Apparatus and methods for non-invasively measuring physiologic parameters of one or more subjects

• US 9,655,530 B2
• Filed: 04/29/2011
• Issued: 05/23/2017
• 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: Eshbaugh, Dave, Goedje, Oliver, Bohn, Matthias
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): ALTER, MITCHELL E
• Application Number:
  US13/098,344
• Publication Number:
  US 20120277597A1
• Time in Patent Office: 2,216 Days
• Field of Search: None
• 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 physiologic parameter sensing apparatus, comprising:

a conformal frame configured to couple to a patient'"'"'s forearm comprising an alignment element comprising an optical alignment guide and a sensor barrier, said frame comprising an aperture, said sensor barrier configured to traverse said aperture;

a host assembly comprising an actuator device configured to mate with a sensor, said host assembly being removably coupled to said frame, and said sensor being placed in communication with said sensor barrier via said host assembly coupled to said frame; and

one or more releasable attachment features configured to facilitate removal of said host assembly from said conformal frame, whereby said removal results in a removal of said actuator and said sensor from contact with said frame and said sensor barrier;

wherein said sensor barrier is configured to permit one or more physiologic parameters to be sensed through said sensor barrier;

wherein said optical alignment guide is configured to facilitate placement of said frame and said sensor relative to a blood vessel of a living subject;

wherein said sensor comprises a removal apparatus configured to configured to enable removal of said sensor from said host assembly, said removal apparatus comprising;

a main body retained within a removal apparatus retainer of a sensor housing; and

a user-graspable projection extended outwardly from said sensor housing configured to be pulled by a user.

2. The apparatus of claim 1, wherein said sensor barrier comprises said optical alignment guide.

3. The apparatus of claim 1, wherein a lubricant is utilized to facilitate movement of said sensor relative to said sensor barrier.

4. The apparatus of claim 3, wherein said lubricant comprises a powder.

5. The apparatus of claim 1, wherein said frame is configured to be disposed of after a single use.

6. The apparatus of claim 1, wherein said sensor comprises an electrical interface configured to directly place said sensor and said actuator device in electrical communication upon said sensor being mated to said actuator device.

18. The apparatus of claim 1, wherein said one or more releasable attachment features comprise a first securing feature of said host assembly and a second securing feature of said frame.

19. The apparatus of claim 18, wherein said first securing feature comprises at least one projection and said second securing feature comprises at least one riser having at least one indentation configured to receive said at least one projection.

20. The apparatus of claim 1, wherein said sensor is indirectly coupled to said frame while said host assembly is directly coupled to said frame.

7. Apparatus configured to sense one or more physiologic parameters from a living subject, said apparatus comprising:

a conformal frame configured to be disposed of after use on a single patient, and comprising an alignment element having a sensor barrier, said sensor barrier comprising a film configured to permit said one or more physiologic parameters to be sensed from a surface of skin of said living subject through said sensor barrier, said sensor barrier being coupled to said conformal frame via, at least, two regions adjacent to an aperture of said conformal frame;

a multi-use sensor configured for use on more than one patient; and

a host device configured to house said multi-use sensor, said host device being removably coupled to said conformal frame via one or more releasable attachment mechanisms of said host device, said host device configured to place said multi-use sensor in relative proximity to said sensor barrier;

wherein removal of said host device from said conformal frame comprises a separation of said multi-use sensor from said conformal frame via said one or more releasable attachment mechanisms of said host device, said multi-use sensor comprising continued engagement to said host device throughout said removal; and

wherein said sensor comprises a removal apparatus configured to configured to enable removal of said sensor from said host assembly, said removal apparatus comprising;

a main body retained within a removal apparatus retainer of a sensor housing; and

a user-graspable projection extended outwardly from said sensor housing configured to be pulled by a user.

8. The apparatus of claim 7, wherein said alignment element comprises a single-use adhesive surface configured to adhere said alignment element to said skin of said living subject.

9. The apparatus of claim 7, wherein said multi-use sensor comprises a pull ring configured to enable removal of said multi-use sensor from said host device when pulled by a user.

10. The apparatus of claim 7, wherein said host device comprises a bracelet-like apparatus configured to encircle a wrist of said living subject when applied.

11. The apparatus of claim 10, further comprising a support apparatus configured to be worn on an arm of said living subject;

wherein said bracelet-like apparatus is configured to couple to said support apparatus.

12. The apparatus of claim 11, wherein said support apparatus comprises a splint.

17. The apparatus of claim 7, wherein:

said host device with said multi-use sensor coupled thereto is further configured to mate to a second conformal frame of a second living subject; and

said multi-use sensor is further configured to obtain measurements of said one or more physiologic parameters of said second living subject.

21. The apparatus of claim 7, wherein said one or more releasable attachment mechanisms comprise a first securing feature of said host device and a second securing feature of said conformal frame.

22. The apparatus of claim 21, wherein said first securing feature comprises at least one projection and said second securing feature comprises at least one riser having at least one indentation configured to receive said at least one projection.

23. The apparatus of claim 7, wherein said sensor is indirectly coupled to said frame while said host assembly is directly coupled to said frame.

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

disposing at least one frame element on said living subject, said at least one frame element comprising an aperture and a membrane, said membrane extending across said aperture, and said at least one frame element configured to be disposed of after a single use;

mating a host device to said at least one frame element, said host device comprising an actuator device configured to mate with a sensor element, said sensor element configured to be used sequentially on multiple patients, said host device configured to be removably coupled to said at least one frame element via releasable coupling of a first securing feature of said host device to second securing feature of said at least one frame element, said act of mating comprising enabling at least an active surface of said sensor element to be disposed within said aperture of said at least one frame element, said sensor element without being indirectly coupled to said at least one frame element via said host device, while said host device is directly coupled to said at least one frame element;

using said host device to automatically position said sensor element at a prescribed monitoring location, and calibrate said sensor element;

measuring said one or more physiologic parameters of said living subject using said sensor element; and

upon completion of said act of measuring, removing said host device with said sensor element coupled thereto from mating to said at least one frame element via uncoupling of said first securing feature from said second securing feature;

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

14. The method of claim 13, wherein said act of using said host device to automatically position said sensor element further comprises automatically zeroing said sensor element with respect to a placement of said sensor element on said living subject.

15. The method of claim 13, further comprising coupling said sensor element to said host device, said act of coupling comprising simultaneously forming both electrical and mechanical connections between said host device and said sensor element.

16. The method of claim 13, further comprising:

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 physiologic parameters of said second living subject.

24. The method of claim 13, further comprising removing said sensor element via a removal apparatus attached to said sensor element.

25. The method of claim 24, wherein said act of removing said sensor element comprises pulling on a user-graspable portion of said removal apparatus, said user-graspable portion being outwardly projected from a housing of said sensor element.

26. The method of claim 13, wherein said act of removing said host device with said sensor element coupled thereto from mating to said at least one frame element comprises release of a projection of said first securing feature from an indentation of said second securing feature.