CN110051390B - Electrical stimulation radio frequency sheath catheter for pain treatment - Google Patents
Electrical stimulation radio frequency sheath catheter for pain treatment Download PDFInfo
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- CN110051390B CN110051390B CN201910445695.7A CN201910445695A CN110051390B CN 110051390 B CN110051390 B CN 110051390B CN 201910445695 A CN201910445695 A CN 201910445695A CN 110051390 B CN110051390 B CN 110051390B
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- stimulation
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- 230000000638 stimulation Effects 0.000 title claims abstract description 29
- 208000002193 Pain Diseases 0.000 title claims abstract description 23
- 238000011282 treatment Methods 0.000 title claims abstract description 20
- 238000005452 bending Methods 0.000 claims abstract description 76
- 238000002347 injection Methods 0.000 claims abstract description 27
- 239000007924 injection Substances 0.000 claims abstract description 27
- 239000000463 material Substances 0.000 claims description 8
- 239000002184 metal Substances 0.000 claims description 7
- 125000004122 cyclic group Chemical group 0.000 claims description 6
- 239000011248 coating agent Substances 0.000 claims description 3
- 238000000576 coating method Methods 0.000 claims description 3
- 230000009471 action Effects 0.000 claims description 2
- 238000005253 cladding Methods 0.000 claims description 2
- 238000002679 ablation Methods 0.000 abstract description 11
- 238000005516 engineering process Methods 0.000 abstract description 3
- 208000000094 Chronic Pain Diseases 0.000 abstract description 2
- 210000005036 nerve Anatomy 0.000 description 8
- 238000013507 mapping Methods 0.000 description 5
- 230000006378 damage Effects 0.000 description 4
- 238000013461 design Methods 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 210000000578 peripheral nerve Anatomy 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 208000022371 chronic pain syndrome Diseases 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 238000005555 metalworking Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 208000004296 neuralgia Diseases 0.000 description 2
- 208000021722 neuropathic pain Diseases 0.000 description 2
- 230000010412 perfusion Effects 0.000 description 2
- 238000007674 radiofrequency ablation Methods 0.000 description 2
- 238000002601 radiography Methods 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000037456 inflammatory mechanism Effects 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000000944 nerve tissue Anatomy 0.000 description 1
- 230000004007 neuromodulation Effects 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000011297 radiofrequency ablation treatment Methods 0.000 description 1
- 210000001032 spinal nerve Anatomy 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
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- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
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- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
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- A61N1/3614—Control systems using physiological parameters based on impedance measurement
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61B2018/00434—Neural system
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- A61B2018/00791—Temperature
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- A—HUMAN NECESSITIES
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Abstract
The invention discloses an electric stimulation radio frequency sheath catheter for pain treatment, which comprises a catheter main body, wherein a hollow cavity is formed in the catheter main body, an insulating layer is arranged on the surface of the catheter main body, one end of the catheter main body is provided with a unidirectional adjustable bending section, the other end of the catheter main body is provided with a unidirectional controllable bending structure for adjusting the bending degree of the adjustable bending section, the unidirectional adjustable bending section is sequentially divided into a head part, a middle part and a tail part, at least two annular working contacts are arranged on the unidirectional adjustable bending section from the tail part to the head part, the annular working contacts are coated on the catheter main body, the outer wall of each annular working contact is flush with the surface of the catheter main body or protrudes out of the surface of the catheter main body, and the head part of the unidirectional adjustable bending section is closed; the hollow cavity comprises a first channel tube cavity and a second channel tube cavity, and a needle-shaped flexible electrode is arranged in the first channel tube cavity. The invention realizes the purpose of minimally invasive intervention technology applied to the field of chronic pain treatment and simultaneously having three pain treatment modes of injection, ablation and electrical stimulation.
Description
Technical Field
The invention relates to the field of medical appliance application, in particular to a radio frequency sheath catheter with injection, ablation and electrical stimulation functions for pain treatment.
Background
Neuromodulation techniques in the area of pain therapy are becoming a future technological development in which short-term spinal and peripheral nerve electrical stimulation techniques achieve good clinical therapeutic effects in the treatment of subacute neuropathic pain caused by various infections, trauma and inflammatory factors. At present, temporary electric stimulation electrode implantation produced by foreign known companies is generally adopted in China, after in vitro test, treatment is usually required to last for two weeks, the temporary electrode product is expensive, meanwhile, a special electric stimulation generator and in vitro program control equipment are required to be equipped, and permanent electrodes and generators implanted for a long time are expensive, so that clinical popularization is difficult.
In the clinical electric stimulation electrode implantation operation, especially in the vicinity of peripheral nerves, due to the lack of design of contrast observation nerves and surrounding tissue structures, currently used implanted electrode products can only repeatedly rely on electric stimulation signals for mapping, thereby increasing operation difficulty and risk, and simultaneously, medical care and patients receive a large amount of radiation doses. For most of the inflammatory mechanisms of early neuropathic pain, the existing temporary electrode products also lack the function of drug injection therapy. For the chronic pain diseases which can be partially analgesic and treated by utilizing the nerve ablation damage technology, the related radio frequency ablation catheter product design is not available at home and abroad at present. Therefore, if a nerve control product with three therapeutic functions of injection, electrical stimulation and ablation is designed, more therapeutic options can be provided for clinicians, and the clinical therapeutic effect of chronic pain diseases can be greatly improved.
Disclosure of Invention
In order to solve the problems in the background art, the invention aims to provide an electric stimulation radio frequency sheath catheter for pain treatment, which is applied to the field of chronic pain treatment and simultaneously has the purpose of minimally invasive intervention technology of three pain treatment modes of injection, ablation and electric stimulation.
In order to achieve the above purpose, the technical scheme of the invention is as follows:
The utility model provides an electric stimulation radio frequency sheath pipe for pain treatment, includes the pipe main part, the inside cavity that is of pipe main part, pipe main part surface is provided with the insulating layer, pipe main part one end is set up to one-way adjustable curved section, and the other end is provided with the one-way controllable curved structure that carries out the camber adjustment to adjustable curved section, one-way adjustable curved section divide into head, middle part and afterbody in proper order, is provided with two at least cyclic annular working contact on the one-way adjustable curved section of afterbody to head, cyclic annular working contact cladding is on the pipe main part, and the outer wall of cyclic annular working contact flushes or stretches out in pipe main part surface with pipe main part surface, the head of one-way adjustable curved section is closed; the hollow cavity comprises a first channel cavity and a second channel cavity, a needle-shaped flexible electrode is arranged in the first channel cavity, the flexible electrode is movably inserted into the first channel cavity and is in contact with the inner wall of the annular working contact, the unidirectional controllable bending structure is arranged at the end part of the first channel cavity far away from the unidirectional adjustable bending section, the other end of the unidirectional controllable bending structure is connected with an electrode socket, the flexible electrode movably penetrates through the unidirectional controllable bending structure and is connected with the electrode socket, and the unidirectional controllable bending structure comprises a unidirectional controllable bending cavity, a sliding block and a locking structure, wherein the sliding block is arranged in the unidirectional controllable bending cavity and can slide left and right, and the locking structure locks the electrode socket; the end part of the second channel pipe cavity far away from the unidirectional adjustable bending section is provided with a second channel tail end joint, and the second channel pipe cavity positioned on the unidirectional adjustable bending section is provided with an injection hole; the catheter body is internally provided with a catheter controllable bending guide wire, controllable bending starting and bending points are arranged between the annular working contacts, and the controllable bending starting and bending points are positioned close to the tail end; when the catheter main body is bent under the action of the unidirectional controllable bending structure, and the space position of the annular working contact of the adjustable bending section is changed, the bending dimension is kept at least 5 mm.
Preferably, the catheter body is made of insulating high-temperature-resistant PVC material.
Preferably, the insulating layer is made of a smooth coating material.
Preferably, the head of the unidirectional adjustable bend section is designed into a atraumatic conical blunt shape.
Preferably, the number of the annular working contacts is four, and the distance between every two adjacent annular working contacts is more than or equal to 6mm.
Preferably, the width of the annular working contact is 3mm.
Preferably, the second channel tail connector is an extension tube, which is a standard luer connector.
Preferably, the flexible electrode is connected with a generator capable of generating stimulation current and radio frequency current with different frequencies through an electrode socket.
Preferably, the two injection holes are respectively arranged at the head part, the middle part and the tail part of the unidirectional adjustable bending section, the distance between the two adjacent injection holes of the head part and the middle part and the distance between the two adjacent injection holes of the middle part and the tail part are larger than or equal to 15mm, and the distance between the two injection holes of the head part, the middle part and the tail part is 5mm.
Preferably, the length of the flexible electrode is consistent with the length of the first channel lumen and the inner diameter of the tube, and the impedance and temperature sensors are arranged at the positions of the flexible electrode and the first channel lumen corresponding to the middle section of the controllable bending section.
According to the technical scheme, the electric stimulation radio frequency sheath catheter for pain treatment is selectively subjected to drug injection, electric stimulation treatment and target nerve radio frequency ablation treatment through epidural space or peripheral nerve puncture implantation; the medical device can accurately perform multipoint nerve mapping, is provided with the radio frequency sheath catheter for delivering stimulation current or radio frequency current to perform multipoint stimulation and ablation, and achieves the clinical treatment purposes of electric stimulation of a target nerve structure and full ablation and destruction through the working contact at the front end of the sheath catheter; through a reasonable arrangement mode, the tube diameter size which can be achieved by the existing materials is met, an injection channel structure is independently designed on the radio frequency sheath catheter, the purposes of injecting contrast agent and medicine are achieved, and meanwhile cold saline injection is achieved during ablation; and simultaneously, the stimulation generating device with flexible electrodes for mapping, electrical stimulation and ablation is provided.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below.
FIG. 1 is a schematic diagram of a structure disclosed in an embodiment of the present invention;
FIG. 2 is a cross-sectional view of an annular working contact according to an embodiment of the present invention;
fig. 3 is a cross-sectional view of an injection hole according to an embodiment of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.
The invention provides an electric stimulation radio frequency sheath catheter for pain treatment, as shown in fig. 1-3, which comprises a catheter main body, wherein a hollow cavity is formed in the catheter main body, an insulating layer 1 is arranged on the surface of the catheter main body, the insulating layer 1 is made of a smooth coating material, one end of the catheter main body is provided with a unidirectional adjustable bending section, the other end of the catheter main body is provided with a unidirectional controllable bending structure for bending the adjustable bending section, the unidirectional adjustable bending section is sequentially divided into a head part 6, a middle part and a tail part, at least two annular working contacts 2 are arranged on the unidirectional adjustable bending section from the tail part to the head part 6, four annular working contacts 2 are arranged in the embodiment, the distance between every two adjacent annular working contacts 2 is more than or equal to 6mm, the width of each annular working contact 2 is 3mm, the annular working contact 2 is coated on the catheter main body, the outer wall of each annular working contact 2 is flush with the insulating layer 1 on the surface of the catheter main body or slightly protrudes out of the insulating layer 1 on the surface of the catheter main body, the inner wall penetrates through the side wall of the first channel cavity 3 and is communicated with the interior of the first channel cavity 3, and the unidirectional adjustable bending section is designed to be a blunt-headed or a closed-type, so as to prevent injury of the head part of a patient in the patient from being scratched; the hollow cavity comprises a first channel cavity 3 and a second channel cavity 4, the second channel cavity 4 is positioned at one side of the first channel cavity 3 and is not communicated with the first channel cavity 3, a flexible electrode 13 is arranged in the first channel cavity 3, the flexible electrode 13 can be movably inserted into the first channel cavity 3 and is contacted with the inner wall of the annular working contact 2, the one-way controllable bending structure is arranged at the end part of the first channel cavity 3 far away from the one-way adjustable bending section, the other end of the one-way controllable bending structure is connected with an electrode socket 8, the flexible electrode 13 movably penetrates through the one-way controllable bending structure and is connected with the electrode socket 8, the one-way controllable bending structure comprises a one-way controllable bending cavity 14, a sliding block 9 and a locking structure 12, and the locking structure 12 is arranged in the one-way controllable bending cavity and can slide left and right in the one-way controllable bending structure, and the locking structure 12 locks the electrode socket 8; the end part of the second channel tube cavity 4 far away from the unidirectional adjustable bending section is provided with a second channel tail end connector 7, the second channel tail end connector 7 is an extension tube which is a standard luer connector, and the second channel tube cavity 4 positioned on the unidirectional adjustable bending section is provided with an injection hole 5; a catheter controllable bending guide wire 10 is further arranged in the catheter main body, controllable bending starting and bending points 11 are arranged between the annular working contacts 2, and the controllable bending starting and bending points 11 are located at positions close to the tail ends; when the catheter body is bent under the adjustment of the operating handle, the bending dimension is kept at least 5mm when the spatial position of the annular working contact 2 of the adjustable bending section is changed.
The catheter body is made of insulating high-temperature-resistant PVC material.
The flexible electrode 13 is connected with the generator capable of generating stimulation current and radio frequency current with different frequencies through the electrode socket 8, the length and the tube inner diameter of the flexible electrode 13 and the first channel tube cavity 3 are consistent, the length dimension is 40-60cm, the impedance and the temperature sensor are arranged at the corresponding position of the middle section of the controllable bending section of the flexible electrode 13 and the first channel tube cavity 3 and used for detecting the impedance and the temperature of the electrode, medical staff can judge the degree of the adhesion between the electrode and focus tissues by detecting the impedance between the electrodes, and the better the adhesion is, the lower the impedance can be.
The injection holes 5 are respectively arranged at the head part 6, the middle part and the tail part of the unidirectional adjustable bending section, the distance between the two adjacent injection holes 5 at the head part and the middle part and the distance between the two adjacent injection holes 5 at the middle part and the tail part are larger than or equal to 15mm, and the distance between the two injection holes 5 at the head part, the middle part and the tail part is 5mm.
The second channel tube cavity 4 is an injection channel, is of an independent catheter structure, is integrally wrapped with the first channel tube cavity 3 from the tail end to the head end, the outer diameters of the head part and the middle part of the adjustable bending section of the first channel tube cavity 3 are larger than or equal to the outer diameter of the tail part, the bending starting point of the adjustable bending section can also be arranged in the middle part of the controllable bending section, the unidirectional adjustable bending section is bent in a unidirectional same radial plane, the included angle range of the axial lead of the unidirectional adjustable bending section is 30-60 degrees, and the first channel tube cavity 3 is provided with an X-ray positioning mark.
The annular working contacts 2 are of annular structures or annular breakpoint structures, when the annular working contacts 2 are of annular breakpoint structures, each annular working contact 2 comprises four rectangular, elliptic or circular metal contacts, the four metal contacts are embedded on the surface of the catheter body in an annular manner along the circumferential direction of the catheter body, one ends of the metal contacts are flush with the outer surface of the insulating layer 1 or slightly protrude out of the outer surface of the insulating layer 1, and the other ends of the metal contacts penetrate through the surface of the catheter body to be in contact with the flexible electrode 13 in the lumen 3 of the first channel.
Besides the drug injection and radiography functions of the common catheter, the invention not only can conveniently carry out the mapping and the electrical stimulation of the target nerve tissue, but also can carry out cold saline perfusion ablation by providing radio frequency current for the first time; not only can reduce the number of catheters used and the frequency of changing treatment equipment, but also can improve the working efficiency; because of adopting independent flexible electrode design, can save the consumptive material expense that clinical use moreover greatly. Besides the functions of auxiliary catheter retention injection, radiography and cold saline perfusion, the main radio-frequency sheath catheter is closed at the head end, the front end of the main radio-frequency sheath catheter is a controllable bent section, four annular metal working contacts are arranged at the front end of the main radio-frequency sheath catheter, the flexible electrode can be placed in a first channel lumen with the closed head end to be contacted with the four annular metal working contacts, when the generating device connected with the tail end of the flexible electrode outputs different frequency electric stimulation signals or radio-frequency ablation currents, the target nerve mapping can be completed through the four annular working contacts respectively, three working modes of short-time-range electric stimulation and nerve ablation damage treatment are realized, and different requirements for different surgical schemes are met by fully utilizing a tubular design.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (10)
1. The utility model provides an electric stimulation radio frequency sheath pipe for pain treatment, includes the pipe main part, the inside cavity that is of pipe main part, its characterized in that, pipe main part surface is provided with the insulating layer, pipe main part one end sets up to one-way adjustable curved section, and the other end is provided with the one-way controllable curved structure that carries out the camber adjustment to adjustable curved section, one-way adjustable curved section divide into head, middle part and afterbody in proper order, is provided with two at least cyclic annular working contact on the one-way adjustable curved section from afterbody to head, cyclic annular working contact cladding is on the pipe main part, and the outer wall of cyclic annular working contact flushes or stretches out in pipe main part surface with the pipe main part surface, the head of one-way adjustable curved section is closed; the hollow cavity comprises a first channel cavity and a second channel cavity, a needle-shaped flexible electrode is arranged in the first channel cavity, the flexible electrode is movably inserted into the first channel cavity and is in contact with the inner wall of the annular working contact, the unidirectional controllable bending structure is arranged at the end part of the first channel cavity far away from the unidirectional adjustable bending section, the other end of the unidirectional controllable bending structure is connected with an electrode socket, the flexible electrode movably penetrates through the unidirectional controllable bending structure and is connected with the electrode socket, and the unidirectional controllable bending structure comprises a unidirectional controllable bending cavity, a sliding block and a locking structure, wherein the sliding block is arranged in the unidirectional controllable bending cavity and can slide left and right, and the locking structure locks the electrode socket; the end part of the second channel pipe cavity far away from the unidirectional adjustable bending section is provided with a second channel tail end joint, and the second channel pipe cavity positioned on the unidirectional adjustable bending section is provided with an injection hole; the catheter body is internally provided with a catheter controllable bending guide wire, controllable bending starting and bending points are arranged between the annular working contacts, and the controllable bending starting and bending points are positioned close to the tail end; when the catheter main body is bent under the action of the unidirectional controllable bending structure, and the space position of the annular working contact of the adjustable bending section is changed, the bending dimension is kept at least 5 mm.
2. The electro-stimulation rf sheath catheter for pain management as in claim 1, wherein the catheter body is made of an insulating high temperature PVC material and the insulating layer is made of a lubricious coating material.
3. The electro-stimulation radio frequency sheath catheter for pain treatment according to claim 1, wherein the annular working contacts are of annular structure or annular breakpoint structure, and each annular working contact comprises four rectangular, elliptic or circular metal contacts which are embedded on the surface of the catheter body in an annular manner along the circumferential direction of the catheter body when the annular working contacts are of annular breakpoint structure, one ends of the metal contacts are flush with the outer surface of the insulating layer or slightly protrude out of the outer surface of the insulating layer, and the other ends of the metal contacts penetrate through the surface of the catheter body to be in contact with the flexible electrode in the lumen of the first channel.
4. The electro-stimulation rf sheath catheter for pain management as in claim 1, wherein the head of the unidirectional adjustable bend is configured as a atraumatic conical blunt tip.
5. The electro-stimulation radio frequency sheath catheter for pain management according to claim 1, wherein four annular working contacts are provided, and a distance between two adjacent annular working contacts is 6mm or more.
6. The electro-stimulation rf sheath catheter for pain management as in claim 5, wherein the annular working contact has a width of 3mm.
7. The electro-stimulation rf sheath catheter for pain management as in claim 1, wherein the second channel end fitting is an extension tube that is a standard luer fitting.
8. The electro-stimulation rf sheath catheter for pain management as in claim 1, wherein the flexible electrode is connected via an electrode socket to a generator that generates stimulation current and rf current at different frequencies.
9. The electro-stimulation rf sheath catheter for pain management according to claim 1, wherein the two injection holes are respectively arranged at the head, the middle and the tail of the unidirectional adjustable bending section, the distance between the two adjacent injection holes of the head and the middle and the two adjacent injection holes of the middle and the tail is greater than or equal to 15mm, and the distance between the two injection holes of the head, the middle and the tail is 5mm.
10. The electro-stimulation rf sheath catheter for pain management as in claim 1, wherein the flexible electrode is of a length and inner diameter of the lumen of the first channel, and wherein the flexible electrode is provided with an impedance and temperature sensor in the lumen of the first channel at a location corresponding to the middle section of the controllable bend.
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