Implantable electrode and system for treating hypertension by adopting same

Abstract

The invention discloses an implantable electrode and a system for treating hypertension by adopting the same. The implantable electrode for treating hypertension comprises a catheter, a stimulating electrode slice, a guide wire and an insulating film, the two stimulating electrode plates are arranged on the two sides of the exterior of the catheter respectively, are connected with the exterior through guide wires arranged in the catheter respectively and are used for emitting current to stimulate nerves according to external signals; one end of the insulating film is arranged outside the catheter and located between the two stimulating electrode slices and used for wrapping the stimulating electrode slices making contact with the nerves and the outside of the nerves so that the stimulating electrode slices can be insulated from the outside. The invention discloses a system for treating hypertension by adopting an implantable electrode. The system comprises an implantable electrical stimulation device, a blood pressure monitoring device and a remote analysis monitoring platform. According to the implantable electrode and the system for treating hypertension by adopting the implantable electrode disclosed by the invention, extremely low-intensity electrical stimulation is given to renal sympathetic nerve introduced nerve fibers in dorsal root nerves through the stimulation electrode to inhibit the activity of the nerve fibers, so that the blood pressure of a patient is kept relatively stable, and the risk of complications caused by blood pressure fluctuation is reduced; the medicine taking amount of a hypertensive patient can be greatly reduced, and even the hypertensive patient may stop taking hypertensive medicines.

Description

Technical Field

[0001] The present invention belongs to the field of medical equipment, and in particular relates to an implantable electrode and a system for treating hypertension using the electrode. Background Art

[0002] In the past 30 years, cardiovascular disease experts and doctors around the world and in my country have attached great importance to the prevention and treatment of hypertension. At present, it has penetrated into urban communities and township hospitals. People generally pay attention to their blood pressure, and the awareness rate has greatly increased compared with before. The widespread use of various therapeutic drugs has greatly improved the control rate of hypertension. Clinically, the number of refractory hypertension without target organ damage has decreased significantly compared with before.

[0003] "Catheter-based renal sympathetic denervation for resistant hypertension" (RSD), also known as catheter renal sympathetic denervation (RDN), was first reported by Australian doctor Knlm et al. in 2009. In 2010, dozens to hundreds of short-term results were reported [the 1- and 6-month follow-up results of the Sympficity HTN-1 and HTN-2 trials. This radiofrequency technique has attracted the attention and attention of cardiovascular interventional physicians from all over the country. Since 2011, there have been special reports at major and minor cardiovascular conferences in China. Many interventional physicians in the Department of Cardiology of tertiary-level A hospitals in various places have carried out this technique, published it in magazines and given thematic lectures at various professional conferences. Because Australian doctors and some domestic interventional physicians have already implemented the application of renal artery ablation to humans, it has caused confusion and anxiety in the medical community.

[0004] The method of percutaneous transrenal radiofrequency ablation of sympathetic nerves is simpler than the sympathetic ganglionectomy 60 years ago, but the technology of radiofrequency ablation is a destructive removal of sympathetic nerves around the kidneys. Due to individual differences, the effect of ablation varies. At the same time, scars are easily formed at the injured site, resulting in the inability to perform ablation surgery at the same site after sympathetic nerve regeneration. The ablation site can only be found again, which increases the damage to the patient. At the same time, radiofrequency ablation surgery also has the risk of renal artery intimal damage and thrombosis, and patients have to take oral anticoagulants for a long time. We should be cautious about the theory, research methods, short-term and long-term effects, and target organ protection of this interventional procedure. Summary of the invention

[0005] The purpose of the present invention is to address the defects of the prior art and provide an implantable electrode and a system for treating hypertension using the above-mentioned electrode stimulation.

[0006] To achieve the above object, the present invention adopts the following technical solutions: An implantable electrode for treating hypertension, comprising: a catheter, a stimulating electrode sheet, a guide wire, and an insulating film;

[0007] There are two stimulating electrode sheets, which are respectively arranged on both sides of the outside of the catheter and are respectively connected to the outside through the guide wires arranged in the catheter, and are used to emit current to stimulate nerves according to external signals;

[0008] One end of the insulating film is arranged on the outside of the catheter between the two stimulating electrode sheets, and is used to wrap the stimulating electrode sheet in contact with the nerve and the outside of the nerve to insulate it from the outside.

[0009] Furthermore, the cross-section of the catheter is rectangular or oval;

[0010] When the cross-section of the catheter is rectangular, the stimulating electrode sheets are arranged on the two sides with a larger surface area outside the catheter;

[0011] When the cross-section of the catheter is oval, the stimulating electrode sheets are arranged on the two opposite sides of the long axis of the oval outside the catheter.

[0012] Furthermore, the outer edge of the insulating film is connected to a section of insulating gel, and protective films are arranged on both side surfaces of the insulating gel.

[0013] Furthermore, the surface of the guide wire is provided with an insulating material.

[0014] A system for treating hypertension using an implantable electrode, comprising: an implantable electrical stimulation device, a blood pressure monitoring device, and a remote analysis and monitoring platform;

[0015] The implantable electrical stimulation device includes the implantable electrode described above. The device is used to be implanted into the anterior and posterior root spaces at the first and / or second lumbar dorsal root ganglia of the patient. After receiving the instruction from the remote analysis and monitoring platform, it emits current to stimulate the first and / or second lumbar dorsal roots;

[0016] The blood pressure monitoring device is used to monitor the blood pressure value of the patient in real time and transmit it to the remote analysis and monitoring platform;

[0017] The remote analysis and monitoring platform is used to, when the received real-time blood pressure value of the patient exceeds the set threshold, send an instruction to the implantable electrical stimulation device for discharging and stimulating.

[0018] Furthermore, the implantable electrical stimulation device further includes a wireless transmission unit and a battery unit;

[0019] The wireless receiving unit is used to receive the instruction from the remote analysis and monitoring platform;

[0020] The battery unit is used to provide power for the entire implantable electrical stimulation device.

[0021] Furthermore, the battery unit also includes means for wireless charging using an external power source.

[0022] Furthermore, the blood pressure monitoring device includes a real-time blood pressure monitoring unit, a wireless transmission unit, and a battery unit;

[0023] The real-time blood pressure monitoring unit is used to monitor the blood pressure value of the patient in real time;

[0024] The wireless transmission unit is used to transmit the real-time blood pressure value of the patient to a remote analysis and monitoring platform;

[0025] The battery unit is used to supply power to the entire blood pressure monitoring device.

[0026] Furthermore, the real-time blood pressure monitoring unit adopts a wearable blood pressure monitoring device, and the wearable blood pressure monitoring device is a headband device for real-time monitoring of the blood pressure value in the temporal artery area of the patient's temple, or a watch-type device for real-time monitoring of the blood pressure value at the patient's wrist.

[0027] Furthermore, the real-time blood pressure monitoring unit adopts a paste-type blood pressure monitoring device, and the paste-type blood pressure monitoring device includes a paste chassis and a blood pressure monitoring unit arranged on the chassis.

[0028] Furthermore, the remote analysis and monitoring platform includes a receiving and transmitting unit, an analysis unit, and an alarm unit;

[0029] The receiving and transmitting unit is used to receive the blood pressure value of the patient monitored in real time sent by the blood pressure monitoring device and send instructions to the implantable electrical stimulation device;

[0030] The analysis unit is used to set the blood pressure threshold of the patient, compare the received blood pressure value with the threshold, and send instructions to the implantable electrical stimulation device through the receiving and transmitting unit when it is higher than the threshold;

[0031] The alarm unit is used to set the time threshold for the patient's blood pressure to exceed the threshold, and send an alarm signal to the patient when the time for monitoring the patient's blood pressure higher than the threshold exceeds the time threshold.

[0032] For the implantable electrode and the system for treating hypertension using the implantable electrode of the present invention, the stimulating electrode is placed at the first and / or second lumbar dorsal root ganglia. When the blood pressure is too high, a very low-intensity electrical stimulation (dozens to 100 mv) is given to the dorsal root nerve through the stimulating electrode, so that the sodium channels of the renal sympathetic nerve afferent nerve fibers in the dorsal root nerve are in an inactivated state, functionally blocking or partially blocking the connection between the central nervous system and the renal sympathetic nerve, reducing the renal sympathetic nerve activity, achieving the same therapeutic effect as RND, without damaging the nerve and causing unnecessary injuries.

[0033] Meanwhile, since the intensity of the electrical stimulation is extremely low, it will not cause damage to the spinal nerves and their surrounding tissues. Secondly, since the electrical stimulation method is used to inhibit the activity of the renal sympathetic nerves at the initial segment, away from the kidneys and renal arteries, it will not cause damage to the kidneys and renal arteries. The intensity (dose) of the treatment can be accurately controlled, avoiding the defects of insufficient ablation (insufficient dose) or excessive ablation (excessive dose, excessive blood pressure drop) caused by individual differences in the RND technique. Thirdly, the method adopted in this invention is to functionally inhibit the activity of the renal sympathetic nerves rather than destroy the structure. It can adjust the stimulation intensity and frequency in real time according to the patient's blood pressure changes (pause the stimulation when necessary), keep the patient's blood pressure relatively stable, reduce the risk of complications caused by blood pressure fluctuations, and can greatly reduce the medication dosage of hypertensive patients, and may even stop taking hypertensive drugs. Brief Description of the Drawings

[0034] Figure 1 It is a schematic structural diagram of the implantable electrode in Embodiment 1. Detailed Embodiment

[0035] In order to enable those skilled in the art to better understand the solution of this application, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of this application. Obviously, the described embodiments are only a part of the embodiments of this application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of this application.

[0036] It should be noted that the terms "including" and "having" and any variations thereof in the description and claims of this application and the above-mentioned drawings are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device including a series of steps or units does not necessarily have to be limited to those steps or units clearly listed, but may include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0037] Embodiment 1

[0038] As Figure 1 shown, the implantable electrode for treating hypertension includes: a catheter 1, a stimulating electrode sheet 2, a guide wire 3, and an insulating film 4.

[0039] The cross-section of the catheter is rectangular. There are two stimulating electrode sheets, which are respectively arranged on the two sides with a larger external surface area of the catheter, and are respectively connected to the outside through the guide wires arranged in the catheter, and are used to emit current to stimulate the nerves according to external signals.

[0040] One end of the insulating film is disposed outside the catheter between two stimulating electrode sheets, and the outer edge is connected to a section of insulating gel 5. Protective films are provided on both side surfaces of the insulating gel. The insulating film is used to wrap the stimulating electrode sheet in contact with the nerve and the outside of the nerve to insulate it from the outside and prevent the electrode sheet from shifting at the same time. After the insulating film wraps the stimulating electrode sheet and the nerve, the protective films on both sides are torn off, and the insulating gel is folded inward to stick to the edge of the insulating film and the inner insulating film for fixation.

[0041] The surface of the guide wire is provided with insulating material.

[0042] Embodiment 2

[0043] A system for treating hypertension using an implantable electrode, comprising: an implantable electrical stimulation device, a blood pressure monitoring device, and a remote analysis and monitoring platform.

[0044] Among them, the implantable electrical stimulation device includes the implantable electrode of Embodiment 1. The device is used to be implanted near the renal sympathetic nerve in the patient's body and emits an electric current to stimulate the renal sympathetic nerve after receiving an instruction from the remote analysis and monitoring platform. The implantable electrical stimulation device further includes a wireless transmission unit and a battery unit; the wireless receiving unit is used to receive an instruction from the remote analysis and monitoring platform; the battery unit is used to provide power for the entire implantable electrical stimulation device.

[0045] The battery unit further includes means for wireless charging using an external power source.

[0046] The blood pressure monitoring device is used to monitor the blood pressure value of the patient in real time and transmit it to the remote analysis and monitoring platform. The blood pressure monitoring device includes a real-time blood pressure monitoring unit, a wireless transmission unit, and a battery unit. The real-time blood pressure monitoring unit is used to monitor the blood pressure value of the patient in real time; the wireless transmission unit is used to transmit the real-time blood pressure value of the patient to the remote analysis and monitoring platform; the battery unit is used to provide power for the entire blood pressure monitoring device.

[0047] In one embodiment, the real-time blood pressure monitoring unit uses a headband device to monitor the blood pressure value in the temporal artery region of the patient's temple in real time.

[0048] In another embodiment, the real-time blood pressure monitoring unit uses a watch-type device to monitor the blood pressure value of the patient's wrist in real time.

[0049] In another embodiment, the real-time blood pressure monitoring unit uses a paste-type blood pressure monitoring device. The paste-type blood pressure monitoring device includes a paste chassis and a blood pressure monitoring unit provided on the chassis.

[0050] The remote analysis and monitoring platform is used to issue an instruction to the implantable electrical stimulation device for discharging and stimulating when the real-time blood pressure value of the received patient exceeds a set threshold.

[0051] The remote analysis and monitoring platform includes a receiving and transmitting unit, an analysis unit, and an alarm unit; the receiving and transmitting unit is used to receive the blood pressure values of the patient monitored in real time sent by the blood pressure monitoring device and send instructions to the implantable electrical stimulation device; the analysis unit is used to set the blood pressure threshold of the patient and compare the received blood pressure value with the threshold, and when it is higher than the threshold, send instructions to the implantable electrical stimulation device through the receiving and transmitting unit; the alarm unit is used to set the time threshold for the patient's blood pressure to exceed the threshold, and when it is monitored that the time when the patient's blood pressure is higher than the threshold exceeds the time threshold, send an alarm signal to the patient.

[0052] For the implantable electrode and the system for treating hypertension using the implantable electrode of the present invention, the stimulating electrode is placed at the first and / or second lumbar dorsal root ganglion. When necessary, a very low-intensity electrical stimulation (dozens to 100 mv) is given to the dorsal root nerve through the stimulating electrode, so that the sodium channels of the renal sympathetic nerve afferent nerve fibers in the dorsal root nerve are in an inactivated state, functionally blocking the connection between the central nervous system and the renal sympathetic nerve, reducing the activity of the renal sympathetic nerve, and achieving the same therapeutic effect as RND without damaging the nerve and causing unnecessary injuries.

[0053] At the same time, because the intensity of the electrical stimulation is very low, it will not cause damage to the spinal nerve and its surrounding tissues, and the electrode is far away from the kidney and renal artery, so it will not cause damage to the kidney and renal artery; secondly, because of the electrical stimulation method, the activity of the sympathetic nerve is inhibited at the starting segment, and the intensity (dose) of the treatment can be accurately controlled, avoiding the defects of insufficient ablation (insufficient dose) or excessive ablation (excessive dose, excessive blood pressure drop) caused by individual differences in the RND technology; thirdly, the method adopted in the present invention is to functionally block the renal sympathetic activity rather than structural damage, and can adjust the stimulation intensity and frequency in real time according to the patient's blood pressure changes (pause the stimulation when necessary), so that the patient's blood pressure remains relatively stable, reducing the risk of complications caused by blood pressure fluctuations. At the same time, the renal sympathetic nerve function of the patient can be restored when necessary, which can greatly reduce the amount of medication for hypertensive patients and even no longer require taking hypertensive drugs.

[0054] The above is only the preferred embodiment of the present invention and is not used to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An implantable electrode for treating hypertension, characterized in that include: Catheters, stimulation electrodes, guidewires, and insulating films; The stimulation electrode sheets are two sheets, which are respectively arranged on both sides of the outside of the catheter and connected to the outside through guide wires arranged in the catheter, and are used to emit current to stimulate nerves according to external signals; One end of the insulating film is arranged outside the catheter between two stimulation electrode sheets, and is used to wrap the stimulation electrode sheet in contact with the nerve and the outside of the nerve to insulate it from the outside.

2. The implantable electrode for treating hypertension according to claim 1, characterized in that: The cross section of the conduit is rectangular or elliptical; When the cross section of the catheter is rectangular, the stimulation electrode sheets are arranged on two sides of the catheter with a larger external surface area; When the cross section of the catheter is elliptical, the stimulation electrode sheets are arranged on two opposite sides of the long axis of the ellipse outside the catheter.

3. The implantable electrode for treating hypertension according to claim 1, characterized in that: The outer edge of the insulating film is connected to a section of insulating gel, and protective films are arranged on both side surfaces of the insulating gel.

4. The implantable electrode for treating hypertension according to claim 1, characterized in that: The surface of the guide wire is provided with insulating material.

5. A system for treating hypertension using implantable electrodes, characterized in that include: Implantable electrical stimulation devices, blood pressure monitoring devices, and remote analysis and monitoring platforms; The implantable electrical stimulation device comprises an implantable electrode as claimed in any one of claims 1 to 4, the device is implanted in the anterior and posterior root gaps at the L1 and / or L2 dorsal root ganglia in the patient's body, and emits current to stimulate the L1 and / or L2 dorsal root nerves after receiving instructions from a remote analysis and monitoring platform; The blood pressure monitoring device is used to monitor the patient's blood pressure value in real time and transmit it to the remote analysis and monitoring platform; The remote analysis and monitoring platform is used to receive the patient's real-time blood pressure value and issue a command to the implantable electrical stimulation device to perform discharge stimulation when it exceeds a set threshold.

6. The system for treating hypertension using implantable electrodes according to claim 5, characterized in that: The implantable electrical stimulation device also includes a wireless transmission unit and a battery unit; The wireless receiving unit is used to receive instructions from the remote analysis and monitoring platform; The battery unit is used to provide power for the entire implantable electrical stimulation device.

7. The system for treating hypertension using implantable electrodes according to claim 6, characterized in that: The battery unit also includes a device for wirelessly charging using an external power source.

8. The system for treating hypertension using implantable electrodes according to claim 5, characterized in that: The blood pressure monitoring device comprises a real-time blood pressure monitoring unit, a wireless transmission unit and a battery unit; The real-time blood pressure monitoring unit is used to monitor the patient's blood pressure value in real time; The wireless transmission unit is used to transmit the patient's real-time blood pressure value to the remote analysis and monitoring platform; The battery unit is used to provide power for the entire blood pressure monitoring device.

9. The system for treating hypertension using implantable electrodes according to claim 8, characterized in that: The real-time blood pressure monitoring unit adopts a wearable blood pressure monitoring device, which adopts a headband device to monitor the blood pressure value of the patient's temple temporal artery area in real time, or adopts a watch-type device to monitor the blood pressure value of the patient's wrist in real time; Alternatively, the real-time blood pressure monitoring unit adopts an adhesive blood pressure monitoring device, and the adhesive blood pressure monitoring device includes an adhesive chassis and a blood pressure monitoring unit arranged on the chassis.

10. The system for treating hypertension using implantable electrodes according to claim 5, characterized in that: The remote analysis and monitoring platform includes a receiving and transmitting unit, an analysis unit and an alarm unit; The receiving and transmitting unit is used to receive the real-time monitoring blood pressure value of the patient sent by the blood pressure monitoring device, and send instructions to the implantable electrical stimulation device; The analysis unit is used to set a patient's blood pressure threshold, and compare the received blood pressure value with the threshold, and send instructions to the implantable electrical stimulation device through the receiving and transmitting unit when the blood pressure value is higher than the threshold; The alarm unit is used to set a time threshold for the patient's blood pressure to exceed the threshold, and send an alarm signal to the patient when it is monitored that the patient's blood pressure is higher than the threshold for a time exceeding the time threshold.

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