Patent Grant
8260424
The present invention is directed to the area of implantable medical lead systems and methods of making and using the systems. The present invention is also directed to implantable medical lead systems that include a connection monitoring system for detecting a loss of electrical connectivity between two or more components of the implantable medical lead system, as well as methods of making and using the implantable medical lead systems.
Implantable medical lead 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, medical lead systems can be implanted subcutaneously to stimulate subcutaneous tissue including subcutaneous nerves such as the occipital nerve.
Implantable medical lead systems have been developed to provide therapy for a variety of treatments. An implantable medical lead system can include a control module (with a pulse generator or a receiver or both), one or more leads, and an array of electrodes on each lead. The electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated or recorded or both. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue. The receiver in the control module receives electrical activity that is recorded by the electrodes from body tissue.
In one embodiment, a connection monitoring system for an implantable medical lead system includes an implantable lead, a first trial system cable, an external trial system, and a sensor. The lead has a distal end and at least one proximal end. The lead includes a plurality of terminals disposed at each proximal end. The first trial system cable has a distal end and at least one proximal end. The distal end of the first trial system cable is configured and arranged to electrically couple with the lead. The external trial system is configured and arranged to electrically couple with the first trial system cable. The sensor is electrically coupled to the external trial system. The sensor is configured and arranged for detecting a loss of electrical connectivity between the external trial system and the lead when the lead becomes electrically decoupled from the external trial system.
In another embodiment, a connection monitoring system for an implantable medical lead system includes an implantable lead, a lead extension, a control module, and a sensor. The implantable lead has a distal end and at least one proximal end. The lead includes a plurality of terminals disposed at each proximal end. The lead extension has a distal end and at least one proximal end. The distal end of the lead extension is configured and arranged to electrically couple with the lead. The control module is configured and arranged to electrically couple with the lead extension. The sensor is electrically coupled to the external trial system. The sensor is configured and arranged for detecting a loss of electrical connectivity between the control module and the lead when the lead becomes electrically decoupled from the control module.
In yet another embodiment, a method for monitoring an implantable medical lead system for a loss of electrical connectivity includes implanting a distal end of a lead into a patient so that a proximal end of the lead extends from the patient. The distal end of the lead includes a plurality of electrodes. The proximal end of the lead includes a plurality of terminals. The proximal end of the lead is electrically coupled to a connector disposed at a distal end of a first trial system cable so that at least one of the terminals electrically couples to a pair of conductor pins disposed in the connector to one another. Each conductor pin of the pair of conductor pins is electrically coupled to a sensor disposed in an external trial system. Impedance values within at least one predetermined range are monitored between the two conductor pins of the trial system cable. An indication is provided when the sensor detects impedance values within one of the predetermined ranges.
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 medical lead systems and methods of making and using the systems. The present invention is also directed to implantable medical lead systems that include a connection monitoring system for detecting a loss of electrical connectivity between two or more components of the implantable medical lead system, as well as methods of making and using the implantable medical lead systems.
An implantable medical lead system may include an implantable electrical recording system or an implantable electrical stimulation system. For clarity, embodiments are discussed with reference to implantable electrical stimulation systems. However, it will be understood that embodiments including implantable electrical recording systems are equally applicable.
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.
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. 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
Implantable electrical recording systems may include leads that are structurally similar to leads of an implantable electrical stimulation system. However, with implantable electrical recording systems, electrodes record electrical activity and a receiver in the control module receives the recorded electrical activity. Processing of the received electrical activity may be performed by a processor in the control module, or by an external processor, or both. In at least some embodiments, implantable medical lead systems may include both recording and stimulation functionality.
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
Sometimes a trial stimulation is performed on a patient before an implantable medical lead system is completely implanted in the patient. During the trial stimulation, the patient's response to a variety of stimulation parameters may be analyzed over a period of time prior to complete implantation of the implantable medical lead system into the patient. A trial stimulation may last for several days, or even one or more weeks. During a trial stimulation, a patient is typically able to make adjustments to received stimulation. For example, a patient may be able to turn the stimulation on and off, or adjust one or more stimulation parameters, such as stimulation amplitude, or switch between two or more different pre-programmed stimulation patterns, as desired. In at least some embodiments, a patient may be able to make stimulation adjustments using a remote control.
During a trial stimulation, a distal end of a lead (or an entire lead and a distal end of a lead extension) is implanted into the patient at a selected location, while a proximal end of the lead (or lead extension) is electrically coupled to an external trial system via a trial system cable (and, optionally, one or more trial system cable extensions). It will be understood that a trial recording may also be performed instead of, or in addition to, a trial stimulation.
In at least some alternate embodiments, the lead 402 may be entirely implanted into the patient and electrically coupled to a distal end of a lead extension with a proximal end that remains external to the patient. Accordingly, in at least some embodiments the proximal end of the lead extension may be electrically coupled to the external trial system 404. In at least some embodiments, an implantable medical lead system may also include other intermediate conductors, such as one or more additional lead extensions.
In at least some alternate embodiments, the lead 422 may be entirely implanted into the patient and electrically coupled to a distal end of a lead extension with a proximal end that remains external to the patient. Accordingly, in at least some embodiments the proximal end of the lead extension may be electrically coupled to the external trial system 426 via the trial system cable 424. In at least some embodiments, an implantable medical lead system may also include other intermediate conductors, such as one or more additional lead extensions.
In at least some embodiments, an implantable medical lead system 420 may include one or more trial system cable extensions. In at least some embodiments, a proximal end of the trial system cable 424 may be electrically coupled to a distal end of a trial system cable extension. In at least some embodiments, a proximal end of the trial system cable extension may, in turn, be electrically coupled to the external trial system 426. In at least some embodiments, the trial system cable 424 may be configured and arranged to receive a plurality of leads or lead extensions.
Electrical connectivity between the lead and the external trial system may, on occasion, become lost. It may be the case that a patient does not immediately notice that electrical connectivity is lost and may, instead, attribute a loss of therapeutic affect to a sub-therapeutic setting on the external trial system. Consequently, the patient may increase one or more of the stimulation parameters. Sometimes the patient may subsequently reconnect the disconnection without first lowering the increased stimulation parameters and accidently overstimulate him or herself. Electrical connectivity may also become lost between a lead and a control module at some point subsequent to implantation of the control module.
An electrical-connectivity monitoring system (“connection monitoring system”) for an implantable medical lead system is described. In some embodiments, the connection monitoring system detects losses of electrical connectivity in an implantable medical lead system occurring somewhere along a conductive path between a lead and an external trial system during a trial stimulation. In other embodiments, the connection monitoring system detects losses of electrical connectivity in an implantable medical lead system occurring somewhere along a conductive path between a lead and a control module subsequent to implantation. In at least some embodiments, the connection monitoring system may also be able to distinguish between different types of trial system cables (e.g., a trial system cable with one proximal end and sixteen conductors for electrically coupling with sixteen electrodes on a connected lead, or a trial system cable with two proximal ends and eight conductors on each proximal end, each conductor coupling with eight electrodes on a connected lead), or one or more other accessory devices, such as a test load box, connector box, or the like.
The loss of connectivity may occur within one or more of the components, such as a lead, lead extension, trial system cable, trial system cable extension, or external trial system. However, in practice it is more likely that the loss of connectivity happens due to one or more disconnections between components. For example, in at least some embodiments, the loss of connectivity may occur between a lead (or lead extension) and a trial system cable. In at least some embodiments, the loss of connectivity may occur between the trial system cable and the trial system cable extension. In at least some embodiments, the loss of connectivity may occur between two trial system cable extensions. In at least some embodiments, the loss of connectivity may occur between the trial system cable (or trial system cable extension) and the external trial system. In at least some embodiments, the loss of connectivity may occur between the lead and the lead extension. In at least some embodiments, the loss of connectivity may occur between the lead (or lead extension) and the control module.
In the case of external trial systems with multiple ports, in addition to a loss of connectivity occurring, trial system cables (and trial system cable extensions) may be inserted into the incorrect port. Insertion of a trial system cable (or a trial system cable extension) into the incorrect port of an external trial system may result in undesired stimulation of a patient.
The trial system cable 506 includes a connector 518 at a distal end and connective contacts 520 and 522 at a proximal end. The connector 518 includes two conductor pins 524 and 526. Each of the conductor pins 524 and 526 is electrically coupled to the connective contacts 520 and 522, respectively, disposed at a proximal end of the trial system cable 506, via conductors 528 and 530, respectively. The lead (or lead extension) 504 includes at least one terminal 532. It will be understood that additional conductor pins disposed in the connector 518 (and in the external trial system 508) are omitted for clarity of illustration. Additionally, it will be understood that additional connective contacts disposed on the proximal end of the trial system cable 506 are also omitted in
In at least some embodiments, the sensor 514 either periodically or continually detects the impedance, current, voltage difference, or the like, between the conductor pins 510 and 512. In at least some embodiments, when the lead (or lead extension) 504 is fully inserted into the connector 518 of the trial system cable 506, the terminal 532 disposed on the lead (or lead extension) 504 electrically couples the two conductor pin 524 and 526 to one another to produce a relatively low impedance path. Additionally, in at least some embodiments, when the trial system cable 506 is fully inserted into the external trial system 508, the connective contacts 520 and 522 disposed in the trial system cable 506 electrically couple to the conductive pins 510 and 512, respectively, of the external trial system 508.
Thus, in at least some embodiments, when the lead (or lead extension) 504 is fully inserted into the trial system cable 506 and the trial system cable 506 is fully inserted into the external trial system 508, the sensor 514 senses that the impedance between the conductor pins 510 and 512 is below a threshold value indicating that the lead (or lead extension) 504 is electrically coupled to the external trial system 508. Conversely, in at least some embodiments, when either or both the lead (or lead extension) 504 is not fully inserted into the trial system cable 506 or the trial system cable 506 is not fully inserted into the external trial system 508, the sensor 514 senses that the impedance between the conductor pins 510 and 512 is above a threshold impedance value indicating that the lead (or lead extension) 504 is not electrically coupled to the external trial system 508 and, accordingly, electrical connectivity is lost between the lead 504 and the external trial system 508.
In at least some embodiments, when a loss of electrical connectivity is detected, one or more signals may be emitted. Many different types of signals may be emitted from the indicator 516 including, for example, at least one auditory signal, at least one visual signal, at least one tactile signal, at least one olfactory signal, a telemetry signal to another device, or the like or combinations thereof. For example, an emitted signal may include one or more beeps, chirps, squeaks, chimes, rings, the activation or de-activation of one or more lights or light-emitting diodes one or more times, a message may be displayed on one or more displays, one or more vibrations or tactile pulses, the emission of one or more peculiar odors, and the like or combinations thereof. In at least some embodiments, the indicator 516 is disposed on the external trial system 508. In at least some embodiments, the indicator 516 is disposed on a remote control (not shown in
In at least some embodiments, when a loss of electrical connectivity is detected, stimulation (or recording) may be allowed to continue. In at least some embodiments, when a loss of electrical connectivity is detected, the external trial system may automatically turn off. In at least some embodiments, when a loss of electrical connectivity is detected, a message is sent via telemetry to another device (e.g., a patient remote control (which may or may not have its own indicator(s) or display a message on a screen)) either actively, or as part of a subsequent communication. In at least some embodiments, when a loss of electrical connectivity is detected, the external trial system may perform a data logging of the connect/disconnect event.
In at least some embodiments, the implantable medical lead system 502 may also include one or more trial system cable extensions.
In at least some embodiments, the trial system cable 506 is formed integrally with the external trial system 508, as shown in
In at least some embodiments, conductor pins (e.g., 524 and 526 of
In at least some embodiments, one or more terminals disposed on the lead (or lead extension) (see e.g., 504 in
In at least some embodiments, the terminals disposed on the lead (or lead extension) 616 are configured and arranged so that, when the proximal-most terminal 618 is aligned with the proximal-most pair of conductor pins 608 and 610 (thereby establishing an indication of electrical conductivity by the connection monitoring system (500 in FIG. 5A)), the remaining terminals disposed on the lead (or lead extension) 616 also align with the remaining conductor pins 606 disposed on the connector 602. It may be an advantage to electrically couple the connection monitoring system (500 in
In at least some embodiments, conductor pins of the connection monitoring system (500 in
In at least some embodiments, a single conductor pin may be split into two electrically-isolated conductor-pin portions that are each independently electrically coupled to connective contacts (see e.g., 520 and 522 of
In at least some embodiments, the connection monitoring system 500 electrically couples with the proximal-most terminal of the inserted lead or lead extension, as shown in
In at least some embodiments, the connection monitoring system 500 is configured and arranged to determine where a disconnection occurs in an implantable medical lead system 502. For example, in at least some embodiments the connection monitoring system 500 differentiates between a disconnection occurring between the lead (or lead extension) 504 and the trial system cable 506 from a disconnection occurring between the trial system cable 506 and the external trial system 508 (or the trial system cable extension 534), or between the trial system cable extension 534 and the external trial system 508.
In at least some embodiments, the connection monitoring system 500 may recognize a plurality of non-overlapping impedance ranges for the implantable medical lead system 502. In at least some embodiments, detection of impedance within a first range may indicate a loss of connectivity at a first location and a detection of impedance within a second range may indicate a loss of connectivity at a second location.
In at least some alternate embodiments, one or more resistors may be placed in a conductive path parallel with conductor pins disposed on a distal end of a trial system cable 506. In
Alternately, in at least some embodiments, one or more additional resistors may be placed in a conductive path in series with R1. In
In at least some embodiments, the connection monitoring system can be used to distinguish which port of a multi-port external trial system a disconnection occurs. Any suitable number of ports may be employed to receive trial system cables or trial system cable extensions including, for example, one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, or more ports. In at least some embodiments, each port may include a unique connection monitoring system, such as the connection monitoring system 500 shown in
In
In at least some embodiments, the indicator may provide a different signal to correspond to the location of a loss of connectivity. For example, a beeping of a first frequency may indicate a loss of connectivity within the implantable medical lead system employing the trial system cable 1004 and a beeping of a second frequency may indicate a loss of connectivity within the implantable medical lead system employing the trial system cable 1006. Moreover, one beep may indicate a loss of connectivity between a lead (or lead extension) and the trial system cable 1004 or 1006 (depending on the frequency) and two beeps may indicate a loss of connectivity between the trial system cable 1004 or 1006 (depending on the frequency) and the external trial system 1002. In at least some embodiments, the indicator may form a message on a display indicating a loss of electrical connectivity. In at least some embodiments, the indicator may form a message on the display indicating where the loss of electrical connectivity occurred.
Some of the components (for example, power source 1112, antenna 1118, receiver 1102, and processor 1104) of the implantable medical lead 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 1112 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, bioclectric 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 1118 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 1112 is a rechargeable battery, the battery may be recharged using the optional antenna 1118, if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit 1116 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 implantable medical lead system. A processor 1104 is generally included to control the timing and electrical characteristics of the implantable medical lead system. For example, the processor 1104 can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, the processor 1104 can select which electrodes can be used to provide stimulation (or recording), if desired. In some embodiments, the processor 1104 may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, the processor 1104 may be used to identify which electrodes provide the most useful stimulation (or recording) 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 1108 that, for example, allows modification of pulse characteristics. In the illustrated embodiment, the processor 1104 is coupled to a receiver 1102 which, in turn, is coupled to the optional antenna 1118. This allows the processor 1104 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 1118 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 1106 which is programmed by a programming unit 1108. The programming unit 1108 can be external to, or part of, the telemetry unit 1106. The telemetry unit 1106 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 1106 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 1108 can be any unit that can provide information to the telemetry unit 1106 for transmission to the implantable medical lead system 1100. The programming unit 1108 can be part of the telemetry unit 1106 or can provide signals or information to the telemetry unit 1106 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 1106.
The signals sent to the processor 1104 via the antenna 1118 and receiver 1102 can be used to modify or otherwise direct the operation of the implantable medical lead system. For example, the signals may be used to modify the pulses of the implantable medical lead system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct the implantable medical lead system 1100 to cease operation, to start operation, to start charging the battery, or to stop charging the battery. In other embodiments, the implantable medical lead system 1100 does not include an antenna 1118 or receiver 1102 and the processor 1104 operates as programmed.
Optionally, the implantable medical lead system 1100 may include a transmitter (not shown) coupled to the processor 1104 and the antenna 1118 for transmitting signals back to the telemetry unit 1106 or another unit capable of receiving the signals. For example, the implantable medical lead system 1100 may transmit signals indicating whether the implantable medical lead system 1100 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 1104 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.
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