JP2016516474A - Multi-mode inflatable limb occlusion device - Google Patents

Abstract

The multi-mode inflatable limb occlusion device (100, 200), including the controller (110, 210) for inflation of the limb occlusion cuff (180, 280), has the following three modes of operation: Configured to operate in at least two of a tourniquet mode to block during a period, a remote conditioning mode for periodic occlusion and release of limb blood flow, and a blood pressure monitoring mode for detecting a subject's blood pressure The [Selection] Figure 7

Description

Cross-reference data This application is a co-pending application of the present applicant entitled “Dual-Mode Remote Ischemic Preconditioning Devices and Methods” filed Jan. 17, 2012. This is a continuation-in-part of US Patent Application No. 13 / 351,257. This application is filed on Jan. 31, 2012, filed on Jan. 31, 2012, entitled “Automated Devices for REMOTE ISCHEMIC PRECONDITIONING”, co-pending US patent application Ser. No. 362,039, which is a continuation-in-part application, and the former further filed on June 22, 2010, “Methods and Devices for Remote Ischemic Preconditioning and Nearly Continuous Blood Pressure Monitoring (METHODS AND DEVICES FOR REMOTE). US patent application Ser. No. 12 / 820,273 entitled “ISCHEMIC PRECONDITIONING AND NEAR-CONTINUOUS BLOOD PRESURE MONITORING” No. 8,114,026, which is a continuation application, which was further entitled “Blood Pressure Cuff Incorporating Device A PRECORDIONING DEVICE” filed on June 23, 2009. United States provisional application 61 / 219,536 and United States filed October 29, 2009 entitled “AMI and preconditioning devices for use in AMI and PERCUTANEOUS INTERVENTION SETTINGS” Claims the benefit of priority of provisional patent application 61 / 256,038, all cited documents are hereby incorporated by reference in their entirety. It is incorporated.

  The present invention relates generally to limb occlusion devices. In particular, the present invention describes a limb occlusion device that can perform one or more functions, for example, as a limb occlusion tourniquet, as a blood pressure monitor, and as a device for automatically performing a remote conditioning procedure.

  An inflatable limb occlusion device generally includes a cuff sized for placement around a limb, such as the subject's upper arm or thigh, and is operatively connected to or incorporated into the cuff, as desired. And a controller configured to inflate and deflate the cuff to achieve the function. An example of such a function is to slowly inflate and deflate the cuff while recording oscillometric oscillations (also known as oscillometric envelopes) that can determine the subject's systolic, diastolic and mean arterial pressures. By detecting the blood pressure of the target. See FIG. Another example of such a desirable function is, for example, to stop blood flow to the limb to provide a bloodless area during knee surgery, or to stop blood loss from a bleeding limb As an emergency tourniquet designed for it, it is to provide longer limb occlusion. Yet another example of such a desirable function is to perform a therapy called remote conditioning.

  The term “remote conditioning” is used in this disclosure to represent a recently discovered therapy in which blood flow is restored after one or more limbs have undergone a series of intermittent blood flow obstructions. . The terms “limb occlusion” and “arrest” of blood flow are used in this disclosure to represent a 90% or greater reduction in limb blood flow compared to unrestricted blood flow. In a typical scenario, blood flow to a limb such as the upper arm or thigh is occluded for 5 minutes and then released for 5 minutes. This treatment cycle may be repeated 4 times so that the entire procedure lasts about 40 minutes. The duration or each occlusion and each release, and the number of treatment cycles can vary, and each occlusion and each release lasts from about 1 minute to about 20 minutes each, and the number of treatment cycles is 2-20 times Good. “Teleconditioning” therapy depends on whether this procedure is performed before or after treatment of an initial occlusion event (eg, acute myocardial infarction or stroke) or such event involving blood flow restoration to the target organ, Referred to in literature as “ischemic conditioning”, “remote ischemic conditioning”, “remote ischemic perconditioning”, “remote ischemic preconditioning”, “remote ischemic perconditioning”, or “remote ischemic postconditioning” Sometimes. In any case, all these modes are generally referred to herein as remote conditioning.

  Teleconditioning therapy has proven clinically beneficial in a variety of situations using manually operated blood pressure cuffs. Many of these situations are related to clinical situations in which perfusion (normal blood flow to the target organ or tissue) is temporarily interrupted, resulting in ischemia (insufficient oxygen delivery to the organ). This may occur deliberately, for example during surgery, or may result from a disease such as a heart attack or stroke. Perfusion recovery is known to cause so-called ischemia-reperfusion injury, which further exacerbates the original ischemic injury and increases the infarct area by as much as 50%. Prevention or at least alleviation of ischemia-reperfusion injury has valuable clinical benefits, and remote conditioning has been shown to be the most powerful known method of providing this benefit.

  Of note, more than 100 published remote conditioning clinical trials for more than 10,000 patients worldwide have reported side effects or complications associated with this non-invasive procedure. The lack of it makes its use particularly attractive and safe.

  Although inflatable cuffs can be used to achieve all three of the above-described modes (limb tourniquet, blood pressure monitor, and remote conditioning device), they are configured to achieve two or more of these modes There are no known devices. Independent blood pressure monitors, independent limb occlusion tourniquets, and independent remote conditioning devices are well known. However, in many clinical situations, it can benefit the subject if more than one modality is performed by the same device on the same limb. Accordingly, there is a need for a multi-mode inflatable limb occlusion device that can provide any two or all three modes of operation described above.

  Accordingly, by providing a novel method of adaptive limb occlusion that allows automatic determination of minimum cuff occlusion pressure and periodic adjustment of minimum cuff occlusion pressure to follow changes in the subject's blood pressure. It is an object of the present invention to overcome these and other deficiencies.

  Another object of the present invention is to provide a novel inflatable limb occlusion device that can operate in any two or all three modes of operation of limb tourniquets, blood pressure monitors, and remote conditioning devices. is there.

  A further object of the present invention is to provide a self-supporting multi-mode limb occlusion device that can operate as a high performance tourniquet once activated, and this tourniquet cuff is minimal to stop bleeding from the limb. Inflated to occlusion pressure. Such optimal cuff pressure may be determined automatically by the device or may be adjusted in response to changes in the subject's blood pressure.

  A further object of the present invention is to provide a multi-mode inflatable limb occlusion device that is configured to be self-supporting and is incorporated in or on the cuff such that no wires or tubes extend from the device to an external controller. It is to be.

  A further object of the present invention is to provide a multi-mode inflatable limb occlusion device incorporating a hospital grade patient monitor or home blood pressure monitor, wherein the cuff is pneumatically driven and attached to the controller with a tube. It is.

  Yet another object of the present invention is to provide a multi-mode device configured to operate during orthopedic surgery by providing a tourniquet function for the duration of the surgery after first performing remote conditioning on the subject. That is.

  The multi-mode inflatable limb occlusion device of the present invention generally includes a cuff and a controller. The cuff may be sized to tightly wrap around a limb such as the subject's upper arm or thigh. In some embodiments, the cuff width and length may be selected to be the same as a standard blood pressure cuff. In other embodiments, the cuff width may be greater than the standard cuff width. In still other embodiments, the cuff may include one bladder, while in other embodiments, it includes two bladders, with one bladder being proximal to the other bladder along the limb of the subject. May be. One or two bladders are not physical bladders contained within a layer of cuff fabric, but a bladder is formed by sealing two layers of cuffs, thereby reducing the thickness of the cuff. It may be incorporated into the cuff itself using a design concept called “rescuff”.

  The controller may include a power source such as a rechargeable or disposable battery or a permanent power source using an AC line. The controller includes at least one pressure sensor configured to monitor internal cuff pressure, an air pump for inflating the cuff, a number of valves configured for cuff expansion and controlled deflation, and a main A central processing unit that may include a CPU and a secondary CPU, an optional display, and a user interface including a START button and optional mode selection or other buttons may also be included. Details of these facilities are described in the applicant's earlier patent application cited above.

Methods for limb occlusion of an adaptable subject are disclosed, one of these methods:
(A) determining the systolic blood pressure of the subject, for example by inflating a cuff placed around the limb of the subject;
(B) calculating a limb occlusion pressure using the systolic blood pressure determined in step (a);
(C) inflating the cuff to a pressure equal to or higher than the limb occlusion pressure calculated in step (b) over the cuff inflation period to cause limb blood flow to stop, wherein the cuff inflation period is at least 1; Lasts minutes, steps;
(D) reducing the cuff pressure sufficiently to determine the subject's updated systolic blood pressure at least once during the cuff inflation period;
(E) calculating an updated limb occlusion pressure using the updated systolic blood pressure determined in step (d);
(F) inflating the cuff to a pressure greater than or equal to the updated limb occlusion pressure calculated in step (e).

  Step (d) of the method may further comprise reducing the cuff pressure over one or several consecutive heartbeats until the amplitude of the detected oscillometric vibration reaches or exceeds a predetermined threshold.

  Steps (d)-(f) are repeated on a schedule throughout the cuff inflation period, thereby causing the cuff pressure to track the subject's varying blood pressure.

  Steps (c) and (f) further reduce the cuff to a pressure that exceeds the limb occlusion pressure by a predetermined safety width, eg, 1 mmHg, 5 mmHg, 10 mmHg, 15 mmHg, 20 mmHg, 30 mmHg, 50 mmHg, 70 mmHg or any intermediate value. You may carry out by expanding.

  By keeping the predetermined safety margin small and frequently detecting the subject's updated systolic blood pressure, it becomes possible to occlude the limb with the lowest cuff pressure, thereby reducing tissue compression, pain, and nerve compression. Risk and other complications that occur after removal of the cuff can be minimized.

  According to some embodiments of the present invention, for example, in a tourniquet mode, the subject's limb occlusion may be performed once for a long period of up to 3 hours. In other embodiments, shorter limb occlusions may be performed multiple times, alternating with periods of limb reperfusion (where blood flow is at least partially restored), such as when performing remote conditioning therapy. Also good.

In some embodiments, another method for limb occlusion of an applicable subject is disclosed, the method comprising:
(A) providing a cuff disposed about the limb, the cuff being configured to define a limb occlusion pressure below the subject's systolic blood pressure;
(B) inflating the cuff to a pressure above the subject's limb occlusion pressure for a cuff inflation period lasting at least 1 minute;
(C) continuously or intermittently monitoring the cuff pressure to verify that the cuff pressure is less than or equal to the subject's systolic blood pressure;
(D) when the cuff pressure is equal to or lower than the target systolic blood pressure and the cuff pressure is equal to or higher than the target limb blockage pressure, the step of inflating the cuff to a pressure exceeding the limb blockage pressure by a predetermined safety width; Including
This maintains cessation of blood flow to the limb throughout the cuff inflation period.

  Step (a) of the method may include providing a cuff having a cuff width: cuff perimeter ratio of 1: 3 or greater.

  Step (b) includes the additional step of inflating the cuff to a sufficiently high pressure to determine the subject's systolic blood pressure, and then the cuff dimensions as described in the applicant's earlier patent application cited. And an optional additional step of calculating limb occlusion pressure using the systolic blood pressure information.

  Step (b) includes inflating the cuff to a pressure that exceeds the limb occlusion pressure by a predetermined safety width, and then at least once or on a schedule until a new systolic pressure is detected in step (c). A step of deflating the cuff based thereon.

  Step (c) further monitors the amplitude of the oscillometric vibration as indicating that the cuff pressure has reached the systolic blood pressure level when the amplitude of the oscillometric vibration increases from the noise level and reaches a predetermined threshold. May be included.

  The method minimizes the cuff pressure required to maintain limb occlusion by selecting a more frequent check of systolic blood pressure in step (b) and reducing the safety margin in step (d). The method may further include the step of:

The controller may be configured to operate in at least two of the following three modes of operation:
(A) the controller can be configured to inflate and deflate the cuff according to a remote conditioning procedure protocol comprising two or more treatment cycles, each treatment cycle comprising:
i. A cuff inflation period during which the cuff can be inflated and maintained at a pressure above the subject's limb occlusion pressure for at least about 1 minute;
ii. A remote conditioning mode, including a cuff contraction period during which the cuff may contract to at least partially restore limb blood flow,
(B) the tourniquet mode, wherein the controller can be configured to inflate the cuff over a predetermined or manually set cuff inflation period that lasts at least one minute of the limb occlusion pressure; and (c) the blood pressure of the subject Blood pressure monitoring mode that can be configured to detect.

  Repeated remote conditioning treatments in subjects with or at risk for blindness in an amount and frequency sufficient to prevent or prevent blindness (also called acquired blindness) Also disclosed is a method for reducing the likelihood of blindness or preventing blindness by performing.

  Further disclosed is a method of suppressing inflammation in a subject at risk of inflammation or having a known inflammation by repeatedly performing remote conditioning therapy at a frequency sufficient to inhibit inflammation. Such inflammation may be short-term, such as after a major surgery, or it may be long-term, for example, chronic inflammation of the joint.

  Further disclosed is a method of improving local circulation to an organ that may suffer from circulatory disorders by repeatedly performing a remote conditioning therapy regimen at a frequency and intensity sufficient to improve local circulation to the affected organ.

  The subject matter is particularly pointed out and distinctly claimed in the concluding portion of the specification. These and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. With the understanding that these drawings are merely illustrative of some embodiments according to the present disclosure and therefore should not be construed as limiting the scope of the present disclosure, the present disclosure may be used with the accompanying drawings. More specific and detailed description will be given below.

1 is an overview of the device of the present invention on a subject. It is the chart which showed the conventional oscillometric method which detects the blood pressure of object using an inflatable cuff. It is the chart which showed the concept of the intentional change (dithering) of the cuff pressure by the controller of the device by this invention. 4 is a chart showing details of oscillometric vibration when the cuff pressure is varied as shown in FIG. 3. Figure 2 is a self-supporting embodiment of the device of the present invention suitable for emergency use. 1 is an overview of a device configured for use in conjunction with a hospital patient monitor. 1 is an overview of a device configured for home use. 1 is a general configuration of a device configured for use during orthopedic surgery. A controller placed around two limbs of a subject and connected to two cuffs, one cuff operated in remote conditioning mode and the other cuff operated in tourniquet mode.

  The following description sets forth various examples along with specific details in order to provide a thorough understanding of claimed subject matter. However, it will be appreciated by persons skilled in the art that the claimed subject matter may be practiced without one or more of the specific details disclosed herein. In addition, well-known methods, procedures, systems, and / or components have not been described in detail in order to avoid unnecessarily obscuring the claimed subject matter. The illustrative embodiments described in the detailed description and claims are not meant to be limiting. Other embodiments may be utilized and other changes may be made without departing from the spirit and scope of the subject matter presented herein. It will be appreciated that aspects of the present disclosure generally described herein may be modified, substituted, combined, and designed in a wide variety of configurations, all of which are explicitly contemplated and disclosed herein. Part of

  FIG. 1 shows an overview of the device 100 on the subject, with a close-up of the device 100 shown generally in FIG. Device 100 includes an inflatable cuff 180 that is operably connected to or incorporates controller 110. As described in Applicant's earlier patent application, the cuff 180 may have one inflatable bladder, or one bladder located distal (lower place on the limb) and the other bladder closer. It may include two inflatable bladders located in close proximity, located higher (on the limb, closer to the heart). The controller 110 may include a programmable processor capable of executing a program of steps to cause controlled inflation and deflation of the cuff. The controller 110 also includes a pneumatic assembly having an air pump configured to execute commands from the processor to inflate and deflate the single or multi-blader cuff 180.

  Specific configurations of the device 100 configured for various clinical applications are discussed in more detail in the following sections of the description.

Blood pressure detection during blood flow arrest Importantly, the controller automatically inflates the cuff to the appropriate cuff pressure over one or more cuff inflation periods so that blood flow arrest of the subject's limb occurs at the desired interval You may be comprised so that it may make. The following describes a method for selecting cuff inflation, subject blood pressure detection, and optimal (minimum) cuff inflation pressure.

  FIG. 2 illustrates a known oscillometric method of detecting a subject's blood pressure using an inflatable cuff. The cuff is slowly inflated or deflated while monitoring the oscillometric vibration and detecting the amplitude. The point at which the oscillometric amplitude reaches a maximum is determined to correspond to a cuff pressure equal to the subject's mean arterial pressure (MP). The systolic blood pressure (SBP) is then determined by calculating the systolic vibration amplitude as a predetermined percentage of the maximum vibration amplitude.

  Importantly, small oscillations in the oscillometric curve can still be observed at cuff pressures higher than the systolic pressure. These small vibrations cause the cuff's upper part to still be exposed to the pulsating blood of the arterial vessels above the occlusion, even though the vessel under the cuff is completely occluded to stop blood flow. Caused mainly by edge effects.

The present invention provides a method for determining a subject's systolic blood pressure without compromising limb blood flow arrest,
(A) providing a cuff sized for placement around the subject's limb, the cuff being configured to define a limb occlusion pressure below the subject's systolic blood pressure; (E.g. selected to be wide enough), steps;
(B) determining a systolic blood pressure of the subject by inflating a cuff disposed around the limb of the subject;
(C) The cuff is slightly lower (by about 1 to 15 mmHg) than the systolic blood pressure calculated in step (b), or the systolic phase calculated in step (b) to cause limb cessation of blood flow. Inflating over a cuff inflation period to a blood pressure or a pressure slightly higher than the systolic blood pressure calculated in step (b), the cuff inflation period lasting at least 1 minute;
(D) sufficiently reducing the cuff pressure at least once during the cuff inflation period without compromising cessation of limb blood flow to determine the subject's updated systolic blood pressure;
(E) The cuff is slightly lower than the updated systolic blood pressure calculated in step (d), the updated systolic blood pressure calculated in step (d), or the updated systolic blood pressure calculated in step (d). Inflating to a pressure slightly above the systolic blood pressure.

  The method of properly selecting the cuff to ensure that the limb occlusion pressure is below the target systolic pressure is described in more detail in the earlier patent application of the present applicant cited.

  Step (d) of the method increases the detected oscillometric vibration amplitude to a predetermined threshold and the cuff pressure is below the updated systolic blood pressure but at least above the corresponding limb occlusion pressure of the subject. It may further include the step of reducing the cuff pressure until indicated, so that an updated systolic blood pressure can be determined without compromising limb cessation of blood flow.

  In some embodiments, providing a sufficiently wide cuff ensures that cessation of blood flow continues even if the cuff pressure is reduced to the updated systolic blood pressure or below several mmHg. With this cuff pressure, it can be detected that the amplitude of vibration is greater than or equal to a predetermined threshold, but the blood flow is still stopped because the cuff pressure has not dropped below the updated limb blockage pressure.

  FIG. 3 shows a general approach to changing the cuff pressure according to the present invention. When the cuff is selected to be sufficiently wide, the limb occlusion pressure is lower than the systolic blood pressure, as seen in FIG. With the standard cuff width of inflatable cuffs used in conventional blood pressure monitors, the limb occlusion pressure can be about 3-10 mmHg lower than the subject's systolic blood pressure.

  FIG. 3 shows a pair of generally parallel linear charts showing the subject's blood pressure and limb occlusion pressure and systolic blood pressure, in which limb occlusion pressure and systolic blood pressure are stable throughout the cuff inflation period. Is shown as being.

  First, the cuff may be inflated to a pressure equal to or higher than the first determination level of systolic blood pressure. Thereafter, the cuff pressure may be reduced at least once (or a plurality of times such as periodically in some embodiments) to a level that is not more than the systolic blood pressure but is still not less than the limb occlusion pressure. Due to the decrease in the cuff pressure, the updated systolic blood pressure can be detected as described below. Once the updated systole is determined, it is slightly lower than the updated systolic blood pressure by a predetermined safe margin, updated systolic blood pressure, or slightly higher than the updated systolic blood pressure by a predetermined safe margin The cuff pressure may be increased to a level, an updated limb occlusion pressure, or a level slightly higher than the updated limb occlusion pressure by a predetermined safety width. Once the target cuff pressure has been reached, the controller may be configured to repeat the process of updating systolic blood pressure information or to maintain the cuff pressure stably over a predetermined time. After the retention time has elapsed, the process of detecting the updated systolic blood pressure may be repeated. In an embodiment, the process of detecting such cuff pressure dithering and the subject's updated systolic blood pressure is 5 seconds, 10 seconds, 20 seconds, 30 seconds, 45 seconds, 1 minute, 3 minutes, 5 minutes It may be repeated every 10 minutes, 30 minutes, 60 minutes or at any frequency in between.

  The desired frequency of updating systolic blood pressure information may depend on the clinical situation and the health of the subject. In some embodiments, the frequency of updates may be fixed and may be programmed such that such updates are performed based on a schedule. In other embodiments, an adaptive schedule of blood pressure updates may be implemented, and in one example, the consistency and stability of systolic blood pressure values in a series of past blood pressure updates may be analyzed. If the systolic blood pressure is stable, the frequency of updates may be reduced. When a strong blood pressure fluctuation is observed, the update frequency may be adaptively increased. In battery-operated devices, frequent updates can cause an undesirable increase in power consumption and shorten the available battery life, so that the air pump and other components of the device can be operated in connection with the determination of the updated blood pressure. The power consumption required for this must be taken into account.

  Steps (c) and (e) further exceed the updated systolic blood pressure, or optionally calculated limb occlusion pressure, by a predetermined safety margin, for example 1 mmHg, 5 mmHg, 10 mmHg, 15 mmHg, 20 mmHg, 30 mmHg, This may be done by inflating the cuff to a pressure that exceeds 50 mmHg, 70 mmHg or any intermediate value.

  FIG. 4 further details a novel method for detecting systolic blood pressure without compromising limb blood flow cessation. FIG. 4 shows two charts, a cuff pressure chart is shown above FIG. 4, and a corresponding oscillometric vibration chart is shown below. The cuff pressure signal may be measured using an appropriate pressure sensor known in the art, and a vibration chart may be extracted therefrom.

As described above, the initial cuff inflation may be performed at a predetermined target pressure that is assumed to be higher than the target systolic pressure, such as 160 mmHg or 200 mmHg. The cuff pressure may then be gradually decreased continuously or in small increments as in FIG. At some point during the initial decrease in cuff pressure, the amplitude of the oscillometric oscillation begins to increase and then reaches a predetermined threshold, indicating that the cuff pressure has reached the systolic blood pressure level (SBP). Once the amplitude of vibration has reached that level and the systolic pressure P _SYS has been determined, the cuff pressure should not be further reduced. Conversely, the controller activates the pneumatic assembly to increase the cuff pressure to a holding pressure P _HOLD equal to or greater than the detected systolic pressure or calculated limb occlusion pressure by a predetermined safety width, thereby The cuff is inflated to the inflated state. When the cuff pressure is increased in this way, the amplitude of the oscillometric vibration decreases to the noise level as shown in FIG.

The controller may be further programmed to initiate a new procedure to detect updated systolic blood pressure immediately after completion of the previous procedure or after a predetermined time interval has elapsed. During this process, the cuff pressure may be gradually decreased again while monitoring the amplitude of the oscillometric vibration. When this amplitude reaches a predetermined threshold, further reduction of the cuff pressure may be stopped and the updated systolic blood pressure P _SYS-UPDATE may be determined. Thereafter, the controller may be programmed to increase the cuff pressure by a predetermined safety width to a new holding pressure value P _HOLD-UPDATE , in this example P _HOLD-UPDATE is illustrated as being higher than the previous value. However, this indicates that the systolic blood pressure has increased from the previous value. If the cuff pressure is increased once more after making this determination, the amplitude of the oscillometric vibration will decrease once again as shown on the right side of FIG. Because cuff pressure is not reduced below the current level of limb occlusion pressure, periodic dithering of cuff pressure (increase or decrease as described above) can be used to reduce systolic blood pressure without compromising cessation of blood flow to the limb. It is possible to frequently detect updated information.

  The oscillometric oscillation may be monitored continuously or intermittently throughout the cuff inflation period, typically during a hold period maintaining the cuff pressure at a stable level. If an increase in amplitude is detected, it may indicate that the subject's systolic blood pressure is increasing. If the amplitude of the oscillometric vibration reaches a predetermined threshold, the systolic blood pressure value is updated and the controller is programmed to inflate the cuff to a new holding pressure that exceeds the updated systolic blood pressure by a predetermined safety width. Good.

  The predetermined threshold value of the oscillometric vibration amplitude indicating the new systolic blood pressure level may be a fixed value derived from a plurality of objects. In other embodiments, this threshold may be derived from the latest record of the subject's complete oscillometric envelope made during full inflation or deflation of the cuff. In this latter case, the maximum value of the oscillometric amplitude may be measured first and designated as indicating the mean arterial blood pressure. Thereafter, a certain part of the value (for example, about 55%) is determined, and this can be used to determine the SBP threshold for the therapy target.

  Depending on the embodiment, other methods of detecting a significant increase in the amplitude of the oscillometric oscillation indicating that the cuff pressure has reached systolic blood pressure may be used. An example of such a method is based on analyzing the rate of increase in amplitude from one heartbeat to the next.

  The device of the present invention is able to occlude the limb with minimal cuff pressure by the method described above, inflating the cuff to stop limb blood flow while tracking variations in systolic blood pressure. This is done by selecting a small safety width (5-20 mm Hg) for inflating the cuff above the detected systolic blood pressure level (or calculated limb occlusion pressure in other embodiments), while This can be accomplished by programming the controller to update information frequently (eg, every 10-30 seconds). Minimal cuff pressure to reduce the risk of nerve and tissue damage by suppressing tissue compression that could otherwise be caused by prolonged limb occlusion at higher cuff pressure, subject pain during cuff inflation It is beneficial. Various specific device configurations will be described below.

High performance tourniquets tourniquets have been used for thousands of years to stop limb bleeding from various injuries, amputations, accidents, and so on. Various types of instant or manufactured free-standing tourniquets are known in the art. Blood loss is a major cause of death in battles and emergency situations where one person may be injured or medical assistance may not be immediately available. The use of tourniquets to stop blood loss from an injured arm or leg is a well-known technique for preventing death in these situations. Once the primary goal of preventing blood loss is achieved, it is desirable to prevent further injury to the limb due to use of tourniquets with excessive pressure and time. In order to minimize mechanical damage to the tissue under the tourniquet, the pressure applied by the tourniquet must be at or slightly higher than that required to stop blood flow. In addition, the tourniquet pressure must be applied evenly and evenly around the limb under the tourniquet so that there are no locally very high or very low pressure areas. To help prevent gangrene and other complications related to the lack of arterial blood flow from the tourniquet to the distal limb segment, a tourniquet pressure of 5 to 5 times after a 2-3 hour arterial blood flow stop period is provided. It is widely accepted that it should be at least partially released for a period of 15 minutes and then added again.

  While mechanical tourniquets, such as various straps and ratchet type tension devices, can apply pressure to the limb, there are limitations with regard to properly applying limb pressure. Controversy over the proper use of such devices continues to be discussed in the literature as there is no simple way to apply the proper degree of limb compression. The ideal compression should not be too loose to risk internal or external bleeding, nor should it be too tight to cause nerve and tissue damage. Proper use of tension tourniquets is not an easy task for experienced medical professionals as well as medically untrained battlefield wounded soldiers.

  The device of the present invention may be conveniently configured to operate as a high performance tourniquet that can be activated by pressing a single START button 130. This device is generally shown in FIG. 5 and is broadly described above. The device includes a cuff 180 and a battery-powered controller 110 incorporated or attached thereto. To serve as a high performance tourniquet, the controller 110 uses the method detailed above and shown in FIGS. 3 and 4 (after the device 100 is placed on the limb and activated) to provide minimum limb occlusion pressure. The cuff may be inflated to a pressure exceeding the limb blockage pressure by a predetermined safety width. The duration of the cuff inflation period may be determined not to exceed 2-3 hours, after which the cuff pressure is automatically released for a short time (partially or all), typically 5-20 minutes, and then the cuff is re- The device may be programmed to inflate and continue the tourniquet function. The display may be configured to communicate to the user the elapsed time of the cuff inflation time, the last measured systolic blood pressure, and other relevant information.

  The controller may be configured to periodically update systolic blood pressure information and adjust the cuff pressure accordingly. The controller detects whether systolic blood pressure has dropped below a predetermined safety limit and activates an optional alarm such as an audio alarm, visual alarm or an alarm that may be transmitted remotely via radio or another wireless transmission You may further comprise so that it may do. Such remote transmission and wireless communication with the central monitoring station may include periodic updates of the subject's blood pressure or heart rate, thereby further facilitating appropriate triage of the patient depending on hemodynamic status. . A GPS location beacon may also be incorporated into the high performance tourniquet of the present invention and used to find injured or injured objects.

  Due to the automation and advanced methods of hemodynamic monitoring, virtually no user skill is required to properly use the tourniquet of the present invention. In many cases, it can also be used by itself. The small size and weight of the device is advantageous for use in various applications such as military scenes, extreme sports, and high altitude climbing. In addition to being simple to use, the device of the present invention conveniently selects the minimum initial cuff inflation pressure and adjusts the cuff pressure during the cuff inflation period as needed to track the subject's blood pressure, Perfusion may be configured to automatically recover over a short time interval to flush out metabolites from the injured tissue.

  In some embodiments, the cuff may include one inflatable bladder, but as described in the applicant's earlier patent application, in other embodiments, the cuff is a proximal inflatable bladder. And a distal inflatable bladder. In dual bladder tourniquets, the distal bladder may be continuously inflated to a fixed or regulated pressure above the limb occlusion pressure or systolic blood pressure. At the same time, the proximal bladder may be inflated and dithered around the systolic blood pressure as described above with respect to FIG. 4 to monitor the subject's varying blood pressure. If a meaningful change in the subject's systolic blood pressure is detected, the cuff pressures of both bladders may be adjusted from time to time.

  Another method of manipulating a dual bladder tourniquet is a distal (lower) while fully inflating and deflating the proximal (higher) bladder to determine systolic blood pressure, mean blood pressure, and diastolic blood pressure values. Use the bladder for blood flow obstruction. After inflating the cuff, start at a level above the limb occlusion pressure, lower to a cuff pressure lower than the limb occlusion pressure, pass through the mean arterial pressure, and further down to the diastolic pressure to perform cuff contraction Just do it. Blood flow to the limb is still stopped by the inflated distal bladder. With this configuration, not only the systolic blood pressure of the target but also the total blood pressure information can be periodically updated.

  In some embodiments, the controller may change the cuff pressure and monitor the resulting increase in distal blood flow to determine if tourniquet use is appropriate in the first place or should continue using the tourniquet. Further, it may be programmed. It is known that tourniquets can be used incorrectly when the level of bleeding is not high enough to cause severe blood loss. In these cases, excessive lengthy tissue compression is often more harmful than profit. The high performance tourniquet of the present invention reduces the risk of severe tissue compression by inflating the cuff to the lowest effective cuff pressure using the techniques described above, while allowing the most appropriate automated manipulation process to be selected. Additional methods of automatically detecting the severity of the may be implemented.

Two types of limb injury may be defined: limb injury with severe amputation of the main blood vessel and limb injury without. Severe damage to major blood vessels can be life threatening. To distinguish between the two types of damage, the controller may be programmed to perform the following steps at least once during the cuff inflation.
(A) inflating the proximal and distal bladders to a pressure above the limb occlusion pressure to prevent any blood loss;
(B) reducing proximal bladder pressure to measure at least a subject's systolic blood pressure, mean arterial pressure or diastolic blood pressure in the absence of blood flow under the tourniquet;
(C) The distal bladder pressure is applied to the limb to at least partially or completely restore blood flow under the tourniquet over a short period (2-30 seconds) over one or more consecutive heartbeats of the subject. Reducing partially or completely below the occlusion pressure,
(D) Record the oscillometric envelope and detect at least the subject's systolic, mean arterial, or diastolic blood pressure while blood flow to the limb is at least partially or fully restored Inflating the bladder again; and (e) comparing each blood pressure measurement or degree of vibration obtained in steps (b) and (d), with a difference above a predetermined threshold being Showing the absence of pressure and the presence of severe damage to the main vessels downstream of the tourniquet.

  Alternatively, both inflatable bladders are first inflated to a pressure above the limb occlusion pressure, and then the proximal bladder pressure is maintained above the diastolic blood pressure of the subject, below the limb occlusion pressure, eg, oscillometric vibration. The controller may be programmed to reduce the mean arterial pressure with the highest amplitude. At this bladder pressure, the portion of the main artery located under the proximal bladder is partially collapsed. The controller should then be programmed to release the downstream limb pressure partially or completely and reduce the distal bladder pressure below the limb occlusion pressure to restore blood flow at least partially or completely. That's fine. By observing the amplitude of vibration under the proximal bladder, the extent of vascular damage can be determined, and if the amplitude decreases below a predetermined threshold, there is little or no back pressure downstream of the tourniquet, and there is damage. It turns out to be severe. On the other hand, if the amplitude has not changed much, the damage may be minor and the cuff may be removed safely.

Three-in-one high performance tourniquet A more advantageous configuration of this device is that a single device can be used as an emergency tourniquet, as a blood pressure monitor, or as a remote conditioning execution tool, independently in one, two or all three modes of operation. May include the ability to operate. An appropriate user interface may be provided that allows the user to select one or more desired operating modes.

  The small size and weight of such devices is advantageous not only in military situations, but also in applications where the size and weight of emergency medical instruments are limited.

  During the tourniquet mode, the device of the present invention can operate by inflating the cuff to a manually set pressure or a predetermined pressure, or by the automatic operation described above.

  In the blood pressure monitoring mode, the device can perform conventional inflation and deflation of the cuff and display the resulting blood pressure results to the user. If it is desired that the blood pressure monitoring feature be active during the tourniquet mode or remote conditioning mode, the device may be configured to provide at least a systolic blood pressure value. In some embodiments, the device may provide estimated diastolic blood pressure and estimated mean arterial pressure while the limb is still occluded.

  In the remote conditioning mode, the device of the present invention may operate automatically by periodically inflating the cuff to cause cessation of blood flow to the limb according to the remote conditioning procedure protocol as described above.

  In addition to independent operation in one or two modes of operation simultaneously as described above, the controller may be programmed to provide a predetermined sequence of modes of operation, for example, blood pressure every 5 minutes or every 10 minutes. When the determination is based on a manually set schedule or a pre-programmed schedule, the blood pressure monitoring mode may be automatically entered after completion of the remote conditioning mode or tourniquet mode.

Benefits of patient monitoring remote conditioning therapy with hospital remote conditioning mode of operation include during various surgery including coronary artery bypass surgery, percutaneous coronary intervention, abdominal aortic aneurysm surgery, large kidney or liver surgery, etc. It is attractive in some clinical situations where prolonged blood flow interruption is a scheduled event. In contrast to emergency situations where the disposable device of the present invention is convenient because time is critical and patients are frequently transferred from one department to another, such scheduled events are predictable High nature. In these situations, the subject typically stays in one place and can receive a scheduled remote conditioning therapy using a reusable device configuration.

  This reusable device configuration is generally illustrated in FIG. A hospital grade patient monitor that typically operates to measure a subject's blood pressure using an inflatable cuff may be configured to include a remote conditioning mode of operation. Such devices may use the same or similar hardware as conventional hospital patient monitors and inflatable blood pressure cuffs. Appropriate user interfaces may be added to allow the user to activate the remote conditioning mode for performing remote conditioning as described above and to manipulate the device to inflate and deflate the cuff. While the blood pressure can be monitored using conventional oscillometric methods before or after performing remote conditioning, the new cuff inflation method described above with respect to FIGS. 3 and 4 allows for continued throughout the 40 minute remote conditioning period. Hemodynamic monitoring becomes possible.

  Another advantage of using the method of the present invention is that teleconditioning therapy runs at the lowest cuff pressure, thereby alleviating the subject's discomfort.

  A further advantage of using the method of the present invention with this product configuration is that one patient monitor and one cuff can be used for both hemodynamic monitoring and remote conditioning therapy execution, and blood pressure and other during the remote conditioning execution period. There is no need to add a second monitor and a second cuff to the other arm of the subject to monitor vital signs.

Blood pressure monitor with remote conditioning mode of operation for use at home or in public places Remote conditioning has proven clinical benefit, simplicity and excellent safety profile, so it can be used outside the hospital, for example at home Or you may apply also to the use in a public place.

  The home blood pressure monitor may be configured to provide remote conditioning therapy to subjects where remote conditioning therapy may benefit. One example of such a device 200 is shown generally in FIG. 7 and includes a cuff 280 connected to a controller 210. In contrast to a conventional blood pressure monitor, the controller 210 allows a user to select a mode, such as a button 220 for activation of a conventional procedure for measuring blood pressure and another button 230 for activation of a remote conditioning therapy. An interface may be provided.

  Another configuration of the device includes incorporating a remote conditioning mode using a blood pressure monitoring station available to the public. Such stations are generally available in pharmacies and malls where amateurs can stop by and check their blood pressure. An example of such a device is described in US Pat. No. 4,998,534, incorporated herein by reference.

  As will be described in more detail below, many subjects can benefit from iterative remote conditioning. To provide the public with the benefits of remote conditioning therapy, because the subject does not have the right device at home or may not be willing to do the therapy himself using a manual inflation blood pressure cuff, The blood pressure monitoring station available to the public may be provided with a remote conditioning operation mode. Such a device may be configured to provide remote conditioning procedures as a public service free of charge or in a service-specific fee setting. Conveniently, even if the therapy is performed free of charge, facilities that provide such equipment can still gain commercial benefits from periodic customer flows into the facility. To further increase the economic benefits, an audio or visual message may be provided to the subject during the 40 minute remote conditioning procedure. Such messages may include entertainment, health-oriented information or commercial advertisements.

  Various types of patients can benefit from repetitive remote conditioning, including patients who are known to have an increased risk of heart attack or stroke, elderly patients and diabetics.

  Another category of such patients are those who have recently undergone major surgery. Remote conditioning may release anti-inflammatory substances, and repeated therapy may help speed up recovery and various post-operative healing processes.

  The anti-inflammatory effect of the therapy is to improve various clinical conditions associated with inflammation, not only once, but also as a result of long-term use over weeks, months or even years Can also be used. Examples of such inflammatory conditions include back pain, arthritis, joint pain, neuralgia, other types of nerve impingement, headache, migraine, multiple sclerosis and the like.

  New aspects of this therapy are discovered on a daily basis and may provide other unknown therapies and treatments. In fact, this therapy may also have non-clinical benefits and has been reported to increase human physical ability and resilience, and to increase viability in harsh environmental conditions such as high altitudes and extreme heat.

  Remote conditioning is further believed to provide neurological benefits and protect neurons in the brain and optic nerve that could otherwise be damaged during brain trauma, stroke or as a result of debilitating diseases such as diabetes or glaucoma.

  According to the present invention, repeated remote conditioning can prevent or at least postpone the onset of blindness or acquired blindness as a result of debilitating conditions such as diabetic retinopathy, glaucoma or age-related macular degeneration. it can. These conditions involve damage to optic nerve tissue, mostly as a result of ischemia due to programmed cell death caused by mitochondrial damage.

  Ischemic conditioning is the most powerful method known to protect mitochondria from ischemic damage. According to the present invention, periodic therapy provides a clinical benefit that reduces blindness or at least slows its progression. Therapies twice a day, once a day, twice a week, once a week, once every two weeks, or other intermediate desired frequency, or at a frequency known to be sufficient for this purpose Just do it. In the United States alone, there are about 5 million patients diagnosed with diabetic retinopathy and an additional 25 million diabetic patients at risk for developing this condition. In addition, there are about 3 million patients diagnosed with glaucoma and another 2 million patients diagnosed with age-related macular degeneration. Together, these patients represent a market opportunity for tens of millions of home devices in the United States alone.

  According to the present invention, remote conditioning is further believed to improve long-term blood flow to circulatory organs. Repeated remote conditioning may improve arterial stenosis or other types of arterial narrowing, particularly caused by endothelial dysfunction or at least contributed by endothelial dysfunction. The method of the present invention allows remote conditioning procedures to be performed with sufficient frequency and intensity (number of cycles and duration or limb occlusion) to subjects with local circulatory disturbances (with appropriate dosing) to improve local organ circulation. It includes a step that is iteratively performed.

  The advantage of using an adaptive method of inflating the cuff as described above with all of these treatment methods is adaptable (compared to other cuff inflation methods for remote conditioning with a fixed inflation pressure) The cuff inflation can minimize the cuff inflation pressure and thus reduce the subject's pain. This is particularly beneficial when therapy is performed frequently over a long period of time on a patient population sensitive to fragile pain, such as the elderly.

Orthopedic surgical tourniquet with blood pressure monitoring mode of operation Still another configuration of the device of the present invention is a limb using a tourniquet placed on the leg or arm and inflated for a long time to ensure a bloodless surgical field. Made for use during orthopedic or other surgical operations.

  Devices are known that are configured for determination of limb occlusion pressure using a blood flow sensor placed on a toe of a subject, such as a plethysmographic sensor or a pulse oximetry sensor. An example of such a device is Zimmer Inc. (Automatic Tournic System ATS3000, manufactured by Warsaw, Indiana). The device's controller is configured to inflate the cuff to a point where blood flow is no longer detected by the sensor downstream of the cuff, thereby allowing the controller to detect limb occlusion pressure.

  This design is limited in that limb occlusion pressure can only be determined once before the tourniquet is inflated and surgery begins. If the downstream sensor reduces the cuff pressure sufficiently enough to detect the onset of blood flow, bleeding will occur at the surgical site and it is not possible to repeatedly determine the limb occlusion pressure using the downstream sensor . Since blood pressure can change during surgery, the initial determination of such limb occlusion pressure is to manually adjust the cuff inflation to avoid the possibility of bleeding at the surgical site later when the blood pressure increases. It is usually only used in the position of an advisor who prompts the user to set with a large safety margin for the tourniquet's target cuff pressure.

The present invention addresses this limitation by providing a novel ability to monitor systolic blood pressure upstream rather than downstream of the cuff using the cuff inflation method described above. Such monitoring may be performed one or more times throughout the surgery, and if the systolic blood pressure appears to be up or down, the cuff pressure may be adjusted accordingly. This design has several advantages over previous designs.
-Appropriate initial inflation and periodic adjustment of the cuff pressure can be made automatically and the user only has to start the device operation by pressing a single START button, which greatly increases the use of the device Simplified.
-Determination of systolic blood pressure can be made automatically both before and during surgery.
-A small safety width can be selected that results in a lower cuff inflation pressure.
-The cuff pressure can be adjusted automatically throughout the surgery without further user involvement.
-The current blood pressure can be displayed for the doctor to observe.
-There is no need to place additional sensors on the subject's toes.

  In an embodiment of the present invention, a device is provided that includes a controller operably connected to a cuff sized for placement around a subject's thigh. See FIG. The controller may be configured to inflate the cuff in a tourniquet mode in a manner similar to that described above for a tourniquet designed to control blood loss. The controller may have an automatic mode of operation in which the controller first determines an initial limb occlusion pressure when activated and then cuffs the pressure above its minimum level by a predetermined safety margin. Inflate. The controller may be programmed to automatically reduce the cuff pressure to a point where the amplitude of the oscillometric oscillation reaches a predetermined threshold at least once or periodically throughout the procedure, as detailed above The updated systolic blood pressure is determined and the cuff is inflated to the adjusted cuff pressure target.

  The controller may be programmed to periodically check the current level of the subject's systolic blood pressure throughout the cuff inflation period and automatically adjust the cuff pressure accordingly. By such an operation, it is possible to ensure minimum tissue compression while tracking blood pressure over the operation period.

  In other embodiments, the cuff may have a dual bladder design and the controller may have two ports for operating the bladders separately. In an example tourniquet mode of operation, the proximal bladder may be operated to periodically check the patient's blood pressure, while the distal bladder may be inflated to cause a stoppage of blood flow to the limb. When a blood pressure shift is detected, the cuff pressures of both bladders need only be adjusted accordingly.

Orthopedic surgical tourniquet total knee replacement with remote conditioning mode of operation is one of the most painful procedures after surgery and pain management can be a challenge. Excessive acute pain after total knee arthroplasty can be difficult to rehabilitate early after surgery if not controlled. This pain is typically managed by medication, which can be accompanied by addiction and increased risk of various side effects including sedation, confusion and falls. These side effects are particularly common in older people who make up the majority of those undergoing these procedures. The addition of non-drug adjuvants for improved healing of wounds and pain management that can reduce the use of medication during the early postoperative period after total knee arthroplasty may be beneficial to patient recovery.

  Ischemic reperfusion injury is a known result of stopping blood flow for an extended period of time. Surgical tourniquets placed on the thigh to create a bloodless area for total knee arthroscopic surgery are known to cause such injury upon removal. Ischemic reperfusion injury can increase surgical trauma and result in increased postoperative pain. Ischemic conditioning is a known therapy that generally reduces ischemia reperfusion injury. According to the present invention, ischemic conditioning can also be effective in reducing postoperative pain in knee arthroscopic surgery and improving overall postoperative recovery.

  The device 300 of the present invention is shown generally in FIG. Device 300 includes a controller 310 connected to at least a first cuff 370 disposed about a first limb such as the upper thigh. The first cuff 370 may have a single bladder or dual bladder design as known in the art of inflatable orthopedic tourniquets.

  The controller 310 may be configured to be attached to a second cuff 380 placed around a second limb such as the upper arm. In some embodiments, the controller 310 may have one cuff attachment port adapted to be connected to the cuff 370 or cuff 380 at different times during the procedure. In other embodiments (as seen in FIG. 9), the controller may include two cuff attachment ports and be configured to inflate and deflate cuffs 370 and 380 independently, including overlapping schedules. . In still other embodiments, when the cuff 370 has two inflatable bladders, the controller 310 may use two to operate the dual bladder cuff 370 and one to operate the single bladder cuff 380. You may have an attachment port.

  In embodiments where the controller 310 is attached to a single cuff 370, the controller 310 may be configured to operate first in a remote conditioning mode and then in a tourniquet mode as described above. In other embodiments, the controller 310 may be configured to operate first in tourniquet mode and then in remote conditioning mode to provide the subject with remote postconditioning benefits. During the remote conditioning mode, the cuff 370 may be placed on the limb undergoing surgery (eg, a leg undergoing knee joint replacement) or placed on another limb (eg, the upper arm). Please note that it is good. Of course, the cuff 370 must be moved to the surgical site after remote conditioning is complete.

  In other embodiments, when controller 310 is attached to both cuffs 370 and 380, remote conditioning mode may be activated on cuff 380 while cuff 370 is operated in tourniquet mode. Both modes can be activated independently, for example, remote conditioning with cuff 380 may be initiated prior to inflation of cuff 370 in tourniquet mode. In other embodiments, the timing is such that the remote conditioning ends near the end of knee surgery and cuff 370 contraction, thereby maximizing the benefits of remote conditioning that reduces ischemia-reperfusion injury of the leg tissue. , Cuff dual operation may be performed.

  Although the invention is described herein with reference to specific embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. Accordingly, it should be understood that numerous modifications may be made to the exemplary embodiments and other settings may be devised without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (10)

A multi-mode inflatable limb occlusion device (100, 200), inflating a cuff (180, 280) disposed around the subject's limb to at least limb occlusion pressure, thereby causing blood in the limb It includes a controller (110, 210) configured to cause a flow stop and has the following three modes of operation:
The controller (110, 210) is configured to inflate and deflate the cuff (180, 280) according to a remote conditioning treatment protocol, the treatment protocol including a plurality of treatment cycles, each treatment cycle comprising:
A cuff inflation period in which the cuff (180, 280) is inflated at a pressure above the limb occlusion pressure and maintained for at least about 1 minute;
A remote conditioning mode of operation comprising a cuff contraction period, wherein the cuff (180, 280) is contracted below the limb occlusion pressure, thereby at least partially restoring blood flow in the limb.
A tourniquet mode of operation, wherein the controller (110, 210) is configured to inflate the cuff (180, 280) to at least the limb occlusion pressure over a predetermined or manually set cuff inflation period lasting at least one minute; and,
A blood pressure monitoring mode of operation, wherein the controller (110, 210) is configured to detect blood pressure of the subject;
The controller (110, 210) is configured to operate independently on at least two of the features,
The controller further includes a user interface for selecting and activating one of the three operating modes.
Multi-mode inflatable limb occlusion device (100, 200).   The multi-mode inflatable limb occlusion device (100) of claim 1, wherein the controller (110, 210) is further configured to detect a systolic blood pressure of the subject at least once during the cuff inflation period. , 200).   The controller (110, 210) is further configured to detect an amplitude of oscillometric vibration of the cuff (180, 280), and the systolic pressure is determined when the amplitude exceeds a predetermined threshold. A multi-mode inflatable limb occlusion device (100, 200) according to claim 2.   The controller (110, 210) is further configured to detect the blood pressure of the subject at least once when the controller (110, 210) operates in the remote conditioning mode of operation or the tourniquet mode of operation. Item 4. The multi-mode inflatable limb occlusion device (100, 200) according to item 1.   The controller (110, 210) is configured to operate simultaneously in the blood pressure monitoring operation mode while the controller (110, 210) operates in either the remote conditioning operation mode or the tourniquet operation mode. The multi-mode inflatable limb occlusion device (100, 200) according to claim 1.   The controller (110, 210) expands the cuff (180, 280) at least once during the cuff inflation period to a pressure that is greater than or equal to the subject's limb occlusion pressure but less than the systolic blood pressure. The multi-mode inflatable limb occlusion device (100, 200) of claim 1, further configured to allow.   During the cuff inflation period, the controller (110, 210) sets the pressure of the cuff (180, 280) between the limb occlusion pressure and a holding pressure that exceeds the limb occlusion pressure by a predetermined safety width. The multi-mode inflatable limb occlusion device (100, 200) of claim 1, further configured to dither at least once or periodically within a range of.   The multi-mode inflatable limb occlusion device (100, 200) according to claim 1, wherein the cuff (180, 280) is configured to define the limb occlusion pressure below the systolic blood pressure of the subject. .   The multi-mode inflation of claim 1, wherein the controller (110, 210) is configured to operate in the remote conditioning mode of operation before the controller (110, 210) operates in the tourniquet mode of operation. The limb occlusion device (100, 200).   The controller (110, 210) is further configured to operate in the blood pressure monitoring operation mode before, during or after the controller (110, 210) operates in the remote conditioning operation mode or the tourniquet operation mode. The multi-mode inflatable limb occlusion device (100, 200) according to claim 1.

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