Non-invasive chemical species delivery apparatus and method

• US 4,250,878 A
• Filed: 11/22/1978
• Issued: 02/17/1981
• Est. Priority Date: 11/22/1978
• Status: Expired due to Term

• Current Assignee: Iomed, Inc. (Enovis Corp.)
• Original Assignee: Motion Control, Inc.
• Inventors: Jacobsen, Stephen C., Stephen, Robert L., Luntz, Richard D., Stenehjem, Jerome C.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US05/963,029
• Time in Patent Office: 818 Days
• Field of Search: 128/635, 128/639-641, 128/644, 128/172.1, 128/380, 128/785, 128/787, 128/793, 128/798, 128/802, 128/803, 128/207.21
• US Class Current: 604/20
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

A bioelectrode for non-invasive and inotophoretic delivery of chemical species (such as ions, polar molecules, etc.) into the skin of a person. The bioelectrode includes a pouch having flexible walls, at least a portion of which is composed of a microporous, permeable or semipermeable membrane. The pouch holds fluid which contains the chemical species to be delivered through the skin. An electrode is attached to the pouch so that when the pouch is placed against the skin, with the membrane portion in contact with the skin, and an electric potential is applied to the electrode, chemical species in the pouch are caused to migrate through the membrane and into the skin.

Claims

1. A bioelectrode for use in the iontophoretic delivery of a chemical species into the skin or tissue of a person comprising

a pouch for holding a fluid containing the chemical species, said pouch including flexible and deformable walls adapted to generally conform to surface shapes against which they are placed, at least a portion of which includes a microporous membrane separating the interior of the pouch from the exterior and having openings of about 0.22 microns or less in diameter, said portion being formed to present a generally planar to convex exterior surface, and

an electrode carried by said pouch for coupling to an electric potential source.

2. A bioelectrode as in claim 1 wherein said electrode is mounted on the exterior surface of said walls in electrical contact therewith and spaced from said membrane.

3. A bioelectrode as in claim 2 wherein said electrode is formed of a flexible conductive material.

4. A bioelectrode as in claim 1 further comprising

a second pouch for holding a fluid containing additional chemical species, said second pouch including flexible and deformable walls adapted to generally conform to surface shapes against which they are placed, at least a portion of which includes a microporous membrane separating the interior of the second pouch from the exterior and having openings of about 0.22 microns or less in diameter, said portion of said second pouch being formed to present a generally planar to convex exterior surface,

a second electrode carried by said second pouch for coupling to an electric potential source, and

flexible means coupling the first-mentioned and second pouch together.

5. A bioelectrode as in claim 1 wherein said pouch is formed in the shape of an annulus and wherein said membrane is disposed about the interior circumference of the annulus.

6. A bioelectrode as in claim 5 wherein said electrode is attached to the exterior surface of said pouch to extend about the exterior circumference of said annulus.

7. A bioelectrode as in claim 1 wherein said pouch is formed in the shape of an elongate bag, and wherein said electrode is formed in the shape of a rod disposed within said bag.

8. A bioelectrode as in claim 7 further including a porous, resilient material disposed between said electrode and the interior surface of the pouch walls.

9. A bioelectrode as in claim 1 wherein said pouch is formed in the shape of a cylinder in which said walls are positioned concentrically.

10. A bioelectrode as in claim 9 wherein said electrode is attached to the exterior surface of said pouch.

11. A bioelectrode as in claim 1 further comprising channel means formed in said pouch to enable introduction therethrough of fluid into said pouch.

12. A bioelectrode for use in the iontophoretic delivery of a chemical species into the skin or tissue of a person comprising

a pouch for holding a fluid containing the chemical species, said pouch including a first flexible and deformable wall portion constructed of a semipermeable membrane having openings of about 0.22 microns or less in diameter, said first wall portion being adapted to allow passage therethrough of certain ions and molecules but to block passage of certain other molecules, and a second flexible and deformable wall portion disposed in a generally facing relationship with said wall portion, and

an electrode carried by said pouch for coupling to an electric potential source.

13. A bioelectrode as in claim 12 wherein said electrode is mounted on the exterior surface of said second wall portion in electrical contact therewith.

14. A method of non-invasively delivering chemical species into the skin or tissue of a person comprising,

placing against the skin or tissue a pouch holding a fluid containing said chemical species, said pouch having flexible walls, one of which consists of a microporous or semipermeable membrane which is positioned in contact with the skin or tissue,

applying pressure to said pouch to cause that portion of the pouch in contact with the skin or tissue to conform to the surface shape of the skin or tissue,

applying a first electric potential to a portion of the skin or tissue spaced from the location of contact of said pouch, and

applying a second electric potential to an exterior surface of said pouch to cause the migration of the chemical species through said membrane and into the skin or tissue.