X-Ray Identification for Active Implantable Medical Device

• US 20140058494A1
• Filed: 08/21/2013
• Published: 02/27/2014
• Est. Priority Date: 08/21/2012
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Nanostim, Inc (Abbott Laboratories Incorporated)
• Inventors: Ostroff, Alan, Paspa, Paul, Jacobson, Peter M., Keller, Wade A., Hubbard, Christopher Alan
• Granted Patent: US 9,808,617 B2
• Time in Patent Office: Days
• US Class Current: 607/122
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• 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
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An active implantable medical device is disclosed herein having a radio-opaque marker. The radio-opaque marker can be formed within an exterior wall of the device or within recesses on the outside of the exterior wall. The implantable medical device can be a leadless pacemaker. The shape of the radio-opaque marker can be designed to facilitate visualization and identification of the location, orientation, and rotation of the implanted medical device by conventional fluoroscopy. Methods of use are also disclosed.

Claims

1. An implantable medical device comprising:

a cell; and

a radio-opaque marker integrated into the cell.

2. The implantable medical device of claim 1, wherein the radio-opaque marker is located inside the cell.

3. The implantable medical device of claim 1, wherein the radio-opaque marker is embedded in an exterior surface of the cell.

4. The implantable medical device of claim 1, wherein the radio-opaque marker comprises tungsten, tantalum, platinum, gold, or other radio-opaque materials.

5. The implantable medical device of claim 1, wherein the implantable medical device is a leadless pacemaker.

6. A method for identifying an implantable device comprising:

marking a portion of a cell of the implantable device with a radio-opaque marker.

7. The method of claim 6, wherein the radio-opaque marker comprises one or more of tungsten, tantalum, platinum, or gold, or other radio-opaque materials.

8. The method of claim 6, wherein the marked portion of the implantable medical device is relatively opaque to x-ray radiation.

9. The method of claim 8, wherein the radio-opaque marker is located within the cell of the implantable device.

10. The method of claim 9, further comprising forming the radio-opaque marker in a desired shape by patterning, laser cutting, wire cutting, chemical machining, stamping, or mechanical machining prior to marking.

11. The method of claim 8, further comprising forming recesses in an exterior surface of the cell, wherein the radio-opaque marker is deposited in the recesses on the exterior surface of the cell.

12. The method of claim 11, further comprising treating the exterior surface of the cell after depositing the radio-opaque marker to smooth the exterior surface of the cell.

13. The method of claim 8, wherein marking comprises inserting a radio-opaque marker within the cell of the implantable device.

14. A leadless pacemaker for pacing a heart of a human comprising:

a cell; and

a radio-opaque marker integrated into the cell.

15. The leadless pacemaker of claim 14, wherein the radio-opaque marker is contained within an interior portion of the cell.

16. The leadless pacemaker of claim 14, wherein the radio-opaque marker is embedded in an exterior surface of the cell.

17. The leadless pacemaker of claim 14, wherein the radio-opaque marker comprises tungsten, tantalum, platinum, gold, or other radio-opaque materials.

18. The leadless pacemaker of claim 14, wherein the radio-opaque marker is shaped to indicate the rotation of the pacemaker when scanned by X-ray radiation.

19. The leadless pacemaker of claim 14, wherein the radio-opaque marker comprises a plurality of markers.

20. A leadless cardiac pacemaker, comprising:

an electronics housing;

pacing electronics disposed in the electronics housing;

a tip electrode electrically coupled to the pacing electronics;

a cell housing;

an energy source disposed in the cell housing and electrically coupled to the pacing electronics; and

a radio-opaque marker integrated into a wall of the cell housing.

21. The leadless cardiac pacemaker of claim 20, wherein the radio-opaque marker is integrally formed within depressions in the wall of the cell housing.

22. The leadless cardiac pacemaker of claim 20, wherein the radio-opaque marker comprises multiple discrete markings.

23. A leadless cardiac pacemaker, comprising:

an electronics housing;

pacing electronics disposed in the electronics housing;

a tip electrode electrically coupled to the pacing electronics;

a cell housing;

an energy source disposed in the cell housing and electrically coupled to the pacing electronics; and

a radio-opaque marker contained within cell housing.

24. The leadless cardiac pacemaker of claim 23 wherein the radio-opaque marker is disposed between an interior side of the cell housing and an anode of the energy source.

25. The leadless cardiac pacemaker of claim 25 further comprising a thermal separator disposed between the anode and a cathode of the energy source.