Treatment kit to percutaneously block painful sensations hosted by a peripheral nerve
View Patent ↗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 kit comprising:
a percutaneous lead; and
a placement apparatus having a body comprising an entry port configured to receive the percutaneous lead, wherein the percutaneous lead is placed at a first angle of insertion defined with respect to an associated surface of the treatment site, and wherein the first angle of insertion is between about 10 degrees and about 90 degrees, and
wherein the body includes a fixed curve region or a flexible region that is bendable to form a curve, to direct the percutaneous lead to a second angle that is parallel, or substantially parallel, to a long axis of a peripheral nerve to provide placement of one or more electrodes of the percutaneous lead over an overlapping nerve region greater than about 3 mm,
wherein an electrical field generated between the electrode and the overlapping nerve region prevent action potential from forming at the overlapping nerve region to block nerve conduction through the overlapping nerve region,
wherein the electrical stimulation system is configured to deliver high frequency stimulation having at least one primary frequency harmonics between about 2 kHz and 100 kHz.
2. The kit of claim 1 , wherein the body of the placement apparatus forms a needle, wherein the needle includes a fixed region configured to be bent to direct the percutaneous lead from the first angle to the second angle.
3. The kit of claim 1 , wherein the body forms an introducer, wherein the introducer includes a fixed curve region to direct the percutaneous lead from the first angle to the second angle.
4. The kit of claim 1 , further comprising:
a needle or an introducer; wherein the body of the placement apparatus forms a sheath, wherein the sheath is insertable through or around the needle or introducer, and wherein retraction of the needle or introducer from the sheath shapes the sheath with a curve to direct the percutaneous lead from the first angle to the second angle.
5. The kit of claim 1 , wherein the body of the placement apparatus is configured to direct a leading point of the percutaneous lead at least about 1 cm at the second angle parallel, or substantially parallel, to the long axis of the peripheral nerve.
6. The kit 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.
7. The kit of claim 1 , further comprising:
a second cable adaptor configured to be coupled to percutaneous lead, wherein the second cable adaptor provides a port for fluid delivery through the percutaneous lead.
8. The kit of claim 1 , further comprising:
a third cable adaptor configured to be coupled to percutaneous lead, wherein the third cable adaptor is configured for one-handed connection between the third cable adaptor and the percutaneous lead.
9. The kit 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.
10. The kit 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, and
wherein the cable adaptor is configured to provide a port for fluid delivery through the percutaneous lead.
11. The kit of claim 1 , further comprising:
an electrical stimulation system configured to deliver electrical stimulation to the one or more electrodes; and
electrical cable to connect a connector of the electrical stimulation system to a connector of the percutaneous lead to establish electrical contact with the one or more electrodes.
12. The kit of claim 11 , wherein the electrical stimulation system is an external electrical stimulation system.
13. The kit of claim 11 , wherein the electrical stimulation system is an implantable electrical stimulation system.
14. The kit of claim 1 , wherein the electrical stimulation system is configured to deliver direct current stimulation.
15. The kit of claim 1 , wherein a controller of the electrical stimulation system is configured to adjust the delivered electrical stimulation at a pre-defined ramp rate, wherein the ramp rate is less than about 2 milliamps/second.
16. The kit of claim 1 , wherein the body of the placement apparatus forms a needle, wherein the needle includes a flexible region configured to be bent to direct the percutaneous lead from the first angle to the second angle.
17. The kit of claim 1 , wherein the body forms an introducer, wherein the introducer includes a flexible region to direct the percutaneous lead from the first angle to the second angle.