Wearable iontophoresis system

• US 5,458,569 A
• Filed: 06/08/1993
• Issued: 10/17/1995
• Est. Priority Date: 06/08/1993
• Status: Expired due to Term

• Current Assignee: Vyteris, Inc.
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pandorf, Robert P., Cohen, Ellen R., Kirk, Karl D. III, Toleman, James R.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/073,923
• Time in Patent Office: 861 Days
• Field of Search: 604/20, 607/149, 607/151
• US Class Current: 604/20
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

A wearable iontophoresis system includes a control housing having a connector and an iontophoretic drug delivery patch for placement against the skin of a patient. The patch has a device for retaining the control housing connector which permits the connector to be removably attached to the patch. The control housing also has at least a power supply device and a current delivery device. The control housing has top and bottom surfaces wherein the top surface has raised, recessed and sloping regions. The thickness of the connector is tapered from a second end to a first end. Furthermore, the second end of the connector is attached to the control housing and oriented so that the first end is unattached to the control housing and proximate to the control housing bottom surface. The iontophoretic drug delivery patch includes top and bottom surfaces wherein mounted to the top surface is the device for retaining the control housing connector. The control housing connector retaining device has first and second open ends and a cavity for placement therein of the connector. The taper of the connector permits it to be easily inserted through one of the first and second open ends and into the control housing connector retaining device cavity.

Claims

1. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient comprising:

a control housing containing at least power supply means for providing electric power and current delivery means for providing electric current, the control housing having top and bottom surfaces and connector means, the connector means having first and second ends defining a connector length, the connector means second end being attached and the connector means first end being unattached to the control housing, the connector means having top and bottom surfaces, at least one of the top and bottom surfaces being attached to the control housing, the connector means having a thickness defined by the connector means top and bottom surfaces; and

an iontophoretic drug delivery patch for placement against the skin of a patient, the iontophoretic drug delivery patch being flexible and including top and bottom surfaces, the top surface of the patch having connector retaining means for retaining the control housing connector, the connector retaining means being defined by a substantially planar base portion and a non-planar top portion, the non-planar top portion being attached to the planar base portion, the non-planar top portion and planar base portion defining a connector retaining means cavity, the connector retaining means cavity having first and second open ends, the first and second open ends having substantially the same size aperture, the aperture of the first and second ends and the cross section of the connector retaining means cavity having a size suitable for at least partial placement of the connector means therein.

2. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 1 wherein one of the control housing and connector means includes first and second electrical contacts coupled to the current delivery means and power supply means, and wherein the iontophoretic drug delivery patch includes third and fourth electrical contacts, and wherein when the first end of the connector means of the control housing is at least partially inserted within one of the first and second open ends of the connector retaining means, the first and second electrical contacts of the control housing are respectively coupled to the third and fourth electrical contacts of the patch.

3. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 2 wherein the iontophoretic drug delivery patch includes first and second electrodes, the iontophoretic drug delivery patch including ionic medication holding means for containing ionic medication situated in relation to the first electrode such that ionic medication held by the ionic medication holding means is in electrical communication with the first electrode, the iontophoretic drug delivery patch including electrolyte holding means for containing electrolyte situated in relation to the second electrode such that an electrolyte held by the electrolyte holding means is in electrical communication with the second electrode, the third and fourth electrical contacts respectively being in electrical communication with the first and second electrodes.

4. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 3 further comprising a target area, the target area being located on the top surface of the iontophoretic drug delivery patch, the target area corresponding to and identifying the position and orientation of the first electrode on the bottom surface of the patch, the first electrode corresponding to the region of the iontophoretic drug delivery patch which delivers the ionic medication.

5. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 4 wherein the target area is defined by the connector retaining means.

6. A wearable iontophoretic drug delivery system as defined by claim 4 wherein the color of the target area is substantially distinct from the color of the top surface of the iontophoretic drug delivery patch.

7. A wearable iontophoretic drug delivery system for delivering medication to fan applied area of a patient as defined by claim 3 wherein when the third and fourth electrical contacts of the iontophoretic drug delivery patch are respectively electrically coupled to the first and second electrical contacts of the control housing, electrical signals can be provided from the control housing to the first and second electrodes of the iontophoretic drug delivery patch so as to induce ionic medication to leave the ionic medication holding means and infuse the skin of the patient.

8. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 2 wherein the non-planar top portion of the connector retaining means includes interior and exterior surfaces, and wherein the third and fourth electrical contacts are located on the interior surface of the non-planar top portion of the iontophoretic drug delivery patch, and wherein the first and second electrical contacts are located on the top surface of the connector means such that when the first end of the connector means is at least partially inserted within one of the first and second open ends, the first and second electrical contacts are electrically coupled to the third and fourth electrical contacts.

9. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 2 wherein the non-planar top portion of the connector retaining means includes interior and exterior surfaces, and wherein the third and fourth contacts are located on the exterior surface of the non-planar top portion of the iontophoretic drug delivery patch, and wherein the first and second electrical contacts are located on the bottom surface of the control housing such that when the first end of the connector means is at least partially inserted within one of the first and second open ends, the first and second electrical contacts are electrically coupled to the third and fourth electrical contacts.

10. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 2 wherein the third and fourth electrical contacts are located on the substantially planar base portion of the connector retaining means, the third and fourth electrical contacts being located within the connector retaining means cavity of the iontophoretic drug delivery patch, and wherein the first and second electrical contacts are located on the bottom surface of the connector means of the control housing such that when the connector means is at least partially inserted within one of the first and second open ends, the first and second electrical contacts are coupled to the third and fourth electrical contacts.

11. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 2 wherein the connector means has a first thickness at the first end and a second thickness at the second end, the second thickness being greater than the first thickness, the connector means thickness being tapered along the length of the connector means from the second end to the first end, the thickness of the connector means as compared to the size of the first and second open ends is such that when the first end of the connector means is inserted through one of the first and second open ends into the connector retaining means cavity, the size of the respective open end restricts the connector means from being inserted into the cavity past a point where the first and second electrical contacts are electrically coupled to the third and fourth electrical contacts.

12. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 3, the iontophoretic drug delivery patch further including a third electrode, the electrolyte holding means being situated in relation to the third electrode such that the electrolyte held by the electrolyte holding means is in electrical communication with the third electrode, the iontophoretic drug delivery patch having a sixth electrical contact in electrical communication with the third electrode, the control housing having a fifth electrical contact,

wherein when the first end of the connector means is inserted within one of the first and second open ends of the connector retaining means cavity, the fourth and sixth electrical contacts of the iontophoretic drug delivery patch are respectively electrically coupled to one of the second and fifth electrical contacts of the control housing and connector means.

13. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 11 wherein the iontophoretic drug delivery patch further comprises a second electrolyte holding means for containing electrolyte situated in relation to the third electrode such that an electrolyte held by the second electrolyte holding means is in electrical communication with the third electrode.

14. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 11 wherein the first, second and third electrodes are located on the bottom surface of the iontophoretic drug delivery patch.

15. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 11 wherein the second and third electrodes of the iontophoretic drug delivery patch are symmetric about the first electrode.

16. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 1 wherein the control device top surface includes raised, recessed and sloping portions, the raised portion and recessed portion being substantially parallel and non-coplanar with each other, the sloping portion coupling the raised portion and the recessed portion of the control device top surface.

17. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 1 wherein the connector means has a first thickness at the first end and a second thickness at the second end, the second thickness being greater than the first thickness wherein the connector means thickness tapers along the length of the connector means from the second end to the first end.

18. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 1 wherein the non-planar top portion of the connector retaining means has an arch-like shape.

19. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 1, the control housing further comprising an on/off switch coupled to the power supply means for activating and deactivating the power supply means.

20. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 19, the control housing further comprising first indicator means coupled to the on/off switch for denoting when the wearable iontophoretic drug delivery device is operating.

21. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 19, the control housing further comprising second indicator means for denoting when the wearable iontophoretic drug delivery device has completed delivery of the ionic medication.

22. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 20, the control housing further comprising third indicator means for denoting when one of the third and fourth electrical contacts of the iontophoretic drug delivery patch is respectively improperly coupled to one of the first and second electrical contacts of the control housing and connector means.

23. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 19 wherein the first indicator means is located on the top surface of the control device, the first indicator means extending along the top surface of the control device from the raised portion across the sloping portion to the recessed portion so that the first indicator means is visible from an orientation which is substantially perpendicular to the top surface of the control device and from at least one orientation which is substantially parallel to one of the raised and recessed portions of the top surface of the control device.

24. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 19 wherein the on/off switch is circumferentially located on the control device at a position which is distal with respect to both the first and second ends of the connector means.

25. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 1 further comprising attachment means for securing the iontophoretic drug delivery patch to the applied area of the patient.

26. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient as defined by claim 25 wherein the attachment means comprises adhesive material provided to the bottom surface of the iontophoretic drug delivery patch, the adhesive means permitting the iontophoretic drug delivery patch to be secured to the skin of the patient.

27. A wearable iontophoretic drug delivery system for delivering medication to an applied area of a patient for delivering medication to an applied area of a patient as defined by claim 1 wherein the iontophoretic drug delivery patch further includes a middle section and first and second end sections, each section of the patch having a width, the width of the middle section being substantially uniform, the first and second end sections each having a tapered width from a point proximate to the middle section to an end of the patch distal to the middle section.