Fiber Optic Assisted Medical Lead

• US 20110071358A1
• Filed: 11/29/2010
• Published: 03/24/2011
• 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
• Granted Patent: US 8,548,603 B2
• Time in Patent Office: Days
• US Class Current: 600/182
• 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 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. Some catheters include a distal mapping electrode readable from the catheter proximal portion or handle. The lead head can be rotated, rotating the helical electrode into the tissue, and the catheter, drive shaft, and fiber optic probe removed. In one use, epicardial pacing leads are placed on the posterior surface of the heart, aided by visualization and mapping to obtain optimal electrode placement and patient outcome.

Claims

1. A medical device for fixing a component to tissue in a human body, the medical device comprising:

a) a flexible, controllably bendable tube having a lumen therethrough, a distal bendable tube region and a proximal bendable tube region;

b) a first handle having a distal region and a proximal region, the first handle distal region operably coupled to the bendable tube, such that bending of the tube can be controlled from the first handle, the first handle having a drive shaft handle receiving region in communication with the bendable tube lumen; and

d) an elongate drive shaft having a second length extending from a proximal drive shaft portion to a distal drive shaft portion, wherein the distal drive shaft portion is releasably attachable to the distal bendable tube region to thereby provide the drive shaft and the bendable tube in a side-by-side relationship and wherein the proximal drive shaft portion is manipulatable by a drive shaft handle to impart rotational movement to the distal bendable tube region to thereby secure a component into body tissue.

2. The medical device of claim 1, wherein a lead body is disposed within the lumen, having an elongated lead body length extending from a proximal lead body portion to a distal lead body portion with at least the distal lead body portion having a first longitudinal axis.

3. The medical device of claim 2, wherein the component is an electrode in communication with the distal lead portion.

4. The medical device of claim 2, wherein an electrical conductor is disposed along at least part of the first length of the lead body.

7. The medical device of claim 1, in which the controllably bendable tube distal region includes at least one sensor for measuring a property and generating a signal indicative of the property, the sensor selected from the group consisting of temperature sensors, pressure sensors, oxygen sensors, pH sensors, and chemical sensors, and combinations thereof, and an elongate signal conductor for conducting the signal at least to the bendable tube proximal region.

8. The medical device of claim 1, further comprising:

a) a sensor shaft sized to be disposed in the bendable tube between at least the bendable tube distal region and the bendable tube proximal region, the sensor shaft having a distal region and a proximal region;

b) at least one sensor for measuring a property and generating a signal indicative of the property disposed near the sensor shaft distal region, where the sensor is selected from the group consisting of temperature sensors, pressure sensors, oxygen sensors, pH sensors, and chemical sensors, and combinations thereof; and

c) an elongate signal conductor for conducting the signal to the sensor shaft proximal region.

5. The medical device of claim. I, further comprising:

a) a fiber optic shaft sized to be disposed in the bendable tube between at least the bendable tube distal region and the drive shaft handle; and

b) a fiber optic viewer coupled to the fiber optic shaft proximal region to view images from the fiber optic shaft distal region.

6. The medical device of claim 5, in which the drive shaft is a tubular shaft having a drive shaft lumen therethrough, in which the fiber optic shaft is removably disposed within the drive shaft lumen.

9. A medical device for fixing an electrode to tissue in a human body, the medical device comprising:

a) a flexible, controllably bendable tube having a lumen therethrough, a distal bendable tube region and a proximal bendable tube region;

b) an elongated lead body disposed within the lumen, having a first length extending from a proximal lead portion to a distal lead portion with at least the distal lead portion having a first longitudinal axis;

c) an electrical conductor disposed along at least part of the first length of the lead body;

d) a lead head comprising an annular sidewall 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 with the first longitudinal axis of the distal lead portion being radially offset from the second longitudinal axis of the lead head aperture;

e) a first handle having a distal region and a proximal region, the first handle distal region operably coupled to the bendable tube, such that bending of the tube can be controlled from the first handle, the first handle having a drive shaft handle receiving region in communication with the bendable tube lumen; and

f) an elongate drive shaft having a second length 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 by a drive shaft handle to impart rotational movement to the lead head to thereby secure an electrode into the body tissue and wherein the drive shaft is further detachable from the lead head connected to the lead with the electrode remaining secured to body tissue.

10. The medical device of claim 9, further comprising:

a) a fiber optic shaft sized to be disposed in the bendable tube between at least the bendable tube distal region and the drive shaft handle; and

b) a fiber optic viewer coupled to the fiber optic shaft proximal region to view images from the fiber optic shaft distal region.

11. The medical device of claim 9, wherein the drive shaft handle is operably coupled to the drive shaft proximal region and rotatably coupled to the drive shaft handle receiving region such that rotating the drive shaft handle rotates the drive shaft within the bendable tube.

12. The medical device of claim 9, in which the drive shaft handle includes at least one constrained path for taking up excess lead length.

13. The medical device of claim 12, in which the constrained path includes a spiral groove path disposed about a portion of the drive shaft handle.

14. The medical device of claim 9, further comprising a cavity in the drive shaft handle for receiving an electrical lead proximal connector, such that rotating the drive shaft handle rotates the drive shaft and the lead body about the drive shaft.

15. The medical device of claim 10, in which the drive shaft is a tubular shaft having a drive shaft lumen therethrough, in which the fiber optic shaft is removably disposed within the drive shaft lumen.

16. The medical device of claim 10 in which the fiber optic shaft is fixedly disposed within the drive shaft.

17. The medical device of claim 9, further comprising means for indicating the number of rotations of the drive shaft.

18. The medical device of claim 9, further comprising means for limiting the number of rotations of the drive shaft to a predetermined number of rotations.

19. The medical device of claim 9, wherein the electrode is in communication with the lead head.

20. The medical device of claim 9, wherein the lead head does not have an aperture for receiving the fiber optic shaft therethrough.

21. The medical device of claim 9, the controllably bendable tube handle further including a locking mechanism having a locked position and an unlocked position, in which rotation of the drive shaft handle is prevented in the locked position and rotation of the drive shaft handle is allowed in the unlocked position.

22. The medical device of claim 9, the first handle further including a locking mechanism having a locked position and an unlocked position, in which advancement of the lead is prevented in the locked position and advancement of the lead is allowed in the unlocked position.

23. The medical device of claim 9, in which the controllably bendable tube distal region includes at least one sensor for measuring a property and generating a signal indicative of the property, the sensor selected from the group consisting of temperature sensors, pressure sensors, oxygen sensors, pH sensors, and chemical sensors, and combinations thereof, and an elongate signal conductor for conducting the signal at least to the bendable tube proximal region.

24. The medical device of claim 9, further comprising:

a) a sensor shaft sized to be disposed in the bendable tube between at least the bendable tube distal region and the bendable tube proximal region, the sensor shaft having a distal region and a proximal region;

b) at least one sensor for measuring a property and generating a signal indicative of the property disposed near the sensor shaft distal region, where the sensor is selected from the group consisting of temperature sensors, pressure sensors, oxygen sensors, pH sensors, and chemical sensors, and combinations thereof; and

c) an elongate signal conductor for conducting the signal to the sensor shaft proximal region.

25. A method for affixing an electrical lead to a tissue surface, the lead having a lead head coupled to a lead body and an electrode coupled to the lead head, the method comprising:

a) advancing the lead head to the sue surface;

b) visualizing the tissue surface using a fiber optic shaft disposed through the lead head;

c) securing the electrode to the tissue surface; and

d) removing the fiber optic shaft from the lead head.