Apparatus and methods for non-invasively measuring hemodynamic parameters

• US 20040073123A1
• Filed: 10/11/2002
• Published: 04/15/2004
• 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: Hessel, Stephen R., Markle, William H., Voss, Gregory I., Hempstead, Russell D., Finburgh, Simon E., Vidischak, Ronald J., Perona, Mark W., Conero, Ronald S.
• Application Number:
  US10/269,801
• Publication Number:
  US 20040073123A1
• Time in Patent Office: Days
• US Class Current: 600/490
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0285 Measuring or recording phase velocity of blood waves
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6841 by using templates
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence

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. Hemodynamic assessment apparatus, comprising:

a brace adapted to receive a portion of the anatomy of a living subject;

actuator apparatus coupled to said brace and adapted to move a sensor; and

alignment apparatus adapted to mate with a portion of said anatomy, said alignment apparatus configured to maintain a desired orientation of said sensor prior to coupling thereof to said actuator.

2. The apparatus of claim 1, wherein said desired orientation comprises disposing the active surface of said sensor above but not in contact with the surface of the skin of said subject.

3. The apparatus of claim 1, wherein said brace comprises first and second portions adapted to substantially receive at least portions of the hand and forearm of said subject, said first portion being adjustable in orientation with respect to said second portion.

4. The apparatus of claim 3, further comprising a third portion adapted to receive at least a portion of the thumb of said subject, said third portion being adjustable in orientation with respect to said first portion.

5. Apparatus adapted for a plurality of hemodynamic measurements of a living subject, comprising an alignment member adapted for removable mating with the skin of said subject, said alignment member being configured to dispose a sensor in a desired orientation with respect to said skin prior to each of said plurality of measurements without removal thereof from said skin.

6. The apparatus of claim 5, wherein said apparatus is disposable.

7. The apparatus of claim 5, wherein at least two of said plurality of measurements are obtained using parent devices disposed at different locations.

8. The apparatus of claim 5, wherein said desired orientation comprises disposing the active surface of said sensor above but not in contact with the surface of the skin of said subject.

9. The apparatus of claim 5, wherein said alignment member further comprises a marker adapted to facilitate initial positioning of said apparatus on said subject.

10. Apparatus adapted for a plurality of hemodynamic measurements of 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 substantially in a desired orientation with respect to said anatomy between said measurements when said sensor is not coupled to said actuator.

11. A method of positioning at least one sensor with respect to the anatomy of a living subject, comprising:

providing said at least one sensor;

providing a positioning apparatus adapted to (i) maintain a substantially constant position with respect to the anatomy of said subject, and (ii) couple to said at least one sensor and;

providing at least one alignment apparatus adapted to align said at least one sensor with respect to said anatomy;

positioning said at least one alignment apparatus with respect to said anatomy;

disposing said positioning apparatus on said anatomy; and

coupling said at least one alignment apparatus to said positioning apparatus, said act of coupling further including aligning said at least one sensor with said anatomy using said at least one alignment apparatus.

12. The method of claim 11, wherein said act of aligning comprises aligning said at least one sensor with a blood vessel of said subject.

13. Apparatus adapted to position at least one sensor with respect to an anatomy, comprising:

alignment apparatus adapted to substantially conform to said anatomy; and

positioning apparatus adapted to maintain a substantially fixed position with respect to said anatomy, and cooperate with said alignment apparatus to position said at least one sensor in the desired orientation.

14. The apparatus of claim 13, wherein said at least one sensor comprises a pressure sensor adapted to sense blood pressure waveforms from a blood vessel.

15. The apparatus of claim 13, wherein said alignment apparatus comprises:

a frame element; and

a reticle element.

16. The apparatus of claim 15, wherein said frame element is adapted to fit substantially over at least a portion of the wrist of said anatomy.

17. The apparatus of claim 15, wherein said reticle comprises a substantially transparent sheet which cooperates with said frame element to dispose a marker on said substantially transparent sheet relative to a blood vessel of said anatomy.

18. The apparatus of claim 13, wherein said positioning apparatus comprises at least one arm adapted to mate with said sensor.

19. The apparatus of claim 18, wherein said at least one arm is articulated in at least two spatial dimensions.

20. The apparatus of claim 18, wherein said at least one arm is substantially “

U”

shaped, said sensor being received at least partly within said U-shape of said arm.

21. Sensor interface apparatus, comprising:

a substantially flexible substrate having first and second regions;

a data storage element disposed at said first region;

a sensor element disposed at said second region; and

a plurality of electrically conductive traces disposed at least partially on said substrate, said traces providing electrical continuity between said data storage element and said sensor element.

22. The apparatus of claim 21, wherein said substrate is substantially elongate and has first and second ends, with said first region disposed at said first end and said second region disposed at said second end.

23. The apparatus of claim 21, wherein said storage element comprises a PROM device, and said sensor element comprises a pressure sensor.

24. The apparatus of claim 21, wherein said storage element comprises a PROM device, and said sensor element comprises a pressure sensor.

25. The apparatus of claim 24, wherein said storage element is configured to contain a plurality of data relating to the calibration of said pressure sensor.

26. The apparatus of claim 24, wherein said storage element is configured to cooperate with a parent device to which said apparatus is connected to validate said apparatus.

27. The apparatus of claim 26, wherein said act of validating comprises:

reading data stored in said storage element; and

evaluating said read data based on at least second data in said parent device.

28. Hemodynamic assessment apparatus, comprising:

a brace adapted to securely receive at least a portion of the anatomy of a living subject;

an alignment apparatus; and

a coupling element cooperating with said alignment apparatus and a sensor to initially position the sensor with respect to said anatomical portion;

wherein said coupling element is adapted to be removable from said assessment apparatus to permit variable positioning of said sensor subsequent to said initial positioning.

29. The assessment apparatus of claim 28, further comprising a sensor.

30. The assessment apparatus of claim 28, further comprising an actuator element coupled to said sensor and said brace, said actuator element adapted to provide said variable positioning of said sensor.

31. The assessment apparatus of claim 28, wherein said coupling element is slidably engaged with said alignment apparatus and said sensor.

32. The assessment apparatus of claim 30, further comprising an actuator arm mounted on said brace and adapted to receive said actuator.

33. A method of positioning a sensor with respect to the anatomy of a subject, comprising:

disposing a marker on a location of said anatomy;

disposing said sensor relative to said marker;

displacing said marker from said location; and

disposing said sensor at said location.

34. The method of claim 33, wherein said act of disposing a marker comprises positioning a support element carrying said marker at said location.

35. The method of claim 33, wherein said act of disposing said sensor relative to said marker comprises disposing said sensor in a known relationship to said marker.

36. The method of claim 35, wherein said act of disposing in a known relationship comprises hingedly relating said sensor to said support element, and said act of disposing said sensor at said location comprises actuating said hinged relationship.

37. Anatomical sensor positioning apparatus, comprising:

a first support element;

a marker movably coupled to said first support element; and

a second support element disposed in known relationship to said marker.

38. The apparatus of claim 37, wherein said known relationship comprises a movably hinged relationship.

39. The apparatus of claim 37, wherein said known relationship comprises a slidable relationship.

40. The apparatus of claim 37, wherein said known relationship comprises a rotatable relationship.

41. The apparatus of claim 37, wherein said movable coupling comprises a sheet carrying said marker, said sheet being removably bonded to said first support element.

42. The apparatus of claim 37, wherein said first support element is removably bonded to the anatomy of the patient.

43. The apparatus of claim 42, wherein said marker is removably bonded to said first support element.

44. Apparatus for positioning a sensor, comprising:

a first support element adapted for mating to the anatomy of a subject;

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.

45. 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 when said sensor is uncoupled from said actuator.

46. The assembly of claim 45, 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.

47. The assembly of claim 45, wherein said alignment apparatus further comprises a removable coupling element adapted to:

(i) maintain said alignment between said sensor and target location when said element is present within said alignment apparatus; and

(ii) decouple said sensor from said alignment apparatus when said element is removed therefrom.

48. A blood pressure monitoring system, comprising:

at least one pressure sensor adapted to measure a pressure waveform from a blood vessel;

an actuator adapted to control the position of said at least one sensor relative to said blood vessel; and

a brace adapted to maintain said actuator in a substantially constant position with respect to said blood vessel;

wherein said brace is further adapted to maintain said sensor in a desired location prior to coupling of said actuator to said sensor.

49. A blood pressure monitoring system, comprising:

at least one pressure sensor adapted to measure a pressure waveform from a blood vessel;

an actuator adapted to control the position of said at least one sensor relative to said blood vessel;

a brace adapted to maintain said actuator in a substantially constant position with respect to said blood vessel; and

a removable alignment apparatus adapted to maintain said sensor in a desired location prior to coupling of said actuator to said sensor.

50. 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; and

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;

wherein said housing element further comprises a coupling adapter for coupling said sensor apparatus to a parent device.

51. The apparatus of claim 50, wherein said coupling adapter is disposed on the top surface of said housing.

52. Pressure sensor apparatus adapted for measurement of a pressure waveform from the blood vessel of a living subject, 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; 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 alignment apparatus.

53. A method of recurrently measuring the blood pressure of a living subject, comprising:

disposing an alignment apparatus adapted to align at least one sensor with respect to the anatomy of said subject;

positioning said at least one sensor with respect to said anatomy using at least in part said alignment apparatus;

measuring blood pressure at a first time using said sensor; and

measuring blood pressure at a second time using said sensor, wherein the position of said sensor is maintained with respect to said anatomy between said measurements using said alignment apparatus.

54. Apparatus for measuring the blood pressure of a living subject, comprising:

alignment apparatus adapted to align at least one sensor with respect to the anatomy of said subject, said alignment apparatus being configured such that at least a portion thereof is retained in a substantially fixed orientation with respect to said anatomy;

an actuator adapted to couple to said at least one sensor and control the position thereof during operations; and

at least one sensor adapted to cooperate with said alignment apparatus to maintain a desired position of said sensor when said sensor is decoupled from said actuator.

55. The apparatus of claim 54, wherein said actuator is displacement driven.

56. Apparatus for coupling a movable sensor having a sensing surface to an actuator, comprising:

a first coupling element disposed on said sensor;

a second coupling element disposed on said actuator, said second element adapted to receive at least a portion of said first element, thereby coupling said actuator and sensor in a substantially rigid configuration.

57. The apparatus of claim 56, wherein said first and second coupling elements are cooperatively configured such that said first element can be received by said second element to form said substantially rigid configuration when said first and second elements are substantially misaligned.

58. The apparatus of claim 56, wherein said first coupling element is adapted to be maintained in substantially fixed orientation by an alignment apparatus prior to coupling of said first and second elements.

59. The apparatus of claim 58, wherein said second coupling element may rotate around an axis substantially normal to said sensing surface within said alignment apparatus prior to coupling.

60. The apparatus of claim 56, wherein said first coupling element comprises at least a base and apex region, at least a portion of said apex region being received with said second coupling element.

61. The apparatus of claim 60, wherein said first coupling element is substantially pyramid-shaped.

62. The apparatus of claim 60, wherein said first coupling element is substantially frustoconical in shape.

63. Sensor support apparatus, comprising:

a brace adapted to receive a portion of the anatomy of a subject; and

a support member adjustably coupled to said brace, said support member being adapted to position a sensor assembly relative to said portion;

wherein said adjustable coupling comprises a ratchet mechanism.

64. The apparatus of claim 63, wherein said ratchet mechanism comprises a linear ratchet.

65. The apparatus of claim 63, wherein said adjustable coupling further comprises at least three degrees of freedom of motion.

66. The apparatus of claim 63, wherein said support member comprises a substantially U-shaped bracket.

67. Apparatus for controlling the position of a hemodynamic sensor with respect to a subject, wherein a single adjustment element permits adjustment of at least three degrees of freedom of said sensor.

68. The apparatus of claim 67, wherein said adjustment element comprises a frictional mechanism.

69. Physiologic sensor support apparatus, comprising:

a support frame adapted to mate substantially with the skin of the subject;

a sensor assembly; and

a support element in communication with said frame element and said sensor assembly, said support element adapted to maintain said sensor in a desired area relative to the skin.

70. The support apparatus of claim 69, wherein said support frame mates with said skin using an adhesive.

71. The support apparatus of claim 69, wherein said support frame substantially conforms to the wrist area of a human being.

72. The support apparatus of claim 69, wherein said support element comprises a substantially flexible sheet of material.

73. The support apparatus of claim 72, wherein said substantially flexible sheet of material comprises an elastomer.

74. The support apparatus of claim 72, wherein said substantially flexible sheet of material is attached to said frame on two sides thereof.

75. The support apparatus of claim 72, wherein said sensor assembly is disposed within an aperture formed in said substantially flexible sheet of material.

76. The support apparatus of claim 75, wherein said sensor assembly is disposed within an aperture formed in said substantially flexible sheet of material.

77. The support apparatus of claim 76, wherein said substantially flexible sheet of material is captured between at least two components of said sensor assembly proximate said aperture.

78. Physiologic sensing apparatus, comprising:

at least one pressure sensor; and

a support structure adapted to receive at least a portion of the anatomy of a subject therein;

wherein said support structure is adapted to couple at least one force felt by said at least one sensor to said at least portion of said anatomy.

79. The apparatus of claim 78, wherein said support structure comprises:

a brace element; and

a moveable arm movably but rigidly coupled to said brace element.

80. The apparatus of claim 78, further comprising an actuator coupled to said at least one sensor, said actuator also being coupled to said support structure so as to transmit said at least one force from said sensor to said support structure.

81. The apparatus of claim 80, wherein said at least one force comprises the reaction force generated by said actuator pressing said at least one sensor against said anatomy.

82. The apparatus of claim 78, wherein said at least portion of said anatomy comprises the forearm, and said coupling of said at least one force to said at least portion of said anatomy comprises transferring said force to the back side of the forearm.

83. Sensor actuator apparatus, comprising:

a stationary element;

a first movable element adapted to move relative to said stationary element, said moveable element further being adapted for coupling to said sensor; and

at least one motor fixedly mounted to said stationary element and operatively coupled to said first moveable element, said at least one motor being adapted to move said first moveable element in a first direction.

84. The apparatus of claim 83, further comprising a second moveable element, said second element being adapted for movement in a second direction substantially independent from said first element.

85. The apparatus of claim 84, wherein said second moveable element is operably coupled to a separate one of said at least one motor.

86. The apparatus of claim 84, wherein said second direction comprises the lateral direction, and said first direction comprises the normal or applanation direction.

87. The apparatus of claim 83, further comprising:

at least one sensor; and

a coupling element adapted to mate with said at least one sensor and said first movable element;

wherein said coupling is further adapted for selective detachment of said at least one sensor from said first movable element.

88. The apparatus of claim 83, wherein said sensor actuator apparatus is further adapted for mating with a support structure, said support structure being adapted for mounting on at least a portion of the anatomy of a living subject, said support structure providing substantially rigid support of said actuator with respect to said at least portion of said anatomy.

89. The apparatus of claim 84, wherein said at least one motor comprises first and second DC motors adapted to drive said first and second moveable elements, respectively.

90. Support apparatus adapted for use in the hemodynamic assessment of a living subject, comprising:

a first portion adapted to receive at least a portion of the hand of said living subject; and

a second portion adapted to receive at least a portion of the forearm of said living subject;

wherein said first and second portions are moveably coupled such that the orientation of said first portion with respect to said second portion can be selectively altered during said hemodynamic assessment.

91. The apparatus of claim 90, further comprising at least first and second restraining elements adapted to restrain said at least portion of said hand with respect to said first portion of said apparatus, and said at least portion of said forearm with respect to said second portion of said apparatus, respectively.

92. The apparatus of claim 90, further comprising a third portion adapted to receive at least a portion of the thumb of said subject, said third portion being adjustable in orientation with respect to said first portion.

93. The apparatus of claim 90, further comprising:

at least one sensor; and

a support structure adapted to support at least one sensor proximate said forearm;

wherein the operation of said sensor is optimized based on said alteration of said orientation.

94. A method of optimizing the measurement of a hemodynamic parameter from a living subject, comprising:

disposing a sensor adapted to measure at least one parameter and generate data relating thereto proximate to the anatomy of said subject, said anatomy containing at least one blood vessel;

disposing said anatomy in a first configuration;

generating first data using said sensor;

disposing said anatomy in a second configuration;

generating second data using said sensor;

evaluating said first and second data; and

optimizing said measurement based at least in part on said act of evaluating.

95. The method of claim 94, wherein said act of optimizing comprises disposing said anatomy in said first or second configuration based on the relative quality of said first and second data.

96. A method of optimizing the measurement of a hemodynamic parameter from a living subject, comprising:

selecting one of a plurality of possible orientations of the anatomy of said subject;

disposing said anatomy in said selected orientation;

disposing a sensor adapted to measure at least one parameter and generate data relating thereto proximate to said anatomy, said anatomy containing at least one blood vessel; and

generating said data using said sensor.

97. The method of claim 96, wherein said act of selecting comprises selecting the orientation of the hand of said subject with respect to the forearm thereof.

98. The method of claim 97, wherein said act of selecting one of a plurality of orientations further comprises selecting said one orientation based at least in part on data gathered from a plurality of subjects.

99. The method of claim 97, wherein said act of selecting one of a plurality of orientations further comprises selecting said one orientation based at least in part on at least one physiologic parameter associated with said subject.

100. The method of claim 99, wherein said act of selecting comprises selecting based at least in part on the body mass index (BMI) of the subject.

101. The method of claim 99, wherein said act of selecting comprises selecting based at least in part on the wrist circumference (WC) of the subject.

102. Hemodynamic assessment apparatus, comprising:

a brace adapted to receive a portion of the anatomy of a living subject;

frame apparatus adapted to mate with a portion of said anatomy, said frame apparatus configured to contain a sensor; and

actuator apparatus coupled to said brace and frame apparatus and adapted to removably couple to said sensor, said actuator further being adapted to selectively press at least a portion of said sensor against said anatomy.

103. A method of operating a sensor used in a hemodynamic assessment apparatus, comprising:

providing a sensor having attributes;

calibrating said sensor and a first of said hemodynamic assessment apparatus based at least in part on said attributes of said sensor;

removing said sensor from said first apparatus;

disposing said sensor in a second hemodynamic assessment apparatus; and

calibrating said second apparatus based at least in part on said attributes;

wherein said act of calibrating said second apparatus does not require re-calibrating said sensor.

104. The method of claim 103, wherein said second apparatus is different than said first.

105. Hemodynamic assessment sensor apparatus, comprising:

a sensor;

a first circuit containing said sensor and adapted to facilitate the calibration of and generation of data using said sensor; and

a second circuit in operative communication with said first circuit, said second circuit adapted to electrically interface with any one of a plurality of different monitor configurations, said first and second circuits cooperating to allow sequential use of different ones of said plurality of without recalibration of said sensor.

106. Hemodynamic assessment apparatus, comprising:

at least one pressure sensor disposed for contact with the tissue of a living subject; and

an actuator coupled to said at least one sensor and adapted to selectively vary the level of compression of said tissue by said at least one sensor;

wherein said actuator further comprises at least one acceleration device adapted to generate a signal relating to the acceleration of at least a portion of said actuator during operation.

107. The assessment apparatus of claim 106, wherein said signal is utilized in the processing of data generated by said at least one pressure sensor.

108. The assessment apparatus of claim 107, wherein said utilization of said signal comprises preventing further use or display of selected portions of said data.

109. The assessment apparatus of claim 107, wherein said utilization of said signal comprises analyzing said signal in conjunction with pressure-based motion data obtained from said at least one sensor.

110. A method of measuring a hemodynamic parameter during movement;

measuring data relating to said parameter from a living subject using apparatus;

determining the presence of movement of said apparatus; and

processing said data based at least in part on said determination.

111. The method of claim 110, wherein said act of determining is accomplished independently of said act of measuring.

112. The method of claim 110, further comprising:

analyzing said data relating to said parameter for movement of said apparatus or said subject, said act of processing being based at least in part on both said acts of determining and analyzing.

113. The method of claim 110, wherein said act of processing comprises selectively blocking portions of said data from further analysis or display.

114. The method of claim 110, wherein said act of processing comprises selectively weighting portions of said data for use in subsequent calculations.