Transdermal porator and patch system and method for using same

• US 9,918,665 B2
• Filed: 01/03/2014
• Issued: 03/20/2018
• Est. Priority Date: 03/11/2002
• Status: Active Grant

• Current Assignee: ​Passport Technologies, Inc.
• Original Assignee: Nitto Denko Corporation
• Inventors: McRae, Stuart, Bowerman, Wendy E., Braun, Stephen Wilson, Spiehl, Regina, Messier, Bernadette, Farquhar, David, Henkel, Erin Koch, O'Leary, Jeremiah Peter, Fisher, Mark James, Kascak, Uros, Lantz, Loren J., Novakovic, Zoran, Eppstein, Jonathan
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/147,263
• Publication Number:
  US 20150190074A1
• Time in Patent Office: 1,537 Days
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation

Abstract

A transdermal permeant delivery of at least one permeant composition into a tissue membrane of a subject including a disposable substrate having at least a portion of a bottom surface of a first release liner connected to an upper surface of the substrate and a patch having a backing layer and a reservoir that is selectively removable from the top surface of the first release liner. In a connected position, a first portion of the backing layer of the patch is releaseably mounted to a top surface of the first release liner in spaced registration with a poration area of the substrate.

Claims

1. A method of transdermal monitoring, comprising steps of:

forming at least one micropore in a tissue membrane by a microporation device, while delivering a vacuum to draw the tissue membrane; and

monitoring a subcutaneous fluid via the at least one micropore by a monitoring device;

wherein

the microporation device comprising;

a vacuum source to generate the vacuum;

a disposable substrate

defining a poration area and

having an upper substrate surface, a lower substrate surface, a conduit that extends between the upper substrate surface and the lower substrate surface;

at least one channel disposed on the upper substrate surface and in fluid communication with the conduit so that the vacuum, is delivered to the poration area via the conduit and the at least one channel;

a means for forming at least one micropore in the tissue membrane, wherein said means is mounted on the substrate, and wherein at least a portion of the means is positioned within the poration area; and

wherein the vacuum acts to draw the tissue membrane into contact with the means for forming at least one micropore, when the microporation device acts to form the at least one micropore in the tissue membrane.

2. The method of transdermal monitoring according to claim 1, wherein the monitoring device comprises a sensor for measuring a characteristic of the subcutaneous fluid.

3. The method of transdermal monitoring according to claim 2, wherein the sensor is for determining a concentration of an analyte in the subcutaneous fluid.

4. The method of transdermal monitoring according to claim 3, wherein the sensor is a glucose sensor.

6. The transdermal monitoring system according to claim 1, wherein the monitoring device comprises a sensor for measuring a characteristic of the subcutaneous fluid.

7. The transdermal monitoring system according to claim 6, wherein the sensor is for determining a concentration of an analyte in the subcutaneous fluid.

8. The transdermal monitoring system according to claim 7, wherein the sensor is a glucose sensor.

5. A transdermal monitoring system, comprising:

a microporation device adapted to form at least one micropore in a tissue membrane, while delivering a vacuum to draw the tissue membrane; and

a monitoring device adapted to monitor a subcutaneous fluid via the at least one micropore;

wherein

the microporation device comprising;

a vacuum source to generate the vacuum;

a disposable substrate

defining a poration area and

having an upper substrate surface, a lower substrate surface, a conduit that extends between the upper substrate surface and the lower substrate surface;

at least one channel disposed on the upper substrate surface and in fluid communication with the conduit so that the vacuum is delivered to the poration area via the conduit and the at least one channel;

a means for forming at least one micropore in the tissue membrane, wherein said means is mounted on the substrate, and wherein at least a portion of the means is positioned within the poration area; and

wherein the vacuum acts to draw the tissue membrane into contact with the means for forming at least one micropore, when the microporation device acts to form the at least one micropore in the tissue membrane.