Apparatus and methods for non-invasively measuring a patient's arterial blood pressure

• US 8,777,862 B2
• Filed: 10/09/2008
• Issued: 07/15/2014
• Est. Priority Date: 10/12/2007
• Status: Active Grant

• Current Assignee: Zhejiang Shanshi Biological Medical Devices Company Limited
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Finburgh, Simon E., Katayama, Andrew S., Vidischak, Ronald J., Butler, Anthony T., Blessinger, Kurt
• Primary Examiner(s): Brown, Melanie Y
• Assistant Examiner(s): Crawford, Erik B
• Application Number:
  US12/287,630
• Publication Number:
  US 20090131806A1
• Time in Patent Office: 2,105 Days
• Field of Search: 600481-507, 606201-202, 128/898
• US Class Current: 600/485
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• 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 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/6841 by using templates
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

Improved apparatus and methods for non-invasively assessing one or more hemodynamic parameters associated with the circulatory system of a living organism. In one aspect, the invention comprises an apparatus adapted to automatically and accurately place and maintain a sensor (e.g., tonometric pressure sensor) with respect to the anatomy of the subject. The apparatus comprised of a sensor device removably coupled to an actuator which is used to position the sensor during measurements. Methods for positioning the alignment apparatus and sensor, and operating the apparatus, are also disclosed.

Claims

1. A sensor assembly adapted to sense a hemodynamic parameter from a living subject, comprising:

a substantially conformal frame; and

a sensor element, said sensor element being encircled by a flexible and resilient suspension loop and coupled to said frame via one or more suspending arms extending from said suspension loop;

wherein said sensor element further comprises an electrical interface, and said sensor element is configured so as to form an electrical connection with a corresponding electrical interface of a host device simultaneously during mating of said sensor element to said host device.

2. The sensor assembly of claim 1, wherein said sensor element comprises a blood pressure sensor, and further comprises:

a biasing element;

a pressure transducer;

a plurality of electrical conductors disposed on at least one printed circuit board and adapted to electrically interface with said host device; and

a housing element adapted to encase at least a portion of said sensor element.

3. The sensor assembly of claim 2, wherein said housing element comprises a substantially pyramid-shaped portion, at least a portion of said electrical conductors being disposed thereon.

4. The sensor assembly of claim 1, wherein said host device comprises an actuator.

5. The sensor assembly of claim 1, wherein said mating of said sensor element to said host device is facilitated via one or more retention features on said frame and said sensor element.

6. The sensor assembly of claim 1, wherein said frame has a substantially smaller surface area on a radial side than on an ulnar side when disposed on said subject.

7. The sensor assembly of claim 1, wherein said frame further comprises a substantially compliant foam backing having at least one adhesive surface adapted to adhere to tissue of said subject.

8. The sensor assembly of claim 1, wherein said assembly comprises an apparatus adapted to facilitate alignment of said sensor element above an artery of said subject without use of an external alignment apparatus.

9. A method of sensing one or more hemodynamic parameters of a living subject, said method comprising:

disposing at least one sensor element on said subject, said sensor element being encircled by a suspension loop which is coupled to a substantially conformal frame via at least one flexible suspending arm extending therefrom;

mating said sensor element to a host device, said mating further comprising mating of an electrical interface of said sensor element to a corresponding electrical interface of said host device;

using said host device to automatically position said sensor element at a prescribed monitoring location, and calibrate said sensor element; and

measuring said one or more parameters of said subject using said calibrated sensor element;

wherein said mating of said host device with said sensor element comprises simultaneously forming both electrical and mechanical connections.

10. The method of claim 9, further comprising automatically zeroing said sensor element.

11. The method of claim 10, wherein said automatic zeroing comprises at least one of:

checking for a quiescent state comprising a substantially steady sensor electrical output; and

retracting said sensor away from tissue of said living subject, and performing one or more sample applanation functions.

12. The method of claim 9, further comprising:

decoupling said host device from said sensor element;

re-mating said host device and said sensor element after a period of time; and

obtaining second measurements of said one or more parameters of said subject without having to recalibrate said sensor element.

13. The method of claim 9, further comprising evaluating whether proper mechanical and electrical coupling has been achieved by evaluating a presence of an electrical attribute associated with said sensor element.

14. The method of claim 13, wherein said attribute comprises at least one of:

determining whether electrical continuity between said sensor element and said host device exists;

or

attempting to access a storage device on said sensor element using circuitry in said host device.

15. A sensor assembly adapted to sense a hemodynamic parameter from a living subject, comprising:

a frame configured to substantially conform to an anatomy of said living subject when applied thereto;

a flexible suspension apparatus, said suspension apparatus comprising a loop feature and at least one suspending arm configured to extend therefrom and attach to said frame; and

a sensor element, said sensor element coupled to said frame via said flexible suspension apparatus such that an entirety of said sensor element is encircled by said loop feature thereof and held to said frame via said at least one suspending arm, said sensor element further comprising a plurality of electrical conductors exposed on at least one surface thereof;

wherein said plurality of electrical conductors are disposed on said surface of said sensor element so as to enable said sensor element to form an electrical connection with a corresponding electrical interface of a host device during mating of said sensor element to said host device.

16. The sensor assembly of claim 15, wherein said sensor element further comprises:

a biasing element;

a pressure transducer; and

a housing element adapted to encase at least a portion of said sensor element.

17. The sensor assembly of claim 16, wherein said housing element comprises a substantially pyramid-shaped portion, at least a portion of said electrical conductors being disposed thereon.

18. The sensor assembly of claim 15, wherein said host device comprises an actuator.

19. The sensor assembly of claim 15, wherein said mating of said sensor element to said host device is facilitated via one or more retention features on said frame and said sensor element.

20. The sensor assembly of claim 15, wherein said assembly further comprises an apparatus configured to facilitate alignment of said sensor element above an artery of said subject without use of an external alignment apparatus.