Flexible Apparatus and Method for Monitoring and Delivery

• US 20090308742A1
• Filed: 06/14/2006
• Published: 12/17/2009
• Est. Priority Date: 12/09/2005
• Status: Active Grant

• Current Assignee: Cambridge Medical Technologies, LLC, Medina Isf Equity, LLC
• Original Assignee: Flexible Medical Systems, LLC
• Inventors: Paranjape, Makarand
• Granted Patent: US 8,333,874 B2
• Time in Patent Office: Days
• US Class Current: 204/403.100
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4547 Evaluating teeth
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention generally relates to a system and method that co-locates in a small flexible, configurable system and multi-level substrate sampling, rapid analysis, bio-sample storage and delivery functions to be performed on living tissues or matter obtained from living organisms. The types of the sampling may include chemical, biochemical, biological, thermal, mechanical, electrical, magnetic and optical sampling. In general, the analysis performed at the point of sampling measures the sample taken and records its value. The bio-sample storage function encapsulates a small sample of analyte and preserves it for subsequent examination or analysis, either on the organism by the system or at a remote location by an independent analysis system. Once stored, the sample can provide a record of a biological state at the precise time of sampling. The delivery at the point of sampling can include chemical, biochemical, thermal, mechanical, electrical, magnetic and optical stimuli.

Claims

1-132. -132. (canceled)

133. A method of manufacturing a device for analyzing a property of a substance, the method comprising:

obtaining a flexible substrate;

depositing at least one metallization layer on the flexible substrate, wherein said at least one metallization layer forms a plurality of electrodes; and

selectively depositing a polymer matrix on a selected electrode of the plurality of electrodes.

134. The method of claim 133, wherein selectively depositing said polymer matrix comprises selectively applying an electrochemical potential to the selected electrode in the presence of the polymer matrix.

135. The method of claim 133, wherein said polymer matrix comprises a bioactive molecule selected from the group consisting of enzymes, antibodies, cells, and DNA.

136. The method of claim 133, further comprising treating the device to improve adhesion of the metallization layer to the flexible substrate.

137. The method of claim 133, further comprising forming the flexible substrate, wherein forming the flexible substrate comprises stacking multiple polymeric layers.

138. The method of claim 137, further comprising forming one or more micro-capillary holes in a plurality of the polymeric layers, such that the micro-capillary holes of adjacent ones of the polymeric layers are aligned.

139. The method of claim 137, further comprising:

forming a cavity or opening in at least one of the multiple polymeric layers; and

enclosing the cavity or opening with at least one other polymeric layer.

140. The method of claim 139, further comprising depositing a delivery material in the cavity.

141. The method of claim 139, wherein the delivery material is a biochemical or a calibration standard.

142. The method of claim 133, further comprising forming a plurality of nanostructures on a surface of at least one of the plurality of electrodes.

143. The method of claim 133, wherein forming a plurality of nanostructures comprises forming an array of nanotubes.

144. The method of claim 133, further comprising forming a micro-heater on the surface of the device.

145. The method of claim 144, wherein the micro-heater is configured to generate a temperature sufficient to disrupt the stratum corneum without ablating the cells.

146. The method of claim 133, further comprising depositing a layer of a piezoelectric material onto the substrate.

147. The method of claim 133, further comprising encapsulating the selected electrode in a protective membrane, wherein the membrane is selected from the group consisting of selectively permeable membranes and non-permeable reactive membranes.

148. A sensor for sensing a property of a substance comprising a biomolecule, the sensor comprising:

a flexible substrate; and

a pair of electrodes supported by the substrate, the pair of electrodes comprising;

a reference electrode, and

a working electrode being electrochemically activated and configured to react with the biomolecule.

149. The sensor of claim 148, further comprising a plurality of nanostructures supported on a surface of the working electrode.

150. The sensor of claim 149, wherein the nanostructures are selected from the group consisting of nanowires and nanotubes.

151. The sensor of claim 149, wherein the nanostructures comprise a polymer matrix, the polymer matrix comprising an electrically conductive polymer and one or more bioactive molecules.

152. The sensor of claim 151, wherein the bioactive molecules are selected from the group consisting of enzymes, antibodies, cells, and DNA.

153. The sensor of claim 152, further comprising:

a cavity within the substrate;

a protective membrane sealing the cavity; and

a resistive element disposed between the reference and working electrodes, the resistive element being configured to disrupt the protective membrane to provide access to the cavity.

154. The sensor of claim 153, wherein the working and reference electrodes are at least partially disposed within the cavity.

155. The sensor of claim 153, further comprising one or more piezoelectric detection devices disposed within the cavity.

156. The sensor of claim 153, further comprising a delivery material contained within the cavity.

157. The sensor of claim 153, wherein the delivery material is selected from the group consisting of a chemical, a drug, a biomolecule a protein, a peptide, and a genetic material.

158. The sensor of claim 148, wherein the substrate comprises one or more micro-capillary holes.

159. The sensor of claim 148, wherein the substrate comprises a multilayer polymeric metal laminate structure.

160. The sensor of claim 148, wherein the substrate includes a piezoelectric material configured for measuring a deformation of the sensor.

161. The sensor of claim 148, wherein at least the working electrode is encapsulated in a protective membrane, wherein the membrane is selected from the group consisting of selectively permeable membranes and non-permeable reactive membranes.

162. A method for filling a cavity in a support layer of a delivery device, the method comprising:

positioning a seal layer having a hole therein on a support layer such that the hole is positioned above a cavity in the support layer;

delivering a material into the cavity through the hole in the seal layer;

displacing the seal layer laterally relative to the support layer such that the hole is moved away from the cavity and the cavity is covered by the seal layer; and

bonding the seal layer to the support layer.

163. The method of claim 162, wherein filling the cavity comprises:

positioning a carrier having a reservoir and a hole therein relative to the seal layer such that the hole in the carrier is substantially aligned with the hole in the seal layer; and

filling the reservoir with the material so that the material flows from the reservoir and through the hole in the carrier and the hole in the seal layer and fills the cavity.

164. The method of claim 162, wherein the support layer comprises at lease one capillary hole that is substantially parallel to the cavity, and wherein positioning the seal layer relative to the support layer comprises moving the seal layer so as to align the hole in the seal layer with the capillary hole in the support layer.