Modular Limb Peripheral Nerve Stimulation System and Method of Use
First Claim
1. A method of limb peripheral nerve stimulation for a patient, comprising:
- gaining access to a peripheral nerve;
positioning a stimulation electrode adjacent the peripheral nerve, the electrode extending from a lead, the lead releasably coupled to a passive receiver stimulator;
implanting the passive receiver and lead into the patient;
providing an external pulse generator capable of communicating a pulse to the passive receiver through the patient'"'"'s skin; and
energizing the external pulse generator thereby actuating the passive receiver to energize the stimulation electrode positioned adjacent the peripheral nerve evaluating the efficacy of stimulation during a first nerve stimulation stage utilizing the passive receiver stimulator;
accessing the lead; and
coupling an implantable pulse generator to the lead, the implantable pulse generator including a power source and control system to independently energize the stimulation electrode positioned adjacent the peripheral nerve during a second nerve stimulation stage.
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Accused Products
Abstract
The present disclosure provides a modular neurostimulator system. The system includes a stage one implant that can be externally powered and controlled. The stage one implant is made of one or more leads as well as a passive receiver and an external controlling and powering device. The receiver and the external device can be utilized either as a long-term trial system, or as a permanent system. Since the receiver and the external device can have limited costs and features, they are suited for a long-term trial without risk of infection and excessive upfront cost. The system may also include a stage two implant that includes an implantable power supply and/or control elements connectable to one or more previously implanted stage one implants. A method of treatment for limb peripheral nerves using such a modular system is also disclosed.
99 Citations
40 Claims
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1. A method of limb peripheral nerve stimulation for a patient, comprising:
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gaining access to a peripheral nerve; positioning a stimulation electrode adjacent the peripheral nerve, the electrode extending from a lead, the lead releasably coupled to a passive receiver stimulator; implanting the passive receiver and lead into the patient; providing an external pulse generator capable of communicating a pulse to the passive receiver through the patient'"'"'s skin; and energizing the external pulse generator thereby actuating the passive receiver to energize the stimulation electrode positioned adjacent the peripheral nerve evaluating the efficacy of stimulation during a first nerve stimulation stage utilizing the passive receiver stimulator; accessing the lead; and coupling an implantable pulse generator to the lead, the implantable pulse generator including a power source and control system to independently energize the stimulation electrode positioned adjacent the peripheral nerve during a second nerve stimulation stage. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of peripheral nerve stimulation for a patient, comprising:
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gaining access to a peripheral nerve; positioning a stimulation electrode adjacent the peripheral nerve, the electrode extending from a lead coupled to a passive receiver, the passive receiver having a first length, a first height and a first width defining a first displacement volume; forming a pocket in the patient'"'"'s tissue; implanting the passive receiver in the pocket; closing the pocket; providing an external pulse generator capable of communicating a pulse to the passive receiver through the patient'"'"'s skin to thereby energize the stimulation electrode in a first stage of nerve stimulation; determining efficacy of the stimulation electrode; accessing the pocket; coupling an implantable pulse generator to the lead, the implantable pulse generator including a power source and a controller to control pulse delivered to the stimulation electrode during a second stage of nerve stimulation; implanting the implantable pulse generator in the pocket within substantially the first displacement volume occupied by the passive receiver; and closing the pocket. - View Dependent Claims (13, 14, 15, 16, 17, 18)
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19. A modular stimulation system for staged stimulation of nerves, comprising:
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a plurality of stimulation electrodes; a lead having a distal portion electrically coupled to said plurality of stimulation electrodes and an opposing proximal portion forming a first portion of a detachable coupling assembly; a first stage implantable passive receiver stimulation module having a distal portion forming a second portion of a detachable coupling assembly complimentary to said first portion to electrically couple said passive receiver stimulation module to said lead, said passive receiver stimulation module configured to convert wireless energy to a pulse suitable to energize said plurality of stimulation electrodes; and a second stage implantable pulse generator module having an internal power source and a controller to control delivery of electrical stimulation pulses, said implantable pulse generator module having a distal portion forming a third portion of a detachable coupling assembly complimentary with said first portion to electrically couple said implantable pulse generator to said lead, wherein said passive receiver stimulation module and said implantable pulse generator module are configured to be sequentially coupled to said first portion of the detachable coupling. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26)
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27. A modular neurostimulation system, comprising:
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a plurality of stimulation electrodes; a lead having a distal portion electrically coupled to said plurality of stimulation electrodes and an opposing proximal portion forming a first portion of a detachable coupling assembly; an implantable passive receiver stimulator having a distal portion forming a second portion of a detachable coupling assembly complimentary to said first portion to electrically couple said passive receiver to said lead, said passive receiver configured to convert wireless energy to a pulse suitable to energize said plurality of stimulation electrodes;
said passive receiver including an expansion connection; andan implantable pulse generator having at least an internal power source or a controller to control delivery of electrical stimulation pulses, said implantable pulse generator having a portion forming an expansion coupling assembly complimentary with said expansion connection to electrically couple said implantable pulse generator to said passive receiver stimulator. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34)
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35. A method of treating pain, comprising
implanting a stimulation system adjacent a nerve to relieve nociceptive pain prior to a surgical intervention to correct the injury causing the nociceptive pain; -
stimulating the nerve to relieve nociceptive pain; and operating on a source of the nociceptive pain while the stimulation system remains implanted in the patient. - View Dependent Claims (36, 37, 38)
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39. A method of treating phantom limb pain, comprising:
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implanting a stimulation system adjacent a nerve associated with the intact limb to be amputated; stimulating the nerve with the limb remaining intact; amputating the limb while the stimulation system remains implanted in the patient; and operating the stimulation system to stimulate the nerve associated with the amputated limb. - View Dependent Claims (40)
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Specification