Computerized system for blood chemistry monitoring

• US 8,956,321 B2
• Filed: 02/26/2010
• Issued: 02/17/2015
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: Ideal Medical Technologies, Inc.
• Original Assignee: Ideal Medical Technologies, Inc.
• Inventors: DeJournett, Leon
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/713,934
• Publication Number:
  US 20100217238A1
• Time in Patent Office: 1,817 Days
• Field of Search: 604/890.1, 604/503, 604/66, 604/67, 600/316, 600/365, 600/368
• US Class Current: 604/66
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An apparatus and computerized method of intravenously monitoring a patient'"'"'s blood chemistry transmits real time measurements to an electronically controlled closed loop system that auto-regulates blood osmolality and glucose level with medications infused through a catheter designed for such purpose. The closed loop system utilizes a glucose algorithm and an osmolality algorithm implemented in hardware and software to control the flow of dextrose, insulin and hypertonic saline to a patient in an effort to achieve better patient outcomes in instances of trauma, surgery and medical illnesses.

Claims

1. A computerized glucose adjustment system for intravenously controlling a patient'"'"'s blood chemistry on a real time basis, said system comprising:

a glucose sensor measuring a patient'"'"'s glucose level;

a pump connected to a source of insulin and a source of dextrose for distributing insulin and dextrose into a patient'"'"'s bloodstream;

a computer processor in electronic communication with said sensor and said pump, said processor receiving an electronic signal from said sensor for calculating the patient'"'"'s real time average glucose level over a specified time period;

a glucose control module stored in said processor, said glucose control module (i) determining where the patient'"'"'s real time average blood glucose level lies along a continuum of glucose values;

(ii) tracking a rate at which the average blood glucose level is changing over time and (iii) iteratively adjusting the dextrose flow rate and insulin flow rate into the patient'"'"'s body to adjust the real time average glucose level closer to a known normal glucose range by sending output signals to said pump and controlling a pump rate at which said pump distributes insulin and dextrose into the patient, wherein the real time average blood glucose level calculated in the processor is a running average (Xa) over a specified time period, wherein the computer processor records a prior running average blood glucose level (Xb) for a prior time period previous to a just completed specified time period, wherein the glucose control module compares the running average glucose level (Xa) to the prior running average glucose level (Xb) to track a real time average blood glucose level rate of change, wherein said glucose control module comprises pump controlling commands divided into categories, that determine an extent to which a dextrose flow rate and an insulin flow rate from said pump are adjusted; and

wherein said processor assigns each running average blood glucose level (Xa) to one of said categories by grouping (A) a difference between a most recently calculated running average blood glucose value (Xa) and a range of Xmin to Xmax;

(B) said real time average blood glucose level rate of change;

(C) a value of a previous weight-based insulin flow rate; and

(D) a value of a previous weight-based dextrose flow rate, and wherein said processor groups A, B, C, and D each time a new average glucose level Xa is calculated, and

wherein said glucose control module determines an extent to which a dextrose flow rate and an insulin flow rate from said pump are adjusted by said pump controlling commands in said one of said categories.

2. A computerized glucose adjustment system according to claim 1, further comprising a catheter distributing insulin and dextrose into a patient'"'"'s bloodstream, wherein said glucose sensor is positioned on said catheter and positioned within the patient'"'"'s bloodstream.

3. A computerized glucose adjustment system according to claim 1, wherein said glucose sensor is positioned within the patient'"'"'s subcutaneous tissues.

4. A computerized glucose adjustment system according to claim 1, wherein said glucose sensor is in an extracorporeal position.

5. A computerized glucose adjustment system according to claim 1, wherein said dextrose flow rate is a function of the patient'"'"'s weight in kilograms.

6. A computerized glucose adjustment system according to claim 1, wherein said insulin flow rate is a function of the patient'"'"'s weight in kilograms.

7. A computerized glucose adjustment system according to claim 1, wherein said processor accepts as an input an initial concentration of said dextrose.

8. A computerized glucose adjustment system according to claim 1, wherein said processor accepts as an input an initial concentration of said insulin.

9. A computerized glucose adjustment system according to claim 7, wherein said initial concentration of said dextrose is selected from the group consisting of 5, 10, 12.5, 15, 20, and 25 in percent weight per volume.

10. A computerized glucose adjustment system according to claim 1, wherein said glucose control module operates continuously on a real time basis with updated glucose measurements.

11. A computerized glucose adjustment system according to claim 1, wherein a user sets said known normal glucose range between Xmin and Xmax, the system further comprising a “

Low Glucose”

alarm set point and a “

High Glucose”

alarm set point both of which are set by medical personnel.

12. A computerized glucose adjustment system according to claim 11, wherein said glucose control module calculates and stores said average blood glucose level Xa in units of milligrams per deciliter over said specified time period.

13. A computerized glucose adjustment system according to claim 12, wherein said glucose control module calculates and stores blood glucose value Xt in milligrams per deciliter every 30 seconds and calculates the average glucose level Xa in milligrams per deciliter over said specified time period equal to 10 minutes.

14. A computerized glucose adjustment system according to claim 13, wherein said pump controlling commands are divided into categories defined by glucose value ranges along a glucose value continuum.

15. A computerized glucose adjustment system, according to claim 14, wherein said pump controlling command category is selected from the group consisting of:

Category 1;

Xa−

Xmin←

10 mg/dl;

Category 2;

−

10≦

Xa−

Xmin←

5 mg/dl

Category 3;

−

5≦

Xa−

Xmin<

0 mg/dl

Category 4;

0≦

Xa−

Xmin<

(Xmax−

Xmin)/3

Category 5;

Xmax−

Xmin)/3≦

Xa−

Xmin<

2(Xmax−

Xmin)/3

Category 6;

2(Xmax−

Xmin)/3≦

Xa−

Xmin<

Xmax−

Xmin

Category 7;

0≦

Xa−

Xmax<

10

Category 8;

10≦

Xa−

Xmax<

30

Category 9;

Xa−

Xmax≧

30.

16. A computerized glucose adjustment system according to claim 15, wherein said controller calculates the category for the current average glucose measurement Xa.

17. A computerized glucose adjustment system according to claim 16, wherein said controller compares a current glucose measurement Xa to a prior average glucose measurement Xb to determine the rate at which the average glucose level is changing.

18. A computerized glucose adjustment system according to claim 16, wherein said controller compares a current glucose measurement Xa to a prior glucose measurement Xc to determine the rate at which the average glucose level is changing over an extended time period.

19. A computerized glucose adjustment system according to claim 17, wherein said pump controlling commands adjust said pump output to control the flow rates of insulin (INSf) and dextrose (Dexf) according to the category in which the current glucose measurement fits and the rate at which the glucose level is changing.

20. A computerized glucose adjustment system according to claim 16, wherein for each category, the next insulin (INSfn) and next dextrose (Dexfh) flow rates are adjusted for condition Xa−

Xb (mg/dl), wherein said condition is selected from the group consisting of Xa−

Xb≦

−

15;

−

15<

Xa−

Xb≦

3; and

Xa−

Xb>

3.

21. A computerized glucose adjustment system according to claim 20, wherein the value for Xa−

Xb is selected from the group consisting of;

a) Xa−

Xb≦

−

15 mg/dL

b) Xa−

Xb>

−

15 mg/dL

c) Xa−

Xb≦

−

6 mg/dL

d) Xa−

Xb>

−

6 mg/dL

e) Xa−

Xb>

−

6 and ≦

0 mg/dL

f) Xa−

Xb≦

−

5 mg/dL

g) Xa−

Xb>

−

5 and ≦

0 mg/dL

h) Xa−

Xb≦

−

4 mg/dL

i) Xa−

Xb>

−

4 mg/dL and ≦

1 mg/dL

j) Xa−

Xb<

−

3 mg/dL

k) Xa−

Xb≦

−

3 mg/dL

l) Xa−

Xb≧

−

3 mg/dL

m) Xa−

Xb>

−

3 mg/dL

n) Xa−

Xb≧

3 mg/dL and ≦

1 mg/dL

o) Xa−

Xb>

−

3 mg/dL and ≦

0 mg/dL

p) Xa−

Xb>

−

3 mg/dL and ≦

3 mg/dL

q) Xa−

Xb<

−

2 mg/dL

r) Xa−

Xb≦

−

2 mg/dL

s) Xa−

Xb≧

−

2 mg/dL

t) Xa−

Xb>

−

2 mg/dL and ≦

3 mg/dL

u) Xa−

Xb<

−

1 mg/dL

v) Xa−

Xb≧

−

1 mg/dL

w) Xa−

Xb<

0 mg/dL

x) Xa−

Xb≦

0 mg/dL

y) Xa−

Xb≦

0 and >

−

4 mg/dL

z) Xa−

Xb≧

0 mg/dL

aa) Xa−

Xb>

0 mg/dL

bb) Xa−

Xb≦

1 mg/dL

cc) Xa−

Xb>

1 mg/dL

dd) Xa−

Xb≦

2 mg/dL

ee) Xa−

Xb>

2 mg/dL

ff) Xa−

Xb>

3 mg/dL.

22. A computerized glucose adjustment system according to claim 20, wherein said pump controlling commands adjust said next insulin (INSfn) and next dextrose (Dexfn) flow rates as a function of the previous insulin (INSfp) and dextrose (Dexfp) flow rates within said specified time period.

23. A computerized glucose adjustment system according to claim 21, wherein said previous insulin flow rate (INSfp) is selected from the group consisting of:

(i) INSfp=0 units/hour;

(ii) INSfp>

0 units/hour;

(iii) 0<

INSfp≦

(0.01*Wt) units/hour

(iv) INSfp<

(0.05*Wt) units/hour

(v) 0<

INSfp≦

(0.02*Wt) units/hour;

(vi) 0<

INSfp≦

(0.05*Wt) units/hour

(vii) 0<

INSfp<

(0.05*Wt) units/hour

(viii) 0<

INSfp≦

(0.1*Wt) units/hour

(ix) INSfp>

(0.01*Wt) units/hour

(x) (0.01*Wt) units/hour<

INSfp≦

(0.1*Wt) units/hour;

(xi) INSfp>

(0.02*Wt) units/hour

(xii) (0.02*Wt) units/hour<

INSfp≦

(0.1*Wt) units/hour

(xiii) INSfp>

(0.05*Wt) units per hour;

(xiv) INSfp≧

(0.05*Wt) units per hour

(xv) INSfp>

(0.1*Wt) units/hour, wherein the value of Wt is the patient'"'"'s weight in kilograms.

24. A computerized glucose adjustment system according to claim 21, wherein the initial concentration of said dextrose solution is C, and said previous dextrose flow rate (DEXfp) is selected from the group consisting of:

(i) DEXfp=0;

(ii) DEXfp>

0 mL/hour;

(iii) 0 mL/hour<

DEXfp≦

(1/C*Wt) mL/hour;

(iv) 0 mL/hour<

DEXfp ((2/C)*Wt) mL/hour;

(v) DEXfp>

(1/C*Wt) mL/hour;

(vi) (1/C*Wt) mL/hour<

DEXfp≦

((6/C)*Wt) mL/hour;

(vii) ((2/C)*Wt) mL/hour<

DEXfp≦

((6/C)*Wt) mL/hour;

(viii) ((2/C)*Wt) mL/hour<

DEXfp

(ix) DEXfp>

((6/C)*Wt) mL/hour, wherein the value of Wt is the patient'"'"'s weight in kilograms.

25. A computerized glucose adjustment system according to claim 20, wherein said controller activates an alarm if the differential between Xa and Xb is greater than 25 or less than −

25 mg/dL.

26. A computerized glucose adjustment system according to claim 20 further comprising a secondary controller for adjusting the output of said glucose control module by multiplying the next insulin flow rate INSfn by a secondary adjustment factor.

27. A computerized glucose adjustment system according to claim 1, further compromising a secondary controller for adjusting a cycle time for algorithm data collection and for calculating a rate at which the average blood glucose level changes from one specified time period to the next.