PERCUTANEOUS LEAD
The exemplified systems and methods facilitate a nerve conduction block at a target nerve using electrical stimulation applied from one or more electrodes located on a percutaneous lead that are placed in parallel, or substantially in parallel, and without direct contact, to a long axis of the peripheral nerve over an overlapping nerve region of greater than about 3 millimeters. The exemplified system and method can be further configured to block nerve condition without eliciting onset activity and co-excitation of non-targeted structures. The exemplified method and system can be performed using conventional percutaneous leads, though an improved percutaneous lead design is disclosed herein. In an aspect, an introducer is disclosed that facilitates accurate and consistent insertion of the percutaneous lead to the specified or intended position relative to the target nerve. In another aspect, a treatment kit comprising the various system components to treat pain is disclosed.
1 . A percutaneous lead comprising:
a longitudinal body having a first end and a second end that define a long axis of the longitudinal body, wherein the first end terminates to form a distal tip, the longitudinal body comprising two or more concentric members, including a first concentric member and a second concentric member, wherein an outer surface of the first concentric member contacts an inner surface of the second concentric member,
wherein the first concentric member has a first insulated body having a first length defined at least by the first end, the first concentric member comprising a first set of conductive members formed in the insulated body, wherein the insulated body includes one or more exposed surface regions located proximal to the first end to form a first set of electrodes, wherein the first set of electrode has an exposed length, or collective exposed length, between about 1 mm and 10 cm;
wherein the second concentric member has a second insulated body having a second length, wherein the second length is less than, and overlaps with, the first length, the second concentric member comprising a second set of conductive members formed in the second insulated body, wherein the second insulated body includes one or more exposed surface regions to form a second set of electrodes, wherein the second set of electrode has an exposed length, or collective exposed length, between about 1 mm and 10 cm.
2 . The percutaneous lead of claim 1 , wherein the first insulated body forms a lumen configured to receive and mate with a removable stiffening stylet.
3 . The percutaneous lead of claim 1 , wherein the first set of electrodes can be placed in parallel, or substantially in parallel to a long axis of a peripheral nerve over an overlapping nerve region.
4 . The percutaneous lead of claim 1 , wherein the first set of electrodes and second set of electrodes are placed in parallel, or substantially in parallel to a long axis of a peripheral nerve over an overlapping nerve region of greater than about 3 millimeters.
5 . The percutaneous lead of claim 1 , wherein conductive elements of the first set of conductive members are interlaced.
6 . The percutaneous lead of claim 1 , wherein conductive elements of the first set of conductive members are coiled.
7 . The percutaneous lead of claim 1 , wherein conductive elements of the second set of conductive members are interlaced.
8 . The percutaneous lead of claim 1 , wherein conductive elements of the second set of conductive members are coiled.
9 .- 10 . (canceled)
11 . The percutaneous lead of claim 1 , further comprising:
a third concentric member, wherein an outer surface of the second concentric member contacts an inner surface of the third concentric member, wherein the third concentric member has a third insulated body having a third length, wherein the third insulated body includes one or more exposed surface regions to form a third set of electrodes, wherein the third set of electrode has an exposed length, or collective exposed length, between about 1 mm and 10 cm.
12 . (canceled)
13 . The percutaneous lead of claim 1 , wherein the insulated body of the first concentric member includes one or more exposed surface regions located proximal to the second end to form a contact for connection to a waveform stimulator.
14 . The percutaneous lead of claim 1 , wherein the insulated body of the second concentric member includes one or more exposed surface regions located proximal to the second end to form a contact for connection to a waveform stimulator .
15 . (canceled)
16 . The percutaneous lead of claim 7 , wherein an associated spacing between conductive elements of the first set of conductive members is different than an associated spacing between conductive elements of the second set of conductive members.
17 . The percutaneous lead of claim 1 , wherein the longitudinal body has a predominantly circular cross-section.
18 . The percutaneous lead of claim 1 , wherein the longitudinal body has a non-circular cross-section.
19 . (canceled)
20 . The percutaneous lead of claim 1 , wherein the longitudinal body has a first constant cross-section and a second constant cross-section.
21 . The percutaneous lead of claim 20 , wherein the first constant cross-section is located proximal to, or defines a portion of, the distal tip.
22 . (canceled)
23 . The percutaneous lead of claim 1 , wherein the first insulated body encapsulates the conductive members to form a wire, the wire being coiled to form the first concentric member.
24 . The percutaneous lead of claim 1 , wherein the second insulated body encapsulates a second conductive member of the second set of conductive members to form a second wire, the second wire being coiled to form the second concentric member.
25 . The percutaneous lead of claim 1 , wherein the first concentric member comprises multiple wires, each having an insulated body encapsulating a respective conductive member.
26 .- 27 . (canceled)
28 . The percutaneous lead of claim 27 , wherein the defined coil spacing is uniform.
29 . The percutaneous lead of claim 27 , wherein the defined coil spacing is non-uniform.
30 .- 31 . (canceled)
32 . The percutaneous lead of claim 1 , wherein the longitudinal body comprises a distal opening located distal to the second end, and wherein the distal opening is defined in the longitudinal body for delivery of fluid injection at the distal opening.
33 . The percutaneous lead of claim 1 , wherein the longitudinal body comprises a plurality of markings indicative of depth of insertion.
34 . (canceled)
35 . The percutaneous lead of claim 1 , further comprising:
a cable adaptor coupled to the second end, wherein the cable adaptor comprises a transparent material and is configured to provide visual confirmation of proper contact between the electrode and an external electrical stimulation system.
36 . The percutaneous lead of claim 1 , further comprising:
a second cable adaptor coupled to the second end, wherein the second cable adaptor provides a port for fluid delivery through the percutaneous lead.
37 . The percutaneous lead of claim 1 , further comprising;
a cable adaptor configured to be coupled to percutaneous lead, wherein the cable adaptor comprises a transparent material and is configured to provide visual confirmation of proper contact between the one or more electrode and an external electrical stimulation system, wherein the cable adaptor is configured to provide a port for fluid delivery through the percutaneous lead, and
wherein the cable adaptor is configured for one-handed connection between the third cable adaptor and the percutaneous lead.
38 .- 41 . (canceled)
42 . The percutaneous lead of claim 1 , wherein the percutaneous lead comprise a material suitable to be imaged via ultrasound, CT scanner, MRI scanner, or x-ray scanner.
43 . (canceled)
44 . A percutaneous lead comprising:
a longitudinal body having a first end and a second end that define a long axis of the longitudinal body, wherein the first end terminates to form a distal tip, the longitudinal body comprising an insulated body having a length defined at least by the first end, the insulated body comprising a set of conductive members, wherein the insulated body includes one or more exposed surface regions located proximal to the first end to form a set of electrodes, wherein the set of electrode has an exposed length, or collective exposed length, between about 1 mm and 10 cm,
wherein the set of conductive members terminate at, or proximal to, the second end of the longitudinal body to form contacts for connection to a waveform stimulator, and
wherein the insulated body forms a lumen configured to receive and mate with a removable stiffening stylet.
45 .- 46 . (canceled)