Expandable neuromodular stimulation lead

• US 8,050,773 B2
• Filed: 09/28/2008
• Issued: 11/01/2011
• Est. Priority Date: 09/28/2008
• Status: Expired due to Fees

• Current Assignee: Jie Zhu
• Original Assignee: Jie Zhu
• Inventors: Zhu, Jie
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Stice; Paula J
• Application Number:
  US12/239,795
• Publication Number:
  US 20100082086A1
• Time in Patent Office: 1,129 Days
• Field of Search: None
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

A medical stimulation lead is provided. The medical stimulation lead includes an elongated lead body including a substantially rounded cross-section and including a first biased portion forming a first section of the substantially rounded cross-section and a second biased portion forming a second section of the substantially rounded cross-section. A plurality of electrodes are provided connected to the elongated lead body. A restraining body is removably connected to the elongated lead body releasably exerting a force substantially counter to the biases of the first biased portion and the second biased portion. The retraining body releasably maintains the substantially rounded cross-section of the elongated lead body, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand, dividing the substantially rounded cross-section. The present invention further provides a method for providing spinal cord stimulation and a stimulation lead including an elongated plate.

Claims

1. A medical stimulation lead comprising:

an elongated lead body biased in directions substantially limited to one plane, the elongated lead body comprising a substantially rounded cross-section formed by a first biased portion and a second biased portion in an unexpanded configuration, wherein in the unexpanded configuration the first biased portion forms a first section of the substantially rounded cross-section and the second biased portion forms a second section of the substantially rounded cross section, and wherein the first biased portion is biased in a first direction substantially within the one plane, and the second biased portion is biased in a second direction substantially within the one plane and substantially opposite the first direction;

a plurality of electrodes connected to the elongated lead body for conducting current; and

a restraining body removably connected to the elongated lead body releasably exerting a force substantially counter to the biases of the first biased portion and the second biased portion, releasably maintaining the substantially rounded cross-section of the elongated lead body in the unexpanded configuration, wherein removal of the restraining body permits the first biased portion and the second biased portion of the elongated lead body to expand into an expanded configuration, dividing the substantially rounded cross-section;

wherein the first biased portion and the second biased portion of the medical stimulation lead are configured to stabilize the medical stimulation lead in an epidural space adjacent to a spinal cord when the first and second biased portions are in the expanded configuration.

2. The medical stimulation lead of claim 1, wherein the elongated lead body comprises a substantially elliptical cross-section and a longitudinal axis, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand away from the longitudinal axis, dividing the substantially elliptical cross-section.

3. The medical stimulation lead of claim 2, wherein the elongated lead body comprises a substantially circular cross-section and a longitudinal axis, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand away from the longitudinal axis in approximately opposite directions, dividing the substantially circular cross-section.

4. The medical stimulation lead of claim 1, wherein the first section comprises a first arced section of the substantially rounded cross-section of the elongated lead body, and the second section comprises a second arced section of the substantially rounded cross-section of the elongated lead body.

5. The medical stimulation lead of claim 4, wherein each of the plurality of electrodes comprises an arced surface positioned substantially flush with a surface of at least one of the first biased portion and the second biased portion.

6. The medical stimulation lead of claim 1, wherein the first biased portion contacts the second biased portion along the one plane, wherein the first biased portion comprises approximately one half of the substantially rounded cross-section of the elongated lead body, wherein the second biased portion comprises approximately one half of the substantially rounded cross-section of the elongated lead body, and wherein the first biased portion and the second biased portion are in slideable contact along the one plane.

7. The medical stimulation lead of claim 6, wherein the elongated lead body comprises a substantially circular cross-section, wherein the first biased portion forms a substantially semi-circular section of the substantially circular cross-section, and wherein the second biased portion forms another substantially semi-circular section of the substantially circular cross-section.

8. The medical stimulation lead of claim 1, wherein the elongated lead body is further formed by a first substantially unbiased elongated portion forming a third section of the substantially rounded cross-section.

9. The medical stimulation lead of claim 8, wherein a first one of the plurality of electrodes is connected to the first biased portion, a second one of the plurality of electrodes is connected to the second biased portion, and a third one of the plurality of electrodes is connected to the first substantially unbiased elongated portion, and wherein at least one of the first one of the plurality of electrodes and the second one of the plurality of electrodes is offset a predetermined distance from the third one of the plurality of electrodes along a length of the elongated lead body.

10. The medical stimulation lead of claim 8, wherein the elongated lead body is further formed by a second substantially unbiased elongated portion forming a fourth section of the substantially rounded cross-section.

11. The medical stimulation lead of claim 1, wherein the second biased portion is biased in a direction substantially away from the first biased portion, wherein a first one of the plurality of electrodes is connected to the first biased portion and a second one of the plurality of electrodes is connected to the second biased portion offset a predetermined distance from the first one of the plurality of electrodes along a length of the elongated lead body.

12. The medical stimulation lead of claim 1, wherein the second biased portion is biased in a direction substantially away from the first biased portion, wherein the plurality of electrodes comprise a plurality of electrode pairs, wherein each of the plurality of electrode pairs comprises a first electrode connected to the first biased portion and a second electrode connected to the second biased portion offset a predetermined distance from the first electrode along a length of the elongated lead body.

13. The medical stimulation lead of claim 1, wherein the elongated lead body comprises a longitudinal axis, wherein the first biased portion and the second biased portion are biased in a direction away from the longitudinal axis, wherein the restraining body comprises an outer cannula slideably positioned around the elongated lead body, wherein sliding the outer cannula away from the first biased portion and the second biased portion along the longitudinal axis permits the first biased portion and the second biased portion to expand away from the longitudinal axis, dividing the substantially rounded cross-section.

14. The medical stimulation lead of claim 13, wherein the elongated lead body comprises at least one resistance feature providing a resisting force releasably maintaining the outer cannula in a position over the first biased portion and the second biased portion, wherein a predetermined amount of force is required to slide the outer cannula away from the first biased portion and the second biased portion along the longitudinal axis in opposition to the resisting force of the resistance feature.

15. The medical stimulation lead of claim 1, wherein the restraining body comprises at least one dissolvable suture around the elongated lead body in contact with the first biased portion and the second biased portion, and wherein the at least one dissolvable suture is dissolvable in the presence of biological fluids to permit the first biased portion and the second biased portion to expand, dividing the substantially rounded cross-section.

16. The medical stimulation lead of claim 1, further comprising a nose cone connected to the elongated lead body having a substantially rounded shape and a blind aperture, wherein the elongated lead body comprises a through aperture running substantially axially therethrough, and wherein the nose cone is configured to removably receive a stylus through the through aperture of the elongated lead body into the blind aperture.

17. The medical stimulation lead of claim 16, further comprising a stylus positioned within the through aperture of the elongated lead body and removably connected to the blind aperture of the nose cone.

18. The medical stimulation lead of claim 1, wherein the first biased portion and the second biased portion are connected at a first connection point and a second connection point distanced from the first connection point along a longitudinal axis of the elongated lead body, and wherein at least one of the first biased portion and the second biased portion is biased to bow outwardly from the longitudinal axis between the first connection point and the second connection point upon removal of the restraining body.

19. The medical stimulation lead of claim 18, wherein the first connection point is located at an end of the elongated lead body.

20. The medical stimulation lead of claim 1, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand to an expanded position, and replacement of the restraining body forces the first biased portion and the second biased portion to contract to a contracted position, wherein in the contracted position the first biased portion contacts the second biased portion to form a substantially smooth and continuous outer surface of the elongated lead body, and wherein in the expanded position the substantially smooth and continuous outer surface is divided.

21. The medical stimulation lead of claim 20, wherein in the contracted position the elongated lead body comprises a substantially circular cross-section and a longitudinal axis, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand away from the longitudinal axis in approximately opposite directions, dividing the substantially circular cross-section.

22. The medical stimulation lead of claim 20, wherein in the contracted position the elongated lead body comprises a substantially radially symmetric cross-section and a longitudinal axis, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand away from the longitudinal axis in approximately opposite directions, dividing the substantially circular cross-section.