Patient status sensor

• US 8,273,053 B2
• Filed: 05/04/2010
• Issued: 09/25/2012
• Est. Priority Date: 05/05/2009
• Status: Active Grant

• Current Assignee: PYNG Medical Corporation (Teleflex Incorporated)
• Original Assignee: PYNG Medical Corporation (Teleflex Incorporated)
• Inventors: Saltzstein, William E.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US12/773,730
• Publication Number:
  US 20100286607A1
• Time in Patent Office: 875 Days
• Field of Search: 600/301, 600/393, 604/93.01
• US Class Current: 604/93.01
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6848 Needles

Abstract

Embodiments of a patient status sensor can be applied to a patient or trauma victim to provide a quick visual and/or audible indication of the patient'"'"'s vital signs (e.g., respiration, heart rate, or other vital signs). Certain embodiments are configured as an adhesive patch that includes electrodes for measuring heart rate (and respiration in some implementations), a processor configured to perform calculations for determining one or more vital signs using information from the electrodes, and audible or visual indicators to communicate information about vital signs or patient status to a medical attendant. Certain embodiments include an access opening for providing intraosseous delivery of fluids to bone marrow (e.g., through sternal or long bone) and can be integrated or used with an intraosseous delivery system. Certain embodiments include wired or wireless components to communicate vital signs or patient status to an external monitoring device.

Claims

1. An intraosseous (IO) fluid delivery and patient status system, the IO system comprising:

an IO infusion device configured to provide access to an IO space in a bone of a patient, the IO infusion device comprising;

a bone portal comprising a fluid delivery channel, the bone portal having a proximal end and a distal end, the distal end configured to be inserted into the bone; and

a fluid delivery conduit configured to be coupled to the proximal end of the bone portal so as to provide fluid access to the fluid delivery channel of the bone portal; and

a patient status sensor configured to monitor at least heart rate and respiration rate of the patient, the patient status sensor comprising;

a substrate comprising an adhesive component configured to adhere the patient status sensor to the patient;

a pair of electrodes disposed in or on the substrate the pair of electrodes configured to receive an electrical signal from the body of the patient and in response to provide a body signal comprising a single-channel electrocardiogram (ECG) signal;

a visual indicator;

a processor configured to (a) receive and process the body signal from the pair of electrodes in order to determine measurements of heart rate and respiration rate, the heart rate determined from the single-channel ECG signal, (b) determine patient status based at least in part on;

(b1) the measurement of the heart rate and one or more heart rate limits and (b2) the measurement of the respiration rate and one or more respiration rate limits, and (c) output a patient status signal to the visual indicator, the visual indicator configured to output visual information indicative of the patient status; and

a power source configured to be electrically connected to the visual indicator and the processor.

2. The IO system of claim 1, wherein the distal end of the bone portal is configured to be inserted into the sternum of the patient.

3. The IO system of claim 1, wherein the electrodes of the pair of electrodes are disposed in or on the adhesive component.

4. The IO system of claim 1, wherein the visual indicator, the processor, and the power source are disposed in or on the substrate.

5. The IO system of claim 1, wherein the visual indicator comprises one or more light emitting diodes.

6. The IO system of claim 5, wherein at least one of the one or more light emitting diodes is configured to output a time-varying visual signal, the time-varying visual signal indicative of a time-variation of the body signal.

7. The IO system of claim 6, wherein the time-varying visual signal comprises blinking or flashing, and the time-variation of the body signal comprises heartbeat or respiration.

8. The IO system of claim 1, wherein the power source comprises a battery.

9. The IO system of claim 1, further comprising a removable pull tab configured to electrically isolate the power source from the visual indicator and the processor and to electrically connect the power source to the visual indicator and the processor when the pull tab is removed.

10. The IO system of claim 9, further comprising a package configured to store the IO system, the package and the pull tab configured such that the pull tab is automatically removed when the package is opened by a user.

11. The IO system of claim 1, wherein the one or more heart rate limits comprise a heart rate lower limit and a heart rate upper limit, the one or more respiration rate limits comprise a respiration rate lower limit and a respiration rate upper limit and the processor is configured to determine patient status based at least in part on one or both of:

whether the measurement of the heart rate is between the heart rate lower limit and the heart rate upper limit; and

whether the respiration rate is between the respiration rate lower limit and the respiration rate upper limit.

12. The IO system of claim 11, wherein the visual indicator comprises a first light source and a second light source, and the processor is configured to illuminate the first light source if the measurement of the heart rate or breathing rate is between the lower limit and the upper limit and to illuminate the second light source if the measurement of the heart rate or breathing rate is not between the lower limit and the upper limit.

13. The IO system of claim 1, further comprising an audible indicator, the processor configured output a second patient status signal to the audible indicator.

14. The IO system of claim 1, wherein the patient status sensor is configured to output an impedance signal via the pair of electrodes, and the electrical signal received by the pair of electrodes comprises a modulation of the impedance signal and the processor is configured to measure the respiration rate based at least in part on the modulation of the impedance signal.

15. The IO system of claim 1, further comprising an analyte sensor disposed in or on the bone portal.

16. The IO system of claim 15, wherein the analyte sensor is disposed on an inner surface of the fluid delivery channel of the bone portal.

17. The IO system of claim 15, wherein the analyte sensor comprises at least one of a pressure sensor, a temperature sensor, a blood oxygen sensor, a pH sensor, or a glucose sensor.

18. The IO system of claim 15, wherein the processor is further configured to receive a signal from the analyte sensor and determine a measurement of an additional vital sign based at least in part on the signal from the analyte sensor.

19. The IO system of claim 18, wherein the processor is further configured to determine the patient status based at least in part on the measurement of the additional vital sign.

20. The IO system of claim 1, further comprising a wired or wireless transmission system configured to communicate information related to the measurement of the one or more of the heart rate, the breathing rate and the patient status to an external device.

21. The IO system of claim 20, wherein the transmission system is configured to communicate a frequency modulated or amplitude modulated audio signal.

22. The IO system of claim 20, wherein the transmission system is configured to communicate a radio frequency signal.

23. A patient status sensor configured to monitor at least heart beat and respiration of a patient, the patient status sensor comprising:

a substrate comprising an adhesive layer configured to adhere the patient status sensor to the patient;

a visual indicator disposed in or on the substrate;

a pair of electrodes disposed in or on the substrate, the patient status sensor configured to output an impedance signal via the pair of electrodes to the body of the patient, the pair of electrodes configured to receive from the body of the patient an electrical signal comprising a single-channel electrocardiogram (ECG) signal and a modulation of the impedance signal;

a processor disposed in or on the substrate, the processor configured to;

receive and process the electrical signal from the pair of electrodes to determine a measurement of heart rate from the single-channel ECG signal and respiration rate from the modulation of the impedance signal;

determine patient status based at least in part on (a) the measurement of the heart rate and one or more heart rate limits and (b) the measurement of the respiration rate and one or more respiration rate limits; and

output a patient status signal to the visual indicator in response to the determination of the patient status, the visual indicator configured to output visual information indicative of at least one of the heart rate, the respiration rate, and the patient status; and

a power source disposed in or on the substrate, the power source configured to be electrically connected to the plurality of electrodes, the visual indicator, and the processor.

24. The patient status sensor of claim 23, wherein the visual indicator comprises one or more light emitting diodes.

25. The patient status sensor of claim 24, wherein at least one of the one or more light emitting diodes is configured to output a time-varying visual signal, the time-varying visual signal indicative of the measurement of the heart rate or the measurement of the respiration rate.

26. The patient status sensor of claim 25, wherein the time-varying visual signal comprises blinking or flashing.

27. The patient status sensor of claim 23, wherein the power source comprises a battery.

28. The patient status sensor of claim 23, further comprising a removable pull tab configured to electrically isolate the power source from the plurality of electrodes, the visual indicator, and the processor and to electrically connect the power source to the plurality of electrodes, the visual indicator, and the processor when the pull tab is removed.

29. The patient status sensor of claim 28, further comprising a package configured to store the patient status sensor, the package and the pull tab configured such that the pull tab is automatically removed when the package is opened by a user.

30. The patient status sensor of claim 23, wherein the one or more heart rate limits comprise a lower heart rate limit and an upper heart rate limit, the one or more respiration rate limits comprise a lower respiration rate limit and an upper respiration rate limit, and the processor is configured to determine patient status based at least in part on whether the measurement of the heart rate is between the lower heart rate limit and the upper heart rate limit and whether the measurement of the respiration rate is between the lower respiration rate limit and the upper respiration rate limit.

31. The patient status sensor of claim 23, wherein the visual indicator comprises a first light source and a second light source, and the processor is configured to illuminate the first light source if the patient status is satisfactory and to illuminate the second light source if the patient status is unsatisfactory.

32. The patient status sensor of claim 23, wherein the processor is configured to illuminate the visual indicator only if there is a change in the patient status.

33. The patient status sensor of claim 23, further comprising an audible indicator, the processor configured output a second patient status signal to the audible indicator.

34. The patient status sensor of claim 23, wherein the impedance signal comprises an alternating current having a frequency greater than about 20 kHz.

35. The patient status sensor of claim 23, wherein the processor is configured to process the electrical signal to separate the ECG signal and the respiration signal from the electrical signal.

36. The patient status sensor of claim 35, wherein the processor is configured to filter the electrical signal with a bandpass at a central ECG frequency to separate the ECG signal and to filter the electrical signal with a bandpass at a central respiration frequency to separate the respiration signal.

37. The patient status sensor of claim 36, wherein the central ECG frequency is about 12 Hz and the central respiration frequency is above about 20 kHz.

38. The patient status sensor of claim 23, wherein the substrate comprises an access opening configured to receive an intraosseous needle assembly for intraosseous delivery of a fluid to bone marrow.

39. The patient status sensor of claim 38, wherein the substrate includes at least one marker for locating the substrate on an anatomical location on the body of the patient.

40. The patient status sensor of claim 39, wherein the anatomical location comprises a location on the sternum of the patient.