Drug dispensing body implantable lead employing molecular sieves and methods of fabrication

• US 4,577,642 A
• Filed: 02/27/1985
• Issued: 03/25/1986
• Est. Priority Date: 02/27/1985
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stokes, Kenneth B.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/706,215
• Time in Patent Office: 391 Days
• Field of Search: 128/419 P, 128/784, 128/785, 128/786, 604/20, 604/21, 604/890, 604/891, 604/892, 604/893, 604/894
• US Class Current: 607/120
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/0568 with drug delivery

Abstract

A body implantable lead for the delivery of stimulation energy to a desired body site including a drug dispenser carried by the lead which retains a drug to be dispensed while allowing the dispensing of that drug at least adjacent the desired body stimulation site. The drug is retained in a cavity within the lead, in the form of a solid plug or a powder wherein the drug is compounded with an appropriate molecular sieve material. The drug is released only after the molecular sieves are activated by exposure to water. In those embodiments in which the molecular sieves take the form of a powder, the molecular sieves and drug may be conveniently loaded into the electrode, after manufacture and prior to implant.

Claims

1. A body implantable electrode lead, comprising:

an elongated insulative lead body having a proximal end and a distal end;

an electrical conductor mounted within said lead body, having a proximal end and a distal end;

an electrical connector mounted to the proximal end of said lead body and electrically coupled to said electrical conductor;

electrode means for contacting body tissue along an exterior surface of said electrode, said electrode mounted to said lead body and electrically coupled to the proximal end of said electrical conductor, said electrode having a cavity therein open to said exterior surface; and

dehydrated molecular sieve material mounted within said cavity.

2. A lead according to claim 1, further comprising:

a polar drug adsorbed on said dehydrated molecular sieve material.

3. A lead according to claim 1, further comprising:

a polar drug absorbed within said molecular sieve material.

4. A lead according to claims 1, 2 or 3 wherein said electrode has a bore connecting the cavity of said electrode to said exterior surface of said electrode.

5. A lead according to claim 4 further comprising retaining means for retaining said molecular sieve material within the cavity of said electrode.

6. A lead according to claim 5 wherein said retaining means comprises a porous material and wherein said molecular sieve material comprises a powder having particles larger than the pore size of said porous material.

7. A method of manufacturing an electrode, comprising the steps of:

fabricating an electrode having an exterior surface, an internal cavity, a first bore extending from said cavity to said exterior surface, a retainer having pores mounted across said first bore, and a second bore connecting said cavity to the exterior of said electrode;

dehydrating a molecular sieve material having a particle size larger than the pore size of said retainer; and

loading said dehydrated molecular sieve material into said cavity via said second bore of said electrode.

8. A method according to claim 7 wherein said fabricating step includes providing said electrode with a layer of pierceable material extending over said second bore and wherein said loading step comprises piercing said pierceable material with a sharpened, tubular instrument having an internal bore and loading said molecular sieve particles via said internal bore.

9. A method of manufacturing an implantable electrode, comprising the steps of:

fabricating an electrode having an internal cavity, an exterior surface, a first bore open to said exterior surface and to said internal cavity, a retainer having pores mounted across said bore and a dehydrated cavity containing molecular sieve material having particle size greater than the pore size of said retainer, mounted within said internal cavity of said electrode;

dissolving a drug having a polar portion smaller than the cavity size of said molecular sieve material in a non-polar solvent; and

soaking said electrode in said non-polar solvent in which said drug has been dissolved.