Apparatus and methods for non-invasively measuring hemodynamic parameters

• US 20050080345A1
• Filed: 08/18/2004
• Published: 04/14/2005
• 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: Hempstead, Russell D., Porreco, Allison C., Markle, William H., Butler, Anthony T., Finburgh, Simon E., Vidischak, Ronald J., Perona, Mark W.
• Application Number:
  US10/920,999
• Publication Number:
  US 20050080345A1
• Time in Patent Office: Days
• US Class Current: 600/485
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61B 5/6824 Arm or wrist
• 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 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.

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 arms.

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

5. The apparatus of claim 2, wherein said at least one substantially flexible element comprises a flexible sheet within which at least a portion of said sensor element is disposed.

6. The apparatus of claim 1, wherein said removable support apparatus comprises a first and second elements movably coupled to one another.

7. The apparatus of claim 6, wherein said first and second elements cooperate to form a reservoir capable of holding a quantity of a substance.

8. The apparatus of claim 7, wherein said reservoir is at least opened when said first and second elements are moved relative to each other.

9. The apparatus of claim 7, wherein said substance comprises a friction-mitigating powder.

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 each comprise at least one fulcrum adapted to permit its associated lever to pivot substantially there around.

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

14. The apparatus of claim 6, wherein said first and second elements cooperate in sliding relative motion to dispense a substance from said removable element.

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 6, further comprising at least one separable coupling between said sensor element and said removable support element, wherein said first and second elements further cooperate to achieve at least one stable mechanical state under lateral tensile load such that said at least one coupling can be separated.

17. A hemodynamic sensor assembly, comprising:

a sensor adapted to be removably coupled to an actuator; and

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 alignment apparatus.

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

a first support element adapted for mating to said anatomy;

a marker removably coupled to said first support element; and

a second support element adapted to receive said sensor;

wherein said second support element is movably coupled to said first support element such that said sensor is disposed in a known relationship to said marker when said movable coupling is actuated.

19. The assembly of claim 17, wherein said alignment apparatus further comprises a removable support element adapted to support said sensor relative to said alignment apparatus when said support element is disposed proximate to said alignment 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;

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 act of removing said sensor restraining portion further comprises dispensing a quantity of a substance proximate to said sensor.

25. The method of claim 23, 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 23, 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. Tonometric pressure sensor apparatus, comprising:

a pressure sensor adapted to generate an electrical signal relating to the pressure applied to at least one surface thereof;

a housing element adapted to at least partly receive said sensor therein;

a bias element coupled to said housing and adapted to bias tissue of a subject proximate said at least one surface when said apparatus is disposed in contact therewith; and

apparatus adapted to permit movable coupling of said sensor apparatus to an external device.

29. The sensor apparatus of claim 28, wherein said apparatus adapted to permit movable coupling comprises a groove formed at least partly within said housing element, said groove adapted to receive a corresponding portion of a flexible coupling element.

30. The sensor apparatus of claim 28, wherein said apparatus adapted to permit movable coupling further comprises said flexible coupling element.

31. Pressure sensor apparatus adapted for measurement of a pressure waveform from the blood vessel of a living subject, comprising:

a tonometric pressure sensor adapted to generate an electrical signal relating to the pressure applied to at least one surface thereof;

a housing element adapted to at least partly receive said sensor therein; and

a coupling element adapted to couple said sensor apparatus to an actuator;

wherein said apparatus is further adapted to be retained in a desired position above said blood vessel when uncoupled from said actuator using an external alignment apparatus.

32. Apparatus adapted for movably yet fixedly coupling a physiologic sensor to another object, comprising at least one substantially flexible arm, said at least one arm allowing said sensor to move in relation to said object in multiple degrees of freedom.

33. The apparatus of claim 32, wherein said at least one arm comprises at least one arm having a substantially serpentine shape.

34. The apparatus of claim 32, wherein said at least one arm comprises at least one arm having a plurality of shape elements adapted to distribute stress within at least portions thereof.

35. The apparatus of claim 32, wherein said at least one arm is bonded to said object via a molding process.

36. The apparatus of claim 32, wherein said at least one arm further comprises at least one sensor coupling portion adapted to be received within a portion of said sensor.

37. The apparatus of claim 36, wherein said at least one sensor coupling portion comprises a dowel adapted to be received within a corresponding recess of said sensor.

38. The apparatus of claim 32, wherein said multiple degrees of freedom comprise at least rotation around first, second and third axes.

39. The apparatus of claim 38, wherein said multiple degrees of freedom further comprise at least translation in first, second and third directions.

40. Support apparatus for an actuator-driven pressure sensor, comprising;

a first element adapted to communicate with at least a portion of said sensor and provide support therefore during coupling to said actuator; and

a second element movably coupled to said first element, said second element adapted for grasping by an operator;

wherein said second element, upon retraction thereof by said operator, is further adapted to engage said first element and retract it from said sensor after some distance of travel by said second element.

41. The support apparatus of claim 40, further comprising a reservoir adapted to contain a quantity of a substance.

42. The support apparatus of claim 41, wherein said substance is dispensed from said reservoir under force of gravity when said first and second elements move relative to one another.

43. The support apparatus of claim 40, wherein said first and second elements comprises substantially molded polymer components.

44. The support apparatus of claim 40, wherein said second element further comprises a pair of substantially opposed levers coupled to latch means, said levers allowing for release of said latch means during said act of grasping.

45. The support apparatus of claim 40, further comprising a first coupling element adapted to cooperate with a corresponding second coupling element on said sensor, said first and second coupling elements allowing said sensor to be maintained in a substantially static orientation with respect to said support apparatus at least before said retraction of said second element.

46. Apparatus adapted for movably yet fixedly coupling a means for sensing to another object, comprising at least one substantially flexible means for coupling, said at least one means for coupling allowing said means for sensing to move in relation to said object in at least multiple translation degrees of freedom.

47. A method of disposing a quantity of a substance relative to a desired location on the anatomy of a living subject, comprising:

disposing first and second apparatus relative to said location, said first apparatus containing said quantity of substance;

removing said first apparatus from said second apparatus so as to leave said second apparatus substantially in place on said anatomy, said act of removing comprising releasing said quantity proximate to said location.

48. The method of claim 47, wherein said act of disposing second apparatus comprises disposing an alignment apparatus proximate to the radial artery of said subject, said alignment apparatus being adapted to removably receive said first apparatus.

49. The method of claim 47, wherein said act of releasing said quantity comprises creating relative motion between first and second elements of said first apparatus, said relative motion opening at least one passage from a reservoir containing said quantity.

50. 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; and

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.

51. A method of assembling a physiologic measurement apparatus, comprising:

providing a physiologic measurement apparatus having a plurality of unassembled components;

visually coding corresponding at least portions of first and second groups of said components so as to indicate a physical relationship between respective ones of components within said first and second groups;

disposing at least a portion of said components from said first group on the anatomy of a living subject; and

subsequently disposing at least a portion of said components from said second group onto said anatomy;

wherein said act of subsequently disposing comprises disposing said at least portion of second components relative to corresponding ones of said at least portion of said first group based at least in part on said visual coding.

52. The method of claim 51, wherein said act of subsequently disposing further comprises disposing in a predetermined sequence based at least in part on said visual coding.