Personalized tourniquet system having dual-purpose cuff

• US 9,039,730 B1
• Filed: 07/10/2014
• Issued: 05/26/2015
• Est. Priority Date: 07/10/2014
• Status: Active Grant

• Current Assignee: Western Clinical Engineering Ltd.
• Original Assignee: Western Clinical Engineering Ltd.
• Inventors: McEwen, James A., Jameson, Michael, Jeyasurya, Jeswin, Glinz, Kenneth L.
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/328,607
• Time in Patent Office: 320 Days
• Field of Search: 606/201, 606/202, 606/203, 600/485, 600/490, 600/493, 600/495, 600/496, 600/499, 600/500, 600/501, 600/502, 600/561
• US Class Current: 606/202
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/92 coded with colour

Abstract

Disclosed is a method and apparatus for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP) to facilitate safe performance of a surgical procedure. The apparatus includes a dual-purpose tourniquet cuff adapted to encircle a region of a patient limb to provide both a sensor during a pre-surgical time period and an effector during a surgical time period. An effector module communicates pneumatically with an inflatable bladder of the cuff for maintaining pressure in the bladder near a PTP during the surgical time period to safely stop penetration of arterial blood past the cuff. A pulsation sensor that communicates pneumatically with the inflatable bladder during the pre-surgical time period senses and characterizes pressure pulsations that are indicative of penetration of arterial blood into the region of the limb encircled by the cuff. A PTP estimator is responsive to the pulsation sensor for producing an estimate of the PTP, such that the estimate of the PTP is a function of the sensed pulsations.

Claims

1. A method for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising the steps of:

estimating a limb occlusion pressure (LOP) by determining a minimum pressure at which penetration of blood past an applied tourniquet cuff is stopped;

measuring a pulsation characteristic associated with the LOP;

establishing a PTP by determining a second pressure that is greater than the LOP and that corresponds to a second pulsation characteristic that differs by a predetermined percentage from the pulsation characteristic associated with the LOP; and

during a surgical time period, maintaining pressure in the applied tourniquet cuff near the PTP.

2. The method of claim 1 wherein the pulsation characteristic is indicative of a shape of the pulsation.

3. The method of claim 1 wherein the pulsation characteristic is a maximum amplitude of pulsation.

4. The method of claim 1 wherein the predetermined percentage is a function of the magnitude of the estimated LOP.

5. The method of claim 1 wherein the step of estimating the LOP includes the substep of sensing a characteristic of blood that penetrates past the applied tourniquet cuff.

6. The method of claim 1 wherein the step of estimating the LOP includes the substep of sensing in an inflatable bladder of the cuff a characteristic of pulsation.

7. A method for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising the steps of:

during a pre-surgical time period;

estimating a limb occlusion pressure (LOP) by determining a minimum pressure at which penetration of blood past an applied tourniquet cuff is stopped,

measuring a pulsation characteristic associated with the LOP,

establishing a PTP by determining a second pressure that is greater than the LOP and that corresponds to a second pulsation characteristic that differs by a predetermined percentage from the pulsation characteristic associated with the LOP; and

during a surgical time period, regulating the cuff pressure to maintain a surgical pulsation characteristic near the second pulsation characteristic.

8. The method of claim 7 wherein the pulsation characteristic is indicative of a shape of the pulsation.

9. The method of claim 7 wherein the pulsation characteristic is a maximum amplitude of pulsation.

10. The method of claim 7 wherein the predetermined percentage is a function of the magnitude of the estimated LOP.

11. The method of claim 7 wherein the step of estimating the LOP includes the substep of sensing a characteristic of blood that penetrates past the applied tourniquet cuff.

12. The method of claim 7 wherein the step of estimating the LOP includes the substep of sensing in an inflatable bladder of the cuff a characteristic of pulsation.

13. The method of claim 7 including the step of producing an alert if the surgical pulsation characteristic is outside a predetermined range.

14. A method for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising the steps of:

applying a surgical tourniquet cuff having a bladder to a patient'"'"'s limb at a location proximal to a surgical site on the limb;

during a pre-surgical time period;

estimating a minimum pressure at which penetration of blood past the applied tourniquet cuff is stopped by analyzing pressure pulsations in the bladder of the cuff that are associated with selected pressures in the bladder, thereby to identify a limb occlusion pressure (LOP) at the location;

establishing a PTP by determining a second pressure that is greater than the LOP and that corresponds to a second pulsation characteristic that differs by a percentage from the pulsation characteristic associated with the LOP; and

during a surgical time period maintaining pressure in the bladder of the applied tourniquet cuff near the PTP.

15. The method of claim 14 including the step of determining a noise level associated with pressure fluctuations in the bladder that are independent of the pressure pulsations analyzed for the estimation of LOP.

16. The method of claim 15 wherein the establishing step includes the substep of compensating for effects of a noise level above a threshold level.

17. The method of claim 15 wherein the establishing step further establishes the PTP to be a first increment of pressure greater than LOP if the noise level is below a first noise threshold.

18. The method of claim 17 wherein the establishing step further establishes the PTP to be a second increment of pressure greater than the first increment of pressure if the noise level is greater than the first noise threshold and less than a second noise threshold.

19. The method of claim 18 wherein the establishing step further establishes the PTP to be a predetermined default pressure if the noise level is greater than the second noise threshold.

20. The method of claim 19 wherein the step of establishing the PTP includes a substep of producing an alert perceptible by a user if the noise level is greater than the second noise threshold.

21. The method of claim 15 wherein the pressure fluctuations are associated with tremor-related muscle contractions during the pre-surgical time period.

22. The method of claim 15 wherein the pressure fluctuations are associated with operation of a tourniquet pressure regulator for inflation of the bladder near the selected pressures during the pre-surgical time period.

23. The method of claim 15 wherein the pressure fluctuations are associated with perioperative activity.