Long-life biomedical transcutaneous drug application device and method of transcutaneous application of drugs

• US 4,693,711 A
• Filed: 04/19/1985
• Issued: 09/15/1987
• Est. Priority Date: 12/22/1981
• Status: Expired due to Term

• Current Assignee: Bio-Signal Partners
• Original Assignee: Charles Anthony Jr, Raymond M. Chappel, Roger E. Bremer
• Inventors: Bremer, Roger E., Anthony, Charles Jr., Chappel, Raymond M.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/725,227
• Time in Patent Office: 879 Days
• Field of Search: 604/289, 604/290, 604/896, 604/897, 604/20, 604/306, 604/304, 604/305, 604/307, 604/308, 604/87, 604/88
• US Class Current: 604/306
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor

Abstract

To separate drugs within a chamber (66) formed beneath a dome-like housing (24) from another biomedically active substance, the chamber (66) is subdivided into two chamber portions (166, 266) by enclosing, within said chamber, a plastic bag (101) or by stretching a membrane (102) thereacross. The plastic bag, or the membrane, respectively, is ruptured upon depression of a terminal element (34) located at the apex of the dome of the housing. The subdivision of the chamber into two chamber portions prevents intermixing of the biologically active substances during storage. One of the chamber portions may retain liquids which are suitable in the article, and preferably are separated from another one of the liquids, such as a surfactant, and thus permits a wide choice, of, respectively, biologically active and other substances. Unintended leakage of the substances through a microporous membrane (76) closing off the housing is prevented by applying a cover strip across the membrane.

Claims

1. Method of transcutaneously applying substances, such as drugs, to a body surface of a person, comprising

providing a biomedical transcutaneous application device,

said transcutaneous application device comprising

a generally cup-shaped housing (24) of a flexible material, including a vaulted, downwardly open dish or cup-like structure forming a dome-shaped roof;

a microporous membrane sealed to and extending across the housing at a base thereof, and closing off the downwardly open housing for defining a chamber (66) within the housing;

a peelable, releasable, fluid-impervious protective cover film (90) overlying said membrane;

a liquid-compatible, pressure-sensitive adhesive means (94) securing said releasable cover film (90) to said base (56) of the housing, said protective film being selectively removable to expose said membrane and permit attachment of said device to a body surface;

means (101,

     102) for subdividing said chamber into a first chamber portion (166, 166a), and a second chamber portion (266, 266a);

a ring-like transformation zone (100) circumscribing said housing at a height intermediate upper and lower limits thereof, said transformation zone extending in a plane generally parallel to said fluid-permeable membrane (76) and forming a mechanical discontinuity of the wall of said housing, said vaulted roof of said housing being displaceable downwardly in response to pressure applied thereto to deform said housing at said transformation zone and providing for snap-over or toggle action upon application of pressure to a top portion of the dome-shaped housing, resulting in deformation of the housing;

said subdividing means (101,

     102) being of frangible material subject to rupture upon deformation and displacement of a wall of the housing;

at least a first body-affecting substance located in one of said chamber portions; and

a second body affecting substance, differing from said first substance located in the other chamber portion,

said substances being separated from each other during storage within said chamber portion but mixing and penetrating through the microporous membrane (76) to affect the skin of the user for transcutaneous application of at least one of said substances thereto,

said method comprising the steps of

stripping the peelable, releasable, fluid-impervious protective cover film from said microporous membrane;

applying the base of said housing to the body surface of a subject;

firmly pressing the housing into positive contact with the body surface of the subject and securing said membrane in contact with the body surface; and

applying pressure to a top portion of the dome-shaped housing and deforming the walls of said housing to physically transform the shape of the housing to assume a different profile with a resulting change of configuration, said pressure applying and deforming step including

rupturing or breaking the separating means to permit mixing of the substances in said chamber portions, and apply pressure on said mixed substances to provide for penetration thereof through the microporous membrane (76) and establish transcutaneous application of said substance to the body surface of the subject.

2. Biomedical transcutaneous application device for transcutaneous application of drugs or the like, comprising

a generally cup-shaped housing (24) of a flexible material, including a vaulted, downwardly open dish or cup-like structure forming a dome-shaped roof;

a microporous membrane sealed to and extending across the housing at a base thereof, and closing off the downwardly open housing for defining a chamber (66) within the housing;

a peelable, releasable, fluid-impervious protective cover film (90) overlying said membrane;

a liquid-compatible, pressure sensitive adhesive means (94) securing said releasable cover film (90) to said base (56) of the housing, said protective film being selectively removable to expose said membrane and permit attachment of said device to a body surface;

and comprising

means (101,

     102) for subdividing said chamber into a first chamber portion (166, 166a), and a second chamber portion (266, 266a);

a ring-like transformation zone (100) circumscribing said housing at a height intermediate upper and lower limits thereof, said transformation zone extending in a plane generally parallel to said fluid-permeable membrane (76) and forming a mechanical discontinuity of the wall of said housing, said vaulted roof of said housing being displaceable downwardly in response to pressure applied thereto to deform said housing at said transformation zone and providing for snap-over or toggle action upon application of pressure to a top portion of the dome-shaped housing, resulting in deformation of the housing;

said subdividing means (101,

     102) being of frangible material subject to rupture upon deformation and displacement of a wall of the housing;

at least a first body-affecting substance located in one of said chamber portions;

and a second body affecting substance, differing from said first substance located in the other chamber portion,

said substances being separated from each other during storage within said chamber portion but mixing and penetrating through the microporous membrane (76) to affect the skin of the user for transcutaneous application of at least one of said substances thereto.

3. Device according to claim 2, wherein the housing has a dome-shaped roof;

and

the subdividing means comprises a frangible separating membrane extending across the housing.

4. Device according to claim 3, wherein the frangible subdividing membrane is joined to the housing at said ring-like transformation zone.

5. Device according to claim 2, wherein said subdividing means comprises a separate frangible plastic bag (101) located within the chamber (66) and subdividing said chamber into said two chamber portions (166, 266), the volume within said bag (101) forming said second chamber portion (266).