|Número de publicación||US20050143787 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||US 11/035,374|
|Fecha de publicación||30 Jun 2005|
|Fecha de presentación||13 Ene 2005|
|Fecha de prioridad||9 May 2002|
|También publicado como||US7076307, US20050004621, US20050131486, US20050131487, US20050149146|
|Número de publicación||035374, 11035374, US 2005/0143787 A1, US 2005/143787 A1, US 20050143787 A1, US 20050143787A1, US 2005143787 A1, US 2005143787A1, US-A1-20050143787, US-A1-2005143787, US2005/0143787A1, US2005/143787A1, US20050143787 A1, US20050143787A1, US2005143787 A1, US2005143787A1|
|Inventores||Birinder Boveja, Angely Widhany|
|Cesionario original||Boveja Birinder R., Angely Widhany|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (39), Citada por (116), Clasificaciones (22), Eventos legales (1)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
This application is a continuation of application Ser. No. 10/841,995 filed May 8, 2004, entitled “METHOD AND SYSTEM FOR MODULATING THE VAGUS NERVE (10th CRANIAL NERVE) WITH ELECTRICAL PULSES USING IMPLANTED AND EXTERNAL COMPONANTS, TO PROVIDE THERAPY FOR NEUROLOGICAL AND NEUROPSYCHIATRIC DISORDERS”, which is a continuation of application Ser. No. 10/196,533 filed Jul. 16, 2002, which is a continuation of Ser. No. 10/142,298 filed on May 9, 2002. The prior applications being incorporated herein in entirety by reference, and priority is claimed from these applications.
The present invention relates to electrical stimulation with implanted medical device, more specifically to neuromoduation of vagus nerve(s) with rechargeable implantable pulse generator, to provide therapy for neurological, neuropsychiatric, and other medical disorders.
Implantable neuromodulation systems are known in the art. This patent application is directed to novel method and system for increasing the useful service life of nerve stimulators which are used for applications that can be demanding on the power source. The implantable neurostimulation system for modulating vagus nerve(s) is used to provide therapy for neurological, neuropsychiatric, and other medical disorders such as obesity, and certain cardiac disorders such as atrial fibrillation and congestive heart failure (CHF). Vagus nerve neuromodulation systems generally fall into two categories, RF coupled devices and implantable pulse generators (IPG).
U.S. Pat. No. 6,205,359 (Boveja), U.S. Pat. No. 6,356,788 (Boveja), U.S. Pat. No. 6,208,902 (Boveja), U.S. Pat. No. 6,269,270 (Boveja), U.S. Pat. No. 6,611,715 (Boveja), and U.S. Pat. No. 6,668,191 (Boveja) are generally directed to neuromodulating vagus nerve(s) with an RF coupled device. U.S. Patents, U.S. Pat. No. 4,702,254 (Zabara), U.S. Pat. No. 5,023,807 (Zabara), and U.S. Pat. No. 4,867,164 (Zabra) are generally directed to neuromodulation of vagus nerve, preferably using an implanted pulse generator (IPG).
The prior art IPG devices are similar to cardiac pacemakers, and have been adapted to deliver pulses at higher frequencies than cardiac pacemakers. In cardiac pacing, pulses are typically delivered at a rate of approximately one Hz (generally 50-70 beats per min.). In contrast, pulses to vagus nerve(s) are typically delivered at frequency of about 20-50 Hz. Electrical pulsed neuromodulation of vagus nerve(s) can be very demanding for an implantable power source. It would be desirable to have an implantable pulse generator comprising a rechargeable power source, such as rechargeable Li-ion battery or re-chargeable Li-ion polymer battery.
This patent application discloses two embodiments of implantable pulse generator comprising rechargeable batteries. Even a rechargeable implanted pulse generator does not have an indefinite life, therefore in order to enhance the service life, in one embodiment the implanted pulse generator may comprise stimulus-receiver means, and a pulse generator means with rechargeable battery. The implanted pulse generator of this embodiment is also adapted to function in conjunction with an external stimulator. In another embodiment, the implanted pulse generator is adapted to be rechargeable, utilizing inductive coupling with an external recharger. Existing vagal nerve stimulators may also be adapted to be used with rechargeable power sources as disclosed herein.
The 10th cranial nerve or the vagus nerve plays a role in mediating afferent information from visceral organs to the brain. The vagus nerve arises directly from the brain, but unlike the other cranial nerves extends well beyond the head. At its farthest extension it reaches the lower parts of the intestines. The vagus nerve provides an easily accessible, peripheral route to modulate central nervous system (CNS) function. Observations on the profound effect of electrical stimulation of the vagus nerve on central nervous system (CNS) activity extends back to the 1930's.
The present invention is primarily directed to a method and system for selective electrical stimulation and/or blocking or neuromodulation of vagus nerve, for providing adjunct therapy for neurological and neuropsychiatric disorders comprises at least one of epilepsy, partial complex epilepsy, generalized epilepsy, and involuntary movement disorders such as in Parkinson's disease, depression, bipolar depression, schizophrenia, anxiety disorders, neurogenic/psycogenic pain, compulsive eating disorders, obesity, obsessive compulsive disorders, dementia including Alzheimer's disease, sleep disorders, learning difficulties, migraines and cardiac disorders such as atrial fibrillation and congestive heart failure(CHF).
In the human body there are two vagal nerves (VN), the right VN and the left VN. Each vagus nerve is encased in the carotid sheath along with the carotid artery and jugular vein. The innervation of the right and left vagus nerves is different. The innervation of the right vagus nerve is such that stimulating it results in profound bradycardia (slowing of the heart rate). The left vagus nerve has some innervation to the heart, but mostly innervates the visceral organs such as the gastrointestinal tract. It is known that stimulation of the left vagus nerve does not cause substantial slowing of the heart rate or cause any other significant deleterious side effects.
One of the fundamental features of the nervous system is its ability to generate and conduct electrical impulses. Most nerves in the human body are composed of thousands of fibers of different sizes. This is shown schematically in
In a cross section of peripheral nerve it is seen that the diameter of individual fibers vary substantially, as is also shown schematically in
The diameters of group A and group B fibers include the thickness of the myelin sheaths. Group A is further subdivided into alpha, beta, gamma, and delta fibers in decreasing order of size. There is some overlapping of the diameters of the A, B, and C groups because physiological properties, especially in the form of the action potential, are taken into consideration when defining the groups. The smallest fibers (group C) are unmyelinated and have the slowest conduction rate, whereas the myelinated fibers of group B and group A exhibit rates of conduction that progressively increase with diameter.
Nerve cells have membranes that are composed of lipids and proteins (shown schematically in
The lipid component of the membrane is a double sheet of phospholipids, elongated molecules with polar groups at one end and the fatty acid chains at the other. The ions that carry the currents used for neuronal signaling are among these water-soluble substances, so the lipid bilayer is also an insulator, across which membrane potentials develop. In biophysical terms, the lipid bilayer is not permeable to ions. In electrical terms, it functions as a capacitor, able to store charges of opposite sign that are attracted to each other but unable to cross the membrane. Embedded in the lipid bilayer is a large assortment of proteins. These are proteins that regulate the passage of ions into or out of the cell. Certain membrane-spanning proteins allow selected ions to flow down electrical or concentration gradients or by pumping them across.
These membrane-spanning proteins consist of several subunits surrounding a central aqueous pore (shown in
A nerve cell can be excited by increasing the electrical charge within the neuron, thus increasing the membrane potential inside the nerve with respect to the surrounding extracellular fluid. As shown in
To stimulate an excitable cell, it is only necessary to reduce the transmembrane potential by a critical amount. When the membrane potential is reduced by an amount ΔV, reaching the critical or threshold potential (TP); Which is shown in
For a stimulus to be effective in producing an excitation, it must have an abrupt onset, be intense enough, and last long enough. These facts can be drawn together by considering the delivery of a suddenly rising cathodal constant-current stimulus of duration d to the cell membrane as shown in
Cell membranes can be reasonably well represented by a capacitance C, shunted by a resistance R as shown by a simplified electrical model in diagram 5C, and shown in a more realistic electrical model in
When the stimulation pulse is strong enough, an action potential will be generated and propagated. As shown in
A single electrical impulse passing down an axon is shown schematically in
The information in the nervous system is coded by frequency of firing rather than the size of the action potential. This is shown schematically in
In terms of electrical conduction, myelinated fibers conduct faster, are typically larger, have very low stimulation thresholds, and exhibit a particular strength-duration curve or respond to a specific pulse width versus amplitude for stimulation, compared to unmyelinated fibers. The A and B fibers can be stimulated with relatively narrow pulse widths, from 50 to 200 microseconds (μs), for example. The A fiber conducts slightly faster than the B fiber and has a slightly lower threshold. The C fibers are very small, conduct electrical signals very slowly, and have high stimulation thresholds typically requiring a wider pulse width (300-1,000 μs) and a higher amplitude for activation. Because of their very slow conduction, C fibers would not be highly responsive to rapid stimulation. Selective stimulation of only A and B fibers is readily accomplished. The requirement of a larger and wider pulse to stimulate the C fibers, however, makes selective stimulation of only C fibers, to the exclusion of the A and B fibers, virtually unachievable inasmuch as the large signal will tend to activate the A and B fibers to some extent as well.
As shown in
TABLE 1 Conduction Fiber Fiber Velocity Diameter Type (m/sec) (μm) Myelination A Fibers Alpha 70-120 12-20 Yes Beta 40-70 5-12 Yes Gamma 10-50 3-6 Yes Delta 6-30 2-5 Yes B Fibers 5-15 <3 Yes C Fibers 0.5-2.0 0.4-1.2 No
The modulation of nerve in the periphery, as done by the body, in response to different types of pain is illustrated schematically in
Vagus nerve stimulation with or without blocking, as performed by the system and method of the current patent application, is a means of directly affecting central function.
The vagus nerve is composed of somatic and visceral afferents and efferents. Usually, nerve stimulation activates signals in both directions (bi-directionally). It is possible however, through the use of special electrodes and waveforms, to selectively stimulate a nerve in one direction only (unidirectionally). The vast majority of vagus nerve fibers are C fibers, and a majority are visceral afferents having cell bodies lying in masses or ganglia in the skull.
In considering the anatomy, the vagus nerve spans from the brain stem all the way to the splenic flexure of the colon. Not only is the vagus the parasympathetic nerve to the thoracic and abdominal viscera, it also the largest visceral sensory (afferent) nerve. Sensory fibers outnumber parasympathetic fibers four to one. In the medulla, the vagal fibers are connected to the nucleus of the tractus solitarius (viceral sensory), and three other nuclei. The central projections terminate largely in the nucleus of the solitary tract, which sends fibers to various regions of the brain (e.g., the thalamus, hypothalamus and amygdala).
As shown in
In the neck, the vagus lies in a groove between the internal jugular vein and the internal carotid artery. It descends vertically within the carotid sheath, giving off branches to the pharynx, larynx, and constrictor muscles. From the root of the neck downward, the vagus nerve takes a different path on each side of the body to reach the cardiac, pulmonary, and esophageal plexus (consisting of both sympathetic and parasympathetic axons). From the esophageal plexus, right and left gastric nerves arise to supply the abdominal viscera as far caudal as the splenic flexure.
In the body, the vagus nerve regulates viscera, swallowing, speech, and taste. It has sensory, motor, and parasympathetic components. Table two below outlines the innervation and function of these components.
TABLE 2 Vagus Nerve Components Component fibers Structures innervated Functions SENSORY Pharynx. larynx, General sensation esophagus, external ear Aortic bodies, aortic arch Chemo- and baroreception Thoracic and abdominal viscera MOTOR Soft palate, pharynx, Speech, swallowing larynx, upper esophagus PARA- Thoracic and abdominal Control of cardiovascular SYMPATHETIC viscera system, respiratory and gastrointestinal tracts
On the Afferent side, visceral sensation is carried in the visceral sensory component of the vagus nerve. As shown in
The afferent fibers project primarily to the nucleus of the solitary tract (shown schematically in
U.S. Pat. Nos. 4,702,254, 4,867,164 and 5,025,807 (Zabara) generally disclose animal research and experimentation related to epilepsy and the like. Applicant's method of neuromodulation is significantly different than that disclosed in Zabara '254, '164’ and '807 patents.
U.S. Pat. No. 5,299,569 (Wernicke et al.) is directed to the use of implantable pulse generator technology for treating and controlling neuropsychiatric disorders including schizophrenia, depression, and borderline personality disorder.
U.S. Pat. No. 6,205,359 B1 (Boveja) and U.S. Pat. No. 6,356,788 B2 (Boveja) are directed to adjunct therapy for neurological and neuropsychiatric disorders using an implanted lead-receiver and an external stimulator.
U.S. Pat. No. 5,807,397 (Barreras) is directed to an implantable stimulator with replenishable, high value capacitive power source.
U.S. Pat. No. 5,193,539 (Schulman, et al) is generally directed to an addressable, implantable microstimulator that is of size and shape which is capable of being implanted by expulsion through a hypodermic needle. In the Schulman patent, up to 256 microstimulators may be implanted within a muscle and they can be used to stimulate in any order as each one is addressable, thereby providing therapy for muscle paralysis.
U.S. Pat. No. 6,553,263B1 (Meadows et al.) is generally directed to an implantable pulse generator system for spinal cord stimulation, which includes a rechargeable battery. In the Meadows '263 patent there is no disclosure or suggestion for combing a stimulus-receiver module to an implantable pulse generator (IPG) for use with an external stimulator, for providing modulating pulses to vagal nerve(s), as in the applicant's disclosure.
U.S. Pat. No. 6,505,077 B1 (Kast et al.) is directed to electrical connection for external recharging coil. In the Kast '077 disclosure, a magnetic shield is required between the externalized coil and the pulse generator case. In one embodiment of the applicant's disclosure, the externalized coil is wrapped around the pulse generator case, without requiring a magnetic shield.
U.S. Pat. No. 6,622,041 B2 (Terry, Jr. et al.) is directed to treatment of congestive heart failure and autonomic cardiovascular drive disorders using implantable neurostimulator.
Method and system of the current invention provides vagal nerve(s) neuromodulation to provide therapy for at least one of epilepsy, partial complex epilepsy, generalized epilepsy, and involuntary movement disorders such as in Parkinson's disease, depression, bipolar depression, schizophrenia, anxiety disorders, neurogenic/psycogenic pain, compulsive eating disorders, obesity, obsessive compulsive disorders, dementia including Alzheimer's disease, sleep disorders, learning difficulties, migraines and cardiac disorders such as atrial fibrillation and congestive heart failure(CHF). The method and system comprises both implantable and external components.
In one aspect of the invention, the method and system for modulating vagal nerve(s) comprises implantable pulse generator with rechargeable battery, and battery charging circuitry. The charging of the implantable battery being performed by an external charger via an inductive link.
In another aspect of the invention, one embodiment of the implanted pulse generator comprises, a stimulus-receiver module that can be used in conjunction with an external stimulator, and an implanted pulse generator module with rechargeable battery.
In another aspect of the invention the implantable pulse generator with rechargeable battery is connected to an implanted lead with at least two electrodes for providing stimulation and/or blocking pulses to vagal nerve(s).
In another aspect of the invention, the recharge coil is externalized from the titanium case and is wrapped around the titanium case in an epoxy header, thereby eliminating the need for a magnetic shield.
In another aspect of the invention, the recharge coil is also used for bi-directional telemetry.
In another aspect of the invention, the rechargeable battery comprises at least one of lithium-ion, lithium-ion polymer battery.
In another aspect of the invention, the lead comprises at least two electrodes which are made of one from a group consisting of platinum, platinum/iridium alloy, platinum/iridium alloy coated with titanium nitride, and carbon.
In another aspect of the invention, the selective stimulation and/or blocking to vagus nerve(s) may be anywhere along the length of the nerve, for example such stimulation may be at the cervical level or at a level near the diaphragm.
In another aspect of the invention, the stimulation and/or blocking may be unilateral or bilateral.
In another aspect of the invention, the implanted lead body may be made of a material selected from the group consisting of polyurethane, silicone, and silicone with polytetrafluoroethylene.
In yet another aspect of the invention, the implanted lead comprises at least two electrodes selected from the group consisting of spiral electrodes, cuff electrodes, steroid eluting electrodes, wrap-around electrodes, and hydrogel electrodes.
Various other features, objects and advantages of the invention will be made apparent from the following description taken together with the drawings.
For the purpose of illustrating the invention, there are shown in accompanying drawing forms which are presently preferred, it being understood that the invention is not intended to be limited to the precise arrangement and instrumentalities shown.
In the method and system of this invention, electrical pulses for stimulation and/or blocking are applied to vagus nerve(s) for afferent neuromodulation. An implantable lead is surgically implanted in the patient. The vagus nerve(s) is/are surgically exposed and isolated, the electrodes on the distal end of the lead are wrapped around the vagus nerve(s), and the proximal end of the lead is tunneled subcutaneously. A pulse generator means is connected to the proximal end of the lead, and surgically implanted in a subcutaneous or submuscular pocket.
Shown in conjunction with
Each parameter may be individually programmed and stored in memory. The range of programmable electrical stimulation parameters are shown in table 3 below.
TABLE 3 Programmable electrical parameter range PARAMER RANGE Pulse Amplitude 0.1 Volt-10 Volts Pulse width 20 μS-5 mSec. Frequency 3 Hz-300 Hz On-time 5 Secs-24 hours Off-time 5 Secs-24 hours Ramp ON/OFF
The pulses delivered to the nerve tissue for stimulation therapy are shown graphically in
Because of the rapidity of the pulses required for modulating nerve tissue 54 (unlike cardiac pacing), there is a real need for power sources that will provide an acceptable service life under conditions of continuous delivery of high frequency pulses.
For the practice of the current invention, two embodiments of implantable pulse generators may be used. Both embodiments comprise re-chargeable power sources, such as Lithium-ion polymer battery.
In one embodiment, the implanted device comprises a stimulus-receiver module and a pulse generator module. Advantageously, this embodiment provides an ideal power source, since the power source can be an external stimulator coupled with an implanted stimulus-receiver, or the power source can be from the implanted rechargeable battery. Shown in conjunction with
In this embodiment, as disclosed in
The system of this embodiment provides a power sense circuit 728 that senses the presence of external power communicated with the power control 730, when adequate and stable power is available from an external source. The power control circuit controls a switch 736 that selects either implanted battery power 740 or conditioned external power from 726. The logic and control section 732 and memory 744 includes the IPG's microcontroller, pre-programmed instructions, and stored changeable parameters. Using input for the telemetry circuit 742 and power control 730, this section controls the output circuit 734 that generates the output pulses.
Shown in conjunction with
The stimulus-receiver portion of the circuitry is shown in conjunction with
In another embodiment, existing nerve stimulators and cardiac pacemakers can be modified to incorporate rechargeable batteries. Among the nerve stimulators that can be adopted with rechargeable batteries can for example be the vagus nerve stimulator manufactured by Cyberonics Inc. (Houston, Tex.). U.S. Pat. No. 4,702,254 (Zabara), U.S. Pat. No. 5,023,807 (Zabara), and U.S. Pat. No. 4,867,164 (Zabara) on Neurocybernetic Prostheses, which can be practiced with rechargeable power source as disclosed in the next section. These patents are incorporated herein by reference.
As shown in conjunction with
In one embodiment, the coil may also be positioned on the titanium case as shown in conjunction with
A schematic diagram of the implanted pulse generator (IPG 391 R), with re-chargeable battery 694, is shown in conjunction with
The operating power for the IPG 391 R is derived from a rechargeable power source 694. The rechargeable power source 694 comprises a rechargeable lithium-ion or lithium-ion polymer battery. Recharging occurs inductively from an external charger to an implanted coil 48B underneath the skin 60. The rechargeable battery 694 may be recharged repeatedly as needed. Additionally, the IPG 391R is able to monitor and telemeter the status of its rechargable battery 691 each time a communication link is established with the external programmer 85.
Much of the circuitry included within the IPG 391 R may be realized on a single application specific integrated circuit (ASIC). This allows the overall size of the IPG 391 R to be quite small, and readily housed within a suitable hermetically-sealed case. The IPG case is preferably made from a titanium and is shaped in a rounded case.
Shown in conjunction with
A simplified block diagram of charge completion and misalignment detection circuitry is shown in conjunction with
The indicator 706 may similarly be used as a misalignment indicator. In normal operation, when coils 46B (external) and 48B (implanted) are properly aligned, the voltage VS sensed by voltage detector 704 is at a minimum level because maximum energy transfer is taking place. If and when the coils 46B and 48B become misaligned, then less than a maximum energy transfer occurs, and the voltage VS sensed by detection circuit 704 increases significantly. If the voltage VS reaches a predetermined level, alignment indicator 706 is activated via an audible speaker and/or LEDs for visual feedback. After adjustment, when an optimum energy transfer condition is established, causing VS to decrease below the predetermined threshold level, the alignment indicator 706 is turned off.
The elements of the external recharger are shown as a block diagram in conjunction with
As also shown in
Since another key concept of this invention is to deliver afferent stimulation, in one aspect efferent stimulation of selected types of fibers may be substantially blocked, utilizing the “greenwave” effect. In such a case, as shown in conjunction with
In one aspect of the invention, the pulsed electrical stimulation and/or blocking to the vagus nerve(s) may be provided anywhere along the length of the vagus nerve(s). As was shown earlier in conjunction with
Referring now to
TABLE 4 Lead design variables Conductor Proximal (connecting Distal End Lead body- proximal End Lead Insulation and distal Electrode - Electrode - Terminal Materials Lead-Coating ends) Material Type Linear Polyurethane Antimicrobial Alloy of Pure Spiral bipolar coating Nickel- Platinum electrode Cobalt Bifurcated Silicone Anti- Platinum- Wrap-around Inflammatory Iridium electrode coating (Pt/Ir) Alloy Silicone with Lubricious Pt/Ir coated Steroid Polytetrafluoroethylene coating with Titanium eluting (PTFE) Nitride Carbon Hydrogel electrodes Cuff electrodes
Once the lead is fabricated, coating such as anti-microbial, anti-inflammatory, or lubricious coating may be applied to the body of the lead.
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|Clasificación de EE.UU.||607/45|
|Clasificación internacional||A61N1/36, A61N1/08, A61N1/362, A61N1/34, A61N1/40|
|Clasificación cooperativa||A61N1/36071, A61N1/3627, A61N1/40, A61N1/36082, A61N1/08, A61N1/36114, A61N1/36007|
|Clasificación europea||A61N1/36Z3J, A61N1/08, A61N1/40, A61N1/36, A61N1/36B, A61N1/36Z3C, A61N1/36Z, A61N1/36Z3E, A61N1/362C|
|14 Sep 2006||AS||Assignment|
Owner name: NEURO AND CARDIAC TECHNOLOGIES, LLC, WISCONSIN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BOVEJA, BIRINDER R.;WIDHANY, ANGELY;REEL/FRAME:018728/0352;SIGNING DATES FROM 20060911 TO 20060914