Abstract:
A medicament delivery system and method of use. A medicament delivery system comprising a medicament, a medicament delivery device, an alerting device, operating instructions, and a carrying case. The medicament can be glucagon for use with Type 1 diabetics. A method where a person assisting a patient in medical distress locates the patient&#39;s medicament injection pen by using an alerting device that sends a signal to the pen&#39;s carrying case, and where a triggered alarm in the case alerts the assisting person of the pen&#39;s whereabouts. A method where a person assisting a patient in medical distress provides a medicament to the patient by pushing an actuator on a medicament injection pen until a diaphragm separating two chambers in the pen breaks allowing medicament and diluting solution to mix, and where the assisting person then injects the mixture into a soft tissue of the patient.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Application Ser. No. 61/485,983 filed with the United States Patent and Trademark Office on May 13, 2011 and which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE DISCLOSURE 
       [0002]    This disclosure relates generally to medical devices and more particularly to kits and methods for providing an injectable medicament. 
       BACKGROUND 
       [0003]    Emergency medicament kits, such as glucagon kits for diabetics or epi-pens for allergies, are life saving devices that contain components necessary to counter the effect of medical problems such as insulin shocks or severe cases of hypoglycemia. These kits usually carry a number of items, such as syringes and various discrete or premixed medications, which need to be administered to the patient. In the case of a patient suffering from an insulin shock, the medication needed is glucagon. However, when a patient is under shock or other distress due to such medical conditions, the patient may not be able to direct a person who is trying to help to the location of the patient&#39;s medicament kit. Additionally, the patient may not be able to tell the assisting person how to use the kit. Thus, there is a need for a kit that is easy to locate and a medicament delivery device that is simple to operate. As used throughout this specification, ‘patient’ or ‘person’ may be used interchangeably, and should not be construed to limit the invention to use by or for a particular individual. 
       SUMMARY 
       [0004]    In one embodiment of the disclosure, the medicament system comprises a medicament, a medicament delivery device, for example, an injection pen or syringe, an alerting device, operating instructions, and a carrying case. The medicament can be glucagon or some other medicament. 
         [0005]    In another embodiment of the disclosure, where a person assisting a patient in medical distress is attempting to locate the patient&#39;s medicament delivery device, the assisting person first reads instructions on an alerting device to press an emergency button. The assisting person then presses the emergency button. This in turn sends a signal from the alerting device to an electronic receiver in a carrying case. The electronic receiver then directs circuitry to enable an alarm sounding system to emit an alarm signal in the carrying case. This alarm then attracts the attention of an assisting person to the whereabouts of the carrying case. The assisting person then opens the carrying case and reveals the medicament delivery device. In an example, the medicament delivery device is an injection pen or syringe, though other delivery devices are contemplated. 
         [0006]    In another embodiment, where a person assisting a patient in medical distress is attempting to provide a medicament to the patient, the assisting person reads or listens to operating instructions for the medicament system. The assisting person pushes an actuator, for example, an activating button, switch, lever and the like, on a medicament injection pen toward a distal end of the pen. This will cause a plunger to move into a first chamber of the pen where the first chamber is filled with diluting solution. The assisting person continues to press the actuator, which creates pressure in the first chamber. This pressure then breaks a seal, for example, a diaphragm, separating the first chamber from a second chamber in the medicament injection pen. The second chamber is filled with a dry medicament and the diluting solution comes in direct contact with the dry medicament. The assisting person then shakes the medicament injection pen to create a mixture of the diluting solution and medicament. The assisting person thrusts a hypodermic needle that is part of the medicament injection pen, into a soft tissue of the patient and activates the actuator until the mixture is completely injected into the patient. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    These as well as other objects and advantages of this disclosure will be more completely understood and appreciated by referring to the following more detailed description of the exemplary embodiments of the disclosure in conjunction with the accompanying drawings of which: 
           [0008]      FIG. 1  is a perspective view showing the different components of a medicament kit; 
           [0009]      FIG. 2  shows a perspective view of an embodiment of a medicament injection pen; 
           [0010]      FIG. 3  shows perspective views of an embodiment of a diaphragm; 
           [0011]      FIG. 4  shows perspective views of an embodiment of an alerting device used as a necklace; 
           [0012]      FIG. 5  shows perspective views of an embodiment of the alerting device used as a wrist band; 
           [0013]      FIG. 6  shows perspective views of an embodiment of the alerting device that can be attached to a person&#39;s chattel; 
           [0014]      FIG. 7  shows a perspective view of an embodiment of a carrying case; and 
           [0015]      FIG. 8  shows a perspective view of an embodiment of a bottom portion of the carrying case. 
       
    
    
       [0016]    While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the disclosure is not to limit the invention to the particular embodiments described. On the contrary, the disclosure is to cover all modifications, equivalents, and alternatives. 
       DETAILED DESCRIPTION 
       [0017]    Advantages and embodiments of this disclosure are illustrated by the following examples, but the particular materials and amounts recited in these examples, as well as other conditions and details, should not be construed to unduly limit this disclosure. The apparatuses and methods disclosed herein may be used to provide a medicament to a person in need of medication. While not meant to be limiting, the systems are illustrated through use of a medicament injection pen. It will be appreciated that the apparatuses and methods are applicable to other medicament delivery devices. 
         [0018]    As used in this document, the terms “a” or “an” are used to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” The term “or” is used to refer to a nonexclusive “or”, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In addition, the terms “first,” “second,” “third,” etc. are used merely as labels and are not intended to impose any numerical requirement or limitation on their objects. In addition, the terms “including” and “having” and their derivatives, as used in the specification, including the claims, have the same meaning as the word “comprising.” The term “in which” is used as the plain-English equivalent of the term “wherein.” 
         [0019]      FIG. 1  is a perspective view showing the different components of the medicament kit  100 . In one embodiment, the kit comprises a carrying case  102 , a medicament injection pen  104 , and an alerting device  106 . In another embodiment, operating instructions for how to use the kit may be printed on the inside of the carrying case  102  or may be included on a tangible medium. Alternatively, operating instructions may be pre-recorded, available to be played by the user. Both the medicament injection pen  104  and any operating instructions are stored in the carrying case  102 . 
         [0020]      FIG. 2  shows a perspective view of an embodiment of the medicament injection pen  200 . In one embodiment, the medicament injection pen  200  comprises an actuator  212  attached to a plunger  210 . The plunger  210  is located in a first chamber  208  that is separated from a second chamber  204  by a diaphragm  206 . A hypodermic needle  202  is coupled to the distal end of chamber  204 . In one embodiment, chamber  204  contains a medicament and chamber  208  contains a diluting solution liquid. In another embodiment, the medicament can be contained in chamber  208  and the diluting solution can be contained in chamber  204 . In another embodiment, a single chamber medicament injection pen can be used for some injection-ready medicaments. 
         [0021]    The medicament can be an injectable medicament that may be carried by the patient, or alternatively, can be provided by a medical practitioner. In some instances, the patient can carry the medicament when the medicament may be needed immediately, for example, when the patient is suffering from insulin shock, a severe case of hypoglycemia, or from a severe allergic reaction. In such cases, the medicament can be, for example, dry glucagon, epinephrine, and the like. The example of glucagon as the medicament is provided as an illustrative example; other medicaments are contemplated. 
         [0022]    In one embodiment, a method for providing a medicament to a person suffering medical distress may include, an assisting person being directed by the operating instructions printed on the inside of the carrying case  102  or included on a tangible medium. Alternatively, an assisting person may be instructed by pre-recorded instructions emanating from the carrying case  102 . The assisting person may be instructed to push the actuator  212  toward the distal end of the syringe (the distal end being at the location of the hypodermic needle  202 ) and into a first chamber  208 . The actuator may be mechanically coupled to a plunger, or the actuator may be coupled to a cylindrical member in turn coupled to a plunger. The plunger can exert pressure on a fluid in the first chamber, and includes a seal to prevent fluid from leaking out of the first chamber. Pushing the actuator has the effect of pushing the plunger  210  into a first chamber  208  and creating pressure on diaphragm  206 . The pressure can break diaphragm  206  and allow the first chamber  208  and second chamber  204  to become in fluid communication with each other. Accordingly, the diluting solution in a first chamber and medicament in a second chamber can mix. The actuator and plunger can indicate when they have traveled a distance sufficient to break the diaphragm, for example, by mechanical interference, by markings on the injector pen  200 , or by a tactile or audible indication. The assisting person may then be instructed to gently shake the medicament injection pen  200  and then thrust the hypodermic needle  202  into a soft tissue of the person suffering medical distress. The assisting person may then be instructed to further push the actuator  212  so that the mixture is injected completely into the person. In another embodiment, the syringe may have only one chamber, the chamber containing injection-ready medicament. In this case, the medicament is injected into the person suffering medical distress in a similar way, but without the need for mixing the medicament before injection. 
         [0023]      FIG. 3  shows perspective views of an embodiment of the diaphragm  206 . The diaphragm  206  is shown in a closed front view  300 A from distal needle end, closed side view  300 B, open front view  300 C from distal needle end, and open side view  300 D. In one embodiment, the diaphragm  206  can be made of plastic such as polystyrene, polypropylene, high-density polyethylene, or any other suitable material susceptible to fracture, breaking or puncture under pressure. In one embodiment, the design of the diaphragm  206  is cone shaped and is scored  302 A/ 302 B into fourths that serve as stress points. When pressure is increased on the closed diaphragm  300 A/ 300 B, the scored lines  302 A/ 302 B will eventually break and become broken slits  302 D. The diaphragm  206  will then become an open diaphragm  300 C/ 300 D and allow the diluting solution and medicament to mix. 
         [0024]      FIG. 4  shows perspective views of an embodiment of the alerting device  106  used as a necklace. The alerting device  106  is shown in a 3-dimensional view  400 A, front view  400 B, back view  400 C, and side view  400 D. In one embodiment, the alerting device  400  is hexagonal shaped, but other shapes, for example, round, rectangular, and the like are contemplated. In one embodiment, the alerting device  400  indicates that the patient is a Type 1 diabetic  406 B and provides instructions to press  408 B an emergency button  402 B. In another embodiment, other types of medical conditions can be listed on the alerting device  400 , for example, “Peanut allergy.” In another embodiment, the back view  400 C of the alerting device  400  may display the universal medical sign  402 C. 
         [0025]    In one embodiment, the alerting device  400  has a front and back side, wherein both sides can be snapped into or coupled to each other by frictional means or mechanical means. In another embodiment, the alerting device  400  has an aperture  404 B which passes through the front and back sides, wherein the aperture  404 B is adapted to accept a length of material, for example, a chain, string, leather strip, and the like, to form a necklace that can suspend the alerting device  400  around the neck of the patient. The front and back sides may enclose a battery compartment, battery, part of the emergency button  402 B and electronic circuitry. In one embodiment, the battery is a standard circular 3 volt battery. 
         [0026]    In one embodiment, a method for locating a medicament delivery device  104  is described, wherein the assisting person first reads the instructions on an alerting device  400  to press  408 B the emergency button  402 B. The assisting person presses the emergency button  402 B and the alerting device  400  produces an electromagnetic wave through the air. The frequency of this electromagnetic wave is picked up by an electronic receiver located in the carrying case  102 . The electronic receiver triggers an alarm sounding system or flashing light, for example a flashing light emitting diode (LED) in the carrying case  102  (to be discussed in more depth with respect to  FIG. 8 ). The assisting person&#39;s attention is attracted to the beeping alarm and/or flashing LED. Thus, the assisting person becomes aware of the location of the carrying case  102  amongst the patient&#39;s belongings. For example, the carrying case  102  may be in a purse or briefcase. The assisting person opens the carrying case  102 , and the medicament injection pen  200  and operating instructions are revealed. 
         [0027]      FIG. 5  shows perspective views of an embodiment of an alerting device  500  used as a wrist band. The alerting device  500  is shown in a 3-dimensional view  500 A, front view  500 B, first side view  500 C, and second side view  500 D. In one embodiment, the alerting device  500  is rectangular shaped with rounded edges. In one embodiment, the alerting device  500  indicates that the patient is a Type 1 diabetic  506 B and provides instructions to press  508 B an emergency button  502 B. In another embodiment, other types of medical conditions can be listed on the alerting device, for example, “Peanut allergy.” In another embodiment, the back view of the alerting device may display the universal medical sign (see  402 C in  FIG. 4 ). 
         [0028]    In one embodiment, the alerting device  500  has a front and back side, wherein both sides can be snapped into each other by frictional means. In another embodiment, the alerting device  500  has two apertures  504 B/ 504 D which pass through the front and back sides, wherein each aperture  504 B/ 504 D is adapted to accept a length of material, for example, a chain, string, leather strip, and the like, to form a wrist band that can suspend the alerting device  500  around the wrist of the patient. The front and back sides may enclose a battery compartment, battery, part of the emergency button  502 B and electronic circuitry. In one embodiment, the battery is a standard circular 3 volt battery. The method for locating a medicament injection pen  200  using the wrist band alerting device  500  is analogous to that described for a necklace. 
         [0029]      FIG. 6  shows perspective views of an embodiment of the alerting device  600  that can be attached to a person&#39;s chattel. The alerting device  600  is shown in a 3-dimensional view  600 A, front view  600 B, first side view  600 C, and second side view  600 D. In one embodiment, the alerting device  600  is hexagonal shaped, however other shapes are possible and contemplated. In one embodiment, the alerting device  600  indicates that the patient is a Type 1 diabetic  606 B and provides instructions to press  608 B an emergency button  602 B. In another embodiment, other types of medical conditions can be listed on the alerting device, for example, “Peanut allergy.” In another embodiment, the back view of the alerting device  600  may display the universal medical sign (see  402 C in  FIG. 4 ). 
         [0030]    In one embodiment, the alerting device  600  has a front and back side, wherein both sides can be snapped into each other by frictional means or otherwise coupled to each other by mechanical means. In another embodiment, the alerting device  600  has a slot  604 C- 604 D attached to the back side, wherein the slot  604 C- 604 D provides a means to attach the alerting device to the patient&#39;s belt loop, clothing, purse, bag, briefcase, keychain or other chattel. The front and back sides may enclose a battery compartment, battery, part of the emergency button  602 B and electronic circuitry. In one embodiment, the battery is a standard circular 3 volt battery. The method for locating a medicament injection pen using the chattel-attaching alerting device is analogous to that described in association with  FIG. 4 . 
         [0031]      FIG. 7  shows a perspective view of an embodiment of the carrying case  700 . The carrying case  700  comprises a cover  702  attached to a main case body  704 . A portion of the main case body  704  comprises the bottom portion of the carrying case  706 . In one embodiment, the cover  702  is dome shaped. In one embodiment, the cover  702  is attached to the main case body  704  via a hinge. There may be one hinge attached to each lateral end of the cover  702 . Both hinges can attach to the main case body  704  and the cover  702  is held in place. The hinge attachment allows the cover to rotate into open and closed positions. In another embodiment, the cover  702  is attached to the main case body  704  via a peg. On each inner end of the main case body  704 , a peg extends laterally toward the center of the case. On each outer end of the cover  702 , a corresponding hole is present which runs laterally toward each outer end. Each hole has a slightly larger diameter than each corresponding peg. Each peg on the main case body  704  fits into its corresponding hole on the cover  702  and the cover  702  is held in place. The peg attachment allows the cover  702  to rotate into open and closed positions. In one embodiment, when the cover  702  moves into the closed position using either the hinge or peg attachment mechanism, the cover  702  fastens with the main case body  704  in a snapping fashion. Other case closure methods are known in the art and are included in this disclosure. 
         [0032]      FIG. 8  shows a perspective view of an embodiment of the bottom portion of the carrying case  800 . The bottom portion of the carrying case  800  can comprise two compartments. One compartment is an elongated compartment  810  that is designed to house the medicament injection pen  200  (see  FIG. 2 ) and operating instructions. The second compartment is an electronics compartment  802  that houses at least one battery, an electronic receiver, an alarm sounding system, an LED, and all required circuitry. In one embodiment, the alarm sounding system rests over a circular hole  804  formed in the bottom portion of the carrying case  800 . The hole can have a constant or varying diameter as depth increases. The circular hole  804  can increase the perceived volume of the alarm sounding system and may make the alarm more audible. In one embodiment, the battery is a standard circular 3 volt battery. On top of the electronics compartment  802  is a cover  808  locked by a fastener  806 . 
         [0033]    In one embodiment, a method for locating a medicament injection pen  200  can include an actuator being activated, for example, an emergency button being pressed, sending a signal. The frequency of the produced electromagnetic wave is picked up by the electronic receiver. The receiving antenna on the electronic receiver picks up radiation from the electromagnetic waves. One skilled in the art should recognize that the signal from the alerting device  400 A- 400 D (see  FIG. 4 ) is synchronized with the electronic receiver. A radio receiver on the electronic receiver converts the radiation into usable form. This information is then decoded and used by the electronic receiver to turn on the circuit. The circuit activates the alarm sounding system or flashing light (e.g. LED) which attracts the attention of the assisting person to the whereabouts of the carrying case  700  (see  FIG. 7 ). 
         [0034]    In one embodiment, the circuit runs on direct current voltage and comprises resistors, timers, capacitors, grounding, and a speaker. In another embodiment, the circuit runs on direct current voltage and comprises a capacitor, a diode, grounding, a speaker, a resistor, and a switch. 
         [0035]    Various embodiments of systems, devices and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the invention. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, feature locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the invention. 
         [0036]    Persons of ordinary skill in the relevant arts will recognize that the invention may comprise fewer or combinations of features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the invention may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the invention may comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art.