Fiber optic assisted medical lead

• US 8,868,210 B2
• Filed: 09/27/2013
• Issued: 10/21/2014
• Est. Priority Date: 08/09/2005
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Swoyer, John M., Kidder, Allison M., Zweber, Jeffrey, Brainard, Scott, Glazier, Valerie
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): LEE, ERICA SHENGKAI
• Application Number:
  US14/038,984
• Publication Number:
  US 20140046163A1
• Time in Patent Office: 389 Days
• US Class Current: 607/116
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

A medical device for placing a medical lead in the human body using minimally invasive techniques is described. One lead includes a lead body connected to a lead head having an aperture for providing fiber optic access to the interior of a helical electrode. The fiber optic shaft may be disposed within or along-side a drive shaft releasably coupled to the lead head to rotate the head. The drive shaft and lead body may be delivered using a delivery catheter. The delivery catheter can be advanced though a small incision to the target tissue site, and the site remotely visualized through the fiber optic scope extending through the lead head aperture. The lead head can be rotated, rotating the helical electrode into the tissue, and the catheter, drive shaft, and fiber optic probe removed.

Claims

1. An implantable medical lead assembly configured for fixing an electrode connected to the lead to tissue in a human body, the lead assembly comprising:

a) an elongated lead body extending from a proximal lead portion to a distal lead portion, wherein the proximal lead portion is detachably connectable to an implantable medical device and wherein at least the distal lead portion has a first longitudinal, axis and a distal lead portion diameter aligned generally perpendicular to the first longitudinal axis;

b) an electrical conductor disposed along at least part of the lead body;

c) a lead head comprising an annular lead head sidewall having a sidewall thickness extending from a sidewall outer surface to a sidewall, inner surface surrounding an aperture in the lead head, the lead head aperture extending along a second longitudinal axis from a proximal lead head end to a distal lead head end providing a tissue contact surface, wherein the distal lead portion is connected to the lead head sidewall at an attachment point so that the first longitudinal axis of the distal lead portion is radially offset from the second longitudinal axis of the lead head aperture; and

d) an electrode coupled to the lead head, the electrode configured to be fixedly secured to body tissue to conduct electricity from the electrical conductor to the body tissue,

e) wherein the distal lead portion is movable at the attachment point to the lead head from a constrained position to an unconstrained position,

i) wherein the distal lead portion diameter is substantially equal to or less than the lead head sidewall thickness so that when in the constrained position, the first longitudinal axis of the distal lead portion is disposed at less than about a 30 degree angle with respect to the second longitudinal axis of the lead head aperture to thereby leave the lead head aperture substantially unobstructed by the distal lead portion, and

ii) wherein in the unconstrained position, the distal lead portion lays across the lead head aperture to contact the lead head sidewall opposite the attachment point.

2. The lead assembly of claim 1 further including a drive shaft extending from a proximal drive shaft portion to a distal drive shaft portion, wherein the distal drive shaft portion is releasably attachable to the proximal end of the lead head to thereby provide the lead body and the drive shaft in a side-by-side relationship and wherein the proximal drive shaft portion is manipulatable to impart rotational movement to the lead head to thereby fixedly secure the electrode into body tissue and wherein the drive shaft is further detachable from the lead head connected to the lead with the electrode remaining fixedly secured to the body tissue.

3. The lead assembly of claim 2 wherein the drive shaft has a drive shaft lumen therethrough, and wherein a fiber optic shaft is movable into the drive shaft lumen and into the lead head aperture.

4. The lead assembly of claim 3 further comprising a delivery tube having a delivery tube lumen therethrough, wherein the drive shaft, the lead body, and the fiber optic shaft are movable into and through the delivery tube lumen for at least a part of their respect drive shaft, lead body and fiber optic shaft lengths.

5. The lead assembly of claim 4 wherein the lead body is disposed at about a right angle to the lead head tissue contact surface while unconstrained and not within the delivery tube.

6. The lead assembly of claim 4 wherein the electrode is a helical electrode having an electrode longitudinal axis and wherein the first longitudinal, axis of the distal lead portion is substantially parallel to the electrode longitudinal axis when the distal lead portion attached to the lead head sidewall are in the constrained position in the delivery tube, and wherein the first longitudinal axis of the distal lead portion is substantially parallel with the lead head tissue contact surface when the distal lead portion is removed from the delivery tube and in the unconstrained position.

7. The lead assembly of claim 4 further comprising a handle coupled to the delivery tube, wherein the handle comprises a locking mechanism having a locked position and an unlocked position and wherein rotation of the drive shaft is prevented in the locked position and rotation of the drive shaft is allowed in the unlocked position.

8. The lead assembly of claim 4 wherein the delivery tube includes a steerable distal portion bendable through remote actuation.

9. The lead assembly of claim 2 wherein the lead body is operably coupled to the drive shaft to rotate with and about the first longitudinal axis during manipulation of the drive shaft in a rotational manner.

10. The lead assembly of claim 1 wherein when the electrode is fixedly secured to the body tissue, the second longitudinal axis of the lead head aperture is aligned substantially orthogonally with respect to the lead head tissue contact surface so that a shaft inserted through the lead head aperture while the tissue contact surface is disposed toward the tissue can contact the tissue.

11. The lead assembly of claim 1 wherein the electrode has an electrode central axis and wherein the second longitudinal, axis of the lead head aperture is substantially axially aligned with the electrode central axis.

12. The lead assembly of claim 1 wherein the electrode is a helical electrode.

13. The lead assembly of claim 12 wherein the helical electrode has an interior and the lead head aperture provides access to the helical electrode interior through the lead head.

14. The lead assembly of claim 12 wherein the helical electrode has an electrode longitudinal axis and a plane orthogonal thereto, and wherein the electrode comprises a helically coiled elongated electrode member having coil turns tilted at an angle with respect to the orthogonal plane.

15. The lead assembly of claim 14 wherein the helically coiled elongated electrode member has a coil turn distance between adjacent coil turns with a helical coil distal portion having a coil turn distance that is greater than a helical coil proximal portion coil turn distance.

16. The lead assembly of claim 15 wherein a helical coil distal portion angle is greater than a helical coil proximal portion angle.

17. The lead assembly of claim 1 wherein in the unconstrained position with the distal lead portion laying across the lead head aperture to contact the lead head sidewall opposite the attachment point, the first longitudinal axis of the distal lead portion is disposed at greater than about a 60 degree angle with respect to the second longitudinal axis of the lead head aperture.

18. The lead assembly of claim 17 wherein the lead head is hingedly connected to the distal lead portion at the attachment point.

19. The lead assembly of claim 1 wherein the electrode is a helical electrode having a distal tip and wherein a tip angle changes near the distal tip to point more towards a distal direction than a proximal portion of the electrode adjacent to a proximal electrode end connected to the lead head.

20. The lead assembly of claim 1 further comprising a fiber optic shaft disposed along at least part of the length of the lead body, wherein the fiber optic shaft is movable into the lead head aperture.

21. The lead assembly of claim 1 wherein in the unconstrained position, the distal lead portion substantially obstructs the lead head aperture.

22. An implantable medical lead comprising:

a) an elongated lead body extending from a proximal lead portion to a distal lead portion, wherein the proximal lead portion is detachably connectable to an implantable medical device and wherein at least the distal lead portion has a first longitudinal axis and a distal lead portion diameter aligned generally perpendicular to the first longitudinal axis;

b) an electrical conductor disposed along at least part of the lead body;

c) a lead head comprising an annular lead head sidewall having a sidewall thickness extending from a sidewall outer surface to a sidewall inner surface surrounding an aperture in the lead head, the lead head aperture extending along a second longitudinal axis from a proximal lead head end to a distal lead head end, wherein the distal lead portion is connected to the lead head sidewall at an attachment point so that the first longitudinal axis of the distal lead portion is radially offset from the second longitudinal axis of the lead head aperture; and

d) an electrode coupled to the distal lead head end, the electrode configured to be fixedly secured to body tissue to conduct electricity from the electrical conductor to the body tissue,

e) wherein the distal lead portion is movable at the attachment point to the lead head from a constrained position to an unconstrained position,

i) wherein the distal lead portion diameter is substantially equal to or less than the lead head sidewall thickness so that when in the constrained position, the first longitudinal axis of the distal lead portion is disposed at less than about a 30 degree angle with respect to the second longitudinal axis of the lead head aperture to thereby leave the lead head aperture substantially unobstructed by the distal lead portion, and

ii) wherein in the unconstrained position, the distal lead portion lays across the lead head aperture to contact the lead head sidewall opposite the attachment point.