Optical fiber-fine wire lead for electrostimulation and sensing

• US 9,242,100 B2
• Filed: 03/14/2013
• Issued: 01/26/2016
• Est. Priority Date: 08/07/2012
• Status: Active Grant

• Current Assignee: Cardia Access, Inc.
• Original Assignee: NuAx, Inc.
• Inventors: Walsh, Robert Gilmore, Shimada, Jin, Grant, Michael E., Shapland, James E.
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US13/831,001
• Publication Number:
  US 20140155948A1
• Time in Patent Office: 1,048 Days
• Field of Search: 607116-118
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02154 by optical transmission
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3655 controlled by body or blood temperature
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36571 controlled by blood flow rate, e.g. blood velocity or cardiac output
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Various aspects of the present disclosure are directed toward an implantable electrostimulation device, a plurality of sensing and pacing elements, and a fine wire lead extending in a sealed relationship from the electrostimulation device and to the plurality of sensing and pacing elements. The fine wire lead includes multiple discrete conductors and a drawn silica or glass fiber core, a polymer cladding on the drawn silica or glass fiber core, and a conductive metal cladding over the polymer cladding. Additionally, the fine wire lead simultaneously delivers different electrical signals or optical signals between the sensing and pacing elements and the electrostimulation device.

Claims

1. An apparatus comprising:

an implantable electrostimulation device;

the implantable electrostimulation device selected from the group consisting of a cardiac pacemaker, cardioverter-defibrillator, and a cardiac resynchronization therapy device;

a plurality of sensing and pacing elements; and

a fiber optic lead extending in a sealed relationship from the electrostimulation device to the plurality of sensing and pacing elements, the fiber optic lead having multiple discrete conductors and a drawn fiber core comprising silica or glass, a polymer cladding on the fiber core, and a coaxial conductive metal layer over the polymer cladding, wherein the fiber optic lead is configured and arranged to simultaneously deliver an electrical signal to or from a first sensing and pacing element and an optical signal to or from a second sensing and pacing element.

2. The apparatus of claim 1, wherein

an outer diameter of the fiber optic lead at the metal layer is no greater than about 750 microns, and

the fine wire lead is sufficiently flexible to bend to a radius of about 8 to 10 times the fiber core'"'"'s diameter without damage.

3. The apparatus of claim 1, wherein the coaxial conductive metal layer comprises a conductive metal configured and arranged to deliver electrical signals between the electrostimulation device and at least a first sensing and pacing element, and further including a biocompatible insulating coating covering the fine wire lead.

4. The apparatus of claim 1, wherein

the conductive metal is comprised of silver, and the polymer cladding is comprised of carbon.

5. The apparatus of claim 1, further comprising a control hub, the control hub configured and arranged to interconnect to the fine wire conductor.

6. The apparatus of claim 1, wherein

at least one of the plurality of sensing elements is an optically-based pressure sensor configured and arranged to measure pressure through a sensing interferometer, dielectric mirror or mirrored pressure-sensitive diaphragm.

7. The apparatus of claim 6, wherein the pressure sensor is configured with a piezoelectric element to measure blood pressure.

8. The apparatus of claim 1, wherein the metal cladding is patterned to provide multiple discrete electrical conductors within the same metal layer.

9. The apparatus of claim 8,

wherein the plurality of sensing elements are connected to the discrete metal conductors with radially placed conductive strands.

10. An apparatus comprising:

an electrostimulation device;

a plurality of sensing and pacing elements;

a fiber optic lead including

a drawn fiber core comprising silica or glass,

a cladding, on the fiber core, the cladding comprising a carbon hermetic seal material,

a coaxial conductive metal layer, on the cladding, configured and arranged into multiple discrete conductors, and

a biocompatible coating configured and arranged to seal the fine wire lead,

wherein the fine wire lead extends in a sealed relationship from the electro stimulation device to the plurality of sensing and pacing elements, and the fine wire lead is configured and arranged to simultaneously deliver electrical signals and optical signals between the sensing and pacing elements and the electrostimulation device.

11. The apparatus of claim 10, wherein

an outer diameter of the fiber optic lead at the metal layer is no greater than about 750 microns, the fiber core has a diameter no greater than about 450 microns,

the fine wire lead is sufficiently flexible to bend to a radius of about 8 to 10 times the fiber core diameter without damage.

12. The apparatus of claim 10, wherein

the conductive metal layer is a conductive metal configured and arranged to deliver electrical energy or signals between the electrostimulation device and a sensor or pacing element,

the conductive metal is silver, and

the electrostimulation device is one of a cardiac pacemaker, cardioverter-defibrillator, cardiac resynchronization therapy device or cardiac diagnostic device.

13. The apparatus of claim 10, wherein

the fiber core is configured and arranged to deliver optical signals from the electrostimulation device to a convertor at a distal end of the lead which is configured and arranged to convert the optical signals into electrical signals to pace the heart.

14. The apparatus of claim 10, wherein at least one of the plurality of sensing and pacing elements is an optically-based pressure sensor configured and arranged to measure pressure through a sensing interferometer, dielectric mirror and mirrored pressure-sensitive diaphragm.

15. The apparatus of claim 14, wherein the optically-based pressure sensor is configured with a piezoelectric element to measure blood pressure.

16. The apparatus of claim 10, wherein the coaxial conductive metal layer is in a spiral pattern around the circumference of the lead, the spiral pattern being adapted to provide EMI shielding.

17. The apparatus of claim 16, wherein the sensing elements are connected to the discrete metal conductors with radially placed conductive strands.

18. The apparatus of claim 10, further including a biocompatible insulating coating covering the fine wire lead.

19. The apparatus of claim 10 wherein at least one of the plurality of sensing and pacing elements is an optical based sensor configured and arranged to measure at least one of blood pressure, temperature, strain, fluid velocity, and intrinsic electrical activity.

20. The apparatus of claim 10 further comprising a converter that converts an electric current into an optical signal, wherein the fiber core is configured and arranged to deliver the optical signal to the electrostimulation device.