Method of manufacturing x-ray visible soluble covering

• US 5,942,276 A
• Filed: 01/16/1998
• Issued: 08/24/1999
• Est. Priority Date: 01/16/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Morris, Mary M., Sandstrom, Richard D., Chivers, Bruce E.
• Primary Examiner(s): PIANALTO, BERNARD D
• Application Number:
  US09/008,236
• Time in Patent Office: 585 Days
• Field of Search: 427/2.12, 427/2.24, 427/2.3, 427/385.5, 427/256, 427/58
• US Class Current: 427/2.12
• CPC Class Codes: A61L 31/082 Inorganic materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61N 1/0568 with drug delivery

Abstract

A method of fabricating a radiopaque dissolvable covering for a member on an implantable lead, including the steps of mixing a radiopaque material with a solvent to form a paste, applying the paste to the member and allowing the paste to harden. The lead preferably is provided with a drug incorporated therein which is subject to degradation at high temperature, located adjacent to the member, and the applying step preferably takes place at about room temperature. The member to which the paste is applied may be an active fixation device such as a barb or a helix or may be a deployable member such as a tine or an electrode bearing member.

Claims

1. A method of fabricating a radiopaque dissolvable covering for a member on an implantable lead, comprising:

mixing a radiopaque material with a solvent to form a paste;

applying said paste to said member; and

allowing said paste to harden; and

wherein said applying step comprises applying said paste to a deployable member mounted to said lead.

2. A method according to claim 1 wherein said step of applying said paste and allowing said paste to harden are carried out at about room temperature.

3. A method according to claim or claim 1 wherein said step of applying said paste comprises applying said paste to a member of a lead having a drug incorporated therein which is subject to degradation at greater than a first temperature, located adjacent said member, and wherein said applying step takes place at less than said first temperature.

4. A method according to claim 1 wherein said mixing step comprises mixing a contrast medium and said step of applying said paste to said member of a lead takes place at a temperature less than said that which might damage the contrast medium.

5. A method according to claim 1 wherein said applying step comprises applying said paste to a deployable barb mounted to said lead.

6. A method according to claim 5 or claim 1 wherein said applying step comprises applying said paste to a member mounted to a lead having sodium dexamethasone phosphate incorporated therein adjacent said member and wherein said applying step takes place at less than 140 degrees Fahrenheit.

7. A method of fabricating a radiopaque dissolvable covering for an member on an implantable lead, comprising:

mixing a radiopaque material with a solvent to form a paste;

applying said paste to said member; and

allowing said paste to harden; and

wherein said applying step comprises applying said paste to an active fixation device, mounted to said lead.

8. A method according to claim 7 wherein said applying step comprises applying said paste to a fixation helix, mounted to said lead.

9. A method of fabricating a radiopaque dissolvable covering for an active fixation device on a lead for implant in a patient'"'"'s heart, comprising:

mixing a powdered contrast medium with a solvent to form a paste;

applying said paste to said active fixation device; and

allowing said paste to harden.

10. A method according to claim 9 wherein said mixing step comprises mixing a powdered contrast medium with a solvent to form a paste consisting essentially of said contrast medium and said solvent.

11. A method according to claim 9 or claim 10 wherein said step of applying said paste comprises applying said paste to an active fixation device of a lead having a drug incorporated therein which is subject to degradation at greater than a first temperature, located adjacent said member, and wherein said applying step takes place at less than said first temperature.

12. A method according to claim 9 or claim 10 wherein said step of applying said paste and allowing said paste to harden are carried out at about room temperature.

13. A method of using a lead having an active fixation device, comprising:

mixing a powdered contrast medium with a solvent to form a paste;

applying said paste to said active fixation device;

allowing said paste to harden;

advancing said lead into a patient'"'"'s heart;

allowing said paste to dissolve; and

engaging said patient'"'"'s heart with said active fixation device.

14. A method according to claim 13 wherein said mixing step comprises mixing a powdered contrast medium with a solvent to form a paste consisting essentially of said contrast medium and said solvent.

15. A method according to claim 13 or claim 14 wherein said step of applying said paste comprises applying said paste to an active fixation device of a lead having a drug incorporated therein which is subject to degradation at greater than a first temperature, located adjacent said member, and wherein said applying step takes place at less than said first temperature.

16. A method according to claim 13 or claim 14 wherein said step of applying said paste and allowing said paste to harden are carried out at about room temperature.