Boston Scientific Neuromodulation Corporation

Jacob B Leven

Michael A Moffitt

John Michael Barker

Anne Margaret Pianca

Michael X Govea

David Ernest Wechter

Joshua Dale Howard

Matthew Lee McDonald

Natalie A Brill

Kevin Peng Wang

Geoffrey Abellana Villarta

James Robert Black

Milad Girgis

Rhys Wheatley

Eric Koji Nagaoka

Abraham Molina Ortega

Ryan Michael Baca

An adapter to add optical stimulation to a stimulation system includes an adapter body and a connector disposed on the distal end of the adapter body. The connector includes a connector body defining a port and a connector lumen; connector contacts disposed in the connector body and arranged along the connector lumen; and a light source disposed in the connector body. The adapter also includes terminals disposed along the proximal end of the adapter body and conductors extending along the adapter body and electrically coupling the connector contacts and the light source to the terminals. The adapter may be used with an optical stylet that fits into a stimulation lead which is, in turn, coupled to the connector of the adapter. Alternatively, the adapter can include a fiber optic coupled to the light source and configured to extend into the stimulation lead.

Optical stimulation system with on-demand monitoring and methods of making and using

A lead introducer includes an integrated sheath/needle including a splittable sheath configured to split a into a first portion and a second portion, a needle having a length and a proximal end region, and a hub coupled to the proximal end regions of the splittable sheath and the needle and configured to split into a first portion and a second portion. The needle is permanently attached to either the first portion of the hub or the first portion of the splittable sheath (or both) so that when the hub is split into the first and second portions, the needle remains attached to the first portion of the hub or the first portion of the splittable sheath.

Lead introducers and systems and methods including the lead introducers

A medical device kit includes a tunneling tool configured to form a tunnel through patient tissue for receiving an electrical stimulation lead. The tunneling tool includes a tunneling-tool body having an elongated shape with a proximal portion and a distal portion. The tunneling-tool body is formed from a material configured to be manually bent prior to insertion into patient tissue to conform to an anatomical contour through which the tunnel is to extend. A blunt tip is disposed at the distal portion. The blunt tip is configured to tunnel through patient tissue. A tunneling-tool suture-receiving element is disposed along the proximal portion of the tunneling-tool body. The tunneling-tool suture-receiving element is configured to receive a suture extendable along the tunnel formed by the tunneling tool.

Systems and methods for introducing an electrical stimulation lead into a patient

A method for implanting a lead includes inserting a needle into the patient; inserting a lead blank through the needle; steering the lead blank to, or near, a lead implantation site; removing the needle from the patient and leaving the lead blank; advancing a flexible sheath over the lead blank after removing the needle; removing the lead blank from the patient and leaving the flexible sheath; inserting a lead through the flexible sheath, after removing the lead blank, and implanting the lead at the lead implantation site; and removing the flexible sheath. The flexible sheath can also be used for explanting a lead and, optionally, implanting a new lead.

Long, flexible sheath and lead blank and systems and methods of making and using

An implantable electrical stimulation lead including a lead body having a distal end, a proximal end, and a longitudinal length, wherein the distal end of the lead body is formed into a hook or coil shape; a plurality of electrodes disposed along the hook or coil at the distal end of the lead body; a plurality of terminals disposed on the proximal end of the lead body; and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals. The lead can be used to stimulate, for example, a dorsal root ganglion with the hook-shaped or coil-shaped distal end disposed around a portion of the dorsal root ganglion.

Distally curved electrical stimulation lead and methods of making and using

A lead anchor includes a lead passageway defined along a central body and configured to receive a lead. The central body includes a twistable region that reversibly twists and stretches. First and second hubs are coupled to opposing ends of the central body. The first hub is rotatable relative to the second hub about the central body. Rotation of the first hub relative to the second hub causes twisting of the twistable region. When a lead is inserted into the lead passageway and the twistable region is twisted into a twisted configuration the central body compresses against the lead to retain the lead within the lead passageway. A locking mechanism transitions the hubs between an unlocked position, where the first hub is rotatable relative to the second hub, and a locked position, where the hubs resist rotation relative to one another.

Lead anchors for electrical stimulation leads and systems and methods of making and using

An implantable electrical stimulation lead includes a lead body having a proximal portion and a distal portion; electrodes disposed along the distal portion of the lead body; terminals disposed along the proximal portion of the lead body; conductor extending along the lead body and electrically coupling the electrodes to the terminals; and a flexible hinge forming part of the distal portion of the lead body and disposed proximal to the electrodes, wherein the flexible hinge is structurally distinguishable from adjacent regions of the lead body and more flexible than the adjacent regions.

Electrical stimulation leads, systems and methods for stimulation of dorsal root ganglia

An electrical stimulation lead includes a body having distal and proximal end portions, a longitudinal length, at least one anchoring lumen, and at least one open slot spaced apart from each end of the lead body. Each anchoring lumen is open at a slot and extends both distally and proximally from the slot. The lead also includes electrodes; terminals; conductors electrically coupling the terminals to the electrodes; and at least one anchoring element at least partially disposed in an anchoring lumen. Each anchoring element includes at least one bent portion biased to extend an extension portion of the anchoring element out of a slot when the anchoring element is in a deployed position and can retract the extension portion into an anchoring lumen when the anchoring element is in a constrained position. The lead further includes an attachment member attached to each anchoring element and disposed proximal to each slot.

Electrical stimulation leads and systems with elongate anchoring elements and methods of making and using

A connector assembly includes a lead with a lead body having proximal and distal portions. The lead body defines a longitudinal axis. Terminals are disposed along the proximal portion and a proximal tip is attached thereto. The proximal tip defines an aperture that is non-parallel to the longitudinal axis. The connector assembly further includes a connector having a connector body, a connector lumen, and connector contacts disposed within the connector body. The connector body includes a fastener aperture proximal to all of the connector contacts and intersecting the connector lumen. The fastener aperture and the aperture of the proximal tip align when the proximal portion is fully received within the connector lumen. At least one of the apertures includes internal threading. The connector assembly also includes a threaded fastener for insertion into the apertures to secure the lead to the connector.

Threaded connector assembly and methods of making and using the same

A connector assembly includes a receptacle body that defines a portion of a connector lumen and further includes connector contacts disposed within the receptacle body along the connector lumen. The connector assembly further includes a rotational member that defines another portion of the connector lumen and includes a head portion and an elongated portion. The elongated portion defines an inner surface and an outer surface. The outer surface is rotatably coupled to the receptacle body. Fastener threading is disposed along at least a portion of the inner surface of the elongated portion. The receptacle body and rotational member are configured and arranged to receive a portion of a lead or a lead extension in the connector lumen.

An electrical stimulation lead includes a lead body that defines a central lumen extending along the longitudinal length of the lead body. The stimulation lead includes electrodes disposed along the distal end of the lead body, terminals disposed along the proximal end of the lead body, and conductors. Each conductor electrically couples at least one of the electrodes to at least one of the terminals. The stimulation lead also includes a tubular reinforcing member disposed in the central lumen of the lead body within a portion of the distal end of the lead body or at least one reinforcing member disposed upon the distal end of the lead body proximal of the plurality of electrodes. The reinforcing member stiffens a portion of the distal end of the lead body.

Distally reinforced lead and methods of making and using

A trial electrical stimulation lead includes a lead body having a distal end portion, a proximal end portion, and a longitudinal length; electrodes disposed along the distal end portion of the lead body; terminals disposed along the proximal end portion of the lead body; conductors electrically coupling the terminals to the electrodes; and a preventer extending proximally from the proximal end portion of the lead body. The preventer has a diameter smaller than a diameter of the lead body. The preventer prevents coupling of the trial electrical stimulation lead to an implantable control module, but permits coupling to an external trial stimulation system.

Systems and methods for making and using a temporary lead

A lead anchor includes an anchor body having a band section, guide members and a support section. The guide members and the support section are spaced apart from each other and define a band channel. Further, the lead anchor includes a flexible band that is coupleable to the guide members with at least a portion of the flexible band positionable within the band channel. The flexible band and the support section define a first lead channel having a spaced-apart distance between the flexible band and the support section. The first lead channel includes an open side for allowing a lateral ingress or egress of a portion of a lead. The lead anchor further includes a fastener movable relative to the anchor body to reduce or increase the spaced-apart distance of the first lead channel to hold or release, respectively, the portion of the lead within the first lead channel.

Lead anchor for an electrical stimulation system

A lead arrangement includes a plurality of proximal leads, a distal lead, and a junction electrically and mechanically coupling the plurality of proximal leads to the at least one distal lead. Each proximal lead has a proximal end and a distal end and includes conductive contacts disposed along the proximal end and conductive wires coupled to the conductive contacts and extending to the distal end of the proximal lead. Each distal lead has a proximal end and a distal end and includes electrodes disposed along the distal end and conductive wires coupled to the electrodes and extending to the proximal end of the distal lead. The junction includes conductive tabs and a non-conductive material encapsulating the conductive tabs. The conductive wires of the at least one distal lead and the conductive wires of the plurality of proximal leads are attached to the conductive tabs of the junction.

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Huntington Beach, CA, United States of America

Jacob B Leven