CN106823140B - Sacral nerve stimulator capable of adjusting electric field direction - Google Patents
Sacral nerve stimulator capable of adjusting electric field direction Download PDFInfo
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- CN106823140B CN106823140B CN201710026584.3A CN201710026584A CN106823140B CN 106823140 B CN106823140 B CN 106823140B CN 201710026584 A CN201710026584 A CN 201710026584A CN 106823140 B CN106823140 B CN 106823140B
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- 230000004048 modification Effects 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
- A61N2001/083—Monitoring integrity of contacts, e.g. by impedance measurement
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
The invention relates to the field of implantable nerve stimulators, and particularly discloses an implantable nerve stimulator capable of adjusting the direction of an electric field, which comprises an external program controller, an implantable pulse generator, a segmented stimulating electrode and a plurality of electrode segments capable of adjusting the direction of the electric field, and further comprises an electric field intensity sensor, wherein the electric field intensity sensor is arranged at a target nerve and used for monitoring the electric field intensity generated by the segmented stimulating electrode, and transmitting monitoring data to the implantable pulse generator or the external program controller; the monitoring data includes a first electric field strength measured at a first location and a second electric field strength measured at a second location. The invention can rapidly adjust the electric field applying direction of the segmented electrode when in use so as to accurately stimulate target nerve tissues.
Description
Technical Field
The invention relates to an implanted nerve stimulator, in particular to an implanted nerve stimulator capable of adjusting the direction of an electric field.
Background
Urinary incontinence, the inability to maintain voluntary control of urination, is a condition that affects millions of men and women worldwide. Control of urination is a complex physiological process that involves neuroreflex pathways, some with central nervous system control, smooth and voluntary muscle, and hormonal effects and some none. A significant portion of urinary incontinence is at least partially neurogenic. The clinical term "overactive bladder" is used generically to refer to any form of incontinence characterized by an increase in the frequency or intent of urination, either complete or sporadic, and wherein loss of voluntary control ranges from partial to complete. "urge incontinence" is involuntary urine loss associated with sudden and intense urinary episodes. Urge incontinence is often associated with urodynamic findings of involuntary (uninhibited) contractions of the detrusor muscle, which provides the primary motive force for voiding urine from the bladder. A large proportion of patients with uninhibited detrusor have some neurological deficit, in this case the clinical term "detrusor hyperreflexia" (DH). Common neurological disorders associated with Detrusor Hyperreflexia (DH) are Parkinson's disease, stroke, diabetes, multiple Sclerosis (MS) and peripheral neuropathy. In addition, individuals suffering from traumatic spinal cord injury often experience symptoms associated with DH.
The external urinary sphincter can also be affected by spinal cord injury, resulting in a condition known as "dyssynergia. Dyssynergia involves the inability of the urethral sphincter to relax as the bladder contracts, which includes active contraction in response to bladder emptying, preventing urine from flowing through the urethra and resulting in incomplete emptying of the bladder and "reflux" of urine into the kidneys.
Some treatments for detrusor hyperreflexia and external urethral sphincter dyssynergia rely on electrical nerve stimulation. This treatment modality relies on the use of electrodes positioned adjacent the nerve/muscle to be stimulated. Activation of the electrodes with an electrical pulse can stimulate adjacent nerves, resulting in contraction of the muscles innervated by the nerves. Non-selective electrodes, however, stimulate every tissue and cell type that is within their electric field. Thus, the fixed-field-direction neurostimulation methods and devices are unable to act locally, cell-type-specifically, on the muscles and nerves that regulate the symptoms responsible for the symptoms associated with detrusor hyperreflexia and external urethral sphincter dyssynergia.
Sacral nerve anterior root electrical stimulation (SARS) is a neurostimulation device used to restore bladder function in patients with persistent spinal cord injury. SARS requires sacral radiculotomy to prevent DH/DSD, resulting in loss of sexual function. In addition, sacral radiculotomy further disrupts afferent pathways of the lower urinary tract, resulting in loss of bladder reflex or loss of bladder contraction. As a result, post-operative electrical stimulation is required to activate the detrusor muscle. At the same time, the electrodes also activate the external urinary sphincter, since the nerves innervating the sphincter are larger than the nerves innervating the detrusor muscle and are therefore recruited first. Individuals who have experienced SARS experience a brief period of post-stimulation emptying because the striated muscle of the sphincter relaxes more rapidly than the smooth muscle of the detrusor muscle. However, in addition to the aforementioned loss of sexual function, SARS often results in very high bladder pressures, which can cause short-term vesicoureteral reflux and long-term association with renal failure.
Segmented electrodes (segment electrodes) have been developed in the prior art that allow the direction of application of an electric field to be adjusted relative to a single electrode, thereby providing more accurate three-dimensional target delivery stimulation, avoiding unnecessary stimulation of other tissues, and reducing side effects (e.g., U.S. patent application publication No. US20150360023 A1). However, when implanting an electrode, how to adjust the position of the electrode in real time, when using, how to monitor whether the electrode is displaced in real time, and after implanting a stimulation electrode, how to rapidly adjust the electric field applying direction of the segmented electrode to accurately stimulate the target nerve tissue are all problems to be solved.
Disclosure of Invention
The invention provides an implantable nerve stimulator capable of adjusting the direction of an electric field, which monitors the electric field intensity at a target nerve, and an electric field intensity sensor transmits monitoring data to an Implantable Pulse Generator (IPG) in time so as to monitor the relative position of a stimulation electrode and provide convenience for adjusting the application direction of the electric field.
In order to solve the above technical problems, the present invention provides an implantable neural stimulator capable of adjusting the direction of an electric field. The technical scheme of the invention is as follows.
An implantable neural stimulator comprises an external program controller, an implantable pulse generator and a segmented stimulating electrode, and comprises a plurality of electrode segments capable of adjusting the direction of an electric field, and further comprises an electric field intensity sensor, wherein the electric field intensity sensor is arranged at a target nerve and used for monitoring the electric field intensity generated by the segmented stimulating electrode, and transmitting monitoring data to the implantable pulse generator or the external program controller; the monitoring data comprises a first electric field strength measured at a first location and a second electric field strength measured at a second location; the implantable pulse generator or external program controller determines the electric field output by the electrode segments based on the monitored data and an expected electric field output configuration.
Further, the electric field intensity sensor is connected with the implanted pulse generator in a wired or wireless mode.
Furthermore, the electric field intensity sensor is in a dormant state at ordinary times, and the implanted pulse generator periodically wakes up the electric field intensity sensor in the dormant state to perform electric field intensity test.
Further, the pulse generator may pulse each electrode segment individually, or pulse a plurality of electrode segments therein, or pulse all of the electrode segments together. The plurality of segment electrodes are used for adjusting the application direction of the electric field.
Further, the external program controller receives data monitored by the electric field strength sensor in a wireless mode, adjusts the pulse of the pulse generator according to the received data, or directly adjusts the on/off of the electrode section, and further adjusts the application direction of the electric field.
Furthermore, the electric field intensity sensor is attached to the target nerve, so that the electric field intensity at the target nerve can be monitored accurately.
Further, the electric field intensity sensor has a storage device for storing the electric field intensity of the detected target nerve.
The electric field strength sensor also has a rechargeable power supply for externally charging the electric field strength sensor.
Specifically, the implantable neural stimulator is an implantable sacral neural stimulator.
The invention has the following beneficial effects: according to the implantable nerve stimulator with the electric field intensity measuring device, the electric field intensity sensor is arranged at the target nerve to monitor the electric field intensity at the target nerve, the electric field intensity sensor transmits monitoring data to the implantable pulse generator in time to monitor the relative position of the stimulation electrode, and convenience is provided for adjusting the stimulation electrode when the implantable nerve stimulator is installed. And in the use process of the implantable neural stimulator, when the stimulating electrode is displaced, the patient and the doctor can immediately realize that the treatment quality is ensured. And the electric field application direction of the segmented electrodes can be rapidly adjusted to accurately stimulate target nerve tissues.
Drawings
In order to more clearly illustrate the technical solution of the present invention, the drawings needed for the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.
Fig. 1 is a schematic structural diagram of an implantable neurostimulator of the present invention.
Fig. 2 is a flow chart of the operation of the implantable neural stimulator of the present invention.
In the figure: 1-an implantable pulse generator; 2-a stimulation electrode; 3-an electric field strength sensor; 4-target nerve; 5-an external program controller; 6-conducting wire.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without any inventive step, are within the scope of protection of the present invention.
In one embodiment of the present invention, as shown in fig. 1 to 2, the present invention is an implantable neurostimulator with an electric field strength measuring device, the implantable neurostimulator is an implantable neurostimulator for applying electric stimulation to a target nerve region of a patient, the implantable neurostimulator comprises an external program controller 5, an implantable pulse generator 1 and a segmented stimulation electrode 2, the segmented stimulation electrode 2 comprises a plurality of electrode segments, the implantable pulse generator 1 and the segmented stimulation electrode are implanted in the patient, the external program controller 5 transmits information to the implantable pulse generator 1, the pulse generator 1 sends a signal to the segmented stimulation electrode 2, and the segmented stimulation electrode 2 performs electric stimulation treatment on a target nerve 4. The segmented stimulation electrode 2 is used to adjust the direction of application of the electric field in order to provide more accurate three-dimensional target delivery stimulation.
The implanted nerve stimulator also comprises an electric field intensity sensor 3, wherein the electric field intensity sensor 3 is used for detecting the electric field intensity of a target nerve 4 and transmitting detection data to the implanted pulse generator or an external program controller. The monitoring data includes a first electric field strength measured at a first location and a second electric field strength measured at a second location. The implantable pulse generator or external programmable controller determines the electric field output by the electrode segments based on the monitored data, and the desired electric field output configuration, and then transmits the output electric field to the segmented stimulation electrode 2, adjusting the direction of application of the electric field to more accurately stimulate the target neural tissue.
The electric field intensity sensor 3 is implanted in the body of the patient and is arranged at the target nerve 4, for example, the electric field intensity sensor 3 is attached to the target nerve 4, the electric field intensity sensor 3 monitors the electric field intensity received by the target nerve 4 from the stimulating electrode 2, and then monitoring information is sent to a pulse generator in the body through internal processing. The first location and the second location may be configured as desired, for example, along the target nerve, or in different directions at the same location in the target nerve.
The electric field intensity sensor 3 has a storage device for storing the electric field intensity of the detected target nerve. The electric field intensity sensor 3 is also provided with a rechargeable power supply for external charging, and the electric field intensity sensor 3 is in wired connection or wireless connection with the implanted pulse generator 1.
The electric field intensity sensor 3 is in a dormant state at ordinary times, the implanted pulse generator 1 awakens the electric field intensity sensor 3 in the dormant state periodically to carry out electric field intensity test, and the arrangement is favorable for saving energy loss. In one embodiment, when the implantable pulse generator 1 applies electric stimulation, the electric field intensity sensor 3 in the sleep state is automatically awakened to perform electric field intensity test.
The invention has the following beneficial effects: according to the implantable nerve stimulator with the electric field intensity measuring device, the electric field intensity sensor is arranged at the target nerve to monitor the electric field intensity at the target nerve, the electric field intensity sensor transmits monitoring data to the implantable pulse generator in time to monitor the relative position of the stimulation electrode, and convenience is provided for adjusting the stimulation electrode when the implantable nerve stimulator is installed. And in the use process of the implantable neural stimulator, when the stimulating electrode is displaced, the patient and the doctor can immediately realize that the treatment quality is ensured. And the electric field application direction of the segmented electrodes can be rapidly adjusted to accurately stimulate target nerve tissues.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
Claims (6)
1. An implantable neural stimulator comprises an external program controller, an implantable pulse generator and a segmented stimulating electrode, wherein the segmented stimulating electrode comprises a plurality of electrode segments capable of adjusting the direction of an electric field, the implantable neural stimulator further comprises an electric field intensity sensor, the electric field intensity sensor is arranged at a target nerve and used for monitoring the electric field intensity received by the target nerve and generated by the segmented stimulating electrode, and the electric field intensity sensor transmits monitoring data to the implantable pulse generator or the external program controller; the monitoring data comprises a first electric field strength measured at a first location and a second electric field strength measured at a second location; the implantable pulse generator or the external program controller monitors the relative position of the stimulating electrode according to the monitoring data, so as to provide convenience for adjusting the stimulating electrode when the implantable neural stimulator is installed and determine whether the stimulating electrode is displaced or not in the using process; and the implantable pulse generator or external program controller further determines the electric field output by the electrode segments according to the monitoring data and an expected electric field output configuration; then the output electric field is transmitted to the segmented stimulating electrode so as to adjust the application direction of the electric field;
the electric field strength sensor is attached to the target nerve at least at the first position and the second position;
the first and second locations are configured along the target nerve, or in different directions at the same location of the target nerve.
2. The implantable neurostimulator of claim 1, wherein the electric field strength sensor is in wired or wireless connection with the implantable pulse generator.
3. The implantable neurostimulator of claim 1, wherein the implantable pulse generator periodically wakes up the electric field strength sensor in a sleep state for an electric field strength test.
4. An implantable neurostimulator as claimed in any one of claims 1 to 3 wherein the electric field strength sensor has a memory device.
5. An implantable neurostimulator as claimed in any one of claims 1 to 3 the electric field strength sensor further having a rechargeable power supply for externally charging the electric field strength sensor.
6. The implantable neural stimulator of any one of claims 1-3,
the implanted nerve stimulator is an implanted sacral nerve stimulator.
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| CN201710026584.3A CN106823140B (en) | 2017-01-14 | 2017-01-14 | Sacral nerve stimulator capable of adjusting electric field direction |
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| CN201710026584.3A CN106823140B (en) | 2017-01-14 | 2017-01-14 | Sacral nerve stimulator capable of adjusting electric field direction |
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| JP7384895B2 (en) | 2018-07-17 | 2023-11-21 | ディグニティー ヘルス | Systems and methods for cancer treatment using alternating current electric field generation |
| CN109731219B (en) * | 2018-12-30 | 2023-05-26 | 北京品驰医疗设备有限公司 | Implantable spinal nerve stimulation device and adjustment method |
| CN117282029B (en) * | 2023-11-27 | 2024-03-29 | 首都医科大学宣武医院 | Spinal cord electrical stimulation parameter adjustment method, bone implantable electrical stimulation device and medium |
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| US20080125833A1 (en) * | 2001-12-04 | 2008-05-29 | Advanced Bionics Corporation | Apparatus and method for determining the relative position and orientation of neurostimulation leads |
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| US20160243358A1 (en) * | 2015-02-24 | 2016-08-25 | Neurostim Solutions LLC | Topical Nerve Stimulator and Sensor for Control of Autonomic Function |
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| US6505074B2 (en) * | 1998-10-26 | 2003-01-07 | Birinder R. Boveja | Method and apparatus for electrical stimulation adjunct (add-on) treatment of urinary incontinence and urological disorders using an external stimulator |
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| EP1654031A1 (en) * | 2002-07-22 | 2006-05-10 | University of Southern California | Method and apparatus for the treatment of urinary tract dysfunction |
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| EP4159273A1 (en) * | 2011-05-13 | 2023-04-05 | Saluda Medical Pty Ltd | Implantable device for controlling a neural stimulus |
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|---|---|---|---|---|
| US20080125833A1 (en) * | 2001-12-04 | 2008-05-29 | Advanced Bionics Corporation | Apparatus and method for determining the relative position and orientation of neurostimulation leads |
| CN101516439A (en) * | 2006-09-26 | 2009-08-26 | 皇家飞利浦电子股份有限公司 | Tissue stimulation method and appartus |
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| CN102665540A (en) * | 2009-10-16 | 2012-09-12 | 神经连结科技公司 | Neural interface system |
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