Paddle lead with indicia and related methods of use

• US 9,162,056 B2
• Filed: 10/26/2012
• Issued: 10/20/2015
• Est. Priority Date: 10/27/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne Margaret
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US13/661,918
• Publication Number:
  US 20130110211A1
• Time in Patent Office: 1,089 Days
• Field of Search: 607/117
• US Class Current: 1/1
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/487 involving fluoroscopy
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

An implantable paddle lead includes a paddle body, configured and arranged for implantation in a patient'"'"'s body, having a first face and a second face opposing the first face. The paddle lead also includes a plurality of electrodes disposed on the paddle body and configured and arranged for stimulating patient tissue adjacent the paddle body. The paddle lead further includes at least one indicium, independent of the plurality of electrodes, disposed on, or formed by, the paddle body. The at least one indicium is configured and arranged such that, when the paddle body is inserted within the patient'"'"'s body and viewed under fluoroscopy, the at least one indicium identifies a facing orientation of the paddle body within the patient'"'"'s body.

Claims

1. An implantable paddle lead, comprising:

a paddle body, configured and arranged for implantation in a patient'"'"'s body, having a first face and a second face opposing the first face;

a plurality of electrodes disposed on the paddle body and configured and arranged for stimulating patient tissue adjacent the paddle body; and

at least one indicium, independent of the plurality of electrodes, disposed on the paddle body, wherein the at least one indicium comprises a radiopaque material and is configured and arranged such that, when the paddle body is inserted within the patient'"'"'s body and viewed under fluoroscopy, the at least one indicium identifies a facing orientation of the paddle body within the patient'"'"'s body, wherein at least 33% of the second face is coated with the at least one indicium including a portion of the second face opposite one or more of the plurality of electrodes to hide the one or more of the plurality of electrodes in a fluoroscopic image if the paddle body is in a correct facing orientation, wherein the at least one indicium is fluoroscopically distinguishable from the plurality of electrodes.

2. The paddle lead of claim 1, wherein at least 90% of the second face is coated with the at least one indicium.

3. A stimulation system, comprising:

the paddle lead of claim 1; and

a control module coupleable to the paddle lead.

4. A method for implanting a paddle lead, the method comprising:

advancing the paddle lead of claim 1 into a patient'"'"'s body;

capturing a fluoroscopic image of the paddle lead; and

identifying a facing orientation of the paddle lead by observing the at least one indicium on the fluoroscopic image.

5. The method of claim 4, wherein identifying a facing orientation of the paddle lead comprises comparing the fluoroscopic image with a predetermined desired image.

6. The method of claim 4, further comprising revising the facing orientation of the paddle lead upon a determination that the paddle lead is implanted with an incorrect facing orientation.

7. The method of claim 6, wherein revising the facing orientation of the paddle lead comprises explanting the paddle lead and then reimplanting the paddle lead.

8. The method of claim 7, further comprising capturing a fluoroscopic image of the reimplanted paddle lead;

and identifying a facing orientation of the reimplanted paddle lead by observing the at least one indicium on the fluoroscopic image.

9. The method of claim 4, further comprising coupling the paddle lead to an implantable control module.

10. The paddle lead of claim 1, wherein at least 50% of the second face is coated with the at least one indicium.

11. The paddle lead of claim 1, wherein all of the second face is coated with the at least one indicium.

12. The paddle lead of claim 1, wherein the at least one indicium is configured and arranged to hide all of the plurality of electrodes from fluoroscopic observation when the paddle body is correctly inserted within the patient'"'"'s body.

13. The paddle lead of claim 1, wherein the at least one indicium is disposed over an entire portion of the second face that is opposite the plurality of electrodes.

14. An implantable paddle lead, comprising:

a paddle body, configured and arranged for implantation in a patient'"'"'s body, having a first face and a second face opposing the first face;

a plurality of electrodes disposed on the paddle body and configured and arranged for stimulating patient tissue adjacent the paddle body; and

at least one indicium, independent of the plurality of electrodes, disposed on the paddle body, wherein the at least one indicium comprises a radiopaque material and is configured and arranged such that, when the paddle body is inserted within the patient'"'"'s body and viewed under fluoroscopy, the at least one indicium identifies a facing orientation of the paddle body within the patient'"'"'s body, wherein the at least one indicium comprises a plurality of cutout sections formed by at least a portion of the paddle body, wherein the cutout sections are all disposed on a same side of the paddle body.

15. The paddle lead of claim 14, wherein the at least one indicium further comprises at least one symbol.

16. The paddle lead of claim 14, wherein the at least one indicium further comprises at least one alphanumeric character.

17. A stimulation system, comprising:

the paddle lead of claim 14; and

a control module coupleable to the paddle lead.

18. A method for implanting a paddle lead, the method comprising:

advancing the paddle lead of claim 14 into a patient'"'"'s body;

capturing a fluoroscopic image of the paddle lead; and

identifying a facing orientation of the paddle lead by observing the at least one indicium on the fluoroscopic image.

19. The paddle lead of claim 14, wherein the cutout sections are disposed in an asymmetric pattern along the same side of the paddle body.