Apparatus and methods for non-invasively measuring hemodynamic parameters

• US 20060184051A1
• Filed: 01/20/2006
• Published: 08/17/2006
• Est. Priority Date: 10/11/2002
• Status: Abandoned Application

• Current Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Jones, Christopher M., Butler, Anthony T., Hempstead, Russell D., Finburgh, Simon E., Vidischak, Ronald J.
• Application Number:
  US11/336,222
• Publication Number:
  US 20060184051A1
• Time in Patent Office: Days
• US Class Current: 600/485
• CPC Class Codes: A61B 2560/0261 using hydrostatic pressure
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• 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 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6841 by using templates

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 apparatus adapted to accurately place and maintain a sensor (e.g., tonometric pressure sensor) with respect to the anatomy of the subject, including an alignment apparatus which is separable from an adjustable fixture. The alignment apparatus 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. Methods for positioning the alignment apparatus and sensor, correcting for hydrostatic pressure effects, and providing treatment to the subject are also disclosed.

Claims

1. Apparatus adapted for physiologic measurements on a living subject, comprising:

an alignment member adapted for removable mating with the anatomy of said subject, said alignment member being configured to maintain an actuator-driven sensor element substantially in a desired orientation with respect to said anatomy;

a sensor element movably yet fixedly coupled to said alignment member; and

a removable support apparatus adapted to support at least a portion of said sensor element to permit the mating thereof to said actuator, said removable support apparatus having a tray adapted to rotate when removably attached to said alignment member.

2. The apparatus of claim 1, wherein said movably yet fixed coupling comprises at least one substantially flexible element fixed to both said sensor element and said alignment member.

3. The apparatus of claim 2, wherein said at least one substantially flexible element comprises at least two substantially serpentine arm portions of a common flexible element.

4. The apparatus of claim 3, wherein said serpentine arms are substantially coplanar.

5. The apparatus of claim 2, wherein said sensor element is adapted to rotate in response to the rotation of said tray of said removable support apparatus.

6. The apparatus of claim 1, wherein said removable support apparatus comprises a reticle.

7. The apparatus of claim 6, wherein said tray rotates away from said reticle when rotated into a vertical position.

8. The apparatus of claim 7, wherein said sensor element is adapted to rotate in response to the rotation of said tray of said removable support apparatus.

9. The apparatus of claim 8, wherein said reticle comprises a molded plastic portion of said removable support apparatus.

10. The apparatus of claim 1, wherein said removable support element comprises at least two substantially opposing levers adapted for grasping by a user or operator.

11. The apparatus of claim 10, wherein said at least two substantially opposing levers comprise at least one latch mechanism, said at least one latch mechanism being adapted to selectively latch said removable support element to said alignment member.

12. The apparatus of claim 10, wherein said at least two opposing levers interact with a surface on said removable support element when compressed to prevent said opposing levers from overcompression.

13. The apparatus of claim 12, wherein each of said at least two opposing levers comprises at least one fulcrum which comprises a substantially flexible molded joint between said level and another structure.

14. The apparatus of claim 13, wherein said removable support apparatus and said alignment member comprise symbology integrally molded into said removable support apparatus and said alignment member, said symbology indicative of proper alignment of said apparatus adapted for physiologic measurements on a living subject.

15. The apparatus of claim 2, further comprising at least one separable coupling between said sensor element and said removable support element.

16. The apparatus of claim 15, wherein one end of said at least one separable coupling is located on said rotatable tray.

17. A hemodynamic sensor assembly, comprising:

a sensor adapted to be removably coupled to a first support apparatus; and

a second support apparatus removably coupled to said first support apparatus to form an alignment apparatus adapted to align said sensor with a target location on the anatomy of a subject;

wherein said sensor is flexibly coupled to said second support apparatus.

18. The assembly of claim 17, wherein said alignment apparatus comprises:

a marker fixedly coupled to said first support apparatus;

wherein said first support apparatus comprises a tray which is rotatably coupled to said sensor so that said marker is visible when said tray is rotated in a vertical position.

19. The assembly of claim 17, wherein said alignment apparatus further comprises a pair of opposed levers, said opposed levers disengaging said first support apparatus from said second support apparatus.

20. The assembly of claim 17, wherein said sensor comprises:

a pressure transducer;

a substantially pliable bias element disposed proximate to said sensor element; and

an actuator coupling apparatus.

21. The assembly of claim 17, further comprising a substantially flexible electrical lead in electrical communication with said sensor, said lead having at least one data storage device associated therewith.

22. The assembly of claim 21, wherein said storage device comprises an EEPROM adapted to store a plurality of calibration parameters.

23. A method of operating an actuator-driven sensor, comprising:

providing an alignment apparatus adapted to align said sensor relative to the anatomy of a living subject, said alignment apparatus having a removable sensor restraining portion;

providing an instruction element instructing at least the placement of said alignment apparatus;

disposing said alignment apparatus and sensor on the anatomy of said subject;

coupling an actuator to said sensor; and

removing said sensor restraining portion, thereby permitting said sensor to be moved by said actuator.

24. The method of claim 23, wherein said instruction element comprises a figure of said alignment apparatus positioned on an individual.

25. The method of claim 24, wherein said act of coupling further comprises coupling an electrical lead associated with said sensor to another device.

26. The method of claim 25, further comprising calibrating said sensor after said coupling of said electrical lead is complete.

27. The method of claim 24, wherein said act of removing said sensor restraining portion comprises:

actuating at least one release mechanism; and

withdrawing said restraining portion, said withdrawing further causing separation of a separable coupling between said sensor and said removable portion.

28. Alignment and support apparatus for use with a blood pressure monitoring system, comprising:

an alignment frame adapted to fit onto the anatomy of a living subject proximate a radial artery thereof;

a sensor assembly adapted to measure pressure from said radial artery;

a coupling mechanism adapted to flexibly couple said sensor assembly to said alignment frame;

a sensor support element having at least one latch mechanism, said support element being adapted to cooperate with said frame to support said sensor assembly, and to be completely separated from said sensor assembly and frame when removed therefrom, said removal being accomplished by at least actuating said at least one latch mechanism; and

a reticle integral to said sensor support element, said sensor support element having a movable tray element adapted to accommodate said sensor assembly so that said reticle can be utilized to position said sensor assembly proximate said radial artery.