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The GlucachuteAn Implantable Emergency Hypoglycemia Treatment Device
Matthew DeNardo and Jordan JacobsMay 1, 2009
Background
This invention relates to treatment for persons with diabetes mellitus type 1, specifically toimproving treatment options for those persons experiencing severe acute hypoglycemia (low levels of  blood glucose). Diabetes is a metabolic disorder that results in high blood glucose levels. Typicaltreatment for diabetes involves administration of insulin, a hormone that triggers absorption of glucosein the blood. Insulin is usually injected into the body or delivered via a pump. Incorrect insulin dosagecan trigger hypoglycemia and can further lead to seizures, coma, and death.Diabetics need to be aware of their blood sugar levels and there are many monitors available toaccomplish this task. The typical monitor requires a blood sample on a test strip. Continuous glucosemonitoring products, such as the Medtronic MiniMed Paradigm or the FreeStyle Navigator have beenintroduced more recently. The invention requires a continuous glucose monitor (CGM) to governtreatment and requires a means of communication between the CGM and the device. Wirelesscommunication between a CGM and an insulin pump has already been used as a method of treatingdiabetes (also by Medtronic).Diabetics experiencing severe hypoglycemia require immediate treatment. Intravenousadministration of dextrose is a treatment that has been used in the past. However, it is difficult for non-trained personnel to perform this task. More recently, “rescue kits” from manufacturers such as Eli Lillyand Company have been furnished to provide glucagon injections to persons suffering from severehypoglycemia. These kits can be used by laypeople without prior training as the drug can be absorbedvia muscle tissue.The problem with performing any hypoglycemia treatment is that the patient must either beconscious or someone else must be present and aware of the situation to administer care. The inventiondescribed herein provides a means of automatically delivering treatment to a person suffering fromsevere hypoglycemia. To the best of our knowledge and the extent of our literature and patent searches,no device for hypoglycemia treatment has been developed that can deliver treatment without user interaction.
Summary
The invention, an implantable hypoglycemia treatment device, works in tandem with existingCGM technology. Both the device and the CGM are implanted and communicate wirelessly with anexternal display monitor and data collection system. The linking of these items facilitates the delivery of hypoglycemia treatment. CGMs already feature alarms that are activated based on blood glucosemeasurements.The device requires a simple modification to existing CGM software so that a severehypoglycemic condition is not only signaled by an alarm, but that it can also activate the implanteddevice and signal it to deliver treatment. When an alarm is triggered, signaling hypoglycemia, the user,caretaker, or bystander requires sufficient time to respond and deliver treatment. Since the user mayMatthew DeNardo and Jordan Jacobs1
 
have mitigated this condition by responding to an earlier alarm by consuming glucose-containingcarbohydrates or by receiving an injection of dextrose or glucagon, it may be beneficial to have someelapsed time before the device automatically takes action.This elapsed time may be displayed on the external monitor as a countdown timer. If the user or other person has mitigated the hypoglycemia, the user should act to prevent the automatic treatmentdelivery. On the other hand, if the user is unconscious and alone, the timer will expire and the devicewill deliver treatment automatically.
Detailed Description
The device has several embodiments and encompasses single and multiple-use paradigms. In thesingle-use device, the liquid portion of the treatment (e.g. dextrose or sterile diluting solution) is storedin a reservoir. The reservoir may be lined with a leak-proof material. In loading the liquid into thechamber, mechanical work is done to increase the chamber volume to accommodate the liquid. Theenergy used for displacement is stored as mechanical potential energy, which provides a force thatattempts to compress the reservoir’s contents.The device’s reservoir has a single outlet that is controlled by a valve. The valve is of thenormally closed type. The valve opens in response to a signal sent by the external monitor when the timeto respond to a hypoglycemic event has elapsed. In opening the valve, the stored mechanical energy isused to displace the contents of the reservoir.In an embodiment where the treatment is solely liquid (e.g. dextrose), the reservoir outlet valveleads to the body. The fluid may be deposited directly at the site or delivered to another site via a tube. Inan embodiment where the treatment is a solution (e.g. sterile diluting solution and freeze-driedglucagon), the reservoir outlet valve leads to a mixing chamber. In the mixing chamber, several liquidsor liquids and solids are combined to produce a solution. The outlet of the mixing chamber leads to the body.In the multiple-use device, the reservoir described above also has an inlet that can be accessedfrom outside of the body. An embodiment of this concept is to use a self-healing compressed siliconeseptum that can be penetrated with a non-coring needle. This method is used to access the reservoir invascular ports. An empty reservoir is refillable by injecting the liquid component of the treatmentthrough the silicone septum. Adding fluid to the reservoir, driven by the syringe pressure, increases thechamber volume, performing mechanical work in the fashion described above. The reservoir outlet iscontrolled with a valve, also as described above. As before, in an embodiment where the treatment issolely liquid (e.g. dextrose), the reservoir outlet valve leads to the body. The fluid may be depositeddirectly at the site or delivered to another site via a tube.In an embodiment of a multi-use device where the treatment is a multi-liquid solution, multiplechambers in series keep the components separate. The chamber farthest from the outlet is preloaded, asdescribed earlier. Subsequent chambers store the other liquid components until mixed. The outlet to the body is as previously described.In an embodiment of a multi-use device where the treatment consists of a liquid that dissolves atleast one solid component (such as a powder), the liquid chamber is refillable and can be pressurized asdescribed above. If it is possible to also refill the solid container percutaneously, then a second septum toaccess that chamber is used. Alternately, if the solid portion must be inserted before the device isimplanted, a different approach is considered.The outlet path of the liquid chamber, downstream of the valve or as part of the valve, alsoMatthew DeNardo and Jordan Jacobs2
 
contains a mechanism for selecting one of several paths where the solid component is stored. The liquidand solid components feed into a mixing chamber as described above, and then the solution exits thedevice into the body.All embodiments require a power supply to operate the device. The power requirements are dueto the operation of the wireless communication module (primary) and the mechanical operation of anyof the components governing fluid flow (secondary). The power supply may be augmented with existingtechnology that uses energy generated by the patient’s motion to extend the life of the device.
Operation
The envisioned usage for an embodiment of the device is as follows: A multi-use device(Figure 1) that relies on a sterile diluting solution and freeze-dried glucagon powder is unpackaged in asterile operating field. The powder has been pre-loaded into the device. The implanting surgeon powersup the device, which performs a self-test and confirms that a communication link with its externalmonitor is established. The surgeon then attaches a syringe to a non-coring needle and loads it with thesterile diluting solution. The needle is inserted through the septum (Figure 1) and the liquid reservoir (Figure 3) is filled, thereby pressurizing it by storing mechanical energy in a spring (Figure 3). Thedevice is then implanted in the abdomen along with a CGM (existing technology, not shown) that provides the external monitor (existing technology, not shown) with the data needed to detect andactivate treatment for severe hypoglycemia. The surgeon places the device and concludes the procedure.When a severe hypoglycemic event occurs as detected by the CGM and reported by the monitor,the monitor sounds an alarm to alert the user and others nearby that the user needs treatment. In addition,the monitor alerts local emergency services of the patient’s location and condition. A timer beginscounting down the time to automatically delivering treatment. The monitor also alerts anyone who may provide manual treatment to deactivate the timer with a button press prior to performing an injection. If the timer expires, then the monitor wirelessly sends a signal to the implanted device that opens the valveto the fluid chamber. The control valve (Figure 3) opens and selects one of the outlet paths and thediluting solution flows out of the reservoir to a mixing chamber (Figure 3). The chamber is pre-loadedwith the freeze-dried glucagon powder, which dissolves when mixed with the solvent. As the pressure builds in the mixing chamber, the outlet valve opens (Figure 4) and allows the solution to enter the body.The external monitor then alerts anyone nearby that the user has already received treatment and thatemergency medical attention is necessary.After receiving care, the user or a medical professional may reset the device by injecting avolume of sterile diluting solution to refill the reservoir. The act of doing so repressurizes the chamber and primes the control valve so it is ready to switch to the next available fluid path that contains a doseof the glucagon powder. Via the monitor, the system is capable of reporting how many doses remain.Once all of the doses have been consumed, the user is alerted of this status and is advised to see their medical professional.Matthew DeNardo and Jordan Jacobs3
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