Method and system for monitoring oxygenation levels of compartments and tissue

• US 9,314,165 B2
• Filed: 12/14/2013
• Issued: 04/19/2016
• Est. Priority Date: 07/31/2007
• Status: Active Grant

• Current Assignee: J&m Shuler, Inc.
• Original Assignee: J&m Shuler, Inc.
• Inventors: Shuler, Michael Simms
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): WEARE, MEREDITH H
• Application Number:
  US14/106,734
• Publication Number:
  US 20140316215A1
• Time in Patent Office: 857 Days
• Field of Search: 600/300, 600/301, 600/323, 600/324, 600473-481, 600/483, 600/485, 600/490, 600500-507
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

A method and system for continually monitoring oxygenation levels in real-time in compartments of an animal limb, such as in a human leg or a human thigh or a forearm, can be used to assist in the diagnosis of a compartment syndrome. The method and system can include one or more near infrared compartment sensors in which each sensor can be provided with a compartment alignment mechanism and a central scan depth marker so that each sensor may be precisely positioned over a compartment of a living organism. The method and system may comprise hardware or software (or both) may adjust one or more algorithms based on whether tissue being monitored was traumatized or is healthy. The method and system can also monitor the relationship between blood pressure and oxygenation levels and activate alarms based on predetermined conditions relating to the oxygenation levels or blood pressure or both.

Claims

1. A method for automatically monitoring oxygenation levels of a compartment of a human body for automatically detecting conditions of a compartment syndrome with a computing device, comprising:

automatically monitoring oxygenation levels of the compartment in a continuous manner with the computing device coupled to a non-invasive compartment sensor;

automatically monitoring oxygenation levels of healthy tissue with the computing device coupled to a non-invasive healthy tissue sensor in a continuous manner, the non-invasive healthy tissue sensor detecting systemic perfusion of the human body from the healthy tissue;

automatically monitoring blood pressure of the human body in a continuous manner with the computing device coupled to a non-invasive blood pressure device, the blood pressure comprising diastolic and systolic blood pressure values; and

activating an alarm module with the computing device when both the blood pressure of the human body comprising the diastolic and systolic blood pressure values decreases and oxygenation levels of the non-invasive compartment sensor start decreasing in value compared to the oxygenation levels of the non-invasive healthy tissue sensor for the healthy tissue.

2. The method of claim 1, further comprising displaying oxygenation levels of the compartment on a display device;

displaying one or more visuals on the display device comprising anatomical locations in which to position the non-invasive compartment sensor to monitor a compartment of injured tissue; and

receiving confirmation with the computing device that the non-invasive compartment sensor is ready.

3. The method of claim 1, further comprising displaying diastolic and systolic blood pressure values simultaneously with the oxygenation levels of the compartment on a display device.

4. The method of claim 1, further comprising detecting lower serial hemoglobins (Hgb) or hematocrits (Hct) in blood of a patient with the computing device based on monitored oxygenation levels.

5. The method of claim 4, further comprising sensing at least one of respiration, pH levels, temperature, pulse, heart rate, and altitude with another sensor coupled to the computing device.

6. The method of claim 5, wherein monitoring oxygenation levels of the compartment with the non-invasive compartment sensor further comprises measuring muscle oxygenation of the compartment with the computing device.

7. The method of claim 6, further comprising calculating and displaying a mean arterial pressure (MAP) on the display device.

8. An electronic system for automatically monitoring oxygenation levels of a compartment of a human body for automatically detecting conditions of a compartment syndrome, the electronic system comprising:

a non-invasive compartment sensor configured for automatically detecting oxygenation levels of injured tissue of the human body in a continuous manner;

a non-invasive healthy tissue sensor configured for automatically detecting oxygenation levels of healthy tissue of the human body in a continuous manner;

a non-invasive blood pressure device configured for automatically sensing blood pressure of the human body in a continuous manner, the blood pressure comprising diastolic and systolic blood pressure values; and

a computing device coupled to the non-invasive compartment sensor, the non-invasive healthy tissue sensor, and non-invasive blood pressure device, wherein the computing device configured for;

monitoring the blood pressure of the human body and monitoring the oxygenation levels of the human body;

monitoring oxygenation levels of the injured tissue from the non-invasive compartment sensor;

monitoring oxygenation levels of the healthy tissue from the non-invasive healthy tissue sensor configured for automatically detecting oxygenation levels of healthy tissue;

activating an alarm device when both the blood pressure of the human body comprising the diastolic and systolic blood pressure values decreases and oxygenation levels of the non-invasive compartment sensor start decreasing in value compared to the oxygenation levels of the non-invasive healthy tissue sensor configured for automatically detecting oxygenation levels of healthy tissue.

9. The system of claim 8, further comprising a display device configured for simultaneously displaying the oxygenation levels and diastolic and systolic blood pressure values of the human body.

10. The system of claim 9, wherein the display device is further configured for displaying one or more visuals comprising anatomical locations in which to position the non-invasive compartment sensor to monitor a compartment of injured tissue.

11. The system of claim 10, further comprising at least one of:

a respiration sensor, a pH level sensor, a temperature sensor, a medicine delivery system, a pulse/oxygenation sensor, a heart rate sensor, a ventilation sensor, an ultrasound sensor, an altitude sensor, a tissue firmness sensor, and an intramuscular pressure sensor.

12. The system of claim 11, wherein the anatomical locations correspond to locations on one of a leg and arm.

13. The system of claim 12, further comprising an array of non-invasive compartment sensors coupled to the computing device, wherein each non-invasive sensor has a different optical wavelength relative to a neighboring non-invasive sensor in order to provide scans of different portions of the human body.

14. The system of claim 9, wherein the display device comprises a computer monitor.

15. The system of claim 14, wherein the computing device is further configured for receiving a pigment value for skin of the human body and calculating an offset value for monitoring the oxygenation levels based on the pigment value.

16. The system of claim 8, wherein the non-invasive compartment sensor comprises a near infrared sensing element.

17. The system of claim 16, further comprising the alarm device coupled to the computing device, wherein the computing device is further configured for activating the alarm device when the blood pressure and oxygenation levels approach predefined levels.

18. The system of claim 8, wherein the computing device is further configured for adjusting oxygenation values based on demographics of a patient.

19. The system of claim 18, wherein the demographics of the patient comprises skin pigment.

20. The system of claim 19, wherein the computing device is further configured for increasing a frequency at which the oxygenation levels and blood pressure are monitored when the oxygenation levels and blood pressure both fall within a predetermined range of values.