Advanced Bionics Corporation

Boston Scientific Neuromodulation Corporation

Alfred E. Mann Foundation for Scientific Research

Other

Alfred E. Mann Foundation for Scientific Research and Advanced Bionics

Carla M Mann

Paul Milton Meadows

Todd K Whitehurst

James P McGivern

Janusz A Kuzma

Joseph H Schulman

Anne Margaret Pianca

Joey Y Chen

Hisashi Tsukamoto

Gerald E Loeb

Tom Xiaohai He

Michael Dogali

David K L Peterson

Michael Allen Faltys

Lee Jay Mandell

Grace Ying Yang Jang

Frances J R Richmond

Kenny Kinyen Chinn

Stephen L Goldman

Donald L Sandford

Larry D Devor

David Karl-Lee Peterson

Francis J R Richmond

Various embodiments of a burr hole plug assembly offer significant improvements for allowing lead and/or cannula access through a burr hole drilled through a patient's skull in connection with a Deep Brain Stimulation system, and subsequent sealing of such burr hole. The various burr hole plug assemblies described: (a) accommodate various burr hole sizes and provide a secure fit in the burr hole; (b) accommodate various locations for lead positioning and adjustment; (c) allow the lead to remain in a static position when the burr hole plug assembly is placed; (d) protect the lead from fracture at the exit location of the plug; (e) remain flush with the skull to avoid skin erosion and to eliminate unsightly flange protrusion from the patients' skull; (f) adequately hold the lead in place over time; and (g) provide a selection of various types of burr hole plug assemblies and sizes for use by the implanting surgeon, thereby eliminating the need for surgeons to resort to custom plugs and plug assemblies made in the operating room specifically to fit a given patient.

Cranial sealing plug

An implantable stimulator(s), small enough to be located near or adjacent to an autonomic nerve(s) innervating urinary and/or gastrointestinal structures, uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, if necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.

Fully implantable neurostimulator for autonomic nerve fiber stimulation as a therapy for urinary and bowel dysfunction

An implantable medical device, such as an implantable pulse generator (IPG) used with a spinal cord stimulation (SCS) system, includes a rechargeable lithium-ion battery having an anode electrode with a substrate made substantially from titanium. Such battery construction allows the rechargeable battery to be discharged down to zero volts without damage to the battery. The implantable medical device includes battery charging and protection circuitry that controls the charging of the battery so as to assure its reliable and safe operation.

Implantable pulse generators using rechargeable zero-volt technology lithium-ion batteries

A full-body charger for charging one or more battery-powered devices wherein such devices are configured for implanting beneath a patient's skin for the purpose of tissue, e.g., nerve or muscle, stimulation and/or parameter monitoring and/or data communication. Devices in accordance with the invention include a support structure, typically chair-shaped or bed-shaped, capable of supporting a patient's body while providing a magnetic field to one or more of the implanted devices using one or more coils mounted within for providing power to the implanted devices. Consequently, in a preferred embodiment, a single, generally sequential, charging cycle can charge all of the implanted devices and thus minimize the charge time requirements for a patient and accordingly improve the patient's life style.

Full-body charger for battery-powered patient implantable device

Leads and introduction tools are proposed for deep brain stimulation and other applications. Some embodiments of the present invention provide lead designs with which may be placed with a stylet, while others do not require a stylet. Some lead embodiments use standard wire conductors, while others use cable conductors. Several embodiments incorporate microelectrodes and/or microelectrode assemblies. Certain embodiments of the present invention provide introduction tools, such as cannula and/or cannula systems, which ensure proper placement of, e.g., leads.

Systems and methods of implanting a lead for brain stimulation

A method and system for treatment of incontinence, urgency, frequency, and/or pelvic pain includes implantation of electrodes on a lead or the discharge portion of a catheter adjacent the perineal nerve(s) or tissue(s) to be stimulated. Stimulation pulses, either electrical or drug infusion pulses, are supplied by a stimulator implanted remotely, and through the lead or catheter, which is tunneled subcutaneously between the stimulator and stimulation site. For instance, the system and method reduce or eliminate the incidence of unintentional episodes of bladder emptying by stimulating nerve pathways that diminish involuntary bladder contractions, improve closure of the bladder outlet, and/or improve the long-term health of the urinary system by increasing bladder capacity and period between emptying. Moreover, the system and method allow a patient to be taught to receive one or more patterns of neural stimulation that can be prescribed by a physician and administered without continuous oversight by a clinical practitioner.

Implantable stimulator methods for treatment of incontinence and pain

A deep brain stimulation (DBS) system () provides a multiplicity of stimulation channels through which stimulation may be delivered deep within the brain of the patient. The DBS system is powered by a rechargeable battery (). In one embodiment, the system has four channels driving sixteen electrodes (). The DBS system is easily programmed for use by a clinician using a clinician programming system (), and further affords a simple but highly advanced hand held programmer () control interface through which the patient may easily change stimulation parameters within acceptable limits. The DBS system () includes a small, implantable pulse generator () that is small enough to be implanted directly in the cranium of the patient, thereby eliminating the long lead wires and tunneling procedures that have been used in the past. Further, the DBS system allows up to two electrode arrays (') to be attached to the implantable pulse generator (), thereby eliminating the requirement for implanting two independent implantable pulse generators for bilateral stimulation of deep brain structures.

Deep brain stimulation system for the treatment of Parkinson's Disease or other disorders

An implantable stimulator(s), small enough to be located near or within an area of the spine responsible for sensations in a region experiencing chronic pain uses a power source/storage device, such as a rechargeable battery. Periodic recharging of such a power source/storage device is accomplished, for example, by inductive coupling with an external appliance. The small stimulator provides a means of stimulating a nerve(s) or other tissue when desired, without the need for external appliances during the stimulation session. When necessary, external appliances are used for the transmission of data to and/or from the stimulator(s) and for the transmission of power, it necessary. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one implant includes at least one sensor, and the sensed condition is used to adjust stimulation parameters.

Fully implantable microstimulator for spinal cord stimulation as a therapy for chronic pain

A method and system for treatment of incontinence and/or pelvic pain includes the injection or laparoscopic implantation of one or more battery- or radio frequency-powered microstimulators ( ) beneath the skin of the perineum and/or adjacent the tibial nerve. The devices are programmed using radio-frequency control via an external controller ( )) that can be used by a physician to produce patterns of output stimulation pulses judged to be efficacious by appropriate clinical testing to diminish symptoms. The stimulation program is retained in the microstimulator device ( ) or external controller ( ) and is transmitted when commanded to start and stop by a signal from the patient or caregiver. The system and method reduce the incidence of unintentional episodes of bladder emptying by stimulating nerve pathways ( ) that diminish involuntary bladder contractions, improve closure of the bladder outlet, and/or improve the long-term health of the urinary system by increasing bladder capacity and period between emptying. The incidence of fecal incontinence is similarly reduced or eliminated. Furthermore, the system and method reduce or eliminate the incidence of pelvic pain by chronically stimulating nerve pathways that derive from the sacral roots using a miniature implantable neurostimulator that can be implanted with a minimal surgical procedure. Moreover, the system and method allow a patient to be taught to receive one or more patterns of neural stimulation that can be prescribed by a physician and administered without continuous oversight by a clinical practitioner.

Implantable stimulator system and method for treatment of incontinence and pain

A neural stimulation system allows the magnitude of electrical stimuli generated by the system to be programmed to a desired level greater than or equal to a minimum perceived threshold and less than or equal to a maximum tolerable perceived threshold. The electrical stimuli are applied through selected groupings of individual electrode contacts of a multi-electrode-contact electrode array attached to pulse generation circuitry as either cathodes or anodes. The electrode array is implanted so that the individual electrode contacts are in contact with the body tissue to be stimulated. Stimulating electrical current pulses, defined by a prescribed set of stimulus parameters are generated and applied to the selected electrode contacts so as to flow from the anode electrodes to the cathode electrodes. The perceived magnitude of the applied stimuli is equalized in order to enable quick, automated, and/or interactive programming of the values of the stimulation parameters.

Magnitude programming for implantable electrical stimulator

An insertion needle facilitates the implantation of an electrode array carried on a flexible, foldable or compressible, subcarrier or substrate. Such subcarrier or substrate folds or compresses during implantation, thereby facilitating its insertion using the insertion needle. Once implanted, such subcarrier or substrate expands, thereby placing the electrodes in a desired spaced-apart positional relationship, and thus achieving a desired electrode array configuration. The insertion needle has a lumen with a non-circular cross-sectional shape, e.g., having a width greater than its height, to facilitate sliding the folded or compressed paddle-type electrode array therein, and further includes a longitudinal slit.

Insertion needle for use with implantable, expandable, multicontact electrodes

A patient and/or a clinician may program an implant device, e.g., an implanted spinal cord stimulator (SCS), through the use of a programming computer, or clinician programmer, linked with the implant device so that the paresthesia resulting from an applied electrical stimulus pattern is adjusted or programmed so as to match the area of perceived pain or other need. Data is initially stored in the computer that relates to known information regarding the anatomical relationships between the spine and the body. The body is divided into dermatomes and/or subdivisions of dermatomes, and a representation of the body, including its dermatomes and/or subdivisions of dermatomes are displayed on the screen (or other display device) associated with the computer. The patient moves a cursor over the regions of the body displayed on the computer screen to select the region of pain, or a region of paresthesia, by a click of a mouse or the press of a button. The patient may select as many dermatomes or body segments/regions/subdivisions as necessary to communicate the area of pain or paresthesia to the computer. The computer uses the patient-provided information, as well as the pre-programmed data therein, to quickly zero in on an electrode combination and appropriate stimulus parameters that create a match (or as close of a match as is possible) between the pain region and the paresthesia region.

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Los Angeles, CA, United States of America

Carla M Mann