Device and system that identifies cardiovascular insufficiency

• US 20070088222A1
• Filed: 03/24/2006
• Published: 04/19/2007
• Est. Priority Date: 03/24/2005
• Status: Active Grant

• Current Assignee: Intelomed, Inc., University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: Intelomed, Inc.
• Inventors: Berkow, Jan, Pinsky, Michael, Puyana, Juan
• Granted Patent: US 7,678,057 B2
• Time in Patent Office: Days
• US Class Current: 600/485
• 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 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis

Abstract

In an embodiment, the present invention provides a device that identifies cardiovascular dysfunction of a subject. The claimed device comprises a controller, a transducer, and a processor. The controller initiates collection of a plurality of data related to a physiological condition. The transducer collects data over a plurality of cycles and transfers the data to the processor, which reduces the received data signal into an output using a novel formula. In an example the data correlate with data that are directly related to cardiovascular dysfunction but that are of limited use.

Claims

1. A device that identifies cardiovascular insufficiency of a subject, comprising:

a. a controller that initiates collection of a plurality of data related to a physiological condition, said controller comprising at least one of the following;

i. a manual or an automated switch;

ii. a plurality of software rules;

or

iii. a combination thereof;

b. a transducer that collects said data over a plurality of cycles and transfers said data as a signal, said cycles being comprised of a plurality of subcycles (c); and

c. a processor that receives and reduces said data signal by calculating at least a variation of said data signal across said cycles to generate an output, said variation being calculated according to the following formula;

percent deviation_{data signal}=(Pmean_max−

Pmean_min)/[(Pmean_max+Pmean_min)/2]×

100,

wherein percent deviation_{data signal} is a variation in said data signal received from said transducer;

wherein Pmean_max is a maximum mean value of said data signal across said plurality of cycles,

wherein Pmean_min is a minimum mean value of said signal across said plurality of cycles,

wherein a mean value of said data signal is calculated for each of a subcycle (c) of said cycles, as follows;

Pmean_c=Pmax_c+Pmin_c/2, wherein Pmax_c is a maximum data signal in a subcycle (c) and Pmin_c is a minimum data signal in said subcycle (c), said Pmean_max and Pmean_min being selected from said plurality of Pmean_c calculated for each of said subcycles (c).

2. A device as in claim 1 wherein said device is invasive, non-invasive, portable, and/or wearable.

3. A device as in claim 1 wherein said data related to said physiological condition is related to a cardiovascular system of said subject or is indicative of a dysfunction of said cardiovascular system.

4. A device as in claim 1 further comprising an activator.

5. A device as in claim 4 wherein said activator is at least one of the following:

a. a volume of fluid;

b. a pharmacologic agent;

c. a physical maneuver;

d. a mechanical ventilation;

e. a manual or an automated switch;

f. a motion sensor;

g. a compression device;

h. a perturbation of a cardiovascular system of said subject;

or

i. a combination thereof.

6. A device as in claim 5 wherein said physical maneuver is raising a leg of said patient by about 30%, a compression of a part of said subject'"'"'s body, or a change in a physical position of said subject.

7. A device as in claim 5 wherein said pharmacologic agent is at least one of:

a. a vasodilator;

b. a vasoconstrictor;

c. a vasoactive agent;

or

d. a combination thereof.

8. A device as in claim 1 wherein said output is said plurality of data collected, said data signal, an information set, an interface, an interpretation, a suggested treatment or protocol, or a combination thereof.

9. A device as in claim 1 or claim 8 wherein said output is graphical, numerical, or textual.

10. A device as in claim 1, 8, or 9 wherein said output is displayed on at least one of the following:

a. a remote display;

b. a handheld display;

c. a display on said device;

d. a display integrated with an interface;

or

e. a combination thereof.

11. A device as in claim 1 wherein said transducer is a photoplethysmographic device.

12. A device as in claim 1 wherein said device is an inflatable cuff.

13. A method of using the device of any of the preceding claims, comprising at least one of the following steps:

a. initiating said data collection;

b. collecting said data;

C. transferring said data as a data signal;

d. perturbing said subject;

e. reducing said data signal into said output; and

f. analyzing said output,

wherein said steps may be carried out in any order and may be optionally repeated more than one time.

14. A method as in claim 13 further comprising the step of using output to:

a. identify a cardiovascular insufficiency;

b. identify a decreased circulatory blood volume;

c. monitor said subject either remotely or non-remotely;

d. manage said subject;

e. institute a treatment protocol;

or

f. a combination thereof.

15. A method as in claim 13 or 14, wherein said device is further used to monitor a subject, identify decreased circulatory blood volume, and/or to institute a treatment protocol.

16. A system that identifies cardiovascular insufficiency of a subject, said system comprising:

a. a subject;

b. a device comprising at least a controller that initiates data collection, a transducer that collects said data and transfers a data signal, and a processor that reduces said data signal, wherein said processor uses a set of instructions to carry out at least one of the following steps;

i. initiating said controller;

ii. instructing said transducer to collect said data and/or transfer said data signal;

iii. perturbing said subject;

iv. reducing said data signal into an output;

v. analyzing said output;

vi. displaying said output;

vii. using said output,

wherein said steps may be carried out in any order and may optionally be repeated more than one time; and

c. a healthcare provider, a researcher, or a leader to receive said output.

17. A system as in claim 16, wherein said processor uses said instructions to do at least one of the following:

a. identify a cardiovascular insufficiency;

b. identify a decreased circulatory blood volume;

c. monitor said subject either remotely or non-remotely;

d. manage said subject;

e. institute a treatment protocol;

or

f. a combination thereof.