Patent Application
20090248124
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 implantable electrical stimulation systems that include one or more leads with lead identifiers for identifying the leads, as well as methods of making and using the lead identifiers, leads, and 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. Deep brain stimulation has also been useful for treating refractory chronic pain syndromes and has been applied to treat movement disorders and epilepsy. 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. Moreover, electrical stimulation systems can be implanted subcutaneously to stimulate subcutaneous tissue including subcutaneous nerves such as the occipital nerve.
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 lead includes a lead body with a distal end and at least one proximal end. The lead also includes a plurality of electrodes disposed on the distal end of the lead body and a plurality of terminals disposed on the at least one proximal end of the lead body. A plurality of conductor wires extend along the lead body and couple the electrodes electrically to the terminals. The lead further includes at least one lead identifier disposed on the lead body. The lead identifier is configured and arranged to visually identify the end of the lead body on which the at least one lead identifier is disposed. The at least one lead identifier includes at least one of a markable-surface-finish region suitable for marking with a pen, at least one laser-ablated identification marking, at least one contrasting band of material formed of a conspicuous color, at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, or a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body.
In another embodiment, an electrical stimulating system includes a first lead, a control module configured and arranged to electrically couple to the first lead, and a connector for receiving the first lead. The first lead includes a lead body with a distal end and at least one proximal end. The lead also includes a plurality of electrodes disposed on the distal end of the lead body and a plurality of terminals disposed on the at least one proximal end of the lead body. A plurality of conductor wires extend along the lead body and couple the electrodes electrically to the terminals. The lead further includes at least one lead identifier disposed on the lead body. The lead identifier is configured and arranged to visually identify the end of the lead body on which the at least one lead identifier is disposed. The at least one lead identifier includes at least one of a markable-surface-finish region suitable for marking with a pen, at least one laser-ablated identification marking, at least one contrasting band of material formed of a conspicuous color, at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, or a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body. The control module includes a housing and an electronic subassembly disposed in the housing. The connector includes a connector housing defining at least one opening for receiving the at least one proximal end of the first lead, and a plurality of connector contacts disposed in the connector housing. The connector contacts are configured and arranged to couple to at least one terminal on the at least one proximal end of the first lead.
In yet another embodiment, a method for stimulating patient tissue includes implanting at least one lead with a plurality of electrodes into a patient, disposing each of at least one proximal end of the at least one lead into at least one connector electrically coupled to at least one control module, and providing electrical signals from at least one of the control modules to electrically stimulate patient tissue using at least one of the plurality of electrodes. The at least one lead including a plurality of terminals disposed on each of at least one proximal end of each of the at least one lead, each of the plurality of terminals electrically coupled to at least one of the plurality of electrodes. Each of the at least one lead also including at least one lead identifier for individually identifying each of the at least one proximal ends of the at least one lead. The at least one lead identifier includes at least one of a markable-surface-finish region suitable for marking with a pen, at least one laser-ablated identification marking, at least one contrasting band of material formed of a conspicuous color, at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, or a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body. Each of the at least one connector defining at least one port for receiving the at least one proximal ends of the at least one lead. Each of the at least one port including a plurality of connective contacts that electrically couple to at least one of the plurality of terminals disposed on each of at least one proximal ends of each of the at least one lead. Each of the at least one the connectors electrically coupled to at least one control module.
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:
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 implantable electrical stimulation systems that include one or more leads with lead identifiers for identifying the leads, as well as methods of making and using the lead identifiers, leads, and 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 applications 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.
The electrical stimulation system or components of the electrical stimulation system, including one or more of the lead bodies 106, the paddle body 104, and the control 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 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 (e.g., 310 in
In at least some embodiments, leads are coupled to connectors disposed on control modules. In
In
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) that electrically couple the conductive contacts 340 to a proximal end 348 of the lead extension 324 that is opposite to the distal end 326. In at least some embodiments, 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. In at least some embodiments, 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
During implantation of a plurality of leads into a patient, or implantation of a lead with multiple proximal ends into a patient, once the distal end(s) are positioned, each proximal end of the one or more leads is typically coupled to a specific port defined in a specific connector of a control module, a lead extension, an adaptor, or an operating room cable. When a plurality of leads or a plurality of proximal ends of one lead is present, determining which proximal end should be coupled to which port can sometimes be difficult or time-consuming. It may be the case that the proximal ends of the one or more leads may be visually and fluoroscopically identical to one another and the distal end of each of the one or more leads may be visually obscured. Moreover, multiple proximal ends may be inserted through a single subcutaneous tunnel and may become overlapped or tangled with each other or various body tissues. Similar proximal-end-identification problems may also exist during revision surgery, for example, during explantation of a malfunctioning lead. It may be a time-consuming task to identify the malfunctioning lead.
In at least some embodiments, a lead identifier is disposed on one or more leads, preferably at or near the proximal ends of the lead, to visually identify (and preferably uniquely identify) the lead. Lead identifiers can be used, for example, to distinguish the proximal end on which the lead identifier is disposed from other proximal ends of the same lead or from proximal ends on different leads to facilitate the coupling of the identified proximal end of the lead to a desired corresponding port of a control module or a lead extension.
In some embodiments, a lead identifier includes at least one markable region with a surface finish different from other portions of the lead.
In a preferred embodiment, a markable surface finish is formed by laser ablation and is suitable for marking with a pen. In at least some embodiments, the markable surface finish can be marked with a pen in order to identify the proximal end of the lead on which the markable surface finish is disposed. In at least some embodiments, the region with the markable surface is at or near a proximal end of the lead. The region may be proximal to, or distal to, or between, the terminals of the lead.
It will be understood that many different possible markings can be formed on the markable surface finish 416 to identify the proximal end of the lead 402. For example, a markable-surface-finish marking may be one or more geometric shapes, lines, numbers, letters, symbols, or pictures. Additionally, markable-surface-finish markings can be identifiable by other determinants, such as size, shape, number of markings, or placement of markings on the markable surface finish 416. For example,
In at least some embodiments, a coding system can be implemented in which various markings formed on the markable surface finish correspond with information about the lead on which the markable surface finish is disposed, such as the lead type, the number of proximal ends associated with the lead, which port a proximal end of a lead is to be inserted, the positioning of the distal end of the lead within the anatomy of a patient, or other information. For example, the coding system might indicate a right lead or a left lead or the coding system might indicate a top lead or bottom lead or rostral lead or caudal lead. For example, in one embodiment, a single dot may correspond with a first port defined in a connector of a control module. Similarly, in another embodiment, two dots may indicate that the proximal end of the lead on which the two dots are disposed corresponds with a second port defined in the connector of the control module. In at least some embodiments, a coding system may also be used to differentiate between multiple proximal ends of a single lead.
In at least some embodiments, a lead identifier includes at least one identification marking laser-ablated onto an outer surface of a proximal end of a lead. In at least some embodiments, the laser-ablated identification marking includes an identification code.
In at least some embodiments, the laser-ablated identification marking includes one or more conspicuous regions. A region can be conspicuous when the region contrasts visually with the portion of the lead on which the conspicuous region is disposed, such that the conspicuous region is visually distinct from the surrounding portions of the lead. Conspicuous laser-ablated regions can be formed in many different regular or irregular shapes, such as an oval, a circle, a rectangle, and the like. In a preferred embodiment, conspicuous laser-ablated regions are formed as one or more bands laser-ablated around a lateral circumference of a proximal end of a lead. In
Laser-ablated bands can be formed in many different sizes. For example, the laser ablated band 512 can be formed with different widths. The number of laser-ablated bands in a lead identifier also may vary. For example, there can be one, two, three, four, five, six, or more laser-ablated bands. As will be recognized, other numbers of laser-ablated bands may also be used. In alternate embodiments, a lead identifier includes at least one laser-ablated identification code and at least one laser-ablated band. For example,
In at least some embodiments, a lead identifier includes at least one piece of contrasting material disposed over an outer surface of a proximal end of a lead. A piece of material can be contrasting when the piece of material is visually distinct, or conspicuous, from the portion of the lead on which the piece of contrasting material is disposed. In at least some embodiments, a piece of material disposed over an outer surface contrasts from the portion of the lead on which the material is disposed when the piece of material is a color that is different from the color of the portion of the lead on which the contrasting piece of material is disposed.
A piece of contrasting material can be formed in many different shapes, such as an oval, a circle, a rectangle, and the like. In a preferred embodiment, a piece of contrasting material is disposed over an outer surface of a proximal end of a lead and is formed as a contrasting band of material (“contrasting band”) that forms either a partial loop around at least a portion of a lateral circumference of a proximal end of a lead, or a complete loop around an entire lateral circumference of a proximal end of a lead.
The contrasting band can be formed in many different sizes. For example, the contrasting band may be formed in many different widths. The number of contrasting bands in a lead identifier may vary. For example, there can be one, two, three, four, five, six, or more contrasting bands in a lead identifier. As will be recognized, other numbers of contrasting bands may be used in a lead identifier. Each contrasting band can have the same or a different width when compared to other contrasting bands.
Contrasting bands can be formed from many different types of materials suitable for implantation that can be made visually distinct in appearance from a proximal end of a lead, including, plastic, metal, silicone, polyurethane, PEEK, epoxy, and the like or combinations thereof. Contrasting bands can be formed on an outer surface of a lead by any process, including heat shrinking colored tubing onto an outer surface of a lead, sliding colored tubing onto an outer surface of a lead, crimping or swaging contrasting bands onto a lead, or the like. Contrasting bands may be attached to an outer surface of a lead by an adhesive.
Additional markings can be used supplementally with one or more contrasting bands. Additional markings may include visible markings on, or in, the contrasting bands. For example, an additional marking may be one or more apertures, notches, grooves, protrusions, or the like formed in the band.
In alternate embodiments, lead identifiers that include one or more contrasting bands wrapped around at least a portion of an outer surface of a lead can be placed in an inset region in the outer surface of the lead.
Various coding systems can be devised using the number of contrasting bands, the widths of the contrasting bands, the types of the materials used to form the contrasting bands, the colors of the contrasting bands, as well as any markings on the contrasting bands. The various coding systems can be used to provide information about the lead on which a lead identifier is disposed, such as the lead type, the number of proximal ends associated with the lead, which port a proximal end of a lead is to be inserted, the positioning of the distal end of the lead, or other information. For example, in one embodiment the number of contrasting bands corresponds to the number of proximal ends on a lead, the color of the contrasting bands corresponds to the type of lead, and the additional markings correspond to the specific ports of a connector into which each proximal end is to be inserted. In another example, one purple contrasting band may indicate that a proximal end of a lead is to be inserted into a first port on a control module and two purple contrasting bands may indicate that a proximal end of a lead is to be inserted into a second port of a control module. In yet another example, an odd number of green contrasting bands may indicate that a proximal end of a lead is to be inserted into a first port on a control module and an even number of green contrasting bands may indicate that a proximal end of a lead is to be inserted into a second port of a control module.
In at least some embodiments, a lead identifier includes one or more conspicuously-colored spacers disposed between adjacent terminals on a proximal end of a lead. In at least some embodiments, a spacer is conspicuously-colored when the spacer is a color that is different from the color of the remaining spacers, the proximal end of the lead, or the proximal tip.
The lead 702 further includes a lead identifier 716 with a conspicuously-colored spacer 718 disposed between the two adjacent terminals 708 and 710. The color of the conspicuously-colored spacer 718 contrasts from the color of the lead body 714, the remaining spacers, and the proximal tip 704. Spacers can be formed from many different kinds of non-conductive, insulating materials suitable for implantation, including, silicone, polyurethane, PEEK, epoxy, and the like or combinations thereof. In at least some embodiments, the materials used to form a spacer are the same as the materials used to form the lead 702 or the proximal tip 704.
In at least some embodiments, a plurality of spacers are conspicuously-colored.
In at least some embodiments, different numbers, relative placement, or types of colors of spacers can be used in different arrangements to create various coding systems. The various coding systems can be used to provide information about the lead on which a lead identifier is disposed, such as the lead type, the number of proximal ends associated with the lead, which port a proximal end of a lead is to be inserted, the positioning of the distal end of the lead, or other information. For example, in one embodiment, a red spacer indicates that a proximal end of a lead corresponds with a first port of a control module. In another embodiment, two green spacers indicate that a proximal end of a lead corresponds with a second port of a control module. In yet another embodiment, a blue spacer indicates that a proximal end of a lead is the left lead body of a paddle body. In another embodiment, a white spacer indicates a right proximal end and a black spacer indicates a left proximal end of the lead. In another embodiment, one or more spacers with contrasting colors indicate a left proximal end and no spacers with contrasting colors indicates a right proximal end.
In at least some embodiments, a lead identifier includes a conspicuously-colored proximal tip on a proximal end of a lead.
In at least some embodiments, a lead identifier may include a conspicuously-colored proximal tip and one or more conspicuously-colored spacers. For example,
In at least some embodiments, different numbers or types of colors of conspicuously-colored spacers and a conspicuously-colored proximal tip can be used in different arrangements to create various coding systems. For example, in one embodiment, a red proximal tip and a black spacer indicates that a proximal end of a lead corresponds with a first port of a control module. In another embodiment, two green spacers and a green proximal tip indicate that a proximal end of a lead corresponds with a second port of a control module. In yet another embodiment, a blue spacer and an orange proximal tip indicates that a proximal end of a lead is the left lead body of a paddle body.
In at least some embodiments, use of specific colors on spacers or a proximal tip (or pattern of spacers or number or arrangements of colors) corresponds to specific topographical information relating to the placement or orientation of a distal end of a lead. For example, in one embodiment, three brown spacers and a brown proximal tip may correspond to a proximal end of a lead with a distal end positioned in proximity to the lumbar vertebra of the patient's spine.
Sometimes connectors are formed out of translucent or transparent materials. Consequently, it may be difficult to insert a proximal end of a lead into an opening in a translucent or transparent connector during surgery. The embodiments shown in
In at least some embodiments, a lead identifier includes various combinations of markable surface finishes, laser-ablated identification markings, contrasting bands wrapped around at least a portion of the proximal end of a lead, conspicuously-colored spacers, and a conspicuously-colored proximal tip. For example,
In at least some embodiments, one or more coding systems may be created using various combinations of markable surface finishes, laser-ablated identification markings, contrasting bands wrapped around at least a portion of the proximal end of a lead, conspicuously-colored spacers, and conspicuously-colored proximal tips. Various combinations and arrangements can be used to provide various types of information about the lead on which the lead identifier is disposed, such as the type of lead, the number of proximal ends associated with the lead, the number of leads implanted in a patient, the location of the distal end of the lead on which the lead identifier is disposed, or any special instructions related to a specific lead.
Some of the components (for example, power source 912, antenna 918, receiver 902, and processor 904) 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 912 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 918 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 912 is a rechargeable battery, the battery may be recharged using the optional antenna 918, if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit 916 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. A processor 904 is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor 904 can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, the processor 904 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, the processor 904 may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, the processor 904 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 908 that, for example, allows modification of pulse characteristics. In the illustrated embodiment, the processor 904 is coupled to a receiver 902 which, in turn, is coupled to the optional antenna 918. This allows the processor 904 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 918 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 906 which is programmed by a programming unit 908. The programming unit 908 can be external to, or part of, the telemetry unit 906. The telemetry unit 906 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, the telemetry unit 906 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 908 can be any unit that can provide information to the telemetry unit 906 for transmission to the electrical stimulation system 900. The programming unit 908 can be part of the telemetry unit 906 or can provide signals or information to the telemetry unit 906 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 906.
The signals sent to the processor 904 via the antenna 918 and receiver 902 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 the electrical stimulation system 900 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 an antenna 918 or receiver 902 and the processor 904 operates as programmed.
Optionally, the electrical stimulation system 900 may include a transmitter (not shown) coupled to the processor 904 and the antenna 918 for transmitting signals back to the telemetry unit 906 or another unit capable of receiving the signals. For example, the electrical stimulation system 900 may transmit signals indicating whether the electrical stimulation system 900 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 904 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.
This application is a utility patent application based on a previously filed U.S. Provisional Patent Application Ser. No. 61/040,098 filed on Mar. 27, 2008, the benefit of which is hereby claimed under 35 U.S.C. §119(e) and incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61040098 | Mar 2008 | US |
