Microprocessor-controlled apparatus and method for detecting the coagulation of blood

• US 5,154,082 A
• Filed: 05/20/1991
• Issued: 10/13/1992
• Est. Priority Date: 05/20/1991
• Status: Expired due to Term

• Current Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Mintz, Michael D.
• Primary Examiner(s): Williams, Hezron E.
• Assistant Examiner(s): ROSKOS, JOSEPH
• Application Number:
  US07/703,288
• Time in Patent Office: 512 Days
• Field of Search: 73/64.41, 73/64.42, 73/64.43, 422/73, 436/69
• US Class Current: 73/64.41
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56

Abstract

Apparatus and method for detecting the coagulation of a sample of blood includes a ferromagnetic member, which is immersed in the blood sample and which is magnetically coupled to a reed switch, and an adjustable source of magnetic flux lines, which is also magnetically coupled to the reed switch. As the blood sample coagulates, the ferromagnetic member is displaced from the reed switch and, as a result, the magnetic field coupled to reed switch is reduced. When the ferromagnetic member reaches a predetermined displacement, the reed switch is open, which indicates that blood has coagulated. A microprocessor calibrates the reed switch by adjusting the density of the magnetic flux lines from the adjustable source such that the reed switch is open when the ferromagnetic member reaches the predetermined distance displacement.

Claims

1. A system for detecting the coagulation of blood from a liquid to a clot comprising:

adjustable-variable source means for providing magnetic flux lines having a density that varies in a time repetitive sequence and that is adjustable;

switching means, magnetically coupled to said adjustable-variable source means by said flux lines, for switching from a second state to a first state when said density of said flux lines enters a first density region;

determining means, responsive to said switching means, for determining said first density region; and

adjusting means, responsive to said determining means and operative on said adjustable-variable source means, for adjusting said density of said flux lines at a first level such that said variation causes said density of said flux lines to fall outside of said first density region, whereby non-coagulation of blood causes said switching means to switch from said second state to said first state or whereby said coagulation of blood causes said switching means not to switch from said second state.

2. A system according to claim 1, wherein said switching means switches to said second state when said density of said flux lines enters a second region, and wherein a hysteresis region is located between said first and second density regions.

3. A system according to claim 2, wherein said switching means includes a reed switch.

4. A system according to claim 3, wherein said determining means further determines said second density region of said reed switch, and wherein said adjusting means includes first setting means for setting said density of said flux lines in said second region.

5. A system according to claim 4, further including detecting means, responsive to said switching means, for detecting when said reed switch switches from said second state to said first state.

6. A system according to claim 5, further including measuring means, responsive to said detecting means, for measuring the time for blood coagulation.

7. A system according to claim 6, wherein said magnetic flux lines consists of first and second lines of flux, and wherein said adjustable-variable source means includes:

a first source, located in proximity of said reed switch, for providing said first lines of flux;

a second source for providing said second lines of flux; and

actuatable moving means for moving said second source from a first position, in which said second source is in proximity of said reed switch, to a second position, such that said density of said flux lines magnetically coupled to said reed switch is decreased, said moving means being actuated when said blood clots.

8. A system according to claim 7, wherein said second source is a permanent magnet.

9. A system according to claim 7, wherein said first source is an electromagnetic coil, wrapped around said reed switch, and wherein said system further includes waveform means for sending a waveform comprising said time repetitive sequence to said electromagnetic coil, said waveform having a low-level voltage, controlled by said first setting means to cause said density of said magnetic flux lines to enter said second density region, said waveform having an intermediate-level voltage, controlled by said second setting means to cause said density of said magnetic flux lines to be at said first level, and wherein said detecting means detects said state of said switch while said intermediate-level voltage is applied to said electromagnetic coil.

10. A system according to claim 9, wherein said waveform also has a high-level voltage, wherein said adjustable means includes third setting means for setting said high-level voltage such that said density of said magnetic flux lines is in said first density region.

11. A system according to claim 10, wherein said duration of said waveform is one second, wherein said third setting means provides said high-level voltage for 850 milliseconds, wherein said first setting means provides said low-level voltage for 75 milliseconds, and wherein said second setting means provides said intermediate-level voltage for 75 milliseconds.

12. A system according to claim 11, wherein said waveform is sent to said electromagnetic coil at a frequency of one hertz.

13. A system according to claim 12, wherein said waveform means is a digital to analog converter.

14. A system according to claim 1, wherein a microprocessor comprises said adjusting means, said determining means, said detecting means and said measuring means.

15. A system according to claim 7, wherein said actuatable moving means includes:

a test tube containing said blood, said second source being immersed in said blood; and

rotating means for rotating said test tube, whereby there is a relative rotational motion between said test tube and said second source when said blood is unclotted, and whereby said clotted blood causes said second source to move conjointly with said test tube from its said first position to its said second position.

16. A system for detecting the coagulation of blood from a liquid to a clot comprising:

a vessel containing said blood;

adjustable magnetic field means, located external said vessel, for providing an adjustable magnetic field;

permanent magnetic field means, disposed within said vessel, for providing a permanent magnetic field, which combines with said adjustable magnetic field to provide a combined magnetic field, whereby said combined magnetic field is adjusted by adjusting said adjustable magnetic field means;

switching means, magnetically coupled to said permanent magnetic field means and said adjustable magnetic field means by said combined magnetic field, for switching from a second state to a first state when said density of said combined magnetic field enters a first density region;

moving means for providing relative motion between said vessel and said permanent magnetic field means until said blood clots, whereupon said permanent magnetic field means moves with said vessel such that the density of said combined magnetic field varies in a time repetitive sequence;

determining means, responsive to said switching means, for determining said first density region; and

adjusting means, responsive to said determining means and operative on said adjustable magnetic field means, for adjusting said density of said adjustable magnetic field such that said variation causes said density of said combined magnetic field to fall outside of said first density region, whereby non-coagulation of blood causes said switching means to switch from said second state to said first state or whereby said coagulation of blood causes said switching means not to switch from said second state.

17. A method of detecting the coagulation of a sample of blood from a liquid to a clot in a system including a vessel containing said blood, adjustable magnetic field means, located external said vessel, for providing an adjustable magnetic field;

a ferromagnetic member, disposed within said vessel, for providing a permanent magnetic field, and a normally-open reed switch, magnetically coupled to said adjustable magnetic field means by said adjustable magnetic field, said method comprising the steps of;

(a) adjusting said adjustable magnetic field to a first level at which said reed switch closes;

(b) placing said ferromagnetic member in proximity of reed switch;

(c) adjusting the adjustable magnetic field to a second level at which the reed switch opens;

(d) rotating said vessel to create a relative rotational motion between said ferromagnetic member and said vessel;

(e) adjusting the adjustable magnetic field to a third level; and

(f) monitoring the state of said reed switch whereupon if said blood has coagulated the reed switch remains open.

18. A method according to claim 17, further comprising the steps of:

(e1) adjusting the density of said adjustable magnetic field to close said reed switch; and

(e2) adjusting the density of said adjustable magnetic field to allow said reed switch to open, wherein said steps (e1) and (e2) are performed prior to performing step (e), and wherein said steps (e1), (e2), (e) and (f) are repeated.

19. A method according to claim 18, wherein steps (e1), (e2) (e) and (f) are repeated at a one hertz rate.

20. A method according to claim 19, wherein said reed switch is closed for 850 milliseconds during step (e1) and opened for 75 during step (e2), and wherein said adjustable magnetic field is applied at said first level for 75 milliseconds during step (e).