatment device. The difference between the non-invasive penetrating radio frequency diagnosis and treatment device provided in this embodiment and the embodiment 1 is that the design of the intermediate film layer 13 is different. Specifically, the material and thickness of the first part 131 and the second part 132 are the same, and a plurality of through holes are pierced on the second part 132. Here, since the first part 131 and the second part 132 are designed to be made of the same material and have the same thickness, the manufacturing process of the intermediate film layer 13 can be further simplified. By punching holes in the second part 132 to form a plurality of through holes on the second part 132, the second part 132 is more likely to deform and better absorb deformation. In this way, after the retractable cavity 114 expands and contracts repeatedly, the first part 131 of the intermediate membrane layer 13 can still maintain a very small deformation, thereby ensuring that the RF electrode array 12 can always remain flat with the intermediate membrane layer 13, and ensuring that when the retractable cavity 114 retracts to the contracted state, the RF electrode array 12 will not bifurcate, thereby preventing the RF electrode array 12 from scratching the inner wall of the organ.

[0046] The embodiments of the invention are described above in conjunction with the accompanying drawings, but the invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the inspiration of the invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the invention and the claims, all of which are within the protection of the invention.

Claims

1. A catheter for non-invasive penetrating radiofrequency diagnostic and therapeutic equipment, It is characterized in that The catheter (1) comprises a tube body (11), an intermediate film layer (13) and a radio frequency electrode array (12); the tube body (11) has a retractable cavity (114); the intermediate film layer (13) is attached to the outer surface of the retractable cavity (114); the intermediate film layer (13) comprises a first part (131) and a second part (132) connected to each other; under the same external force, the deformation degree of the first part (131) is smaller than the deformation degree of the second part (132); the radio frequency electrode array (12) is attached to the first part (131) of the intermediate film layer (13); and the retractable cavity (114) has a contracted state with a smaller volume and an expanded state with a larger volume.

2. The catheter according to claim 1, It is characterized in that The first part (131) and the second part (132) are made of the same material, and the thickness of the first part (131) is greater than the thickness of the second part (132).

3. The catheter according to claim 1, It is characterized in that The first part (131) and the second part (132) are made of different materials, and the hardness of the first part (131) is greater than the hardness of the second part (132).

4. The catheter according to claim 1, It is characterized in that The first part (131) and the second part (132) are made of the same material and have the same thickness, and the second part (132) is provided with a plurality of through holes.

5. The catheter according to claim 1 or 2, It is characterized in that The intermediate film layer (13) is made of a material selected from the group consisting of silicone, polyurethane, silica gel, latex, polyethylene, cross-linked polyethylene, conductive silicone, polyethylene terephthalate, latex, semipermeable membrane, carbon fiber and nylon.

6. The catheter according to claim 1, It is characterized in that The radio frequency electrode array (12) uses a flexible film as a carrier, and the flexible film is completely attached to the first part (131) of the intermediate film layer (13).

7. The catheter according to claim 1, It is characterized in that The opposite ends of the catheter (1) are respectively provided with a first body fluid input and output port (111) and a second body fluid input and output port (112) which are interconnected, and the retractable cavity (114) is located between the first body fluid input and output port (111) and the second body fluid input and output port (112) and close to the second body fluid input and output port (112); a refrigerant injection port (113) is connected to one end close to the first body fluid input and output port (111), and the refrigerant injection port (113) passes through the catheter (1) and is connected to the retractable cavity (114), and the retractable cavity (114) contains refrigerant.

8. The catheter according to claim 1, It is characterized in that The intermediate film layer (13) is detachably attached to the outer surface of the retractable cavity (114).

9. A non-invasive penetrating radiofrequency diagnostic and therapeutic device, It is characterized in that It comprises a radio frequency power source (2), an intelligent controller (3) and a catheter as claimed in any one of claims 1 to 8, wherein the radio frequency power source (2) is electrically connected to the radio frequency electrode array (12) through the intelligent controller (3).

10. The non-invasive penetrating radiofrequency diagnostic and therapeutic device according to claim 9, It is characterized in that It also includes a signal detector and a signal source; when the diagnostic and treatment equipment is used, the signal detector is arranged outside the organ, and the catheter (1) is integrated with a radio frequency electrode array (12) or a signal transmitter, and the signal detector is used to detect the signal emitted by the signal transmitter, and to three-dimensionally locate or diagnose the lesion based on the signal.

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