Stimulation apparatus
Abstract
A desired effect is produced by therapeutically activating tissue at a first site within a patient's body and a corresponding undesired side effect is reduced by blocking activation of tissue or conduction of action potentials at a second site within the patient's body by applying high frequency stimulation and/or direct current pulses at or near the second site. Time-varying DC pulses may be used before or after a high frequency blocking signal. The high frequency stimulation may begin before and continue during the therapeutic activation. The high frequency stimulation may begin with a relatively low amplitude, and the amplitude may be gradually increased. The desired effect may be promotion of micturition or defecation and the undesired side effect may be sphincter contraction.
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Projected expiry passed 1 May 2022, 4.4 years ago.
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13 claims: 13 independent, 0 dependent
- 1Device to achieve a desired effect by activating or excitation of tissue at a first predetermined location in a body to produce and undesirable corresponding side effect by blocking or blocking of excitation of fabric or line of action or excitation potentials to reduce a second predetermined location in the body, the apparatus comprising comprising:first generator means (114) To low frequency stimulation to create;second generator means for high frequency and / or DC pulse stimulation to create;a first electrode (118) Operatively is coupled to the first generator means, said first electrode (118is formed) to tissue at a first predetermined Place to encourage by providing low frequency stimulation;and a second electrode (140), The second with the Generator means is coupled, marked by education the second electrode (140) To block an excitation of electrically excitable tissue at the second location by providing of high frequency stimulation or one or more direct current pulse (s) or pulse (s) or of both high frequency stimulation and one or a plurality of DC pulse (s) at or near the second Site so that the high frequency stimulation and / or the direct current pulses the low-frequency stimulation, which is provided at the first location, at the suggestion of the electrically excitable tissue or causing stop of line excitation potentials at the second location. Vorrichtung, um einen gewünschten Effekt durch Aktivieren bzw. Anregen von Gewebe an einer ersten vorbestimmten Stelle in einem Körper zu erzeugen und einen unerwünschten korrespondierenden Nebeneffekt durch Blocken bzw. Abblocken der Anregung von Gewebe oder Leitung von Aktions- bzw. Anregungspotentialen zu einer zweiten vorbestimmten Stelle im Körper zu vermindern, wobei die Vorrichtung aufweist: erste Generatormittel (114), um Niederfrequenzstimulation zu erzeugen;zweite Generatormittel, um Hochfrequenz- und/oder Gleichstrompulsstimulation zu erzeugen;eine erste Elektrode (118), die operativ mit den ersten Generatormitteln gekoppelt ist, wobei die erste Elektrode (118) ausgebildet ist, um Gewebe an einer ersten vorbestimmten Stelle durch das Bereitstellen von Niederfrequenzstimulation anzuregen;und eine zweite Elektrode (140), die mit den zweiten Generatormitteln gekoppelt ist, gekennzeichnet durch Ausbildung der zweiten Elektrode (140) zum Blocken einer Anregung von elektrisch anregbarem Gewebe an der zweiten Stelle durch Bereitstellen von Hochfrequenzstimulation oder einem oder mehreren Gleichstrompuls(en) bzw. -impuls(en) oder von sowohl Hochfrequenzstimulation als auch einem oder mehreren Gleichstrompuls(en) bei oder nahe bei der zweiten Stelle, so dass die Hochfrequenzstimulation und/oder die Gleichstrompulse die Niederfrequenzstimulation, die an der ersten Stelle bereitgestellt wird, an der Anregung des elektrisch anregbaren Gewebes oder der Verursachung von Leitung von Anregungspotentialen an der zweiten Stelle hindern.
- 2Device according to claim 1, wherein:the first Generator means comprises a first signal generator (114) to comprise the generation of low frequency stimulation, and the second generator means for generating a second signal generator comprise of RF and / or DC pulse stimulation. Vorrichtung nach Anspruch 1, wobei: die ersten Generatormittel einen ersten Signalgenerator (114) zur Erzeugung von Niederfrequenzstimulation aufweisen, und die zweiten Generatormittel einen zweiten Signalgenerator zur Erzeugung von Hochfrequenz- und/oder Gleichstrompulsstimulation aufweisen.
- 3The apparatus of claim 1, further comprising at least an implantable lead or lead (115. 116) comprising, operatively the first and second electrodes (118. 140) coupled with the first and second signal generators. Vorrichtung nach Anspruch 1, die ferner mindestens eine implantierbare Leitung bzw. Zuleitung (115, 116) aufweist, die operativ die erste und zweite Elektrode (118, 140) mit den ersten und zweiten Signalgeneratoren koppelt.
- 4Device according to claim 2, further comprising a first implantable lead (116) Operatively the first electrode (118) Coupled to the first signal generator, and second implantable lead (115) Operatively the second electrode (140) Coupled to the second signal generator, having. Vorrichtung nach Anspruch 2, die ferner eine erste implantierbare Leitung (116), die operativ die erste Elektrode (118) mit dem ersten Signalgenerator koppelt, und eine zweite implantierbare Leitung (115), die operativ die zweite Elektrode (140) mit dem zweiten Signalgenerator koppelt, aufweist.
- 5Device according to one of the preceding claims, wherein the first generator means and the second generator means comprise at least a signal generator (114) Include, at the same time Low frequency stimulation and high frequency stimulation or direct current pulses can generate. Vorrichtung nach einem der vorstehenden Ansprüche, wobei die ersten Generatormittel und die zweiten Generatormittel mindestens einen Signalgenerator (114) umfassen, der gleichzeitig Niederfrequenzstimulation und Hochfrequenzstimulation oder Gleichstrompulse erzeugen kann.
- 6Device according to one of claims 1 to 5, wherein the second Generator means further includes means which start before excitation and during the proceed suggestion that high frequency stimulation or the direct current pulses provide or both the high frequency stimulation and the direct current pulses. Vorrichtung nach einem der Ansprüche 1 bis 5, wobei die zweiten Generatormittel ferner Mittel aufweisen, die vor der Anregung beginnen und während der Anregung fortfahren, die Hochfrequenzstimulation oder die Gleichstrompulse oder sowohl die Hochfrequenzstimulation als auch die Gleichstrompulse bereitzustellen.
- 7Device according to one of claims 1 to 6, wherein the second Generator means further comprises means for the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses with a relatively small amplitude to start and gradually increasing amplitude. Vorrichtung nach einem der Ansprüche 1 bis 6, wobei die zweiten Generatormittel ferner Mittel aufweisen, um die Hochfrequenzstimulation oder die Gleichstrompulse oder sowohl die Hochfrequenzstimulation als auch die Gleichstrompulse mit einer relativ kleinen Amplitude zu beginnen und allmählich die Amplitude zu erhöhen.
- 8Device according to one of claims 1 to 7, wherein the second Generator means further comprises means for the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses by gradually reducing the amplitude of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses to finish. Vorrichtung nach einem der Ansprüche 1 bis 7, wobei die zweiten Generatormittel ferner Mittel aufweisen, um die Hochfrequenzstimulation oder die Gleichstrompulse oder sowohl die Hochfrequenzstimulation als auch die Gleichstrompulse durch allmähliche Verminderung der Amplitude der Hochfrequenzstimulation oder der Gleichstrompulse oder sowohl der Hochfrequenzstimulation als auch der Gleichstrompulse zu beenden.
- 9Device according to one of claims 1 to 8, further comprising:a Sensor for detecting or measuring at the second location or at a position second from both the first as well as the is point away;and Means responsive to the sensor, at least one parameter of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses adjust, wherein the parameter is selected from the group, consisting of: pulse amplitude, pulse width, pulse frequency, pulse duty cycle, pulse polarity and pulse waveform. Vorrichtung nach einem der Ansprüche 1 bis 8, ferner aufweisend: einen Sensor zur Erfassung bzw. Messung an der zweiten Stelle oder an einer Stelle, die sowohl von der ersten als auch von der zweiten Stelle entfernt ist;und Mittel, die auf den Sensor reagieren, um mindestens einen Parameter der Hochfrequenzstimulation oder der Gleichstrompulse oder sowohl der Hochfrequenzstimulation als auch der Gleichstrompulse anzupassen, wobei der Parameter aus der Gruppe gewählt ist, die besteht aus: Pulsamplitude, Pulsbreite, Pulsfrequenz, Pulsarbeitszyklus, Pulspolarität und Pulskurvenform.
- 10Device according to one of claims 1 to 8, further comprising:a Sensor for sensing at the second site or at a site, which is away from both the first and the second location;and Means responsive to a sensor indication of the excitation at the second site or at the remote location to respond to the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses provide at the second location. Vorrichtung nach einem der Ansprüche 1 bis 8, ferner aufweisend: einen Sensor zur Erfassung an der zweiten Stelle oder an einer Stelle, die von sowohl der ersten als auch der zweiten Stelle entfernt ist;und Mittel, die auf ein Sensoranzeichen der Anregung an der zweiten Stelle oder an der entfernten Stelle reagieren, um die Hochfrequenzstimulation oder die Gleichstrompulse oder sowohl die Hochfrequenzstimulation als auch die Gleichstrompulse an der zweiten Stelle bereitzustellen.
- 11Device according to one of claims 1 to 10, wherein the first Generator means a stimulation at a frequency less than 100 Hertz generate, and the second generator means comprises a stimulation at a frequency above 100 generate Hertz. Vorrichtung nach einem der Ansprüche 1 bis 10, wobei die ersten Generatormittel eine Stimulation mit einer Frequenz unter 100 Hertz erzeugen, und die zweiten Generatormittel eine Stimulation mit einer Frequenz über 100 Hertz erzeugen.
- 12Device according to one of claims 1 to 11, wherein the second Generator means includes a stimulation at a frequency of more than 100, but generate less than 185 Hertz. Vorrichtung nach einem der Ansprüche 1 bis 11, wobei die zweiten Generatormittel eine Stimulation mit einer Frequenz von mehr als 100, aber weniger als 185 Hertz erzeugen.
- 13
Independent claims13
71 paragraphs in 1 section, as filed
description of the prior art
it is often desired excitable or excitable tissues, such as. for example, nerves, muscles, or glandular cells of a patient by electrical stimulation therapeutically to stimulate or by medications. an unwanted Side effect of such therapeutic stimulation of irritable Tissue is that other tissue, either adjacent or removed, undesirable can be stimulated, either directly through the same type of excitation, or indirectly by sensory feedback or sensory feedback or other reflections.
in the generally, undesirable Action or excitation potentials in sensory nerve or dorsal Roots either uncomfortable for cause to be the patient or adverse effects. When stimulated is to peristalsis in the esophagus, in the ureter, the stomach or in the intestine to support, can a co-contraction of the sphincter or unpleasant sensations or reverse peristalsis be undesirable. If z. B. a patient is not able to urinate or to control bowel movements, the stimulation of peripheral nerves or ventral roots desirable be to a patient's bladder for micturition to contract or to move the intestinal contents. Such excitation or even a lower amplitude stimulation, however typically generate action potentials in sphincters, such as in those in the outer urethra or in the anus. Such action potentials tend contraction the sphincters cause what in an inability may result, urine or fecal material through the sphincters let happen. In addition, increased Pressure in the bladder, by the simultaneous compression of the bladder of the patient and the contraction of the external urethral sphincter the patient will cause to injury to the patient to lead, including an increased Pressure and damage to one or both the bladder and the kidneys. A conventional Approach for Patients has been proposed which are essentially paralyzed, is to cut the nerve of the patient that lead back into the spinal cord (dorsal roots), so that stimulation of the bladder caused no major neural activity in the spinal cord. If a patient's bladder is significantly overfilled, an autonomous Dysreflexia occur that in a very large and dangerous rise in blood pressure caused the patient, which can cause a stroke.
If is stimulated to defibrillate a patient's heart, typically the patient because of the simultaneous excitation of many afferent fibers, some of which even the axons of Nociceptors are extremely intense pain added.
If certain motor neurons are stimulated, can direct or spinal caused reflex of antagonistic motor neurons and muscles Suggestions with the desired Motion interfere, causing an increase in the strength of stimulation needed does what increased Stiffness of joints of a patient caused.
Electrical Stimulation of tissue at low frequencies (eg., Less than 100 Hertz) is known to cause action potentials in nerve and Muscles. additionally are described some techniques to action potentials in certain to block nerve fibers or to block, the best observations were made in animal experiments.
US-A-6,064,911 discloses a device that combines two types of stimulation, a low frequency stimulation and a high-frequency stimulation, wherein the high frequency stimulation counteracts the pain generated by the low frequency stimulation.
Tanner (Nature, vol 195, 1962. 712-713) and Woo & Campbell showed that the stimulation (87-94 Bull LA Neurol Soc, vol 29 1964....) a nerve with 20,000 Hz is capable of, the passage of action potentials block to where higher voltages (Amplitudes) needed be to block smaller fibers progressively. Recently, was the therapeutic stimulation of the brain in patients with tremors and other symptoms of Parkinson's disease the evidence provided that high-frequency stimulation (100-185 hertz) depolarize the neuron holding and therefore unable is to generate action potentials (Benabid et al., Lancet, vol. 337, 1991: 403-406; Benazzouz et al., Neurosci. Lett., Vol. 189, 1995: 77-80). it received reports that high-frequency stimulation of the spinal cord or nerve (250 Hertz and more) relieves chronic pain, but it is unknown if this works by blocking action potentials (Picaza et al, Surg Neurol, vol 4, 1975: 105-114 and 115-126; Sheldon.... et al., Surg. Neurol., Vol. 4, 1975: 127-132; Benett et al., Neuromodulation, vol. 2, 1999: 202-210).
Mendel & Wall (J. Physiol., vol. 172, 1964: 274-294) and Campbell & Woo showed: (63-71 Bull Los Angeles Neurol Soc, vol 31 1966....) a similar amplitude-dependent Blocking of action potentials in progressively smaller axons, wherein they direct current (DC) use signals. Recently, evidence was provided that in rats the repeated stimulation the brain area that <?page 3?>Corpus is called amygdaloideum which cramps due caused by kindling, kindling effects by using 5 to 15 microamps DC currents, the once daily for 15 Minutes be created, attenuate can (Weiss et al, Exper Neurol, vol 154, 1998:.... 185-192).
Of the Disadvantage of direct current pulses is that they damage tissue or electrodes (Pudenz, et al., Surg. Neurol, vol. 4, 1975: 265-270) or asynchronous repeated cause action potential discharges can (Manfredi, Arch Ital Biol, vol 108, 1970,... 52-71; Sassen & Zimmermann, Pflugers Arch. Total Physiol. People Animals, vol. 341, 1973: 179-195).
Van the Honert & Mortimer (IEEE Trans BME, vol 28, 1981:... 373-378 and 379-382) developed a technique to create action potentials that differs only in a direction along the axon move by a tripolar Cuff with three electrodes and two regulated Stromstimulatoren use. This method was developed by Brindley & Craggs (J. Neurol. Neurosurg. Psychiat., vol. 43, 1980: 1083-1090) used only the smaller (parasympathetic) fibers in the spinal nerve roots and peripheral nerves for bladder emptying excite. Ungar, Mortimer & Sweeney (Ann. Biomed. Engng, vol. 14, 1986: 437-450) were also able to to produce unidirectional locomotive action potentials in nerve, by using an asymmetric monopolar electrode cuff. However, need both of these partially blocking techniques a complete encirclement the interesting axons with non-conductive materials, something which does not require the high-frequency and DC technology.
Around the unwanted Side effects associated with the therapeutic stimulation of the tissue, to reduce, including, but not limited to, the side effects that have been mentioned above, it may desirable be certain excitable tissue during the time during which the desirable Effect is produced in therapeutically excited tissue to disable or to prevent or suppress.
it would therefore desirable be, action potentials, consisting of a low-frequency stimulation were deliberately created to block the tissue. blocking has not fully be and it may be a asynchronous, even repeated generation of some action potentials during the Process take place, but under certain circumstances it may be possible, to suppress most of the action potentials in certain nerves that otherwise produced by other electrodes in nearby tissue can be, Use the intended low frequency pulses to action potentials to cause. The volume of the tissue near the electrodes for the intention "excitation" recruited, and the volume of tissue which blocks electrodes near the "blocking" or is inactivated, would both of the parameters of stimulation, especially the amplitude and the pulse width, depend.
SUMMARY THE INVENTION
The present invention provides a device and a device according to claim 1 ready.
a first embodiment the invention is a stimulation apparatus, which generally first generator means, to produce low-frequency stimulation (eg., less than 100 Hertz) and second generator means for RF and / or DC pulse stimulation to produce, has. A first electrode is operatively connected to the coupled first generator means, the first electrode formed is to tissue at a first predetermined location by providing to encourage low-frequency stimulation. A second electrode is coupled to the second generator means, the second electrode is adapted to the excitation of electrically excitable tissue in the second position by providing high-frequency stimulation or one or more direct current pulse (s) or pulse (s) or of both high frequency stimulation and one or more DC pulse (s) at or near the second location to block.
To the example the first generator means and the second generator means comprise at least have a signal generator for simultaneously generating of both low frequency stimulation and high frequency stimulation or direct current pulses is capable. Alternatively, the first Generator means comprises a first signal generator for producing low frequency stimulation and the second generator means comprises a second signal generator for have the generation of high frequency and / or direct current pulse stimulation.
Also z can. B. an implantable lead or lead used are to the first and second electrodes with the first and second Signal Generators operatively coupling. Alternatively, a first implantable lead, the first electrode with the first signal generator and a second implantable lead, the second electrode pair operatively connected to the second signal generator.
preferably , the second generator means further includes one or more of following means: (a) means for beginning the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current<?page 4?>pulses with a relatively low amplitude and a gradual Increase the amplitude; and / or (b) means for terminating the high frequency stimulation or the direct current pulses or both the high frequency stimulation than and the direct current pulses by gradually reducing the amplitude the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses.
Optional a sensor for detecting and measuring at said second location or at a location of the both the first as well as of second location is located, are provided, and means respond to the sensor, can be provided to at least one parameter of the high frequency stimulation or the direct current pulses or both the high frequency stimulation adapt as well as the direct current pulses, the parameter of selected group is consisting of: pulse amplitude, pulse width, pulse frequency, pulse duty cycle, pulse polarity and pulse waveform.
Also may optionally include a sensor for detecting at the second location or at a location of each of the first and of the second Site has been removed, are provided, and means responsive to a sensor indication of the excitation at the second site or at the react remote location, can for providing the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses are provided at the second location.
In accordance with certain inventive principles is a desirable Effect of therapeutic stimulation of tissue at a first Site in the body a patient is generated and a corresponding undesirable Side effect by blocking the excitation of tissue at a second place in the body the patient by applying high frequency stimulation and / or one or more direct current pulses (S) at or near the second Point reduced.
In accordance with various inventive principles of the desired effect, the support be of urination; the undesirable side effect, the Contraction of the sphincter be; the first place, the bladder apex, the sacral roots or the Plexus his pelvis of the patient; and the second location can the patient: sacral dorsal roots, spinal Columnae (vertebral) dorsalis, conus medullaris, pudendal nerve, hypogastric plexus his or nerve perineales.
Of the desired Effect can support his stool; of unwanted Side effect, the contraction of the sphincter, a raised pelvic floor be or an acute anorectal angle; the first digit can the patient: hypogastric plexus, Plexus pelvis, nerves to the rectum, to the sacral roots, plexus pelvis or a rectal his muscle; and the second location may be the patient's: sacral dorsal Roots, spinal dorsal Columnae, conus medullaris, pudendal nerve his or nerves to the pelvic floor muscles of the patient.
Of the desired Effect may be peristalsis of the esophagus of the patient; the undesirable Side effect may be a contraction of the gastroesophageal sphincter be patient; the first place can the patient: esophagus, nerves to esophagus be patient, pharynx or nerves to pharynx of the patient; and the second location may be the patient's: Area of the hiatus esophagus close of the patient's diaphragm, or nerves to the esophagus of be patient.
Of the desired Effect may be peristalsis of the ureter of the patient; the undesirable side effect , the closure of the anti-reflux valve of the patient in the vicinity of the bubble triangle be patient; the first place can the patient: Pelvis renal, or a region of the ureter of the patient; and the second place can the patient: bubble bottom near the entrance the ureter, be hypogastric plexus or plexus pelvis.
Of the desired Effect may be peristalsis of the stomach of the patient; the undesirable effect may be the closure of the pyloric sphincter of the patient; the first place can the patient: stomach wall muscles or nerves, leading to the stomach wall muscles of the patient, his; and the second Agency may the patient: muscle fibers of the pyloric sphincter his or nerves to the pyloric sphincter.
Of the desired Effect may be peristalsis of the intestine of the patient; the undesirable effect , the closure of the ileocecal his flap of the patient to the colon of the patient; the first place can the patient: smooth intestinal wall muscle, hypogastric plexus his or nerves to the hypogastric plexus of the patient; and the second place can the patient: ileozäkale flap Ganglia mesenteric, dorsal root Columnae spinal dorsal or splanchnic nerve be.
Of the desired Effect can be selected be selected from the group consisting of: defibrillation of the atria of Patient or defibrillation of the ventricles of the patient; the undesirable side effect can be a pain; the first body may close a pacemaker / defibrillation lead be: within the ventricles of the patient or outside the ventricles of the patient; the second body may<?page 5?>the patient: Vagus nerve, branches of the vagus nerve of the patient from the heart the patient, sympathetic nerve thoracalis, Ansa subclavian Ganglia the sympathetic trunk (T1-T4) Ganglia stellata, Ganglia cervicalia (C1-C8), celiac plexus, Plexus brachial dorsal roots (C1-T4) be Columnae spinal dorsal or dorsal roots.
Of the desired Effect can be the extension of the leg of the patient; the undesirable side effect , the co-contraction be the antagonist muscles; the first point, the femoral nerve be patient for the quadriceps femoris of the patient; and the second place, the tibial nerve of the patient for musculus his gastrocnemius of the patient.
Of the desired Effect, the movement of one of the joints of the patient in be a predetermined direction; the undesirable side effect, the his co-contraction of antagonistic muscles; the first place may be a peripheral nerve of the patient; and the second location , the diversion of the nerve of the patient to an antagonistic his muscle.
The can radiate radio frequency blocking stimulation before therapeutic Excitation start and during proceed or continue the therapeutic stimulation. The high frequency blocking stimulation can begin with a relatively small amplitude, and the amplitude can gradually increase. The high frequency blocking stimulation may by gradual reduction the amplitude of the high frequency stimulation to close.
On Sensor for detecting the condition of the tissue at the second Body or be used at a more remote location. Means for adjusting the pulse amplitude of the pulse width, pulse rate, the pulse duty cycle, pulse polarity, and pulse waveform of the High frequency blocking stimulation at the second site based on the Sensor react to also be employed.
Direct current pulses can be used to the excitation of tissue at the second location to block. When they gradually be moved up or down, this can be a neural accommodation of allow or to adapt and prevent action potentials. DC pulses may also be before or after a Series of high frequency blocking signals are used so that a big part the stimulation to block a charge balance comprising, to protect the electrodes or tissue.
Preferred embodiments are now of example only with reference to the drawing described.
Short description the drawing
<figref idrefs="S35">1</figref> is a diagrammatic illustration of a system for blocking excitation in tissue in a patient, in accordance with various inventive principles.
<figref idrefs="S35">2</figref> shows a blocking stimulation before stimulation for the intended Effect begins and ends for her.
The <figref idrefs="S36">3a</figref> to <figref idrefs="S37">3d</figref> show various combinations and permutations of RF and / or DC blocking pulses with and / or without a ramp at the start and / or at the end of the pulses.
<figref idrefs="S38">4</figref> is a flow chart depicting the steps which are executed, the stimulation of tissue in accordance to block with certain inventive principles.
<figref idrefs="S38">5</figref> is a schematic diagram of the arrangement of an electrode support micturition in accordance shows with various inventive principles.
<figref idrefs="S39">6</figref> is a schematic diagram of an electrode arrangement in the an intrathecal space of the patient near a dorsal root of the patient for blocking sensations associated with stimulation of the another part of the body the patient related, shows.
<figref idrefs="S39">7</figref> is a schematic diagram of the arrangement of an electrode support the esophageal peristalsis a patient and / or the emptying of the stomach of the patient shows.
<figref idrefs="S40">8</figref> is a schematic diagram of the arrangement of the electrode Stretching of a lower leg of a patient.
<figref idrefs="S40">9</figref> is a schematic diagram of the arrangement of an electrode support stool in accordance shows with various inventive principles.
<figref idrefs="S41">10</figref> is is a schematic diagram showing the arrangement of a suitable electrode for the reduction of pain a patient in conjunction with Defibriallationspulsen suffers, shows.
Detailed Description of the Invention
supporting documents or signs from the brain stimulation for tremor and other symptoms of Parkinson's disease, suggest that high<?page 6?>frequency stimulation, the neurons keeps depolarized, and therefore unable is to produce an action potential. See AL Benabid et al., Long-Term Suppression of tremor by chronic stimulation of the VETRAL Intermediate Thalamic Nucleus, the Lancet, vol. 337, 1991, pp. 403-406. Accordingly use therapies of deep brain stimulation for blocking tremor and to block neural pathways, the desirable intentional movement (freezing, akinesia, bradykinesia) prevent often high-rate pacing. For example, disclose the commonly assigned US Patents 5,716,377 and 5,833,709, such systems and methods. As used herein, the phrase "high frequency stimulation" refers to electrical Stimulation of at least about 100-120 Hz, while to "low frequency stimulation" to electrical stimulation with less than about 100 Hz applies.
<figref idrefs="S35">1</figref> is a schematic view of a patient <figref>110</figref>Which is a implant having a neurological stimulation system, the a preferred form of the present invention. A system in accordance with the principles of the invention, in an implantable pulse generator <figref>114</figref> used are to stimulation pulses at different predetermined locations within of the body to generate a patient. As an example, as shown in<figref idrefs="S35">1</figref> ready, is the concept of provision of high frequency blocking stimulation to electrode <figref>140</figref> schematically depicted. High frequency stimulation is provided to an undesirable side effect of spinal cord stimulation, the above the electrode <figref>118</figref> is provided to prevent. In accordance with the principles of this invention is the point at which an undesirable Side effect is blocked by using high frequency stimulation is often in the vicinity of the site in the body of Patients on the low frequency stimulation for the intended effect Provided, are. Nevertheless, the two types of stimulation in Areas of the body a patient are provided, the relatively far are as z. B. <figref idrefs="S35">1</figref> is shown. Another example is to provide and apply high frequency blocking stimulation, to block the pain perceived by a patient , while a Defibrillation pulse is administered to the patient's heart, wherein the blocking stimulation distant from the heart Ask can be provided as described in more detail below is.
In a preferred embodiment, can the implantable signal generator <figref>114</figref> a modified Signal generator, such as, for. Example, the model 7424, the Medtronic, Inc. branded Itrel<sup>®</sup> is prepared to be, or the pulse generator <figref>114</figref> can not have a battery and may instead programming signals and energy from a modified external transmitter <figref>120</figref> and an antenna <figref>124</figref> as a radio-frequency or high-frequency system by Medtronic, Inc. is prepared, and as X-trel<sup>®</sup> or Mattrix<sup>®</sup> known is obtained. The signal generator<figref>114</figref> could simultaneously both high Low frequency stimulation, z. B. at frequencies each on or produce less than 100 Hz. Alternatively, the signal generator<figref>114</figref> either high- or issue low-frequency stimulation and a second signal generator, which is not shown, could be used to output the other type of stimulation.
to Spinal Cord Stimulation (SCS), the signal generator <figref>114</figref> usually subcutaneously into a human body in the abdomen or back implanted. In accordance with the principles of this Invention, one or a plurality of signal generator (s) near a location therapeutically stimulated is, or near an area where the excitation is blocked, or close to both of these types of areas are arranged. electrodes <figref>140</figref> and <figref>118</figref> can each operatively with the signal generator <figref>114</figref> about the lines <figref>115</figref> or. <figref>116</figref> be coupled. alternative can the electrodes <figref>140</figref> and <figref>118</figref> operatively connected to said signal generator <figref>114</figref> over a single line to be coupled.
<figref idrefs="S35">2</figref> shows a high frequency blocking stimulation, the earlier in time than the stimulation for the intended Effect begins and until after the end of the stimulation for the intended Effect lasts. started By RF blocking stimulation , before the stimulation for the intended effect is provided, and is continued, after the stimulation for the intended effect is provided, undesired side effects associated with the stimulation of the intended effect related, be blocked more effectively than would be possible if the high frequency blocking stimulation at the same time not to as or later as the stimulation for the intended effect began and / or not for the same time as or earlier as the stimulation for the intended effect ended. Stimulation for the intended effect may be a single pulse or multiple pulses.
The Waveform in the upper region of <figref idrefs="S36">3a</figref> shows High frequency blocking stimulation pulses without a ramp or gradually Increase or decreasing the amplitude of the pulses begin and end. The middle and lower waveforms show blocking pulse waveforms, in which the amplitude of the waveforms at the beginning of the waveform booted or gradually elevated is, or shut down at the end of the waveform or gradually lowered is. By such a driving can be used to produce the to reduce of action potentials, the abrupt by<?page 7?>res Begin and / or more abrupt stopping the high frequency blocking stimulation caused.
The Generating a blocking signal without action potentials generated by the high frequency blocking pulses is desirable. how in <figref idrefs="S36">3b</figref> shown, a pure direct current pulse on the or during the time of jamming can be used. He can depolarizing be, particularly if it has a gradual ramp that an accommodation of the neural tissue allowed to action potentials to prevent them from forming. Action potentials, which Area approach, run into areas where neuronal sodium goals already affected are and therefore not open can. It may also have an opposite sign, so hyperpolarizing be. This prevents action potentials at the start, when the transmembrane Potential is not enough can be reduced to open the sodium channels, but action potentials, reach the area, can always still pass therethrough.
a Risks associated with direct current pulses is that an electrode and resolution neuronal damage due to a stable and far-reaching ion flux can occur. however such a stimulation can be provided relatively rare, z. B. only a few times per hour or per month, depending on treatment. The possibility, Side effects shield, therefore, the risks of temporary DC stimulation cancel.
<figref idrefs="S37">3c</figref> shows a combination of the types of blocking. There is a gradual DC Ramp and after a series of high-frequency pulses. The ramp may create an accommodation of neurons and prevent action potentials. The continuation of high-frequency stimulation, the neurons disabled hold while still pulses are generated charge balanced. This technique can be used advantageously to initial action potentials to prevent and reduce electrode or tissue problems.
<figref idrefs="S37">3d</figref> shows several combinations with a change in the DC pulses. The initial Pulse can an exponential increase rather than a linear increase exhibit. The end of the blocking signal can also include a DC pulse use to allow the neuronal tissue, in its stimulable return state without causing suggestions such. B. anode breaks.
<figref idrefs="S38">4</figref> is a flow diagram showing the steps that are carried out can, an excitation of tissue in accordance to block with certain inventive principles. At step<figref>402</figref> shall started a high-frequency blocking stimulation and can optionally be raised, as described above with reference to <figref>3</figref> described is. At step<figref>404</figref> is the low-frequency stimulation for the intended effect started. At step<figref>406</figref> is determined, how a high frequency stimulation or more undesirable side effects effectively blocked, with the stimulation for the intended effect related. This determination may be by a suitable sensor for measuring various parameters, such as. for example, movement of a limb, contraction of a sphincter or any other suitable measurement indicating the degree to which an undesirable Side effect has been blocked, done.
If blocking stimulation is determined to be insufficient, it is determined whether a predetermined limit or a predetermined reached limit the blocking stimulation provided is as shown at <figref>408</figref> and <figref>410</figref> is shown. If the Limit of the blocking stimulation is not yet been reached, blocking stimulation may in step <figref>402</figref> increase, the low frequency stimulation may be continued as described in step <figref>404</figref> is shown, and the rules can be repeated be made as shown at <figref>408</figref> and <figref>410</figref> shown is.
If blocking stimulation is determined to be sufficient, stimulation for the intended effect, also referred to as target tissue, stimulation is as long as desired are continued, as in <figref>408</figref> and <figref>412</figref> shown. After completion of the stimulation for the intended effect at <figref>412</figref> the high frequency blocking stimulation terminated , as at <figref>414</figref> shown.
applies now to exemplary deployments and uses the principles this invention is, <figref idrefs="S38">5</figref> a schematic diagram, the arrangement of one electrode to the support of the bladder voiding in accordance shows with various inventive principles. It is shown that the front sacral root <figref>513</figref> from the spinal cord <figref>512</figref> assumes that is shown in a cross-sectional view. electrode<figref>515</figref> is Nearby facilities and close proximity to the front sacral root (S1-S4) <figref>513</figref> shown. Low frequency stimulation for the intended effect can to the sacral root <figref>513</figref> on the electrode <figref>515</figref> provided in order to empty the bladder by causing action potentials the nerve <figref>507</figref>, Of the bladder <figref>510</figref> leads to support. To the suggestion of the external sphincter <figref>508</figref> the to block the urethra in the pelvic floor muscles of a patient, can radiate radio frequency blocking stimulation near the turnoff <figref>509</figref> of Pudendal nerve, which the external sphincter <figref>508</figref><?page 8?> leads, provided be. The high frequency blocking stimulation is preferably before deployment of low frequency stimulation for the intended begun effect and continues after deployment. In addition to the sacral roots can low frequency stimulation for the intended Provided effect to other parts of the body of a patient be, including, but not limited to, the bladder apex of the patient and / or the Plexus pelvis the nerve of the patient. Sphincter contraction can also Provision of high frequency blocking stimulation to other Points are provided as the pudendal nerve of the patient, including, but not limited to, the sacral dorsal roots of the patient, Columnae spinal dorsal, conus medullaris, hypogastric plexus and nerve perineales.
<figref idrefs="S39">6</figref> is a schematic diagram illustrating the arrangement of the electrode <figref>614</figref> in the intrathecal space of a patient near the dorsal root of the patient for blocking sensations, the other to the stimulation of Parts of the body a patient related, shows. As discussed above in the Background section, can the stimulation of the nerves that the bladder <figref>510</figref> run without Blocking the stimulation of the external sphincter <figref>508</figref> Next other complications for reflex sympathetic dystrophy syndrome and stroke to lead. Unlike the afferent nerve cut off, as in the US patents to Tanagho and Schmidt et al. No. 4,607,639. 4,703,755 and 4,771,779 it has been proposed to the dorsal roots with High frequency are stimulated to block the excitation, while the bladder contracts, whereby the stimulation of the dorsal Root tissue is reversibly blocked as described in <figref idrefs="S39">6</figref> shown. additionally for preventing the reflex sympathetic dystrophy syndrome, the provision of High frequency stimulation over the administration <figref>616</figref> undesirable Sensation associated with the low frequency stimulation, is provided to contract the patient's bladder through Preventing the stimulation of the dorsal roots of a patient prevent. As will be appreciated, undesirable Sensations from many other sources other than the patient's bladder in a similar Way are blocked. As is apparent also, the electrode<figref>614</figref> in be arranged other suitable areas to the excitation of to block other tissues, causing other undesirable effects the low-frequency stimulation for the intended effect that somewhere else in the body of a Patient is provided can be prevented. For example, the electrode <figref>614</figref> outside the arachnoid <figref>660</figref> in subdural <figref>654</figref> or outside of Dura <figref>652</figref> in the epidural space <figref>670</figref> to be ordered.
blocking signals can be issued to each of these points, not only to prevent pain, but also to nerve action potentials from entering into the spinal cord and on causing unwanted to prevent reflections. If pain of major adverse side effect is of the nerve or tissue stimulation, then it is possible for him to block, since it the spinal cord close the surface the ventrolateral quadrant ascends spinothalamicus the tract to the opposite Side of the spinal cord, because pain fibers cross near its origin. It may be advantageous be to place in this case, an electrode under the dura, next to the pial surface, not even a loss of sensation or motor control on the opposite causing side.
<figref idrefs="S39">7</figref> is a schematic diagram of the arrangement of an electrode support the esophageal peristalsis a patient and / or the emptying of the stomach of the patient shows. Branches of the vagus nerve<figref>46</figref> are lining the esophagus <figref>38</figref> and the stomach <figref>35</figref> shown and connect to the myenteric nervous system <figref>44</figref>Which consists of local neurons, which involved in peristaltic esophageal contraction are. High frequency blocking stimulation may be on the electrode<figref>32</figref> near the hiatal portion of the esophagus are provided, which there is where the lower portion of the esophagus <figref>38</figref> the upper portion of the stomach <figref>35</figref> applies. Low frequency stimulation for the intended effect can then through the upper electrode <figref>31</figref> provided in order to support the peristalsis of the esophagus in order Food esophagus down to move into the stomach. The high frequency blocking stimulation is the low-frequency stimulation of the intended effect on the undesirable prevent causing the contraction of the hiatal region of the esophagus. The esophageal peristalsis of Patients can also through the provision of low-frequency stimulation for the intended effect of the pharynx of the patient support. The Contraction of the gastroesophageal sphincter of patients, by providing high frequency blocking stimulation to the nerves leading into this area of the patient's esophagus, preventing be.
On a similar Example, the contraction of the pyloric sphincter <figref>37</figref> by Provision of high-frequency stimulation via the electrode <figref>39</figref> prevented are while Low frequency stimulation to the stomach muscle <figref>35</figref> or the electrodes <figref>33</figref> and <figref>34</figref>. in close proximity to the down leading branches of Ganglia celiac <figref>40</figref> are arranged is provided to the food stomach <figref>35</figref> of the patient in the intestine <figref>36</figref> the patient to move.
<?page 9?>
The Peristalsis of the ureter to move urine into the bladder, and the Bowel, to transport feed materials are also common physiological functions of the urinary and digestive system by trauma or disease may be damaged. Although it not in <figref idrefs="S39">7</figref> shown, could in these cases are stimulated with low frequency to the peristalsis of material to start. In the case of the ureter, the excitation should range of the renal pelvis of the kidney or near the upper end of the ureter over a Segment which destroyed is, or provided on intact nerves, leading to these structures, be. In the case of the intestine should be anywhere along the intestine, having a functional problem, or at intact nerves that lead to this area of the intestine, excited be. The suggestion has in a delayed, sequential process along the length of Structural done to peristalsis in an appropriate motion to hold. Blocking of excitation by high frequency stimulation and / or direct current potentials should be done where a certain Flap not functionally open as needed. in the The case of the ureter, this may be close to the bladder triangle, where a Antireflux flap usually helps reflux prevent urine toward the kidneys, or in intact Nerves that innervate this area of the bladder. In the case of the intestine This can be at the ileocecal Damper or with nerves be leading in this area of the intestine. In the cases where peristalsis be recovered by low-frequency stimulation can and an undesired Sensation is generated, the block to the dorsalis can Columnae made or dorsal roots of sensory signals produced by the spinal cord and the brain go. It is conceivable that blocking of tissue excitation at should be done in two places: on a broken door, to prevent suggestions by peristaltic waves, carried at an appropriate time, with the speed of peristalsis Distances and related, and the spinal sensory pathways to the passage to prevent action potentials, mainly in the vicinity of the time useful is, if the desired Peristalsis is initiated by low-frequency stimulation.
Referring on <figref idrefs="S40">8</figref>, Is the position of an electrode for functional shown electrical stimulation to the muscles to stretch the leg of a patient to control. The nerve<figref>54</figref>Which to the muscle <figref>50</figref> leads, can through the electrode <figref>56</figref> are stimulated, which causes that the muscle <figref>50</figref> contracts, so that the shin <figref>52</figref> of the patient in the direction of arrow <figref>58</figref> will move thereby the patient's leg is stretched. Such stimulation can undesirably the simultaneous contraction of antagonistic muscle, as z. B. Muscle <figref>51</figref>, to cause. Therefore, the nerve<figref>55</figref> With High frequency blocking stimulation at the electrode <figref>57</figref> stimulated are to the action potentials in nerve <figref>55</figref> in causing the contraction of the muscle <figref>51</figref> to prevent. As can be seen is, can the provision of different levels of high-frequency stimulation to the muscle <figref>51</figref> he wishes be to the shin <figref>52</figref> in a controlled manner to move. The length and / or Duration of either or both types of stimulation, as above in connection with <figref idrefs="S38">4</figref> describes controlled. If, for. Example, a person stands up, a voltage in both muscles he wishes. Low frequency stimulation of electrode <figref>56</figref> can to both annoy <figref>54</figref> and <figref>55</figref> be provided during high frequency stimulation provided is to modulate the action potentials that muscle <figref>51</figref> to accomplish, whereby the amount of axons in nerve <figref>55</figref> is reduced which the contraction of the muscle <figref>51</figref> caused.
<figref idrefs="S40">9</figref> is a schematic diagram of the arrangement of an electrode support stool in accordance shows with various inventive principles. The nerves<figref>75</figref>. the outside colon <figref>70</figref> reduced lead, and the nerve plexus <figref>76</figref> in the wall of the rectum <figref>71</figref> are shown. Low frequency stimulation in the area of the pelvis plexus Nerves to the rectum <figref>77</figref>Which could be used to the rectum contract to assist the bowel movements, can also the pudendal nerve <figref>78</figref> directly or through a reflex arc in a similar Manner as described above with respect to the bladder, and <figref idrefs="S38">5</figref> described, stimulate. Accordingly, high frequency blocking stimulation on electrode <figref>79</figref> the pudendal nerve <figref>78</figref> provided are to action potentials in pudendal nerve <figref>78</figref> to prevent, which undesirably Thus, the contraction of the pelvic floor muscles or anal sphincters <figref>72</figref> to cause would. The plexus pelvic nerve <figref>77</figref> incurred as of the sacred Roots as the pudendal nerve <figref>78</figref>, When using Low frequency stimulation of the sacral root pudendal nerve of <figref>78</figref> With a smaller amplitude than the plexus pelvic nerve <figref>77</figref> encouraged because the pudendal nerve <figref>78</figref> Axons of larger diameter having. At higher Amplitudes of the low frequency stimulation the rectum may contract, but the pudendal nerve <figref>78</figref> will be excited and will prevent defecation. This phenomenon also applies to stimulation the nerves discussed with respect to the bladder. Accordingly, not contracted the bladder and the rectum with low frequency stimulation be until her sphincter undesirable is contracted, in the absence of high frequency blocking stimulation, which is provided to a nerve leading to the sphincter. Around to assist the bowel movements, can low-frequency stimulation for the intended effect <?page 10?>to other areas in the body of a Patients are provided, including, but not limited on, the hypogastric plexus of the patient, the Plexus pelvis, the nerves along the rectum of the patient and the sacred roots. Unwanted Side effects of such low frequency stimulation for the intended effect can lock in, but are not limited on, sphincter contraction, Raising of the pelvic floor and support of an acute anorectal angle. This can by providing high frequency or direct current blocking stimulation to other parts of the body of the patient can be prevented, including, but not limited on, the sacral dorsal roots of the patient, the spinal Columnae dorsalis, the conus medullaris and the nerves to the pelvic floor muscles of the patient.
how mentioned above, is the defibrillation of the heart of a patient by using strong electric pulses extremely painful. Commonly assigned US Patent 5,817,131, which for Elsberry et al. is granted, discloses blocking pain messages wherein spinal cord stimulation or stimulation at other sites in peripheral or central Pathways used. The '131 patent of Elsberry discloses Blocking pain messages via the gate control hypothesis which stimulation typically at a frequency below 100 Hz used near the Columnae dorsalis. Probably fibers with larger diameter stimulated to block the smaller diameter fibers, transport which pain and temperature sensations. In accordance with the principles the present invention high frequency stimulation, in other Words stimulation with frequencies above 100 Hz, used to substantially all afferent nerves near the heart, including the small diameter fibers, which often pain messages transport, to block. RF or DC blocking stimulation can preferably on the peripheral nerves, including Nerves from the heart, such. As the vagus nerve or the sympathetic nerve or both, are provided which tend axons to have a small diameter.
<figref idrefs="S41">10</figref> is is a schematic diagram showing the arrangement of a suitable electrode for the reduction of pain perceived by a patient is and is related to defibrillation pulses, shows. Pain Information can migrate from the heart by in left <figref idrefs="S41">10</figref> by the vagus nerve parasympathetic <figref>81</figref> through its branches <figref>82</figref>-<figref>84</figref> goes. Pain information may also the heart to the right in <figref idrefs="S41">10</figref> in the sympathetic over the nerves, the heart, the <figref>91</figref> left, are transported. These Nerves bring information, especially about pain, to the Ganglia sympathetica stellata <figref>85</figref> or the T1-T4 ganglia thoracalia <figref>86</figref>. <figref>88</figref>. <figref>89</figref> and <figref>90</figref>, To block the pain signals in the efferent nerves sympathici, could the electrodes near these nerves either before, <figref>93</figref> and <figref>100</figref>or after you, <figref>94</figref> and <figref>99</figref>That Ganglia sympathetica <figref>85</figref>. <figref>86</figref>. <figref>88</figref>. <figref>89</figref> and <figref>90</figref> happens have to be arranged. These electrodes may be placed endoscopically , whereby a needle near the branches of these nerves used is. While the Atria or a patient's ventricle defibrillation, can a low frequency stimulation for the intended effect on a pacemaker / defibrillation within the ventricle of Patient or a pacemaker / defibrillation lead outside of the patient's ventricle to be provided. Pain associated with defibrillation of the atria related or ventricle of a patient, by providing of high-frequency or dc blocking stimulation at sites within the body the patient including, but not limited to, the Nervi vagi bilateral, the branches the Nervi vagi near of the patient's heart, the nerves sympathici in the vicinity of the heart, the Ansa subclavian, the ganglia of the sympathetic trunk (T1-T4) Ganglia stellata, the Ganglia cervicalia, celiac plexus, the Plexi brute who Columnae dorsalis and the dorsal roots (C1-T4) be prevented.
If the ventricle defibrillation, the blocking stimulation z. B. to the lower Ganglia <figref>89</figref> and <figref>90</figref> about the electrode <figref>93</figref> to be provided. On the other hand atrial Defibrillation typically more needed be such. as often per day. High frequency stimulation can on the electrodes <figref>94</figref>. <figref>99</figref> or <figref>100</figref> for the upper Ganglia sympathetica <figref>85</figref>. <figref>86</figref>. <figref>88</figref> provided be and the electrodes <figref>96</figref>. <figref>97</figref> or <figref>98</figref> can to Blocking the pain information are used, via the vagus received vagus is, depending upon where defibrillation occurs.
16 members in 6 offices
Priority claims10
| Document | Office | Kind | Date |
|---|---|---|---|
| 85928001 | United States of America | A | |
| 85928001 | United States of America | A | |
| 85928001 | United States of America | – | |
| 0214143 | United States of America | W | |
| 0214143 | United States of America | W | |
| 0214143 | United States of America | – | |
| 859280 | – | – | – |
| PCTUS0214143 | – | – | – |
| US20010859280 | – | – | – |
| WO2002US14143 | – | – | – |
Members16
| Document | Office | Kind | |
|---|---|---|---|
| WO02092165A1 | World Intellectual Property Organization (WIPO) | A1 | |
| EP1392393A1 | European Patent Office (EPO) | A1 | |
| US2004162594A1 | United States of America | A1 | |
| EP1392393B1 | European Patent Office (EPO) | B1 | |
| AT283093T | Austria | T | |
| ATE283093T1 | Austria | T1 | |
| DE60202063D1 | Germany | D1 | |
| ES2233822T3 | Spain | T3 | |
| US2005149148A1 | United States of America | A1 | |
| US6928320B2 | United States of America | B2 | |
| DE60202063T2This record | Germany | T2 | |
| US2008058878A1 | United States of America | A1 | |
| US2008058888A1 | United States of America | A1 | |
| US7433734B2 | United States of America | B2 | |
| US8165672B2 | United States of America | B2 | |
| US8165681B2 | United States of America | B2 |
2 legal events, as the office reported them to INPADOC
Over the term
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| Change in the person/name/address of the agent8328 | 8328 | |
| No opposition during term of oppositionOpposition8364 | 8364 |
Numbers
- Publication
- 60202063
- Publication, DOCDB
- 60202063
- Publication, EPODOC
- DE60202063T
- Application
- 60202063
- Application, DOCDB
- 60202063
- Application, EPODOC
- DE20026002063T
Titles2
- German
- REIZUNGSGERÃT
- English
- IRRITATION DEVICE
Classification
- CPC, 3
- A61N1/36007
- A61N1/36071
- A61N1/39624
- IPC, 2
- A61N1 34
- A61N1 36