An implantable pulse generator (IPG) system and method for spinal cord stimulation (SCS) are disclosed, incorporating advanced percutaneous lead placement, optical fiber integration, and secure lead coupling. A method is provided for inserting and securing an optical fiber within a stylet channel, ensuring precise optical alignment using a frustoconical centering surface and buffer gap. A percutaneous lead placement method is also disclosed, utilizing a Touhy needle-guided approach, securing leads in the IPG header with anchor screws and ferrule alignment mechanisms. The system further includes an optical threading assembly that facilitates fiber insertion, reducing damage and improving optical signal transmission. These innovations enhance stimulation precision, signal stability, and device longevity, reducing power consumption and noxious stimulation. The disclosed methods improve surgical accuracy and lead retention, optimizing spinal cord therapy by maintaining consistent electrode positioning and optical feedback for dynamic current modulation.
G02B 6/42 - Coupling light guides with opto-electronic elements
H01R 4/30 - Clamped connectionsSpring connections using a screw or nut clamping member
H01R 13/08 - Resiliently-mounted rigid pins or blades
H02J 7/02 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from AC mains by converters
H02J 50/10 - Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling
2.
DEVICE FOR REDUCING MRI RF-INDUCED HEATING IN ACTIVE IMPLANTED MEDICAL DEVICE LEADS
The present invention relates to a device for reducing MRI-induced RF heating in active implantable medical device (AIMD) leads, particularly spinal cord stimulator leads. The device incorporates an air-core transformer to increase inductance within the lead system, significantly reducing RF coupling and localized heating at the electrode-tissue interface during MRI procedures. The transformer features a primary coil formed by the lead and a secondary coil embedded in a biocompatible toroidal bobbin, which doubles as an anchoring mechanism. The bobbin securely holds the lead while maintaining flexibility for implantation. Anchoring is achieved through shape-memory retaining pins that adapt upon deployment, ensuring positional stability. This innovative design enhances MRI compatibility without compromising AIMD functionality, providing a safer and more effective solution for managing chronic pain and other neurological conditions. By addressing both lead stability and RF heating, the device supports safer imaging for AIMD patients.
The invention relates to a system and method for improving spinal cord stimulation (SCS) by simultaneously modulating ascending and descending pain pathways. The invention utilizes a Randomized Intermittent Dichotomous Stimulation (RIDS) paradigm, introducing a randomly timed target stimulation signal interspersed with a background stimulation signal. This novel method enhances the cognitive processing of pain signals by utilizing event-related potentials, such as the P300 brain potential, to activate both inhibitory pathways and minimize pain habituation. The target stimulus, distinct from the background SCS signal, elicits a cognitive response by prompting the patient to recognize the target and perform a physical or mental task. This simultaneous modulation of pain pathways increases treatment efficacy, extends the longevity of SCS therapy, and reduces habituation effects, offering an optimized therapeutic solution for chronic pain management.
This disclosure provides an SCS system comprised of an adaptive IPG. The IPG selectively chooses certain burst pulse parameters according to a pattern of frequencies and amplitudes that are determined by a low power hardware circuit. Alternatively, the patterns of frequencies and amplitudes are dictated by a predetermined list of parameters from a table of limited length. The IPG also is capable of receiving and storing vital sign telemetry, and spinal cord position to train an adaptive neural network to produce paresthesia pulses. Training of the IPG takes place after closing. Retraining the neural network allows the system to adapt to habituation, lead migration, and physiological changes in the patient's condition to maintain efficacy of the system over time. Training the neural network is also accomplished outside the IPG by a separate processor, which serves to conserve battery power and facilitate frequent retraining.
G16H 40/63 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
A percutaneous lead is provided which includes a generally tubular, multi-duct, flexible lead body. The lead body supports a distal set of electrodes and a proximal set of contacts which are connected by conductors in the ducts. The lead body further houses an optical fiber with a side firing section. The side firing section is held adjacent an optical transmission window, integrally formed with the flexible lead body. A cylindrical ferrule is provided to position the fiber in the header of an IPG.
G02B 6/42 - Coupling light guides with opto-electronic elements
H02J 7/02 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from AC mains by converters
H02J 50/10 - Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling
H01R 4/30 - Clamped connectionsSpring connections using a screw or nut clamping member
H01R 13/08 - Resiliently-mounted rigid pins or blades
6.
FULL-DUPLEX IPG SYSTEM AND ELECTRO-OPTICAL PERCUTANEOUS LEAD
The invention provides an IPG and lead configuration which boasts both a novel optical folding assembly and an optical processor assembly which offers the advantages of low heat generation and compact package size. The invention further provides a novel heat dissipation pattern formed in the exterior of the case. The pattern ideally takes the form of closely packed hemispherical indentions on one or more of the top and bottom IPG surfaces.
The system incorporates a feed forward control system which automatically adjusts mean stimulation current to maintain consistent dosing of electrical current applied to the spinal cord despite motion of the spinal cord relative to the epidural electrode array. Optical boundary conditions are captured using a sample and hold circuit when the spinal cord is in its most dorsal position (supine patient position) and most ventral position (prone or sitting positions). Optimal mean stimulation current is manually set for these two ordinal positions during setup. During operation, the mean current is actively modulated by interpolating the mean current between the two current boundary conditions using a nominally inverse linear relation to the instantaneous optical reflectance which is bounded by the optical boundary conditions.
The system incorporates a feed forward control system which automatically adjusts mean stimulation current to maintain consistent dosing of electrical current applied to the spinal cord despite motion of the spinal cord relative to the epidural electrode array. Optical boundary conditions are captured using a sample and hold circuit when the spinal cord is in its most dorsal position (supine patient position) and most ventral position (prone or sitting positions). Optimal mean stimulation current is manually set for these two ordinal positions during setup. During operation, the mean current is actively modulated by interpolating the mean current between the two current boundary conditions using a nominally inverse linear relation to the instantaneous optical reflectance which is bounded by the optical boundary conditions.
In the present invention, an IPG incorporates electrical resistivity monitoring with a reflectometry trigger. The IPG is configured to determine both optically and electrically if migration occurs between the electrodes. If the light intensity variation in the optical trigger is greater than an optical threshold value, then the system will pause stimulation and conduct a resistivity test. A resistivity test is also conducted periodically in the absence of the reflectometry trigger to verify that no lead migration has occurred. The stimulation signal is automatically adjusted if a variation in resistivity values is detected above a resistivity threshold value. The resistivity threshold value is set above the normal variation that occurs due to routine movement of the spinal cord in the spinal canal.
The invention provides an IPG and lead configuration which boasts both a novel optical folding assembly and an optical processor assembly which offers the advantages of low heat generation and compact package size. The surgical leads provided offer additional advantages over the prior art including integral formation of optical and electrical components in a compact size. The invention further provides processing advantages which measure and compensate for degradation in the optical system over time.
The invention provides an EPG system and lead configuration which boasts both a novel optical folding assembly and compact package size. The percutaneous leads provided offer additional advantages over the prior art including integral formation of optical and electrical components in a compact size.
The invention provides an IPG and lead configuration which boasts both a novel optical folding assembly and an optical processor assembly which offers the advantages of low heat generation and compact package size. The surgical leads provided offer additional advantages over the prior art including integral formation of optical and electrical components in a compact size. The invention further provides processing advantages which measure and compensate for degradation in the optical system over time.
The invention provides an IPG and lead configuration which boasts both a novel optical folding assembly and an optical processor assembly which offers the advantages of low heat generation and compact package size. The surgical leads provided offer additional advantages over the prior art including integral formation of optical and electrical components in a compact size. The invention further provides processing advantages which measure and compensate for degradation in the optical system over time.
The invention provides an EPG system and lead configuration which boasts both a novel optical folding assembly and compact package size. The percutaneous leads provided offer additional advantages over the prior art including integral formation of optical and electrical components in a compact size. The operative components of the system comprise optical folding assembly, optically aligned with leads. Optical folding assembly directs optical signals from leads to optical signal processor. Optical signal processor is operatively connected to main processor, which controls the functions of the EPG.
A connector system is provided for a positional sensitive spinal cord stimulation apparatus using reflectometry which incorporates the ability to connect to current IPG's either in a percutaneous or laminectomy form and which utilizes a novel light to frequency converter to generate a stimulation voltage in wave form to effect spinal cord stimulation.
The Randomized Intermittent Dichotomous Stimulation (RIDS) paradigm disclosed provides an alternate stimulus for the patient to attend to, besides the typical SCS signal, thus providing a somatotopically-matched non-noxious stimulus to replace the cognitive attention to the nociceptive stimulus. The randomly intermittent stimulus is paired with an implicit virtual task to reinforce selective attention to the non-noxious stimulus.
The invention described is comprised of a system and method for rapid fixation of a lead anchor. The system includes a lead anchor and insertion device. The insertion device houses a lead anchor. A lead is threaded through the insertion device and the device is depressed against the fascia to insert the lead anchor and fix the lead in the desired position. This method produces repeatable amount of lead body compression grasp force, and controlled bend radius. This results in rapid lead anchoring, lowers the risk of lead migration, prevents mechanical damage to the lead due to over-compression and eliminates the need for tying a suture.
An implantable pulse generator is provided comprising a non-metallic shell adjacent a header. The header abuts an optical window in the shell. The header aligns a series of surgical or percutaneous leads with the optical window. The leads incorporate optical fibers, electrodes and contacts which distribute stimulation signals. Behind the optical window, a set of optical devices is provided which transmit or receive light from the fibers. Signal processors are provided to interpret the signals from the optical fibers, and to mitigate a continuous inductive charging function.
An implantable pulse generator is provided comprising a non-metallic shell adjacent a header. The header abuts an optical window in the shell. The header aligns a series of surgical or percutaneous leads with the optical window. The leads incorporate optical fibers, electrodes and contacts which distribute stimulation signals. Behind the optical window, a set of optical devices is provided which transmit or receive light from the fibers. Signal processors are provided to interpret the signals from the optical fibers, and to mitigate a continuous inductive charging function.
G02B 6/42 - Coupling light guides with opto-electronic elements
H02J 7/02 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from AC mains by converters
H02J 50/10 - Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling
A61N 1/372 - Arrangements in connection with the implantation of stimulators
H01R 4/30 - Clamped connectionsSpring connections using a screw or nut clamping member
H01R 13/08 - Resiliently-mounted rigid pins or blades
23.
IMPROVED SURGICAL ELECTRODE AND LEAD FOR USE WITH IMPLANTED PULSE GENERATOR AND METHOD OF USE
An implantable pulse generator is provided comprising a non-metallic shell adjacent a header. The header abuts an optical window in the shell. The header aligns a series of surgical or percutaneous leads with the optical window. The leads incorporate optical fibers, electrodes and contacts which distribute stimulation signals. Behind the optical window, a set of optical devices is provided which transmit or receive light from the fibers. Signal processors are provided to interpret the signals from the optical fibers, and to mitigate a continuous inductive charging function.
A percutaneous lead is provided which includes a generally tubular, multi-duct, flexible lead body. The lead body supports a distal set of electrodes and a proximal set of contacts which are connected by conductors in the ducts. The lead body further houses an optical fiber with a side firing section. The side firing section is held adjacent an optical transmission window, integrally formed with the flexible lead body. A cylindrical ferrule is provided to position the fiber in the header of an IPG.
A surgical lead is provided which includes a generally flexible polymeric panel incorporating a set of electrode arrays embedded in one side. The electrode arrays are connected to integrally formed leads which house conductors that connect the electrodes to a set of contacts. The contacts engage an IPG header. The leads incorporate an optical fiber which extends from the IPG header to a set of window portals in the flexible panel. Each of the fibers includes a side firing section adjacent the optical windows for transmission or reception of light. Optimally placed reflectors and heat shields are also provided.
G02B 6/42 - Coupling light guides with opto-electronic elements
H01R 4/30 - Clamped connectionsSpring connections using a screw or nut clamping member
H01R 13/08 - Resiliently-mounted rigid pins or blades
H02J 7/02 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from AC mains by converters
H02J 50/10 - Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling
A percutaneous lead is provided which includes a generally tubular, multi-duct, flexible lead body. The lead body supports a distal set of electrodes and a proximal set of contacts which are connected by conductors in the ducts. The lead body further houses an optical fiber with a side firing section. The side firing section is held adjacent an optical transmission window, integrally formed with the flexible lead body. A cylindrical ferrule is provided to position the fiber in the header of an IPG.
H02J 7/02 - Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from AC mains by converters
H01R 13/08 - Resiliently-mounted rigid pins or blades
A surgical lead is provided which includes a generally flexible polymeric panel incorporating a set of electrode arrays embedded in one side. The electrode arrays are connected to integrally formed leads which house conductors that connect the electrodes to a set of contacts. The contacts engage an IPG header. The leads incorporate an optical fiber which extends from the IPG header to a set of window portals in the flexible panel. Each of the fibers includes a side firing section adjacent the optical windows for transmission or reception of light. Optimally placed reflectors and heat shields are also provided.
A percutaneous lead is provided which includes a generally tubular, multi-duct, flexible lead body. The lead body supports a distal set of electrodes and a proximal set of contacts which are connected by conductors in the ducts. The lead body further houses an optical fiber with a side firing section. The side firing section is held adjacent an optical transmission window, integrally formed with the flexible lead body. A cylindrical ferrule is provided to position the fiber in the header of an IPG.
A system and method for anchoring an electrode that stimulates a dorsal root ganglion. The anchoring device includes a screw, collet, and locking cap. The screw is inserted into bone of the pars interarticularis and the electrode is inserted through the screw and positioned next to the dorsal root ganglion for stimulation. The screw includes a recess that is shaped to fit the collet. The collet has flexible arms. When assembled, the locking cap forces the collet into the recess thereby moving the flexible arms inward radially, impinging on the electrode and holding the electrode in place adjacent the dorsal root ganglion.
A connector system is provided for a positional sensitive spinal cord stimulation apparatus using near infrared reflectometry which incorporates the ability to connect to current IPG's either in a percutaneous or laminectomy form and which utilizes a novel light to frequency converter to generate a stimulation voltage in wave form to effect spinal cord stimulation.
A positionally sensitive spinal cord stimulation apparatus and method using near-infrared (NIR) reflectometry are provided for automatic adjustments of spinal cord stimulation. The system comprises an electrode assembly with an integrated optical fiber sensor for sensing spinal cord position. The integrated optical fiber sensor, comprising a pair of optical elements for emitting light from an IR emitter and for collecting reflected light into a photodetector, determines a set of measured photocurrents. As the spinal cord changes position, the angles of incidence for light from the IR emitter and the measured optical intensities change. Electrode pulse characteristics are adjusted in real time, based on the set of measured optical intensities, to minimize changes in stimulation perceived by the patient during motion. The system includes automatic calibration of the optical fiber sensor when the patient is at rest, and a patient orientation detection.
A positionally sensitive spinal cord stimulation apparatus and method using near-infrared (NIR) reflectometry are provided for automatic adjustments of spinal cord stimulation. The system comprises an electrode assembly with an integrated optical fiber sensor for sensing spinal cord position. The integrated optical fiber sensor, comprising a pair of optical elements for emitting light from an IR emitter and for collecting reflected light into a photodetector, determines a set of measured photocurrents. As the spinal cord changes position, the angles of incidence for light from the IR emitter and the measured optical intensities change. Electrode pulse characteristics are adjusted in real time, based on the set of measured optical intensities, to minimize changes in stimulation perceived by the patient during motion. The system includes automatic calibration of the optical fiber sensor when the patient is at rest, and a patient orientation detection.
A positionally sensitive spinal cord stimulation apparatus and method using near-infrared (NIR) reflectometry are provided for automatic adjustments of spinal cord stimulation. The system comprises an electrode assembly with an integrated optical fiber sensor for sensing spinal cord position. The integrated optical fiber sensor, comprising a pair of optical elements for emitting light from an IR emitter and for collecting reflected light into a photodetector, determines a set of measured photocurrents. As the spinal cord changes position, the angles of incidence for light from the IR emitter and the measured optical intensities change. Electrode pulse characteristics are adjusted in real time, based on the set of measured optical intensities, to minimize changes in stimulation perceived by the patient during motion. The system includes automatic calibration of the optical fiber sensor when the patient is at rest, and a patient orientation detection.
A positionally sensitive spinal cord stimulation apparatus and method using near-infrared (NIR) reflectometry are provided for automatic adjustments of spinal cord stimulation. The system comprises an electrode assembly with an integrated optical fiber sensor for sensing spinal cord position. The integrated optical fiber sensor, comprising a set of optical elements for emitting light from a set of IR emitters and for collecting reflected light into a set of IR photodetectors, determines a set of measured optical intensities. As the spinal cord changes position, the angles of incidence for light from the IR emitter and the measured optical intensities change. A ratio of measured optical intensities in combination with a total measured optical intensity is used to interpolate a set of electrode stimulation settings from a calibration table. Electrode pulse characteristics are adjusted in real time to minimize changes in stimulation perceived by the patient during motion.
A61N 1/36 - Applying electric currents by contact electrodes alternating or intermittent currents for stimulation, e.g. heart pace-makers
G01N 21/359 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
A61B 5/11 - Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
A61N 1/05 - Electrodes for implantation or insertion into the body, e.g. heart electrode
A61N 1/372 - Arrangements in connection with the implantation of stimulators
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
35.
Apparatus and method using near infrared reflectometry to reduce the effect of positional changes during spinal cord stimulation
A positionally sensitive spinal cord stimulation apparatus and method using near-infrared (NIR) reflectometry are provided for automatic adjustments of spinal cord stimulation. The system comprises an electrode assembly with an integrated optical fiber sensor for sensing spinal cord position. The integrated optical fiber sensor, comprising a set of optical elements for emitting light from a set of IR emitters and for collecting reflected light into a set of IR photodetectors, determines a set of measured optical intensities. As the spinal cord changes position, the angles of incidence for light from the IR emitter and the measured optical intensities change. Electrode pulse characteristics are adjusted in real time, based on the set of measured optical intensities, to minimize changes in stimulation perceived by the patient during motion.
A spinal cord stimulation apparatus and method for automatic adjustments of SCS using near-infrared (NIR) reflectometry are provided. A positionally sensitive system for spinal cord stimulation including an electrode assembly with integrated optical components for sensing spinal cord position relative to a stimulating electrode array is provided. The integrated optical components include an IR emitter and a pair of IR photodetectors. As light from the IR emitter reflects from the spinal cord, it is detected by each of the pair of IR photodetectors. As the spinal cord changes position so do the angles of incidence for detected light from the IR emitter, a ratio of optical intensities in combination with a total optical intensity is measured and used to interpolate a set of electrode stimulation settings from a calibration table. Electrode pulse characteristics are adjusted in real time to minimize changes in stimulation perceived by the patient during motion.
A spinal cord stimulation apparatus and method for automatic adjustments of SCS using near-infrared (NIR) reflectometry are provided. A positionally sensitive system for spinal cord stimulation including an electrode assembly with integrated optical components for sensing spinal cord position relative to a stimulating electrode array and an SCS controller for controlling electrode stimulation parameters is provided. The integrated optical components include an IR emitter and a pair of IR photodetectors. As light from the IR emitter reflects from the spinal cord, it is detected by each of the pair of IR photodetectors. As the spinal cord changes position so do the angles of incidence for detected light from the IR emitter, a ratio of optical intensities in combination with a total optical intensity is measured and used to interpolate a set of electrode stimulation settings from a calibration table. Electrode pulse characteristics are adjusted in real time to minimize changes in stimulation perceived by the patient during motion.
A spinal cord stimulation apparatus and method for automatic adjustments of SCS using near-infrared (NIR) reflectometry are provided. A positionally sensitive system for spinal cord stimulation including an electrode assembly with integrated optical components for sensing spinal cord position relative to a stimulating electrode array and an SCS controller for controlling electrode stimulation parameters is provided. The integrated optical components include an IR emitter and a pair of IR photodetectors. As light from the IR emitter reflects from the spinal cord, it is detected by each of the pair of IR photodetectors. As the spinal cord changes position so do the angles of incidence for detected light from the IR emitter, a ratio of optical intensities in combination with a total optical intensity is measured and used to interpolate a set of electrode stimulation settings from a calibration table. Electrode pulse characteristics are adjusted in real time to minimize changes in stimulation perceived by the patient during motion.
