X-ray identification for active implantable medical device

• US 9,808,617 B2
• Filed: 08/21/2013
• Issued: 11/07/2017
• Est. Priority Date: 08/21/2012
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ostroff, Alan, Paspa, Paul, Jacobson, Peter M., Keller, Wade A., Hubbard, Christopher Alan
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US13/972,828
• Publication Number:
  US 20140058494A1
• Time in Patent Office: 1,539 Days
• Field of Search: 607122
• 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 battery, wherein the battery comprises;

a battery housing comprising an exterior side and an interior side, and

an energy source disposed in the battery housing; and

a radio-opaque marker integrated into the battery, wherein the radio-opaque marker is located inside the battery, and wherein the radio-opaque marker is disposed between the interior side of the battery housing and the energy source.

2. The implantable medical device of claim 1, wherein the radio-opaque marker comprises tantalum.

3. The implantable medical device of claim 1, wherein the implantable medical device is a leadless pacemaker configured to be implanted within the heart of a human.

4. The implantable medical device of claim 1, wherein the battery housing is not surrounded by or enclosed in a separate housing.

5. The implantable medical device of claim 1, wherein the radio-opaque marker has a thickness of about 0.001 inches to about 0.01 inches.

6. The implantable medical device of claim 1, wherein

the radio-opaque marker is in contact with the energy source.

7. A method for identifying an implantable device comprising:

marking a portion of a battery of the implantable device with a radio-opaque marker, wherein the battery comprises a battery housing and an energy source disposed in the battery housing, wherein the battery housing comprises an exterior side and an interior side, and wherein the radio-opaque marker is located between the interior side of the battery housing and the energy source.

8. The method of claim 7, wherein the radio-opaque marker comprises tantalum.

9. A leadless pacemaker configured to be implanted within a heart of a human for pacing the heart, the leadless pacemaker comprising:

a battery comprising a battery housing and an energy source disposed in the battery housing, wherein the battery housing comprises an exterior side and an interior side; and

a radio-opaque marker disposed between the interior side of the battery housing and the energy source.

10. The leadless pacemaker of claim 9, wherein the radio-opaque marker is in contact with the energy source.

11. The leadless pacemaker of claim 9, wherein the radio-opaque marker comprises tantalum.

12. The leadless pacemaker of claim 9, wherein the radio-opaque marker comprises a plurality of markers.

13. 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 battery comprising a battery housing, wherein the battery is electrically coupled to the pacing electronics, and wherein the battery housing comprises an exterior side and an interior side; and

a radio-opaque marker disposed between the interior side of the battery housing and the energy source, wherein the battery housing is not surrounded by or enclosed in a separate housing.

14. The leadless cardiac pacemaker of claim 13, wherein the radio-opaque marker is disposed between an interior side of the battery housing and an anode of the energy source.

15. The leadless cardiac pacemaker of claim 14, further comprising a thermal separator disposed between the anode and a cathode of the energy source, wherein the radio-opaque marker comprises dull edges such as to prevent the edges of the marker from piercing the anode and breaking through the thermal separator.

16. The leadless cardiac pacemaker of claim 13, wherein the radio-opaque marker is shaped to indicate the rotation of the leadless pacemaker when scanned by X-ray radiation and wherein the radio-opaque marker is disposed between the interior side of the battery housing and the energy source such that it does not create an elevated surface on the exterior of the leadless pacemaker.

17. The leadless cardiac pacemaker of claim 13, wherein the radio-opaque marker has a thickness of about 0.001 inches to about 0.01 inches.

18. The leadless cardiac pacemaker of claim 13, wherein the radio-opaque marker is in contact with the energy source.

19. The leadless cardiac pacemaker of claim 18, wherein the radio-opaque marker comprises tantalum.

20. An implantable medical device configured to for delivery through a catheter and passage into vasculature, comprising:

a battery comprising a battery housing and an energy source disposed in the battery housing; and

a radio-opaque marker integrated into the battery, wherein;

the battery housing comprises an exterior side and an interior side, and

the radio-opaque marker is disposed between the interior side of the battery housing and the energy source.

21. The implantable medical device of claim 20, wherein the battery housing is not surrounded by or enclosed in a separate housing.