Sensing Patch Applications

• US 20130261409A1
• Filed: 11/30/2010
• Published: 10/03/2013
• Est. Priority Date: 11/30/2010
• Status: Abandoned Application

• Current Assignee: Avery Dennison Corporation
• Original Assignee: Avery Dennison Corporation
• Inventors: Pathak, Srikant, Edwards, David N.
• Application Number:
  US13/990,452
• Publication Number:
  US 20130261409A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/1118 Determining activity level
• 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 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/0246 characterised by the skin-adhering layer
• CPC Class Codes: A61F 2013/00429 for conducting tests
• CPC Class Codes: A61F 2013/00565 : with hook and loop-type fastener connecting means
• CPC Class Codes: A61F 2013/00604 : Multilayer
• CPC Class Codes: A61F 2013/0094 : for sensing physical parameters
• CPC Class Codes: A61F 2013/8473 : for diagnostic purposes

Abstract

Various methods, devices and systems for patch based physical, physiological, chemical, and biochemical sensors that diagnose and monitor disease states are described. The patch based sensors provide a panel of specific analyte parameters that determine one or more physiological conditions and/or the level of healing progression of a wound. The use of such analyte panels in local or remote monitoring of parameters related to various disease states is also described.

Claims

1. A wound healing indicator device comprising:

a functional layer, wherein the functional layer determines the level of at least one specific parameter from wound exudates and provides an indication as to the status of a wound healing process.

2. The wound healing indicator device of claim 1, further comprising a carrier layer.

3. The wound healing indicator device of claim 1, further comprising a sampling layer.

4. The wound healing indicator device of claim 3, wherein the sampling layer operates through at least one of an electrophoretic mechanism, an electrokinetic mechanism, a capillary effect, a pressure driven mechanism, and combinations thereof.

5. The wound healing indicator device of claim 1, wherein the at least one specific parameter includes concentration of chemical or biochemical agents associated with at least one of bacteria, inflammation cytokines, proteases, growth factors, ECM receptors, pH, iconicity, NO_x/O₂, temperature, integrins, and combinations thereof.

6. The wound healing indicator device of claim 1, wherein the status of the wound healing process is indicated through at least one of a color change, a digital display, and combinations thereof.

7. The wound healing indicator device of claim 6, wherein the color change is provided by use of at least one of a coulometric assay, a luminescence assay, an electrochemical assay, and combinations thereof.

8. The wound healing indicator device of claim 1, further comprising a handheld device, wherein the status of the wound healing process is received by the handheld device.

9. The wound healing indicator device of claim 8, wherein the handheld device sends information as to the status of the wound healing process to a medical monitoring facility wirelessly or through internet.

10. The wound healing indicator device of claim 1, wherein the wound healing indicator device is included in a wound care bandage.

11. A wound healing indicator patch adapted for attachment to a user, the patch comprising a wound healing indicator device, wherein the wound healing indicator device comprises:

a functional layer, wherein the functional layer determines the level of at least one specific parameter from wound exudates and provides an indication as to the status of a wound healing process.

12. The wound healing indicator patch of claim 11, further comprising at least one sensor for sensing physical characteristics associated with the user, the physical characteristics including at least one of heart rate, respiration rate, blood pressure, ECG, oxymetry, beat, activity, sleep pattern and combinations thereof.

13. The wound healing indicator patch of claim 11, further comprising a carrier layer.

14. The wound healing indicator patch of claim 13, further comprising fastening means.

15. The wound healing indicator patch of claim 14, wherein the fastening means is selected from the group consisting of a pressure sensitive adhesive, an activatable adhesive, a physical fastening means, and combinations thereof.

16. The wound healing indicator patch of claim 11, further comprising at least one of a medication and a healing modality.

17. A method of monitoring a wound healing status of a patient with a wound area, the method comprising the steps of:

applying a wound healing patch with a wound healing indication device on the wound area;

selectively activating the wound healing indication device; and

reading the results from the wound healing indication device.

18. The method of claim 17, further comprising:

sending the results to a medical monitoring facility through wireless or internet communication.

19. The method of claim 18, further comprising:

releasing medication to the wound area.

20. The method of claim 18, further comprising:

receiving advice through wireless or internet communication.

21. A method of monitoring compliance of a patient having a wound, the method comprising:

applying a wound sensing device on the wound; and

financially rewarding or penalizing the patient according to the degree of patient compliance.

22. A wound healing indicator device comprising:

a functional layer adapted for positioning on a wound;

a colored film strip disposed on the functional layer, the strip including at least a first region having a first color and a second region having a second color different than the first color.

23. The wound healing indicator of claim 22 wherein the strip includes a wound location region for placement over the wound, and the first region is located between the wound location and the second region.

24. The wound healing indicator of claim 22 further comprising a standard indicator line positioned alongside at least a portion of the colored film strip.

25. The wound healing indicator of claim 22 wherein the functional layer includes at least one functional component.

26. The wound healing indicator of claim 25 wherein the functional component reacts selectively with relevant analytes in the wound.

27. The wound healing indicator of claim 26 wherein the functional component triggers an indication component to provide indication as to wound healing.

28. The wound healing indicator of claim 25 wherein the functional component responds to at least one factor selected from the group consisting of proteases, bacterial load, inflammation cytokines, biofilm presence, moisture content, integrins, chemokines, growth factor receptors, level of Ca²⁺/Mg²⁺, NO_x/O₂, pH, temperature, and combinations thereof.

29. A wound healing indicator device comprising:

a sampling layer including a wound location region for placement over a wound, a microfluidic sample channel, and a sample port extending between the wound location region and the microfluidic sample channel;

a means for establishing a pressure gradient in the channel upon placement of the indicator device over a wound.

30. The wound healing indicator device of claim 29 wherein the means for establishing a pressure gradient includes a tab in communication with the microfluidic sample channel, wherein upon placement of the indicator device over a wound and removal of the tab from the sample channel, a pressure gradient forms in the sample channel.

31. The wound healing indicator device of claim 29 wherein the means for establishing a pressure gradient is selected from physical rupture of a wall of the microfluidic sample channel, and applying an electric field across the microfluidic sample channel to induce transport of charged particles across the sample channel.

32. The wound healing device of claim 29 further comprising a plurality of microfluidic sample channels in the sampling layer, each sample channel configured to direct wound exudates to a different analyte test site.

33. The wound healing device of claim 32 further comprising a plurality of sampling ports, each sampling port disposed between the wound location region and a corresponding microfluidic sample channel.

34. The wound healing device of claim 32 further comprising a single sample port providing communication between the wound location region and the plurality of microfluidic sample channels.

35. The wound healing device of claim 29 further comprising a plurality of test sites each in communication with the microfluidic sample channel and the plurality of test sites arranged sequentially along the sample channel.

36. The wound healing device of claim 35 wherein the plurality of test sites include immobilized receptors for detecting one or more analytes.

37. The wound healing device of claim 29 further comprising a plurality of test sites and a plurality of microfluidic sample channels, wherein each sample channel provides communication between the wound location region and a corresponding test site.

38. The wound healing device of claim 37 wherein the plurality of test sites include immobilized receptors for detecting one or more analytes.