Medical lead and method of making and using with sodium sulfosuccinic ester

• US 5,931,862 A
• Filed: 12/22/1997
• Issued: 08/03/1999
• Est. Priority Date: 12/22/1997
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Carson, Dean F.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/995,685
• Time in Patent Office: 589 Days
• Field of Search: 607/116, 607/119, 607/120
• US Class Current: 607/120
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion

Abstract

A continuous sheath of open-celled porous plastic, preferably ePTFE, is used on the outside of a medical lead, extending along the lead body and the electrodes. Because the plastic is open-celled, when the pores are filled with saline, the lead can deliver electrical energy through the pores in the plastic. Pore size is chosen to discourage tissue ingrowth while allowing for defibrillation energy delivery and electrical signals through it. The porous plastic has a biocompatible wetting agent applied to it to speed the process of filling the pores with saline.

Claims

1. A medical device having a body fluid contacting surface for placement within the interior of a patient'"'"'s body comprising:

a porous material having open-celled pores comprising a portion of said surface; and

a sodium sulfosuccinic ester located within said pores in a quantity sufficient to accelerate wetting out of said pores with bodily fluids when said medical device is placed within the interior of said patient.

2. A medical device having a body fluid contacting surface for placement within the interior of a patient'"'"'s body comprising:

an electrode;

a porous material overlaying at least a portion of said electrode and having open-celled pores comprising a portion of said surface; and

a sodium sulfosuccinic ester located within said pores in a quantity sufficient to accelerate wetting out of said pores with bodily fluids when said medical device is placed within the interior of said patient.

3. The medical device of claim 2 wherein said medical device is an implantable electrical lead for sensing electrical signals from said patient'"'"'s body or for delivering therapeutic current to said patient, and wherein said medical device further comprises:

an insulated conductor electrically coupled to said electrode; and

a lead connector electrically coupled to said insulated conductor.

4. The medical device of claim 2 wherein said sodium sulfosuccinic ester comprises sodium dioctyl sulfosuccinate (DSS).

5. The medical device of claim 4 wherein said DSS is loaded into said pores from a solution of 1% to 10% DSS in isopropanol (IPA).

6. The medical device of claim 5 wherein said DSS is loaded into said pores from a solution of about 2% DSS in IPA.

7. A medical electrical lead for placement within the interior of a patient'"'"'s body, comprising:

at least one electrode for sensing electrical signals from said patient'"'"'s body or for delivering therapeutic current to said patient;

an insulated conductor electrically coupled to said electrode;

a lead connector electrically coupled to said insulated conductor;

a fluoropolymer layer having open-celled pores; and

a sodium sulfosuccinic ester located within said pores in a quantity sufficient to accelerate wetting out of said pores with bodily fluids when said medical device is placed within the interior of said patient'"'"'s body.

8. The medical electrical lead of claim 7 wherein said fluoropolymer layer comprises expanded polytetrafluoroethylene (ePTFE).

9. The medical electrical lead of claim 7 wherein said sodium sulfosuccinic ester comprises sodium dioctyl sulfosuccinate (DSS).

10. The medical electrical lead of claim 7 wherein said DSS is loaded into said pores from a solution of 1% to 10% DSS in IPA.

11. The medical electrical lead of claim 10 wherein said DSS is loaded into said pores from a solution of about 2% DSS in IPA.

12. The medical electrical lead of claim 7 wherein said electrode and at least a portion of said insulated conductor are adapted for transvenous implantation.

13. The medical electrical lead of claim 7 and further comprising a hydrogel layer located between said electrode and said fluoropolymer layer.

14. The medical electrical lead of claim 13 wherein said electrode comprises a porous material and wherein said hydrogel layer is mechanically attached to said electrode.

15. The medical electrical lead of claim 13 and further including a chemical bonding agent for chemically bonding said hydrogel layer to said electrode.

16. A method for applying a wetting agent to a porous portion of a medical device comprising the steps of:

(a) dissolving a sodium sulfosuccinic ester in a solvent to form a sodium sulfosuccinic ester solution;

(b) applying said sodium sulfosuccinic ester solution to at least a portion of said porous portion of said medical device; and

(c) evaporating off said solvent.

17. The method of claim 16 wherein said sodium sulfosuccinic ester comprises DSS and wherein said step (a) comprises dissolving a sufficient quantity of DSS in IPA to form a 1% to 10% solution of DSS in IPA.

18. The method of claim 16 wherein said porous portion of said medical device comprises ePTFE and wherein said step (b) comprises applying said sodium sulfosuccinic ester solution to at least a portion of said ePTFE.

19. The method of claim 16 wherein said medical device comprises at least one electrode and wherein said porous portion comprises ePTFE and wherein said step (b) comprises applying said sodium sulfosuccinic ester solution to a portion of said ePTFE which overlies said at least one electrode.