Patent Description:
Hemophilia is a medical condition in which the ability of blood to clot is severely reduced, causing a sufferer to bleed severely from even a slight injury. Deep internal bleeding, especially in the knees, ankles and elbows, can damage organs and tissues, and may be life-threatening. Hemophilia A or "classical hemophilia," is the most common form of hemophilia (<NUM> in <NUM>,<NUM> to <NUM> in <NUM>,<NUM> males worldwide are born with this disorder). Patients with hemophilia A are prone to frequent hemorrhages as a result of a lack of Factor VIII. This congenital deficiency has been successfully treated by infusions of Factor VIII concentrate preparations isolated and purified from either blood plasma of donors having normal levels of Factor VIII, or from cell cultures genetically engineered to express the Factor VIII coagulant protein.

<CIT> discloses an auto-release tourniquet apparatus having a strap, a housing having a first slot therein suitable for receiving a first end of the strap and a second slot suitable for receiving another portion of the strap therein, and a strap releasing mechanism positioned in the housing. The strap releasing mechanism serves to release at least one of the first and second ends of the strap from the housing after a predetermined period of time. A solenoid is positioned in the housing and acts upon the first end of the strap so as to allow for the ejection of the first end of the strap from the first slot after the predetermined period of time. A strap tensioning mechanism is associated with the second slot of the housing for allowing the strap to be suitably tensioned. A switching mechanism is configured to transmit a signal to a microprocessor to start a timer when the strap is tensioned.

<CIT> discloses an aspiration and delivery safety system that includes a blood restriction unit, an inflating unit, a needle unit, and a puncture site press unit. The blood restriction unit is constituted by a plurality of air bands. The needle unit is a syringe or butterfly needle or blood collector or intravenous catheter or arteriovenous fistula needle. The inflating unit has a controller that monitors a patient's blood pressure and heart rate, and records these data by means of a recording device into which a medical person can also input other medical data.

While there is no cure for hemophilia, most hemophilia sufferers can and do lead fairly normal lives by taking infusions of recombinant Factor VIII whenever they bleed (e.g., because of an injury or surgery). Some people strive for "zero days of bleeding" by taking prophylactic infusions, for example, every two days or every three days. In either case, there is a need to track the date and time of a bleed and/or infusion. A hemophilia sufferer can use an application (e.g., one running on their smart phone) to record their bleeding episodes and/or infusions. Every time the person bleeds and/or takes an infusion, they can enter the date and time into the application.

Sometimes, however, a hemophilia sufferer is in a lot of pain when they are bleeding and taking an infusion to stop the bleeding. The pain makes it very difficult for the person to record the date and time of the bleed and/or infusion. Often a hemophilia sufferer is more interested in carrying on with what they were doing before an infusion and they sometimes forgets to record the date and time of their bleed and/or infusion. Incomplete information about bleeds and/or infusions or a delay in delivering this information to a health care provider can lead to misjudging the person's condition or missing a time or window for treating the person. The end result can be pain and suffering or much worse. What is needed is a way from a hemophilia sufferer to record the date and time of a bleed and/or infusion, automatically, with as little intervention as possible.

Accordingly, a smart tourniquet according to the appended independent claim is provided that records, automatically, the date and time of a bleed and/or infusion, each time a patient uses the smart tourniquet for an infusion.

The smart tourniquet includes an elongate member having a first end and a second end. There is a longitudinal axis extending between the first end and the second end. The elongate member is adapted for wrapping about a limb of a patient, such as their arm. The smart tourniquet further includes a recording module. The recording module has a slot extending through it for slidably receiving the elongate member and a fastening end for releasably capturing the second end of the elongate member. When the elongate member is wrapped about the patient's limb and the second end of elongate member is captured by the fastening end and fixed to the recording module, pulling the first end of the elongate member away from the second end in the longitudinal direction tightens the smart tourniquet about the limb. This action also causes the recording module to save a record, including a timestamp of the patient using the tourniquet to self-administer the infusion.

The recording module saves a confirmation timestamp in response to the patient confirming a strength and dosage of the drug. The recording module can include a display and one or more keys for: i) entering the dosage of the drug self-administered by the patient so that the record includes the timestamp and the dosage, ii) inquiring about past records, iii) adjusting the timestamp, iv) changing the language of text displayed by the recording module or v) a combination thereof. The recording module can include a function key, which when depressed and held for at least a pre-defined period of time causes the recording module to save the timestamp of the patient using the tourniquet to self-administer the drug. The recording module can include memory for storing the record and previous records with earlier timestamps of the patient using the tourniquet to self-administer the drug.

The recording module can also include a wireless interface for communicating with a computing device, for example, using BLUETOOTH, WIFI, ZIGBEE or ZWAVE. The recording module can include an audio alarm configured to provide an aural cue in response to the fastening end of the recording module capturing the second end of the elongate member. The recording module can also include a visual alarm configured to provide a visual cue in response to the fastening end of the recording module capturing the second end of the elongate member.

In some examples of the smart tourniquet, the second end of the elongate member and fastening end of the recording module can form a buckle assembly comprising a male portion and a female portion. The recording module can shut off in response to the second end being released from the fastening end.

The smart tourniquet includes an electrode electrically coupled to the recording module for measuring a galvanic skin response. When the smart tourniquet is tightened about the patient's limb, the electrode contacts the patient's skin. The recording module then saves the timestamp in response to the galvanic skin response measured by the electrode.

An associated method for tracking when a patient self-administers a drug includes providing a smart tourniquet, wherein said method does not form part of the claimed invention. The smart tourniquet includes an elongate member having a first end and a second end. There is a longitudinal axis extending between the first end and the second end. The elongate member is adapted for wrapping about a limb of a patient, such as their arm. The smart tourniquet further includes a recording module. The recording module has a slot extending through it for slidably receiving the elongate member and a fastening end for releasably capturing the second end of the elongate member. When the elongate member is wrapped about the patient's limb and the second end of elongate member is captured by the fastening end and fixed to the recording module, pulling the first end of the elongate member away from the second end in the longitudinal direction tightens the smart tourniquet about the limb. This action also causes the recording module to save a record, including a timestamp of the patient using the tourniquet to self-administer the infusion.

The method further includes saving in the recording module a record that includes a timestamp of the patient using the tourniquet to self-administer a drug. Saving the record is in response to the second end of elongate member being captured by the fastening end of the recording module and the tourniquet being tighten about the limb.

Advantageously, using the smart tourniquet can help the patient record when they took an infusion of a drug. Moreover, the usefulness of the smart tourniquet is not tied to particular drug but can be extended to include any drug administered, intravenously, made by any pharmaceutical company. As such, the smart tourniquet can be widely adopted by pharmaceutical companies and patients alike.

Examples of a smart tourniquet for a patient to use to administer medication to themselves are described with reference to the figures. When the patient needs to inject themselves with medication, intravenously, called an "infusion," the patient wears the smart tourniquet around their arm, for example, and tightens the smart tourniquet. Tightening the smart tourniquet helps the patient locate a vein for the infusion. While the patient is using the smart tourniquet, the device can automatically record, the date and time of the infusion, called a "timestamp". The patient can also use the smart tourniquet to record the dosage or "number of units" of medication taken at the time of the infusion. The smart tourniquet can store the timestamp as well as other related information as a record. At a later time, the patient can recall prior records on the smart tourniquet itself. In another example, the smart tourniquet can be synchronized with an application and records can be downloaded from the smart tourniquet for review by the patient, nurse or doctor.

A hemophilia sufferer can use the smart tourniquet to take an infusion of recombinant Factor VIII, such as ADVATE produced by the SHIRE pharmaceutical company. They take the infusion whenever they bleed, which can occur spontaneously or as a result of an injury, to stop the bleeding. In this case, a timestamp of an infusion also represents a date and time of a bleeding episode. As such, any discussion below of the smart tourniquet recording a timestamp of an infusion also applies to recording a timestamp of a bleeding episode. Automatically recording the date and time when a hemophilia sufferer bleeds is particular beneficial because they may be in too much pain to record a bleeding episode themselves or they may forget.

<FIG> shows an example of the smart tourniquet <NUM> having an elongate member <NUM> for wrapping tightly around a patient's limb during an infusion and a recording module <NUM> for recording a timestamp of the infusion (or bleeding episode). The elongate member <NUM> has a first end <NUM> and second end <NUM>, and a longitudinal axis extending between the first and second ends <NUM>, <NUM> (shown in <FIG> as a double-headed arrow labeled LA). The elongate member <NUM> is of a sufficient length of that allows the first end <NUM> to be pulled on while the second end <NUM> is wrapped around the patient's limb. The elongate member <NUM> can be of different lengths to accommodate different limb sizes, for example, a longer elongate member <NUM> for an adult arm and a shorter elongate member <NUM> for a child arm. The elongate member <NUM> can be made of a material that is compatible with the patient's skin, for example vinyl if the patient is allergic to latex.

The recording module <NUM> includes a slot <NUM> (shown in <FIG> in phantom line) through which the elongate member <NUM> can slide. As shown in <FIG>, the long dimension of the recording module <NUM> is aligned with the longitudinal axis LA of the elongate member <NUM>. The recording module <NUM> further includes, along its short dimension, a fastening end <NUM> that is adapted to releasably capture the second end <NUM> of the elongate member <NUM>. To use the smart tourniquet <NUM>, the patient wraps the second end <NUM> of the elongate number <NUM> around a limb, for example their arm, and fastens the second end <NUM> to the fastening end <NUM> of the recording module <NUM>. This forms a loop about the second end <NUM> of the elongate member <NUM> around the patient's limb. The patient pulls the first end <NUM> of the elongate member <NUM> away from the second end <NUM> in the direction of the longitudinal axis (shown in <FIG> as arrow labeled X). This tightens the loop around the around the patient's limb and reduces blood circulation in the limb. The reduction in blood circulation causes veins near the surface of the patient's skin to enlarge and become more pronounced, thereby helping the patient locate a vein for the infusion. After the infusion, the patient can push a release button <NUM> on the recording module <NUM> to uncouple the second end <NUM> of the elongate number <NUM> from the fasting end <NUM> of the recording module <NUM>.

In a convenient example of the smart tourniquet <NUM>, the second end <NUM> of the elongate member <NUM> and the fastening end <NUM> of the recording module <NUM> can form a buckle. The second end <NUM> is the male portion of the buckle and the fastening end <NUM> is the female portion of the buckle. In using this example, fastening the smart tourniquet <NUM> includes inserting the second end <NUM> into the fastening end <NUM>. In an alternative example, the gender of the second end <NUM> and the fastening end <NUM> are reversed, and the fastening end <NUM> is inserted into the second end <NUM> to fasten the smart tourniquet <NUM>.

The smart tourniquet <NUM> can include mechanisms that help the patient use the device correctly. For example, the recording module <NUM> can include an audio alarm configured to provide an aural cue in response to the fastening end <NUM> of the recording module <NUM> capturing the second end <NUM> of the elongate member <NUM>. By way of a non-limiting example, a single chirp from the audio alarm confirms that the smart tourniquet <NUM> is properly fastened around the patient's limb. In contrast, an absent of noise from the audio alarm, signifies that the smart tourniquet <NUM> is not properly fastened around the patient's limb.

In another example of the smart tourniquet <NUM>, the recording module <NUM> can include a visual alarm configured to provide a visual cue in response to the fastening end <NUM> of the recording module <NUM> capturing the second end <NUM> of the elongate member <NUM>. By way of a non-limiting example, a green light from the visual alarm confirms that the smart tourniquet <NUM> is properly fastened around the patient's limb. In contrast, a red light from the visual alarm signifies that the smart tourniquet <NUM> is not properly fastened around the patient's limb. In still yet another example of the smart tourniquet <NUM>, a combination of aural and visual cues can be used to notify the patient whether they are using the device correctly. Advantageous, based on such aural and/or visual cues, the patient can readily know if they are using the smart tourniquet <NUM> correctly.

As described above, the smart tourniquet <NUM> can automatically document a timestamp of an infusion. The smart tourniquet <NUM> records a timestamp when the device is fastened around the patient's arm, for example. In this way, a timestamp is recorded without the patient manually entering a date and time into the smart tourniquet <NUM>. Fastening the smart tourniquet <NUM> around the patient's arm brings the smart tourniquet into contact with the patient's skin. One or more electrodes associated with the smart tourniquet <NUM> measure the conductance of the patient's skin, which is very different than air (as would be case if the smart tourniquet was not fastened around the patient's arm). Upon detecting the galvanic skin response, the smart tourniquet <NUM> records a timestamp. For ease of reference, this timestamp is called the "wakeup timestamp".

The smart tourniquet <NUM> also records the date and time when the patient confirms the strength and dosage of an infusion, which for ease of reference, is called the "confirmation timestamp. " Again, a timestamp is recorded without the patient manually entering a date and time into the smart tourniquet <NUM>. The wake up timestamp and the confirmation timestamp can be used to track when the user has taken an infusion and/or has had a bleeding episode, as will describe in greater detail below.

Additionally, records including the wakeup and confirmation timestamps can be used to identify when information about an infusion/bleeding episode is missing and to remind the patient to provide the missing information. For example, when a record of wakeup timestamp is not followed by a record of a confirmation timestamp, there may be information missing about an infusion/bleeding episode. The smart tourniquet <NUM> or an application associated with the device (an example of such application is described below with reference to <FIG>) can prompt the patient to enter the missing date, time, strength, and dosage.

The process of reminding the patient to record infusion/bleeding episode information can also be based on time. For example, when the smart tourniquet <NUM> records a wakeup timestamp, a timer starts counting down. If the smart tourniquet <NUM> does not record a confirmation timestamp by the time the timer expires, the smart tourniquet <NUM> (or device) reminds the patient to provide information about an infusion/bleeding episode. Advantageously, the foregoing reduces the likelihood of information about an infusion or bleeding episode not being recorded.

<FIG> shows an example of the recording module <NUM> having a face <NUM>, and opposing first side 145a and second side 145b that are aligned with the long dimension of the recording module <NUM>. The face <NUM> includes a display <NUM> for showing the patient for information, e.g., a timestamp of an infusion. The display <NUM> can be an LCD (liquid crystal display) panel. As shown, on the face <NUM> near the display <NUM> there is an indicator <NUM> for providing visual cues to the patient. The indicator <NUM> can be an LED (light-emitting diode) light that is illuminated when the smart tourniquet <NUM> is "awake" and ready to record a timestamp. The LED light is not illuminated when the smart tourniquet <NUM> is "asleep" and not ready to record a timestamp. Beneficially, the patient can readily tell whether the smart tourniquet <NUM> is ready for them to use by looking at the indicator <NUM>. As another example of information conveyed by the indicator <NUM>, a blinking LED can indicate that the smart tourniquet <NUM> is not functioning properly and requires servicing or replacement.

In the arrangement shown in <FIG>, along the first side 145a of the recording module <NUM>, there is a function key <NUM> for switching operating modes of the smart tourniquet <NUM>, as will be described later in greater detail. Additionally, along the second side 145b of the recording module <NUM>, there is a first key 165a and a second key 165b for inputting information into the recording module <NUM>. The first key 165a and the second key 165b can be used to increase or decrease the value of an input. The first key 165a and the second key 165b can also be used to go forward or backward when selecting an input to enter. For ease of reference, the first key 165a and the second key 165b are called a "plus key" and a "minus key", respectively; and collectively "plus/minus keys" <NUM>. Independent of their label, the plus/minus keys <NUM> are used to enter information, as will be described in greater detail below.

The keys can be in the form of a button or a bar, just to name a few possible shapes. For example, the plus/minus keys <NUM> can be a "toggle" bar that acts as a plus button or minus button depending upon which end of the toggle bar the patient presses. The keys can also be multifunctional. In a convenient example, the function key <NUM> can have the added function of recording a timestamp. In this example, the patient holds down the function key <NUM> for a predetermined period of time (e.g., at least three seconds) to record a timestamp. Advantageously, the foregoing example provides an alternative way of recording a timestamp adding robustness and increasing usability of the smart tourniquet <NUM>.

One or more keys can be used to turn on and/or off the smart tourniquet <NUM>. For example, pressing and holding the plus/minus keys <NUM> for three second turns on the smart tourniquet <NUM>. Doing the same again turns the smart tourniquet <NUM> off. It should be appreciated that the smart tourniquet <NUM> can be designed to turn on and/or off using any combination on keys and hold down times.

In an alternative example, there are no keys and the display <NUM> is sensitive to the patient's touch. In this "touchscreen" example, physical keys are replaced with icons shown on the display <NUM> that the patient can touch. Any of the aforementioned functions can be accessed by the patient with one or more taps of the touchscreen.

As described above, the smart tourniquet <NUM> can record the dosage or "number of units" of medication taken by the patient and recall records of past infusions. These and other features are described with reference to <FIG> with additional reference to <FIG>. Starting with <FIG> the figure shows a series of interfaces <NUM> for activating the operating modes of the smart tourniquet <NUM>. The series <NUM> includes a welcome interface <NUM>, a dosage input interface <NUM>, a record inquiry interface <NUM>, a time adjustment interface <NUM>, and language interface <NUM>. These interfaces can be shown on the display <NUM> as screens. The welcome interface <NUM> or "home screen" can provide information such as the current date and time. Other information that can be provided to the patient, include instructions on how to use the smart tourniquet <NUM>, a firmware version number, and legal information.

The patient switches between the interfaces to select an operating mode. By way of non-limiting example, the smart tourniquet <NUM> starts (e.g., after the smart tourniquet <NUM> wakes up) with the welcome interface <NUM>. The patient can press the function key <NUM> on the recording module <NUM> to switch from the welcome interface <NUM> to the dosage input interface <NUM>. At this time, the patient can wait for the dosage input operating mode to activate or the patient can press the function key <NUM> again to switch to the next interface, the record inquiry interface <NUM>. The user can cycle through the series of interfaces <NUM>, again and again, until an operating mode is activated. There can more or fewer interfaces as shown in <FIG> so long as the patient can activate an operating mode.

For a more complete record of an infusion, the dosage of medication that was taken can be tracked along with the date and time of an infusion. Knowing when and how much medication can be helpful to devising a dosing plan, for example. By convention, a medication dosage is measured in International Units (IU's). <FIG> shows an example of the smart tourniquet <NUM> functioning in the dosage input operating mode, referred to as process <NUM> for ease of reference. Interactions between the process <NUM> and the patient can be carried out using the function key <NUM>, the plus/minus keys <NUM>, and the display <NUM>, as described above.

The process <NUM> starts (<NUM>) with the patient switching to the dosage input interface <NUM> and activating the dosage input operating mode, as described above with reference to <FIG>. The process <NUM> shows the patient the strength and dosage saved from the last infusion and asks (<NUM>) whether they want to use the saved values. When the process <NUM> receives a "yes" from the patient, the process <NUM> jumps forward to step <NUM> of <FIG> and asks the patient to confirm recording the strength and dosage from the last infusion. Advantageously, this saves the patient time by not having them reenter information when there is no change from the prior infusion.

Returning to <FIG>, when the process <NUM> at check <NUM> receives a "no" from the patient, the process <NUM> then asks (<NUM>) the patient to select a strength (increment) for entering the dosage. The patient uses the plus/minus keys <NUM> to make the strength selection. As a non-limiting example, the patient pushes the minus key 165b to select the strength of <NUM> IU and pushes the plus key 165a to select the strength of <NUM> IU.

The process <NUM> asks (<NUM>) the patient to confirm the strength selected. The patient uses the plus/minus keys <NUM> to confirm the strength selection (e.g., the patient pushes the minus key 165b for no and pushes the plus key 165a for yes). When the process <NUM> at check <NUM> receives a "no" from the patient; the process <NUM> returns to asking (<NUM>) the patient to select the strength. When the process <NUM> at check <NUM> receives a "yes" from the patient, the process <NUM> provides (<NUM>) a default dosage. The default dosage can be the last dosage entered by the patient.

The patient uses the plus/minus keys <NUM> to increase or decrease the default dosage by the selected strength. As a non-limiting example, the patient selects and confirms the strength of <NUM> IU. The patient pushes the plus key 165a to increase the default dosage of <NUM> IU by <NUM> IU, resulting in a dosage of <NUM> IU being entered. The patient pushes the minus key 165b to decrease the default dosage of <NUM> IU by <NUM> IU, resulting in a dosage of <NUM> IU being entered.

Continuing with <FIG>, after the patient enters the dosage, the process <NUM> asks (<NUM>) the patient to confirm the entered dosage. The user uses the plus/minus keys <NUM> to confirm the dosage entry (e.g., the patient pushes the minus key 165b for no and pushes the plus key 165a for yes). When process <NUM> at check <NUM> receives a "no" from the patient; the process <NUM> returns to providing (<NUM> of <FIG>) the default dosage to the patient to increase or decrease by the selected strength. When the process <NUM> at check <NUM> receives a "yes" from the patient, the process <NUM> records (<NUM>) the entered dosage. The process <NUM> ends (<NUM>) with the patient being returned to the dosage input interface <NUM>. The patient can also be brought to the welcome interface <NUM>.

In a convenient example, the process <NUM> records the entered dosage such that data representing dosage and timestamp of an infusion are associated or otherwise linked together. Advantageously, a dosage can be looked by based on a timestamp. Alternatively, a dosage can used to look up one or more timestamps. Such information can be useful in analyzing how well the patient is responding to the infusions, for example.

It may be helpful to know when in the past, the patient has taken medication and, in some instances, how much they took. For example, a doctor can review a history of past infusions to analyze the effectiveness of a prescribed treatment. As another example, the patient can use the date and time of their last infusion to determine whether it is time for their next infusion. <FIG> shows an example of the smart tourniquet <NUM> functioning in the record inquiry operating mode, which for ease of reference is referred to as process <NUM>. The process <NUM> provides the patient with the ability to recall timestamps of past infusions or "records. " A record can also include the medication dosage taken at the time of the infusion. Interactions between the process <NUM> and the patient can be carried out using the function key <NUM>, the plus/minus keys <NUM>, and the display <NUM>, as described above.

The process <NUM> starts (<NUM>) with the patient switching to the record inquiry interface <NUM> and activating the record inquiry operating mode, as described above with reference to <FIG>. The process <NUM> shows (<NUM>) the last saved record on the display <NUM>, including the timestamp of the last infusion. The patient can use the plus/minus keys <NUM> to see the "next saved record. " The records can be organized in reverse chronological order, with the newest record shown first and the oldest record shown last. In response to the patient pressing the plus/minus keys <NUM>, the process <NUM> displays (<NUM>) the next saved record. As the patient continues to press the plus/minus keys <NUM>, the process <NUM> continues to display (<NUM>) the next saved record (which is represented in the figure as a looped arrow). The process <NUM> can stop displaying (<NUM>) the next saved record when all the saved records have been shown to the patient. Alternatively, the process <NUM> can continue displaying (<NUM>) the next saved record, looping through the saved records, as long as the patient continues to press the plus/minus keys <NUM>. The process <NUM> ends (<NUM>) when the patient presses the function key <NUM> to exit the record inquiry operating mode and returned to the welcome interface <NUM>.

As described earlier, the recording module <NUM> can include a clock for providing date and time of an infusion. The clock could be set manually, for example, the patient can use the function key <NUM> and the plus/minus keys <NUM> to set the date and time. The clock can also be set automatically without the patient's intervention. For example, the smart tourniquet <NUM> can be synchronized with an application and the clock can be set by the application. In this example, the patient switches to the time adjusting interface <NUM> to activate the time adjusting operating mode. The smart tourniquet <NUM> acquires the present date and time from the application (e.g., by querying the application) to adjust the clock. (The synchronization process between the smart tourniquet <NUM> and the application will be described in greater detail below. ) In another example, the smart tourniquet <NUM> can be connected to the Internet and receive date and time information according to a networking protocol for clock synchronization, such as the Network Time Protocol (NTP). In yet another example, the smart tourniquet <NUM> can receive wireless signals carrying date and time information, such as a beacon frame transmitted by a WIFI access point.

Synchronizing the smart tourniquet <NUM> with an application can be useful because the patient's infusion records can be sent from the smart tourniquet <NUM> to the application. The application can then, for example, combine the records with other information (which may have been given by the patient using the application) and provide analytics, which can help the patient manage their own care. For a hemophilia sufferer, who is taking an infusion of recombinant Factor VIII, the information entered into the application can include the reason for the infusion (e.g., prophylaxis, spontaneous, injury, surgery/dental, follow-up or other). Such information can also be made available to a network of care providers to provide the patient with more complete care.

<FIG> shows an example care network <NUM>, including a patient <NUM>, and healthcare providers, such as doctor 510a and nurse 510b, collectively referred to as <NUM>. The patient <NUM> uses the smart tourniquet <NUM> for self-administer infusions and to record the date and time of the infusions, as described above. The smart tourniquet <NUM> is wirelessly connected to a computing device <NUM> in accordance with any number of wireless communication protocols, such as BLUETOOTH, WIFI, ZIGBEE, and ZWAVE just to name a few.

The smart tourniquet <NUM> is wirelessly connected to a computing device <NUM> using a wireless communication protocol <NUM>. As shown in the example, the wireless communication protocol <NUM> is BLUETOOTH. The wireless communication protocol <NUM> can also be WIFI, ZIGBEE, and ZWAVE just to name a few. The computing device <NUM> can be a smartphone or other mobile device (as shown), and can run an application <NUM> that is a companion to the smart tourniquet <NUM>. When connected to the computing device <NUM>, the smart tourniquet <NUM> can be synchronized with the application <NUM>, and records and other information can be sent to the computing device <NUM>. Downloading the records to the computing device <NUM> is advantageous because there is more memory to store the records than on the smart tourniquet <NUM>. Additionally, the computing device <NUM> has more computing power to perform analytics.

Another benefit to transferring saved records from the smart tourniquet <NUM> is that the records can then be shared with the healthcare providers <NUM>, along with other patient information. The computing device <NUM> is coupled to a network, such as the Internet or a private network (not shown). The healthcare providers <NUM> can access the patient's information, including records of self-administered infusions, by sending and receiving electronic messages (e.g., requests and responses) over the network. The electronic messages can be secured to provide privacy and security of health information in accordance with local regulations (e.g., in the U. , the Health Insurance Portability and Accountability Act or "HIPAA").

Based on the information provided by the patient using the smart tourniquet <NUM> and application, the healthcare providers <NUM> can analyze the effectiveness of the prescribed treatment and, in some instance, modify that treatment. Advantageously, the care network <NUM> includes the patient <NUM> and their feedback in rendering them care.

The care network <NUM> is advantageous because it connects the patient <NUM> with the healthcare providers <NUM>. Additionally, the care network <NUM> enables information about infusions to be automatically collected (by way of the smart tourniquet <NUM>), thereby reducing any delay in delivering that information to the healthcare providers <NUM>. For example, infusion information is collected in response to the smart tourniquet <NUM> being synchronized with the application <NUM>. In turn, the healthcare providers <NUM> can provide the patient <NUM> with care that is timely and accurate.

<FIG> show a series of screenshots of an application <NUM> used by a hemophilia sufferer to track infusions of recombinant Factor VIII. As shown in <FIG>, the application <NUM> includes a virtual button <NUM> that the person presses to synchronize and download records of past infusions from a smart tourniquet (such as the smart tourniquet <NUM> of <FIG> and <FIG>). In <FIG>, the application <NUM> can display downloaded records 610a-f as a list. In <FIG>, the person selects the record 610a (shown in the figure as a pointing icon). In <FIG>, in response to the selection, the application <NUM> provides a popup window <NUM> asking the person to identify the reason for the selected infusion as being either preventative (e.g., prophylactic treatment) or treatment (e.g., to stop spontaneous bleeding). Advantageously, the application <NUM> guides the person through the steps for providing more information about infusions, the timestamps of which were recorded by the smart tourniquet without the patient having to enter in the timestamps.

Example uses of a smart tourniquet, such as the smart tourniquet <NUM> of <FIG> and <FIG>, are described with reference to the tables set out below.

Tables <NUM>, 9A-B, and 10A-C are diagrams showing a patient using the smart tourniquet to take an infusion, including waking up the smart tourniquet and inputting the dosage taken.

Tables 11A-D are diagrams showing a patient using the smart tourniquet to review infusion records stored in the device.

Tables 12A-D are diagrams showing a patient adjusting the time on the smart tourniquet.

Tables 13A-D are diagrams showing a patient selecting which language the smart tourniquet communicates with the patient.

Table <NUM> is a diagram showing the patient confirming that a connection between the smart tourniquet and the application be established. Operation: Wake up the smart tourniquet by: a) fastening the smart tourniquet around patient's arm in preparation for infusion or b) press the function button on the smart tourniquet for <NUM> seconds (or other amount of time).

Record: Insert first record (SN = <NUM>) into the database.

Operation: Press '+' or '-' button on the smart tourniquet to switch to the 'Dosage' screen.

Operation: Press function button on the smart tourniquet to confirm last saved strength and dosage.

Operation: Press '+' `-` button on the smart tourniquet to choose the strength. Press function button on the smart tourniquet to show the screen for inputting the dosage.

Operation: Press function button on the smart tourniquet to confirm the strength and dosage.

Operation: Press function button on the smart tourniquet to show the screen for querying saved records.

Operation: Press '-' button on the smart tourniquet to display previous records and press '+' button to display next records.

Operation: Press '+' `-` button on the smart tourniquet to switch to the `Time Adjustment' screen.

Operation: Press function button on the smart tourniquet to enter the time adjustment function.

Operation: With each press of the function button on the smart tourniquet, a number flashes from left to right, one by one. Press '+' `-` button on the smart tourniquet to increase or decrease the number.

Operation: When the last number flashes, press function button on the smart tourniquet again to return to the `Time Adjustment' screen.

Operation: Press '+' `-` button on the smart tourniquet to switch to the 'Language' screen.

Operation: Press function button on the smart tourniquet to show the screen for selecting the language.

Operation: Press '+' `-` button on the smart tourniquet to switch language and highlight the selected language.

Operation: Press function button on the smart tourniquet and return to the 'Language' screen.

Operation: The patient is asked to confirm a connection between the smart tourniquet and an application in response to the application requesting that the connection be established. Press function button on the smart tourniquet to confirm the connection, or hold '+' button to cancel.

The uses are described in terms of the actions taken by the patient (which are identified in the tables by the label "Operation:") and information displayed and recorded by the smart tourniquet (which are identified in the tables by the labels "Display:" and "Record:"). In some instances, the smart tourniquet does not record information and this is denoted in the figures as "NA" for not applicable.

For the sake of discussion, the records are described as being saved to a "database". The database is shown in the tables as having rows and columns. Each row of information represents a collection of related information. Those skilled in the art will readily recognize that the records can be implemented as any number of data structures, such as a linked list or an array.

Tables <NUM>, 9A-B, and 10A-C show the patient using the smart tourniquet to take an infusion, including waking up the smart tourniquet, and inputting the strength and dosage taken. In Table <NUM>, the patient wakes up the smart tourniquet by tightening the device around their arm. In response, the smart tourniquet saves a first record (labeled in the figure as "SN <NUM>") that includes the date and time when the device woke up (i.e., a wakeup timestamp). Because the patient does not take an infusion at the same time as the device wakes up, strength and dosage values associated with the wakeup time are "NULL" as shown in the table.

Tables 9A-B show the patient using the smart tourniquet to input the strength and dosage of the infusion they took. In Table 9A, the patient switches to a 'Dosage' screen (e.g., the dosage input interface <NUM> of <FIG>) and activates the dosage input operating mode, as described above with reference to <FIG>. In Table 9B, the smart tourniquet displays the last saved strength and dosage. In the event there is no last saved strength and dosage (e.g., the smart tourniquet is being used for the first time or after being reset), the device displays a value of zero. In the example shown, the strength and dosage of the infusion is the same as the last saved strength and dosage. The patient confirms the last saved strength and dosage. In response to the confirmation, the smart tourniquet saves a second record (labeled in the figure as "SN <NUM>") that includes the date and time of when the strength and dosage are confirmed (i.e., a confirmation timestamp). In a convenient example, the smart tourniquet displays 'Success' for <NUM> second (or other amount time) and returns to 'Dosage' screen.

Tables 10A-C show the smart tourniquet in the dosage input operating mode and patient entering the strength and dosage of an infusion that is different than a prior infusion. In Table 10A, the patient selects the strength and then in Table 10B, adjusts a dosage by incrementing (as is shown) or decrementing by that strength until the desired dosage is reached. In Table 10C, the patient confirms the inputted dosage. The smart tourniquet, in turn, saves a third record (labeled in the figure as "SN <NUM>") that includes the date and time of when the strength and dosage are confirmed. In a convenient example, the smart tourniquet does not add a record with zero dosage to the database (i.e., a confirmation timestamp). The smart tourniquet displays 'Success' for <NUM> seconds (or other amount time) and returns to 'Dosage' screen.

Tables 11A-D show the patient using the smart tourniquet to review infusion records stored in the device. In Table 11A, the patient switches to a 'Records' screen (e.g., the record inquiry interface <NUM> of <FIG>) and activates the record inquiry operating mode, as described above with reference to <FIG>. In Table 11B, the smart tourniquet displays the last saved record that includes the timestamp, strength, and dosage of the last infusion. In Table 11C, the patient can view other infusion records using, for example, the plus/minus keys <NUM> of <FIG> and <FIG>. The smart displays records having strength and dosage values that are not NULL. This feature can help a patient differentiate between times when they actually took an infusion from times when they started to but for some reason did not take an infusion. This is particularly beneficial considering patients typically have full and active lives making it difficult from them to recall past events clearly. In Table 11D, the patient presses the function button to return to the 'Records' screen.

Tables 12A-C show the patient adjusting the time on the smart tourniquet. In Table 11A, the patient switches to a `Time Adjustment' screen (e.g., the time adjustment interface <NUM> of <FIG>) and activates the time adjustment operating mode, as described above with reference to <FIG>. In Tables 12B-C, while in this mode, the patient can adjust the time as shown. In Table 12D, the patient presses the function button to return to the `Time Adjustment' screen.

Tables 13A-D show the patient selecting which language the smart tourniquet communicates with the patient. In Table 13A, the patient switches to a 'Language' screen (e.g., the language interface <NUM> of <FIG>) and activates a time adjustment operating mode. In the example shown, the 'Language' screen is written in Chinese. In Tables 13B-C, while operating in this mode, the patient can select a language from the languages available on the smart tourniquet. In the example shown, the patient selects English. In Table 13D, the patient presses the function button to return to the 'Language' screen, which is now written in English.

As described previously, the smart tourniquet can be synchronized with an application, such as the application <NUM> of <FIG>. Once synchronized, infusions records can be transferred to the application for analysis and/or sharing with others. The synchronization process can include establishing a connection (e.g., a wireless BLUETOOTH connection) between the smart tourniquet and the application. Table <NUM> shows the patient confirming that a connection between the smart tourniquet and the application be established. (In the example shown, the application is running on a mobile phone and the connection is being made between the smart tourniquet and the mobile phone. ) In a convenient example, the patient is asked to confirm the connection in response to the smart tourniquet receiving a request from the application to connect.

As described above, the smart tourniquet <NUM> can help the patient record when they took an infusion of a drug. It should be noted that the usefulness of the smart tourniquet <NUM> extends beyond a single particular drug but can be readily applied to any drug administered, intravenously, made by any pharmaceutical company. It is common practice in the drug industry for a drug marker to design and market a drug delivery device, such as an auto injector, that must be used to administer their drug. For example, a patient can only inject themselves with company X's insulin using company X's insulin pen (even if company Y's device is easier for patient to use). Advantageously, the smart tourniquet <NUM> is not tied to a particular drug and can be widely adopted by pharmaceutical companies and patients alike.

Claim 1:
A tourniquet for self-administrating a drug, the tourniquet comprising:
an elongate member including a first end and a second end, and a longitudinal axis extending between the first end and the second end, the elongate member being adapted for wrapping about a limb of a patient;
a recording module including: a) a slot extending therethrough for slidably receiving the elongate member and b) a fastening end for releasably capturing the second end of the elongate member, the recording module being configured to save a confirmation timestamp in response to the patient confirming a strength and dosage of the drug;
an electrode electrically coupled to the recording module that contacts the patient's skin when the tourniquet is tightened about the limb of the patient; and
when the elongate member is wrapped about the limb of the patient and the second end of the elongate member is captured by the fastening end so that the second end is fixed to the recording module, in response to pulling the first end of the elongate member away from the second end in the longitudinal direction: a) the tourniquet tightens about the limb and b) the recording module saves in a record, a timestamp in response to a galvanic skin response measured by the electrode.