Implantable medical device with radiopaque ID tag

• US 10,046,167 B2
• Filed: 02/08/2016
• Issued: 08/14/2018
• Est. Priority Date: 02/09/2015
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Schmidt, Brian L., Swackhamer, Bryan J., Jones, Robert A., Kubow, Steven A.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/018,379
• Publication Number:
  US 20160228716A1
• Time in Patent Office: 918 Days
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable medical device includes a housing. A first ID tag is secured relative to the housing at a first position and defines a first radiopaque manufacturer code section that visually identifies a manufacturer of the implantable medical device. A second ID tag is secured relative to the housing at a second position that is offset from the first position in at least one dimension. The second ID tag defines a second radiopaque manufacturer code section that also visually identifies the manufacturer of the implantable medical device.

Claims

1. A leadless cardiac pacemaker comprising:

an elongated housing having a length, an energy storage section and a circuit section, the energy storage section defining a first volume that extends along a first fraction of the length of the elongated housing and the circuit section defining a second volume that extends along a second fraction of the length of the elongated housing, wherein the first faction does not overlap with the second fraction of the length of the elongated housing;

an energy source disposed within the first volume;

a circuit board disposed within the second volume but not in the first volume, the circuit board operably coupled to the energy source;

a first electrode and a second electrode each exposed along an exterior of the elongated housing and operatively coupled to the circuit board; and

an ID tag disposed on or in the energy storage section of the elongated housing, the ID tag configured to define a radiopaque manufacturer code that visually identifies a manufacturer of the leadless cardiac pacemaker.

2. The leadless cardiac pacemaker of claim 1, further comprising an insulative coating disposed over at least part of the energy storage section of the elongated housing, and the ID tag is covered by the insulative coating.

3. The leadless cardiac pacemaker of claim 1, wherein the energy source comprises a battery liner, an anode disposed within the battery liner, and a cathode disposed within the anode, and the ID tag is disposed on or in one of the battery liner, the anode and the cathode.

4. The leadless cardiac pacemaker of claim 3, further comprising a battery pin extending from the cathode of the energy source, wherein the ID tag is disposed on or in the battery pin.

5. A leadless cardiac pacemaker, comprising:

an elongated housing extending along a central axis between a distal end and a proximal end;

a distal electrode secured relative to the elongated housing;

a proximal electrode secured relative to the elongated housing proximally of the distal electrode;

fixation tines extending distally of the distal end of the elongated housing;

a controller disposed within the elongated housing and configured to sense cardiac electrical signals via the distal electrode and the proximal electrode, and further configured to provide therapy to a patient'"'"'s heart via the distal electrode and the proximal electrode; and

an ID tag system secured relative to the elongated housing, the ID tag system comprising a first radiopaque manufacturer code section that visually identifies a manufacturer of the leadless cardiac pacemaker and a second radiopaque manufacturer code section that also visually identifies the manufacturer of the leadless cardiac pacemaker, wherein the first radiopaque manufacturer code section and the second radiopaque manufacturer code section face different radial directions relative to the central axis of the elongated housing.

6. The leadless cardiac pacemaker of claim 5, further comprising a desiccant inside of the elongated housing, wherein at least part of the ID tag system is disposed on or in the desiccant.

7. The leadless cardiac pacemaker of claim 5, further comprising an epoxy overmolding, wherein at least part of the ID tag system is disposed on or in the overmolding.

8. The leadless cardiac pacemaker of claim 5, further comprising a drug collar, wherein at least part of the ID tag system is disposed on or in the drug collar.

9. The leadless cardiac pacemaker of claim 5, wherein the elongated housing comprises a proximal end feature for retrieval of the leadless cardiac pacemaker, and at least part of the ID tag system is secured to the proximal end feature.

10. The leadless cardiac pacemaker of claim 5, further comprising an axial rotation marker, and at least part of the ID tag system is disposed within a cutout formed in the axial rotation marker.

11. The leadless cardiac pacemaker of claim 5, wherein at least part of the ID tag system is formed from a platinum wire disposed within a slot formed in the elongated housing.

12. The leadless cardiac pacemaker of claim 5, wherein the ID tag system further comprises a first radiopaque MRI code section and a second radiopaque MM code section, wherein the first radiopaque MRI code section and the second radiopaque MRI code section face different radial directions relative to the central axis of the elongated housing.

13. A leadless cardiac pacemaker, comprising:

an elongated housing including a wall with an inside surface that defines an internal cavity, the inside surface of the wall having a shape;

a pair of electrodes spaced apart and secured relative to the elongated housing;

a controller disposed within the internal cavity defined by the wall of the elongated housing and operably coupled to the pair of electrodes;

a power source disposed within the internal cavity defined by the wall of the elongated housing and operably coupled to the controller; and

a radiopaque tag that is shaped to conform with the shape of the inside surface of the wall of the elongated housing, the radiopaque tag is further configured to define a radiopaque manufacturer code that visually identifies a manufacturer of the leadless cardiac pacemaker.

14. The leadless cardiac pacemaker of claim 13, wherein:

the inside surface of the wall defines an internal cavity with a cylindrical shape in cross-section;

the power source comprises a battery having a cylindrical outer shape in cross-section; and

the radiopaque tag is shaped to fit around the cylindrical outer shape of the battery and to conform with the inside surface of the wall of the elongated housing.

15. The leadless cardiac pacemaker of claim 13, wherein the power source comprises a battery having a battery liner, an anode disposed within the battery liner, and a cathode disposed within the anode, and the radiopaque tag is configured to be secured on or in one of the battery liner, the anode and the cathode.

16. The leadless cardiac pacemaker of claim 13, wherein the radiopaque tag comprises a first radiopaque tag oriented in a first radial direction, and the leadless cardiac pacemaker further comprises a second radiopaque tag oriented in a second radial direction that is different from the first radial direction.

17. The leadless cardiac pacemaker of claim 16, wherein the first radiopaque tag and the second radiopaque tag each define one or more radiopaque alphanumeric characters.

18. The leadless cardiac pacemaker of claim 17, wherein the one or more radiopaque alphanumeric characters are configured to be human readable in an x-ray image of the implantable medical device.

19. The leadless cardiac pacemaker of claim 13, wherein the radiopaque tag is structured to define a radiopaque manufacturer code as well as a reverse image of the radiopaque manufacturer code.

20. The leadless cardiac pacemaker of claim 13, further comprising fixation tines extending beyond a distal end of the elongated housing.