Apparatus and method for determining the concentration of a component of a sample

• US 6,635,167 B1
• Filed: 11/21/2000
• Issued: 10/21/2003
• Est. Priority Date: 12/04/1997
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Svetnik, Vladimir, Wilson, Richard W., Carpenter, Greg Paul, Brothers, William, Klem, Kurt Gerard, Byrd, Nancy Kennedy, Parker, James R., Batman, Carol Jane, Hopkinson, Patricia A., Sly, Lynne Denise, Ranney, Timothy L., Davies, Robert Glenn, Glass, Marvin W., Kasle, Richard J., Vetsch, Leonard Allen, Ray, Michael Steven, Parks, Robert Anthony, Belisle, Christopher Louis, Richards, Sandy Mark
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/555,659
• Time in Patent Office: 1,064 Days
• Field of Search: 204/400, 204/403.02, 204/408, 204/406, 422/82.01, 422/50, 422/62, 422/82.05, 324/426, 324/431, 324/450, 439/786, 439/729, 439/759, 439/816, 205/775, 235/145.R
• US Class Current: 205/775
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: H01M 10/425 Structural combination with electronic components, e.g. electronic circuits integrated to the outside of the casing printed circuits H05K1/00
• CPC Class Codes: H01M 50/213 adapted for cells having curved cross-section, e.g. round or elliptic H01M50/209, H01M50/216 take precedence
• CPC Class Codes: H01M 50/247 specially adapted for portable devices, e.g. mobile phones, computers, hand tools or pacemakers
• CPC Class Codes: H01M 50/262 with fastening means, e.g. locks
• CPC Class Codes: H01M 50/269 Mechanical means for varying the arrangement of batteries or cells for different uses, e.g. for changing the number of batteries or for switching between series and parallel wiring methods or arrangements for servicing or maintenance H01M6/50, H01M10/42
• CPC Class Codes: H01M 50/284 with incorporated circuit boards, e.g. printed circuit boards [PCB]
• CPC Class Codes: H01M 50/50 Current conducting connections for cells or batteries
• CPC Class Codes: H01R 13/24 resilient; resiliently-mounted
• CPC Class Codes: Y02E 60/10 Energy storage using batteries

Abstract

An instrument (20) has a well (28a-b) for receiving a dry cell (75), an opening (78) through which a first connector (74) is exposed to the well (28a-b), and a boss (76) adjacent the opening (78). The boss (76) precludes the wrong terminal of the dry cell (75) from engaging the first connector (74) when the dry cell (75) is inserted into the well (28a-b) in incorrect orientation. A second connector (80) includes a base (81), a first leg (82) resiliently connected to and extending away from the base portion, a second leg (84) resiliently connected to and extending away from the first leg (82), and a third leg (86) resiliently connected to and extending away from the second leg (84) and toward the first leg (82). A display (42) for the instrument (20) has a lens (90) having a substantially transparent substrate with a polyurethane coating. The instrument housing has first and second portions. At least one locator pin (30) extends from one (24) of the housing portions and at least one complementary socket (32) extends from the other (22) of the housing portions for receiving the pin (30) to maintain the first (22) and second (24) portions in assembled orientation.

Claims

1. An electrical apparatus for use with an electrical cell for providing power, the cell having two terminals, the apparatus including a first connector for contacting one of the terminals and a second connector for contacting the other of the terminals when the cell is installed in the apparatus, the second connector including:

a base portion fixed in apparatus, a first generally planar leg portion resiliently connected to and extending away from the base portion, a second generally planar leg portion resiliently connected to and extending away from the base portion, and a third generally planar leg portion resiliently connected to and extending away from the second generally planar leg portion and toward the first generally planar leg portion, installation of the cell in the apparatus causing the other terminal to resiliently engage the second generally planar leg portion.

2. The electrical apparatus of claim 1 comprising an instrument for determining the concentration of a medically significant component of a biological sample.

3. The electrical apparatus of claim 1 further comprising a dry cell, the installation of the dry cell in the apparatus causing the one terminal to engage the first connector.

4. The electrical apparatus of claim 1 including a circuit board to which the base portion of the second connector is fixed.

5. The electrical apparatus of claim 1 wherein the first generally planar leg portion of the second extends away from the base portion at an angle between about five degrees and about ten degrees with respect to a line perpendicular to the base portion ad generally in a first direction, the second generally planar leg portion extends away from the first generally planar leg portion at an angle between about fifteen degrees and about twenty five degrees with respect the perpendicular line and generally in a second direction opposite to first direction, and the third generally planar leg portion extends toward the base portion at an angle of between about forty degrees and about fifty degrees with respect to the perpendicular line and generally in the first direction.

6. The electrical apparatus of claim 5 wherein the second connector comprises BeCu 190 alloy.

7. The electrical apparatus of claim 6 wherein the second connector comprises a 60/40 tin/lead plating.

8. The electrical apparatus of claim 5 wherein the radii of curvature of the portions of the second connector between the base portion and the first generally planar leg portion, the first generally planar leg portion and the second generally planar leg portion, and the second generally planar leg portion and the third generally planar leg portion are substantially constant.

9. The electrical apparatus of claim 8 wherein the third generally planar leg portion has an extension that extends away from the base portion, and wherein the radius of curvature of the portion of the second connector between the extension and the third generally planar leg portion is also substantially constant.

10. An electrical apparatus for use with an electrical cell for providing power, the cell having two terminals, the apparatus including a first connector for contacting one of the terminals and a second connector for contacting the other of the terminal when the cell is installed in the apparatus, the second connector including:

a base portion fixed in the apparatus, a first generally planar leg portion resiliently connected to and extending away from the base portion, a second generally planar leg portion resiliently connected to and extending away from the first generally planar leg portion, and a third generally planar leg portion resiliently connected to and extending away from the second generally planar leg portion and toward the first generally planar leg portion, installation of the cell in the apparatus causing the other terminal to resiliently engage the second generally planar leg portion, a well for receiving the cell, the well including an opening through which the first connector is exposed to the well, a boss adjacent the opening, the boss precluding the other terminal from engaging the first connector when the cell is inserted into the well in incorrect orientation.

11. The electrical apparatus of claim 10 comprising an instrument for determining the concentration of a medically significant component of a biological sample.

12. The electrical apparatus of claim 10 further comprising a dry cell, the installation of the dry cell in the apparatus causing the one terminal to engage the first connector.

13. The electrical apparatus of claim 10 including a circuit board to which the base portion of the second connector is fixed.

14. The electrical apparatus of claim 10 wherein the first generally planar leg portion of the second connector extends away from the base portion at an angle between about five degrees and about ten degrees with respect to a line perpendicular to the base portion and generally in a first direction, the second generally planar leg portion extends away from the first generally planar leg portion at an angle between about fifteen degrees and about twenty five degrees with respect to the perpendicular line and generally in a second direction opposite to the first direction, and the third generally planar leg portion extends toward the base portion at an angle of between about forty degrees and about fifty degrees with respect to the perpendicular line and generally in the first direction.

15. The electrical apparatus of claim 14 wherein the second connector comprises BeCu 190 alloy.

16. The electrical apparatus of claim 15 wherein the second connector comprises a 60/40 tin/lead plating.

17. The electrical apparatus of claim 14 wherein the radii of curvature of the portions of the second connector between the base portion and the first generally planar leg portion, the first generally planar leg portion and the second generally planar leg portion, and the second generally planar leg portion and the third generally planar leg portion are substantially constant.

18. The electrical apparatus of claim 17 wherein the third generally planar leg portion has an extension that extends away from the base portion, and wherein the radius of curvature of the portion of the second connector between the extension and the third generally planar leg portion is also substantially constant.

19. An apparatus for determining the concentration of a medically significant component of a biological sample, the apparatus including first and second keys for use in operating the apparatus, the keys extending from a common support mounted in the apparatus, each of the keys having a reduced cross sectional hinge portion adjacent to the common support whereby substantially independent activation of the first and second keys is provide, a third key disposed between the first and second keys for use in operating the apparatus, the third key also having a reduced cross sectional hinge portion adjacent to a second support mounted in the apparatus, the common support having a relief portion for receiving the second support such that the three keys generally define a surface when the apparatus is assembled.

20. The apparatus of claim 19 including a housing having first and second portions, the apparatus including a circuit mounted to one of the housing portions and having a set of three terminals, the apparatus further including means for securing the keys when the first and second housing portions are assembled together such that the keys, when activated, operate respective ones of the terminals.

21. The apparatus of claim 20 including a compressible member disposed between the keys and the terminals of the circuit.

22. The apparatus of claim 21 wherein the compressible member comprises a resilient pad dimensioned to isolate the terminals physically to reduce the possibility of contaminants interfering with the operation of the instrument.

23. The apparatus of claim 20 wherein the means for securing the keys comprises pins extending from the other housing portion for reception in a corresponding plurality of openings disposed in the key supports to capture the supports between the other housing portion and the circuit.

24. An apparatus for determining the concentration of a medically significant component of a biological sample, the apparatus comprising a strip and an instrument, the instrument comprising a slot through which the strip is intended to be inserted, the strip having at least one electrical contact thereon in communication with the sample, the instrument including an electrical connector for engagement with the electrical contact of the strip when the strip is inserted into the instrument for determining the concentration, the instrument including first and second housing portions, the slot being provided in one of the portions and the connector being mounted in the other of the housing portions, the other housing portion including a member fixed thereto to engage the connector resiliently when the housing portions are assembled together to promote alignment of the connector with the slot, and a circuit board mounted in the other housing portion, the electrical connector disposed on the circuit board.

25. The apparatus of claim 24 wherein the slot has a rib portion for guiding the strip when the strip is inserted into the instrument to promote engagement of the electrical contact of the strip with the electrical connector of the instrument.

26. The apparatus of claim 25 wherein the resilient engagement of the member with the connector promotes alignment of the connector with the slot generally in a first direction, the rib portions guiding the strip in a second direction generally perpendicular to the first direction.

27. An apparatus for determining the concentration of a medically significant component of a biological sample, the apparatus comprising a strip and an instrument, the instrument comprising a slot through which the strip is intended to be inserted, the strip having at least one electrical contact thereon in communication with the sample, the instrument including an electrical connector for engagement with the electrical contact of the strip when the strip is inserted into the instrument for determining the concentration, the instrument including first and second housing portions, the slot being provided in one of the housing portions and the connector being mounted in the other of the housing portions, the other housing portion including a member fixed thereto to engage the connector resiliently when the housing portions are assembled together to promote alignment of the connector with the slot, and a second member fixed to the other housing portion for resiliently engaging the connector when the housing portions are assembled together to promote alignment of the connector with the slot in cooperation with the first-mentioned member.

28. A method of operating an instrument, the instrument including a housing for at least some of the instrument components, the instrument components housed within the housing having at least first and second operating states, the instrument components evolving heat at a first time rate when the instrument is in the first operating state and at a second time rate when the instrument is in the second operating state, the instrument components including a controller, the controller keeping a record of how long the instrument is operated in each of said first and second states and calculating from the record the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states.

29. The method of claim 28 wherein the instrument components housed within the instrument include a device for producing an output indicative of temperature, the method further comprising the step of adjusting the indicated temperature based upon the calculated heating of the interior of the housing.

30. The method of claim 29 wherein the step of adjusting the indicated temperature based upon the calculated heating of the interior of the housing comprises the step of subtracting the calculated heating of the interior of the housing from the indicated temperature.

31. The method of claim 30 wherein the instrument comprises an instrument for determining the concentration of a medically significant component of a sample, the method further comprising providing a strip, providing on the instrument a port for receiving the strip, inserting the strip into the port, dosing the strip with the sample, determining an ambient temperature within the housing, adjusting the determined ambient temperature to an adjusted ambient temperature based upon the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, and determining the concentration of the medically significant component of the sample based upon the adjusted ambient temperature.

32. The method of claim 29 wherein the instrument comprises an instrument for determining the concentration of a medically significant component of a sample, the method further comprising providing a strip, providing on the instrument a port for receiving the strip, inserting the strip into the port, dosing the strip with the sample, determining an ambient temperature within the housing, adjusting the determined ambient temperature to an adjusted ambient temperature based upon the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, and determining the concentration of the medically significant component of the sample based upon the adjusted ambient temperature.

33. The method of claim 28 wherein the instrument comprises an instrument for determining the concentration of a medically significant component of a sample, the method further comprising providing a strip, providing on the instrument a port for receiving the strip, inserting the strip into the port, dosing the strip with the sample, determining an ambient temperature within the housing, adjusting the determined ambient temperature to an adjusted ambient temperature based upon the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, and determining the concentration of the medically significant component of the sample based upon the adjusted ambient temperature.

34. The method of claim 33, 32, or 31, wherein the strip contains a chemistry for reacting with the medically significant component of the sample and producing across two terminals of the strip a signal a indicative of the reaction, receiving the strip in the port and dosing of the strip enabling the determination of the concentration.

35. The method of claim 34 wherein the medically significant component is glucose and the chemistry reacts with glucose to produce at least one of a voltage and a current indicative of the glucose concentration of the sample across the terminals of the strip.

36. An instrument including a housing for at least some components of the instrument, the instrument components housed within housing having at least first and second operating states, the instrument components housed within the housing evolving heat at a first time rate when the instrument is in the first operating state and a second time rate when the instrument is in the second operating state, the instrument components including a controller for keeping a record of how long the instrument is operated in each of said first and second states and calculating from the record the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, the instrument comprising an instrument for determining the concentration of a medically significant component of a sample, the apparatus further comprising a strip for dosing with the sample, the instrument including a port for receiving the strip, the controller adjusting the determined ambient temperature to an adjusted ambient temperature based upon the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, and determining the concentration of the medically significant component of the sample based upon the adjusted ambient temperature.

37. The apparatus of claim 36 wherein the instrument components housed within the housing include a device for producing an output indicative of temperature, the controller coupled to the device for producing an output indicative of temperature for adjusting the indicated temperature based upon the calculated heating of the interior of the housing.

38. The apparatus of claim 37 wherein the controller is coupled to the device for producing an output indicative of temperature for subtracting the calculated heating of the interior of the housing from the indicated temperature.

40. The apparatus of claim 36 or 39 wherein the strip contains a chemistry for reacting with the medically significant component of the sample and at least two strip terminals, the port including at least two complementary instrument terminals, the strip terminals making contact with respective instrument terminals when the strip is inserted into the port, the chemistry reacting with the medically significant component of the sample to produce across at least two of the strip terminals a signal indicative of the reaction, receiving the strip in the port and dosing of the strip enabling the determination of the first concentration.

41. The apparatus of claim 40 wherein the medically significant component is glucose and the chemistry reacts with glucose to produce at least one of a voltage and a current indicative of the glucose concentration of the sample across the strip terminals.

39. An instrument including a housing for at least some of the instrument components of the instrument, the instrument components housed within the housing having at least first and second operating states, the instrument components housed within the housing evolving heat at a first time rate when the instrument is in the first operating state and at a second time rate when the instrument is in the second operating state, the instrument components including a controller for keeping a record of how long the instrument is operated in each of said first and second states and calculating from the record the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, the instrument components housed within the housing including a device for producing an output indicative of temperature, the controller coupled to the device for producing an output indicative of temperature for adjusting the indicated temperature based upon the calculated heating of the interior of the housing, the instrument comprising an instrument for determining the concentration of a medically significant component of a sample, the apparatus further comprising a strip for dosing with the sample, the instrument including a port for receiving the strip, the controller adjusting the determined ambient temperature to an adjusted ambient temperature based upon the heating of the interior of the housing resulting from the operation of the instrument in each of said first and second states, and determining the concentration of the medically significant component of the sample based upon the adjusted ambient temperature.

42. The apparatus of claim 39 wherein the controller is coupled to the device for producing an output indicative of temperature for subtracting the calculated heating of the interior of the housing from the indicated temperature.

43. An instrument for determining the concentration of a medically significant component of a sample, the instrument including a controller and a power supply for providing power to the controller, the power supply including one or more cells for providing direct current at a first voltage, an inductance and a first solid state switch in series across the one or more cells, the controller providing a first switching signal for the first switch, a first rectifier and a first capacitance in a second circuit for rectifying and storing the voltage variations appearing across one of the first switch and inductance, the second circuit storing voltage variations of a first polarity appearing across one of the first switch and inductance and the third circuit storing voltage variations of a second and opposite polarity appearing across one of the first switch and inductance.

44. The apparatus of claim 43 further comprising a transistor-transistor logic-to-RS-232 (TTL-to-RS-232) interface, the TTL-to-RS-232 interface being coupled across the second circuit and the third circuit.

45. The apparatus of claim 43 further comprising a third rectifier and a third capacitance, the second and third rectifiers and the second and third capacitances in a fourth circuit configured as a voltage multiplier.

46. The apparatus of claim 43 further comprising a second switch in circuit with the first capacitance, the controller further providing a second switching signal for the second switch.

47. The apparatus of claim 46 wherein the second switch comprises a second solid state device for regulating the voltage across the first capacitance when the second switch is in a first state, the second solid state device halting regulation of the voltage across the first capacitance when the second switch is in a second state.

48. The apparatus of claim 43, 44, 45, 46 or 47 wherein the first switching signal is pulsewidth modulated.

49. An instrument for determining the concentration of a medically significant component of a sample, the instrument including a first key for selecting a function from a group of at least two functions, a second key, a controller for assigning to the second key the function selected from a group of at least two functions by the first key, and a display for displaying for the user an assignment by the controller of the function to the second key, a strip for dosing with the sample, the instrument including a port for receiving the strip to enable the instrument to determine the concentration of the medically significant component of the sample, the strip containing a chemistry for reacting with the medically significant component of the sample and a pair of strip terminals, the port including a complementary pair of instrument terminals, the strip terminals making contact with respective instrument terminals when the strip is inserted into the port, the chemistry reacting with the medically significant component of the sample to produce across the pair of strip terminals a signal indicative of the reaction, receiving the strip in the port and dosing of the strip enabling the determination of the first concentration.

50. The apparatus of claim 49 wherein the instrument comprises a hand held instrument for determining the glucose concentration of the sample.

51. A hand held instrument for determining the glucose concentration of a sample, the instrument including a first key for selecting a function from a group of at least two functions, a second key, a controller for assigning to the second key the function selected from a group of at least two functions by the first key, and a display for displaying for the user an assignment by the controller of the function to the second key, a strip for dosing with sample, the instrument including a port for receiving the strip to enable the instrument to determine the glucose concentration of the sample.

52. A hand held instrument for determining the glucose concentration of a sample, the instrument including a first key for selecting a function from a group of at least two functions, a second key, a controller for assigning to the second key the function selected from a group of at least two functions by the first key, and a display for displaying for the user an assignment by the controller of the function to the second key, a strip containing a chemistry for reacting with glucose in the sample, the instrument including a port for receiving the strip and a device for assessing the reaction of the chemistry with glucose in the sample and for producing a signal indicative of assessment, receiving the strip in the port and dosing of the strip enabling the determination of the glucose concentration of the sample.

53. An electrical apparatus for use with an electrical cell for providing power, the cell having two terminals, the apparatus including a first connector for contacting one of the terminals and a second connector for contacting the other of the terminals when the cell is installed in the apparatus, the second connector including:

a base portion fixed in the apparatus, a first generally planar leg portion resiliently connected to and extending away from the base portion at an angle between about five degrees and about ten degrees with respect to a line perpendicular to the base portion and generally in a first direction, a second generally planar leg portion resiliently connected to and extending away from the first generally planar leg portion at an angle between about fifteen degrees and about twenty five degrees with respect to the perpendicular line and generally in a second direction apposite to the first direction, the second generally planar leg portion also extending away from the base portion, and a third generally planar leg portion resiliently connected to and extending away from the second generally planar leg portion and toward the first generally planar leg portion, the third generally planar leg portion extending toward the base portion at an angle of between about forty degrees and about fifty degrees with respect to the perpendicular line and generally in the first direction, installation of the cell in the apparatus causing the other terminal to resiliently engage the second generally planar leg portion.

54. The electrical apparatus of claim 53 wherein the second connector comprises BeCu 190 alloy.

55. The electrical apparatus of claim 54 wherein the second connector comprises a 60/40 tin/lead plating.

56. The electrical apparatus of claim 53 wherein the radii of curvature of the portions of the second connector between the base portion and the first generally planar leg portion, the first generally planar leg portion and the second generally planar leg portion, and the second generally planar leg portion and the third generally planar leg portion are substantially constant.

57. The electrical apparatus of claim 56 wherein the third generally planar leg portion has an extension that extends away from the base portion, and wherein the radius of curvature of the portion of the second connector between the extension and the third generally planar leg portion is also substantially constant.