On-Patient Autonomous Blood Sampler and Analyte Measurement Device

• US 20150182157A1
• Filed: 12/30/2013
• Published: 07/02/2015
• Est. Priority Date: 12/30/2013
• Status: Abandoned Application

• Current Assignee: CardioCanary, Inc.
• Original Assignee: CardioCanary, Inc.
• Inventors: Boriah, Varun, Damani, Ramesh, Chua, Beelee
• Application Number:
  US14/143,918
• Publication Number:
  US 20150182157A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1477 non-invasive
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: A61B 5/6849 : in combination with a needle set
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The invention relates to systems, apparati, and methods for real-time diagnostics to detect and diagnose disease conditions in patients. In an embodiment, the apparatus is attached to a patient, takes samples of the patient'"'"'s blood, allows real-time detection of markers in the patient'"'"'s blood, and provides rapid diagnosis of the patient.

Claims

1. A wearable apparatus for diagnosis of a patient, the apparatus comprising:

a biosensor module with an individual spring-loaded skin puncturing element;

an electromechanical actuator to release the spring-loaded skin puncturing element at a programmed time;

a mechanism for moving a sample from a sampling chamber to a sensing chamber;

a mechanism for introducing a buffer and a reagent into the sensing chamber;

a mechanism for collecting a waste product;

a wireless data transceiver capable of receiving an authentication signal and capable of sending a processed biosensor data;

at least one diagnosis algorithm that uses the biosensor data to perform a rapid diagnosis of the patient; and

an onboard computer that controls a release of the skin puncturing element, an operation of the biosensor;

the data processing, and the data transmission.

2. The apparatus of claim 1, further comprising at least two additional biosensor modules each with an individual spring-loaded skin puncturing element.

3. The apparatus of claim 1, wherein the biosensor detects a biochemical marker for a disease condition.

4. The apparatus of claim 1, further comprising an electronic display showing a status of a measurement, the biosensor data, and a patient data.

5. The apparatus of claim 3, wherein the housing comprises a means for wireless transmission of a data obtained from the sensor.

6. The apparatus of claim 5, further comprising at least one temperature sensor to compensate for a temperature variation in an electrochemical measurement.

7. The apparatus of claim 6, further comprising at least one microprocessor programmed with a temperature compensation algorithm that uses a temperature data to adjust a calculation of the biosensor data.

8. The apparatus of claim 7, further comprising at least one audible alarm and at least one visual alarm for an adverse event.

9. The apparatus of claim 8, further comprising a skin adhesive wherein the skin adhesive is on the underside of the apparatus between the skin and the apparatus.

10. The apparatus of claim 9, wherein the skin adhesive has cutouts at a location where the skin puncturing element can puncture a skin.

11. The apparatus of claim 5, further comprising at least one motion sensor to determine an orientation of the apparatus.

12. The apparatus of claim 11, wherein the motion sensor is selected from the group consisting of an accelerometer and a gyroscope.

13. A method for diagnosis of a patient, the method comprising the steps of:

contacting a wearable apparatus to a patient'"'"'s skin, wherein the apparatus comprises an onboard computer, a wireless transceiver, a skin puncturing element, a sample chamber, a biosensor module, and a waste reservoir;

inputting a patient information into the onboard computer;

receiving an authentication signal at the apparatus via the wireless transceiver;

releasing the skin puncturing element at a programmed time to puncture the skin;

collecting a blood sample from the punctured skin in the sample chamber of the apparatus;

transporting the blood sample from the sample chamber into the biosensor module;

deploying a reagent in the biosensor module and routing an excess of the blood sample into the waste reservoir;

measuring a marker concentration in the biosensor module;

transmitting a biosensor data from the apparatus; and

running at least one diagnosis algorithm that uses the biosensor data to perform a rapid diagnosis of the patient.

14. The method of claim 13, wherein the apparatus further comprises a plurality of skin puncturing elements wherein each of the skin puncturing elements is spring loaded.

15. The method of claim 13, wherein the marker is measured electrochemically.

16. The method of claim 13, wherein the biosensor further comprises a optical measuring apparatus, and wherein the marker is measured optically by the optical measuring apparatus.

17. The method of claim 13, wherein the apparatus further comprises at least one additional skin puncturing element.

18. The method of claim 17, wherein the additional skin puncturing elements are released to puncture the skin at predetermined time intervals, and wherein at least one additional blood sample is collected from the additional skin′

punctures, transported, analyzed for the marker, and the diagnosis algorithm utilizes the marker data obtained from each blood sample to perform the diagnosis of the patient.

19. An on patient apparatus for diagnosis of a patient, the apparatus comprising:

a biosensor module and a waste reservoir;

an electromechanical mechanism capable of piercing a stratum corneum at a scheduled time;

a mechanism for moving a sample from a sampling chamber to a sensing chamber;

a mechanism for introducing a buffer and a reagent into the sensing chamber;

a wireless data transceiver capable of receiving an authentication signal and capable of sending a processed biosensor data;

at least one diagnosis algorithm that uses the biosensor data to perform a diagnosis of the patient; and

an onboard computer that controls the electromechanical mechanism, an operation of the biosensor;

the data processing, and the data transmission.