RADIOPAQUE MARKERS FOR IMPLANTABLE MEDICAL DEVICES

• US 20120065503A1
• Filed: 10/26/2011
• Published: 03/15/2012
• Est. Priority Date: 09/15/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rogers, Charles R., Differding, David D., Gray, John M., Baade, Michael J., Deininger, Steven T., Bach, Katherine J., Byland, Steven D.
• Granted Patent: US 8,903,473 B2
• Time in Patent Office: Days
• US Class Current: 600/431
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 6/506 for diagnosis of nerves
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• 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

Abstract

A radiopaque marker for inclusion within an implantable medical device (IMD) may comprise one or more radiopaque articles selected from a predetermined set of radiopaque articles. The one or more radiopaque articles may be carried by an object formed of or including, a desiccant. The predetermined set of radiopaque articles may undergo a single qualification process that approves the use of any combination of one or more of the articles as a radiopaque marker within an IMD. This allows a potentially-limitless number of markers to be made available based on a single qualification process. The radiopaque marker may serve to provide information such as the make, model, and feature set of the device.

Claims

1. An implantable medical device (IMD), comprising:

a radiopaque marker comprising multiple radiopaque articles arranged in a predetermined manner; and

an object adapted to carry the radiopaque marker.

2. The IMD of claim 1, wherein the radiopaque articles are selected from a predetermined set of radiopaque articles, each of the radiopaque articles in the set having at least one characteristic in common with other radiopaque articles in the set.

3. The IMD of claim 2, wherein the at least one characteristic is a physical dimension.

4. The IMD of claim 1, wherein the radiopaque articles comprise alphanumeric characters formed of radiopaque material.

5. The IMD of claim 1, wherein the radiopaque articles indicate one or more of a manufacturer, a type of the IMD, a model of the IMD, features of the IMD, a date associated with the IMD, and a location associated with the IMD.

6. The IMD of claim 1, wherein the radiopaque articles are formed of tungsten or Hastelloy®

.

7. The IMD of claim 1, wherein the object adapted to carry the radiopaque marker is formed of a desiccant.

8. The IMD of claim 1, wherein the object adapted to early the radiopaque marker is a flex circuit or a cup assembly of the IMD.

9. The IMD of claim 1, wherein the object adapted to carry the radiopaque marker comprises one or more features adapted to retain the radiopaque articles in a predetermined arrangement.

10. The IMD of claim 9, wherein the one or more features are adapted to mate with one or more features of the radiopaque articles.

11. The IMD of claim 1, wherein the multiple radiopaque articles comprise features adapted to retain the radiopaque articles with respect to the object adapted to carry the radiopaque marker.

12. The IMD of claim 1, wherein the radiopaque articles comprise at least one arbitrary symbol formed of radiopaque material.

13. A method, comprising:

selecting one or more radiopaque articles from a predetermined set of multiple radiopaque articles; and

carrying the one or more radiopaque articles as a radiopaque marker within an implantable medical device (IMD).

14. The method of claim 13, wherein each of the predetermined set of multiple radiopaque articles has an attribute in common with the other radiopaque articles in the set.

15. The method of claim 14 wherein the attribute is a physical dimension.

16. The method of claim 14, wherein the attribute is a feature adapted to retain the radiopaque article in a predetermined arrangement within the IMD.

17. The method of claim 13, further comprising providing an object adapted to carry the one or more radiopaque articles.

18. The method of claim 13, wherein one or more of the predetermined set of multiple radiopaque articles is adapted to provide a positive image when detected by imaging technology.

19. The method of claim 13, wherein one or more of the predetermined set of multiple radiopaque articles is an alphanumeric character.

20. The method of claim 13, further comprising arranging the one or more radiopaque articles in a fixed relationship relative to one another.

21. The method of claim 20, further comprising arranging the one or more radiopaque articles in a three-dimensional arrangement relative to one another.

22. The method of claim 13, wherein carrying the one or more radiopaque articles comprises embedding the one or more radiopaque articles within a desiccant article or a polymer article carried by the IMD.

23. The method of claim 13, wherein carrying the one or more radiopaque articles comprises affixing the one or more radiopaque articles with an adhesive or a tape

24. The method of claim 13, further comprising requiring the predetermined set of multiple radiopaque articles to undergo a qualification process to allow any combination of the multiple radiopaque articles to be selected for inclusion in the IMD.

25. A radiopaque marker for an implantable medical device, comprising:

multiple radiopaque articles arranged in a predetermined manner; and

a marker object adapted to carry the multiple radiopaque articles in the predetermined manner.