Abstract: In one embodiment, an introducer is provided for implanting a paddle style electrical stimulation lead to enable electrical stimulation of nerve tissue. The introducer includes an outer sheath and an inner penetrator. The outer sheath may accommodate insertion of the paddle style electrical stimulation lead and may be inserted into a human body near the nerve tissue. The inner penetrator is removably housed within the outer sheath and includes an inner channel configured to accommodate a guide wire, a tip end having a shape and size substantially conforming to that of the guide wire, a body region having a shape and size substantially conforming to that of the outer sheath, and one or more transition regions substantially connecting the tip end with the body region.

Abstract: In one embodiment, a method, for fabricating an implantable apparatus for delivering electrical stimulation from a pulse generator, comprises: providing a plurality of conductors, wherein at least one of the plurality of conductors passes through at least one interior passage of a body, wherein the body is formed of a first insulative material having prescribed mechanical properties; coupling at least one terminal to each conductor of the plurality of conductors, the terminals being adapted to receive electrical signals from the pulse generator, wherein adjacent terminals are separated by a second insulative material with prescribed mechanical properties that are consistent with the first insulative material; and over-molding a region of the apparatus containing the terminals with a third insulative material with prescribed mechanical properties that are consistent with the material of the body.

Abstract: In one embodiment, an electrical stimulation lead is adapted for implantation in a person's body to provide therapeutic electrical stimulation of target nerve tissue within the person's body. The stimulation lead includes one or more stimulating electrodes and one or more sensing electrodes integrated into the stimulation lead and adapted for implantation in the person's body with the stimulation lead. The stimulating electrodes are operable to provide electrical stimulation to target nerve tissue within the person's body. The sensing electrodes are operable to detect electrical signals produced by nerve cells within the person's body to facilitate precise positioning of the stimulating electrodes proximate the target nerve tissue during implantation of the stimulation lead.

Abstract: The invention is directed to a dose control apparatus for manipulating the dosage of one or more pharmaceutical solutions emanating from an implantable drug infusion pump. The dose control apparatus has a movable core that is held in a desired position by a magnet. The apparatus has at least one coil that, when activated, motivates the core to move to a new position. The core may be held in the second position by another magnet. The apparatus may have more that one coil provide various control options. In addition, the coils may be used to determine core position or the presence and strength of an externally applied magnetic field such as that produced in an MRI. The coils may also be used to produce a magnetic field counteracting the externally applied field or to produce a degaussing field.

Abstract: The present invention relates to a percutaneous insertion-capable lead, wherein insertion made through a percutaneous insertion structure. For one embodiment of such lead, the electrode-supporting stimulation portion of the lead includes at least one waisted region, relative to a transverse dimension of the lead, to facilitate lead steerability.

Abstract: An implantable, substantially isodiametric, low resistance implantable lead having at least one electrode positioned in a stimulation/sensing portion of the lead as well as a method of manufacturing the same. At least the stimulation/sensing portion is unitized through partially surrounding and supporting insulation and conductive element(s) of the stimulation/sensing portion with a fused matrix of material having mechanical properties consistent with a body of the lead.

Abstract: A lead, method of manufacturing same, and system for stimulation is provided. The lead includes an insulative member or layer that masks a portion of the electrode(s) to effectively generate a directional lead that focuses or directs the stimulation to desired location(s). In another embodiment, the lead further includes a marking system to allow a clinician to orient the directional lead, as desired, while the lead is within a body.

Abstract: An improved needle for use in percutaneous insertion of a lead, and method for insertion of same, is provided. The needle includes a flare or lip on the needle heel proximate the needle orifice.

Abstract: In one aspect, an apparatus is provided for securing an electrical stimulation lead in position in a person's brain. The apparatus includes a body configured to seat within a burr hole formed in the person's skull. The apparatus also includes a central elastic membrane coupled to the body and extending across a central aperture of the body. The elastic membrane includes a number of pre-formed openings provided for purposes of securing the lead in position within the brain after implantation. Each pre-formed opening may penetrate through an entire thickness of the elastic membrane. Each pre-formed opening may be selected for insertion of the lead into the brain. Each pre-formed opening is adapted to elastically expand as the lead is inserted through the pre-formed opening and positioned in the brain and is adapted to elastically contract on the lead to secure the lead in position within the brain after implantation.

Abstract: An implantable, substantially isodiametric, low resistance implantable lead having at least one electrode positioned in a stimulation/sensing portion of the lead as well as a method of manufacturing the same. At least the stimulation/sensing portion is unitized through partially surrounding and supporting insulation and conductive element(s) of the stimulation/sensing portion with a fused matrix of material having mechanical properties consistent with a body of the lead.

Abstract: In one aspect, an apparatus is provided for securing an electrical stimulation lead in position in a person's brain. The apparatus includes a flexible disc comprising a substantially radial slot adapted to secure the lead in position within the brain after implantation. The slot is adapted to elastically expand as the lead is inserted into the slot and is also adapted to elastically contract on the lead to secure the lead in position within the brain after implantation. The apparatus further includes a ring adapted to seat within a burr hole formed in the person's skull. The ring comprises a channel adapted to receive and secure the flexible disc.

Abstract: An implantable, substantially isodiametric, low resistance implantable lead having at least one electrode positioned in a stimulation/sensing portion of the lead as well as a method of manufacturing the same. At least the stimulation/sensing portion is unitized through partially surrounding and supporting insulation and conductive element(s) of the stimulation/sensing portion with a fused matrix of material having mechanical properties consistent with a body of the lead.

Abstract: An electrical contact to electrically couple epidural stimulation leads to a tissue stimulation device. This electrical contact includes a conductive disc having an inner aperture that is electrically and operably coupled to the tissue stimulation device. A number of conducted projections extend inward from the inner aperture of the disc and flex elastically to receive an epidural stimulation lead. These conductive projections electrically couple with a number of terminals within the epidural stimulation lead. Tension exerted by flexing the conducted projections maintains the epidural stimulation lead in a relatively fixed position relative to the electrical contact. A number of projections at the outer perimeter of the conductive disc electrically and operably couple the conductive disc to a conductive housing wherein the conductive housing is electrically and operably coupled to the tissue stimulation device.

Abstract: The present invention relates to a percutaneous insertion-capable lead, wherein insertion is made through a percutaneous insertion structure. For one embodiment of such lead, the electrode-supporting stimulation portion of the lead includes at lease one waisted region, relative to a transverse dimension of the lead, to facilitate lead steerability.

Abstract: In one embodiment, an introducer is provided for implanting an electrical stimulation lead to enable electrical stimulation of nerve tissue. The introducer includes an outer sheath and an inner penetrator. The outer sheath is configured to accommodate insertion of the electrical stimulation lead through the outer sheath and may be inserted into a human body near the nerve tissue. The inner penetrator is removably housed within the outer sheath and includes an inner channel configured to accommodate a guide wire. The inner penetrator may be advanced along the guide wire to a desired location relative to the nerve tissue and removed from the outer sheath leaving the outer sheath substantially in position for insertion of the electrical stimulation lead through the outer sheath into position proximate the nerve tissue.

Abstract: The invention is directed to a bendable needle with a removable stylet. Needles are typically used in the practice of inserting electrodes and other small instruments into patients. Stylets fit flush with the cutting end of the needle to prevent tissue from entering the needle. This invention is directed to a needle that may be bent or shaped to better suit a specific application. Typical stylets are irremovable from a bent needle. However, the present invention incorporates a stylet with a coil, flexible tube, and/or flexible rod attached to a tip. The tip fits flush with the cutting end of the needle and the coil, tube, or rod extends through the bore of the needle. As such, the stylet is removable from the needle once bent.

Abstract: The present invention relates to an implantable infusion pump having a refillable infusate reservoir in fluid communication with a delivery site via a flow path. This flow path includes a flow resistance. The infusion pump includes a sensing device(s), positioned relative to the flow path, to provide data regarding a flow rate along the flow path. The infusion pump effects a division of a total flow period into at least a plurality of unit dose periods, each unit dose period effecting delivery of a unit dose of infusate. The cumulative effect of delivering the total number of unit dose periods is the delivery of a desired dose over the total flow period. The present invention permits a reservoir pressure to vary over any portion of total flow period but effects a constant-pressure state over each unit dose cycle.

Abstract: The invention is directed to a dose control apparatus for manipulating the dosage of one or more pharmaceutical solutions emanating from an implantable drug infusion pump. The dose control apparatus has a movable core that is held in a desired position by a magnet. The apparatus has at least one coil that, when activated, motivates the core to move to a new position. The core may be held in the second position by another magnet. The apparatus may have more that one coil provide various control options. In addition, the coils may be used to determine core position or the presence and strength of an externally applied magnetic field such as that produced in an MRI. The coils may also be used to produce a magnetic field counteracting the externally applied field or to produce a degaussing field.

Abstract: The invention is directed to a dose control module for manipulating the dosage of one or more pharmaceutical solutions emanating from an implantable drug infusion pump. The dose control module has a processor and other circuitry for manipulating flow valves and other dose manipulators. Effluent catheters from one or more implantable drug infusion pumps may be connected to the dose control module. The dose control module may direct the effluent pharmaceutical solution to one or more catheters. These catheters direct the pharmaceutical solutions to treatment locations. The invention is also directed to induction coil valves for use in or with the dose control module. The use of induction coils permits the dose control module to determine valve position and counteract large directional magnetic fields produced by MRIs.

Abstract: The present invention relates to an implantable infusion pump having a refillable infusate reservoir in fluid communication with a delivery site via a flow path. This flow path includes a flow resistance. The infusion pump includes a sensing device(s), positioned relative to the flow path, to provide data regarding a flow rate along the flow path. The infusion pump effects a division of a total flow period into at least a plurality of unit dose periods, each unit dose period effecting delivery of a unit dose of infusate. The cumulative effect of delivering the total number of unit dose periods is the delivery of a desired dose over the total flow period. The present invention permits a reservoir pressure to vary over any portion of total flow period but effects a constant-pressure state over each unit dose cycle.