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Publication Number
US-11027139-B2
Publication Date
2021-06-08
Expiration Date
Abstract
A method for treating neurological pain includes inserting an introducer needle of gauge 18 or smaller through a percutaneous incision site on a body, coupling a first mating feature at a distal end of an elongate member of a stylet to a second mating feature of an implantable device that is configured to receive a wireless signal and to generate one or more electrical pulses from the wireless signal for exciting a tissue within the body, advancing the stylet and the implantable device together as an assembly to the tissue within the body through a lumen of the introducer needle, and applying the one or more electrical pulses to one or more electrodes of the implantable device to modulate the tissue within the body.
Core Innovation
A miniature implantable device for neurological stimulation and/or recording is inserted through a percutaneous incision site using an introducer needle of gauge 18 or smaller. The implantable device is advanced together with a stylet as an assembly through a lumen of the introducer needle to a tissue region within the body, and the implantable device excites the tissue by generating one or more electrical pulses.
The implantable device has a cylindrical body defining a longitudinal axis, and a plurality of electrodes distributed along the cylindrical body. An anchoring feature adjacent the cylindrical body and disposed proximal to the plurality of electrodes secures the implantable device to the tissue, while the stylet includes a distal mating feature that couples with a proximal mating feature of the implantable device to allow in-line advancement and positioning.
Power and pulse generation are provided wirelessly: the implantable device is configured to receive a wireless signal and generate one or more electrical pulses from the wireless signal. The device includes one or more circuits that rectify and perform charge balancing to generate charge-balanced electrical pulses that are delivered to the plurality of electrodes, using an external RF antenna architecture with radiative coupling from a physically separate antenna.
The system architecture further includes external components including an external RF pulse generator and a programmer, with telemetry signal and feedback to adjust closed-loop parameters. The implantable device may be used with multiple electrode configurations and with multiple implanted devices, and the document describes implant placement hardware including a placement stylet with mating features and a suction stylet with a locking mechanism.
Claims Coverage
The partial content includes one independent claim defining a method for treating neurological pain, centered on percutaneous insertion of a wireless-signal implantable electrode device through an introducer needle and delivering electrical pulses to modulate tissue. The inventive features are further specified across multiple dependent claims, particularly the wireless antenna/power-transfer architecture, electrode/anchoring geometry, and stylet/device coupling and insertion hardware.
Percutaneous insertion using gauge 18 or smaller introducer needle and stylet advancement
The method comprises inserting an introducer needle through a percutaneous incision site, the introducer needle being of gauge 18 or smaller, and advancing the stylet and the implantable device together as an assembly to the tissue within the body through a lumen of the introducer needle.
In-line mating-feature coupling between stylet and implantable device
The method includes coupling a first mating feature at a distal end of an elongate member of a stylet to a second mating feature of an implantable device, wherein the second mating feature is disposed proximal to the anchoring feature, disposed in-line with the longitudinal axis of the implantable device, and defines a proximal end of the implantable device.
Cylindrical body with distributed plurality of electrodes for tissue modulation
The implantable device includes a cylindrical body defining a longitudinal axis of the implantable device and a plurality of electrodes distributed along the cylindrical body and configured to deliver the one or more electrical pulses for exciting a tissue within the body.
Anchoring feature proximal to electrodes for securing the implantable device
The implantable device further comprises an anchoring feature adjacent the cylindrical body and disposed proximal to the plurality of electrodes for securing the implantable device to the tissue.
Wireless-signal implantable device generating electrical pulses from received wireless signal
The implantable device is configured to receive a wireless signal and to generate one or more electrical pulses from the wireless signal for exciting a tissue within the body.
Wireless radiative coupling using first and second antennas
The implantable device uses a first antenna to receive an energy-carrying input signal via electrical radiative coupling from a separate second antenna.
Charge-balanced pulse generation using rectification and charge balancing circuitry
The implantable device includes one or more circuits that rectify the wireless signal and generate charge-balanced electrical pulses.
Convex-concave mating-feature geometry for coupling
The method specifies that one mating feature is convex while the other mating feature is concave.
Cylindrical in-line electrode configuration
The plurality of electrodes are cylindrical and aligned in-line with the cylindrical body.
Stylet rigidity to facilitate passage through needle lumen
The rigidity of the stylet helps the stylet assembly and the implantable device pass through the lumen of the introducer needle and the percutaneous incision site.
Anchoring feature with suture passageway
The anchoring feature includes a passageway through which a suture is passed to secure the implantable device to tissue.
Across the partial content, the claims coverage centers on a percutaneous method using an introducer needle (gauge 18 or smaller) and a stylet that couples to an in-line implantable device having a cylindrical body, distributed electrode array, and anchoring feature. The implantable device is wireless-signal powered using first and second antennas via electrical radiative coupling and generates charge-balanced electrical pulses that are applied to the electrodes to modulate tissue, with dependent claim refinements specifying mating-feature geometry, electrode geometry, stylet rigidity, and anchoring via a suture passageway.
Stated Advantages
Smaller form factor and reduced invasiveness compared with wired or IPG systems.
Elimination of implantable pulse generator/battery dependence.
Reduced cost compared with wired or IPG systems.
Documented Applications
Treating neurological pain by exciting a tissue within the body using one or more electrical pulses delivered by electrodes of a wireless-signal implantable device.
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