Radiopaque markers for implantable medical leads, devices, and systems

• US 9,956,402 B2
• Filed: 04/28/2010
• Issued: 05/01/2018
• Est. Priority Date: 04/30/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olsen, James M., Klardie, Michael R., Stone, Richard T., Cai, Chad Q., Bondhus, Spencer M., Conroy, Mark J., Abraham, Timothy R., Mehdizadeh, Bruce R., Kern, Michael J., Lahti, Jay K.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US13/265,283
• Publication Number:
  US 20120130461A1
• Time in Patent Office: 2,925 Days
• Field of Search: 607 63, 607116
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0488 Details about the lead
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 2001/058 Fixing tools
• CPC Class Codes: A61N 2001/0582 Suture sleeves
• CPC Class Codes: Y10T 29/49016 Antenna or wave energy "plumbing" making
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/4921 with bonding
• CPC Class Codes: Y10T 29/49227 Insulator making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Radiopaque markers represent that a lead is suitable for a particular medical procedure such as a magnetic resonance image scan and are added to the lead or related device. The markers may be added after implantation of the lead in various ways including suturing, gluing, crimping, or clamping a radiopaque tag to the lead or to the device. The markers may be added by placing a radiopaque coil about the lead, and the radiopaque coil may radially contract against the lead to obtain a fixed position. The markers may be added by placing a polymer structure onto the lead where the polymer structure includes a radiopaque marker within it. The polymer structure may include a cylindrical aperture that contracts against the lead to fix the position of the structure. The polymer structure may form a lead anchor that includes suture wings that can be sutured to the lead.

Claims

1. An implantable medical system comprising:

a lead having an insulative body;

at least one connector on a proximal end of the insulative body of the lead that is configure to be coupled to an implantable medical stimulation device;

a conductive filar surrounded by the insulative body of the lead and electrically connected to the at least one connector;

a radiopaque marker comprising a coil; and

a structure that affixes the radiopaque marker in a fixed position relative to the lead on an outside surface of the insulative body of the lead in a position that is closer to the proximal end of the insulative body of the lead than to the distal end of the lead and such that the entire coil is distal of the at least one connector.

2. The implantable medical system of claim 1, wherein the structure comprises sutures holding the marker in place against the lead.

3. The implantable medical system of claim 1, wherein the structure comprises glue holding the marker in place against the lead.

4. The implantable medical system of claim 1, wherein the structure comprises a clamp holding the marker in place against the lead.

5. The implantable medical system of claim 1, wherein the structure comprises a crimp holding the marker in place.

6. The implantable medical system of claim 1, wherein the radiopaque marker comprises a tag.

7. The implantable medical system of claim 1, wherein the structure comprises

a polymer structure having a cylindrical aperture, and while the polymer structure is in a first state the cylindrical aperture has a diameter that is greater than a diameter of the lead.

8. The implantable medical system of claim 7, wherein while the polymer structure is in a second state the cylindrical aperture has a diameter that is not greater than a diameter of the lead to fix the polymer structure in place on the lead.

9. The implantable medical system of claim 7, wherein the radiopaque marker comprises a plate offset from the cylindrical aperture.

10. The implantable medical system of claim 7, wherein the coil is offset from the cylindrical aperture.

11. The implantable medical system of claim 7, wherein the polymer structure includes suture wings that are sutured to the lead.

12. The implantable medical system of claim 1, wherein the lead comprises a shield.

13. The implantable medical system of claim 12, wherein the radiopaque marker indicates that the shield is present.

14. An implantable medical system comprising:

a lead having an insulative body;

at least one connector on a proximal end of the insulative body of the lead that is configure to be coupled to an implantable medical stimulation device;

a conductive filar surrounded by the insulative body of the lead and electrically connected to the at least one connector;

and

a radiopaque coil positioned around the insulative body of the lead in a position that is closer to the proximal end of the insulative body of the lead than to the distal end of the lead and such that the entire coil is distal of the at least one connector, the radiopaque coil having a first state has a diameter that is greater than a diameter of the lead to allow movement of the radiopaque coil relative to the lead and having a second state that has a diameter that is not greater than a diameter of the lead to fix the coil in place on the lead.

15. The implantable medical system of claim 14, further comprising an implantable medical device connected to the lead.

16. The implantable medical system of claim 14, wherein the lead comprises a shield.

17. The implantable medical system of claim 16, wherein the radiopaque marker indicates that the shield is present.