Ultrasonic monitoring device for measuring physiological parameters of a mammal

• US 8,864,670 B2
• Filed: 01/26/2012
• Issued: 10/21/2014
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Lisiecki, Ronald S., Ban, Tamas
• Primary Examiner(s): Cwern, Jonathan
• Application Number:
  US13/358,609
• Publication Number:
  US 20120197118A1
• Time in Patent Office: 999 Days
• Field of Search: 600/438, 600/485
• US Class Current: 600/438
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/02141 Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits A61B5/02233, A61B5/0235 take precedence
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 8/04 Measuring blood pressure
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/4236 characterised by adhesive patches
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer

Abstract

An ultrasonic monitoring device includes a substrate, a plurality of ultrasonic transducer elements, a computer readable memory medium, a microprocessor, and a power source. The ultrasonic transducer elements are coupled to the substrate. Each ultrasonic transducer element is separately configured to transmit a signal to a target area of a mammal and to receive an echo return signal from the target area. The computer readable memory medium includes program instructions. The microprocessor is coupled to the ultrasonic transducer elements and to the computer readable memory medium for executing the program instructions to determine a physiological parameter of the mammal based on a combined analysis of the echo return signals received by the ultrasonic transducer elements. The power source is coupled to at least one of the ultrasonic transducer elements, the computer readable memory medium, or the microprocessor for supplying electrical energy.

Claims

1. A central venous pressure ultrasonic monitoring device comprising:

a substrate;

a plurality of ultrasonic transducer elements coupled to the substrate, wherein each ultrasonic transducer element is separately configured to transmit a signal to a jugular vein of a mammal and to receive an echo return signal from the jugular vein;

a computer readable memory medium comprising program instructions;

a microprocessor coupled to the plurality of ultrasonic transducer elements and to the computer readable memory medium, the microprocessor configured to execute the program instructions to determine central venous pressure of the mammal based on a combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements without ultrasonically scanning the mammal or generating an ultrasonic image of the jugular vein; and

a power source, coupled to at least one of the plurality of ultrasonic transducer elements, the computer readable memory medium, or the microprocessor, configured to supply electrical energy.

2. The central venous pressure ultrasonic monitoring device of claim 1 wherein the microprocessor configured to execute the program instructions is configured to determine, based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements, whether there is a transition location at which the jugular vein changes from a collapsed state to an expanded state, and if so, to determine a distance of the transition location away from a portion of a heart of the mammal, and to determine the central venous pressure of the mammal based on the distance.

3. The central venous pressure ultrasonic monitoring device of claim 1 further comprising an inclinometer coupled to the microprocessor, the microprocessor configured to execute the program instructions to determine the central venous pressure of the mammal based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements in conjunction with inclination data received by the inclinometer indicating an inclination state of the mammal from a supine position.

4. The central venous pressure ultrasonic monitoring device of claim 1 wherein the microprocessor configured to execute the program instructions is configured to determine, based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements, a location and quantity of blood positioned in the jugular vein, and to determine the central venous pressure of the mammal based on the location and the quantity of the blood.

5. The central venous pressure ultrasonic monitoring device of claim 1 wherein each ultrasonic transducer element is separately configured to transmit the signal to a carotid artery of the mammal and to receive the echo return signal from the carotid artery, and the microprocessor configured to execute the program instructions is configured to determine, based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements from the carotid artery and the jugular vein, a location of the central venous pressure ultrasonic monitoring device relative to the carotid artery and to the jugular vein, and whether the location is a desired central venous pressure monitoring location relative to the mammal.

6. The central venous pressure ultrasonic monitoring device of claim 1 wherein the plurality of ultrasonic transducer elements coupled to the substrate is positioned in an array comprising five to ten rows of the transducer elements and three to five columns of the transducer elements for a total of fifteen to fifty of the transducer elements.

7. The central venous pressure ultrasonic monitoring device of claim 1 wherein each ultrasonic transducer element is separately configured to transmit the signal having a voltage of approximately 75 Volts, and a frequency of approximately 10 MHz, and each ultrasonic transducer element is configured to receive the echo return signal from the jugular vein for a time ranging between 1 to 50 microseconds.

8. The central venous pressure ultrasonic monitoring device of claim 1 wherein the program instructions comprise an algorithm configured to determine the central venous pressure of the mammal based on the combined analysis of the echo return signals received by the plurality of the ultrasonic transducer elements, wherein the algorithm comprises central venous pressure =(a +b +c +d)*(sin θ

), wherein “

a”

=a first linear distance from a most superior portion of a right atrium of the mammal to a sternal notch of the mammal, “

b”

=a second linear distance from the sternal notch of the mammal to a base of a neck of the mammal, “

c”

=a third linear distance from the base of the neck of the mammal to a surface of the central venous pressure ultrasonic monitoring device which is closest to the base of the neck of the mammal when the central venous pressure ultrasonic monitoring device is attached to a skin of the mammal and transmitting the signal, “

d”

=a fourth linear distance from the surface of the central venous pressure ultrasonic monitoring device which is closest to the base of the mammal, when the central venous pressure ultrasonic monitoring device is attached to the skin of the mammal and transmitting the signal, to a transition location at which the jugular vein of the mammal changes from a collapsed state to an expanded state, and “

θ

”

=an inclination angle of the mammal from a supine position.

9. A method of monitoring central venous pressure of a mammal comprising:

positioning a central venous pressure ultrasonic monitoring device against skin of a mammal;

transmitting separate signals from a plurality of ultrasonic transducer elements of the central venous pressure ultrasonic monitoring device to a jugular vein of the mammal;

receiving, with the plurality of ultrasonic transducer elements, echo return signals from the jugular vein of the mammal; and

determining the central venous pressure of the mammal using a microprocessor to execute program instructions to process a combined analysis of the echo return signals received by the plurality of transducer elements without ultrasonically scanning the mammal or generating an ultrasonic image of the jugular vein.

10. The method of claim 9 wherein the determining step further comprises determining, based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements, whether there is a transition location at which the jugular vein changes from a collapsed state to an expanded state, and if so, determining a distance of the transition location away from a portion of a heart of the mammal, and determining the central venous pressure of the mammal based on the distance.

11. The method of claim 9 wherein the determining step further comprises determining the central venous pressure of the mammal based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements in conjunction with inclination data received by an inclinometer indicating an inclination state of the mammal from a supine position.

12. The method of claim 9 wherein the determining step further comprises determining, based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements, a location and quantity of blood positioned in the jugular vein, and determining the central venous pressure of the mammal based on the location and the quantity of the blood.

13. The method of claim 9 wherein the transmitting step further comprises transmitting the separate signals to a carotid artery of the mammal, the receiving step further comprises receiving the echo return signals from the carotid artery of the mammal, and the determining step further comprises determining, based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements from the carotid artery and the jugular vein, a location of the central venous pressure ultrasonic monitoring device relative to the carotid artery and to the jugular vein, and determining whether the location is a desired central venous pressure monitoring location relative to the mammal.

14. The method of claim 9 wherein the transmitting step further comprises transmitting the separate signals from the plurality of ultrasonic transducer elements of the central venous pressure ultrasonic monitoring device at a voltage of approximately 75 Volts, and a frequency of approximately 10 MHz, and the receiving step further comprises receiving, with the plurality of ultrasonic transducer elements, the echo return signals from the jugular vein of the mammal for a time ranging between 1 to 50 microseconds.

15. The method of claim 9 further comprising transmitting the determined central venous pressure to a display device, and displaying the determined central venous pressure with the display device.

16. The method of claim 9 wherein the determining the central venous pressure of the mammal using the microprocessor to execute the program instructions to process the combined analysis of the echo return signals received by the plurality of transducer elements comprises an algorithm determining the central venous pressure of the mammal, wherein the algorithm comprises central venous pressure =(a +b +c +d)*(sin θ

), wherein “

a”

=a first linear distance from a most superior portion of a right atrium of the mammal to a sternal notch of the mammal, “

b”

=a second linear distance from the sternal notch of the mammal to a base of a neck of the mammal, “

c”

=a third linear distance from the base of the neck of the mammal to a surface of the central venous pressure ultrasonic monitoring device which is closest to the base of the neck of the mammal as the central venous pressure ultrasonic monitoring device is positioned against the skin of the mammal and transmitting the separate signals, “

d”

=a fourth linear distance from the surface of the central venous pressure ultrasonic monitoring device which is closest to the base of the neck of the mammal, when the central venous pressure ultrasonic monitoring device is placed against the skin of the mammal and transmitting the separate signals, to a transition location at which the jugular vein of the mammal changes from a collapsed state to an expanded state, and “

θ

”

=an inclination angle of the mammal from a supine position.

17. The method of claim 9 further comprising continuously monitoring the central venous pressure of the mammal for a period of one to five days.

18. A jugular venous pressure ultrasonic monitoring device comprising:

a substrate;

a plurality of ultrasonic transducer elements coupled to the substrate, wherein each ultrasonic transducer element is separately configured to transmit a signal to a jugular vein of a mammal and to receive an echo return signal from the jugular vein;

a computer readable memory medium comprising program instructions;

a microprocessor coupled to the plurality of ultrasonic transducer elements and to the computer readable memory medium, the microprocessor configured to execute the program instructions to determine jugular venous pressure of the mammal based on a combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements without ultrasonically scanning the mammal or generating an ultrasonic image of the jugular vein; and

a power source, coupled to at least one of the plurality of ultrasonic transducer elements, the computer readable memory medium, or the microprocessor, configured to supply electrical energy.

19. The jugular venous pressure ultrasonic monitoring device of claim 18 wherein the program instructions comprise an algorithm configured to determine the jugular venous pressure of the mammal based on the combined analysis of the echo return signals received by the plurality of the ultrasonic transducer elements, wherein the algorithm comprises jugular venous pressure =sin θ

*(b +c +d), wherein “

b”

=a first linear distance from a sternal notch of the mammal to a base of a neck of the mammal, “

c”

=a second linear distance from the base of the neck of the mammal to a surface of the jugular venous pressure ultrasonic monitoring device which is closest to the base of the neck of the mammal when the jugular venous pressure ultrasonic monitoring device is attached to a skin of the mammal and transmitting the signal, “

d”

=a third linear distance from the surface of the jugular venous pressure ultrasonic monitoring device which is closest to the base of the mammal, when the jugular venous pressure ultrasonic monitoring device is attached to the skin of the mammal and transmitting the signal, to a transition location at which the jugular vein of the mammal changes from a collapsed state to an expanded state, and “

θ

”

=an inclination angle of the mammal from a supine position.

20. A central venous pressure ultrasonic monitoring device comprising:

a substrate;

a plurality of ultrasonic transducer elements coupled to the substrate, wherein each ultrasonic transducer element is separately configured to transmit a signal to a jugular vein of a mammal and to receive an echo return signal from the jugular vein;

a computer readable memory medium comprising program instructions;

a microprocessor coupled to the plurality of ultrasonic transducer elements and to the computer readable memory medium, the microprocessor configured to execute the program instructions to determine central venous pressure of the mammal based on a combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements; and

a power source, coupled to at least one of the plurality of ultrasonic transducer elements, the computer readable memory medium, or the microprocessor, configured to supply electrical energy;

wherein each ultrasonic transducer element is separately configured to transmit the signal to a carotid artery of the mammal and to receive the echo return signal from the carotid artery, and the microprocessor configured to execute the program instructions is configured to determine, based on the combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements from the carotid artery and the jugular vein, a location of the central venous pressure ultrasonic monitoring device relative to the carotid artery and to the jugular vein, and whether the location is a desired central venous pressure monitoring location relative to the mammal.

21. A central venous pressure ultrasonic monitoring device comprising:

a substrate;

a plurality of ultrasonic transducer elements coupled to the substrate, wherein each ultrasonic transducer element is separately configured to transmit a signal to a jugular vein of a mammal and to receive an echo return signal from the jugular vein;

a computer readable memory medium comprising program instructions;

a microprocessor coupled to the plurality of ultrasonic transducer elements and to the computer readable memory medium, the microprocessor configured to execute the program instructions to determine central venous pressure of the mammal based on a combined analysis of the echo return signals received by the plurality of ultrasonic transducer elements; and

a power source, coupled to at least one of the plurality of ultrasonic transducer elements, the computer readable memory medium, or the microprocessor, configured to supply electrical energy;

wherein the program instructions comprise an algorithm configured to determine the central venous pressure of the mammal based on the combined analysis of the echo return signals received by the plurality of the ultrasonic transducer elements, wherein the algorithm comprises central venous pressure =(a +b +c +d)*(sin θ

), wherein “

a”

=a first linear distance from a most superior portion of a right atrium of the mammal to a sternal notch of the mammal, “

b”

=a second linear distance from the sternal notch of the mammal to a base of a neck of the mammal, “

c”

=a third linear distance from the base of the neck of the mammal to a surface of the central venous pressure ultrasonic monitoring device which is closest to the base of the neck of the mammal when the central venous pressure ultrasonic monitoring device is attached to a skin of the mammal and transmitting the signal, “

d”

=a fourth linear distance from the surface of the central venous pressure ultrasonic monitoring device which is closest to the base of the mammal, when the central venous pressure ultrasonic monitoring device is attached to the skin of the mammal and transmitting the signal, to a transition location at which the jugular vein of the mammal changes from a collapsed state to an expanded state, and “

θ

”

=an inclination angle of the mammal from a supine position.