Compact apparatus and methods for non-invasively measuring hemodynamic parameters

• US 9,247,886 B2
• Filed: 05/23/2011
• Issued: 02/02/2016
• Est. Priority Date: 10/07/2004
• 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., Perona, Mark W., Hempstead, Russell D.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US13/113,794
• Publication Number:
  US 20110288382A1
• Time in Patent Office: 1,716 Days
• Field of Search: 600/301, 600/485, 600/304
• US Class Current: 1/1
• 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 5/681 Wristwatch-type devices

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 spatially compact “bracelet” embodiment adapted to accurately place and maintain a sensor (e.g., tonometric pressure sensor) with respect to the anatomy of the subject, including an optional alignment apparatus which moveably captures the sensor to, inter alia, facilitate coupling thereof to an actuator used to position the sensor during measurements. The alignment apparatus also advantageously allows the sensor position to be maintained when the fixture is removed from the subject, such as during patient transport. A completely autonomous variant of the bracelet apparatus having internal power supply and wireless interfaces is also disclosed. Methods for positioning the alignment apparatus and sensor and providing treatment to the subject are also described.

Claims

1. Non-invasive hemodynamic monitoring apparatus comprising:

a bracelet-like structure configured to receive a patient'"'"'s wrist said bracelet-like structure comprising;

a first portion configured to interface with an inner portion of said patient'"'"'s wrist, said first portion comprising a first actuator assembly at least partially enclosed within a housing said first actuator assembly configured to couple to at least one sensor and position said at least one sensor according to at least one of a sagittal displacement and a lateral displacement;

a second portion configured to interface with an exterior portion of said patient'"'"'s wrist; and

a third portion pivotally coupled to said first and second portions, said third portion further comprising a second actuator assembly configured to allow selective control of a motion of said first and second portions according to a static compression of said bracelet-like structure on said patient'"'"'s wrist; and

signal processing apparatus in communication with said at least one sensor, said signal processing apparatus configured to generate scaled hemodynamic signals based on data obtained from said patient via said at least one sensor.

2. The apparatus of claim 1, wherein said scaled hemodynamic signals comprise scaled blood pressure signals.

3. The apparatus of claim 1, wherein said at least one sensor comprises a silicone interface medium configured to interface with skin disposed at said patient'"'"'s wrist.

4. The apparatus of claim 1, further comprising a sensor support frame flexibly coupled to said at least one sensor, said sensor support frame further configured to couple to said bracelet-like structure.

5. A method of measuring one or more physiologic parameters of a living subject, comprising:

temporarily affixing a sensing assembly to said living subject at a position above a blood vessel thereof, said sensor assembly comprising at least a sensor element and an alignment apparatus, said alignment apparatus configured to assist in alignment of said sensor element above said blood vessel in at least one lateral dimension;

positioning a bracelet-like actuator assembly over said sensing assembly such that a first portion thereof is configured to interface with an inner portion of a wrist of said living subject, and a second portion thereof is configured to interface with an exterior portion of said wrist of said living subject;

obtaining data relating to one or more physiologic parameters of said living subject; and

scaling said data based at least in part on measurement of one or more physiologic characteristics of said living subject;

wherein a third portion of said bracelet-like actuator is pivotally coupled to said first and second portions and further comprises an actuator assembly configured to allow selective control of a motion of said first and second portions according to a static compression of said bracelet-like structure on said wrist of said living subject.

6. The method of claim 5, wherein said first portion of said bracelet-like actuator further comprises a second actuator assembly at least partially enclosed within a housing, said second actuator assembly configured to couple to said sensor element and position said sensor element according to at least one of a sagittal displacement and a lateral displacement.

7. The method of claim 5, wherein said act of positioning said bracelet-like actuator assembly comprises locking one or more features of said bracelet-like actuator assembly when a predetermined level of compressive force is applied thereto.

8. The method of claim 5, further comprising utilizing said bracelet-like actuator assembly to position said sensor element over said blood vessel, and to applanate said sensor element to achieve said predetermined level of compressive force.

9. The method of claim 5, further comprising utilizing said bracelet-like actuator assembly to position said sensor element over said blood vessel, and to applanate said sensor element to achieve a desired level of signal coupling to said blood vessel.

10. The method of claim 5, wherein said one or more physiologic characteristics of said living subject comprise a body mass index (BMI).

11. Non-invasive hemodynamic assessment apparatus comprising:

a bracelet assembly configured to adjustably clamp onto a limb of a patient proximate a blood vessel of interest, said bracelet assembly comprising;

a first actuator disposed on a first portion of said bracelet assembly, said first portion configured to interface with an inner portion of said patient'"'"'s wrist; and

a second actuator disposed on a second portion of said bracelet assembly, said second portion being pivotally coupled to said first portion of said bracelet assembly and a third portion of said bracelet assembly, said third portion of said bracelet assembly configured to interface with an exterior portion of said patient'"'"'s wrist; and

signal processing apparatus in signal communication with at least one sensor and configured to process signals generated by said at least one sensor and generate scaled hemodynamic signals based thereon;

wherein said first actuator apparatus is configured to position the at least one sensor over said blood vessel of interest; and

wherein said second actuator apparatus is configured to allow selective control of a motion of said first and third portions of said bracelet assembly according to a static compression of said bracelet-like structure on said patient'"'"'s wrist.

12. The non-invasive hemodynamic assessment apparatus of claim 11, wherein said at least one sensor is configured to, in conjunction with said signal processing apparatus, perform a tonometric measurement of a blood pressure of said blood vessel, and where said first actuator apparatus is configured to position said at least one sensor according to a sagittal displacement configured to optimize said tonometric measurement.

13. The non-invasive hemodynamic assessment apparatus of claim 12, wherein said tonometric measurement is continuously performed.

14. The non-invasive hemodynamic assessment apparatus of claim 11, wherein said static compression is based on one or more preloaded compression levels.

15. The non-invasive hemodynamic assessment apparatus of claim 14, wherein said one or more preloaded compression levels trigger a locking mechanism.

16. The non-invasive hemodynamic assessment apparatus of claim 11, wherein said at least one sensor comprises a disposable silicone interface medium configured to interface with a skin of said patient.