Multi-electrode peripheral nerve evaluation lead and related system and method of use

• US 20070255369A1
• Filed: 04/28/2006
• Published: 11/01/2007
• Est. Priority Date: 04/28/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonde, Eric, Tronnes, Carole, Stetz, Eric, Henry, James
• Granted Patent: US 8,892,214 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable electrical lead for applying stimulation energy to bodily tissue, such as a patient'"'"'s nervous system, from an external power source. The lead is defined by a distal section, an intermediate section and a proximal section, and includes a lead body, a plurality of insulated wires, and a plurality of connector elements. The lead body includes a plurality of electrodes and an anchoring device. The insulated wires are electrically coupled to the electrodes, respectively. A wire intermediate segment extends proximal the lead body and is characterized as having a non-coiled configuration, terminating at a respective connector element for coupling to an external power source. The wire intermediate segments are extendible through a patient'"'"'s skin and are sealable relative to the skin. The lead is adapted for providing temporary electrical stimulation to a sacral nerve in a bipolar mode, with the anchoring device inhibiting electrode migration.

Claims

1. An implantable medical electrical lead for applying an electrical stimulation energy to bodily tissue of a patient from a power source located external the patient, the lead defined by a distal section, an intermediate section, and a proximal section, and the lead comprising:

a lead body at the distal section and including;

a plurality of stimulating electrodes arranged in an electrode array,

at least one anchoring device;

a plurality of insulated conductor wires electrically insulated from one another and each having a distal segment terminating at a distal end, an intermediate segment, and a proximal segment terminating at a proximal end, wherein;

the distal end of each of the insulated wires is electrically coupled to a respective one of the stimulating electrodes,

the intermediate segments each extend proximal the lead body to define the intermediate section of the lead, the intermediate segments characterized as having a non-coiled configuration; and

a plurality of connector elements formed in a connector array at the proximal section, individual ones of the connector elements being electrically coupled to the proximal end of a respective one of the insulated wires;

wherein the lead is configured such that the intermediate segments of the insulated wires are extendible through a patient'"'"'s skin and are sealable relative to a surface of a patient'"'"'s skin.

2. The lead of claim 1, wherein the lead includes at least two of the stimulating electrodes and a corresponding number of the insulated wires.

3. The lead of claim 2, wherein the lead includes four stimulating electrodes and four insulated wires.

4. The lead of claim 1, wherein the anchoring device is a tine assembly having a plurality of radially extendible tines.

5. The lead of claim 4, wherein the lead includes a plurality of tine assemblies longitudinally spaced along the lead body.

6. The lead of claim 1, wherein the lead is configured such that individual ones of the plurality of insulated wires are not exteriorly enclosed along the intermediate segments thereof.

7. The lead of claim 1, wherein the lead is configured such that each of the insulated wires are movable relative to one another along the respective intermediate segments.

8. The lead of claim 1, wherein the lead body further includes a plurality of coiled wire lead conductors, individual ones of each electrically couple one of the stimulating electrodes to a respective one of the insulated wires.

9. The lead of claim 1, wherein the distal segment of each of the insulated wires forms a coil disposed within the lead body.

10. The lead of claim 1, wherein the connector array is configured for connection to a power source to establish electrical connection between the power source and each of the stimulating electrodes via the conductor wires.

11. The lead of claim 1, further comprising:

a tether extending proximally from the lead body along the intermediate section and the proximal section, the tether configured to translate a pulling force applied on the proximal section to the lead body.

12. A system for applying an electrical stimulation energy to bodily tissue of a patient from a power source located external the patient, the system comprising:

a lead defined by a distal section, an intermediate section, and a proximal section, the lead including;

a lead body at the distal section and including a plurality of stimulating electrodes arranged in an electrode array, and at least one anchoring device,

a plurality of insulated conductor wires electrically isolated from one another and each having a distal segment terminating at distal end, an intermediate segment, and a proximal segment terminating at a proximal end, wherein the distal ends are electrically coupled to a respective one of the stimulating electrodes and the intermediate segments extend proximal the lead body and are characterized as having a non-coiled configuration,

wherein the lead body defines a lumen; and

a stylet slidably disposed within the lumen of the lead body and extending proximally therefrom.

13. The system of claim 12, wherein the stylet defines a distal portion, an intermediate portion, and a proximal portion, the intermediate portion being selectively associated with the intermediate segments of the insulated wires upon final assembly of the distal portion of the stylet within the lead body lumen.

14. The system of claim 13, wherein the intermediate portion of the stylet is not directly connected to the intermediate segments of the insulated wires.

15. The system of claim 13, wherein the intermediate segments of the insulated wires are wrapped about the intermediate portion of the stylet.

16. The system of claim 12, further comprising:

a connector assembly maintaining the connector array and a proximal portion of the stylet.

17. The system of claim 16, further comprising:

an introducer including a sheath defining a lumen sized to coaxially receive the lead body;

wherein the connector assembly and the introducer assembly are configured to be releasably mounted to one another.

18. The system of claim 12, wherein the lead body lumen is open at a distal end of the lead body, and further wherein the stylet is a directional guide wire having an electrode tip that is distally extendible through the lead body lumen.

19. The system of claim 18, wherein the electrode tip is a needle tip.

20. The system of claim 12, wherein the lead includes at least two of the stimulating electrodes and a corresponding number of the insulated wires.

21. The system of claim 12, wherein the anchoring device is a tine assembly having a plurality of radially extendible tines.

22. The system of claim 12, wherein the lead is configured such that individual ones of the plurality of insulated wires are not exteriorly enclosed along the intermediate segment apart from a component separate from the lead.

23. A method of providing electrical stimulation to bodily tissue of a patient at a stimulation site via a power source external the patient, the method comprising:

providing an implantable medical lead defined by a distal section, an intermediate section, and a proximal section, the lead including;

a lead body at the distal section and including a plurality of stimulating electrodes arranged in an electrode array, and at least one anchoring device,

a plurality of insulative conductor wires electrically isolated from one another and each having a distal segment terminating at a distal end, an intermediate segment, and a proximal segment terminating in a proximal end, wherein the distal ends are electrically coupled to a respective one of the stimulating electrodes, and the intermediate segments each extend proximal the lead body and are characterized as having a non-coiled configuration,

a plurality of connector elements formed in a connector array at the proximal section, individual ones of the connector elements being electrically coupled to the proximal end of a respective one of the insulated wires;

percutaneously delivering the lead body to the stimulation site via an incision in a skin of the patient;

extending the individual insulated wires through the incision whereby a first region of each of the intermediate segments is beneath the patient'"'"'s skin and a second region of each of the intermediate segments extends outwardly from the patient'"'"'s skin;

sealing at least a portion of a perimeter of each of the insulated wires relative to the patient'"'"'s skin; and

coupling the plurality of connector elements to a power source located external the patient.

24. The method of claim 23, wherein the method is performed as part of a peripheral sacral nerve stimulation evaluation such that the stimulation site is proximate a sacral nerve.

25. The method of claim 23, further comprising:

individually securing a portion of each of the insulated wires external the patient to an exterior of the patient.

26. The method of claim 23, further comprising:

providing an introducer, wherein percutaneously delivering the lead body includes percutaneously accessing the stimulation site with the introducer followed by directing the lead body through the introducer to the stimulation site.

27. The method of claim 26, wherein a stylet is further provided and is slidably disposed within a lumen defined in the lead body, and further wherein directing the lead body through the introducer includes:

assembling the stylet to the lead body prior to placement of the lead body within the introducer; and

removing the stylet from the lead following delivery of the lead body to the stimulation site.

28. The method of claim 23, wherein a directional guide wire is further provided, the directional guide wire slidably movable within a lumen formed by the lead body such that an electrode tip of the directional guide wire is selectively extendable distal the lead body, and further wherein delivering the lead body includes:

assembling the directional guide wire to the lead body such that the electrode tip extends distal the lead body;

percutaneously directing the electrode tip and the lead body toward the stimulation site; and

energizing the electrode tip to determine a proximity of the electrode tip relative to the stimulation site.

29. The method of claim 23, wherein the method is characterized by the absence of forming a subcutaneous tunnel for receiving the conductor wires.

30. A temporarily implantable medical electrical lead for non-direct contact electrical stimulation of a sacral nerve, the lead defined by a distal section, an intermediate section, and a proximal section, the lead comprising:

a lead body at the distal section and including;

a plurality of stimulating electrodes arranged in an electrode array,

at least one anchoring device,

a plurality of insulated conductor wires electrically insulated from one another and each having a distal segment terminating at a distal end, an intermediate segment, and a proximal segment terminating at a proximal end, wherein;

the distal end of each of the insulated wires is electrically coupled to a respective one of the stimulating electrodes,

the intermediate segments each extend proximal the lead body to define the intermediate section of the lead, the intermediate segments characterized as having a non-coiled configuration; and

a plurality of connector elements formed in a connector array at the proximal section, individual ones of the connector elements being electrically coupled to the proximal end of a respective one of the insulated wires;

wherein the lead is configured such that the intermediate segments of the insulated wires are extendible through a patient'"'"'s skin and are sealable relative to a surface of a patient'"'"'s skin;

and further wherein the lead body is capable of being inserted through a foramen of the sacrum to position at least one of the stimulating electrodes into operative relation with a sacral nerve to provide stimulation to the sacral nerve.