Medical devices for contemporaneous decision support in metabolic control

• US 6,582,366 B1
• Filed: 12/21/2001
• Issued: 06/24/2003
• Est. Priority Date: 04/10/1998
• Status: Active Grant

• Current Assignee: Porumbescu Aureliu M
• Original Assignee: Proactive Metabolics Company
• Inventors: Porumbescu, Aureliu M.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): ASTORINO, MICHAEL C
• Application Number:
  US10/029,909
• Time in Patent Office: 550 Days
• Field of Search: 600/300-301, 600/345, 600/347, 600/365, 600/310, 600/316, 128/903, 128/904, 128/897-898, 128/920, 128/923
• US Class Current: 600/300
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

The invention addresses hardware and software products capable to make contemporaneous accurate predictions regarding how a person'"'"'s biological system will respond to a series of stimuli. The predictions can be communicated in real time, enabling confirmation if good control status, need for corrective action, planning future actions, or even outside intervention in case of emergency. Also addressed by the invention is a family of diagnostic hardware base on intelligent optoelectronic sensors that incorporate one or more Wedge-and-Strip Position-Sensitive Photo-Detectors optimized for probabilistic real time evaluation of spectroscopy data from living subjects.

Claims

1. A medical device comprising a personal assistive apparatus that computes the bio-availability of exogenous glucose and other nutrients contained in food, comprising:

(a) an interface and control device that accepts user inputs, time stamps said inputs, and provides information for the assessment and control of ongoing metabolic states for an individual user;

(b) a data storage device containing an addressable food database and software, wherein each entry in said food database is decomposed into elementary food categories;

(c) a data storage device containing a plurality of coefficient values and time functions, wherein said coefficients and time functions describe the expected variation in time of one or more metabolites in vivo;

(d) software and a means for computing and storing predicted input time functions;

wherein one of said plurality of said time functions comprises the general formula;

2. The medical device according to claim 1, further comprising a hierarchical software structure, wherein said hierarchical software can be programmed with a prescription and wherein said hierarchical software limits the type and extent of actions a patient is allowed to take.

3. The medical device according to claim 2, wherein said output value is blood glucose.

4. The medical device according to claim 2, further comprising a means for presenting to the user, through a user interface, a color-coded or pictorial representation of the time course of said output value, wherein said color-coded or pictorial representation enables a user to assess how a new action taken will modify the user'"'"'s future metabolic status.

5. The medical device according to claim 4, further comprising a means for alerting the user whenever predicted output parameter values fall outside a prescribed range.

6. The medical device according to claim 4, wherein said output value is blood glucose.

7. The medical device according to claim 5, wherein said output value is blood glucose.

8. The medical device according to claim 1, further comprising a means for determining current values for at least one output parameter, wherein said current values are input by an individual patient or downloaded from an instrument measuring the concentration of said output value.

9. The medical device according to claim 1, further comprising a means to compute and store functions indicating the degree of control achieved by the individual patient over a period of time.

10. The personal assistive apparatus for contemporaneous metabolic control of claim 1, further comprising at least one of the following devices:

(a) an insulin infusion pump;

(b) blood glucose meter;

(c) a modem for communicating with other computers;

(d) wireless communication means for emergency situations;

(e) a meter that can test both glucose and fructosamine in the blood;

(f) a non-invasive blood glucose meter;

(g) a minimally-invasive blood glucose meter; and

/or a transdermal glucose measurement system;

or

(h) an optical spectroscopy apparatus.

11. The medical device according to claim 10, further comprising software that calculates the cross-correlation between serum glucose and serum fructosamines and estimates the instantaneous time gradient of blood glucose.

12. The medical device according to claim 1, wherein said plurality of time functions include:

13. The medical device according to claim 12, wherein b=1.0 for regular insulin, b=0.5 for NPH insulin, b=0.25 for lente insulin, and b=0.2 for ultralente insulin.

14. The medical device according to claim 1, wherein

a=12 for all sugars, a=1/1.5 for starchy glucose, a=1/2 for starchy galactose, a=1/3 for starchy fructose, a=1/5 for protein, and a=1/8 for fats or “

a”

is a population averaged value or is specific for an individual;

b=1.0 for regular insulin, b=0.5 for NPH insulin, b=0.25 for lente insulin, and b=0.2 for ultralente insulin or “

b”

is a population averaged value or is specific for an individual; and

N=1 to 5 or N=4.

15. The medical device according to claim 14, wherein a =12 for all sugars, a=1/1.5 for starchy glucose, a=1/2 for starchy galactose, a=1/3 for starchy fructose, a=1/5 for protein, and a=1/8 for fats.

16. The medical device according to claim 14, wherein “

a”

is a population averaged value or is specific for an individual.

17. The medical device according to claim 14, wherein “

b”

is a population averaged value or is specific for an individual.

18. The medical device according to claim 14, wherein N=1 to 5.

19. The medical device according to claim 14, wherein N=4.

20. The medical device according to claim 14, wherein b=1.0 for regular insulin, b=0.5 for NPH insulin, b=0.25 for lente insulin, and b=0.2 for a lente insulin.

21. The medical device according to claim 1, wherein

a=12 for all sugars, a=1/1.5 for starchy glucose, a=1/2 for starchy galactose, a=1/3 for starchy fructose, a=1/5 for protein, and a=1/8 for fats or “

a”

is a population averaged value or is specific for an individual;

b=1.0 for regular insulin, b=0.5 for NPH insulin, b=0.25 for lente insulin, and b=0.2 for ultralente insulin or “

b”

is a population averaged value or is specific for an individual; and

N=1 to 5 or N=4.

22. The medical device according to claim 21, wherein a =12 for all sugars, a=1/1.5 for starchy glucose, a=1/2 for starchy galactose, a=1/3 for starchy fructose, a=1/5 for protein, and a=1/8 for fats.

23. The medical device according to claim 21, wherein “

a”

is a population averaged value or is specific for an individual.

24. The medical device according to claim 21, wherein “

b”

is a population averaged value or is specific for an individual.

25. The medical device according to claim 21, wherein N=1 to 5.

26. The medical device according to claim 21, wherein N=4.

27. The medical device according to claim 21, wherein b=1.0 for regular insulin, b=0.5 for NPH insulin, b=0.25 for lente insulin, and b=0.2 for a lente insulin.

28. The medical device according to claim 1, wherein said user is selected from the group consisting of an astronaut, pancreatic transplant patients, beta-cell transplant patients, newly diagnosed diabetic patients, trauma patients, epileptic patients, patients in intensive care, premature infants, and performance athletes.

29. The medical device according to claim 1, wherein b=1.0 for regular insulin, b=0.5 for NPH insulin, b=0.25 for lente insulin, and b=0.2 for ultralente insulin.