US20110071593A1 - Couplings for implanted leads and external stimulators, and associated systems and methods - Google Patents
Couplings for implanted leads and external stimulators, and associated systems and methods Download PDFInfo
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- US20110071593A1 US20110071593A1 US12/562,892 US56289209A US2011071593A1 US 20110071593 A1 US20110071593 A1 US 20110071593A1 US 56289209 A US56289209 A US 56289209A US 2011071593 A1 US2011071593 A1 US 2011071593A1
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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
-
- 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
- A61N1/0553—Paddle shaped electrodes, e.g. for laminotomy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3752—Details of casing-lead connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
-
- 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
-
- 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
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/048—Electrodes characterised by a specific connection between lead and electrode
-
- 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
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0488—Details about the lead
Definitions
- the present disclosure is directed generally to couplings for implanted leads and external stimulators, and associated systems and methods.
- Implantable neurological stimulation systems generally have an implantable pulse generator and one or more leads that deliver electrical pulses to neurological tissue or muscle tissue.
- a neurological stimulation system for spinal cord stimulation have cylindrical leads that include a lead body with a circular cross-sectional shape and one or more conductive rings spaced apart from each other at the distal end of the lead body.
- the conductive rings operate as individual electrodes and, in many cases, the SCS leads are implanted percutaneously through a large needle inserted into the epidural space, with or without the assistance of a stylet.
- the pulse generator applies electrical pulses to the electrodes, which in turn modify the function of the patient's nervous system, such as by altering the patient's responsiveness to sensory stimuli and/or altering the patient's motor-circuit output.
- the pulse generator applies electrical pulses to the electrodes, which in turn can generate sensations that mask or otherwise alter the patient's sensation of pain. For example, in many cases, patients report a tingling or paresthesia that is perceived as more pleasant and/or less uncomfortable than the underlying pain sensation.
- One problem associated with existing stimulation systems and methods is that the practitioner may not initially implant the SCS lead in the optimal position. Accordingly, practitioners typically make small adjustments to the position of the implanted lead while the patient is in the operating room. The practitioner then applies stimulation to the lead via an external stimulator, which is temporarily attached to the lead while the lead still extends out of the patient's body. This process is repeated until the practitioner determines the position of the lead that is expected to produce the best patient result. The patient and practitioner can also use the external stimulator during a post-operative trial period, to optimize the characteristics of the applied signal before an implantable pulse generator is connected to the lead and implanted beneath the patient's skin.
- FIG. 1 is a partially schematic illustration of an implantable spinal cord stimulation system positioned at the spine to deliver a therapeutic signal in accordance with an embodiment of the present disclosure.
- FIG. 2 is a partially schematic illustration of a lead having stimulation contacts and externally positioned connector contacts, suitable for providing stimulation in accordance with representative methods of present disclosure.
- FIG. 3 is a partially schematic, isometric illustration of a cable assembly suitable for releasably coupling a patient lead or other signal delivery element to an external stimulator or other device in accordance with an embodiment of the disclosure.
- FIG. 4 is a partially schematic, isometric illustration of a connector configured in accordance with an embodiment of the disclosure.
- FIG. 5 is an exploded, partially schematic illustration of an embodiment of the connector shown in FIG. 4 .
- FIG. 6 is a partially schematic, upwardly looking isometric view of a first housing portion of an embodiment of the connector shown in FIGS. 4 and 5 .
- FIG. 7A and 7B illustrate a connector shown in an unsecured position and a secured position, respectively, in accordance with an embodiment of the disclosure.
- FIGS. 8A-8C illustrate a method for operating a cable system in accordance with an embodiment of the disclosure.
- aspects of the present disclosure are directed generally to couplings that may be used to connect implanted leads or other implanted signal delivery elements, with external stimulators and/or other devices positioned external to a patient.
- a spinal cord stimulation (SCS) system for purposes of illustration.
- the disclosed systems and methods may be used in the context of other patient treatment and/or patient diagnostic systems.
- FIGS. 1-8C Several embodiments of representative systems and methods are described below with reference to FIGS. 1-8C . A person skilled in the relevant art will understand, however, that the disclosure may have additional embodiments, and/or that aspects of the disclosure may be practiced without several of the details of the embodiments described below.
- a patient treatment system in accordance with a particular embodiment includes a cable assembly that in turn includes an electrical cable having a proximal end and a distal end, with a first connector attached to the cable toward the proximal end, and a second connector attached to the cable toward the distal end.
- the first connector can include a plurality of first connector contacts positioned to releasably connect to an external patient device, for example, an external stimulator.
- the second connector can include a first portion and a second portion pivotably connected to the first portion.
- the first portion can have a slot elongated along a slot axis and positioned to receive an implantable patient signal delivery element axially along the slot axis.
- the second portion can have a plurality of second connector contacts positioned to releasably, electrically contact the signal delivery element when the signal delivery element is positioned within the slot and the first and second portions are placed in a secured position.
- the first and second portions are pivotable relative to each other between the secured position and an unsecured position.
- a representative method for operating a patient treatment system can include implanting an implantable signal delivery element in a patient, and positioning a cable proximate to connection contacts of the implantable signal delivery device.
- the cable can include a proximal end with a first connector having first connector contacts, and a distal end with a second connector having first and second portions.
- the method can further include sliding the connection contacts of the signal delivery element axially into a slot carried by the second portion of the second connector.
- the method can still further include pivoting at least one of the first and second portions relative to the other to electrically connect the connection contacts of the signal delivery device with second connector contacts carried by the second portion of the second connector.
- the first connector can be releasably connected to an external patient device, for example, an external patient stimulator.
- aspects of the foregoing systems and associated methods can allow the practitioner to manipulate the cable assembly connectors with only one hand, and/or can improve patient comfort while the cable assembly is connected to an implanted lead or other signal delivery element.
- FIG. 1 schematically illustrates a representative treatment system 100 for providing relief from chronic pain and/or other conditions, arranged relative to the general anatomy of a patient's spinal cord 191 .
- the system 100 can include a pulse generator 101 , which may be implanted subcutaneously within a patient 190 and coupled to a signal delivery element 110 .
- the signal delivery element 110 includes a lead or lead body 111 that carries features or elements for delivering therapy to the patient 190 after implantation.
- the pulse generator 101 can be connected directly to the lead 111 , or it can be coupled to the lead 111 via a communication link 102 (e.g., an extension).
- the lead 111 can include a terminal section that is releasably connected to an extension at a break 114 (shown schematically in FIG. 1 ). This allows a single type of terminal section to be used with patients of different body types (e.g., different heights).
- the terms lead and lead body include any of a number of suitable substrates and/or support members that carry devices for providing therapy signals to the patient 190 .
- the lead 111 can include one or more electrodes or electrical contacts that direct electrical signals into the patient's tissue, such as to provide for patient relief.
- the signal delivery element 110 can include devices other than a lead body (e.g., a paddle) that also direct electrical signals and/or other types of signals to the patient 190 .
- the pulse generator 101 can transmit signals to the signal delivery element 110 that up-regulate (e.g., stimulate or excite) and/or down-regulate (e.g., block or suppress) target nerves.
- up-regulate e.g., stimulate or excite
- down-regulate e.g., block or suppress
- target nerves e.g., a nerve that has either type of effect on the target nerves.
- the pulse generator 101 can include a machine-readable (e.g., computer-readable) medium containing instructions for generating and transmitting suitable therapy signals.
- the pulse generator 101 and/or other elements of the system 100 can include one or more processors 107 , memories 108 and/or input/output devices.
- the process of providing stimulation signals and executing other associated functions can be performed by computer-executable instructions contained on computer-readable media, e.g., at the processor(s) 107 and/or memory(s) 108 .
- the pulse generator 101 can include multiple portions, elements, and/or subsystems (e.g., for directing signals in accordance with multiple signal delivery parameters), housed in a single housing, as shown in FIG. 1 , or in multiple housings.
- the pulse generator 101 can obtain power to generate the therapy signals from an external power source 103 .
- the external power source 103 can transmit power to the implanted pulse generator 101 using electromagnetic induction (e.g., RF signals).
- the external power source 103 can include an external coil 104 that communicates with a corresponding internal coil (not shown) within the implantable pulse generator 101 .
- the external power source 103 can be portable for ease of use.
- the pulse generator 101 can obtain the power to generate therapy signals from an internal power source, in addition to or in lieu of the external power source 103 .
- the implanted pulse generator 101 can include a non-rechargeable battery or a rechargeable battery to provide such power.
- the internal power source includes a rechargeable battery
- the external power source 103 can be used to recharge the battery.
- the external power source 103 can in turn be recharged from a suitable power source (e.g., conventional wall power).
- an external programmer 105 e.g., a trial stimulator
- an external programmer 105 is coupled to the signal delivery element 110 during an initial implant procedure, prior to implanting the pulse generator 101 .
- a practitioner e.g., a physician and/or a company representative
- the practitioner uses a cable assembly 120 to temporarily connect the external programmer 105 to the signal delivery device 110 .
- the cable assembly 120 can accordingly include a first connector 121 that is releasably connected to the external programmer 105 , and a second connector 122 that is releasably connected to the signal delivery element 110 .
- the practitioner can test the efficacy of the signal delivery element 110 in an initial position.
- the practitioner can then disconnect the cable assembly 120 , reposition the signal delivery element 110 , and reapply the electrical stimulation. This process can be performed iteratively until the practitioner obtains the desired position for the signal delivery device 110 .
- the practitioner may move the partially implanted signal delivery element 110 without disconnecting the cable assembly 120 .
- the practitioner will connect and disconnect the cable assembly 120 at least once during the process. Further details of features that facilitate this process are described below with reference to FIGS. 3-8C .
- the patient 190 can receive therapy via signals generated by the external programmer 105 , generally for a limited period of time. In a representative application, the patient 190 receives such therapy for a one-week trial period. During this time, the patient wears the cable assembly 120 and the external programmer 105 outside the body. Assuming the trial therapy is effective or shows the promise of being effective, the practitioner then replaces the external programmer 105 with the implanted pulse generator 101 , and programs the pulse generator 101 with parameters selected based on the experience gained during the trial period. Optionally, the practitioner can also replace the signal delivery element 110 .
- the signal delivery parameters provided by the pulse generator 101 can still be updated remotely via a wireless physician's programmer (e.g., a physician's remote) 111 and/or a wireless patient programmer 106 (e.g., a patient remote).
- a wireless physician's programmer e.g., a physician's remote
- a wireless patient programmer 106 e.g., a patient remote
- the patient 190 has control over fewer parameters than does the practitioner.
- the capability of the patient programmer 106 may be limited to starting and/or stopping the pulse generator 101 , and/or adjusting stimulation amplitude.
- FIG. 2 is a partially schematic illustration of a representative signal delivery device 110 that includes a lead 111 having a plurality of stimulation contacts 112 toward the distal end that are implanted within the patient.
- the lead 111 includes internal wires that extend between the stimulation contacts 112 at the distal end and connection contacts 113 positioned at the proximal end.
- the connection contacts 113 extend outside the patient's body and are connected to an external stimulator. After the trial period is complete, the connection contacts 113 are connected to the implanted pulse generator 101 ( FIG. 1 ).
- a stylet 160 or other delivery device is temporarily connected to the lead 111 to support the lead 111 as it is positioned within the patient.
- the stylet 160 can include a shaft 161 and a handle 162 .
- the shaft 161 is generally flexible, but more rigid than the lead 111 to allow the practitioner to insert the lead 111 and control its position during implantation.
- FIG. 3 is a partially schematic, isometric illustration of a cable assembly 120 that can be releasably connected to the signal delivery element 110 shown in FIG. 2 .
- the cable assembly 120 includes a cable 125 carrying a plurality of electrical conductors 126 .
- a first connector 125 having first connector contacts 127 is positioned toward a proximal end 123 , with the first connector contacts 127 electrically connected to the electrical conductors 126 .
- a second connector 122 is connected to the cable 125 toward a distal end 124 and includes second connector contacts, also connected to the electrical conductors 126 and described later with reference to FIG. 5 .
- FIG. 4 is a partially schematic, isometric illustration of the distal end 124 of the cable 125 and the second connector 122 .
- the bulk of the second connector 122 can be formed from ABS or another suitable biocompatible plastic or other material.
- the second connector 122 includes a first portion, e.g., a first housing portion 130 pivotably connected to a second portion, e.g., a second housing portion 150 via a hinge 180 . Accordingly, at least one of the first housing portion 130 and the second housing portion 150 can be pivoted relative to the other (as indicated by arrow A) between a secured position and an unsecured position.
- the second connector 122 can have a corresponding secured configuration and unsecured continuation, respectively.
- the first housing portion 130 includes a slot 131 elongated along a slot axis 132 .
- the slot 131 can include a first opening 133 a positioned toward one end of the slot axis 132 , a second opening 133 b positioned toward the opposite end of the slot axis 132 , and a third opening 133 c extending along the slot axis 132 between the first opening 133 a and the second opening 133 b.
- the slot 131 is positioned to receive a lead or other signal delivery device, and an associated stylet.
- the first opening 133 a can have a first width W 1 sized to receive the lead
- the second opening 133 b can have a smaller second width W 2 sized to receive the stylet shaft
- the third opening 133 c can have a third width W 3 , also sized to receive the stylet shaft.
- the first housing portion 130 can include a lead stop 139 within the slot 131 to stop the axial progress of the lead and to align the lead with electrical contacts in the second housing portion.
- the lead stop 139 is a surface facing toward the first opening 133 a, and located at a point where the cross-sectional shape of the slot 131 changes from one that accommodates both the lead 111 and the stylet shaft, to one that accommodates the stylet shaft only.
- An alignment indicator 138 provides the practitioner with visual confirmation that the lead is properly aligned.
- the first housing portion 130 can include a first tab 134 and the second housing portion 150 can include a second tab 154 , both of which facilitate pivoting the two housing portions relative to each other.
- the two tabs 134 , 154 can be offset from each other in a direction generally parallel to the slot axis 132 to operate in a manner similar to that of a change purse.
- a latch 170 can hold the housing portions 130 , 150 in a secured position when the lead or other signal delivery element is positioned in the slot 131 .
- FIG. 5 is a partially schematic, partially exploded isometric illustration of an embodiment of the second connector 122 shown in FIG. 4 .
- the second housing portion 150 includes two outer hinge elements 184 , each having second pin apertures 183 that slidably receive a corresponding hinge pin 181 .
- the hinge pin 181 also passes through a corresponding inner hinge element described further below with reference to FIG. 6 .
- the second housing portion 150 can carry a support member 151 that in turn carries second connector contacts 152 .
- the second connector contacts 152 are electrically connected to the electrical conductors 126 carried by the cable 125 .
- the second connector contacts 152 project upwardly toward the first housing portion 130 so as to releasably engage with a lead placed in the slot 131 of the first housing portion 130 .
- the slot 131 can include a funnel surface 136 at the first opening 133 a to facilitate sliding a lead into the slot 131 along the slot axis 132 .
- a ramp surface 135 at the second opening 133 b can facilitate movement of the stylet handle 162 ( FIG. 2 ) relative to the slot 131 .
- the first housing portion 130 can include a first latch element 171 that releasably engages with a corresponding second latch element 172 of the second housing portion 150 .
- the second latch element 172 can include a latching slot 174 that receives the first latch element 171 when the second connector 122 is secured.
- the second housing portion 150 can also include a pivot stop slot 175 that also receives the first latch element 171 in the unsecured position to prevent the first housing portion 130 from over-rotating away from the second housing portion 150 .
- the stop slot 175 can also inhibit the practitioner from inadvertently placing the second connector 122 in the secured configuration.
- FIG. 6 is an isometric, upward-looking view toward the inner surface of the first housing portion 130 .
- This view illustrates the inner hinge element 185 of the first housing portion 130 , which has two first pin apertures 182 that slidably receive the hinge pin 181 described above with reference to FIG. 5 .
- the first housing portion 130 further includes contact apertures 137 .
- the contact apertures 137 can be blind slots that receive the upwardly projecting portions of the second connector contacts 152 shown in FIG. 5 .
- the first latch element 171 shown in FIG. 6 can include a projection 173 that is releasably received in the latching slot 174 shown in FIG. 5 when the second connector 122 is secured, and in the pivot stop slot 175 (also shown in FIG. 5 ) when the second connector 122 is unsecured.
- FIGS. 7A and 7B are cross-sectional illustrations of the second connector 122 shown in the unsecured position ( FIG. 7A ) and the secured position ( FIG. 7B ).
- FIG. 7A the first housing portion 130 is pivoted away from the second housing portion 150 to the unsecured position.
- a lead 111 is inserted into the first opening 133 a, but does not yet contact the second connector contacts 152 carried by the support member 151 of the second housing portion 150 .
- the first housing portion 130 can be prevented from rotating too far away from the second housing portion 150 because the projection 173 of the first latch element 171 is received in the pivot stop slot 175 of the second housing portion 150 .
- the pivot stop slot 175 can be positioned to prevent the first and second housing portions 130 , 150 from rotating by more than about 5° away from each other.
- the amount of rotation can be greater, for example, less than 45° , or less than 90° .
- the particular angular value can be selected so that the connection contacts of the lead just disengage from the second connector contacts 152 when the second connector 122 is in the unsecured position. In any of these embodiments, it is expected that limiting the relative rotation of the two housing portions 130 , 150 can facilitate the user's ability to secure and/or unsecure the second connector 122 , for example, by facilitating single handed operation of the second connector 122 .
- the pivot stop slot 175 alone prevents the housing portions 130 , 150 from over-rotating relative to each other.
- this function can be supplemented by another pivot stop 176 formed by the respective shapes of a downward-facing first surface 140 of the first housing portion 130 , and an upward-facing second surface 153 of the second housing portion 150 .
- the first and second surfaces 130 , 153 can be shaped to rotate smoothly relative to each other up to the selected maximum pivot angle, and to mechanically interfere with each other at angles beyond the maximum pivot angle.
- the first surface can be cylindrical (e.g., radially symmetric about the pivot axis) over only the part of its circumference that facilitates smooth rotation.
- this arrangement can replace the similar function provided by the pivot stop slot 175 .
- FIG. 7B illustrates the second connector 122 in the secured position.
- the first and second housing portions 130 , 150 have been pivoted toward each other, so that the lead 111 engages with the second connector contacts 152 .
- At least a portion of each second connector contact 152 can be received in a corresponding contact aperture 137 so that the second connector contacts 152 do not interfere with moving the housing portions 130 , 150 toward each other to the secured position.
- the first latch element 171 (and in particular, the projection 173 ) can be secured to the second latch element 172 , e.g., received in the latching slot 174 .
- the second connector 122 can remain in the secured position until positively acted upon by the practitioner.
- FIGS. 8A-8C are schematic illustrations of the second connector 122 illustrating a sequence of operation steps in accordance with an embodiment of the disclosure.
- the second connector 122 is in the unsecured configuration, with the first latch element 171 disengaged from the second latch element 172 .
- One feature of this arrangement is that the practitioner can easily discern that the second connector 122 is in the unsecured configuration by noting the visibly exposed latching slot 174 (e.g., the inner surfaces of the latching slot 174 ). With the second connector 122 in the unsecured configuration, the practitioner can slide the lead 111 axially into the first opening 133 a of the slot 131 .
- the practitioner slides the lead 111 axially into the slot 131 until the distal end of the lead 111 engages with the lead stop 139 located within the slot 131 .
- the stylet 160 can optionally be pre-inserted into the lead 111 before the lead 111 is placed in the slot 131 .
- the third opening 133 c can receive the stylet shaft 161 without interfering with the practitioner's axial insertion of the lead 111 .
- the width W 3 of the third opening 133 c is wide enough to allow the stylet shaft 161 to move downwardly into the slot 131 , yet narrow enough to prevent the lead 111 from inadvertently being moved upwardly out of the slot 131 .
- the ramp surface 135 at the second opening 133 b can allow the stylet handle 162 to pivot upwardly and downwardly relative to the first housing portion 130 , without catching on the upper edge of the first housing portion 130 .
- FIG. 8B is a top view of the second connector 122 , illustrating the lead 111 after it has been pushed as far as possible into the slot 131 , so as to engage with the lead stop 139 .
- at least one of the connection contacts 113 e.g., the first in a row of connection contacts
- the alignment indicator 138 the practitioner can receive visual confirmation that the lead 111 is properly positioned in the slot 131 .
- the practitioner can move at least one of the first housing portion 130 and the second housing portion 150 relative to each other to the secured position using only a single hand.
- the practitioner can engage the first closure tab 134 with a first part of the hand (e.g., the forefinger 198 ) and engage the second closure tab 154 with a second part of the hand (e.g., the thumb 197 ) and press the two housing portions 130 , 150 together, providing both a pivoting force to move the housing portions toward each other, and a reaction force to hold the second connector 122 in position, all with one hand.
- a first part of the hand e.g., the forefinger 198
- the second closure tab 154 e.g., the thumb 197
- the second connector 122 can have a relatively small size.
- the second connector can have an overall length of about 33.4 millimeters, an overall width of about 21.6 millimeters, and an overall thickness of 8.7 millimeters.
- the exposed surface area is accordingly about 7.2 square centimeters, which is significantly smaller than existing connectors sized to receive a lead having eight connection contacts 113 .
- the footprint of the second connector 122 can be even smaller.
- FIG. 8C illustrates the second connector 122 in the secured configuration.
- the projection 173 of the first latch element 171 is received in the latching slot 174 of the second latch element 172 .
- the latching slot 174 is no longer visible to the practitioner, thus confirming that the second connector 122 is in the secured configuration.
- the practitioner can also hear and/or feel a click or snap as the projection 173 is received in the latching slot 174 .
- the practitioner can apply signals to the lead 111 , and, based on feedback (e.g., patient feedback), can adjust the position of the lead as desired.
- feedback e.g., patient feedback
- the lead 111 or other signal delivery element 110 can be introduced into the second connector 122 by sliding it axially into and along the slot 131 , without at the same time engaging the connection contacts 113 with the second connector contacts 152 .
- the lead 111 can be moved into the slot 131 easily, with low frictional resistance, and with a reduced likelihood for dislodging or otherwise moving the lead 111 relative to the patient.
- the practitioner can do so with only one hand, allowing the practitioner to hold the lead 111 in place relative to the patient with the other hand.
- the practitioner's hand can provide both the moving force and the reaction force imparted to the second connector 122 , which reduces the likelihood for the second connector 122 to slip out of the practitioner's grasp.
- the angle between the two housing portions 130 , 150 is relatively small when the second connector 122 is in the unsecured configuration.
- the angle can be less than 90° , less than 45° or less than 5° .
- An advantage of this arrangement is that it facilitates the practitioner's ability to secure and unsecure the second connector 122 with one hand.
- the angle has a value less than 90°
- the practitioner can avoid placing forces on the housing portions 130 , 150 that have a vector component which tends to unsecure the second connector 122 when the practitioner is attempting to secure the second connector 122 .
- the amount of hand movement required to secure and/or unsecure the second connector 122 is relatively small, which decreases the likelihood that the practitioner will fumble with the second connector 122 .
- the second connector 122 has a relatively small footprint (e.g., projected area, generally normal to the major surfaces of the first or second housing portions 130 , 150 ).
- a relatively small footprint e.g., projected area, generally normal to the major surfaces of the first or second housing portions 130 , 150 .
- An expected advantage of this feature is that the small size makes the second connector 122 easier to manipulate.
- Another expected advantage of this feature is that the second connector will be less bulky and therefore more comfortable for the patient to wear during the trial period.
- the second connector can include other arrangements that limit or prohibit over-rotating one housing portion relative to the other.
- the second connector can include other arrangements for securing one housing portion relative to the other, and/or for halting the axial movement of the lead or other signal delivery element positioned in the second connector.
- the practitioner can leave the second connector attached to the implanted signal delivery element while the signal delivery element is repositioned, rather than disconnecting and reconnecting the connector with each new signal delivery element position.
- the signal delivery element can have features different than those shown in FIG. 2 , and/or can be supported by a device other than a stylet.
- advantages associated with certain embodiments have been described in the context of those embodiments, other embodiments may also exhibit such advantages and not all embodiments need necessarily exhibit such advantages to fall within the scope of the present disclosure. Accordingly, the disclosure can encompass other embodiments not expressly described or shown herein.
Abstract
Couplings for implanted leads and external stimulators, and associated systems and methods are disclosed. A system in accordance with a particular embodiment includes a cable assembly that in turn includes an electrical cable having a proximal end and a distal end. A first connector is attached to the cable toward the proximal end and has a plurality of first connector contacts positioned to releasably connect to an external patient device. A second connector is attached by the cable toward the distal end, and includes a first portion and a second portion pivotably connected to the first portion. The first portion has a slot elongated along a slot axis and positioned to receive an implantable patient signal delivery element axially along the slot axis. The second portion has a plurality of second connector contacts positioned to releasably, electrically contact the signal delivery element when the signal delivery element is positioned within the slot and the first and second portions are placed in a secured position. At least one of the first and second portions is pivotable relative to the other between the secured position and an unsecured position.
Description
- The present disclosure is directed generally to couplings for implanted leads and external stimulators, and associated systems and methods.
- Neurological stimulators have been developed to treat pain, movement disorders, functional disorders, spasticity, cancer, cardiac disorders, and various other medical conditions. Implantable neurological stimulation systems generally have an implantable pulse generator and one or more leads that deliver electrical pulses to neurological tissue or muscle tissue. For example, several neurological stimulation systems for spinal cord stimulation (SCS) have cylindrical leads that include a lead body with a circular cross-sectional shape and one or more conductive rings spaced apart from each other at the distal end of the lead body. The conductive rings operate as individual electrodes and, in many cases, the SCS leads are implanted percutaneously through a large needle inserted into the epidural space, with or without the assistance of a stylet.
- Once implanted, the pulse generator applies electrical pulses to the electrodes, which in turn modify the function of the patient's nervous system, such as by altering the patient's responsiveness to sensory stimuli and/or altering the patient's motor-circuit output. In pain treatment, the pulse generator applies electrical pulses to the electrodes, which in turn can generate sensations that mask or otherwise alter the patient's sensation of pain. For example, in many cases, patients report a tingling or paresthesia that is perceived as more pleasant and/or less uncomfortable than the underlying pain sensation.
- One problem associated with existing stimulation systems and methods is that the practitioner may not initially implant the SCS lead in the optimal position. Accordingly, practitioners typically make small adjustments to the position of the implanted lead while the patient is in the operating room. The practitioner then applies stimulation to the lead via an external stimulator, which is temporarily attached to the lead while the lead still extends out of the patient's body. This process is repeated until the practitioner determines the position of the lead that is expected to produce the best patient result. The patient and practitioner can also use the external stimulator during a post-operative trial period, to optimize the characteristics of the applied signal before an implantable pulse generator is connected to the lead and implanted beneath the patient's skin.
- To facilitate the foregoing process of alternately providing stimulation to the patient and moving the implanted portion of the lead, manufacturers have developed cables with releasable connectors. Accordingly, the practitioner can connect the cable to the external stimulator and the lead, apply the stimulation, then disconnect the cable, move the lead, and reconnect the cable with the lead in the new position. As noted above, this process can be repeated, as needed, until the desired lead location is obtained.
- One drawback with the foregoing approach is that it may be difficult for the practitioner to repeatedly manipulate the connector that attaches the cable to the lead, while still maintaining control over the position of the lead. Another drawback is that the connectors, which are outside the patient's body, may be awkward and/or cumbersome for the patient during the post-operative trial period. Accordingly, there remains a need for improved techniques and systems for releasably connecting implanted patient leads to external stimulation devices.
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FIG. 1 is a partially schematic illustration of an implantable spinal cord stimulation system positioned at the spine to deliver a therapeutic signal in accordance with an embodiment of the present disclosure. -
FIG. 2 is a partially schematic illustration of a lead having stimulation contacts and externally positioned connector contacts, suitable for providing stimulation in accordance with representative methods of present disclosure. -
FIG. 3 is a partially schematic, isometric illustration of a cable assembly suitable for releasably coupling a patient lead or other signal delivery element to an external stimulator or other device in accordance with an embodiment of the disclosure. -
FIG. 4 is a partially schematic, isometric illustration of a connector configured in accordance with an embodiment of the disclosure. -
FIG. 5 is an exploded, partially schematic illustration of an embodiment of the connector shown inFIG. 4 . -
FIG. 6 is a partially schematic, upwardly looking isometric view of a first housing portion of an embodiment of the connector shown inFIGS. 4 and 5 . -
FIG. 7A and 7B illustrate a connector shown in an unsecured position and a secured position, respectively, in accordance with an embodiment of the disclosure. -
FIGS. 8A-8C illustrate a method for operating a cable system in accordance with an embodiment of the disclosure. - Overview
- Aspects of the present disclosure are directed generally to couplings that may be used to connect implanted leads or other implanted signal delivery elements, with external stimulators and/or other devices positioned external to a patient. Several aspects of the disclosure are described in the context of a spinal cord stimulation (SCS) system for purposes of illustration. In other embodiments, the disclosed systems and methods may be used in the context of other patient treatment and/or patient diagnostic systems. Several embodiments of representative systems and methods are described below with reference to
FIGS. 1-8C . A person skilled in the relevant art will understand, however, that the disclosure may have additional embodiments, and/or that aspects of the disclosure may be practiced without several of the details of the embodiments described below. - A patient treatment system in accordance with a particular embodiment includes a cable assembly that in turn includes an electrical cable having a proximal end and a distal end, with a first connector attached to the cable toward the proximal end, and a second connector attached to the cable toward the distal end. The first connector can include a plurality of first connector contacts positioned to releasably connect to an external patient device, for example, an external stimulator. The second connector can include a first portion and a second portion pivotably connected to the first portion. The first portion can have a slot elongated along a slot axis and positioned to receive an implantable patient signal delivery element axially along the slot axis. The second portion can have a plurality of second connector contacts positioned to releasably, electrically contact the signal delivery element when the signal delivery element is positioned within the slot and the first and second portions are placed in a secured position. The first and second portions are pivotable relative to each other between the secured position and an unsecured position.
- A representative method for operating a patient treatment system can include implanting an implantable signal delivery element in a patient, and positioning a cable proximate to connection contacts of the implantable signal delivery device. The cable can include a proximal end with a first connector having first connector contacts, and a distal end with a second connector having first and second portions. The method can further include sliding the connection contacts of the signal delivery element axially into a slot carried by the second portion of the second connector. The method can still further include pivoting at least one of the first and second portions relative to the other to electrically connect the connection contacts of the signal delivery device with second connector contacts carried by the second portion of the second connector. The first connector can be releasably connected to an external patient device, for example, an external patient stimulator. As will be described further below, aspects of the foregoing systems and associated methods can allow the practitioner to manipulate the cable assembly connectors with only one hand, and/or can improve patient comfort while the cable assembly is connected to an implanted lead or other signal delivery element.
- Representative Systems and Methods
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FIG. 1 schematically illustrates arepresentative treatment system 100 for providing relief from chronic pain and/or other conditions, arranged relative to the general anatomy of a patient'sspinal cord 191. Thesystem 100 can include apulse generator 101, which may be implanted subcutaneously within apatient 190 and coupled to asignal delivery element 110. In a representative example, thesignal delivery element 110 includes a lead orlead body 111 that carries features or elements for delivering therapy to thepatient 190 after implantation. Thepulse generator 101 can be connected directly to thelead 111, or it can be coupled to thelead 111 via a communication link 102 (e.g., an extension). Accordingly, thelead 111 can include a terminal section that is releasably connected to an extension at a break 114 (shown schematically inFIG. 1 ). This allows a single type of terminal section to be used with patients of different body types (e.g., different heights). As used herein, the terms lead and lead body include any of a number of suitable substrates and/or support members that carry devices for providing therapy signals to thepatient 190. For example, thelead 111 can include one or more electrodes or electrical contacts that direct electrical signals into the patient's tissue, such as to provide for patient relief. In other embodiments, thesignal delivery element 110 can include devices other than a lead body (e.g., a paddle) that also direct electrical signals and/or other types of signals to thepatient 190. - The
pulse generator 101 can transmit signals to thesignal delivery element 110 that up-regulate (e.g., stimulate or excite) and/or down-regulate (e.g., block or suppress) target nerves. As used herein, and unless otherwise noted, the terms “stimulate” and “stimulation” refer generally to signals that have either type of effect on the target nerves. Thepulse generator 101 can include a machine-readable (e.g., computer-readable) medium containing instructions for generating and transmitting suitable therapy signals. Thepulse generator 101 and/or other elements of thesystem 100 can include one ormore processors 107,memories 108 and/or input/output devices. Accordingly, the process of providing stimulation signals and executing other associated functions can be performed by computer-executable instructions contained on computer-readable media, e.g., at the processor(s) 107 and/or memory(s) 108. Thepulse generator 101 can include multiple portions, elements, and/or subsystems (e.g., for directing signals in accordance with multiple signal delivery parameters), housed in a single housing, as shown inFIG. 1 , or in multiple housings. - In some embodiments, the
pulse generator 101 can obtain power to generate the therapy signals from anexternal power source 103. Theexternal power source 103 can transmit power to the implantedpulse generator 101 using electromagnetic induction (e.g., RF signals). For example, theexternal power source 103 can include anexternal coil 104 that communicates with a corresponding internal coil (not shown) within theimplantable pulse generator 101. Theexternal power source 103 can be portable for ease of use. - In another embodiment, the
pulse generator 101 can obtain the power to generate therapy signals from an internal power source, in addition to or in lieu of theexternal power source 103. For example, the implantedpulse generator 101 can include a non-rechargeable battery or a rechargeable battery to provide such power. When the internal power source includes a rechargeable battery, theexternal power source 103 can be used to recharge the battery. Theexternal power source 103 can in turn be recharged from a suitable power source (e.g., conventional wall power). - In many cases, an external programmer 105 (e.g., a trial stimulator) is coupled to the
signal delivery element 110 during an initial implant procedure, prior to implanting thepulse generator 101. For example, a practitioner (e.g., a physician and/or a company representative) can use theexternal programmer 105 to vary the stimulation parameters provided to thesignal delivery element 110 in real time, and select optimal or particularly efficacious parameters. These parameters can include the position of thesignal delivery element 110, as well as the characteristics of the electrical signals provided to thesignal delivery element 110. In a typical process, the practitioner uses acable assembly 120 to temporarily connect theexternal programmer 105 to thesignal delivery device 110. Thecable assembly 120 can accordingly include afirst connector 121 that is releasably connected to theexternal programmer 105, and asecond connector 122 that is releasably connected to thesignal delivery element 110. The practitioner can test the efficacy of thesignal delivery element 110 in an initial position. The practitioner can then disconnect thecable assembly 120, reposition thesignal delivery element 110, and reapply the electrical stimulation. This process can be performed iteratively until the practitioner obtains the desired position for thesignal delivery device 110. Optionally, the practitioner may move the partially implantedsignal delivery element 110 without disconnecting thecable assembly 120. In either embodiment, the practitioner will connect and disconnect thecable assembly 120 at least once during the process. Further details of features that facilitate this process are described below with reference toFIGS. 3-8C . - After the position of the
signal delivery element 110 and appropriate signal delivery parameters are established using theexternal programmer 105, thepatient 190 can receive therapy via signals generated by theexternal programmer 105, generally for a limited period of time. In a representative application, thepatient 190 receives such therapy for a one-week trial period. During this time, the patient wears thecable assembly 120 and theexternal programmer 105 outside the body. Assuming the trial therapy is effective or shows the promise of being effective, the practitioner then replaces theexternal programmer 105 with the implantedpulse generator 101, and programs thepulse generator 101 with parameters selected based on the experience gained during the trial period. Optionally, the practitioner can also replace thesignal delivery element 110. Once theimplantable pulse generator 101 has been positioned within thepatient 190, the signal delivery parameters provided by thepulse generator 101 can still be updated remotely via a wireless physician's programmer (e.g., a physician's remote) 111 and/or a wireless patient programmer 106 (e.g., a patient remote). Generally, thepatient 190 has control over fewer parameters than does the practitioner. For example, the capability of thepatient programmer 106 may be limited to starting and/or stopping thepulse generator 101, and/or adjusting stimulation amplitude. -
FIG. 2 is a partially schematic illustration of a representativesignal delivery device 110 that includes a lead 111 having a plurality ofstimulation contacts 112 toward the distal end that are implanted within the patient. Thelead 111 includes internal wires that extend between thestimulation contacts 112 at the distal end andconnection contacts 113 positioned at the proximal end. During the trial period, theconnection contacts 113 extend outside the patient's body and are connected to an external stimulator. After the trial period is complete, theconnection contacts 113 are connected to the implanted pulse generator 101 (FIG. 1 ). During implantation, astylet 160 or other delivery device is temporarily connected to thelead 111 to support thelead 111 as it is positioned within the patient. Accordingly, thestylet 160 can include ashaft 161 and ahandle 162. Theshaft 161 is generally flexible, but more rigid than thelead 111 to allow the practitioner to insert thelead 111 and control its position during implantation. -
FIG. 3 is a partially schematic, isometric illustration of acable assembly 120 that can be releasably connected to thesignal delivery element 110 shown inFIG. 2 . Thecable assembly 120 includes acable 125 carrying a plurality ofelectrical conductors 126. Afirst connector 125 havingfirst connector contacts 127 is positioned toward aproximal end 123, with thefirst connector contacts 127 electrically connected to theelectrical conductors 126. Asecond connector 122 is connected to thecable 125 toward adistal end 124 and includes second connector contacts, also connected to theelectrical conductors 126 and described later with reference toFIG. 5 . -
FIG. 4 is a partially schematic, isometric illustration of thedistal end 124 of thecable 125 and thesecond connector 122. The bulk of thesecond connector 122 can be formed from ABS or another suitable biocompatible plastic or other material. In a particular aspect of this embodiment, thesecond connector 122 includes a first portion, e.g., afirst housing portion 130 pivotably connected to a second portion, e.g., asecond housing portion 150 via ahinge 180. Accordingly, at least one of thefirst housing portion 130 and thesecond housing portion 150 can be pivoted relative to the other (as indicated by arrow A) between a secured position and an unsecured position. Thesecond connector 122 can have a corresponding secured configuration and unsecured continuation, respectively. Thefirst housing portion 130 includes aslot 131 elongated along aslot axis 132. Theslot 131 can include afirst opening 133 a positioned toward one end of theslot axis 132, asecond opening 133 b positioned toward the opposite end of theslot axis 132, and athird opening 133 c extending along theslot axis 132 between thefirst opening 133 a and thesecond opening 133 b. Theslot 131 is positioned to receive a lead or other signal delivery device, and an associated stylet. Accordingly, thefirst opening 133 a can have a first width W1 sized to receive the lead, thesecond opening 133 b can have a smaller second width W2 sized to receive the stylet shaft, and thethird opening 133 c can have a third width W3, also sized to receive the stylet shaft. - The
first housing portion 130 can include alead stop 139 within theslot 131 to stop the axial progress of the lead and to align the lead with electrical contacts in the second housing portion. In a particular embodiment, the lead stop 139 is a surface facing toward thefirst opening 133 a, and located at a point where the cross-sectional shape of theslot 131 changes from one that accommodates both thelead 111 and the stylet shaft, to one that accommodates the stylet shaft only. Analignment indicator 138 provides the practitioner with visual confirmation that the lead is properly aligned. Thefirst housing portion 130 can include afirst tab 134 and thesecond housing portion 150 can include asecond tab 154, both of which facilitate pivoting the two housing portions relative to each other. For example, the twotabs slot axis 132 to operate in a manner similar to that of a change purse. Alatch 170 can hold thehousing portions slot 131. -
FIG. 5 is a partially schematic, partially exploded isometric illustration of an embodiment of thesecond connector 122 shown inFIG. 4 . As shown inFIG. 5 , thesecond housing portion 150 includes twoouter hinge elements 184, each havingsecond pin apertures 183 that slidably receive acorresponding hinge pin 181. Thehinge pin 181 also passes through a corresponding inner hinge element described further below with reference toFIG. 6 . Thesecond housing portion 150 can carry asupport member 151 that in turn carriessecond connector contacts 152. Thesecond connector contacts 152 are electrically connected to theelectrical conductors 126 carried by thecable 125. Thesecond connector contacts 152 project upwardly toward thefirst housing portion 130 so as to releasably engage with a lead placed in theslot 131 of thefirst housing portion 130. As shown inFIG. 5 , theslot 131 can include afunnel surface 136 at thefirst opening 133 a to facilitate sliding a lead into theslot 131 along theslot axis 132. Aramp surface 135 at thesecond opening 133 b can facilitate movement of the stylet handle 162 (FIG. 2 ) relative to theslot 131. As is also shown inFIG. 5 , thefirst housing portion 130 can include afirst latch element 171 that releasably engages with a correspondingsecond latch element 172 of thesecond housing portion 150. Thesecond latch element 172 can include alatching slot 174 that receives thefirst latch element 171 when thesecond connector 122 is secured. Thesecond housing portion 150 can also include apivot stop slot 175 that also receives thefirst latch element 171 in the unsecured position to prevent thefirst housing portion 130 from over-rotating away from thesecond housing portion 150. Thestop slot 175 can also inhibit the practitioner from inadvertently placing thesecond connector 122 in the secured configuration. -
FIG. 6 is an isometric, upward-looking view toward the inner surface of thefirst housing portion 130. This view illustrates theinner hinge element 185 of thefirst housing portion 130, which has twofirst pin apertures 182 that slidably receive thehinge pin 181 described above with reference toFIG. 5 . Thefirst housing portion 130 further includescontact apertures 137. Thecontact apertures 137 can be blind slots that receive the upwardly projecting portions of thesecond connector contacts 152 shown inFIG. 5 . Thefirst latch element 171 shown inFIG. 6 can include aprojection 173 that is releasably received in thelatching slot 174 shown inFIG. 5 when thesecond connector 122 is secured, and in the pivot stop slot 175 (also shown inFIG. 5 ) when thesecond connector 122 is unsecured. -
FIGS. 7A and 7B are cross-sectional illustrations of thesecond connector 122 shown in the unsecured position (FIG. 7A ) and the secured position (FIG. 7B ). InFIG. 7A , thefirst housing portion 130 is pivoted away from thesecond housing portion 150 to the unsecured position. Alead 111 is inserted into thefirst opening 133 a, but does not yet contact thesecond connector contacts 152 carried by thesupport member 151 of thesecond housing portion 150. In this position, thefirst housing portion 130 can be prevented from rotating too far away from thesecond housing portion 150 because theprojection 173 of thefirst latch element 171 is received in thepivot stop slot 175 of thesecond housing portion 150. In a particular embodiment, thepivot stop slot 175 can be positioned to prevent the first andsecond housing portions second connector contacts 152 when thesecond connector 122 is in the unsecured position. In any of these embodiments, it is expected that limiting the relative rotation of the twohousing portions second connector 122, for example, by facilitating single handed operation of thesecond connector 122. - In one embodiment, the
pivot stop slot 175 alone prevents thehousing portions FIG. 7A , this function can be supplemented by another pivot stop 176 formed by the respective shapes of a downward-facingfirst surface 140 of thefirst housing portion 130, and an upward-facingsecond surface 153 of thesecond housing portion 150. For example, the first andsecond surfaces pivot stop slot 175. -
FIG. 7B illustrates thesecond connector 122 in the secured position. In this position, the first andsecond housing portions lead 111 engages with thesecond connector contacts 152. At least a portion of eachsecond connector contact 152 can be received in acorresponding contact aperture 137 so that thesecond connector contacts 152 do not interfere with moving thehousing portions second latch element 172, e.g., received in thelatching slot 174. In this position, thesecond connector 122 can remain in the secured position until positively acted upon by the practitioner. -
FIGS. 8A-8C are schematic illustrations of thesecond connector 122 illustrating a sequence of operation steps in accordance with an embodiment of the disclosure. InFIG. 8A , thesecond connector 122 is in the unsecured configuration, with thefirst latch element 171 disengaged from thesecond latch element 172. One feature of this arrangement is that the practitioner can easily discern that thesecond connector 122 is in the unsecured configuration by noting the visibly exposed latching slot 174 (e.g., the inner surfaces of the latching slot 174). With thesecond connector 122 in the unsecured configuration, the practitioner can slide thelead 111 axially into thefirst opening 133 a of theslot 131. In a particular embodiment, the practitioner slides thelead 111 axially into theslot 131 until the distal end of thelead 111 engages with the lead stop 139 located within theslot 131. In another aspect of the illustrated embodiment, thestylet 160 can optionally be pre-inserted into thelead 111 before thelead 111 is placed in theslot 131. In this case, thethird opening 133 c can receive thestylet shaft 161 without interfering with the practitioner's axial insertion of thelead 111. In particular, the width W3 of thethird opening 133 c is wide enough to allow thestylet shaft 161 to move downwardly into theslot 131, yet narrow enough to prevent the lead 111 from inadvertently being moved upwardly out of theslot 131. Theramp surface 135 at thesecond opening 133 b can allow the stylet handle 162 to pivot upwardly and downwardly relative to thefirst housing portion 130, without catching on the upper edge of thefirst housing portion 130. -
FIG. 8B is a top view of thesecond connector 122, illustrating thelead 111 after it has been pushed as far as possible into theslot 131, so as to engage with thelead stop 139. In this position, at least one of the connection contacts 113 (e.g., the first in a row of connection contacts) is visible through theslot 131, and is aligned with thealignment indicator 138. Accordingly, the practitioner can receive visual confirmation that thelead 111 is properly positioned in theslot 131. With thelead 111 in this position, the practitioner can move at least one of thefirst housing portion 130 and thesecond housing portion 150 relative to each other to the secured position using only a single hand. For example, the practitioner can engage thefirst closure tab 134 with a first part of the hand (e.g., the forefinger 198) and engage thesecond closure tab 154 with a second part of the hand (e.g., the thumb 197) and press the twohousing portions second connector 122 in position, all with one hand. - As is also shown in
FIG. 8B , thesecond connector 122 can have a relatively small size. For example, the second connector can have an overall length of about 33.4 millimeters, an overall width of about 21.6 millimeters, and an overall thickness of 8.7 millimeters. The exposed surface area is accordingly about 7.2 square centimeters, which is significantly smaller than existing connectors sized to receive a lead having eightconnection contacts 113. In other embodiments, the footprint of thesecond connector 122 can be even smaller. -
FIG. 8C illustrates thesecond connector 122 in the secured configuration. In this configuration, theprojection 173 of thefirst latch element 171 is received in thelatching slot 174 of thesecond latch element 172. Accordingly, the latchingslot 174 is no longer visible to the practitioner, thus confirming that thesecond connector 122 is in the secured configuration. The practitioner can also hear and/or feel a click or snap as theprojection 173 is received in thelatching slot 174. With thesecond connector 122 in the secured configuration, the practitioner can apply signals to thelead 111, and, based on feedback (e.g., patient feedback), can adjust the position of the lead as desired. - One feature of at least some of the foregoing embodiments described above with reference to
FIGS. 1-8C is that thelead 111 or othersignal delivery element 110 can be introduced into thesecond connector 122 by sliding it axially into and along theslot 131, without at the same time engaging theconnection contacts 113 with thesecond connector contacts 152. As a result, thelead 111 can be moved into theslot 131 easily, with low frictional resistance, and with a reduced likelihood for dislodging or otherwise moving thelead 111 relative to the patient. When the practitioner does engage theconnection contacts 113 with thesecond connector contacts 152, the practitioner can do so with only one hand, allowing the practitioner to hold thelead 111 in place relative to the patient with the other hand. For example, the practitioner's hand can provide both the moving force and the reaction force imparted to thesecond connector 122, which reduces the likelihood for thesecond connector 122 to slip out of the practitioner's grasp. - Another feature of at least some of the foregoing embodiments is that the angle between the two
housing portions second connector 122 is in the unsecured configuration. For example, the angle can be less than 90° , less than 45° or less than 5° . An advantage of this arrangement is that it facilitates the practitioner's ability to secure and unsecure thesecond connector 122 with one hand. For example, when the angle has a value less than 90° , the practitioner can avoid placing forces on thehousing portions second connector 122 when the practitioner is attempting to secure thesecond connector 122. In addition, the amount of hand movement required to secure and/or unsecure thesecond connector 122 is relatively small, which decreases the likelihood that the practitioner will fumble with thesecond connector 122. - Still another feature of at least some of the foregoing embodiments is that the
second connector 122 has a relatively small footprint (e.g., projected area, generally normal to the major surfaces of the first orsecond housing portions 130, 150). An expected advantage of this feature is that the small size makes thesecond connector 122 easier to manipulate. Another expected advantage of this feature is that the second connector will be less bulky and therefore more comfortable for the patient to wear during the trial period. - From the foregoing, it will be appreciated that specific embodiments of the disclosure have been described herein for purposes of illustration, but that various modifications may be made without deviating from the disclosure. For example, in other embodiments, the second connector can include other arrangements that limit or prohibit over-rotating one housing portion relative to the other. In still further embodiments, the second connector can include other arrangements for securing one housing portion relative to the other, and/or for halting the axial movement of the lead or other signal delivery element positioned in the second connector. In yet further embodiments, the practitioner can leave the second connector attached to the implanted signal delivery element while the signal delivery element is repositioned, rather than disconnecting and reconnecting the connector with each new signal delivery element position.
- Certain aspects of the disclosure described in the context of particular embodiments may be combined or eliminated in other embodiments. For example, in certain embodiments, the signal delivery element can have features different than those shown in
FIG. 2 , and/or can be supported by a device other than a stylet. Further, while advantages associated with certain embodiments have been described in the context of those embodiments, other embodiments may also exhibit such advantages and not all embodiments need necessarily exhibit such advantages to fall within the scope of the present disclosure. Accordingly, the disclosure can encompass other embodiments not expressly described or shown herein.
Claims (35)
1. A patient treatment system, comprising:
a cable assembly that includes:
an electrical cable having a proximal end and a distal end;
a first connector attached to the cable toward the proximal end, the first connector having a plurality of first connector contacts positioned to releasably connect to an external patient device; and
a second connector attached to the cable toward the distal end, the second connector including:
a first portion having a slot elongated along a slot axis and positioned to receive an implantable patient signal delivery element axially along the slot axis;
a second portion pivotably connected to the first portion, at least one of the first and second portions being pivotable relative to the other between an unsecured position and a secured position, the second portion having a plurality of second connector contacts positioned to releasably, electrically contact the signal delivery element when the signal delivery element is positioned within the slot and the first and second portions are placed in the secured position.
2. The system of claim 1 , further comprising the signal delivery element.
3. The system of claim 2 wherein the signal delivery element includes a lead having a terminal portion and an extension portion releasably connected to the terminal portion, and wherein the second connector contacts are positioned to releasably, electrically contact the extension portion.
4. The system of claim 1 wherein the second portion includes eight second connector contacts positioned to releasably contact the signal delivery element when the signal delivery element is positioned within the slot and the first and second portions are in the secured position, and wherein the second connector has a footprint of about 7.2 cm2 or less.
5. The system of claim 1 wherein the second connector includes a pivot stop positioned to allow a maximum opening between the first and second housing portions in the unsecured position is less than about 90° .
6. The system of claim 1 wherein the second connector includes a pivot stop positioned to allow a maximum opening between the first and second housing portions in the unsecured position is less than about 45° .
7. The system of claim 1 wherein the second connector includes a pivot stop positioned to allow a maximum opening between the first and second housing portions in the unsecured position is less than about 5° .
8. The system of claim 1 , further comprising a lead stop positioned along the slot axis to prevent axial motion of the signal delivery element beyond the lead stop.
9. The system of claim 1 wherein the slot has first, second and third openings, the first opening being toward a first end of the slot axis and having first width, the second opening being toward a second end of the axis and having a second width, and the third opening extending along the slot axis from the first opening to the second opening and having a third width, the first width being greater than the third width, the first portion further having an alignment indicator that is visually accessible from outside the first portion, and wherein the system further comprises:
a support member carried by the first portion, the support member carrying the second connector contacts in position to releasably contact the signal delivery element when the signal delivery element is positioned within the slot and the first and second portions are placed in the secured position; and
a latch having a first element carried by the first portion and a second element carried by the second portion, the first and second elements being releasably engaged with each other when the first and second portions are placed in the secured position.
10. A patient treatment system, comprising:
a cable assembly that includes:
a cable having a proximal end and a distal end, the cable carrying a plurality of conductors;
a first connector attached to the cable at the proximal end, the first connector having a plurality of first connector contacts, with individual first connector contacts electrically connected to corresponding individual conductors and positioned to releasably connect to an external patient stimulator; and
a second connector attached to the cable at the distal end, the second connector including:
a first housing portion having a slot elongated along a slot axis, the slot having first, second and third openings, the first opening being positioned toward a first end of the slot axis and having first width, the second opening being positioned toward a second end of the axis and having a second width, and the third opening extending along the slot axis from the first opening to the second opening and having a third width, the first width being greater than the third width, the first housing portion further having an alignment indicator that is visually accessible from outside the first housing portion;
a second housing portion pivotably connected to the first housing portion, at least one of the first and second housing portions being pivotable relative to the other between an unsecured position and a secured position;
a support member carried by the second housing portion, the support member having a plurality of second connector contacts positioned to releasably contact an implantable patient lead when the implantable patient lead is positioned within the slot and the first and second housing portions are placed in the secured position, with individual second connector contacts electrically connected to corresponding individual conductors; and
a latch having a first element carried by the first housing portion and a second element carried by the second housing portion, the first and second elements being releasably engaged with each other when the second housing portion is placed in the secured position.
11. The treatment system of claim 10 , further comprising the external patient stimulator, and wherein the first connector is releasably connected to the external patient stimulator.
12. The treatment system of claim 10 , further comprising the implantable patient lead, and wherein the second connector is releasably connected to the implantable patient lead.
13. The treatment system of claim 12 wherein the implantable patient lead includes a row of connection contacts, and wherein a first connection contact in the row is positioned directly adjacent to the alignment indicator, with both the first connection contact and the alignment indicator visually accessible from outside the first housing portion.
14. The treatment system of claim 12 , further comprising a stylet slidably positioned within the implantable patient lead, the implantable patient lead having a lead width, the stylet having a stylet width, and wherein the first width of the first opening is greater than the lead width, and wherein the third width of the third opening is greater than the stylet width and less than the lead width.
15. The treatment device of claim 10 wherein the first opening has a funnel shape.
16. The treatment device of claim 10 wherein the second opening is positioned adjacent to a ramped surface of the first housing portion.
17. The treatment device of claim 10 wherein the first housing portion includes a first outwardly extending closure tab, and wherein the second housing portion includes a second outwardly extending closure tab, the first and second closure tabs being offset from each other in a direction generally parallel to a pivot axis about which the second housing portion pivots relative to the first housing portion.
18. The system of claim 10 wherein the first element of the latch includes a recess and wherein the second element of the latch includes a flexible projection, and wherein an inner surface of the recess is covered by the projection when the second housing portion is in the secured position to provide a visual indication that the second housing portion is secured, and wherein the inner surface of the recess is exposed when the second housing portion is in the unsecured position to provide a visual indication that the second housing portion is unsecured.
19. The system of claim 18 wherein the recess is a first recess, and wherein the latch includes a second recess, the second recess receiving the projection when the first and second housing portions are in the unsecured position to at least resist further pivoting of the first and second housing portions away from each other.
20. The system of claim 10 , further comprising a lead stop positioned along the slot axis to prevent axial motion of the lead beyond the lead stop.
21. A method for operating a patient treatment system, comprising:
implanting an implantable signal delivery element in a patient;
positioning a cable assembly proximate to connector contacts of the implantable signal delivery element, the cable assembly having a proximal end with a first connector having first connector contacts, and a distal end with a second connector having first and second portions;
sliding the connector contacts of the signal delivery element axially into a slot carried by the second portion of the second connector, the slot being elongated axially along a slot axis;
pivoting at least one of the first and second portions relative to the other to electrically connect the connection contacts of the signal delivery element with second connector contacts carried by the second portion of the second connector; and
releasably connecting the first connector to an external patient device.
22. The method of claim 21 , further comprising halting axial motion of the signal delivery element by sliding the signal delivery element into contact with a stop carried by the second connector.
23. The method of claim 21 wherein pivoting at least one of the first and second portions includes pivoting at least one of the first and second portions with only a single hand.
24. The method of claim 23 , further comprising both applying a pivoting force to the at least one of the first and second portions, and reacting the pivoting force, with the single hand.
25. The method of claim 21 , further comprising pivoting at least one of the first and second portions away from the other with a only single hand to electrically disconnect the connector contacts of the signal delivery element from the second connector contacts.
26. The method of claim 21 , further comprising:
pivoting at least one of the first and second portions away from the other to electrically disconnect the connector contacts of the signal delivery element from the second connector contacts; and
at least restricting relative pivoting between the first and second portions beyond about 90° .
27. The method of claim 21 , further comprising:
pivoting at least one of the first and second portions away from the other to electrically disconnect the connector contacts of the signal delivery element from the second connector contacts; and
at least restricting relative pivoting between the first and second portions beyond about 45° .
28. The method of claim 21 , further comprising:
pivoting at least one of the first and second portions away from the other to electrically disconnect the connector contacts of the signal delivery element from the second connector contacts; and
at least restricting relative pivoting between the first and second portions beyond about 5° .
29. The method of claim 21 , further comprising latching the first and second portions to each other with the connection contacts of the signal delivery element in electrical contact with the second connector contacts.
30. The method of claim 21 wherein sliding the connection contacts of the signal delivery element axially into a slot includes sliding the connection contacts fully into the slot without electrically connecting the connection contacts of the signal delivery element with the second connector contacts.
31. A method for operating a patient treatment system, comprising:
implanting an implantable patient lead in a patient by inserting a stylet into the implantable patient lead and inserting the lead and the stylet together into the patient, the implantable patient lead having distal contacts and proximal contacts, the distal contacts being positioned within the patient, the proximal contacts being positioned outside the patient;
positioning a cable assembly proximate to the proximal contacts of the implantable patient lead, the cable assembly having a proximal end with a first connector and a distal end with a second connector, the second connector having a first housing portion and a second housing portion pivotably connected to the first housing portion, the first housing portion having a slot elongated along a slot axis, the slot having a first slot opening toward a first end of the slot axis, a second slot opening toward a second end of the slot axis, and a third slot opening extending along the slot axis from the first slot opening to the second slot opening;
sliding the proximal contacts of the patient implantable lead into the first slot opening;
passing the stylet into the slot through the third slot opening so that the stylet extends outwardly from the slot through the second slot opening;
visually confirming alignment of at least one of the proximal contacts of the implantable patient lead with an alignment indicator of the first housing portion;
releasably securing the patient lead to the second connector using only a single hand by:
pivoting the at least one of the first and second housing portions toward the other with only the single hand;
clamping the proximal contacts of the implantable patient lead against corresponding second contacts carried by the second housing portion with only the single hand; and
releasably latching the first and second housing portions together with only the single hand; wherein the method further comprises:
releasably connecting the first connector to an external patient stimulator.
32. The method of claim 31 wherein implanting the patient lead includes implanting the patient lead proximate to the patient's spine, and wherein the method further comprises activating the external patient stimulator to address the patient's pain.
33. The method of claim 31 wherein pivoting at least one of the first and second housing portions relative to the other includes:
engaging a first tab carried by the first housing portion with a first part of the hand;
engaging a second tab carried by the second housing portion with a second part of the hand, the second tab being offset from the first tab in a direction generally parallel to a pivot axis about which the second housing portion pivots relative to the first housing portion; and
moving at least one of the first and second parts of the hand toward the other.
34. The method of claim 31 wherein latching includes engaging a flexible projection carried by one of the first and second housing members with a recess carried by the other of the first and second housing members.
35. The method of claim 31 , further comprising unclamping the proximal contacts from the second contacts by pivoting at least one of the first and second housing portions away from the other with only a single hand.
Priority Applications (7)
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AU2010295422A AU2010295422B2 (en) | 2009-09-18 | 2010-09-17 | Couplings for implanted leads and external stimulators, and associated systems and methods |
JP2012529949A JP2013505075A (en) | 2009-09-18 | 2010-09-17 | Joint for implanted lead and external stimulator, and related systems and methods |
CA2774545A CA2774545A1 (en) | 2009-09-18 | 2010-09-17 | Couplings for implanted leads and external stimulators, and associated systems and methods |
PCT/US2010/049376 WO2011035189A2 (en) | 2009-09-18 | 2010-09-17 | Couplings for implanted leads and external stimulators, and associated systems and methods |
EP10817939.1A EP2477693A4 (en) | 2009-09-18 | 2010-09-17 | Couplings for implanted leads and external stimulators, and associated systems and methods |
US13/935,294 US8996128B2 (en) | 2009-09-18 | 2013-07-03 | Couplings for implanted leads and external stimulators, and associated systems and methods |
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US12/562,892 US20110071593A1 (en) | 2009-09-18 | 2009-09-18 | Couplings for implanted leads and external stimulators, and associated systems and methods |
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EP (1) | EP2477693A4 (en) |
JP (1) | JP2013505075A (en) |
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EP2477693A2 (en) | 2012-07-25 |
AU2010295422B2 (en) | 2014-05-01 |
US8996128B2 (en) | 2015-03-31 |
WO2011035189A3 (en) | 2011-08-04 |
WO2011035189A2 (en) | 2011-03-24 |
AU2010295422A1 (en) | 2012-05-10 |
JP2013505075A (en) | 2013-02-14 |
EP2477693A4 (en) | 2013-06-05 |
CA2774545A1 (en) | 2011-03-24 |
US20130325092A1 (en) | 2013-12-05 |
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