DEVICE AND METHOD FOR AUTOMATICALLY SAMPLING AND MEASURING BLOOD ANALYTES

• US 20110137208A1
• Filed: 07/23/2009
• Published: 06/09/2011
• Est. Priority Date: 07/24/2008
• Status: Abandoned Application

• Current Assignee: Admetsys Corporation
• Original Assignee: Admetsys Corporation
• Inventors: Valk, Timothy Walter
• Application Number:
  US13/055,207
• Publication Number:
  US 20110137208A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• 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 5/15119 comprising shape memory alloys
• CPC Class Codes: A61B 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The present invention includes a device and method used for automated sampling and measurement of blood analytes, such as blood glucose, from a subject patient. The blood sampling and measurement may be performed automatically by the device on a patient without requiring user intervention or supervision. The sampling and measuring device comprises a sensor unit operably attached to a replaceable cartridge. The replaceable cartridge provides a disposable body that contains a number of lancets and test strips used for collecting and analyzing a blood sample. The sensor unit contains an actuator and microcontroller that fires the lancet and collects blood sample data from the test strips. The blood sampling and measurement process may be initiated by an external controller or may be autonomously initiated in a specific interval. A further embodiment involves integration and use of the sampling and measurement device within an automated monitoring and treatment system.

Claims

1. An automated device for sampling and measuring blood analytes, comprising:

a sensor unit structured to be positioned on a patient body, the sensor unit including electronic circuitry, lancet firing means, and variable pressure control means; and

a replaceable cartridge having a plurality of consumable products disposed therein, the consumable products including one or more lancets and one or more test strips for measuring a blood analyte of the patient;

wherein the replaceable cartridge and the sensor unit are structured to temporarily mate with one another via an attachment means such that the replaceable cartridge is removable from the sensor unit;

wherein the electronic circuitry enables automated blood extraction and analysis of a blood analyte from the patient body iteratively over time without need for manual intervention; and

wherein the automated blood extraction and analysis is performed through electronically controlled use of the variable pressure control means, the lancet firing means, the one or more lancets, and the one or more blood test strips.

2. The automated device of claim 1, wherein the sensor unit comprises an upper portion and a lower portion operably connected thereto.

3. The automated device of claim 2, wherein the upper portion and the lower portion of the sensor unit is configured to be positioned around a finger of the patient, to obtain a blood analyte measurement from a measurement site at a tip of the finger of the patient.

4. The automated device of claim 1, wherein the sensor unit is adjustable during positioning of the sensor unit upon the patient body.

5. The automated device of claim 1, wherein the lancet firing means provided by the sensor unit comprises an actuator, a tension spring, and an actuator carriage enclosed within an actuator casing.

6. The automated device of claim 1, wherein the lancet firing means includes an actuator, and wherein depth of lancet actuation is adjustable for the one or more lancets individually or in combination.

7. The automated device of claim 1, wherein the automated device automatically applies anesthetic or analgesic solution to skin proximate to a measurement site of the patient prior to firing of the one or more lancets.

8. The automated device of claim 1, wherein the sensor unit further comprises an electronic contact used to read a test strip provided by the replaceable cartridge during automated blood analysis.

9. The automated device of claim 1, wherein the replaceable cartridge provides a plurality of reaction areas, each reaction area containing a lancet and a test strip deployed for obtaining a single blood sample.

10. The automated device of claim 9, further comprising a barrier structure comprising a combination of an absorbent material and a material non-permeable to blood arranged around each reaction area, and wherein the barrier structure separates the consumable products of the replaceable cartridge from the sensor unit.

11. The automated device of claim 1, wherein the replaceable cartridge contains electronic circuitry to provide status of the consumable products.

12. The automated device of claim 1, wherein the blood analyte is selected from the group consisting of triglycerides, total cholesterol, HDL-cholesterol, fibrinogen, hemoglobin, ferritin, and glucose.

13. The automated device of claim 1, wherein the blood analyte is glucose, and wherein the one or more test strips comprise one or more glucose test strips.

14. The automated device of claim 1, wherein the electronic circuitry is connected to a remote controller.

15. The automated device of claim 1, wherein the electronic circuitry includes a microcontroller.

16. The automated device of claim 15, wherein a set of electronic instructions causes the microcontroller to initiate the sequence iteratively within the electronic circuitry over a period of time.

17. The automated device of claim 15, wherein a remote controller causes the microcontroller to initiate the sequence within the electronic circuitry upon request.

18. An automated device for sampling and measuring a blood analyte of a patient, comprising:

a sensor unit structured to be positioned adjacent a measurement site of a patient, the sensor unit including an upper portion and a lower portion operably connected thereto, the sensor unit including an lancet firing means; and

a replaceable cartridge in mating relationship with the sensor unit via an attachment means such that the replaceable cartridge is removable from the sensor unit, the replaceable cartridge housing a plurality of consumable products disposed therein for producing a blood sample, the consumable products including one or more lancets and one or more test strips for measuring the blood analyte of the patient;

a microcontroller and electronic circuitry operably coupled to the sensor unit and capable of controlling use of the lancets and test strips relative to the measurement site; and

a set of electronic instructions executable by the microcontroller such that upon execution, the electronic instructions causes the microcontroller to initiate a sequence comprising selecting a lancet for deployment at a measurement site, firing the lancet to obtain a blood sample from the measurement site, and collecting a blood sample from the measurement site onto a test strip;

wherein the microcontroller receives inputs from the test strip to determine the blood analyte and further wherein the electronic instructions causes the microcontroller to initiate the sequence without the need for manual intervention.

19. The automated device of claim 18, wherein the sensor unit further contains the microcontroller, the electronic circuitry, and a variable pressure control means.

20. The automated device of claim 18, wherein the sensor unit is structured to be positioned around the finger of a patient.

21. The automated device of claim 18, wherein the sensor unit is adjustable during positioning of the sensor unit adjacent the measurement site of the patient.

22. The automated device of claim 18, wherein the lancet firing means provided by the sensor unit comprises an actuator, a tension spring, and an actuator carriage enclosed within an actuator casing.

23. The automated device of claim 18, wherein the lancet firing means includes an actuator, and wherein depth of lancet actuation is adjustable for the one or more lancets individually or in combination.

24. The automated device of claim 18, wherein the automated device automatically applies anesthetic or analgesic solution to skin proximate to the measurement site prior to firing the lancet.

25. The automated device of claim 18, wherein the sensor unit further comprises an electronic contact used to read the test strip provided by the replaceable cartridge during automated blood analysis.

26. The automated device of claim 18, wherein the replaceable cartridge provides a plurality of reaction areas, each reaction area containing a lancet and a test strip deployed for obtaining a single blood sample.

27. The automated device of claim 26, further comprising a barrier structure comprising a combination of an absorbent material and a material non-permeable to blood arranged around each reaction area, and wherein the barrier structure separates the consumable products of the replaceable cartridge from the sensor unit.

28. The automated device of claim 18, wherein the replaceable cartridge contains electronic circuitry to provide status of the consumable products.

29. The automated device of claim 18, wherein the blood analyte is selected from the group consisting of triglycerides, total cholesterol, HDL-cholesterol, fibrinogen, hemoglobin, ferritin, and glucose.

30. The automated device of claim 18, wherein the blood analyte is glucose, and wherein the one or more test strips comprise one or more glucose test strips.

31. The automated device of claim 18, wherein the microcontroller is connected via a communications interface to a remote controller.

32. The automated device of claim 31, wherein the remote controller causes the microcontroller to initiate execution of the sequence within the electronic circuitry upon request.

33. An automated system for monitoring blood analytes of a patient, comprising:

a sampling and measurement device structured to be positioned adjacent a measurement site of a patient, the device housing a replaceable supply of consumable products including a plurality of lancets and a plurality of test strips for the measurement of blood analytes;

a microcontroller operably coupled to the sampling and measurement device and capable of controlling the plurality of lancets and plurality of test strips relative to the measurement site; and

a set of electronic instructions executable by the microcontroller such that upon execution, the electronic instructions causes the microcontroller to initiate a sequence comprising selecting a lancet and test strip for use at the measurement site, firing the lancet to obtain a blood sample from the measurement site, collecting a blood sample from the measurement site; and

depositing the blood sample onto the test strip;

wherein the microcontroller processes a electrochemical reaction from the test strip to determine the level of blood analytes and further wherein the electronic instructions causes the microcontroller to initiate the sequence without the need for manual intervention.

34. The automated system of claim 33, wherein the device comprises a sensor unit and a replaceable cartridge.

35. The automated system of claim 33, wherein the replaceable cartridge houses the consumable products.

36. The automated system of claim 33, wherein the electronic instructions for initiating the sequence are executed by the microcontroller upon command by an external controller.

37. The automated system of claim 33, wherein multiple blood sampling and measurement devices are linked to each other via a communications interface to obtain measurements from a plurality of measurement sites.

38. The automated system of claim 33, further comprising a monitoring device connected to a communications interface of the blood sampling and measurement device.

39. The automated system of claim 38, wherein the monitoring device controls initiation of measurements taken by the blood sampling and measurement device.

40. The automated system of claim 33, further comprising a treatment control device connected to a communications interface of the blood sampling and measurement device.

41. The automated system of claim 40, wherein the treatment control device controls initiation of measurements taken by the blood sampling and measurement device.

42. The automated system of claim 40, wherein the treatment control device automatically administers treatment to the patient based on the results obtained from the sampling and measuring device.

43. The automated system of claim 42, wherein the treatment to the patent includes automated infusion of one or more agents used to modify levels of blood analytes in the patient.

44. The automated system of claim 33, further comprising a monitoring and treatment system connected to the sampling and measuring device, wherein the monitoring and treatment system includes an intelligent control device and a multi-channel delivery device for providing an automated and controlled intravenous delivery of medications to affect the blood analyte levels in the patient.

45. A method for deploying an automated device for sampling and measuring blood analytes from a patient, comprising:

positioning an automated sampling and measuring device proximate to a measurement site on a patient, the sampling and measuring device configured to obtain blood analyte measurements from blood samples initiated with an automated process;

providing a set of replaceable materials to the automated sampling and measuring device, the set of replaceable materials including a plurality of reactive areas, each reactive area including one or more lancets and one or more test strips;

performing an automated blood analyte sampling and measurement using a blood sample obtained from the measurement site, the blood sample introduced to one of the plurality of the reactive areas provided to the automated sampling and measuring device; and

automatically repeating the step of performing a blood analyte measurement using a unused reactive area from the plurality of reactive areas, thereby performing a new blood analyte sampling and measurement at the measurement site without user intervention.

46. The method of claim 45, wherein during the automated blood analyte sampling and measurement the automated sampling and measuring device performs the steps of:

applying pressure proximate to the measurement site on the patient;

firing the one or more lancets to obtain the blood sample from the measurement site;

collecting the blood sample from the measurement site onto the one or more test strips;

retracting the one or more lancets from the measurement site;

electrochemically analyzing the one or more test strips; and

obtaining a blood analyte measurement from the electrochemical analysis of the one or more test strips.

47. The method of claim 46, further comprising executing a set of electronic instructions within the automated sampling and measuring device to perform the sampling and measurement steps.

48. The method of claim 46, further comprising automatically applying an anesthetic or analgesic solution to skin proximate to the measurement site prior to firing the one or more lancets.

49. The method of claim 45, further comprising verifying existence of an unused reactive area prior to performing a blood analyte sampling and measurement.

50. The method of claim 45, further comprising querying a status of the replaceable materials prior to performing a blood analyte sampling and measurement.

51. The method of claim 45, further comprising verifying placement of the automated sampling and measuring device at a valid measurement site prior to performing a blood analyte measurement.

52. The method of claim 45, wherein the blood analyte is selected from the group consisting of triglycerides, total cholesterol, HDL-cholesterol, fibrinogen, hemoglobin, ferritin, and glucose.

53. The method of claim 45, wherein the automated sampling and measuring device comprises a sensor unit including electronic circuitry and a microcontroller for conducting the automated performance of the blood analyte sampling and measurement.

54. The method of claim 53, wherein the microcontroller is connected via a communications interface to an external controller for initiating the automated performance of the blood analyte sampling and measurement.

55. The method of claim 53, wherein automatically repeating the step of performing a blood analyte measurement occurs by execution of a set of electronic instructions causing the microcontroller to initiate the blood analyte measurement iteratively over a period of time.

56. A method for sampling and measuring of blood analytes from a patient with an automated device, comprising:

affixing an automated sampling and measuring device to a patient, the sampling and measuring device accessing a supply of consumable products including a plurality of lancets and a plurality of test strips; and

executing a set of electronic instructions by a microcontroller within the sampling and measuring device, the execution of the electronic instructions causing the microcontroller to initiate a sequence for sampling and measuring a level of a blood analyte with the sampling and measuring device, the sequence including;

applying pressure proximate to a measurement site on the patient;

firing a lancet to obtain a blood sample from the measurement site;

exposing a test strip to the blood sample from the measurement site; and

obtaining an electrochemical measurement of the blood analyte level from the test strip;

wherein the set of electronic instructions for initiating the sampling and measuring the blood analyte level are executed by the microcontroller iteratively over a period of time or upon request, thereby enabling the sampling and measuring device to perform a series of automated sampling and measuring events without need for manual intervention.

57. The method of claim 56, wherein pressure proximate to the measurement site is removed after collecting a blood sample to prevent additional bleeding at the measurement site.

58. The method of claim 56, wherein pressure proximate to the measurement site is applied after collecting a blood sample to prevent additional bleeding at the measurement site.

59. The method of claim 56, wherein the sequence for sampling and measuring a level of a blood analyte further includes automatically applying an anesthetic or analgesic solution to skin proximate to the measurement site prior to firing the lancet.

60. The method of claim 56, wherein the sequence for sampling and measuring a level of a blood analyte further includes retracting the lancet from the measurement site.

61. The method of claim 56, further comprising verifying test supplies before executing the sequence.

62. The method of claim 61, wherein exhaustion of the consumable products is reported if test supplies are not verified.

63. The method of claim 56, wherein the request causing the initiation of a sequence for sampling and measuring is provided by a remote device connected via a communications interface to the microcontroller.

64. The method of claim 56, wherein the blood analyte is selected from the group consisting of triglycerides, total cholesterol, HDL-cholesterol, fibrinogen, hemoglobin, ferritin, and glucose.