Biological Sample Collection Device and System

• US 20140066726A1
• Filed: 03/08/2012
• Published: 03/06/2014
• Est. Priority Date: 03/11/2011
• Status: Abandoned Application

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Costello, Benedict
• Application Number:
  US14/004,395
• Publication Number:
  US 20140066726A1
• Time in Patent Office: Days
• US Class Current: 600/302
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150091 by electricity
• 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 5/150984 Microneedles or microblades
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting

Abstract

A biological sample collection device includes a top cover plate, a bottom portion attached to the top cover plate, the bottom portion comprising a remotely-analyzable biological sample collection portion to collect a biological sample from a body of a subject. The biological sample is to be analyzed at a remote processing facility at a later time. A fastening portion is provided on the bottom portion to affix the remotely-analyzable biological sample collection device to the body of the subject. A real time clock is coupled to the top cover plate and a memory is coupled to the top cover plate and electrically coupled to the real time clock. The remotely-analyzable biological sample collection device may further include a processing unit, at least two electrodes coupled to the processing unit, and a transbody conductive communication module. Additionally, a remotely-analyzable biological sample collection device communication system includes a wireless communication device configured to communicate with a communication device external to the patient.

Claims

1. A biological sample collection device, comprising:

a top cover plate;

a bottom portion attached to the top cover plate, the bottom portion comprising a remotely-analyzable biological sample collection portion to collect a biological sample from a body of a subject, wherein the biological sample is to be analyzed at a remote processing facility at a later time;

a fastening portion provided on the bottom portion to affix the remotely-analyzable biological sample collection device to the body of the subject;

2. The biological sample collection device of claim 1, comprising a real time clock coupled to the top cover plate.

3. The biological sample collection device of claim 2, comprising a memory coupled to the top cover plate and electrically coupled to the real time clock.

4. The biological sample collection device of claim 3, wherein the memory coupled to the real time clock is operative to time-stamp when the biological sample collection device is applied to the body of the subject

5. The biological sample collection device of claim 1, wherein the remotely-analyzable biological collection portion comprises a sorbent material.

6. The biological sample collection device of claim 5, wherein the sorbent material comprises an adsorbent material.

7. The biological sample collection device of claim 5, wherein the sorbent material comprises an absorbent material.

8. The biological sample collection device of claim 1, wherein the remotely-analyzable biological collection portion comprises an adhesive material.

9. The biological sample collection device of claim 1, wherein the remotely-analyzable biological collection portion comprises at least one micro-needle.

10. The biological sample collection device of claim 1, wherein the remotely-analyzable biological collection portion comprises a color indicator to indicate a presence or absence of a substance.

11. The biological sample collection device of claim 1, wherein the fastening portion comprises an adhesive material.

12. The biological sample collection device of claim 1, comprising:

at least two electrodes; and

an electronic module to extract fluids from the body of the subject via reverse electrophoresis and drive the biological sample from the body of the subject into the sample collection portion.

13. The biological sample collection device of claim 1, comprising:

a framework comprising a first and second dissimilar materials to generate an operational voltage when exposed to a conductive fluid when the biological collection device is applied to the body of the subject.

14. A biological sample collection system, comprising:

a top cover plate;

a bottom portion attached to the top cover plate, the bottom portion comprising a remotely-analyzable biological sample collection portion to collect a biological sample from the subject to be analyzed at a remote processing facility at a later time;

a fastening portion provided on the bottom portion to affix the remotely-analyzable biological sample collection device to the body of the subject;

a processing unit;

at least two electrodes coupled to the processing unit, the at least two electrodes configured to contact skin of a subject; and

a transbody conductive communication module coupled to the processing unit and the at least two electrodes, the transbody conductive communication module operative to detect and gather physiological information from the subject in the form of an electric current flow through the at least two electrodes at a first frequency, wherein the current flow at the first frequency is associated with a device associated with the subject.

15. The biological sample collection system of claim 14, comprising:

a physiological sensing module coupled to the processing unit and the at least two electrodes, the physiological sensing module operative to sense physiological information from the subject in the form of electric current flow through the at least two electrodes at the second frequency, wherein the second frequency current flow is associated with the physiology of the subject.

16. The biological sample collection system of claim 14, comprising:

a wireless communication module coupled to the processing unit operative to communicate information from the remotely-analyzable biological collection device to a communication device external to the subject.

17. The biological sample collection system of claim 14, wherein the remotely-analyzable biological sample collection portion comprises a sorbent material.

18. The biological sample collection system of claim 14, wherein the remotely-analyzable biological sample collection portion comprises an adhesive material.

19. The biological sample collection system of claim 14, wherein the remotely-analyzable biological sample collection portion comprises at least one micro-needle.

20. The biological sample collection system of claim 14, wherein the remotely-analyzable biological sample collection portion comprises a color indicator to indicate a presence or absence of a substance.

21. A biological sample collection system, comprising:

a top cover plate;

a bottom portion attached to the top cover plate, the bottom portion comprising a remotely-analyzable biological sample collection portion to collect a biological sample from the subject to be analyzed at a remote processing facility at a later time;

a fastening portion provided on the bottom portion to affix the remotely-analyzable biological sample collection device to the body of the subject;

a processing unit;

at least two electrodes coupled to the processing unit, the at least two electrodes configured to contact skin of a subject;

a transbody conductive communication module coupled to the processing unit and the at least two electrodes, the transbody conductive communication module operative to detect and gather physiological information from the subject in the form of an electric current flow through the at least two electrodes at a first frequency, wherein the current flow at the first frequency is associated with a device associated with the subject;

a physiological sensing module coupled to the processing unit and the at least two electrodes, the physiological sensing module operative to sense physiological information from the subject in the form of electric current flow through the at least two electrodes at a second frequency, wherein the current flow at the second frequency is associated with the physiology of the subject; and

a wireless communication module coupled to the processing unit operative to communicate information from the biological collection device to a communication device external to the subject.

22. The biological sample collection system of claim 21, wherein the transbody conductive communication module is configured to receive communications from an ingestible event marker located inside the body of the subject.

23. The biological sample collection system of claim 21, wherein the physiological sensing module is configured to receive communications from a device embedded in the body of the subject.

24. The biological sample collection system of claim 22, wherein the wireless communication module is configured to communicate data obtained from the ingestible event marker.

25. The biological sample collection system of claim 24, wherein the wireless communication module is configured to receive data providing for subject directed permissions.