Physiologic tourniquet with safety circuit

• US 5,931,853 A
• Filed: 12/04/1997
• Issued: 08/03/1999
• Est. Priority Date: 08/25/1995
• Status: Expired due to Term

• Current Assignee: Zimmer Orthopaedic Surgical Products (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Abatis Medical Technologies Limited
• Inventors: McEwen, James A., Jameson, Michael
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/793,411
• Time in Patent Office: 607 Days
• Field of Search: 606/201-203, 128/DIG. 12-DIG. 13, 604/30, 604/31, 604/65-67
• US Class Current: 606/203
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 5/02255 the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence

Abstract

A configuration register is incorporated into an electrically powered tourniquet apparatus for enabling an operator to change the values of parameters initially employed at the time of the next use of the apparatus, such as the initial pressure settings and elapsed time limits. These changed initial values of parameters are stored in memory and remain there despite inadvertent or intentional interruption of electrical power to the apparatus. An event register provides capability for recording the occurrence of events (cuff inflation, cuff deflation, etc.) and for relating the occurrence of the events to hazards and undesirable outcomes such as nerve damage associated with tourniquet usage. A safety circuit is included to detect and respond safely to certain failures which are possible within the tourniquet apparatus.

Claims

1. An electrically operated physiologic tourniquet system, comprising:

a pressurizing cuff for encircling and applying pressure to a limb;

selector means for permitting an operator to select an initial reference pressure level;

configuration register means for enabling the operator to record in a memory the selected initial reference pressure level, wherein the memory retains the recorded initial reference pressure level irrespective of whether the power to the system is interrupted;

the configuration register means including selector read means for periodically determining whether the operator has changed the initial reference pressure level; and

regulator means for retrieving from the memory at the beginning of each use of the system the last recorded initial reference pressure level, and for regulating the pressure in the cuff to be near the retrieved initial reference pressure level,

the regulator means including recommended cuff pressure means for determining the minimum pressure applied by the cuff to the limb that prevents blood flow past the cuff, and for determining as a function of the minimum pressure a recommended cuff pressure to be applied by the cuff, and for enabling the operator to record the recommended cuff pressure in memory as the initial reference pressure level.

2. The system of claim 1 further comprising timing means for retrieving from memory at the beginning of each use of the system an initial time limit during which the cut should be applied;

the selector means permitting an operator to change the initial time limit; and

the configuration register means detecting changes to the initial time limit and permitting the operator to record in the memory the changed time limit as the initial time limit, wherein the memory retains the initial time limit irrespective of whether power to the system is interrupted.

3. The system of claim 1 wherein the selector means includes operator interface means for displaying to an operator menu selections from which the operator may select the initial reference pressure level.

4. The system of claim 2 wherein the selector means includes operator interface means for displaying to an operator menu selections from which the operator may select the initial time limit.

8. The system of claim 1 wherein the initial reference pressure level selected by the operator is a pressure estimated by the operator to be sufficient to stop blood flow past the cuff.

9. The system of claim 1 wherein the selector means includes operator interface means for enabling the operator to select any one of a predetermined number of initial reference pressure levels and for enabling the operator to generate a record signal, and wherein the configuration register means responds to the record signal by recording in memory the selected initial reference pressure level.

5. An electrically operated physiologic tourniquet system, comprising:

an inflatable and deflatable cuff;

selector means for displaying to an operator selections of initial time limits and for permitting the operator to select one of the displayed initial time limits and to change the selected one of the initial time limits;

configuration register means for enabling an operator to record in a memory the selected initial time limit and for periodically determining whether the operator has changed the selected initial time limit, wherein the memory retains the last recorded initial time limit irrespective of whether power to the system is interrupted; and

timing means for retrieving from the memory at the beginning of each use of the system the last recorded initial time limit, for monitoring a time period, and for alerting the operator when the time period equals the time limit.

6. The system of claim 5 including:

control means for establishing and monitoring the values of a plurality of system operating parameters; and

event register means for recording in the memory the values of the parameters.

7. The system of claim 5 including:

control means for establishing and monitoring the values of a plurality of system operating parameters; and

event register means for providing a readable record of the values of the parameters.

10. A physiologic tourniquet system comprising:

an inflatable and deflatable cuff for encircling and applying pressure to a limb;

at least one pressure source selectably pneumatically connected to the cuff;

at least one exhaust line selectably connected to the cuff;

a microprocessor that determines when to inflate the cuff, deflate the cuff, or regulate the pressure in the cuff, and that produces a cuff mode signal having one of a plurality of predefined signals indicative of whether to inflate, deflate or regulate the pressure in the cuff;

a first inlet valve responsive to a first inlet valve actuation signal and a first inlet valve deactuation signal from the microprocessor, wherein the first inlet valve is opened by the first inlet valve actuation signal to pneumatically connect the pressure source to the cuff, or deactuated by the first inlet valve deactuation signal to close the pneumatic connection between the cuff and pressure source;

a first inlet valve status output signal from the first inlet valve to indicate whether the first inlet valve is actuated or deactuated; and

a safety circuit that monitors the cuff mode signal and the first inlet valve status output signal for undesired combinations of cuff mode signal and first inlet valve status output signal and produces a fault signal if an undesired combination is detected.

11. The apparatus of claim 10 wherein production of the fault signal prevents actuation of the first inlet valve.

12. The apparatus of claim 10 further comprising:

a second inlet valve responsive to a second inlet valve actuation signal and a second inlet valve deactuation signal from the microprocessor, wherein the second inlet valve is opened by the second inlet valve actuation signal to pneumatically connect the pressure source to the cuff, or closed by the second inlet valve deactuation signal;

a second inlet valve status output signal from the second inlet valve to indicate whether the second inlet valve is actuated or deactuated; and

wherein the safety circuit further monitors the second inlet valve status output signal for undesired combinations of cuff mode signal and first and second inlet valve status output signals and produces a fault signal if an undesired combination is detected.

15. The apparatus of claim 12 further comprising:

a first exhaust valve responsive to a first exhaust valve actuation signal and a first exhaust valve deactuation signal from the microprocessor, wherein the first exhaust valve is opened by the first exhaust valve actuation signal to pneumatically connect the cuff to the exhaust line, or deactuated by the first exhaust valve deactuation signal to close the pneumatic connection between the cuff and the exhaust line;

a first exhaust valve status output signal from the first exhaust valve to indicate whether the first exhaust valve is actuated or deactuated;

a second exhaust valve responsive to a second exhaust valve actuation signal and a second exhaust valve deactuation signal from the microprocessor, wherein the second exhaust valve is opened by the second exhaust valve actuation signal to pneumatically connect the cuff to the exhaust line, or deactuated by the second exhaust valve deactuation signal;

a second exhaust valve status output signal from the second exhaust valve to indicate whether the second exhaust valve is actuated or deactuated; and

wherein the safety circuit further monitors the first and second exhaust valve status output signals for undesired combinations of cuff mode signal and first and second exhaust and inlet valve status output signals and produces a fault signal if an undesired combination is detected.

16. The apparatus of claim 15 wherein the safety circuit produces the fault signal:

when the cuff is in a cuff inflating mode and is connected to the exhaust line or disconnected from the pressure source;

or

when the cuff is in a cuff deflating mode and is connected to the pressure source or disconnected from the exhaust line;

or

when the cuff is in a regulating mode and is simultaneously connected to both the pressure source and the exhaust line.

17. The apparatus of claim 16 wherein production of the fault signal prevents actuation of any of the first or second exhaust or inlet valves.

13. A physiologic tourniquet system comprising:

an inflatable and deflatable cuff for encircling and applying pressure to a limb;

at least one pressure source selectably pneumatically connected to the cuff;

at least one exhaust line selectably connected to the cuff;

a microprocessor that determines when to inflate the cuff, deflate the cuff, or regulate the pressure in the cuff, and that produces a cuff mode signal having one of a plurality of predefined signals indicative of whether to inflate, deflate or regulate the pressure in the cuff;

a first exhaust valve responsive to a first exhaust valve actuation signal and a first exhaust valve deactuation signal from the microprocessor, wherein the first exhaust valve is opened by the first exhaust valve actuation signal to pneumatically connect the cuff to the exhaust line, or deactuated by the first exhaust valve deactuation signal to close the pneumatic connection between the cuff and the exhaust line;

a first exhaust valve status output signal from the first exhaust valve to indicate whether the first exhaust valve is actuated or deactuated; and

a safety circuit that monitors the cuff mode signal and the first exhaust valve status output signal for undesired combinations of cuff mode signal and first exhaust valve status output signal and produces a fault signal if an undesired combination is detected.

14. The apparatus of claim 13 further comprising:

a second exhaust valve responsive to a second exhaust valve actuation signal and a second exhaust valve deactuation signal from the microprocessor, wherein the second exhaust valve is opened by the second exhaust valve actuation signal to pneumatically connect the cuff to the exhaust line, or deactuated by the second exhaust valve deactuation signal to close the pneumatic connection between the cuff and the exhaust line;

a second exhaust valve status output signal from the second exhaust valve to indicate whether the second exhaust valve is actuated or deactuated; and

wherein the safety circuit further monitors the second exhaust valve status output signal for undesired combinations of cuff mode signal and first and second exhaust valve status output signals and produces a fault signal if an undesired combination is detected.

18. A physiologic tourniquet system, comprising:

an inflatable and deflatable cuff;

a microprocessor that determines when to inflate the cuff, deflate the cuff, or regulate the pressure in the cuff, and that produces a cuff mode signal having one of a plurality of predefined levels indicative of whether to inflate, deflate or regulate the pressure in the cuff;

a regulator responsive to the cuff mode signal for inflating the cuff, deflating the cuff and regulating the pressure in the cuff; and

a safety circuit operable independently of the microprocessor and responsive to the cuff mode signal and having a plurality of stored levels for the cuff mode signal, wherein the safety circuit operates by comparing the level of the cuff mode signal to the plurality of levels for the cuff mode signal and produces a microprocessor fault signal when the cuff mode signal level does not correspond to one of the sets of stored levels.

19. An electrically operated physiologic tourniquet system, comprising:

an inflatable and deflatable cuff for encircling and applying pressure to a limb;

a pressure source for supplying pressurized gas to the cuff;

first and second valves through which the pressure source is independently connected to the cuff;

regulator means for producing a cuff mode signal and first and second inlet valve actuation signals; and

wherein the pressure source is selectively pneumatically connected to the cuff through actuation of the first or second valves by the regulator means, and a safety circuit senses preset undesired combinations of the cuff mode signal and actuation of the first and second valves, and produces a fault signal in response to detection of any of the undesired combinations; and

wherein the cuff is connected to an exhaust line through actuation of separate third or fourth valves by the regulator means, and the safety circuit senses preset undesired combinations of the cuff mode signal and actuation of the third and fourth valves, and produces the fault signal in response to detection of any of the undesired combinations of the cuff mode signal and actuation of the third and fourth valves.