US20150060136A1 - Systems and methods for forming an end of an elongated member of an electrical stimulation system - Google Patents
Systems and methods for forming an end of an elongated member of an electrical stimulation system Download PDFInfo
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- US20150060136A1 US20150060136A1 US14/537,643 US201414537643A US2015060136A1 US 20150060136 A1 US20150060136 A1 US 20150060136A1 US 201414537643 A US201414537643 A US 201414537643A US 2015060136 A1 US2015060136 A1 US 2015060136A1
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R4/00—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation
- H01R4/10—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation
- H01R4/18—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation by crimping
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R24/00—Two-part coupling devices, or either of their cooperating parts, characterised by their overall structure
- H01R24/58—Contacts spaced along longitudinal axis of engagement
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R24/00—Two-part coupling devices, or either of their cooperating parts, characterised by their overall structure
- H01R24/76—Two-part coupling devices, or either of their cooperating parts, characterised by their overall structure with sockets, clips or analogous contacts and secured to apparatus or structure, e.g. to a wall
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R4/00—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation
- H01R4/10—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation
- H01R4/18—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation by crimping
- H01R4/183—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation by crimping for cylindrical elongated bodies, e.g. cables having circular cross-section
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R4/00—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation
- H01R4/10—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation
- H01R4/18—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation by crimping
- H01R4/20—Electrically-conductive connections between two or more conductive members in direct contact, i.e. touching one another; Means for effecting or maintaining such contact; Electrically-conductive connections having two or more spaced connecting locations for conductors and using contact members penetrating insulation effected solely by twisting, wrapping, bending, crimping, or other permanent deformation by crimping using a crimping sleeve
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/02—Contact members
- H01R13/33—Contact members made of resilient wire
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- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R2107/00—Four or more poles
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49124—On flat or curved insulated base, e.g., printed circuit, etc.
- Y10T29/49147—Assembling terminal to base
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49124—On flat or curved insulated base, e.g., printed circuit, etc.
- Y10T29/49147—Assembling terminal to base
- Y10T29/49151—Assembling terminal to base by deforming or shaping
- Y10T29/49153—Assembling terminal to base by deforming or shaping with shaping or forcing terminal into base aperture
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49124—On flat or curved insulated base, e.g., printed circuit, etc.
- Y10T29/49155—Manufacturing circuit on or in base
- Y10T29/49162—Manufacturing circuit on or in base by using wire as conductive path
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49124—On flat or curved insulated base, e.g., printed circuit, etc.
- Y10T29/49155—Manufacturing circuit on or in base
- Y10T29/49165—Manufacturing circuit on or in base by forming conductive walled aperture in base
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49174—Assembling terminal to elongated conductor
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49117—Conductor or circuit manufacturing
- Y10T29/49174—Assembling terminal to elongated conductor
- Y10T29/49181—Assembling terminal to elongated conductor by deforming
- Y10T29/49183—Assembling terminal to elongated conductor by deforming of ferrule about conductor and terminal
Definitions
- the present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems.
- the present invention is also directed to systems and methods of forming one or more ends of elongated members of electrical stimulation systems.
- Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders.
- spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes.
- Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation.
- Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients.
- a stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead.
- the stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated.
- the pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue.
- a method for forming a lead or lead extension having an arrangement of a plurality of elongated conductors disposed in a body of the lead or lead extension, each of the elongated conductors extending from a proximal end of the arrangement to a distal end of the arrangement includes ablating a plurality of spaced-apart channels in proximity to at least one of the proximal end or the distal end of the body to expose at least part of at least one of the plurality of elongated conductors.
- a C-shaped contact is disposed into each of a different one of the transverse channels. Each of the C-shaped contacts is electrically coupled to at least one of the elongated conductors.
- Each of the C-shaped contacts is closed so that opposing ends of the C-shaped contact are adjacent to one another and aligned over one of the elongated conductors. For each of the C-shaped contacts, the two opposing ends are coupled together such that the C-shaped contact forms a continuous path around the arrangement within the transverse channel in which the C-shaped contact is disposed.
- a method for forming a lead or lead having an arrangement of a plurality of elongated conductors disposed in a body of the lead or lead extension, each of the elongated conductors extending from a proximal end of the arrangement to a distal end of the arrangement includes ablating a plurality of access ports in at least one of the proximal end or the distal end of the body, each of the access ports exposing one of the elongated conductors.
- C-shaped contacts are disposed over each of the access ports such that each C-shaped contact is disposed over at least one of the access ports.
- the C-shaped contacts are electrically coupled to at least one of the elongated conductors.
- Each of the C-shaped contacts is closed so that the two opposing ends of the C-shaped contacts are adjacent to one another.
- the two opposing ends are coupled together such that the C-shaped contact forms a continuous path around the arrangement over the at least one access port over which the C-shaped contact is disposed.
- a lead in yet another embodiment, includes a lead body with an outer layer and having a distal end, a proximal end, and a transverse circumference.
- the lead body defines a plurality of spaced-apart channels around the transverse circumference of the lead body in proximity to at least one of the distal end or the proximal end of the lead body.
- the lead body includes a plurality of cylindrical electrodes disposed on the distal end of the lead body, a plurality of cylindrical terminals disposed on the proximal end of the lead body, and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals.
- At least one of the plurality of electrodes or at least one of the plurality of terminals includes a C-shaped contact that has been disposed over the transverse circumference of the lead body and closed with opposing ends of the C-shaped contact coupled together.
- the opposing ends of the C-shaped contact define a coupling aperture.
- At least one of the plurality of conductors extends into the coupling aperture and electrically couples to the C-shaped contact.
- FIG. 1 is a schematic view of one embodiment of an electrical stimulation system, according to the invention.
- FIG. 2 is a schematic view of another embodiment of an electrical stimulation system, according to the invention.
- FIG. 3A is a schematic view of one embodiment of a proximal portion of a lead and a control module of an electrical stimulation system, according to the invention
- FIG. 3B is a schematic view of one embodiment of a proximal portion of a lead and a lead extension of an electrical stimulation system, according to the invention.
- FIG. 4 is a schematic perspective view of one embodiment of a proximal end of an elongated member, according to the invention.
- FIG. 5 is a schematic perspective view of one embodiment of a proximal end of an elongated member and a C-shaped contact, the elongated member having transverse channels ablated into the elongated member to expose conductors extending within the elongated member, according to the invention;
- FIG. 6 is a schematic perspective view of one embodiment of the C-shaped contact of FIG. 5 disposed over a transverse channel ablated into the elongated member of FIG. 5 , according to the invention
- FIG. 7 is a schematic perspective view of one embodiment of the C-shaped contact of FIG. 5 disposed over a transverse channel ablated into the elongated member of FIG. 5 with opposing inwardly-bending ends of the C-shaped contact coupled together to form a continuous path around the transverse channel, according to the invention.
- FIG. 8 is a schematic overview of one embodiment of components of a stimulation system, including an electronic subassembly disposed within a control module, according to the invention.
- the present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems.
- the present invention is also directed to systems and methods of forming one or more ends of elongated members of electrical stimulation systems.
- Suitable implantable electrical stimulation systems include, but are not limited to, an electrode lead (“lead”) with one or more electrodes disposed on a distal end of the lead and one or more terminals disposed on one or more proximal ends of the lead.
- an electrode lead (“lead”) with one or more electrodes disposed on a distal end of the lead and one or more terminals disposed on one or more proximal ends of the lead.
- Leads include, for example, percutaneous leads, paddle leads, and cuff leads.
- Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S. patent application Ser. Nos. 10/353,101, 10/503,281, 11/238,240; 11/319,291; 11/327,880; 11/375,638; 11/393,991; and 11/396,309, all of which are incorporated by reference.
- FIG. 1 illustrates schematically one embodiment of an electrical stimulation system 100 .
- the electrical stimulation system includes a control module (e.g., a stimulator or pulse generator) 102 , a paddle body 104 , and at least one lead body 106 coupling the control module 102 to the paddle body 104 .
- the paddle body 104 and the one or more lead bodies 106 form a lead.
- the paddle body 104 typically includes an array of electrodes 134 .
- the control module 102 typically includes an electronic subassembly 110 and an optional power source 120 disposed in a sealed housing 114 .
- the control module 102 typically includes a connector 144 ( FIGS. 2 and 3A , see also 322 and 350 of FIG.
- the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the electrical stimulation system references cited herein.
- the electrodes 134 can be disposed in an array at or near the distal end of the lead body 106 forming a percutaneous lead, as illustrated in FIG. 2 .
- a percutaneous lead may be isodiametric along the length of the lead.
- one or more lead extensions 312 can be disposed between the one or more lead bodies 106 and the control module 102 to extend the distance between the one or more lead bodies 106 and the control module 102 of the embodiments shown in FIGS. 1 and 2 .
- the electrical stimulation system or components of the electrical stimulation system are typically implanted into the body of a patient.
- the electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like.
- the electrodes 134 can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof.
- the number of electrodes 134 in the array of electrodes 134 may vary. For example, there can be two, four, six, eight, ten, twelve, fourteen, sixteen, or more electrodes 134 . As will be recognized, other numbers of electrodes 134 may also be used.
- the electrodes of the paddle body 104 or one or more lead bodies 106 are typically disposed in, or separated by, a non-conductive, biocompatible material including, for example, silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, and the like or combinations thereof.
- the paddle body 104 and one or more lead bodies 106 may be formed in the desired shape by any process including, for example, molding (including injection molding), casting, and the like. Electrodes and connecting wires can be disposed onto or within a paddle body either prior to or subsequent to a molding or casting process.
- the non-conductive material typically extends from the distal end of the lead to the proximal end of each of the one or more lead bodies 106 .
- the non-conductive, biocompatible material of the paddle body 104 and the one or more lead bodies 106 may be the same or different.
- the paddle body 104 and the one or more lead bodies 106 may be a unitary structure or can be formed as two separate structures that are permanently or detachably coupled together.
- Terminals are typically disposed at the proximal end of the one or more lead bodies 106 for connection to corresponding connector contacts (e.g., 314 in FIG. 3A and 340 of FIG. 3B ) in connectors (e.g., 144 in FIGS. 1-3A and 322 and 350 of FIG. 3B ) disposed on, for example, the control module 102 (or to other devices, such as connector contacts on a lead extension, an operating room cable, or an adaptor).
- Conductive wires (“conductors”) (not shown) extend from the terminals (e.g., 310 in FIG. 3A and 336 of FIG. 3B ) to the electrodes 134 .
- one or more electrodes 134 are electrically coupled to a terminal (e.g., 310 in FIG. 3A and 336 of FIG. 3B ).
- each terminal e.g., 310 in FIG. 3A and 336 of FIG. 3B
- the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead. In some embodiments, there is an individual lumen for each conductive wire. In other embodiments, two or more conductive wires may extend through a lumen.
- the one or more lumens may be flushed continually, or on a regular basis, with saline, epidural fluid, or the like.
- the one or more lumens can be permanently or removably sealable at the distal end.
- leads are coupled to connectors disposed on control modules.
- a lead 308 is shown configured and arranged for insertion to the control module 102 .
- the connector 144 includes a connector housing 302 .
- the connector housing 302 defines at least one port 304 into which a proximal end 306 of a lead 308 with terminals 310 can be inserted, as shown by directional arrow 312 .
- the connector housing 302 also includes a plurality of connector contacts 314 for each port 304 . When the lead 308 is inserted into the port 304 , the connector contacts 314 can be aligned with the terminals 310 on the lead 308 to electrically couple the control module 102 to the electrodes ( 134 of FIG.
- a connector 322 is disposed on a lead extension 324 .
- the connector 322 is shown disposed at a distal end 326 of the lead extension 324 .
- the connector 322 includes a connector housing 328 .
- the connector housing 328 defines at least one port 330 into which a proximal end 332 of a lead 334 with terminals 336 can be inserted, as shown by directional arrow 338 .
- the connector housing 328 also includes a plurality of connector contacts 340 . When the lead 334 is inserted into the port 330 , the connector contacts 340 disposed in the connector housing 328 can be aligned with the terminals 336 on the lead 334 to electrically couple the lead extension 324 to the electrodes ( 134 of FIG. 1 ) disposed at a distal end (not shown) of the lead 334 .
- the proximal end of a lead extension is similarly configured and arranged as a proximal end of a lead.
- the lead extension 324 may include a plurality of conductive wires (not shown) disposed in a body of the lead extension that electrically couple the connector contacts 340 to a proximal end 348 of the lead extension 324 that is opposite to the distal end 326 .
- the conductive wires disposed in the lead extension 324 can be electrically coupled to a plurality of terminals (not shown) disposed on the proximal end 348 of the lead extension 324 .
- the proximal end 348 of the lead extension 324 is configured and arranged for insertion into a connector disposed in another lead extension. In other embodiments, the proximal end 348 of the lead extension 324 is configured and arranged for insertion into a connector disposed in a control module. As an example, in FIG. 3B the proximal end 348 of the lead extension 324 is inserted into a connector 350 disposed in a control module 352 .
- an elongated member e.g., a lead, a lead extension, or the like
- the proximal end of the body of the elongated member is typically radially ablated to expose underlying conductors extending within the body of the elongated member.
- Cylindrical contacts e.g., terminals
- Each of the contacts is electrically coupled to a different one of the conductors.
- Additional steps may also be necessary including, for example, back filling lumens in which the conductors are disposed with epoxy and grinding the contacts to size so that outer surfaces of the contacts are flush with outer surfaces of the elongated body.
- the distal end of the elongated members may be assembled in a similar manner, with the contacts being electrodes instead of terminals.
- the distal end of the elongated members may be assembled in a similar manner, with the contacts being connector contacts instead of terminals.
- a plurality of spaced-apart C-shaped contacts may be disposed over portions of the elongated member and electrically coupled to underlying conductors extending within the elongated member.
- each of the C-shaped contacts has opposing inwardly-bending ends that wrap around a transverse axis of the elongated member and that may be closed and coupled together to form a continuous path around the transverse axis of the elongated member.
- portions of the elongated member may be ablated to form spaced-apart transverse channels that are configured and arranged to receive C-shaped contacts and that provide access to electrically couple the C-shaped contacts to the underlying conductors.
- the elongated member includes an arrangement of elongated conductors disposed in an outer layer.
- the conductors may be disposed in elongated members in many different possible configurations (e.g., arranged into units, coiled into a helical configuration, disposed in a multi-lumen retention element, disposed over a sleeve, disposed over a mandrel, or the like).
- the conductors are also individually encased by a layer of insulation. It will be understood that, when the conductors are individually encased by a layer of insulation, the layer of insulation encasing the conductor may also be ablated to expose underlying conductors.
- FIG. 4 is a schematic perspective view of one embodiment of an elongated member 402 .
- the elongated member 402 includes a body 404 .
- the body 404 includes a multi-lumen retention element 406 and an outer layer 408 .
- the outer layer 408 is part of the multi-lumen retention element 406 .
- One or more conductors, such as conductor 410 may be disposed in one or more of the lumens, such as lumen 412 . It will be understood that the conductor 410 is shown extending from the elongated member 402 for clarity of illustration.
- the conductors are exposed.
- One technique for exposing the conductors is ablating portions of the outer layer 408 of the elongated member 402 .
- the outer layer 406 of the elongated member 402 is ablated to form spaced-apart transverse channels to access a plurality of the conductors and also to receive a C-shaped contact.
- the transverse channels are laser ablated.
- FIG. 5 is a schematic perspective view of one embodiment of the elongated member 402 and a C-shaped contact 502 .
- the outer layer 408 of the elongated member 402 has been ablated to form transverse channels 504 - 506 extending along a transverse axis of the elongated member.
- the transverse channels 504 - 506 are deep enough to expose a plurality of underlying conductors when conductors are disposed in the elongated member 402 . It will be understood that, when conductors are disposed in the lumens of the multi-lumen retention element 406 , an outer portion of the multi-lumen retention element 404 may also be ablated to expose the conductors.
- the outer portion of the multi-lumen retention element 404 is ablated before the conductors are disposed in the multi-lumen retention element 404 . In other embodiments, the outer portion of the multi-lumen retention element 404 is ablated after the conductors are disposed in the multi-lumen retention element 404 .
- the C-shaped contact 502 includes two opposing inwardly-bending ends 508 and 510 .
- each of the opposing ends define a portion of a coupling aperture 512 a and 512 b, respectively, which collectively form a coupling aperture ( 512 in FIG. 7 ) when the C-shaped contact 502 is closed, as described below.
- the C-shaped contact 502 may be formed from any biocompatible conductive material suitable for implantation into a patient including, for example, metals (e.g., platinum, iridium, and the like), alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof.
- metals e.g., platinum, iridium, and the like
- alloys e.g., conductive polymers, conductive carbon, and the like, as well as combinations thereof.
- the C-shaped contact 502 defines a transverse length between the opposing inwardly-bending ends 508 and 510 . In some embodiments, the transverse length of the C-shaped contact 502 is equal to a transverse circumference of the ablated portion of the transverse channels 504 - 506 of the elongated body 402 . In other embodiments, the transverse length of the C-shaped contact 502 is equal to a transverse circumference of the outer layer of the elongated body 402 . In some embodiments, the C-shaped contact 502 is configured and arranged to be disposed in the transverse channels 504 - 506 (as described below and as shown in FIGS. 6 and 7 ). In other embodiments, the C-shaped contact 502 is configured and arranged to be disposed over the outer layer 408 of the elongated member 402 .
- An elongated member may be isodiametric.
- An isodiametric elongated member may reduce the chance of the elongated member getting caught on patient tissue during insertion of the elongated member into the patient, or during patient movement subsequent to implantation of the elongated member.
- the C-shaped contact 502 in the transverse channel 504 may be formed with a transverse cross-sectional profile that is thicker than with conventional contacts, when the elongated member is isodiametric. A thicker contact may promote better electrical contact and may increase durability of the electrical stimulation system. It may further be an advantage to inset the C-shaped contact 502 in the transverse channel 504 because the thickness of the transverse cross-sectional profile of the C-shaped contact 502 may be formed so that an outer surface of the C-shaped contact 502 is flush with the outer layer 408 of the elongated member without needing to grind down the C-shaped contact 502 .
- FIG. 6 is a schematic perspective view of one embodiment of the C-shaped contact 502 disposed in the transverse channel 504 of the elongated member 402 .
- the C-shaped contact 502 is flexible.
- the C-shaped contact 502 is disposed within the transverse channel 504 .
- the C-shaped contact 502 is snapped over the transverse channel 504 .
- the depth of the transverse channel 504 is no greater than the thickness of the C-shaped contact 502 .
- the depth of the transverse channel 504 is equal to the thickness of the C-shaped contact 502 .
- an outer surface of the C-shaped contact 502 is flush with outer surfaces of the elongated member 402 .
- the outer surfaces of the C-shaped contact 502 extend radially outward from the outer surfaces of the elongated member 402 .
- the outer surfaces of the C-shaped contact 502 may be ground down to be flush with the outer surfaces of the elongated member 402 .
- FIG. 7 is a schematic perspective view of one embodiment of the C-shaped contact 502 disposed over the transverse channel 504 of the elongated member 402 .
- the opposing ends 508 and 510 of the C-shaped contact 502 are closed so that the opposing inwardly-bending ends 508 and 510 are adjacent to one another.
- a tooling fixture may be used to close the C-shaped contact 502 .
- the portions of the coupling aperture align to form a complete coupling aperture 512 .
- the opposing ends 508 and 510 of the C-shaped contact 502 may be coupled together to form a continuous path around a transverse circumference of the elongated member 402 .
- the opposing ends 508 and 510 are coupled together using an electrically-conductive medium (e.g., welding, soldering, or the like).
- the closed opposing ends 508 and 510 of the C-shaped contact 502 may be aligned around the transverse circumference of the elongated member 402 such that the coupling aperture 512 aligns with one of the conductors. In at least some embodiments, when the coupling aperture 512 is aligned with one of the conductors, electrically coupling the opposing ends 508 and 510 of the C-shaped contact 502 together also electrically couples the aligned conductor to the C-shaped contact 502 , via the coupling aperture 512 .
- the aligned conductor may be extended through the coupling aperture 512 so that coupling the opposing ends 508 and 510 of the C-shaped contact 502 also couples the conductor to the C-shaped contact 502 . It will be understood that, when multiple C-shaped contacts are coupled to the elongated member 402 , each of the coupling apertures of different C-shaped contacts may be aligned with different conductors.
- one of the underlying conductors may be electrically coupled to the C-shaped contact 502 prior to the C-shaped contacts being closed.
- the C-shaped contact 502 may be disposed within the transverse channel 504 in an open position and one of the underlying conductors accessible from one of the transverse channels 504 may be coupled to an undersurface of the C-shaped contact 502 , or coupled to one of the opposing ends (preferably within a portion of one of the coupling apertures) of the C-shaped contact 502 .
- the C-shaped contact 502 may subsequently be closed and the ends of the C-shaped contact 502 may be coupled together.
- coupling the C-shaped contact 502 is performed by an automated system. It may be an advantage to employ an automated system to increase one or more of productivity or consistency.
- one or more access holes may by ablated in the elongated body in addition to, or in lieu of, ablating one or more transverse channels.
- One or more access holes may be ablated through the outer layer 406 to access one of the conductors individually, without accessing multiple conductors. It may be an advantage to ablate individual access holes instead of ablating transverse channels to prevent undesired conductors from contacting the C-shaped contact and potentially causing a short circuit.
- the C-shaped contact 502 may be disposed over the outer layer 408 of the elongated body and the C-shaped contact 502 may be electrically coupled to the underlying conductor via the one or more access holes.
- the C-shaped contact 502 is electrically coupled to the underlying conductor prior to coupling the C-shaped contact 502 , in a similar manner as describe above.
- the C-shaped contact 502 is closed without being electrically coupled to the conductors.
- the coupling aperture 512 of the C-shaped contact 502 is aligned over at least one of the access holes and the C-shaped contact 502 is electrically coupled to the underlying conductor, via the coupling aperture 512 , as the opposing ends 508 and 510 of the C-shaped contact 502 are coupled together.
- the underlying conductor is extended through the coupling aperture 512 when the opposing ends 508 and 510 of the C-shaped contact 502 are coupled together.
- FIG. 8 is a schematic overview of one embodiment of components of an electrical stimulation system 800 including an electronic subassembly 810 disposed within a control module. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein.
- Some of the components (for example, power source 812 , antenna 818 , receiver 802 , and processor 804 ) of the electrical stimulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing of an implantable pulse generator, if desired.
- Any power source 812 can be used including, for example, a battery such as a primary battery or a rechargeable battery.
- Examples of other power sources include super capacitors, nuclear or atomic batteries, mechanical resonators, infrared collectors, thermally-powered energy sources, flexural powered energy sources, bioenergy power sources, fuel cells, bioelectric cells, osmotic pressure pumps, and the like including the power sources described in U.S. Patent Application Publication No. 2004/0059392, incorporated herein by reference.
- power can be supplied by an external power source through inductive coupling via the optional antenna 818 or a secondary antenna.
- the external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the user on a permanent or periodic basis.
- the battery may be recharged using the optional antenna 818 , if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit 816 external to the user. Examples of such arrangements can be found in the references identified above.
- electrical current is emitted by the electrodes 134 on the paddle or lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system.
- a processor 804 is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor 804 can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, the processor 804 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, the processor 804 may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, the processor 804 may be used to identify which electrodes provide the most useful stimulation of the desired tissue.
- Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from an external programming unit 808 that, for example, allows modification of pulse characteristics.
- the processor 804 is coupled to a receiver 802 which, in turn, is coupled to the optional antenna 818 . This allows the processor 804 to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired.
- the antenna 818 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 806 which is programmed by a programming unit 808 .
- the programming unit 808 can be external to, or part of, the telemetry unit 1506 .
- the telemetry unit 1506 can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired.
- the telemetry unit 806 may not be worn or carried by the user but may only be available at a home station or at a clinician's office.
- the programming unit 808 can be any unit that can provide information to the telemetry unit 806 for transmission to the electrical stimulation system 800 .
- the programming unit 808 can be part of the telemetry unit 806 or can provide signals or information to the telemetry unit 806 via a wireless or wired connection.
- One example of a suitable programming unit is a computer operated by the user or clinician to send signals to the telemetry unit 806 .
- the signals sent to the processor 804 via the antenna 818 and receiver 802 can be used to modify or otherwise direct the operation of the electrical stimulation system.
- the signals may be used to modify the pulses of the electrical stimulation system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength.
- the signals may also direct the electrical stimulation system 800 to cease operation, to start operation, to start charging the battery, or to stop charging the battery.
- the stimulation system does not include an antenna 818 or receiver 802 and the processor 804 operates as programmed.
- the electrical stimulation system 800 may include a transmitter (not shown) coupled to the processor 804 and the antenna 818 for transmitting signals back to the telemetry unit 806 or another unit capable of receiving the signals.
- the electrical stimulation system 800 may transmit signals indicating whether the electrical stimulation system 800 is operating properly or not or indicating when the battery needs to be charged or the level of charge remaining in the battery.
- the processor 804 may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics.
Abstract
A method for forming a lead or lead extension having an arrangement of elongated conductors disposed in a body of a lead or lead extension includes ablating a plurality of spaced-apart channels in proximity to at least one of the proximal end or the distal end of the body to expose at least part of at least one of the conductors. A C-shaped contact is disposed into each of a different one of the transverse channels. Each C-shaped contact is electrically coupled to at least one of the conductors. Each C-shaped contact is closed so that opposing ends of the C-shaped contact are adjacent to one another and aligned over one of the elongated conductors. The two opposing ends of each C-shaped contact is coupled together such that each C-shaped contact forms a continuous path around the arrangement within the transverse channel in which the C-shaped contact is disposed.
Description
- This application is a divisional of U.S. patent application Ser. No. 12/473,170 filed May 27, 2009, which is incorporated herein by reference.
- The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to systems and methods of forming one or more ends of elongated members of electrical stimulation systems.
- Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation. Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients.
- Stimulators have been developed to provide therapy for a variety of treatments. A stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue.
- In one embodiment, a method for forming a lead or lead extension having an arrangement of a plurality of elongated conductors disposed in a body of the lead or lead extension, each of the elongated conductors extending from a proximal end of the arrangement to a distal end of the arrangement, includes ablating a plurality of spaced-apart channels in proximity to at least one of the proximal end or the distal end of the body to expose at least part of at least one of the plurality of elongated conductors. A C-shaped contact is disposed into each of a different one of the transverse channels. Each of the C-shaped contacts is electrically coupled to at least one of the elongated conductors. Each of the C-shaped contacts is closed so that opposing ends of the C-shaped contact are adjacent to one another and aligned over one of the elongated conductors. For each of the C-shaped contacts, the two opposing ends are coupled together such that the C-shaped contact forms a continuous path around the arrangement within the transverse channel in which the C-shaped contact is disposed.
- In another embodiment, a method for forming a lead or lead having an arrangement of a plurality of elongated conductors disposed in a body of the lead or lead extension, each of the elongated conductors extending from a proximal end of the arrangement to a distal end of the arrangement, includes ablating a plurality of access ports in at least one of the proximal end or the distal end of the body, each of the access ports exposing one of the elongated conductors. C-shaped contacts are disposed over each of the access ports such that each C-shaped contact is disposed over at least one of the access ports. The C-shaped contacts are electrically coupled to at least one of the elongated conductors. Each of the C-shaped contacts is closed so that the two opposing ends of the C-shaped contacts are adjacent to one another. For each of the C-shaped contacts, the two opposing ends are coupled together such that the C-shaped contact forms a continuous path around the arrangement over the at least one access port over which the C-shaped contact is disposed.
- In yet another embodiment, a lead includes a lead body with an outer layer and having a distal end, a proximal end, and a transverse circumference. The lead body defines a plurality of spaced-apart channels around the transverse circumference of the lead body in proximity to at least one of the distal end or the proximal end of the lead body. The lead body includes a plurality of cylindrical electrodes disposed on the distal end of the lead body, a plurality of cylindrical terminals disposed on the proximal end of the lead body, and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals. At least one of the plurality of electrodes or at least one of the plurality of terminals includes a C-shaped contact that has been disposed over the transverse circumference of the lead body and closed with opposing ends of the C-shaped contact coupled together. The opposing ends of the C-shaped contact define a coupling aperture. At least one of the plurality of conductors extends into the coupling aperture and electrically couples to the C-shaped contact.
- Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.
- For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein:
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FIG. 1 is a schematic view of one embodiment of an electrical stimulation system, according to the invention; -
FIG. 2 is a schematic view of another embodiment of an electrical stimulation system, according to the invention; -
FIG. 3A is a schematic view of one embodiment of a proximal portion of a lead and a control module of an electrical stimulation system, according to the invention; -
FIG. 3B is a schematic view of one embodiment of a proximal portion of a lead and a lead extension of an electrical stimulation system, according to the invention; -
FIG. 4 is a schematic perspective view of one embodiment of a proximal end of an elongated member, according to the invention; -
FIG. 5 is a schematic perspective view of one embodiment of a proximal end of an elongated member and a C-shaped contact, the elongated member having transverse channels ablated into the elongated member to expose conductors extending within the elongated member, according to the invention; -
FIG. 6 is a schematic perspective view of one embodiment of the C-shaped contact ofFIG. 5 disposed over a transverse channel ablated into the elongated member ofFIG. 5 , according to the invention; -
FIG. 7 is a schematic perspective view of one embodiment of the C-shaped contact ofFIG. 5 disposed over a transverse channel ablated into the elongated member ofFIG. 5 with opposing inwardly-bending ends of the C-shaped contact coupled together to form a continuous path around the transverse channel, according to the invention; and -
FIG. 8 is a schematic overview of one embodiment of components of a stimulation system, including an electronic subassembly disposed within a control module, according to the invention. - The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to systems and methods of forming one or more ends of elongated members of electrical stimulation systems.
- Suitable implantable electrical stimulation systems include, but are not limited to, an electrode lead (“lead”) with one or more electrodes disposed on a distal end of the lead and one or more terminals disposed on one or more proximal ends of the lead.
- Leads include, for example, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S. patent application Ser. Nos. 10/353,101, 10/503,281, 11/238,240; 11/319,291; 11/327,880; 11/375,638; 11/393,991; and 11/396,309, all of which are incorporated by reference.
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FIG. 1 illustrates schematically one embodiment of anelectrical stimulation system 100. The electrical stimulation system includes a control module (e.g., a stimulator or pulse generator) 102, apaddle body 104, and at least onelead body 106 coupling thecontrol module 102 to thepaddle body 104. Thepaddle body 104 and the one ormore lead bodies 106 form a lead. Thepaddle body 104 typically includes an array ofelectrodes 134. Thecontrol module 102 typically includes anelectronic subassembly 110 and anoptional power source 120 disposed in a sealedhousing 114. Thecontrol module 102 typically includes a connector 144 (FIGS. 2 and 3A , see also 322 and 350 ofFIG. 3B ) into which the proximal end of the one ormore lead bodies 106 can be plugged to make an electrical connection via connector contacts on thecontrol module 102 and terminals (e.g., 310 inFIG. 3A and 336 ofFIG. 3B ) on each of the one ormore lead bodies 106. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the electrical stimulation system references cited herein. For example, instead of apaddle body 104, theelectrodes 134 can be disposed in an array at or near the distal end of thelead body 106 forming a percutaneous lead, as illustrated inFIG. 2 . A percutaneous lead may be isodiametric along the length of the lead. In addition, one or more lead extensions 312 (seeFIG. 3B ) can be disposed between the one or morelead bodies 106 and thecontrol module 102 to extend the distance between the one or morelead bodies 106 and thecontrol module 102 of the embodiments shown inFIGS. 1 and 2 . - The electrical stimulation system or components of the electrical stimulation system, including one or more of the
lead bodies 106, thepaddle body 104, and thecontrol module 102, are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like. - The
electrodes 134 can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. The number ofelectrodes 134 in the array ofelectrodes 134 may vary. For example, there can be two, four, six, eight, ten, twelve, fourteen, sixteen, ormore electrodes 134. As will be recognized, other numbers ofelectrodes 134 may also be used. - The electrodes of the
paddle body 104 or one or morelead bodies 106 are typically disposed in, or separated by, a non-conductive, biocompatible material including, for example, silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, and the like or combinations thereof. Thepaddle body 104 and one or morelead bodies 106 may be formed in the desired shape by any process including, for example, molding (including injection molding), casting, and the like. Electrodes and connecting wires can be disposed onto or within a paddle body either prior to or subsequent to a molding or casting process. The non-conductive material typically extends from the distal end of the lead to the proximal end of each of the one or morelead bodies 106. The non-conductive, biocompatible material of thepaddle body 104 and the one or morelead bodies 106 may be the same or different. Thepaddle body 104 and the one or morelead bodies 106 may be a unitary structure or can be formed as two separate structures that are permanently or detachably coupled together. - Terminals (e.g., 310 in
FIG. 3A and 336 ofFIG. 3B ) are typically disposed at the proximal end of the one or morelead bodies 106 for connection to corresponding connector contacts (e.g., 314 inFIG. 3A and 340 ofFIG. 3B ) in connectors (e.g., 144 inFIGS. 1-3A and 322 and 350 ofFIG. 3B ) disposed on, for example, the control module 102 (or to other devices, such as connector contacts on a lead extension, an operating room cable, or an adaptor). Conductive wires (“conductors”) (not shown) extend from the terminals (e.g., 310 inFIG. 3A and 336 ofFIG. 3B ) to theelectrodes 134. Typically, one ormore electrodes 134 are electrically coupled to a terminal (e.g., 310 inFIG. 3A and 336 ofFIG. 3B ). In some embodiments, each terminal (e.g., 310 inFIG. 3A and 336 ofFIG. 3B ) is only connected to oneelectrode 134. The conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead. In some embodiments, there is an individual lumen for each conductive wire. In other embodiments, two or more conductive wires may extend through a lumen. There may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead, for example, for inserting a stylet rod to facilitate placement of the lead within a body of a patient. Additionally, there may also be one or more lumens (not shown) that open at, or near, the distal end of the lead, for example, for infusion of drugs or medication into the site of implantation of thepaddle body 104. In at least one embodiment, the one or more lumens may be flushed continually, or on a regular basis, with saline, epidural fluid, or the like. In at least some embodiments, the one or more lumens can be permanently or removably sealable at the distal end. - In at least some embodiments, leads are coupled to connectors disposed on control modules. In
FIG. 3A , alead 308 is shown configured and arranged for insertion to thecontrol module 102. Theconnector 144 includes aconnector housing 302. Theconnector housing 302 defines at least oneport 304 into which aproximal end 306 of a lead 308 withterminals 310 can be inserted, as shown bydirectional arrow 312. Theconnector housing 302 also includes a plurality ofconnector contacts 314 for eachport 304. When thelead 308 is inserted into theport 304, theconnector contacts 314 can be aligned with theterminals 310 on thelead 308 to electrically couple thecontrol module 102 to the electrodes (134 ofFIG. 1 ) disposed at a distal end of thelead 308. Examples of connectors in control modules are found in, for example, U.S. Pat. No. 7,244,150 and U.S. patent application Ser. No. 11/532,844, which are incorporated by reference. - In
FIG. 3B , aconnector 322 is disposed on alead extension 324. Theconnector 322 is shown disposed at adistal end 326 of thelead extension 324. Theconnector 322 includes aconnector housing 328. Theconnector housing 328 defines at least oneport 330 into which aproximal end 332 of a lead 334 withterminals 336 can be inserted, as shown bydirectional arrow 338. Theconnector housing 328 also includes a plurality ofconnector contacts 340. When thelead 334 is inserted into theport 330, theconnector contacts 340 disposed in theconnector housing 328 can be aligned with theterminals 336 on thelead 334 to electrically couple thelead extension 324 to the electrodes (134 ofFIG. 1 ) disposed at a distal end (not shown) of thelead 334. - In at least some embodiments, the proximal end of a lead extension is similarly configured and arranged as a proximal end of a lead. The
lead extension 324 may include a plurality of conductive wires (not shown) disposed in a body of the lead extension that electrically couple theconnector contacts 340 to aproximal end 348 of thelead extension 324 that is opposite to thedistal end 326. In at least some embodiments, the conductive wires disposed in thelead extension 324 can be electrically coupled to a plurality of terminals (not shown) disposed on theproximal end 348 of thelead extension 324. In at least some embodiments, theproximal end 348 of thelead extension 324 is configured and arranged for insertion into a connector disposed in another lead extension. In other embodiments, theproximal end 348 of thelead extension 324 is configured and arranged for insertion into a connector disposed in a control module. As an example, inFIG. 3B theproximal end 348 of thelead extension 324 is inserted into aconnector 350 disposed in acontrol module 352. - Assembling the ends of an elongated member (e.g., a lead, a lead extension, or the like) may be complex, tedious, and expensive. For example, with conventional methods, the proximal end of the body of the elongated member is typically radially ablated to expose underlying conductors extending within the body of the elongated member. Cylindrical contacts (e.g., terminals) are placed over the exposed conductors in a spaced-apart manner with one or more non-conductive spacers positioned between adjacent contacts. Each of the contacts is electrically coupled to a different one of the conductors. Additional steps may also be necessary including, for example, back filling lumens in which the conductors are disposed with epoxy and grinding the contacts to size so that outer surfaces of the contacts are flush with outer surfaces of the elongated body. In some cases (e.g., with percutaneous leads), the distal end of the elongated members may be assembled in a similar manner, with the contacts being electrodes instead of terminals. In other cases (e.g., with lead extensions), the distal end of the elongated members may be assembled in a similar manner, with the contacts being connector contacts instead of terminals.
- In at least some embodiments, a plurality of spaced-apart C-shaped contacts may be disposed over portions of the elongated member and electrically coupled to underlying conductors extending within the elongated member. In at least some embodiments, each of the C-shaped contacts has opposing inwardly-bending ends that wrap around a transverse axis of the elongated member and that may be closed and coupled together to form a continuous path around the transverse axis of the elongated member. In at least some embodiments, portions of the elongated member may be ablated to form spaced-apart transverse channels that are configured and arranged to receive C-shaped contacts and that provide access to electrically couple the C-shaped contacts to the underlying conductors.
- Typically, the elongated member includes an arrangement of elongated conductors disposed in an outer layer. The conductors may be disposed in elongated members in many different possible configurations (e.g., arranged into units, coiled into a helical configuration, disposed in a multi-lumen retention element, disposed over a sleeve, disposed over a mandrel, or the like). Additionally, in at least some embodiments, the conductors are also individually encased by a layer of insulation. It will be understood that, when the conductors are individually encased by a layer of insulation, the layer of insulation encasing the conductor may also be ablated to expose underlying conductors.
- In at least some embodiments, the conductors are disposed in a multi-lumen retention element.
FIG. 4 is a schematic perspective view of one embodiment of anelongated member 402. Theelongated member 402 includes abody 404. Thebody 404 includes amulti-lumen retention element 406 and anouter layer 408. In at least some embodiments, theouter layer 408 is part of themulti-lumen retention element 406. One or more conductors, such asconductor 410, may be disposed in one or more of the lumens, such aslumen 412. It will be understood that theconductor 410 is shown extending from theelongated member 402 for clarity of illustration. - To electrically couple the conductors to contacts, the conductors are exposed. One technique for exposing the conductors is ablating portions of the
outer layer 408 of theelongated member 402. In at least some embodiments, theouter layer 406 of theelongated member 402 is ablated to form spaced-apart transverse channels to access a plurality of the conductors and also to receive a C-shaped contact. In preferred embodiments, the transverse channels are laser ablated. -
FIG. 5 is a schematic perspective view of one embodiment of theelongated member 402 and a C-shapedcontact 502. Theouter layer 408 of theelongated member 402 has been ablated to form transverse channels 504-506 extending along a transverse axis of the elongated member. The transverse channels 504-506 are deep enough to expose a plurality of underlying conductors when conductors are disposed in theelongated member 402. It will be understood that, when conductors are disposed in the lumens of themulti-lumen retention element 406, an outer portion of themulti-lumen retention element 404 may also be ablated to expose the conductors. In some embodiments, the outer portion of themulti-lumen retention element 404 is ablated before the conductors are disposed in themulti-lumen retention element 404. In other embodiments, the outer portion of themulti-lumen retention element 404 is ablated after the conductors are disposed in themulti-lumen retention element 404. - The C-shaped
contact 502 includes two opposing inwardly-bending ends 508 and 510. In at least some embodiments, each of the opposing ends define a portion of acoupling aperture FIG. 7 ) when the C-shapedcontact 502 is closed, as described below. - The C-shaped
contact 502 may be formed from any biocompatible conductive material suitable for implantation into a patient including, for example, metals (e.g., platinum, iridium, and the like), alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. - In at least some embodiments, the C-shaped
contact 502 defines a transverse length between the opposing inwardly-bending ends 508 and 510. In some embodiments, the transverse length of the C-shapedcontact 502 is equal to a transverse circumference of the ablated portion of the transverse channels 504-506 of theelongated body 402. In other embodiments, the transverse length of the C-shapedcontact 502 is equal to a transverse circumference of the outer layer of theelongated body 402. In some embodiments, the C-shapedcontact 502 is configured and arranged to be disposed in the transverse channels 504-506 (as described below and as shown inFIGS. 6 and 7 ). In other embodiments, the C-shapedcontact 502 is configured and arranged to be disposed over theouter layer 408 of theelongated member 402. - It may be an advantage for an elongated member to be isodiametric. An isodiametric elongated member may reduce the chance of the elongated member getting caught on patient tissue during insertion of the elongated member into the patient, or during patient movement subsequent to implantation of the elongated member.
- It may be an advantage to inset the C-shaped
contact 502 in thetransverse channel 504 because the C-shapedcontact 502 may be formed with a transverse cross-sectional profile that is thicker than with conventional contacts, when the elongated member is isodiametric. A thicker contact may promote better electrical contact and may increase durability of the electrical stimulation system. It may further be an advantage to inset the C-shapedcontact 502 in thetransverse channel 504 because the thickness of the transverse cross-sectional profile of the C-shapedcontact 502 may be formed so that an outer surface of the C-shapedcontact 502 is flush with theouter layer 408 of the elongated member without needing to grind down the C-shapedcontact 502. - In other embodiments, there can be grinding of the lead (e.g., the contacts, the lead body, or both) to form an isodiametric lead.
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FIG. 6 is a schematic perspective view of one embodiment of the C-shapedcontact 502 disposed in thetransverse channel 504 of theelongated member 402. In at least some embodiments, the C-shapedcontact 502 is flexible. In at least some embodiments, the C-shapedcontact 502 is disposed within thetransverse channel 504. For example, in at least some embodiments the C-shapedcontact 502 is snapped over thetransverse channel 504. In at least some embodiments, the depth of thetransverse channel 504 is no greater than the thickness of the C-shapedcontact 502. In at least some embodiments, the depth of thetransverse channel 504 is equal to the thickness of the C-shapedcontact 502. - Accordingly, in at least some embodiments, when the C-shaped contacts are disposed in the transverse channels, an outer surface of the C-shaped
contact 502 is flush with outer surfaces of theelongated member 402. Alternatively, in at least some other embodiments, the outer surfaces of the C-shapedcontact 502 extend radially outward from the outer surfaces of theelongated member 402. In which case, the outer surfaces of the C-shapedcontact 502 may be ground down to be flush with the outer surfaces of theelongated member 402. - In at least some embodiments, once the C-shaped
contact 502 is disposed over one of the transverse channels, the C-shapedcontact 502 is closed (e.g., crimped, clamped, squeezed, or the like) so that the opposing inwardly-bending ends 508 and 510 of the C-shapedcontact 502 are adjacent to one another.FIG. 7 is a schematic perspective view of one embodiment of the C-shapedcontact 502 disposed over thetransverse channel 504 of theelongated member 402. The opposing ends 508 and 510 of the C-shapedcontact 502 are closed so that the opposing inwardly-bending ends 508 and 510 are adjacent to one another. In at least some embodiments, a tooling fixture may be used to close the C-shapedcontact 502. In at least some embodiments, when the opposing ends 508 and 510 are closed, the portions of the coupling aperture (512 a and 512 b ofFIG. 5 ) align to form acomplete coupling aperture 512. - Once the C-shaped
contact 502 is closed, the opposing ends 508 and 510 of the C-shapedcontact 502 may be coupled together to form a continuous path around a transverse circumference of theelongated member 402. In preferred embodiments, the opposing ends 508 and 510 are coupled together using an electrically-conductive medium (e.g., welding, soldering, or the like). - In at least some embodiments, the closed opposing ends 508 and 510 of the C-shaped
contact 502 may be aligned around the transverse circumference of theelongated member 402 such that thecoupling aperture 512 aligns with one of the conductors. In at least some embodiments, when thecoupling aperture 512 is aligned with one of the conductors, electrically coupling the opposing ends 508 and 510 of the C-shapedcontact 502 together also electrically couples the aligned conductor to the C-shapedcontact 502, via thecoupling aperture 512. For example, the aligned conductor may be extended through thecoupling aperture 512 so that coupling the opposing ends 508 and 510 of the C-shapedcontact 502 also couples the conductor to the C-shapedcontact 502. It will be understood that, when multiple C-shaped contacts are coupled to theelongated member 402, each of the coupling apertures of different C-shaped contacts may be aligned with different conductors. - In alternate embodiments, one of the underlying conductors may be electrically coupled to the C-shaped
contact 502 prior to the C-shaped contacts being closed. For example, the C-shapedcontact 502 may be disposed within thetransverse channel 504 in an open position and one of the underlying conductors accessible from one of thetransverse channels 504 may be coupled to an undersurface of the C-shapedcontact 502, or coupled to one of the opposing ends (preferably within a portion of one of the coupling apertures) of the C-shapedcontact 502. The C-shapedcontact 502 may subsequently be closed and the ends of the C-shapedcontact 502 may be coupled together. In at least some embodiments, coupling the C-shapedcontact 502 is performed by an automated system. It may be an advantage to employ an automated system to increase one or more of productivity or consistency. - In at least some other embodiments, one or more access holes may by ablated in the elongated body in addition to, or in lieu of, ablating one or more transverse channels. One or more access holes may be ablated through the
outer layer 406 to access one of the conductors individually, without accessing multiple conductors. It may be an advantage to ablate individual access holes instead of ablating transverse channels to prevent undesired conductors from contacting the C-shaped contact and potentially causing a short circuit. - When one or more access holes are ablated in the elongated body, the C-shaped
contact 502 may be disposed over theouter layer 408 of the elongated body and the C-shapedcontact 502 may be electrically coupled to the underlying conductor via the one or more access holes. In some embodiments, the C-shapedcontact 502 is electrically coupled to the underlying conductor prior to coupling the C-shapedcontact 502, in a similar manner as describe above. In other embodiments, the C-shapedcontact 502 is closed without being electrically coupled to the conductors. Then, once the C-shapedcontact 502 is closed, thecoupling aperture 512 of the C-shapedcontact 502 is aligned over at least one of the access holes and the C-shapedcontact 502 is electrically coupled to the underlying conductor, via thecoupling aperture 512, as the opposing ends 508 and 510 of the C-shapedcontact 502 are coupled together. In at least some embodiments, the underlying conductor is extended through thecoupling aperture 512 when the opposing ends 508 and 510 of the C-shapedcontact 502 are coupled together. -
FIG. 8 is a schematic overview of one embodiment of components of anelectrical stimulation system 800 including anelectronic subassembly 810 disposed within a control module. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein. - Some of the components (for example,
power source 812,antenna 818,receiver 802, and processor 804) of the electrical stimulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing of an implantable pulse generator, if desired. Anypower source 812 can be used including, for example, a battery such as a primary battery or a rechargeable battery. Examples of other power sources include super capacitors, nuclear or atomic batteries, mechanical resonators, infrared collectors, thermally-powered energy sources, flexural powered energy sources, bioenergy power sources, fuel cells, bioelectric cells, osmotic pressure pumps, and the like including the power sources described in U.S. Patent Application Publication No. 2004/0059392, incorporated herein by reference. - As another alternative, power can be supplied by an external power source through inductive coupling via the
optional antenna 818 or a secondary antenna. The external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the user on a permanent or periodic basis. - If the
power source 812 is a rechargeable battery, the battery may be recharged using theoptional antenna 818, if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to arecharging unit 816 external to the user. Examples of such arrangements can be found in the references identified above. - In one embodiment, electrical current is emitted by the
electrodes 134 on the paddle or lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system. Aprocessor 804 is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, theprocessor 804 can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, theprocessor 804 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, theprocessor 804 may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, theprocessor 804 may be used to identify which electrodes provide the most useful stimulation of the desired tissue. - Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from an
external programming unit 808 that, for example, allows modification of pulse characteristics. In the illustrated embodiment, theprocessor 804 is coupled to areceiver 802 which, in turn, is coupled to theoptional antenna 818. This allows theprocessor 804 to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired. - In one embodiment, the
antenna 818 is capable of receiving signals (e.g., RF signals) from anexternal telemetry unit 806 which is programmed by aprogramming unit 808. Theprogramming unit 808 can be external to, or part of, the telemetry unit 1506. The telemetry unit 1506 can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired. As another alternative, thetelemetry unit 806 may not be worn or carried by the user but may only be available at a home station or at a clinician's office. Theprogramming unit 808 can be any unit that can provide information to thetelemetry unit 806 for transmission to theelectrical stimulation system 800. Theprogramming unit 808 can be part of thetelemetry unit 806 or can provide signals or information to thetelemetry unit 806 via a wireless or wired connection. One example of a suitable programming unit is a computer operated by the user or clinician to send signals to thetelemetry unit 806. - The signals sent to the
processor 804 via theantenna 818 andreceiver 802 can be used to modify or otherwise direct the operation of the electrical stimulation system. For example, the signals may be used to modify the pulses of the electrical stimulation system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct theelectrical stimulation system 800 to cease operation, to start operation, to start charging the battery, or to stop charging the battery. In other embodiments, the stimulation system does not include anantenna 818 orreceiver 802 and theprocessor 804 operates as programmed. - Optionally, the
electrical stimulation system 800 may include a transmitter (not shown) coupled to theprocessor 804 and theantenna 818 for transmitting signals back to thetelemetry unit 806 or another unit capable of receiving the signals. For example, theelectrical stimulation system 800 may transmit signals indicating whether theelectrical stimulation system 800 is operating properly or not or indicating when the battery needs to be charged or the level of charge remaining in the battery. Theprocessor 804 may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics. - The above specification, examples and data provide a description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.
Claims (20)
1. A lead comprising:
a lead body having a distal portion, a proximal portion, an outer layer, a longitudinal length, and a circumference;
a plurality of transverse channels defined along at least one of the distal portion or the proximal portion of the lead body, the plurality of transverse channels each extending around the circumference of the lead body;
a plurality of contacts disposed along the lead body, the plurality of contacts comprising
a plurality of cylindrical electrodes disposed along the distal portion of the lead body, and
a plurality of cylindrical terminals disposed along the proximal portion of the lead body,
wherein at least one of the plurality of contacts is formed as a C-shaped contact disposed around the circumference of the lead body within one of the plurality of transverse channels and closed with opposing ends of the C-shaped contact coupled together;
a plurality of conductors coupling the plurality of electrodes to the plurality of terminals;
a plurality of access holes defined along the plurality of transverse channels with at least one of the plurality of access holes defined within each of the plurality of transverse channels, each of the plurality of access holes individually exposing one of the plurality of conductors such that the remaining conductors are not exposed.
2. The lead of claim 1 , wherein the opposing ends of the at least one C-shaped contact define a coupling aperture disposed over one of the plurality of access holes, and wherein at least one of the plurality of conductors extends through the coupling aperture and electrically couples to the at least one C-shaped contact.
3. The lead of claim 1 , wherein a single conductor of the plurality of conductors electrically couples to each of the at least one C-shaped contacts.
4. The lead of claim 1 , wherein the coupling aperture of the at least one C-shaped contact is disposed directly over one of the plurality of access holes.
5. The lead of claim 1 , wherein the number of transverse channels is equal to the number of contacts.
6. The lead of claim 1 , wherein the at least one C-shaped contact has a thickness that is no greater than a depth of the transverse channel within which the at least one C-shaped contact is disposed.
7. The lead of claim 1 , wherein the at least one C-shaped contact has a thickness that is no less than a depth of the transverse channel within which the at least one C-shaped contact is disposed.
8. The lead of claim 1 , wherein the at least one C-shaped contact has a thickness that is equal to a depth of the transverse channel within which the at least one C-shaped contact is disposed.
9. The lead of claim 1 , wherein the lead is isodiametric.
10. The lead of claim 1 , further comprising a multi-lumen retention element disposed along the lead body, the multi-lumen retention element defining a plurality of conductor lumens, wherein the plurality of conductors extend within the plurality of conductor lumens.
11. The lead of claim 10 , wherein each of the plurality of spaced-apart transverse channels is defined along the multi-lumen retention element.
12. The lead of claim 10 , wherein each conductor of the plurality of conductors is disposed in a different conductor lumen of the multi-lumen retention element from the remaining conductors of the plurality of conductors.
13. The lead of claim 1 , wherein exactly one access hole is defined in each of the plurality of transverse channels.
14. The lead of claim 1 , wherein each of the plurality of access holes extends less than a complete circumference around the lead body.
15. The lead of claim 1 , wherein at least one of the plurality of electrodes is a C-shaped contact.
16. The lead of claim 1 , wherein each of the plurality of electrodes is a C-shaped contact.
17. The lead of claim 1 , wherein at least one of the plurality of terminals is a C-shaped contact.
18. The lead of claim 1 , wherein each of the plurality of terminals is a C-shaped contact.
19. The lead of claim 18 , wherein a different C-shaped contact is disposed within each transverse channel of the plurality of transverse channels.
20. An electrical stimulating system comprising:
the lead of claim 1 ; and
a control module electrically coupleable to the plurality of electrodes of the lead, the control module comprising
a housing, and
an electronic subassembly disposed in the housing; and
a connector for receiving the lead, the connector comprising
a connector housing defining a port configured and arranged for receiving the proximal portion of the lead body of the lead, and
a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to the plurality of terminals of the lead when the proximal portion of the lead is received by the port.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US14/537,643 US20150060136A1 (en) | 2009-05-27 | 2014-11-10 | Systems and methods for forming an end of an elongated member of an electrical stimulation system |
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US12/473,170 US8910376B2 (en) | 2009-05-27 | 2009-05-27 | Systems and methods for forming an end of an elongated member of an electrical stimulation system |
US14/537,643 US20150060136A1 (en) | 2009-05-27 | 2014-11-10 | Systems and methods for forming an end of an elongated member of an electrical stimulation system |
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US12/473,170 Division US8910376B2 (en) | 2009-05-27 | 2009-05-27 | Systems and methods for forming an end of an elongated member of an electrical stimulation system |
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US14/537,643 Abandoned US20150060136A1 (en) | 2009-05-27 | 2014-11-10 | Systems and methods for forming an end of an elongated member of an electrical stimulation system |
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US8380325B2 (en) * | 2009-08-05 | 2013-02-19 | Boston Scientific Neuromodulation Corporation | Systems and methods for coupling coiled conductors to conductive contacts of an electrical stimulation system |
US9005503B2 (en) * | 2012-12-13 | 2015-04-14 | Boston Scientific Neuromodulation Corporation | Methods of manufacturing a contact array assembly and leads and systems containing the assembly |
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US8910376B2 (en) | 2014-12-16 |
US20100304626A1 (en) | 2010-12-02 |
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