Personalized tourniquet methods and apparatus

• US 9,931,126 B2
• Filed: 08/27/2015
• Issued: 04/03/2018
• 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): Lynch, Robert
• Application Number:
  US14/837,999
• Publication Number:
  US 20160008006A1
• Time in Patent Office: 950 Days
• CPC Class Codes: A61B 17/132 Tourniquets sphygmomanometer A61B5/022
• CPC Class Codes: A61B 17/1322 comprising a flexible encircling member A61B17/135 takes precedence
• 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 2017/00022 Sensing or detecting at the treatment site
• 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 2090/0807 Indication means
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• 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 90/92 coded with colour
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders

Abstract

Disclosed are methods and apparatus for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP) to facilitate safe performance of surgical and medical procedures. The apparatus includes a dual-purpose tourniquet cuff adapted to encircle a region of a patient to provide both a sensor during a first time period and an effector during a second 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 second time period to safely stop penetration of arterial blood past the cuff. A pulsation sensor that communicates pneumatically with the inflatable bladder during the first time period senses and characterizes pressure pulsations that are indicative of penetration of arterial blood into the region of a patient 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. An apparatus for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising:

a dual-purpose tourniquet cuff having an inflatable bladder adapted to encircle a portion of a patient;

a sensor module having a pulsation sensor communicating pneumatically with the inflatable bladder of the dual-purpose cuff for sensing and characterizing pressure pulsations indicative of a distal occlusion pressure (DOP), thereby to identify a minimum pressure at which penetration of blood past the cuff is stopped;

a PTP estimator responsive to the pulsation sensor for producing an estimate of a PTP, wherein the estimate of the PTP is a function of the DOP;

an effector module communicating pneumatically with the inflatable bladder of the dual-purpose cuff for maintaining pressure in the bladder near the PTP; and

a controller selectively operating the inflatable bladder in conjunction with the sensor module and the effector module.

2. The apparatus of claim 1 wherein the portion of the patient is a limb proximal to a surgical site.

3. The apparatus of claim 1 wherein the portion of the patient is a region of the patient'"'"'s scalp.

4. The apparatus of claim 1 wherein the controller operates the inflatable bladder with the sensor module during a first time period.

5. The apparatus of claim 4 wherein the controller operates the inflatable bladder with the effector module during a second time period.

6. The apparatus of claim 5 wherein the controller further operates the inflatable bladder with the sensor module for sensing and characterizing pressure pulsations during the second time period.

7. The apparatus of claim 1 further comprising a cuff identification module for alerting a user in instances when the inflatable bladder is not part of a dual-purpose cuff.

8. The apparatus of claim 1 wherein the function is a percentage of the DOP.

9. An apparatus for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising:

a sensor module for estimating a distal occlusion pressure (DOP) by determining an estimated DOP equal to a minimum pressure at which penetration of blood past an applied tourniquet cuff is stopped, and measuring a first pulsation characteristic associated with the DOP;

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

an effector module operable during a time period for maintaining pressure in an applied tourniquet cuff near the PTP.

10. The apparatus of claim 9 wherein the percentage is a function of a magnitude of the estimated DOP.

11. The apparatus of claim 9 wherein the sensor module is also for sensing a characteristic of blood that penetrates past the applied tourniquet cuff.

12. The apparatus of claim 9 wherein the sensor module is also for sensing in an inflatable bladder of the cuff a series of pulsation characteristics from which at least one of the first and second pulsation characteristics is determined.

13. An apparatus for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising:

a dual-purpose tourniquet cuff having a bladder and configured to be applied to a patient at a desired location;

a controller operable during a first time period for;

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 distal occlusion pressure (DOP) at the location and a first pulsation characteristic associated with the DOP;

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

maintaining pressure in the bladder of the dual-purpose tourniquet cuff near the PTP during a second time period.

14. The apparatus of claim 13 further comprising a noise sensor module for determining a noise level associated with pressure fluctuations in the bladder that are independent of the pressure pulsations analyzed for the estimation of DOP.

15. The apparatus of claim 14 wherein the controller causes an alert perceptible by a user to be produced if the noise level is greater than a noise threshold.

16. A method for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising:

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

measuring a first pulsation characteristic associated with the DOP;

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

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

17. The method of claim 16 wherein the first or second pulsation characteristic is indicative of a shape of the pulsation.

18. The method of claim 16 wherein the first or second pulsation characteristic is a maximum amplitude of pulsation.

19. The method of claim 16 wherein the percentage is a function of the magnitude of the estimated DOP.

20. The method of claim 16 wherein estimating the DOP includes sensing a characteristic of blood that penetrates past the applied tourniquet cuff.

21. The method of claim 16 wherein estimating the DOP includes sensing in an inflatable bladder of the cuff a series of pulsation characteristics from which at least one of the first and second pulsation characteristics is selected.

22. The method of claim 16 wherein the applied tourniquet cuff encircles a portion of a limb of a patient.

23. The method of claim 16 wherein the applied tourniquet cuff encircles a region of a patient'"'"'s scalp.

24. A method for regulating tourniquet cuff pressure based on a personalized tourniquet pressure (PTP), comprising:

during a first time period, estimating a distal occlusion pressure (DOP) by determining a minimum pressure at which penetration of blood past an applied tourniquet cuff is stopped,

measuring a first pulsation characteristic associated with the DOP,

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

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

25. The method of claim 24 wherein estimating the DOP includes sensing a characteristic of blood that penetrates past the applied tourniquet cuff.

26. The method of claim 24 wherein estimating the DOP includes sensing in an inflatable bladder of the cuff a series of pulsation characteristics from which at least one of the first and second pulsation characteristics is selected.

27. The method of claim 24 including producing an alert if the procedure pulsation characteristic is outside a predetermined range.

28. The method of claim 24 wherein the applied tourniquet cuff encircles a region of a patient'"'"'s scalp.

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

applying a tourniquet cuff having a bladder to a patient at a location;

during a first 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 distal occlusion pressure (DOP) at the location;

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

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

30. The method of claim 29 wherein applying a tourniquet cuff comprises applying the tourniquet cuff at a location proximal to a portion of a limb.

31. The method of claim 29 wherein applying a tourniquet cuff comprises applying the tourniquet cuff at a location proximal to a region of a patient'"'"'s scalp.

32. The method of claim 29 further comprising determining a noise level associated with pressure fluctuations in the bladder that are independent of the pressure pulsations analyzed for the estimation of DOP.

33. The method of claim 29 wherein establishing comprises compensating for effects of a noise level above a threshold level.

34. The method of claim 29 wherein determining a noise level comprises producing an alert perceptible by a user if the noise level is greater than a noise threshold.

35. The method of claim 29 wherein the pressure fluctuations are associated with muscle contractions during the first time period.