Iontophoretic delivery device with integral hydrating means

• US 6,223,075 B1
• Filed: 12/09/1996
• Issued: 04/24/2001
• Est. Priority Date: 08/22/1994
• Status: Expired due to Term

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: Iomed, Inc. (Enovis Corp.)
• Inventors: Lloyd, Lindsay B., Petelenz, Tomasz J., Beck, Jon E.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/762,051
• Time in Patent Office: 1,597 Days
• Field of Search: 383/210, 383/211, 222/94, 222/541.6, 222/541.9, D24/189, 602/48, 604/20, 604/87, 604/410, 604/416, 604/244, 604/890.1, 607/149-153, 424/447-449
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

The present invention provides methods and apparatus permitting rapid and thorough hydration of an initially dry hydratable matrix element contained within an iontophoretic bioelectrode. The apparatus of the invention comprises a bioelectrode system for iontophoretic delivery of medicaments having at least one hydratable matrix element and associated removable hydration assembly. The preferred embodiment of the present invention comprises two hydratable matrix elements each having an associated removable hydration assembly and each being associated with an electrical current distribution element. The removable hydration assembly includes an initially sealed liquid-storage component which maintains the desired hydrating liquid in isolation from the hydratable matrix element until such time as hydration is desired. At that time, the removable hydration assembly can be activated by the user through application of force to an extending tab member attached to the sealed liquid-storage component thereby causing progressive unsealing of the sealed liquid-storage component and progressively depositing the hydrating liquid uniformly onto the entire surface of the hydratable matrix element. Following hydration of the matrix element, the spent hydration assembly can be withdrawn completely from within the bioelectrode system.

Claims

1. A hydration assembly for use in hydrating a hydratable matrix element of an iontophoresis bioelectrode, said hydration assembly comprising:

a hydrating liquid;

hydrating liquid isolation means for maintaining said hydrating liquid in isolation from said hydratable matrix element until it is desired to hydrate the hydratable matrix element, said hydrating liquid isolation means comprising a first portion reversibly sealed to a strip element to define a liquid-storage component therebetween; and

hydration activation means for effecting progressive release of said hydrating liquid from said liquid-storage component, said hydration activation means comprising a strip extension, said strip extension having a first end and a second end, said first end being continuous with said strip element and said strip extension being folded over at said first end such that said strip extension is folded upon, adjacent to, and aligned with said strip element over substantially the entire length of said strip element, and said second end having an accessible tab member continuous with said strip extension;

wherein operation of said tab member causes progressive movement of said strip extension away from said liquid-storage component, progressive inverting of said strip element upon itself, and progressive reversing of the seal between the strip element and the first portion.

2. A hydration assembly as defined in claim 1 wherein the strip element comprises a liquid-impermeable material.

3. A hydration assembly as defined in claim 1 wherein the first portion is continuous with said strip element and said first portion is folded upon, facing, and aligned with said strip element such that said first portion, said strip element, and said strip extension are foldable positioned in a substantially flattened z-shaped configuration and said first portion is reversibly sealed to said strip element to form a pocket member having an open end, which open end is filled with hydrating liquid and, subsequently, reversibly sealed closed.

4. A hydration assembly as defined in claim 3 wherein the seal closing the open end of said pocket member is applied in a chevron-shape to permit unsealing to commence at a single point.

5. A hydration assembly as defined in claim 1 wherein the first portions and the strip element are sealed by heat.

6. A hydration assembly as defined in claim 1 wherein the first portion and the strip element are sealed with pressure sensitive adhesive.

7. A hydration assembly as defined in claim 1 wherein the first portion and the strip element are sealed by crimping.

8. A hydration assembly as defined in claim 1 wherein the first portion further comprises an end flap.

9. A hydration assembly as described in claim 1 further comprising a mounting element, said mounting element having a surface comprising said first portion of said hydrating liquid isolation means wherein said strip element is reversibly sealed to a portion of said surface to form a pocket member having an open end, which open end is filled with hydrating liquid and, subsequently reversibly sealed closed.