APPARATUS AND METHODS FOR NON-INVASIVELY MEASURING PHYSIOLOGIC PARAMETERS OF ONE OR MORE SUBJECTS

• US 20120277597A1
• Filed: 04/29/2011
• Published: 11/01/2012
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Zhejiang Shanshi Biological Medical Devices Company Limited
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Goedje, Oliver, Bohn, Matthias, Eshbaugh, Dave
• Granted Patent: US 9,655,530 B2
• Time in Patent Office: Days
• US Class Current: 600/481
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• 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 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/684 Indicating the position of the sensor on the body

Abstract

Improved apparatus and methods for non-invasively assessing one or more physiologic (e.g., hemodynamic) parameters associated with a living organism. In one embodiment, 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 is comprised of a sensor device removably coupled to a host device 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 frame assembly for use with a physiologic parameter sensing apparatus, the frame assembly comprising:

a substantially conformal frame comprising;

at least one aperture for receiving at least an active surface of a sensor; and

at least one mating element for mating said sensing apparatus to said frame assembly, said apparatus having said sensor; and

a substantially transparent membrane disposed proximate said frame and substantially traversing said aperture.

2. The frame assembly of claim 1, wherein said mating of said sensing apparatus to said frame assembly is facilitated via one or more raised features on said frame adapted to be received within said sensing apparatus.

3. The frame assembly of claim 1, wherein said frame has a substantially smaller surface area on a radial side than on an ulnar side thereof.

4. The frame assembly of claim 1, wherein said frame further comprises a substantially compliant foam backing disposed between said frame element and said membrane.

5. The frame assembly of claim 1, wherein said membrane comprises an optical alignment apparatus adapted to facilitate placement of said frame assembly relative to a blood vessel of a living subject.

6. The frame assembly of claim 1, wherein said membrane comprises an optical alignment apparatus adapted to facilitate alignment of said sensor above a blood vessel of a living subject.

7. The frame assembly of claim 1, wherein said membrane substantially protects said sensor from coming into contact with a surface of the skin of a living subject when the frame is applied to the subject, thereby enabling said sensor to be reused on at least two different subjects.

8. The frame assembly of claim 1, wherein said frame comprises a feature adapted to locate said frame assembly relative to a styloid process of a living subject.

9. A physiologic parameter sensing apparatus, comprising:

an alignment element having an optical alignment guide and a sensor barrier;

a sensor; and

a host device configured to place the sensor relative to the barrier;

wherein the sensor barrier is configured to permit sensing of one or more physiologic parameters through said barrier.

10. The apparatus of claim 9, wherein said barrier comprises said optical alignment guide.

11. The apparatus of claim 9, wherein a lubricant is utilized to facilitate movement of said sensor relative to said barrier.

12. The apparatus of claim 9, wherein said lubricant comprises a powder.

13. The apparatus of claim 9, wherein said alignment element is configured to be disposed of after a single use.

14. The apparatus of claim 9, wherein said sensor comprises an electrical interface configured to directly place said sensor and said host device in electrical communication upon said sensor being mated to said host device.

15. Apparatus for sensing one or more physiologic parameters from a living subject, the apparatus comprising:

an alignment element having a sensor barrier, the sensor barrier comprising a film configured to permit sensing of one or more physiologic parameters from the skin of the living subject through said barrier;

a multi-use sensor; and

a host device configured to place the sensor relative to the barrier;

wherein the alignment element is configured to be disposed of after a single use, and replaced; and

wherein the sensor is configured for multiple uses.

16. The apparatus of claim 15, wherein the alignment element comprises a single-use adhesive surface for adhering the alignment element to the skin of the subject.

17. The apparatus of claim 15, wherein the sensor comprises a pull tab enabling removal of the sensor from the host device when pulled by a user.

18. The apparatus of claim 15, wherein the host device comprises a substantially bracelet-like apparatus that substantially encircles the wrist of the subject when applied.

19. The apparatus of claim 18, further comprising a support apparatus configured to be worn on an arm of the subject;

wherein the substantially bracelet-like apparatus couples to the support apparatus.

20. The apparatus of claim 19, wherein the support apparatus comprises a splint.

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

disposing at least one frame element on said subject;

mating a host device having a sensor coupled thereto to said frame element, said mating comprising enabling at least an active surface of said sensor to be disposed within an aperture of said frame element;

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 sensor element;

wherein said measuring is performed through a membrane which substantially inhibits said sensor from contact with a surface of said subject'"'"'s skin.

22. The method of claim 21, wherein said act of positioning said sensor element further comprises automatically zeroing said sensor with respect to the placement of said sensor element on said subject.

23. The method of claim 21, further comprising coupling said sensor element to said host device, said coupling comprising simultaneously forming both electrical and mechanical connections between said host device and sensor element.

24. The method of claim 21, further comprising:

removing said host device with said sensor element coupled thereto from mating to said frame element;

mating said host device with said sensor element coupled thereto to a second frame element of a second living subject; and

obtaining measurements of said one or more hemodynamic parameters of said second subject.

25. A method of obtaining parametric measurements from a living subject, comprising:

disposing a support element on the anatomy of said subject, said support element comprising a membrane;

disposing a host device having a sensor on said anatomy and in communication with said support element so that sensor is substantially proximate said membrane; and

obtaining a parametric measurement through said membrane using said sensor.

26. A support element configured to mate with the physiology of a living subject and substantially position a sensor relative thereto, the support element comprising:

an at least partly flexible frame configured to substantially conform to a shape of a portion of said physiology;

a first element; and

a second element having an adhesive disposed on at least a portion thereof;

wherein;

the first element is substantially sandwiched between the frame and the second element; and

the adhesive of the second element is useful for removably bonding the support element to said portion of said physiology.

27. The support element of claim 26, wherein the second element comprises a layer or film having a prescribed thickness, said thickness selected so that said sensor may sense one or more parameters from said subject through said second element.