US20140200639A1 - Self-expanding neurostimulation leads having broad multi-electrode arrays - Google Patents
Self-expanding neurostimulation leads having broad multi-electrode arrays Download PDFInfo
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- US20140200639A1 US20140200639A1 US14/048,352 US201314048352A US2014200639A1 US 20140200639 A1 US20140200639 A1 US 20140200639A1 US 201314048352 A US201314048352 A US 201314048352A US 2014200639 A1 US2014200639 A1 US 2014200639A1
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Definitions
- One or more embodiments of the subject matter described herein generally relate to systems having leads for generating electric fields proximate to nerve tissue.
- Neurostimulation systems include devices that generate electrical pulses and deliver the pulses to nerve tissue to treat a variety of disorders.
- Spinal cord stimulation is a common type of neurostimulation.
- electrical pulses are delivered to nerve tissue in the spine typically for the purpose of chronic pain control. While a precise understanding of the interaction between the applied electrical energy and the nerve tissue is not fully appreciated, it is known that application of an electric field to spinal nerve tissue can effectively mask or alleviate certain types of pain transmitted from regions of the body associated with the stimulated nerve tissue. SCS may have applications other than pain alleviation as well.
- NS and SCS systems generally include a pulse generator and one or more leads electrically coupled to the pulse generator.
- a lead includes an elongated body of insulative material.
- a stimulating end portion of the lead includes multiple electrodes that are electrically coupled to the pulse generator through wire conductors.
- the stimulating end portion of a lead is implanted proximate to nerve tissue (e.g., within epidural space of a spinal cord) to deliver the electrical pulses.
- a trailing end portion of the lead body includes multiple terminal contacts, which are also electrically coupled to the wire conductors.
- the terminal contacts are electrically coupled to the pulse generator.
- the terminal contacts receive electrical pulses from the pulse generator that are then delivered to the electrodes through the wire conductors to generate the electric fields.
- the pulse generator is typically implanted within the individual and may be programmed (and re-programmed) to provide the electrical pulses in accordance with a designated sequence.
- the first type is a percutaneous lead, which has a rod-like shape and includes electrodes spaced apart from each other along a single axis.
- the second type of lead is a laminectomy or laminotomy lead (hereinafter referred to as a paddle lead).
- a paddle lead has an elongated planar body with a thin rectangular shape (i.e., paddle-like shape).
- the paddle lead may include only one row or column of electrodes, the paddle lead typically includes an array of electrodes that are spaced apart from each other along a substantially common plane.
- the number of electrodes may be, for example, two, four, eight, or sixteen.
- a single paddle lead enables more coverage of the nerve tissue relative to a single percutaneous lead.
- paddle leads require a surgical procedure (e.g. a partial laminectomy) to implant the lead.
- the paddle lead is typically positioned within the epidural space adjacent to the dura of the spinal cord.
- Conventional percutaneous leads are inserted into the body through a narrow introducer. Compared to paddle leads, the percutaneous leads have dimensions that may enable an easier insertion into the spinal cord and/or may cause less trauma to the insertion site of the spinal cord.
- a self-expanding lead in accordance with an embodiment, includes a lead body having a distal body end, a proximal body end, and a central axis extending therebetween.
- the lead body includes first and second outer arms and an inner arm disposed between the first and second outer arms. The first and second outer arms and the inner arm extend lengthwise between the proximal body end and the distal body end.
- the lead also includes an array of electrodes that are configured to apply a neurostimulation therapy within an epidural space of a patient. At least some of the electrodes are positioned along the first and second outer arms.
- Each of the first and second outer arms includes a resilient member that is biased to flex the respective outer arm from a collapsed condition to an expanded condition in a direction that is away from the inner arm.
- the resilient member permits the respective outer arm to flex toward the inner arm from the expanded condition to the collapsed condition when a force is applied.
- a self-expanding lead in accordance with another embodiment, includes first and second outer arms extending between respective proximal and distal arm ends. Each of the first and second outer arms includes electrodes that are positioned along a length of the respective outer arm.
- the lead also includes an inner arm that is disposed between the first and second outer arms. The inner arm extends between a respective base end and a respective distal arm end. The proximal ends of the inner arm and the first and second outer arms are coupled to each other proximate to a proximal body end of the self-expanding lead.
- the lead also includes a multi-electrode array having the electrodes of the first and second arms.
- the multi-electrode array is configured to apply a neurostimulation therapy within an epidural space of a patient.
- Each of the first and second outer arms includes a resilient member that is biased to flex the respective outer arm from a collapsed condition to an expanded condition in a direction that is away from the inner arm. The resilient member permits the respective outer arm to flex toward the inner arm from the expanded condition to the collapsed condition when a force is applied.
- FIG. 1 is a schematic view of one embodiment of a neurostimulating (NS) system in accordance with one embodiment.
- FIG. 2A illustrates a plan view of a self-expanding lead that is in an expanded or relaxed state in accordance with one embodiment.
- FIG. 2B is an enlarged view of a distal portion of the self-expanding lead shown in FIG. 2A .
- FIG. 2C is an enlarged view of a proximal portion of the self-expanding lead shown in FIG. 2A .
- FIG. 3 is a cross-section of the self-expanding lead taken along the line 3 - 3 in FIG. 2A while in the expanded state.
- FIG. 4 is a cross-section of the self-expanding lead taken along the line 4 - 4 in FIG. 2A while in the expanded state.
- FIG. 5 is a cross-section of the self-expanding lead taken along the line 5 - 5 in FIG. 2A while in the expanded state.
- FIG. 6 is a cross-section of the self-expanding lead in a collapsed state while within an insertion tool in accordance with one embodiment.
- FIG. 7 is a cross-section of a self-expanding lead in accordance with one embodiment while the lead is in a collapsed state within an insertion tool.
- FIG. 8 illustrates a series of stages during an insertion process in which a self-expanding lead clears an insertion tool.
- FIG. 9 illustrates a guide wire device that may be used to direct a self-expanding lead into an anatomical space of a patient in accordance with one embodiment.
- FIG. 10 is a perspective view of a self-expanding lead in accordance with one embodiment that utilizes a flexible membrane.
- FIG. 11 is a cross-section of a self-expanding lead having a flexible membrane in accordance with one embodiment.
- FIG. 12 is a cross-section of a self-expanding lead having a flexible membrane in accordance with one embodiment.
- FIG. 13 illustrates a plan view of a self-expanding lead that is in an expanded state in accordance with one embodiment.
- FIG. 14 illustrates a plan view of a self-expanding lead that is in an expanded state in accordance with one embodiment.
- FIG. 15 is a block diagram illustrating a method of manufacturing a self-expandable lead in accordance with one embodiment.
- Embodiments described herein include self-expanding leads that are capable of flexing into an operative shape or configuration as the self-expanding lead is inserted into the epidural space.
- the self-expanding lead may include one or more resilient members that are biased to expand the self-expanding lead when the self-expanding lead is permitted to expand (e.g., when a force is removed).
- the self-expanding lead may include a plurality of arms, at least one of which may be capable of flexing into an expanded condition. The individual arms may reduce the amount of pressure along the spinal nerves within the epidural space relative to conventional paddle leads.
- the individual arms of the lead may include one or more electrodes.
- the electrodes of the individual arms may form a multi-electrode array (e.g., two-dimensional array) that provides electrode coverage comparable to conventional paddle leads.
- the multi-electrode array may be configured to have a coverage similar to PentaTM paddle leads distributed by St. Jude.
- the expandable/collapsible lead may enable delivery of the lead through introducers that are typically used for inserting percutaneous leads. As such, incisions for inserting the lead into the patient may be smaller than those used for inserting paddle leads, which may reduce recovery and clinical cost.
- FIG. 1 depicts a neurostimulation (NS) system 100 that generates electrical pulses for application to tissue, such as spinal cord tissue, of a patient according to one embodiment.
- the nerve tissue may include dorsal column (DC) fibers and/or dorsal root (DR) fibers.
- the NS system 100 includes an NS device (or pulse generator) 150 that is adapted to generate electrical pulses in order to apply electric fields to the tissue.
- the NS device 150 is typically implantable within an individual (e.g., patient) and, as such, may be referred to as an implantable pulse generator (IPG).
- IPG implantable pulse generator
- the implantable NS device 150 typically comprises a housing 158 that encloses a controller 151 , which may include or be operably coupled to a pulse generating circuit module 152 , a charging coil 153 , a battery 154 , a far-field and/or near field communication circuit module 155 , a battery charging circuit module 156 , a switching circuit module 157 , etc. of the device.
- the controller 151 may include a processor or other logic-based device for controlling the various other components of the NS device 150 .
- Software code is typically stored in memory of the NS device 150 for execution by the NS device 150 to control the various components of the device.
- the controller 151 may be programmable controller that controls the various modes of stimulation therapy for the NS device 150 .
- the controller 151 may include a microprocessor, or equivalent control circuitry, designed specifically for controlling delivery of stimulation therapy and may further include RAM or ROM memory, logic and timing circuitry, state machine circuitry, and I/O circuitry.
- the microcontroller 151 may have the ability to process or monitor input signals (data) as controlled by a program code stored in memory. The details of the design and operation of the microcontroller 151 are not critical to the present invention. Rather, any suitable microcontroller 151 may be used.
- FIG. 1 illustrates various blocks in which some of the blocks are referred to as a “circuit module.”
- the circuit modules that may be implemented as hardware with associated instructions (e.g., software stored on a tangible and non-transitory computer readable storage medium, such as a computer hard drive, ROM, RAM, or the like) that perform the operations described herein.
- the hardware may include state machine circuitry hard wired to perform the functions described herein.
- the hardware may include electronic circuits that include and/or are connected to one or more logic-based devices, such as microprocessors, processors, controllers, or the like.
- the circuit modules may represent processing circuitry such as one or more field programmable gate array (FPGA), application specific integrated circuit (ASIC), or microprocessor.
- FPGA field programmable gate array
- ASIC application specific integrated circuit
- the circuit modules in various embodiments may be configured to execute one or more algorithms to perform functions described herein.
- the one or more algorithms may include aspects of embodiments disclosed herein, whether or not expressly identified in a flowchart or a method.
- the NS device 150 may comprise a separate or an attached extension component 170 . If the extension component 170 is a separate component, the extension component 170 may connect with the “header” portion of the NS device 150 as is known in the art. If the extension component 170 is integrated with the NS device 150 , internal electrical connections may be made through respective conductive components. Within the NS device 150 , electrical pulses are generated by the pulse generating circuit module 152 and are provided to the switching circuit module 157 . The switching circuit module 157 connects to outputs of the NS device 150 . Electrical connectors (e.g., “Bal-Seal” connectors) within a connector portion 171 of the extension component 170 or within the header portion may be employed to conduct the electrical pulses.
- Electrical connectors e.g., “Bal-Seal” connectors
- Terminal contacts (not shown) of one or more neurostimulator leads 110 are inserted within the connector portion 171 or within the header for electrical connection with respective connectors. Thereby, the pulses originating from NS device 150 are provided to the neurostimulator lead 110 . The pulses are then conducted through wire conductors of the lead 110 and applied to tissue of an individual via electrodes 111 .
- the neurostimulator lead is a lead configured for insertion after a laminectomy or a laminotomy.
- the neurostimulator lead 110 is hereinafter referred to as a “self-expanding lead.”
- a processor and associated charge control circuitry for an implantable pulse generator is described in U.S. Patent Application Publication No. 2006/0259098, entitled “SYSTEMS AND METHODS FOR USE IN PULSE GENERATION,” which is incorporated herein by reference in its entirety.
- Circuitry for recharging a rechargeable battery of an implantable pulse generator using inductive coupling and external charging circuits are described in U.S. Pat. No. 7,212,110, entitled “IMPLANTABLE DEVICE AND SYSTEM FOR WIRELESS COMMUNICATION,” which is incorporated herein by reference in its entirety.
- One or more NS devices and one or more paddle leads that may be used with embodiments described herein are described in U.S. Patent Application Publication No. US 2013/0006341 in its entirety.
- a controller device 160 may be implemented to recharge battery 154 of the NS device 150 .
- a wand 165 may be electrically connected to the controller device 160 through suitable electrical connectors (not shown).
- the electrical connectors may be electrically connected to a primary coil 166 at the distal end of wand 165 through respective wires (not shown).
- the primary coil 166 may be placed against the patient's body immediately above the charging coil (or secondary coil) 153 of the NS device 150 .
- the controller device 160 may generate an AC-signal to drive current through the primary coil 166 . Current may be induced in the secondary coil 153 to recharge the battery 154 .
- the controller device 160 preferably provides one or more user interfaces to allow the user to the NS device 150 according to one or more stimulation programs to treat the patient's disorder(s).
- Each stimulation program may include one or more sets of stimulation parameters including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), etc.
- the NS device 150 modifies its internal parameters in response to the control signals from controller device 160 to vary the stimulation characteristics of stimulation pulses transmitted through stimulation lead 110 to the tissue of the patient. Neurostimulation systems, stimsets, and multi-stimset programs are discussed in PCT Publication No.
- FIG. 2A is a plan view of a self-expandable lead 200 and includes two isolated, enlarged views of the lead 200 .
- the lead 200 may be similar or identical to the lead 110 ( FIG. 1 ) and may be used with an NS system, such as the NS system 100 ( FIG. 1 ).
- the lead 200 includes a lead body 202 having a distal body end 204 , a proximal body end 206 , and a central axis 208 extending therebetween.
- a portion of the lead body 202 near the distal body end 204 is shown in greater detail in FIG. 2B
- a portion of the lead body 202 near the proximal body end 206 is shown in greater detail in FIG. 2C .
- FIG. 2C With respect to FIG.
- the central axis 208 extends generally along a geometric center of a cross-section of the lead 200 .
- the lead body 202 includes a plurality of arms or splines 211 - 215 that extend lengthwise between the distal body end 204 and the proximal body end 206 of the lead body 202 .
- the arms 211 - 215 include first and second outer arms 211 , 214 , first and second inner arms 212 , 213 , and a center inner arm 215 .
- the inner arms 212 , 213 , 215 are disposed between the outer arms 211 , 214 , and the center inner arm 215 is disposed between the first and second inner arms 212 , 213 .
- the inner arms 212 , 213 may be described or characterized intermediate arms 212 , 213 .
- Each of the arms 211 - 215 extends lengthwise between a respective distal arm end 218 (shown in FIG. 2B ) and a respective proximal arm end 220 (shown in FIG. 2C ).
- the distal arm ends 218 are located proximate to the distal body end 204
- the proximal arm ends 220 are located proximate to the proximal body end 206
- the proximal body end 206 may include an end 216 (or cable end) of a lead cable 210 .
- the lead body 202 also includes a first paddle side 222 , which is shown in FIG. 2 , and a second paddle side 224 (shown in FIG. 3 ).
- the first and second paddle sides 222 , 224 face in opposite directions and extend lengthwise between the distal body end 204 and the proximal body end 206 .
- the lead body 202 has a lead profile or footprint 225 that constitutes a spatial volume defined by exterior surfaces of the lead body 202 when the leady body 202 is in a relaxed state.
- the lead profile 225 is represented by a dashed line that extends alongside a perimeter of the lead body 202 .
- the dashed line is spaced apart from the exterior surfaces of the lead body 202 that define the lead profile 225 .
- the lead body 202 may have a first dimension or width 231 that extends between exterior surfaces of the outer arms 211 , 214 and which face in opposite directions.
- the lead body 202 also has a second dimension or length 232 that extends between an exterior surface of the distal body end 204 and a location where the proximal body end 206 joins the lead cable 210 .
- the lead body 202 may also have a third dimension or thickness 233 (shown in FIG. 3 ) that extends between paddle sides 222 , 224 .
- Each of the width 231 , the length 232 , and the thickness 233 may have a varying or non-uniform value as the lead body 202 extends along the dimensions. For instance, the length 232 is greatest when measured along the central axis 208 .
- the lead profile 225 may include elongated windows or openings 241 - 244 that are defined between adjacent arms. More specifically, with respect to the illustrated embodiment, the lead body 202 defines the elongated window 241 between the outer arm 211 and the inner arm 212 , the elongated window 242 between the inner arm 212 and the inner arm 215 , the elongated window 243 between the inner arm 215 and the inner arm 213 , and the elongated window 244 between the inner arm 213 and the outer arm 214 .
- the elongated windows 241 extend lengthwise along the central axis 208 and widthwise between the adjacent arms.
- the elongated windows 241 - 244 reduce or shrink when the lead 200 is in a collapsed state.
- the lead profile 225 of the lead body 202 may be substantially planar widthwise and lengthwise.
- the arms 211 - 215 may be substantially coplanar (e.g., substantially coincide along a common plane).
- the lead profile 225 may have a curved contour when the lead body 202 is in a relaxed state.
- the lead profile 225 may curve as the lead body 202 extends along the length 232 (e.g., such that the central axis 208 is not linear and has a curved or bent shape) and/or as the lead body 202 extends along the width 231 (e.g., the lead body 202 may be C-shaped as viewed along the central axis 208 ).
- the contours may be predetermined by the manufacturing process of the lead 200 .
- the contours may be predetermined to complement the anatomical structure that the lead 200 will interface.
- the distal body end 204 is typically the first end that is inserted through an incision and into the spinal column.
- the lead cable 210 extends away from the lead body 202 from the proximal body end 206 .
- the lead cable 210 may include conductive pathways 286 (shown in FIG. 3 ), such as wire conductors, which extend from the lead body 202 to an NS device or pulse generator (not shown), such as the NS device 150 ( FIG. 1 ).
- the conductive pathways 286 also extend lengthwise along the arms 211 - 215 to electrically couple the corresponding electrodes 250 to the pulse generator.
- the lead 200 also includes a plurality of electrodes 250 that are disposed along the outer arms 211 , 214 and the inner arms 212 , 213 , but not the inner arm 215 .
- the inner arm 215 may include one or more of the electrodes 250 .
- the electrodes 250 may comprise Platinum-Iridium (Pt—Ir) or other equivalent material. As one specific example only, the electrodes may be 90-10 Pt—Ir (i.e., 90% Platinum, 10% Iridium).
- the electrodes 250 may be positioned relative to each other to form a multi-electrode array 252 .
- the multi-electrode array 252 is a two-dimensional array in the illustrated embodiment.
- the electrodes 250 and/or the multi-electrode array 252 may be configured to provide a neurostimulation therapy in an epidural space of a patient.
- electrical pulses transmitted from the NS device 150 may be provided at a predetermined schedule or frequency to provide therapy to the patient.
- FIG. 2 illustrates only one arrangement of the electrodes 250 .
- the electrodes 250 may have any one of a variety of arrangements.
- one of the paddle sides may interface with nerve tissue and the other paddle side may interface with an anatomical structure (e.g., bone, ligament, or other portions of the spine).
- the electrodes 250 may be exposed along each of the paddle sides 222 , 224 . In other embodiments, the electrodes 250 may be exposed only along one of the paddle sides, such as the paddle side 222 shown in FIG. 2 , and not the other paddle side.
- each of the outer arms 211 , 214 and each of the inner arms 212 , 213 include a series or column of electrodes 250 that are spaced apart from each other along a length of the respective arm.
- an operative state e.g., an expanded state
- the arms are spaced apart from each other thereby laterally separating the electrodes 250 of adjacent arms.
- the electrodes 250 may be disposed along the lengths of the respective arms at designated locations and the arms 211 - 215 may be configured to have a designated separation when in the expanded state so that the electrodes 250 form the multi-electrode array 252 .
- multi-electrode array 252 includes a 4 ⁇ 5 grid of electrodes 250 in which the electrodes 250 are substantially evenly distributed along (e.g. parallel to) the central axis 208 .
- the electrodes 250 may form a single row or column that extends along the central axis 208 and are spaced apart from each other.
- the multi-electrode array 252 may have a 4 ⁇ 4 grid of electrodes 250 or a 4 ⁇ 8 grid of electrodes 250 .
- the multi-electrode array 252 may be configured to have a coverage similar to PentaTM paddle leads distributed by St. Jude.
- the lead body 202 may include a plurality of resilient members 261 - 264 (shown in FIG. 2B ) proximate to the distal body end 204 and a plurality of resilient members 271 - 274 (shown in FIG. 2C ) proximate to the proximal body end 206 .
- the resilient members 261 - 264 are located within the arms 211 - 214 , respectively, and the resilient members 271 - 274 are located within the arms 211 - 214 , respectively.
- the resilient members 261 - 264 and 271 - 274 include a resilient material that is capable of being collapsed when a force is applied and biased to flex back to a designated shape when the force is removed.
- the resilient material is a metal or metal alloy.
- the resilient material may have shape memory.
- the resilient material includes nitinol, which is a metal alloy of nickel and titanium. However, other materials, including combinations of materials, may be used.
- FIGS. 2A-2C show the lead 200 in a relaxed or expanded state.
- the resilient members are biased to flex the respective arm from a collapsed condition to an expanded condition in a direction that is away from the central axis 208 (or the center inner arm 215 ).
- the resilient members also permit the respective arm to flex toward the central axis 208 (or the center inner arm 215 ) from the expanded condition to the collapsed condition when a force is applied.
- FIGS. 3-5 illustrate different cross-sections of the lead 200 as shown in FIG. 2A .
- FIG. 3 is taken along the line 3 - 3 in FIG. 2A and illustrates cross-section of the arms 211 - 215 in greater detail.
- the lead profile 225 is shown.
- the lead body 202 includes the paddle sides 222 and 224 .
- Each of the arms 211 - 215 has a cross-section that includes an arm width 281 and an arm height 283 .
- the arm height 283 may be substantially equal to the thickness 233 of the lead body 202 or the lead profile 225 at the cross-section shown in FIG. 3 .
- the arms 211 - 215 are narrow, elongated splines or beams in which the arm width 281 and the arm height 283 are approximately equal.
- the arm width 281 and the arm height 283 may differ by at most 50% of the greater of the arm width 281 and the arm height 283 .
- the arm width 281 were about 1.5 mm, the arm height 283 may be about 0.75 mm.
- the arm height 283 is larger and is, for example, about 1.0 mm, the arm width 281 may be about 0.75 mm.
- the arm width 281 and the arm height 283 may differ by at most 25% of the greater of the arm width 281 and the arm height 283 or, more particularly, by at most 10% of the greater of the arm width 281 and the arm height 283 .
- the cross-section of the arms 211 - 215 have a substantially circular shape or substantially square shape such that the arm width 281 and the arm height 283 are substantially equal
- the arms 211 - 215 may have a substantially rectangular shape.
- the arm width 281 may be about 2.25 mm and the arm height 283 may be about 1.0 mm.
- the arms 211 - 215 comprise an insulative material 284 that may include the exterior surfaces of the arms 211 - 215 .
- the arms 211 - 214 also include conductive pathways 286 (e.g., wire conductors).
- the conductive pathways 286 comprise a conductive material, such as copper, and are configured to transmit electrical signals (e.g., current) to corresponding electrodes 250 ( FIG. 2A ).
- the conductive pathways 286 are electrically coupled to the pulse generator of the NS system 100 .
- a designated frequency may be transmitted to the electrodes 250 in order to provide therapy to a patient.
- the conductive pathways 286 may include jackets that insulate the conductive pathways 286 from each other.
- the inner arm 215 includes a steering lumen 288 .
- the steering lumen 288 may be defined by an interior surface of the insulative material 284 .
- the steering lumen 288 may extend lengthwise through the inner arm 215 from the proximal body end 206 ( FIGS. 2A and 2C ) to and, optionally, through the distal body end 204 ( FIGS. 2A and 2B ).
- the steering lumen 288 is sized and shaped to receive an elongated tool 290 , such as a guide wire.
- the elongated tool 290 may be used during the insertion process to guide the lead 200 ( FIG. 2A ).
- the insulative material 284 may include one or more biocompatible materials.
- biocompatible materials include polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET) film (also known as polyester or Mylar), polytetrafluoroethylene (PTFE) (e.g., Teflon), or parylene coating, polyether bloc amides, polyurethane.
- the material of the lead body 202 that surrounds the metal components includes at least one of polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET) film, polytetrafluoroethylene (PTFE), parylene, polyether bloc amides, or polyurethane.
- PEEK polyetheretherketone
- PET polyethylene terephthalate
- PTFE polytetrafluoroethylene
- parylene polyether bloc amides
- polyurethane e.g., polyurethane.
- FIG. 4 shows cross-sections of the arms 211 - 215 taken along the line 4 - 4 of FIG. 2A .
- each of the arms 211 - 214 includes one of the electrodes 250 .
- the electrode 250 is configured to be exposed along an outer surface of the respective arm so that the electrode 250 may interface with an anatomical structure, such as nerve tissue.
- the electrodes 250 are completely exposed along the outer surface.
- one or more portions of the electrodes 250 may be covered such that the corresponding portion(s) is not exposed.
- the insulative material 284 may cover the one or more portions of the electrodes 250 .
- the electrode 250 may be separated from an adjacent electrode 250 by a gap 292 .
- the gaps 292 may be part of the elongated windows 241 - 244 .
- FIG. 5 shows cross-sections of the joints 265 - 268 of the respective arms 211 - 215 ( FIG. 2A ) taken along the line 5 - 5 in FIG. 2A .
- each of the joints 265 - 268 includes the respective resilient member 261 - 264 that is at least partially surrounded by the insulative material 284 .
- the resilient members 261 - 264 of the respective joints 265 - 268 are dimensioned and shaped to function as described herein.
- the resilient members 261 - 264 may be etched, creased, and/or have varying dimensions in order to provide sufficient resiliency for returning the arms 211 - 214 to the expanded state when the force is removed.
- the resilient members 261 - 264 may be etched (e.g., laser-cut) to provide the designated shape.
- FIG. 6 shows a cross-section of the lead body 202 when each of the arms 211 - 214 is in a collapsed condition within an insertion tool 296 , which may also be referenced as an introducer.
- the resilient members 261 - 264 , 271 - 274 may be configured such that the arms 211 - 214 collapse in a designated manner.
- the resilient members 261 - 264 , 271 - 274 may be shaped such that when a laterally-inward force F 1 (indicated by the inwardly pointing arrows) is provided, the arms 211 - 214 collapse toward (e.g., move toward) the inner arm 215 and/or the central axis 208 .
- the laterally-inward force F 1 may be applied when the lead body 202 is drawn into or advanced into a cavity of an insertion tool.
- the cavity may be defined by interior surfaces of the insertion tool.
- the lead body 202 may slide through the insertion tool when a linear force is applied.
- the linear force may be translated into the laterally-inward force F 1 as the unyielding interior surface of the insertion tool collapses the arms 211 - 214 .
- each of the arms 211 - 214 coincides with a body plane 298 prior to the arms 211 - 214 collapsing.
- the arms 211 - 214 move along the body plane 298 in an inward direction toward the inner arm 215 and/or toward the central axis 208 .
- the arms 211 - 214 may be co-planar with one another such that the arms 211 - 214 coincide with the body plane 298 .
- FIG. 7 shows a cross-section of a lead body 302 when the lead body 302 is located within an insertion tool 396 .
- the lead body 302 may be similar or identical to the lead body 202 ( FIG. 2A ).
- the lead body 302 includes arms 311 - 315 .
- each of the arms 311 - 314 is in a collapsed condition within a cavity 397 of the insertion tool 396 .
- the cavity 397 is defined by one or more interior surfaces of the insertion tool 396 .
- the arms 311 - 314 may include resilient members, such as the resilient members 261 - 264 , 271 - 274 ( FIGS.
- the resilient members may be shaped such that when an inward force F 2 (indicated by arrows) is provided, the arms 311 - 314 collapse toward the inner arm 315 and/or a central axis 308 of the lead body 302 .
- the resilient members of the arms 311 - 314 may be biased such that the arms 311 - 314 move toward the inner arm 315 or the central axis 308 in a different manner than the arms 211 - 214 shown in FIG. 6 .
- the inner arms 312 , 313 may move above or below the inner arm 315 and the inner arms 311 , 314 may move below or above the inner arms 312 , 313 , respectively.
- the inner arms 311 - 315 may have a substantially stacked or overlapping configuration as shown in FIG. 7 .
- the stacked configuration may include the inner arms 311 - 314 forming a square perimeter that surrounds the inner arm 315 within a center of the stacked configuration.
- FIG. 8 illustrates a series of stages 401 - 406 during an insertion process in which a self-expanding lead 410 clears an end opening 412 of an insertion tool 414 (e.g., an introducer).
- the lead 410 may be similar or identical to other self-expanding leads described herein and have a distal body end 416 and a proximal body end 418 (shown with respect to the stage 406 ).
- the lead 410 may include arms 421 - 424 that have resilient members (not shown) that enable the arms 421 - 424 to flex between collapsed and expanded conditions.
- the lead 410 does not include a central inner arm through which a steering lumen extends. In alternative embodiments, the lead 410 may include such an inner arm.
- the lead 410 is disposed within a cavity, such as the cavity 397 ( FIG. 7 ), of the insertion tool 414 .
- the relaxed state of the lead 410 may be the expanded state.
- interior surfaces of the insertion tool 414 that define the cavity may engage one or more of the arms, such as the arms 421 and 424 .
- the insertion tool 414 may resist lateral deformation such that the insertion tool 414 pushes the arms 421 and 424 and, consequently, the arms 422 , 423 laterally-inward as the lead 410 is advanced into the cavity.
- the linear insertion force that is applied to the lead 410 may be translated by the interior surface(s) of the insertion tool 414 into a laterally-inward force that collapses the arms 211 - 214 .
- the insertion tool 414 may be advanced into a patient (not shown) through one or more incisions.
- the insertion tool 414 may be advanced through one or more incisions that provide access to the spinal cord (not shown).
- the insertion tool 414 may be identical to the introducers that are used to insert percutaneous leads into the spinal cord.
- the insertion tool 414 may not be identical, but may have dimensions that are approximate to or similar to the dimensions of conventional percutaneous introducers.
- the distal body end 416 clears the end opening 412 of the insertion tool 414 .
- the distal body end 416 may expand to have a larger lead profile.
- the distal body end 416 may engage tissue within the anatomical space (not shown).
- Geometries of the anatomical space, including the epidural space, vary from patient to patient. In some cases, it may be desirable for the lead 410 to be capable of moving around obstructions, such as bone or tissue, and/or to be capable for moving tissue without causing significant trauma to the patient.
- the resiliency of the arms 421 - 424 at the distal body end 416 may be configured such that the distal body end 416 is capable of engaging and flexing to slide around tissue and/or is capable of engaging and moving tissue within the anatomical space.
- the distal body end 416 has cleared the end opening 412 of the insertion tool 414 and a majority of a length of the lead 410 has advanced into the anatomical space.
- the proximal body end 418 has expanded such that the arms 421 - 424 are fully expanded and the lead 410 has a maximum lead profile.
- the tool 414 may be withdrawn through the one or more incision cites.
- FIG. 9 illustrates a guiding device 500 that may be used to direct the self-expanding lead 200 into an anatomical space of a patient.
- the guiding device 500 includes a guide wire 502 that is operably coupled to a handle 504 that is configured to be gripped by an individual (e.g., doctor).
- the guide wire 502 is inserted entirely through the steering lumen 288 ( FIG. 3 ) of the inner arm 215 such that the guide wire 502 extends beyond the distal body end 204 of the lead 200 .
- the insertion process with respect to the lead 200 may be similar to the insertion process described with respect to FIG. 8 .
- the guide wire 502 of the guiding device 500 may be inserted through the steering lumen 288 of the inner arm 215 .
- the guide wire 502 may be moved into the anatomical space before the lead 200 clears the end opening (not shown) of the insertion tool.
- the lead 200 may be advanced into the anatomical space with the guide wire 502 directing or guiding the lead 200 .
- the distal body end 204 of the lead 200 expands.
- the expanding of the lead 200 may displace tissue or other obstructions thereby permitting the guide wire 502 to advance.
- the lead 200 may then be further advanced into the anatomical space.
- FIGS. 10-13 illustrate self-expandable leads having flexible membranes.
- a flexible membrane may be desirable to have a flexible membrane extend across the width of the lead and join the arms of the lead body.
- the flexible membranes may impede growth of tissue around the arms which may enable a simpler process for withdrawing the lead with a decreased likelihood of trauma or injury to the patient.
- FIG. 10 is a perspective view of a self-expanding lead 600 that utilizes a flexible membrane 602 in accordance with one embodiment.
- the lead 600 may be identical to the lead 200 ( FIG. 2A ).
- the lead 200 may include a lead body 604 having arms 611 - 615 . In the, expanded state shown in FIG.
- the lead body 604 has first and second paddle sides 622 , 624 . Also shown, the lead 600 includes elongated windows or openings 641 - 644 that are defined between adjacent arms.
- the flexible membrane 602 extends along the paddles side 624 and covers the elongated windows 641 - 644 .
- FIG. 11 is a cross-section of the lead 600 taken along the line 11 - 11 in FIG. 10 .
- the flexible membrane 602 may be attached to the arms 611 - 615 along the paddle side 624 in one or more manners.
- the flexible membrane 602 may comprise a biocompatible material, which may be the same as or similar to the insulative material 284 , that is attached by selectively applying heat to the flexible membrane 602 .
- an adhesive may be applied to the flexible membrane 602 , which may then be attached to the arms 611 - 614 .
- the lead 600 has a uni-directional configuration. More specifically, the flexible membrane 602 may extend along the paddle side 624 such that electrodes 650 ( FIG. 10 ) of the lead 600 are covered by the flexible membrane 602 and are only exposed along the paddle side 622 . In such embodiments, it may be necessary to orient the lead 600 so that a predetermined paddle side interfaces with the nerve tissue.
- FIG. 12 is a cross-section of a self-expanding lead 700 having a flexible membrane 702 in accordance with one embodiment.
- the lead 700 may be identical to the lead 200 ( FIG. 2A ).
- the flexible membrane 702 is applied to a paddle side 724 of the lead 700 .
- the flexible membrane 702 may have electrode openings 752 that expose the electrodes 750 along the paddle side 724 .
- the electrode openings 752 may be fabricate by etching the flexible membrane 702 material after the flexible membrane 702 has been applied to the paddle side 724 .
- the flexible membrane 702 may be applied through an injection molding process. With injection molding, the lead 700 may be positioned within a mold that covers portions of the electrodes 750 so that molten membrane material cures at designated portions thereby forming the electrode openings 752 .
- embodiments described herein may have a flexible membrane along one or both paddle sides.
- the flexible membrane may limit adhesion of the self-expanding lead to the patient by limiting growth of tissue or other material within the epidural space around the arms of the lead.
- the flexible membrane may be capable of folding over within the cavity of the insertion tool, such as the insertion tool 414 , thereby permitting the expanding/collapsing abilities of the leads described herein.
- FIG. 13 illustrates a plan view of a self-expanding lead 850 in an expanded state.
- the lead 850 may be similar to other leads described herein, such as the lead 200 ( FIG. 2A ).
- the lead 850 includes a lead body 852 having a distal body end 854 , a proximal body end 856 , and a central axis 858 extending therebetween.
- the proximal body end 856 may include an end 866 (or cable end) of a lead cable 860 .
- the lead body 852 includes a plurality of arms or splines 861 - 865 that extend lengthwise between the distal body end 854 and the proximal body end 856 along the central axis 858 .
- the arms 861 - 865 include first and second outer arms 861 , 864 , first and second inner arms 862 , 863 , and a center inner arm 865 .
- the inner arms 862 , 863 , 865 are disposed between the outer arms 861 , 864
- the center inner arm 865 is disposed between the first and second inner arms 862 , 863 .
- the lead cable 860 may include conductive pathways (not shown), such as wire conductors, which extend from the lead body 852 to an NS device or pulse generator (not shown), such as the NS device 150 ( FIG. 1 ).
- the conductive pathways also extend lengthwise along the arms 861 - 865 to electrically couple corresponding electrodes 890 to the pulse generator.
- the corresponding electrodes 890 are disposed along each of the arms 861 - 865 , including the inner arm 865 .
- the electrodes 890 may be positioned relative to each other to form a multi-electrode array 896 .
- the lead body 852 may include a plurality of resilient members proximate to the distal body end 854 and a plurality of resilient members proximate to the proximal body end 856 .
- the resilient members may be similar to the resilient members 261 - 264 and 271 - 274 ( FIGS. 2B and 2C , respectively) described with respect to the lead 200 and located within the arms.
- the resilient members may include a resilient material that is capable of being collapsed when a force is applied and biased to flex back to a designated shape when the force is removed.
- the inner arm 865 includes a steering lumen 888 .
- the steering lumen 888 extends through the lead cable 860 into the inner arm 865 .
- the steering lumen 888 may be defined by an interior surface of an insulative material of the lead cable 860 and the inner arm 865 .
- the steering lumen 888 extends lengthwise through the inner arm 865 from the proximal body end 856 and through the distal body end 854 .
- the steering lumen 888 is sized and shaped to receive an elongated tool, which is illustrated as a guide wire 892 in FIG. 13 .
- the guide wire 892 may be used during the insertion process to guide the lead 850 to a designated position in the epidural space (not shown).
- the distal body end 854 may have an opening that permits a wire end 894 of the guide wire 892 to clear the distal body end 854 and be positioned within the epidural. With the wire end 894 located within the epidural space, the lead 850 may then be directed along the guide wire 892 and delivered to the epidural space. The path taken by the lead 850 is determined by the shape of the guide wire 892 .
- the center inner arm 865 may not include resilient material for flexing between different positions.
- the center inner arm 865 may not include such resilient material and, instead, may include a more rigid material.
- the rigid material may be more suitable for receiving a tool, such as the guide wire 892 .
- FIG. 14 illustrates a plan view of a self-expanding lead 900 in an expanded state.
- the lead 900 may have a lead body 902 that is similar in shape as the lead body 852 .
- a center inner arm 925 of the lead body 902 may not have a steering lumen that extends entirely through the lead body 902 .
- the center inner arm 925 may end short of a distal body end 932 and permit inner arms 922 and 923 to be directly coupled by a joint 927 and outer arms 921 and 924 to be directly coupled by a joint 928 .
- the lead body 902 may have a steering lumen 904 that extends to and ends at a cable end 906 of a lead cable 908 .
- a guide wire 910 may be inserted into the steering lumen 904 until a wire end 912 of the guide wire 910 engages the cable end 906 of the lead body 902 .
- the guide wire 910 may be operated to move the lead body 902 into a designated orientation. For example, when the lead body 902 is inserted into the epidural space (not shown), the lead body 902 may be moved to into a designated orientation by the guide wire 910 . More specifically, the lead body 902 may pivot (as indicated by the arrows) about a point 930 located within the cable end 906 .
- FIG. 15 is a block diagram illustrating a method 800 of manufacturing a self-expandable lead in accordance with one embodiment.
- the lead may be similar to the leads shown and described in the present application.
- the method 800 includes fabricating (at 802 ) resilient members.
- the resilient members may be fabricated (at 802 ) by etching a sheet of resilient material (e.g., metal alloy or plastic).
- the sheet of resilient material includes nitinol.
- the etching may include laser-cutting the sheet material.
- the resilient members may be elongated structures that extend along curved paths. For instance, in a relaxed state, the resilient members may extend along curved paths that have similar shapes as the arms that the resilient members will be located within.
- the resilient members may be shaped similar to the resilient members 261 - 264 and 271 - 274 shown in FIGS. 2B and 2C , respectively.
- the method 800 also includes assembling (at 804 ) wire conductors and electrodes of the lead.
- the assembling (at 804 ) may include positioning the resilient members relative to the wire conductors and the electrodes.
- an insulative material may be applied (e.g., molded) to the assembly of wire conductors, electrodes, and resilient members.
- the insulative material may be a biocompatible material, such as the materials described herein.
- the insulative material may completely cover or insulate the wire conductors and at least partially cover the electrodes.
- the resilient members may be at least partially covered by the insulative material.
- a lead body may be formed upon applying the insulative material at 806 .
- the lead body may be similar to other leads or lead bodies described herein, such as the lead body 200 .
- the lead body may include a plurality of arms that extend between a distal body end and a proximal body end of the lead body.
- the arms may include first and second outer arms and an inner arm generally disposed between the first and second outer arms. The first and second outer arms and the inner arm may extend lengthwise between the proximal body end and the distal body end.
- the electrodes may form a multi-electrode array that is configured to apply a neurostimulation therapy. Some or all of the electrodes may be positioned along the first and second outer arms. Each of the first and second outer arms may include at least one of the resilient members.
- the resilient members may bias the respective outer arm to flex from a collapsed condition to an expanded condition in a laterally-outward direction. The resilient members may also permit the respective outer arm to flex laterally-inward from the expanded condition to the collapsed condition when a force is applied.
- a flexible membrane may be applied to a paddle side of the lead body.
- the flexible membrane may be similar to the flexible membranes 602 or 702 ( FIGS. 10 and 12 , respectively).
- the flexible membrane may be applied (at 808 ) after the lead body is formed.
- the flexible membrane may be applied as the lead body is formed.
- the flexible membrane may be molded with the arms of the lead body.
- a flexible membrane may be applied on each of the paddle sides.
Abstract
Self-expanding lead including a lead body having a distal body end, a proximal body end, and a central axis extending therebetween. The lead body includes first and second outer arms and an inner arm disposed between the first and second outer arms. The first and second outer arms and the inner arm extend lengthwise between the proximal body end and the distal body end. The lead also includes an array of electrodes that are configured to apply a neurostimulation therapy within an epidural space of a patient. At least some of the electrodes are positioned along the first and second outer arms. Each of the first and second outer arms includes a resilient member that is biased to flex the corresponding first and second outer arms from a collapsed condition to an expanded condition in a lateral direction away from the inner arm.
Description
- The present application claims the benefit of U.S. Provisional Application No. 61/753,429, filed on 16 Jan. 2013, which is incorporated by reference in its entirety.
- One or more embodiments of the subject matter described herein generally relate to systems having leads for generating electric fields proximate to nerve tissue.
- Neurostimulation systems (NS) include devices that generate electrical pulses and deliver the pulses to nerve tissue to treat a variety of disorders. Spinal cord stimulation (SCS) is a common type of neurostimulation. In SCS, electrical pulses are delivered to nerve tissue in the spine typically for the purpose of chronic pain control. While a precise understanding of the interaction between the applied electrical energy and the nerve tissue is not fully appreciated, it is known that application of an electric field to spinal nerve tissue can effectively mask or alleviate certain types of pain transmitted from regions of the body associated with the stimulated nerve tissue. SCS may have applications other than pain alleviation as well.
- NS and SCS systems generally include a pulse generator and one or more leads electrically coupled to the pulse generator. A lead includes an elongated body of insulative material. A stimulating end portion of the lead includes multiple electrodes that are electrically coupled to the pulse generator through wire conductors. The stimulating end portion of a lead is implanted proximate to nerve tissue (e.g., within epidural space of a spinal cord) to deliver the electrical pulses. A trailing end portion of the lead body includes multiple terminal contacts, which are also electrically coupled to the wire conductors. The terminal contacts, in turn, are electrically coupled to the pulse generator. The terminal contacts receive electrical pulses from the pulse generator that are then delivered to the electrodes through the wire conductors to generate the electric fields. The pulse generator is typically implanted within the individual and may be programmed (and re-programmed) to provide the electrical pulses in accordance with a designated sequence.
- Typically, one of two types of leads is used. The first type is a percutaneous lead, which has a rod-like shape and includes electrodes spaced apart from each other along a single axis. The second type of lead is a laminectomy or laminotomy lead (hereinafter referred to as a paddle lead). A paddle lead has an elongated planar body with a thin rectangular shape (i.e., paddle-like shape). Although the paddle lead may include only one row or column of electrodes, the paddle lead typically includes an array of electrodes that are spaced apart from each other along a substantially common plane. The number of electrodes may be, for example, two, four, eight, or sixteen.
- A single paddle lead enables more coverage of the nerve tissue relative to a single percutaneous lead. However, due to their dimensions and physical characteristics, paddle leads require a surgical procedure (e.g. a partial laminectomy) to implant the lead. The paddle lead is typically positioned within the epidural space adjacent to the dura of the spinal cord. Conventional percutaneous leads are inserted into the body through a narrow introducer. Compared to paddle leads, the percutaneous leads have dimensions that may enable an easier insertion into the spinal cord and/or may cause less trauma to the insertion site of the spinal cord.
- Therefore, a need remains for implantable leads that may be inserted into the spinal cord with a simpler insertion procedure than conventional paddle leads and also have electrode coverage of the nerve tissue that is broader than conventional percutaneous leads.
- In accordance with an embodiment, a self-expanding lead is provided that includes a lead body having a distal body end, a proximal body end, and a central axis extending therebetween. The lead body includes first and second outer arms and an inner arm disposed between the first and second outer arms. The first and second outer arms and the inner arm extend lengthwise between the proximal body end and the distal body end. The lead also includes an array of electrodes that are configured to apply a neurostimulation therapy within an epidural space of a patient. At least some of the electrodes are positioned along the first and second outer arms. Each of the first and second outer arms includes a resilient member that is biased to flex the respective outer arm from a collapsed condition to an expanded condition in a direction that is away from the inner arm. The resilient member permits the respective outer arm to flex toward the inner arm from the expanded condition to the collapsed condition when a force is applied.
- In accordance with another embodiment, a self-expanding lead is provided that includes first and second outer arms extending between respective proximal and distal arm ends. Each of the first and second outer arms includes electrodes that are positioned along a length of the respective outer arm. The lead also includes an inner arm that is disposed between the first and second outer arms. The inner arm extends between a respective base end and a respective distal arm end. The proximal ends of the inner arm and the first and second outer arms are coupled to each other proximate to a proximal body end of the self-expanding lead. The lead also includes a multi-electrode array having the electrodes of the first and second arms. The multi-electrode array is configured to apply a neurostimulation therapy within an epidural space of a patient. Each of the first and second outer arms includes a resilient member that is biased to flex the respective outer arm from a collapsed condition to an expanded condition in a direction that is away from the inner arm. The resilient member permits the respective outer arm to flex toward the inner arm from the expanded condition to the collapsed condition when a force is applied.
- While multiple embodiments are described, still other embodiments of the described subject matter will become apparent to those skilled in the art from the following detailed description and drawings, which show and describe illustrative embodiments of disclosed inventive subject matter. As will be realized, the inventive subject matter is capable of modifications in various aspects, all without departing from the spirit and scope of the described subject matter. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
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FIG. 1 is a schematic view of one embodiment of a neurostimulating (NS) system in accordance with one embodiment. -
FIG. 2A illustrates a plan view of a self-expanding lead that is in an expanded or relaxed state in accordance with one embodiment. -
FIG. 2B is an enlarged view of a distal portion of the self-expanding lead shown inFIG. 2A . -
FIG. 2C is an enlarged view of a proximal portion of the self-expanding lead shown inFIG. 2A . -
FIG. 3 is a cross-section of the self-expanding lead taken along the line 3-3 inFIG. 2A while in the expanded state. -
FIG. 4 is a cross-section of the self-expanding lead taken along the line 4-4 inFIG. 2A while in the expanded state. -
FIG. 5 is a cross-section of the self-expanding lead taken along the line 5-5 inFIG. 2A while in the expanded state. -
FIG. 6 is a cross-section of the self-expanding lead in a collapsed state while within an insertion tool in accordance with one embodiment. -
FIG. 7 is a cross-section of a self-expanding lead in accordance with one embodiment while the lead is in a collapsed state within an insertion tool. -
FIG. 8 illustrates a series of stages during an insertion process in which a self-expanding lead clears an insertion tool. -
FIG. 9 illustrates a guide wire device that may be used to direct a self-expanding lead into an anatomical space of a patient in accordance with one embodiment. -
FIG. 10 is a perspective view of a self-expanding lead in accordance with one embodiment that utilizes a flexible membrane. -
FIG. 11 is a cross-section of a self-expanding lead having a flexible membrane in accordance with one embodiment. -
FIG. 12 is a cross-section of a self-expanding lead having a flexible membrane in accordance with one embodiment. -
FIG. 13 illustrates a plan view of a self-expanding lead that is in an expanded state in accordance with one embodiment. -
FIG. 14 illustrates a plan view of a self-expanding lead that is in an expanded state in accordance with one embodiment. -
FIG. 15 is a block diagram illustrating a method of manufacturing a self-expandable lead in accordance with one embodiment. - Embodiments described herein include self-expanding leads that are capable of flexing into an operative shape or configuration as the self-expanding lead is inserted into the epidural space. For example, the self-expanding lead may include one or more resilient members that are biased to expand the self-expanding lead when the self-expanding lead is permitted to expand (e.g., when a force is removed). The self-expanding lead may include a plurality of arms, at least one of which may be capable of flexing into an expanded condition. The individual arms may reduce the amount of pressure along the spinal nerves within the epidural space relative to conventional paddle leads.
- The individual arms of the lead may include one or more electrodes. Collectively, the electrodes of the individual arms may form a multi-electrode array (e.g., two-dimensional array) that provides electrode coverage comparable to conventional paddle leads. For instance, the multi-electrode array may be configured to have a coverage similar to Penta™ paddle leads distributed by St. Jude. In addition to the broad electrode coverage, the expandable/collapsible lead may enable delivery of the lead through introducers that are typically used for inserting percutaneous leads. As such, incisions for inserting the lead into the patient may be smaller than those used for inserting paddle leads, which may reduce recovery and clinical cost.
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FIG. 1 depicts a neurostimulation (NS)system 100 that generates electrical pulses for application to tissue, such as spinal cord tissue, of a patient according to one embodiment. For embodiments that stimulate spinal cord tissue, the nerve tissue may include dorsal column (DC) fibers and/or dorsal root (DR) fibers. TheNS system 100 includes an NS device (or pulse generator) 150 that is adapted to generate electrical pulses in order to apply electric fields to the tissue. TheNS device 150 is typically implantable within an individual (e.g., patient) and, as such, may be referred to as an implantable pulse generator (IPG). Theimplantable NS device 150 typically comprises ahousing 158 that encloses acontroller 151, which may include or be operably coupled to a pulsegenerating circuit module 152, a chargingcoil 153, abattery 154, a far-field and/or near fieldcommunication circuit module 155, a batterycharging circuit module 156, aswitching circuit module 157, etc. of the device. Thecontroller 151 may include a processor or other logic-based device for controlling the various other components of theNS device 150. Software code is typically stored in memory of theNS device 150 for execution by theNS device 150 to control the various components of the device. - The
controller 151 may be programmable controller that controls the various modes of stimulation therapy for theNS device 150. Thecontroller 151 may include a microprocessor, or equivalent control circuitry, designed specifically for controlling delivery of stimulation therapy and may further include RAM or ROM memory, logic and timing circuitry, state machine circuitry, and I/O circuitry. Themicrocontroller 151 may have the ability to process or monitor input signals (data) as controlled by a program code stored in memory. The details of the design and operation of themicrocontroller 151 are not critical to the present invention. Rather, anysuitable microcontroller 151 may be used. -
FIG. 1 illustrates various blocks in which some of the blocks are referred to as a “circuit module.” It is to be understood that the circuit modules that may be implemented as hardware with associated instructions (e.g., software stored on a tangible and non-transitory computer readable storage medium, such as a computer hard drive, ROM, RAM, or the like) that perform the operations described herein. The hardware may include state machine circuitry hard wired to perform the functions described herein. Optionally, the hardware may include electronic circuits that include and/or are connected to one or more logic-based devices, such as microprocessors, processors, controllers, or the like. Optionally, the circuit modules may represent processing circuitry such as one or more field programmable gate array (FPGA), application specific integrated circuit (ASIC), or microprocessor. The circuit modules in various embodiments may be configured to execute one or more algorithms to perform functions described herein. The one or more algorithms may include aspects of embodiments disclosed herein, whether or not expressly identified in a flowchart or a method. - The
NS device 150 may comprise a separate or an attachedextension component 170. If theextension component 170 is a separate component, theextension component 170 may connect with the “header” portion of theNS device 150 as is known in the art. If theextension component 170 is integrated with theNS device 150, internal electrical connections may be made through respective conductive components. Within theNS device 150, electrical pulses are generated by the pulsegenerating circuit module 152 and are provided to theswitching circuit module 157. Theswitching circuit module 157 connects to outputs of theNS device 150. Electrical connectors (e.g., “Bal-Seal” connectors) within aconnector portion 171 of theextension component 170 or within the header portion may be employed to conduct the electrical pulses. Terminal contacts (not shown) of one or more neurostimulator leads 110 are inserted within theconnector portion 171 or within the header for electrical connection with respective connectors. Thereby, the pulses originating fromNS device 150 are provided to theneurostimulator lead 110. The pulses are then conducted through wire conductors of thelead 110 and applied to tissue of an individual viaelectrodes 111. In the illustrated embodiment, the neurostimulator lead is a lead configured for insertion after a laminectomy or a laminotomy. Theneurostimulator lead 110 is hereinafter referred to as a “self-expanding lead.” - For implementation of the components within
NS device 150, a processor and associated charge control circuitry for an implantable pulse generator is described in U.S. Patent Application Publication No. 2006/0259098, entitled “SYSTEMS AND METHODS FOR USE IN PULSE GENERATION,” which is incorporated herein by reference in its entirety. Circuitry for recharging a rechargeable battery of an implantable pulse generator using inductive coupling and external charging circuits are described in U.S. Pat. No. 7,212,110, entitled “IMPLANTABLE DEVICE AND SYSTEM FOR WIRELESS COMMUNICATION,” which is incorporated herein by reference in its entirety. One or more NS devices and one or more paddle leads that may be used with embodiments described herein are described in U.S. Patent Application Publication No. US 2013/0006341 in its entirety. - An example and discussion of “constant current” pulse generating circuitry is provided in U.S. Patent Application Publication No. 2006/0170486 entitled “PULSE GENERATOR HAVING AN EFFICIENT FRACTIONAL VOLTAGE CONVERTER AND METHOD OF USE,” which is incorporated herein by reference in its entirety. One or multiple sets of such circuitry may be provided within the
NS device 150. Different pulses on different electrodes may be generated using a single set of pulse generating circuitry using consecutively generated pulses according to a “multi-stimset program.” Complex pulse parameters may be employed such as those described in U.S. Pat. No. 7,228,179, entitled “METHOD AND APPARATUS FOR PROVIDING COMPLEX TISSUE STIMULATION PATTERNS,” and International Patent Publication No. WO 2001/093953 A1, entitled “NEUROMODULATION THERAPY SYSTEM,” each of which is incorporated herein by reference in its entirety. Alternatively, multiple sets of such circuitry may be employed to provide pulse patterns that include simultaneously generated and delivered stimulation pulses through various electrodes of one or more stimulation leads as is also known in the art. Various sets of parameters may define the pulse characteristics and pulse timing for the pulses applied to various electrodes as is known in the art. Although constant current pulse generating circuitry is contemplated for some embodiments, any other suitable type of pulse generating circuitry may be employed such as constant voltage pulse generating circuitry. - In some embodiments, a
controller device 160 may be implemented to rechargebattery 154 of theNS device 150. For example, awand 165 may be electrically connected to thecontroller device 160 through suitable electrical connectors (not shown). The electrical connectors may be electrically connected to aprimary coil 166 at the distal end ofwand 165 through respective wires (not shown). Theprimary coil 166 may be placed against the patient's body immediately above the charging coil (or secondary coil) 153 of theNS device 150. Thecontroller device 160 may generate an AC-signal to drive current through theprimary coil 166. Current may be induced in thesecondary coil 153 to recharge thebattery 154. - In some embodiments, the
controller device 160 preferably provides one or more user interfaces to allow the user to theNS device 150 according to one or more stimulation programs to treat the patient's disorder(s). Each stimulation program may include one or more sets of stimulation parameters including pulse amplitude, pulse width, pulse frequency or inter-pulse period, pulse repetition parameter (e.g., number of times for a given pulse to be repeated for respective stimset during execution of program), etc. TheNS device 150 modifies its internal parameters in response to the control signals fromcontroller device 160 to vary the stimulation characteristics of stimulation pulses transmitted throughstimulation lead 110 to the tissue of the patient. Neurostimulation systems, stimsets, and multi-stimset programs are discussed in PCT Publication No. WO 01/93953, entitled “NEUROMODULATION THERAPY SYSTEM,” and U.S. Pat. No. 7,228,179, entitled “METHOD AND APPARATUS FOR PROVIDING COMPLEX TISSUE STIMULATION PATTERNS,” which are incorporated herein by reference. -
FIG. 2A is a plan view of a self-expandable lead 200 and includes two isolated, enlarged views of thelead 200. Thelead 200 may be similar or identical to the lead 110 (FIG. 1 ) and may be used with an NS system, such as the NS system 100 (FIG. 1 ). Thelead 200 includes alead body 202 having adistal body end 204, aproximal body end 206, and acentral axis 208 extending therebetween. A portion of thelead body 202 near thedistal body end 204 is shown in greater detail inFIG. 2B , and a portion of thelead body 202 near theproximal body end 206 is shown in greater detail inFIG. 2C . With respect toFIG. 2A , thecentral axis 208 extends generally along a geometric center of a cross-section of thelead 200. As shown, thelead body 202 includes a plurality of arms or splines 211-215 that extend lengthwise between thedistal body end 204 and theproximal body end 206 of thelead body 202. - In the illustrated embodiment, the arms 211-215 include first and second
outer arms inner arms inner arm 215. Theinner arms outer arms inner arm 215 is disposed between the first and secondinner arms inner arms intermediate arms FIG. 2B ) and a respective proximal arm end 220 (shown inFIG. 2C ). The distal arm ends 218 are located proximate to thedistal body end 204, and the proximal arm ends 220 are located proximate to theproximal body end 206. Theproximal body end 206 may include an end 216 (or cable end) of alead cable 210. Thelead body 202 also includes afirst paddle side 222, which is shown inFIG. 2 , and a second paddle side 224 (shown inFIG. 3 ). The first and second paddle sides 222, 224 face in opposite directions and extend lengthwise between thedistal body end 204 and theproximal body end 206. - In the illustrated embodiment, the
lead body 202 has a lead profile orfootprint 225 that constitutes a spatial volume defined by exterior surfaces of thelead body 202 when theleady body 202 is in a relaxed state. InFIG. 2 , thelead profile 225 is represented by a dashed line that extends alongside a perimeter of thelead body 202. For illustrative purposes, the dashed line is spaced apart from the exterior surfaces of thelead body 202 that define thelead profile 225. By way of example, thelead body 202 may have a first dimension orwidth 231 that extends between exterior surfaces of theouter arms lead body 202 also has a second dimension orlength 232 that extends between an exterior surface of thedistal body end 204 and a location where theproximal body end 206 joins thelead cable 210. Thelead body 202 may also have a third dimension or thickness 233 (shown inFIG. 3 ) that extends betweenpaddle sides width 231, thelength 232, and thethickness 233 may have a varying or non-uniform value as thelead body 202 extends along the dimensions. For instance, thelength 232 is greatest when measured along thecentral axis 208. - As shown, the
lead profile 225 may include elongated windows or openings 241-244 that are defined between adjacent arms. More specifically, with respect to the illustrated embodiment, thelead body 202 defines theelongated window 241 between theouter arm 211 and theinner arm 212, theelongated window 242 between theinner arm 212 and theinner arm 215, theelongated window 243 between theinner arm 215 and theinner arm 213, and theelongated window 244 between theinner arm 213 and theouter arm 214. Theelongated windows 241 extend lengthwise along thecentral axis 208 and widthwise between the adjacent arms. The elongated windows 241-244 reduce or shrink when thelead 200 is in a collapsed state. - When the
lead 200 is in a relaxed state prior to insertion as shown inFIG. 2 , thelead profile 225 of thelead body 202 may be substantially planar widthwise and lengthwise. For example, the arms 211-215 may be substantially coplanar (e.g., substantially coincide along a common plane). In other embodiments, thelead profile 225 may have a curved contour when thelead body 202 is in a relaxed state. For example, thelead profile 225 may curve as thelead body 202 extends along the length 232 (e.g., such that thecentral axis 208 is not linear and has a curved or bent shape) and/or as thelead body 202 extends along the width 231 (e.g., thelead body 202 may be C-shaped as viewed along the central axis 208). The contours may be predetermined by the manufacturing process of thelead 200. For example, the contours may be predetermined to complement the anatomical structure that thelead 200 will interface. - During an implantation procedure, the
distal body end 204 is typically the first end that is inserted through an incision and into the spinal column. As shown, thelead cable 210 extends away from thelead body 202 from theproximal body end 206. Thelead cable 210 may include conductive pathways 286 (shown inFIG. 3 ), such as wire conductors, which extend from thelead body 202 to an NS device or pulse generator (not shown), such as the NS device 150 (FIG. 1 ). Theconductive pathways 286 also extend lengthwise along the arms 211-215 to electrically couple thecorresponding electrodes 250 to the pulse generator. - As shown in
FIG. 2 , thelead 200 also includes a plurality ofelectrodes 250 that are disposed along theouter arms inner arms inner arm 215. In other embodiments, theinner arm 215 may include one or more of theelectrodes 250. Theelectrodes 250 may comprise Platinum-Iridium (Pt—Ir) or other equivalent material. As one specific example only, the electrodes may be 90-10 Pt—Ir (i.e., 90% Platinum, 10% Iridium). Theelectrodes 250 may be positioned relative to each other to form amulti-electrode array 252. Themulti-electrode array 252 is a two-dimensional array in the illustrated embodiment. Theelectrodes 250 and/or themulti-electrode array 252 may be configured to provide a neurostimulation therapy in an epidural space of a patient. For example, electrical pulses transmitted from theNS device 150 may be provided at a predetermined schedule or frequency to provide therapy to the patient. It is noted that theFIG. 2 illustrates only one arrangement of theelectrodes 250. However, in other embodiments, theelectrodes 250 may have any one of a variety of arrangements. - When the
lead 200 is disposed in the epidural space, one of the paddle sides may interface with nerve tissue and the other paddle side may interface with an anatomical structure (e.g., bone, ligament, or other portions of the spine). In some embodiments, theelectrodes 250 may be exposed along each of the paddle sides 222, 224. In other embodiments, theelectrodes 250 may be exposed only along one of the paddle sides, such as thepaddle side 222 shown inFIG. 2 , and not the other paddle side. - In the illustrated embodiment, each of the
outer arms inner arms electrodes 250 that are spaced apart from each other along a length of the respective arm. When in an operative state (e.g., an expanded state), the arms are spaced apart from each other thereby laterally separating theelectrodes 250 of adjacent arms. To form themulti-electrode array 252 with a predetermined configuration, theelectrodes 250 may be disposed along the lengths of the respective arms at designated locations and the arms 211-215 may be configured to have a designated separation when in the expanded state so that theelectrodes 250 form themulti-electrode array 252. - In the illustrated embodiment,
multi-electrode array 252 includes a 4×5 grid ofelectrodes 250 in which theelectrodes 250 are substantially evenly distributed along (e.g. parallel to) thecentral axis 208. In alternative embodiments, theelectrodes 250 may form a single row or column that extends along thecentral axis 208 and are spaced apart from each other. In other embodiments, themulti-electrode array 252 may have a 4×4 grid ofelectrodes 250 or a 4×8 grid ofelectrodes 250. In particular embodiments, themulti-electrode array 252 may be configured to have a coverage similar to Penta™ paddle leads distributed by St. Jude. - To this end, the
lead body 202 may include a plurality of resilient members 261-264 (shown inFIG. 2B ) proximate to thedistal body end 204 and a plurality of resilient members 271-274 (shown inFIG. 2C ) proximate to theproximal body end 206. In the illustrated embodiment, the resilient members 261-264 are located within the arms 211-214, respectively, and the resilient members 271-274 are located within the arms 211-214, respectively. In an exemplary embodiment, the resilient members 261-264 and 271-274 include a resilient material that is capable of being collapsed when a force is applied and biased to flex back to a designated shape when the force is removed. In certain embodiments, the resilient material is a metal or metal alloy. The resilient material may have shape memory. In particular embodiments, the resilient material includes nitinol, which is a metal alloy of nickel and titanium. However, other materials, including combinations of materials, may be used. -
FIGS. 2A-2C show thelead 200 in a relaxed or expanded state. The resilient members are biased to flex the respective arm from a collapsed condition to an expanded condition in a direction that is away from the central axis 208 (or the center inner arm 215). The resilient members also permit the respective arm to flex toward the central axis 208 (or the center inner arm 215) from the expanded condition to the collapsed condition when a force is applied. -
FIGS. 3-5 illustrate different cross-sections of thelead 200 as shown inFIG. 2A .FIG. 3 is taken along the line 3-3 inFIG. 2A and illustrates cross-section of the arms 211-215 in greater detail. For illustrative purposes, thelead profile 225 is shown. Thelead body 202 includes the paddle sides 222 and 224. Each of the arms 211-215 has a cross-section that includes anarm width 281 and anarm height 283. In some embodiments, thearm height 283 may be substantially equal to thethickness 233 of thelead body 202 or thelead profile 225 at the cross-section shown inFIG. 3 . In particular embodiments, the arms 211-215 are narrow, elongated splines or beams in which thearm width 281 and thearm height 283 are approximately equal. For example, thearm width 281 and thearm height 283 may differ by at most 50% of the greater of thearm width 281 and thearm height 283. For example, if thearm width 281 were about 1.5 mm, thearm height 283 may be about 0.75 mm. If thearm height 283 is larger and is, for example, about 1.0 mm, thearm width 281 may be about 0.75 mm. In other embodiments, thearm width 281 and thearm height 283 may differ by at most 25% of the greater of thearm width 281 and thearm height 283 or, more particularly, by at most 10% of the greater of thearm width 281 and thearm height 283. - In the illustrated embodiment, the cross-section of the arms 211-215 have a substantially circular shape or substantially square shape such that the
arm width 281 and thearm height 283 are substantially equal In other embodiments, the arms 211-215 may have a substantially rectangular shape. For example, thearm width 281 may be about 2.25 mm and thearm height 283 may be about 1.0 mm. - As shown, the arms 211-215 comprise an
insulative material 284 that may include the exterior surfaces of the arms 211-215. InFIG. 3 , the arms 211-214 also include conductive pathways 286 (e.g., wire conductors). Theconductive pathways 286 comprise a conductive material, such as copper, and are configured to transmit electrical signals (e.g., current) to corresponding electrodes 250 (FIG. 2A ). Theconductive pathways 286 are electrically coupled to the pulse generator of theNS system 100. As described above, a designated frequency may be transmitted to theelectrodes 250 in order to provide therapy to a patient. In an exemplary embodiment, theconductive pathways 286 may include jackets that insulate theconductive pathways 286 from each other. - The
inner arm 215 includes asteering lumen 288. Thesteering lumen 288 may be defined by an interior surface of theinsulative material 284. Thesteering lumen 288 may extend lengthwise through theinner arm 215 from the proximal body end 206 (FIGS. 2A and 2C ) to and, optionally, through the distal body end 204 (FIGS. 2A and 2B ). Thesteering lumen 288 is sized and shaped to receive anelongated tool 290, such as a guide wire. Theelongated tool 290 may be used during the insertion process to guide the lead 200 (FIG. 2A ). - The
insulative material 284 may include one or more biocompatible materials. Non-limiting examples of such materials include polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET) film (also known as polyester or Mylar), polytetrafluoroethylene (PTFE) (e.g., Teflon), or parylene coating, polyether bloc amides, polyurethane. In some embodiments, the material of thelead body 202 that surrounds the metal components (e.g.,electrodes 250 and theconductive pathways 286 that couple to the electrodes 250) includes at least one of polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET) film, polytetrafluoroethylene (PTFE), parylene, polyether bloc amides, or polyurethane. -
FIG. 4 shows cross-sections of the arms 211-215 taken along the line 4-4 ofFIG. 2A . InFIG. 4 , each of the arms 211-214 includes one of theelectrodes 250. Theelectrode 250 is configured to be exposed along an outer surface of the respective arm so that theelectrode 250 may interface with an anatomical structure, such as nerve tissue. InFIG. 4 , theelectrodes 250 are completely exposed along the outer surface. In other embodiments, one or more portions of theelectrodes 250 may be covered such that the corresponding portion(s) is not exposed. For instance, theinsulative material 284 may cover the one or more portions of theelectrodes 250. As shown inFIG. 4 , theelectrode 250 may be separated from anadjacent electrode 250 by agap 292. Thegaps 292 may be part of the elongated windows 241-244. -
FIG. 5 shows cross-sections of the joints 265-268 of the respective arms 211-215 (FIG. 2A ) taken along the line 5-5 inFIG. 2A . As shown, each of the joints 265-268 includes the respective resilient member 261-264 that is at least partially surrounded by theinsulative material 284. The resilient members 261-264 of the respective joints 265-268 are dimensioned and shaped to function as described herein. For example, the resilient members 261-264 may be etched, creased, and/or have varying dimensions in order to provide sufficient resiliency for returning the arms 211-214 to the expanded state when the force is removed. In some embodiments, the resilient members 261-264 may be etched (e.g., laser-cut) to provide the designated shape. -
FIG. 6 shows a cross-section of thelead body 202 when each of the arms 211-214 is in a collapsed condition within aninsertion tool 296, which may also be referenced as an introducer. The resilient members 261-264, 271-274 (FIGS. 2B and 2C , respectively) may be configured such that the arms 211-214 collapse in a designated manner. For example, the resilient members 261-264, 271-274 may be shaped such that when a laterally-inward force F1 (indicated by the inwardly pointing arrows) is provided, the arms 211-214 collapse toward (e.g., move toward) theinner arm 215 and/or thecentral axis 208. The laterally-inward force F1 may be applied when thelead body 202 is drawn into or advanced into a cavity of an insertion tool. The cavity may be defined by interior surfaces of the insertion tool. Thelead body 202 may slide through the insertion tool when a linear force is applied. The linear force may be translated into the laterally-inward force F1 as the unyielding interior surface of the insertion tool collapses the arms 211-214. - In the illustrated embodiment, when the
lead body 202 is in an expanded state, each of the arms 211-214 coincides with abody plane 298 prior to the arms 211-214 collapsing. As the arms 211-214 collapse, the arms 211-214 move along thebody plane 298 in an inward direction toward theinner arm 215 and/or toward thecentral axis 208. When the arms 211-214 are in the collapsed conditions as shown inFIG. 6 , the arms 211-214 may be co-planar with one another such that the arms 211-214 coincide with thebody plane 298. -
FIG. 7 shows a cross-section of alead body 302 when thelead body 302 is located within aninsertion tool 396. Thelead body 302 may be similar or identical to the lead body 202 (FIG. 2A ). For example, thelead body 302 includes arms 311-315. As shown inFIG. 7 , each of the arms 311-314 is in a collapsed condition within acavity 397 of theinsertion tool 396. Thecavity 397 is defined by one or more interior surfaces of theinsertion tool 396. Although not shown, the arms 311-314 may include resilient members, such as the resilient members 261-264, 271-274 (FIGS. 2B and 2C , respectively), which may be configured to expand the arms 311-314 in a designated manner and permit the arms 311-314 to collapse in a designated manner. For instance, the resilient members may be shaped such that when an inward force F2 (indicated by arrows) is provided, the arms 311-314 collapse toward theinner arm 315 and/or acentral axis 308 of thelead body 302. However, the resilient members of the arms 311-314 may be biased such that the arms 311-314 move toward theinner arm 315 or thecentral axis 308 in a different manner than the arms 211-214 shown inFIG. 6 . For instance, theinner arms inner arm 315 and theinner arms inner arms FIG. 7 . In other embodiments, the stacked configuration may include the inner arms 311-314 forming a square perimeter that surrounds theinner arm 315 within a center of the stacked configuration. -
FIG. 8 illustrates a series of stages 401-406 during an insertion process in which a self-expandinglead 410 clears anend opening 412 of an insertion tool 414 (e.g., an introducer). Thelead 410 may be similar or identical to other self-expanding leads described herein and have adistal body end 416 and a proximal body end 418 (shown with respect to the stage 406). Thelead 410 may include arms 421-424 that have resilient members (not shown) that enable the arms 421-424 to flex between collapsed and expanded conditions. Unlike other self-expandable leads described herein, thelead 410 does not include a central inner arm through which a steering lumen extends. In alternative embodiments, thelead 410 may include such an inner arm. - At
stage 401, thelead 410 is disposed within a cavity, such as the cavity 397 (FIG. 7 ), of theinsertion tool 414. As described above, the relaxed state of thelead 410 may be the expanded state. When thelead 410 is advanced into thecavity 397, interior surfaces of theinsertion tool 414 that define the cavity may engage one or more of the arms, such as thearms insertion tool 414 may resist lateral deformation such that theinsertion tool 414 pushes thearms arms 422, 423 laterally-inward as thelead 410 is advanced into the cavity. Thus, the linear insertion force that is applied to thelead 410 may be translated by the interior surface(s) of theinsertion tool 414 into a laterally-inward force that collapses the arms 211-214. - Before or after the
lead 410 has been disposed within theinsertion tool 414, theinsertion tool 414 may be advanced into a patient (not shown) through one or more incisions. For example, theinsertion tool 414 may be advanced through one or more incisions that provide access to the spinal cord (not shown). In some embodiments, theinsertion tool 414 may be identical to the introducers that are used to insert percutaneous leads into the spinal cord. In other embodiments, theinsertion tool 414 may not be identical, but may have dimensions that are approximate to or similar to the dimensions of conventional percutaneous introducers. - At
stage 402, thedistal body end 416 clears the end opening 412 of theinsertion tool 414. As the lead 410 transitions to stage 403, thedistal body end 416 may expand to have a larger lead profile. At this time, thedistal body end 416 may engage tissue within the anatomical space (not shown). Geometries of the anatomical space, including the epidural space, vary from patient to patient. In some cases, it may be desirable for thelead 410 to be capable of moving around obstructions, such as bone or tissue, and/or to be capable for moving tissue without causing significant trauma to the patient. In accordance with some embodiments, the resiliency of the arms 421-424 at thedistal body end 416 may be configured such that thedistal body end 416 is capable of engaging and flexing to slide around tissue and/or is capable of engaging and moving tissue within the anatomical space. - At
stage 404, thedistal body end 416 has cleared the end opening 412 of theinsertion tool 414 and a majority of a length of thelead 410 has advanced into the anatomical space. Atstages proximal body end 418 has expanded such that the arms 421-424 are fully expanded and thelead 410 has a maximum lead profile. Before or after thelead 410 is properly position within the epidural space, thetool 414 may be withdrawn through the one or more incision cites. -
FIG. 9 illustrates a guidingdevice 500 that may be used to direct the self-expandinglead 200 into an anatomical space of a patient. As shown, the guidingdevice 500 includes aguide wire 502 that is operably coupled to ahandle 504 that is configured to be gripped by an individual (e.g., doctor). InFIG. 9 , theguide wire 502 is inserted entirely through the steering lumen 288 (FIG. 3 ) of theinner arm 215 such that theguide wire 502 extends beyond thedistal body end 204 of thelead 200. - The insertion process with respect to the
lead 200 may be similar to the insertion process described with respect toFIG. 8 . However, before or after thelead 200 is loaded into the insertion tool (not shown), theguide wire 502 of the guidingdevice 500 may be inserted through thesteering lumen 288 of theinner arm 215. After the insertion tool has been advanced through the incision site and positioned proximate to the designated anatomical space as described above, theguide wire 502 may be moved into the anatomical space before thelead 200 clears the end opening (not shown) of the insertion tool. With theguide wire 502 located within the anatomical space, thelead 200 may be advanced into the anatomical space with theguide wire 502 directing or guiding thelead 200. As thelead 200 is advanced into the anatomical space, thedistal body end 204 of thelead 200 expands. In some embodiments, the expanding of thelead 200 may displace tissue or other obstructions thereby permitting theguide wire 502 to advance. After thelead 200 has partially expanded, thelead 200 may then be further advanced into the anatomical space. -
FIGS. 10-13 illustrate self-expandable leads having flexible membranes. For some applications, it may be desirable to have a flexible membrane extend across the width of the lead and join the arms of the lead body. The flexible membranes may impede growth of tissue around the arms which may enable a simpler process for withdrawing the lead with a decreased likelihood of trauma or injury to the patient. For example,FIG. 10 is a perspective view of a self-expandinglead 600 that utilizes aflexible membrane 602 in accordance with one embodiment. Other than theflexible membrane 602, thelead 600 may be identical to the lead 200 (FIG. 2A ). For example, thelead 200 may include alead body 604 having arms 611-615. In the, expanded state shown inFIG. 10 , thelead body 604 has first and second paddle sides 622, 624. Also shown, thelead 600 includes elongated windows or openings 641-644 that are defined between adjacent arms. Theflexible membrane 602 extends along thepaddles side 624 and covers the elongated windows 641-644. -
FIG. 11 is a cross-section of thelead 600 taken along the line 11-11 inFIG. 10 . Theflexible membrane 602 may be attached to the arms 611-615 along thepaddle side 624 in one or more manners. For example, theflexible membrane 602 may comprise a biocompatible material, which may be the same as or similar to theinsulative material 284, that is attached by selectively applying heat to theflexible membrane 602. In other embodiments, an adhesive may be applied to theflexible membrane 602, which may then be attached to the arms 611-614. - In the embodiment of
FIG. 11 , thelead 600 has a uni-directional configuration. More specifically, theflexible membrane 602 may extend along thepaddle side 624 such that electrodes 650 (FIG. 10 ) of thelead 600 are covered by theflexible membrane 602 and are only exposed along thepaddle side 622. In such embodiments, it may be necessary to orient thelead 600 so that a predetermined paddle side interfaces with the nerve tissue. -
FIG. 12 is a cross-section of a self-expandinglead 700 having aflexible membrane 702 in accordance with one embodiment. Other than theflexible membrane 702, thelead 700 may be identical to the lead 200 (FIG. 2A ). In the embodiment ofFIG. 12 , theflexible membrane 702 is applied to apaddle side 724 of thelead 700. Theflexible membrane 702 may haveelectrode openings 752 that expose theelectrodes 750 along thepaddle side 724. Theelectrode openings 752 may be fabricate by etching theflexible membrane 702 material after theflexible membrane 702 has been applied to thepaddle side 724. In some embodiments, theflexible membrane 702 may be applied through an injection molding process. With injection molding, thelead 700 may be positioned within a mold that covers portions of theelectrodes 750 so that molten membrane material cures at designated portions thereby forming theelectrode openings 752. - Accordingly, embodiments described herein may have a flexible membrane along one or both paddle sides. The flexible membrane may limit adhesion of the self-expanding lead to the patient by limiting growth of tissue or other material within the epidural space around the arms of the lead. In such embodiments that utilize a flexible membrane, the flexible membrane may be capable of folding over within the cavity of the insertion tool, such as the
insertion tool 414, thereby permitting the expanding/collapsing abilities of the leads described herein. -
FIG. 13 illustrates a plan view of a self-expandinglead 850 in an expanded state. Thelead 850 may be similar to other leads described herein, such as the lead 200 (FIG. 2A ). For example, thelead 850 includes alead body 852 having adistal body end 854, aproximal body end 856, and acentral axis 858 extending therebetween. Theproximal body end 856 may include an end 866 (or cable end) of alead cable 860. As shown, thelead body 852 includes a plurality of arms or splines 861-865 that extend lengthwise between thedistal body end 854 and theproximal body end 856 along thecentral axis 858. In the illustrated embodiment, the arms 861-865 include first and secondouter arms inner arms inner arm 865. Theinner arms outer arms inner arm 865 is disposed between the first and secondinner arms - The
lead cable 860 may include conductive pathways (not shown), such as wire conductors, which extend from thelead body 852 to an NS device or pulse generator (not shown), such as the NS device 150 (FIG. 1 ). The conductive pathways also extend lengthwise along the arms 861-865 to electricallycouple corresponding electrodes 890 to the pulse generator. As shown, the correspondingelectrodes 890 are disposed along each of the arms 861-865, including theinner arm 865. Theelectrodes 890 may be positioned relative to each other to form amulti-electrode array 896. - Although not shown, the
lead body 852 may include a plurality of resilient members proximate to thedistal body end 854 and a plurality of resilient members proximate to theproximal body end 856. The resilient members may be similar to the resilient members 261-264 and 271-274 (FIGS. 2B and 2C , respectively) described with respect to thelead 200 and located within the arms. The resilient members may include a resilient material that is capable of being collapsed when a force is applied and biased to flex back to a designated shape when the force is removed. - In the illustrated embodiment, the
inner arm 865 includes asteering lumen 888. Thesteering lumen 888 extends through thelead cable 860 into theinner arm 865. Thesteering lumen 888 may be defined by an interior surface of an insulative material of thelead cable 860 and theinner arm 865. As shown, thesteering lumen 888 extends lengthwise through theinner arm 865 from theproximal body end 856 and through thedistal body end 854. Thesteering lumen 888 is sized and shaped to receive an elongated tool, which is illustrated as aguide wire 892 inFIG. 13 . Theguide wire 892 may be used during the insertion process to guide thelead 850 to a designated position in the epidural space (not shown). More specifically, thedistal body end 854 may have an opening that permits awire end 894 of theguide wire 892 to clear thedistal body end 854 and be positioned within the epidural. With thewire end 894 located within the epidural space, thelead 850 may then be directed along theguide wire 892 and delivered to the epidural space. The path taken by thelead 850 is determined by the shape of theguide wire 892. - In some embodiments, the center
inner arm 865 may not include resilient material for flexing between different positions. For example, in particular embodiments, the centerinner arm 865 may not include such resilient material and, instead, may include a more rigid material. The rigid material may be more suitable for receiving a tool, such as theguide wire 892. -
FIG. 14 illustrates a plan view of a self-expandinglead 900 in an expanded state. Thelead 900 may have alead body 902 that is similar in shape as thelead body 852. However, as shown inFIG. 14 , a centerinner arm 925 of thelead body 902 may not have a steering lumen that extends entirely through thelead body 902. Instead, the centerinner arm 925 may end short of adistal body end 932 and permitinner arms outer arms - However, the
lead body 902 may have asteering lumen 904 that extends to and ends at acable end 906 of alead cable 908. As shown, aguide wire 910 may be inserted into thesteering lumen 904 until awire end 912 of theguide wire 910 engages thecable end 906 of thelead body 902. Theguide wire 910 may be operated to move thelead body 902 into a designated orientation. For example, when thelead body 902 is inserted into the epidural space (not shown), thelead body 902 may be moved to into a designated orientation by theguide wire 910. More specifically, thelead body 902 may pivot (as indicated by the arrows) about apoint 930 located within thecable end 906. -
FIG. 15 is a block diagram illustrating amethod 800 of manufacturing a self-expandable lead in accordance with one embodiment. The lead may be similar to the leads shown and described in the present application. Themethod 800 includes fabricating (at 802) resilient members. The resilient members may be fabricated (at 802) by etching a sheet of resilient material (e.g., metal alloy or plastic). In particular embodiments, the sheet of resilient material includes nitinol. The etching may include laser-cutting the sheet material. The resilient members may be elongated structures that extend along curved paths. For instance, in a relaxed state, the resilient members may extend along curved paths that have similar shapes as the arms that the resilient members will be located within. As one example, the resilient members may be shaped similar to the resilient members 261-264 and 271-274 shown inFIGS. 2B and 2C , respectively. - The
method 800 also includes assembling (at 804) wire conductors and electrodes of the lead. The assembling (at 804) may include positioning the resilient members relative to the wire conductors and the electrodes. At 806, an insulative material may be applied (e.g., molded) to the assembly of wire conductors, electrodes, and resilient members. The insulative material may be a biocompatible material, such as the materials described herein. The insulative material may completely cover or insulate the wire conductors and at least partially cover the electrodes. The resilient members may be at least partially covered by the insulative material. - A lead body may be formed upon applying the insulative material at 806. The lead body may be similar to other leads or lead bodies described herein, such as the
lead body 200. In particular, the lead body may include a plurality of arms that extend between a distal body end and a proximal body end of the lead body. For example, the arms may include first and second outer arms and an inner arm generally disposed between the first and second outer arms. The first and second outer arms and the inner arm may extend lengthwise between the proximal body end and the distal body end. - The electrodes may form a multi-electrode array that is configured to apply a neurostimulation therapy. Some or all of the electrodes may be positioned along the first and second outer arms. Each of the first and second outer arms may include at least one of the resilient members. The resilient members may bias the respective outer arm to flex from a collapsed condition to an expanded condition in a laterally-outward direction. The resilient members may also permit the respective outer arm to flex laterally-inward from the expanded condition to the collapsed condition when a force is applied.
- Optionally, at 808, a flexible membrane may be applied to a paddle side of the lead body. The flexible membrane may be similar to the
flexible membranes 602 or 702 (FIGS. 10 and 12 , respectively). In some embodiments, the flexible membrane may be applied (at 808) after the lead body is formed. In other embodiments, the flexible membrane may be applied as the lead body is formed. For example, the flexible membrane may be molded with the arms of the lead body. In some embodiments, a flexible membrane may be applied on each of the paddle sides. - It is to be understood that the subject matter described herein is not limited in its application to the details of construction and the arrangement of components set forth in the description herein or illustrated in the drawings hereof. The subject matter described herein is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
- Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings. Also, it is to be understood that phraseology and terminology used herein with reference to device or element orientation (such as, for example, terms like “central,” “upper,” “lower,” “front,” “rear,” “distal,” “proximal,” and the like) are only used to simplify description of one or more embodiments described herein, and do not alone indicate or imply that the device or element referred to must have a particular orientation. In addition, terms such as “outer” and “inner” are used herein for purposes of description and are not intended to indicate or imply relative importance or significance.
- It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the presently described subject matter without departing from its scope. While the dimensions, types of materials and coatings described herein are intended to define the parameters of the disclosed subject matter, they are by no means limiting and are exemplary embodiments. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the inventive subject matter should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. Further, the limitations of the following claims are not written in means—plus-function format and are not intended to be interpreted based on 35 U.S.C. §112, sixth paragraph, unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure.
- The following claims recite aspects of certain embodiments of the inventive subject matter and are considered to be part of the above disclosure.
Claims (20)
1. A self-expanding lead comprising:
a lead body having a distal body end, a proximal body end, and a central axis extending therebetween, the lead body comprising first and second outer arms and an inner arm disposed generally between the first and second outer arms, the first and second outer arms and the inner arm extending lengthwise between the proximal body end and the distal body end; and
an array of electrodes configured to apply a neurostimulation therapy within an epidural space of a patient, at least some of the electrodes being positioned along the first and second outer arms;
wherein each of the first and second outer arms includes a resilient member that is biased to flex the corresponding first and second outer arms from a collapsed condition to an expanded condition in a lateral direction away from the inner arm, the resilient members permitting the corresponding first and second outer arms to flex toward the inner arm from the expanded condition to the collapsed condition when a force is applied.
2. The self-expanding lead of claim 1 , wherein the inner arm includes a steering lumen at the distal body end, the steering lumen sized and shaped to receive an elongated tool for directing the lead body during an insertion process.
3. The self-expanding lead of claim 2 , wherein the steering lumen extends through the proximal body end to the distal body end.
4. The self-expanding lead of claim 1 , wherein the inner arm includes at least some of the electrodes from the array of electrodes.
5. The self-expanding lead of claim 4 , wherein the inner arm includes a respective resilient member that biases the inner arm to flex from a corresponding collapsed condition to a corresponding expanded condition, the resilient member of the inner arm permitting the inner arm to be flexed to the collapsed condition when the force is applied.
6. The self-expanding lead of claim 1 , wherein the inner arm is a first inner arm and the lead body includes a second inner arm, each of the first and second inner arms including at least some of the electrodes of the array.
7. The self-expanding lead of claim 1 , wherein the first and second outer arms partially define first and second elongated windows, respectively, the first and second elongated windows extending between the proximal body end and distal body end and between the respective outer arm and the inner arm.
8. The self-expanding lead of claim 7 , further comprising a flexible membrane that is coupled to the lead body and covers at least one of the first and second elongated windows.
9. The self-expanding lead of claim 7 , wherein the lead body has opposite paddle sides when the first and second arms are in the expanded conditions, the self-expanding lead further comprising a flexible membrane that is coupled to the lead body and covers at least one of the paddle sides.
10. The self-expanding lead of claim 1 , wherein each of the first and second arms has an arm cross-section that includes first and second dimensions, the first and second dimensions being perpendicular with respect to each other and differing by at most 50%.
11. A self-expanding lead comprising:
first and second outer arms extending between respective base and distal arm ends;
an inner arm disposed generally between the first and second outer arms, the inner arm extending between a respective base end and a respective distal arm end, the base ends of the inner arm and the first and second outer arms being coupled to each other proximate to a proximal body end of the self-expanding lead; and
a multi-electrode array including a plurality of electrodes, the first and second arms including at least one electrode of the multi-electrode array, wherein each of the first and second outer arms includes a resilient member that is biased to flex the corresponding first and second outer arms from a collapsed condition to an expanded condition in a laterally-outward direction, the resilient members permitting the corresponding first and second outer arms to flex in a laterally-inward direction from the expanded condition to the collapsed condition when a force is applied;
wherein the electrodes of the multi-electrode array are configured to have predetermined positions with respect to one another when the first and second outer arms are in the expanded conditions in order to apply a neurostimulation therapy within an epidural space of a patient.
12. The self-expanding lead of claim 11 , wherein the distal arm ends of the inner arm and the first and second outer arms are coupled to each other proximate to a distal body end of the self-expanding lead.
13. The self-expanding lead of claim 11 , wherein the inner arm includes a steering lumen, the steering lumen sized and shaped to receive an elongated tool for directing the lead body during an insertion process.
14. The self-expanding lead of claim 11 , wherein the inner arm includes electrodes positioned along a length of the inner arm, the electrodes of the inner arm being part of the multi-electrode array.
15. The self-expanding lead of claim 11 , wherein the inner arm is a first inner arm and the self-expandable lead also includes a second inner arm, each of the first and second inner arms including electrodes that form part of the multi-electrode array.
16. The self-expanding lead of claim 15 , wherein the first outer arm and the first inner arm are adjacent to each other and the second outer arm and the second inner arm are adjacent to each other, the first outer arm and inner arm moving in a common direction toward the second outer arm and the second inner arm when the lead is collapsed.
17. The self-expanding lead of claim 11 , wherein the self-expandable lead has opposite paddle sides when the first and second arms are in the expanded conditions, the self-expandable lead further comprising a flexible membrane that is coupled to the lead body and covers at least one of the paddle sides.
18. The self-expandable lead of claim 16 , wherein the flexible membrane extends along only one of the paddle sides.
19. The self-expanding lead of claim 16 , wherein the flexible membrane has electrode openings that expose portions of the electrodes along the at least one paddle side.
20. The self-expanding lead of claim 11 , wherein each of the first and second arms has an arm cross-section that includes first and second dimensions, the first and second dimensions being perpendicular with respect to each other and differing by at most 50%.
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EP (6) | EP4101372A1 (en) |
JP (3) | JP6050522B2 (en) |
CN (1) | CN104968261B (en) |
WO (1) | WO2014113612A1 (en) |
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5931862A (en) * | 1997-12-22 | 1999-08-03 | Pacesetter, Inc. | Medical lead and method of making and using with sodium sulfosuccinic ester |
US6415187B1 (en) * | 1998-02-10 | 2002-07-02 | Advanced Bionics Corporation | Implantable, expandable, multicontact electrodes and insertion needle for use therewith |
US6522932B1 (en) * | 1998-02-10 | 2003-02-18 | Advanced Bionics Corporation | Implantable, expandable, multicontact electrodes and tools for use therewith |
US20030065371A1 (en) * | 2001-09-28 | 2003-04-03 | Shutaro Satake | Radiofrequency thermal balloon catheter |
US8019442B1 (en) * | 2006-10-25 | 2011-09-13 | Advanced Neuromodulation Systems, Inc. | Assembly kit for creating paddle-style lead from one or several percutaneous leads and method of lead implantation |
Family Cites Families (116)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US878997A (en) | 1907-04-05 | 1908-02-11 | Darius W Payne | Apparatus for tempering cream and other liquids. |
US2421261A (en) | 1938-10-13 | 1947-05-27 | American Steel & Wire Co | Hardware and screen cloth machine |
US3116195A (en) | 1960-04-27 | 1963-12-31 | Lathrop Castle Engerprises Inc | Tape applicator |
US3109953A (en) | 1960-09-28 | 1963-11-05 | Gen Electric | Cathode ray tube having a plurality of interchangeable cathodes |
US4085943A (en) | 1976-10-12 | 1978-04-25 | C. R. Reichel Engineering Co. Inc. | Self ejecting drill chuck key |
US4522212A (en) | 1983-11-14 | 1985-06-11 | Mansfield Scientific, Inc. | Endocardial electrode |
US4699147A (en) | 1985-09-25 | 1987-10-13 | Cordis Corporation | Intraventricular multielectrode cardial mapping probe and method for using same |
US4963128A (en) * | 1989-03-21 | 1990-10-16 | University Of Virginia Alumni Patents Foundation | Chest tube and catheter grid for intrathoracic afterload radiotherapy |
US5044368A (en) | 1990-04-23 | 1991-09-03 | Ad-Tech Medical Instrument Corporation | Diagnostic electrode for use with magnetic resonance imaging |
US5156151A (en) * | 1991-02-15 | 1992-10-20 | Cardiac Pathways Corporation | Endocardial mapping and ablation system and catheter probe |
US5387234A (en) * | 1992-05-21 | 1995-02-07 | Siemens-Elema Ab | Medical electrode device |
US5772590A (en) | 1992-06-30 | 1998-06-30 | Cordis Webster, Inc. | Cardiovascular catheter with laterally stable basket-shaped electrode array with puller wire |
US5385146A (en) * | 1993-01-08 | 1995-01-31 | Goldreyer; Bruce N. | Orthogonal sensing for use in clinical electrophysiology |
US5730127A (en) | 1993-12-03 | 1998-03-24 | Avitall; Boaz | Mapping and ablation catheter system |
US6216043B1 (en) * | 1994-03-04 | 2001-04-10 | Ep Technologies, Inc. | Asymmetric multiple electrode support structures |
US5797905A (en) * | 1994-08-08 | 1998-08-25 | E. P. Technologies Inc. | Flexible tissue ablation elements for making long lesions |
US5885278A (en) | 1994-10-07 | 1999-03-23 | E.P. Technologies, Inc. | Structures for deploying movable electrode elements |
US5836947A (en) * | 1994-10-07 | 1998-11-17 | Ep Technologies, Inc. | Flexible structures having movable splines for supporting electrode elements |
US5702438A (en) | 1995-06-08 | 1997-12-30 | Avitall; Boaz | Expandable recording and ablation catheter system |
NL1001890C2 (en) * | 1995-12-13 | 1997-06-17 | Cordis Europ | Catheter with plate-shaped electrode array. |
US5879295A (en) * | 1997-04-02 | 1999-03-09 | Medtronic, Inc. | Enhanced contact steerable bowing electrode catheter assembly |
US6477423B1 (en) * | 1997-05-28 | 2002-11-05 | Transneuronix, Inc. | Medical device for use in laparoscopic surgery |
US6652515B1 (en) | 1997-07-08 | 2003-11-25 | Atrionix, Inc. | Tissue ablation device assembly and method for electrically isolating a pulmonary vein ostium from an atrial wall |
US5964757A (en) | 1997-09-05 | 1999-10-12 | Cordis Webster, Inc. | Steerable direct myocardial revascularization catheter |
US6123699A (en) | 1997-09-05 | 2000-09-26 | Cordis Webster, Inc. | Omni-directional steerable catheter |
JP2002501769A (en) * | 1997-10-30 | 2002-01-22 | イー.ピー. テクノロジーズ, インコーポレイテッド | Catheter distal assembly with pull wire |
US6171277B1 (en) | 1997-12-01 | 2001-01-09 | Cordis Webster, Inc. | Bi-directional control handle for steerable catheter |
US6183463B1 (en) | 1997-12-01 | 2001-02-06 | Cordis Webster, Inc. | Bidirectional steerable cathether with bidirectional control handle |
US6120476A (en) * | 1997-12-01 | 2000-09-19 | Cordis Webster, Inc. | Irrigated tip catheter |
US6558378B2 (en) * | 1998-05-05 | 2003-05-06 | Cardiac Pacemakers, Inc. | RF ablation system and method having automatic temperature control |
US6029091A (en) | 1998-07-09 | 2000-02-22 | Irvine Biomedical, Inc. | Catheter system having lattice electrodes |
US6198974B1 (en) | 1998-08-14 | 2001-03-06 | Cordis Webster, Inc. | Bi-directional steerable catheter |
US6210407B1 (en) | 1998-12-03 | 2001-04-03 | Cordis Webster, Inc. | Bi-directional electrode catheter |
US6267746B1 (en) | 1999-03-22 | 2001-07-31 | Biosense Webster, Inc. | Multi-directional steerable catheters and control handles |
US6292678B1 (en) * | 1999-05-13 | 2001-09-18 | Stereotaxis, Inc. | Method of magnetically navigating medical devices with magnetic fields and gradients, and medical devices adapted therefor |
US7387628B1 (en) | 2000-09-15 | 2008-06-17 | Boston Scientific Scimed, Inc. | Methods and systems for focused bipolar tissue ablation |
ATE418287T1 (en) * | 2001-04-27 | 2009-01-15 | Bard Inc C R | CATHETER FOR THREE-DIMENSIONAL IMAGING OF ELECTRICAL ACTIVITY IN BLOOD VESSELS |
US6669693B2 (en) * | 2001-11-13 | 2003-12-30 | Mayo Foundation For Medical Education And Research | Tissue ablation device and methods of using |
US6748255B2 (en) | 2001-12-14 | 2004-06-08 | Biosense Webster, Inc. | Basket catheter with multiple location sensors |
US6741878B2 (en) | 2001-12-14 | 2004-05-25 | Biosense Webster, Inc. | Basket catheter with improved expansion mechanism |
US20030120328A1 (en) * | 2001-12-21 | 2003-06-26 | Transneuronix, Inc. | Medical implant device for electrostimulation using discrete micro-electrodes |
US6961602B2 (en) | 2001-12-31 | 2005-11-01 | Biosense Webster, Inc. | Catheter having multiple spines each having electrical mapping and location sensing capabilities |
US7089045B2 (en) | 2002-08-30 | 2006-08-08 | Biosense Webster, Inc. | Catheter and method for mapping Purkinje fibers |
US7400931B2 (en) | 2002-09-18 | 2008-07-15 | Cardiac Pacemakers, Inc. | Devices and methods to stimulate therapeutic angiogenesis for ischemia and heart failure |
US7027851B2 (en) | 2002-10-30 | 2006-04-11 | Biosense Webster, Inc. | Multi-tip steerable catheter |
US8021362B2 (en) * | 2003-03-27 | 2011-09-20 | Terumo Kabushiki Kaisha | Methods and apparatus for closing a layered tissue defect |
US7003342B2 (en) | 2003-06-02 | 2006-02-21 | Biosense Webster, Inc. | Catheter and method for mapping a pulmonary vein |
US7326206B2 (en) | 2004-01-16 | 2008-02-05 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Conforming-electrode catheter and method for ablation |
US20080319418A1 (en) * | 2004-03-30 | 2008-12-25 | Cathrx Pty Ltd | Catheter Steering Device |
US7591799B2 (en) | 2004-06-14 | 2009-09-22 | Biosense Webster, Inc. | Steering mechanism for bi-directional catheter |
US20060089637A1 (en) | 2004-10-14 | 2006-04-27 | Werneth Randell L | Ablation catheter |
US7429261B2 (en) | 2004-11-24 | 2008-09-30 | Ablation Frontiers, Inc. | Atrial ablation catheter and method of use |
US7945331B2 (en) | 2005-01-11 | 2011-05-17 | Bradley D. Vilims | Combination electrical stimulating and infusion medical device and method |
AU2006262447A1 (en) | 2005-06-20 | 2007-01-04 | Medtronic Ablation Frontiers Llc | Ablation catheter |
US7301332B2 (en) * | 2005-10-06 | 2007-11-27 | Biosense Webster, Inc. | Magnetic sensor assembly |
WO2007079268A2 (en) | 2005-12-30 | 2007-07-12 | C.R. Bard, Inc. | Methods and apparatus for ablation of cardiac tissue |
US7879029B2 (en) | 2005-12-30 | 2011-02-01 | Biosense Webster, Inc. | System and method for selectively energizing catheter electrodes |
WO2007109171A2 (en) | 2006-03-17 | 2007-09-27 | Microcube, Llc | Devices and methods for creating continuous lesions |
US8744599B2 (en) | 2007-03-09 | 2014-06-03 | St. Jude Medical, Atrial Fibrillation Division, Inc. | High density mapping catheter |
EP2136702B1 (en) * | 2007-03-26 | 2015-07-01 | Boston Scientific Limited | High resolution electrophysiology catheter |
US8979837B2 (en) * | 2007-04-04 | 2015-03-17 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Flexible tip catheter with extended fluid lumen |
US8187267B2 (en) | 2007-05-23 | 2012-05-29 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Ablation catheter with flexible tip and methods of making the same |
WO2008141150A2 (en) * | 2007-05-09 | 2008-11-20 | Irvine Biomedical, Inc. | Basket catheter having multiple electrodes |
US8974454B2 (en) | 2009-12-31 | 2015-03-10 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Kit for non-invasive electrophysiology procedures and method of its use |
US11395694B2 (en) | 2009-05-07 | 2022-07-26 | St. Jude Medical, Llc | Irrigated ablation catheter with multiple segmented ablation electrodes |
WO2009023385A1 (en) | 2007-07-03 | 2009-02-19 | Irvine Biomedical, Inc. | Magnetically guided catheter with flexible tip |
US8734440B2 (en) | 2007-07-03 | 2014-05-27 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Magnetically guided catheter |
US10220187B2 (en) | 2010-06-16 | 2019-03-05 | St. Jude Medical, Llc | Ablation catheter having flexible tip with multiple flexible electrode segments |
US20120010490A1 (en) | 2010-06-16 | 2012-01-12 | Kauphusman James V | Medical devices having flexible electrodes mounted thereon |
WO2009001325A1 (en) | 2007-06-27 | 2008-12-31 | Flip Technologies Limited | A device and a system for use in a procedure for improving a sealing function of a sphincter and a method for improving the sealing function of a sphincter |
US8565894B2 (en) | 2007-10-17 | 2013-10-22 | Neuronexus Technologies, Inc. | Three-dimensional system of electrode leads |
US8157848B2 (en) | 2008-02-01 | 2012-04-17 | Siemens Medical Solutions Usa, Inc. | System for characterizing patient tissue impedance for monitoring and treatment |
US8882761B2 (en) * | 2008-07-15 | 2014-11-11 | Catheffects, Inc. | Catheter and method for improved ablation |
WO2010042653A1 (en) | 2008-10-07 | 2010-04-15 | Mc10, Inc. | Catheter balloon having stretchable integrated circuitry and sensor array |
US8712550B2 (en) | 2008-12-30 | 2014-04-29 | Biosense Webster, Inc. | Catheter with multiple electrode assemblies for use at or near tubular regions of the heart |
US8271099B1 (en) | 2009-03-23 | 2012-09-18 | Advanced Neuromodulation Systems, Inc. | Implantable paddle lead comprising compressive longitudinal members for supporting electrodes and method of fabrication |
JP5786108B2 (en) * | 2009-05-08 | 2015-09-30 | セント・ジュード・メディカル・ルクセンブルク・ホールディング・エスエーアールエル | Method and apparatus for controlling lesion size in catheter ablation therapy |
US8979839B2 (en) | 2009-11-13 | 2015-03-17 | St. Jude Medical, Inc. | Assembly of staggered ablation elements |
EP2512330A1 (en) * | 2009-12-14 | 2012-10-24 | Mayo Foundation for Medical Education and Research | Device and method for treating cardiac disorders by modulating autonomic response |
US9616199B2 (en) * | 2009-12-31 | 2017-04-11 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Irrigated catheter employing multi-lumenal irrigation tubing |
US8357140B2 (en) * | 2010-01-29 | 2013-01-22 | Cordis Corporation | Highly flexible tubular device with high initial torque response for medical use |
US8560086B2 (en) | 2010-12-02 | 2013-10-15 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Catheter electrode assemblies and methods of construction therefor |
JP2012130392A (en) | 2010-12-20 | 2012-07-12 | Japan Lifeline Co Ltd | Electrode catheter |
US8391947B2 (en) * | 2010-12-30 | 2013-03-05 | Biosense Webster (Israel), Ltd. | Catheter with sheet array of electrodes |
CN103354730B (en) | 2010-12-30 | 2016-01-27 | 圣犹达医疗用品电生理部门有限公司 | For the system and method that diagnose arrhythmia and guide catheter are treated |
US9044245B2 (en) | 2011-01-05 | 2015-06-02 | Medtronic Ablation Frontiers Llc | Multipolarity epicardial radiofrequency ablation |
JP6193766B2 (en) | 2011-03-10 | 2017-09-06 | アクタス メディカル インク | A device for the geometric measurement of the electric dipole density of the heart wall. |
CN202069688U (en) | 2011-03-11 | 2011-12-14 | 北京天助畅运医疗技术股份有限公司 | Radio frequency ablation electrode capable of treating resistant hypertension |
US20120296232A1 (en) | 2011-05-18 | 2012-11-22 | St. Jude Medical, Inc. | Method and apparatus of assessing transvascular denervation |
US8909316B2 (en) * | 2011-05-18 | 2014-12-09 | St. Jude Medical, Cardiology Division, Inc. | Apparatus and method of assessing transvascular denervation |
US8706258B2 (en) * | 2011-08-08 | 2014-04-22 | Medamp Electronics, Llc | Method and apparatus for treating cancer |
CN103889348B (en) | 2011-08-25 | 2016-10-12 | 柯惠有限合伙公司 | For treating the system of cavity tissue, apparatus and method |
JP5729660B2 (en) | 2011-11-21 | 2015-06-03 | 株式会社ディナーヴ | Catheter and system for renal artery ablation |
US8903508B2 (en) | 2012-03-08 | 2014-12-02 | Advanced Neuromodulation Systems, Inc. | Flexible paddle lead body with scored surfaces |
US9314299B2 (en) | 2012-03-21 | 2016-04-19 | Biosense Webster (Israel) Ltd. | Flower catheter for mapping and ablating veinous and other tubular locations |
US9717555B2 (en) | 2012-05-14 | 2017-08-01 | Biosense Webster (Israel), Ltd. | Catheter with helical end section for vessel ablation |
US20140025069A1 (en) | 2012-07-17 | 2014-01-23 | Boston Scientific Scimed, Inc. | Renal nerve modulation catheter design |
JP6247691B2 (en) | 2012-09-07 | 2017-12-13 | デーナ リミテッド | Ball type continuously variable transmission / continuously variable transmission |
US9248255B2 (en) | 2012-11-14 | 2016-02-02 | Biosense Webster (Israel) Ltd. | Catheter with improved torque transmission |
US9833608B2 (en) | 2012-11-20 | 2017-12-05 | NeuroTronik IP Holding (Jersey) Limited | Positioning methods for intravascular electrode arrays for neuromodulation |
US20140316496A1 (en) | 2012-11-21 | 2014-10-23 | NeuroTronik IP Holding (Jersey) Limited | Intravascular Electrode Arrays for Neuromodulation |
US10537286B2 (en) | 2013-01-08 | 2020-01-21 | Biosense Webster (Israel) Ltd. | Catheter with multiple spines of different lengths arranged in one or more distal assemblies |
US9351789B2 (en) | 2013-05-31 | 2016-05-31 | Medtronic Ablation Frontiers Llc | Adjustable catheter for ostial, septal, and roof ablation in atrial fibrillation patients |
WO2015057521A1 (en) | 2013-10-14 | 2015-04-23 | Boston Scientific Scimed, Inc. | High resolution cardiac mapping electrode array catheter |
JP6795977B2 (en) | 2013-10-25 | 2020-12-02 | インテュイティブ サージカル オペレーションズ, インコーポレイテッド | Flexible equipment with embedded drive lines |
US9820664B2 (en) | 2014-11-20 | 2017-11-21 | Biosense Webster (Israel) Ltd. | Catheter with high density electrode spine array |
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US20170007157A1 (en) * | 2015-07-08 | 2017-01-12 | Rainbow Medical Ltd. | Electrical-signal-based electrode-tissue contact detection |
JP6528010B1 (en) * | 2016-05-03 | 2019-06-12 | セント・ジュード・メディカル,カーディオロジー・ディヴィジョン,インコーポレイテッド | Irrigation type high density electrode catheter |
US10702177B2 (en) * | 2016-08-24 | 2020-07-07 | Biosense Webster (Israel) Ltd. | Catheter with bipole electrode spacer and related methods |
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USD840027S1 (en) * | 2017-10-23 | 2019-02-05 | Helios Medical Ventures Llc | Injection targeting device |
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US11040202B2 (en) * | 2018-03-30 | 2021-06-22 | Boston Scientific Neuromodulation Corporation | Circuitry to assist with neural sensing in an implantable stimulator device |
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-
2013
- 2013-10-08 US US14/048,352 patent/US20140200639A1/en not_active Abandoned
-
2014
- 2014-01-16 EP EP22188371.3A patent/EP4101372A1/en active Pending
- 2014-01-16 EP EP20158596.5A patent/EP3679861B1/en active Active
- 2014-01-16 WO PCT/US2014/011940 patent/WO2014113612A1/en active Application Filing
- 2014-01-16 EP EP20180888.8A patent/EP3738508B1/en active Active
- 2014-01-16 EP EP20183495.9A patent/EP3738509B1/en active Active
- 2014-01-16 CN CN201480005128.5A patent/CN104968261B/en active Active
- 2014-01-16 EP EP14703679.2A patent/EP2908723B1/en active Active
- 2014-01-16 JP JP2015552690A patent/JP6050522B2/en active Active
- 2014-01-16 EP EP23198506.0A patent/EP4272631A2/en active Pending
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2016
- 2016-04-06 US US15/092,454 patent/US20160213916A1/en not_active Abandoned
- 2016-11-24 JP JP2016228255A patent/JP6445509B2/en active Active
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2018
- 2018-09-28 JP JP2018183506A patent/JP2019030685A/en not_active Withdrawn
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2019
- 2019-10-31 US US16/670,678 patent/US11383078B2/en active Active
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2020
- 2020-06-10 US US16/898,420 patent/US10857349B2/en active Active
- 2020-07-01 US US16/918,801 patent/US10842990B2/en active Active
- 2020-11-25 US US29/759,859 patent/USD940310S1/en active Active
- 2020-11-25 US US29/759,860 patent/USD951438S1/en active Active
-
2021
- 2021-12-07 US US29/818,196 patent/USD952140S1/en active Active
- 2021-12-07 US US29/818,199 patent/USD952843S1/en active Active
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2022
- 2022-05-06 US US29/837,647 patent/USD966506S1/en active Active
- 2022-05-06 US US29/837,663 patent/USD966507S1/en active Active
- 2022-06-08 US US17/835,661 patent/US20220370792A1/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5931862A (en) * | 1997-12-22 | 1999-08-03 | Pacesetter, Inc. | Medical lead and method of making and using with sodium sulfosuccinic ester |
US6415187B1 (en) * | 1998-02-10 | 2002-07-02 | Advanced Bionics Corporation | Implantable, expandable, multicontact electrodes and insertion needle for use therewith |
US6522932B1 (en) * | 1998-02-10 | 2003-02-18 | Advanced Bionics Corporation | Implantable, expandable, multicontact electrodes and tools for use therewith |
US20030065371A1 (en) * | 2001-09-28 | 2003-04-03 | Shutaro Satake | Radiofrequency thermal balloon catheter |
US8019442B1 (en) * | 2006-10-25 | 2011-09-13 | Advanced Neuromodulation Systems, Inc. | Assembly kit for creating paddle-style lead from one or several percutaneous leads and method of lead implantation |
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Also Published As
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JP2016502912A (en) | 2016-02-01 |
EP4272631A2 (en) | 2023-11-08 |
EP3738509B1 (en) | 2023-10-25 |
US20200138378A1 (en) | 2020-05-07 |
US20200330752A1 (en) | 2020-10-22 |
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CN104968261B (en) | 2019-05-31 |
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EP3738508B1 (en) | 2024-02-28 |
USD966507S1 (en) | 2022-10-11 |
EP3738508A1 (en) | 2020-11-18 |
US11383078B2 (en) | 2022-07-12 |
JP2017077479A (en) | 2017-04-27 |
US20220370792A1 (en) | 2022-11-24 |
JP2019030685A (en) | 2019-02-28 |
US20160213916A1 (en) | 2016-07-28 |
JP6050522B2 (en) | 2016-12-21 |
USD951438S1 (en) | 2022-05-10 |
USD952140S1 (en) | 2022-05-17 |
EP3679861B1 (en) | 2021-02-17 |
US10857349B2 (en) | 2020-12-08 |
EP2908723A1 (en) | 2015-08-26 |
US20200297996A1 (en) | 2020-09-24 |
CN104968261A (en) | 2015-10-07 |
EP4101372A1 (en) | 2022-12-14 |
EP3679861A1 (en) | 2020-07-15 |
WO2014113612A1 (en) | 2014-07-24 |
JP6445509B2 (en) | 2018-12-26 |
EP2908723B1 (en) | 2020-03-25 |
US10842990B2 (en) | 2020-11-24 |
USD966506S1 (en) | 2022-10-11 |
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