Abstract:
A self-contained system for medication injection is activated by the user, who is able to distribute the medication through the self-contained needle system for intradermal or intramuscular application of the medication. The self-contained system may be a medication delivery pen having a pen body assembly comprising a distal end, a proximal end and a needle array containing a plurality of needles disposed within the pen body assembly.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a Continuation Application of U.S. Ser. No. 11/761,861 filed Jun. 12, 2007, which is herein incorporated by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Health care costs are rapidly escalating, with the combined issues of an aging population here in the United States and elsewhere, as well as the increased prevalence of chronic disease states such as diabetes mellitus and asthma. Many of these disease states are now being effectively treated on an outpatient basis. Unfortunately, this places a greater emphasis on patient compliance to achieve satisfactory outcomes. Diseases such as insulin dependent diabetes mellitus, and insulin resistant diabetes mellitus, to name but two, frequently utilize injectable medications to stabilize the patient. Injectable medications include insulin, as well as other types of medications such as incretin mimetics, the first of which in the class is labeled Byetta. 
         [0003]    In order to effectively control many disease states, the repeated application of injectable medications is required. Many patients are quite resistant to such applications, and as a consequence, the disease state is less controlled than is optimal. Issues principally stem from compliance with following the drug schedule, especially if it is required one or more times each day. This problem is further compounded by the need for injection of the medication. Many patients resist injections due to the fear of pain, difficulty with manipulation of the needles, discomfort at the injection site, and the need to properly purchase, and dispose of the needle and container after use is completed. Further, with the advent of such communicable diseases such as HIV, or Hepatitis C, the risk of exposed needles to others is increased. What is needed is an improved self-contained medication injection system. 
         [0004]    Therefore, it is a primary object, feature or advantage of the present invention to improve upon the state of the art. 
         [0005]    It is a further object, feature, or advantage of the present invention to provide a self-contained medication injection system incorporating built in needles, so that the user is not required to dispose of the expended materials. 
         [0006]    Yet another object, feature, or advantage of the present invention is to provide a system that is wholly contained, eliminating the need to place and replace needles into the system with each usage. 
         [0007]    Still another object, feature or advantage of the present invention is to provide a method for delivery of a drug where the user, or other health care workers are protected from inadvertent contact with the needle. 
         [0008]    Still a further object, feature or advantage of the present invention is to provide a system for monitoring temperature of the medication to be dispensed, and to provide a warning if such parameters are breached. 
         [0009]    Still yet another object, feature or advantage of the present invention is to provide a communication link from the device that requires very low power. 
         [0010]    It is a further feature of the present invention to incorporate a wireless link for communication to an electronic device that records data such as dosing information and distributions, or receiving updates from the electronic device. 
         [0011]    These and/or other objects, features or advantages of the present invention will become apparent from the specification and claims. 
       BRIEF SUMMARY OF THE INVENTION 
       [0012]    The present invention relates to a self-contained medication delivery device, such as an injection system for administration of intramuscular or intradermal medications. In one embodiment of the present invention, the needle system is wholly contained in the device, and is mechanically moved into position for administration of the medication. The needle is wholly contained initially within the device. Upon initiating the system for medication administration, the needle is moved into the appropriate position for injection. The needle system can then be advanced outward from the device either before the injection of the medication, or in conjunction with the distribution of the medication. After the injection of the medication, the needle is then retracted back into the body of the self-contained medication delivery device, preventing unwanted contact with the patient or others. Storage of all needles used in injection is facilitated within the device, segregating the used needles from the unused ones. In the electromechanical system, sensors and/or small motors may facilitate the needle control system, as well as monitor various parameters of the administration of the medication. These parameters may include such variables as time of administration, dose administered, skin temperature or ambient temperature at the time of administration, failure of dosing or of the needle advance/retract system, location of the administration on the body, geographic location of the administration, among other parameters. Storage of data is contemplated, with the capability for wireless transmission to a receptor device. Although the present invention also provides for sensing at the injection site, a plurality of sensors is also postulated to monitor other parameters. Linkage of the device through a low power communication link is postulated. The use of a low power communication link such as Bluetooth, or UWB allows for reductions in transmit power required and for greater bandwidth applications between the self-contained medication delivery device, and the linked electronic device. 
         [0013]    According to one aspect of the present invention, a medication delivery pen is disclosed. The medication delivery pen includes a pen body assembly comprising a distal end, a proximal end and a needle array containing a plurality of needles disposed within the pen body assembly. 
         [0014]    According to yet another aspect of the present invention, a medication delivery pen includes a pen body assembly comprising a distal end, a proximal end, a needle array containing a plurality of needles, and a needle assembly adapted to convey clean needles of the needle array towards the proximal end of the pen body assembly for delivering medication via injection. 
         [0015]    According to another aspect of the present invention, a method for delivery of medication includes providing a self-contained medication injection system containing a plurality of needles and adapted for concurrently storing both a plurality unused needle and a plurality of used needles and reporting information about delivery of medication using the self-contained injection system. 
         [0016]    According to yet another aspect of the present invention, a medication delivery pen is provided. The medication delivery pen includes a pen body assembly comprising a distal end, a proximal end, a reservoir of medication disposed within the pen body, a needle operative connected to the pen body assembly for delivering the medication to a user, and at least one sensor on the pen body assembly, and a short range transceiver operatively connected to the at least one sensor and disposed within the pen body assembly for reporting information associated with use of the medication delivery pen. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is a perspective view of a self-contained medication device such as a medication delivery pen according to one embodiment of the present invention. 
           [0018]      FIG. 2  is a perspective view of a medication delivery pen according to another embodiment of the present invention. 
           [0019]      FIG. 3  is an end view illustrating one embodiment of the skin contact area of a medication delivery pen. 
           [0020]      FIG. 4  is a block diagram illustrating one embodiment of a self-contained medication device such as a medication delivery pen. 
           [0021]      FIGS. 5A and 5B  show one configuration for a medication delivery pen. 
           [0022]      FIG. 5C  illustrates the cartridge portion of a medication delivery pen. 
           [0023]      FIG. 6A  to  FIG. 6F  illustrate a non-coupling embodiment where the needle is threaded onto the cartridge connect using a thumbwheel. 
           [0024]      FIG. 7  illustrates a non-coupling embodiment where there are breaks in the bore so that a portion of the bore rotates separate from the rest of the bore. 
           [0025]      FIG. 8A  is an embodiment which could incorporate either quick-connect, quick-coupling, manual, or automatic threading of the needle onto the cartridge connect. 
           [0026]      FIG. 8B-8E  show a manually threaded embodiment. 
           [0027]      FIG. 9A-9D  and  FIG. 10  show an alternative embodiment of the medication delivery pen using a double-sided needle. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0028]    The present invention relates to a self-contained medication delivery device, such as an injection system for administration of intramuscular or intradermal medications. To assist in describing the invention various embodiments of the invention are described. It is to be understood that the scope of the invention is not to be limited to the specific embodiments described. It is also to be understood that various features or structures of the various embodiments may be combined together where appropriate to do so. 
         [0029]    In one embodiment of the present invention, the needle system is wholly contained in the device, and is mechanically moved into position for administration of the medication. The needle is wholly contained initially within the device. Upon initiating the system for medication administration, the needle is moved into the appropriate position for injection. The needle system can then be advanced outward from the device either before the injection of the medication, or in conjunction with the distribution of the medication. After the injection of the medication, the needle is then retracted back into the body of the self-contained medication delivery device, preventing unwanted contact with the patient or others. Storage of all needles used in injection is facilitated within the device, segregating the used needles from the unused ones. In the electromechanical system, sensors and/or small motors would facilitate the needle control system, as well as monitor various parameters of the administration of the medication. These parameters could be such variables as time of administration, dose administered, skin temperature or ambient temperature at the time of administration, failure of dosing or of the needle advance/retract system, location of the administration on the body, geographic location of the administration, among other parameters. Storage of data is contemplated, with the capability for wireless transmission to a receptor device. Although the present invention also provides for sensing at the injection site, a plurality of sensors is also postulated to monitor other parameters. Linkage of the device through a low power communication link is postulated. The use of a low power communication link such as Bluetooth, or UWB allows for reductions in transmit power required and for greater bandwidth applications between the self-contained medication delivery device, and the linked electronic device. 
         [0030]    It should be understood that when describing the invention, the term “user” is used to refer to either a person administering or overseeing or observing the administration of medication and/or the person receiving the injection. Although, often times the “user” may be self-administering the medication, this is not necessarily so, so the term “user” is not to be limited to such instances. 
         [0031]      FIG. 1  is a pictorial representation of a self-contained medication device according to one embodiment of the present invention. In  FIG. 1 , a medication delivery pen  100  is shown. The medication delivery pen  100  has a pen body assembly  101  having a distal end  106  and a proximal end  108 . The medication delivery pen  100  may also include a pen cap  102  with clip  104 . A bore  110  is shown in skin contact area  112 . One or more sensors may be at the skin contact area  112 . When actuated, such as by activation of button  124 , a needle extends from bore  110  for delivery of medication. 
         [0032]    A display  118  is shown on the pen body assembly  101 . The display  118  can be used for displaying dosage settings or information based on sensor readings such as, but not limited to, skin temperature, or temperature of the medication. In addition, the display  118  may display information that assists the user with administering the medication. For example, the display  118  may indicate that additional skin contact pressure may need to be applied based on sensor information. The display  118  may provide information helpful in determining a proper dosage setting. The display  118  may also include time and date information. The display  118  may also indicate the amount of medication left or that additional medication is required. The display  118  may also allow for loading of specific patient information such as e-mails or phone numbers to call if a dose is missed, indicate the number of needles left or indicate that new needles are required. The display  118  may also display historical information that has been stored such as information regarding the time of prior injections, the dosage of prior injections, or other information. A speaker  117  is shown. Verbal cues, warnings or confirmations can be distributed to the user. 
         [0033]    User inputs such as buttons  120 ,  122  are shown. The user input buttons  120 ,  122  may be used to increase or decrease dosage settings, cycle between display modes, or make selections, such as by holding one of the buttons for a longer period of time, or depressing both buttons simultaneously. Additional user inputs may also be used where desirable, such as where greater functionality is imparted to the device. In addition, buttons  120 ,  122  and display  118  may be of different configurations and may be placed at different locations. 
         [0034]      FIG. 2  is a pictorial representation of a self-contained medication device according to another embodiment of the present invention. The device shown in  FIG. 2  is similar to the device shown in  FIG. 1 , however, instead of using an electronic system to control dosage, a dose setting  126  which includes a dial is provided. In addition, to activate delivery of a dose of the medication, an activation input  128  is shown which may be mechanical or electromechanical. 
         [0035]      FIG. 3  illustrates one embodiment of the skin contact area  112 . The skin contact area  112  surrounds a bore  110  through which a needle extends in order to deliver medication. Sensors  142 ,  144 ,  146 , and  148  are shown. The sensors  142 ,  144 ,  146 ,  148  may be of various types to serve various purposes. For examples, sensors  144 ,  148  may be contact sensors or pressure sensors. Information obtained from sensors  144 ,  148  may be used to determine if sufficient pressure is being applied to the skin for the needle to properly deliver medication. If insufficient pressure is being applied, an audible and/or visual warning may be given to the user, or where electronic activation is used, it may be disabled until proper pressure is applied. Speaker  117  may be utilized to provide feedback. As sensors  144 ,  148  are opposite of one another, information can also be used to determine angle of entry of a needle. Sensor  146  and/or sensor  142  may be temperature sensors for determining skin temperature of the user being injected. Pore  110  could also utilize a separate clean needle array to assay physiologic parameters such as blood glucose, before a dose is readied for injection. 
         [0036]      FIG. 4  is a block diagram illustrating one embodiment of the present invention. A pen  160  is shown. The pen  160  includes one or more temperature sensors  162 , one or more contact or pressure sensors  164 , one or more skin temperature sensors  166 , one or more medication temperature sensors  168 , all of which are electrically connected (either directly or indirectly) to an intelligent control  170 . The medication temperature sensors  168  may include an ambient temperature sensor so that instead of directly measuring temperature of the medication, ambient temperature is measured and associated with the medication. The intelligent control  170  may be a circuit, a processor, a microcontroller, or other type of intelligent control. The intelligent control  170  is also electrically connected to a display  172  and a short range transceiver or transmitter  174 . The pen  160  communicates with an electronic device such as, but not limited to either a cell phone  176  or computer  178 . If a dose is missed, the pen could use the phone number or e-mail the user to remind them a dose is imminent. The electronic device may also be a medical device, or other type of electronic device. The short range transceiver  174  allows for information obtained from the sensors  162 ,  164 ,  166 ,  168  to be communicated to other devices for storage or analysis. 
         [0037]    It should be understood that the intelligent control  170  may be configured to perform a number of intelligent operations or functions. For example, the intelligent control  170  may be configured to monitor the temperature of the medication and if the temperature of the medication falls above or below critical thresholds, alert the user that the medication is not safe and effective to use. The intelligent control  170  may be configured to monitor the state of various sensors over time and provide appropriate alerts or record sensed information. The intelligent control  170  may be configured to control audio associated with the use of the medication injection system such as to provide verbal acknowledgements or instructions such as, but not limited to “Injection complete”, “Replace cartridge”, “Apply additional pressure”, and other acknowledgements or instructions which assist the user. The intelligent control  170  may also be configured to control simple beeps or other audio alerts or visual indicators in addition to the display, such as LEDs. Using the sensors, and preferably a clock component which may be integrated into the intelligent control  170 , the intelligent control  170  can determine information regarding distribution, time of distribution and depth of injection attained, or other parameters as well as provide audible or visual reminders for distribution of the drug and feedback. Such information may be provided to other electronic devices. 
         [0038]    The pen body may include various mechanical or electromechanical configurations for holding multiple needles and for removing needles from a needle array, or arrays, coupling the needle in place for rejection, extending the needle for injection, retracting the needle after injection, decoupling the now used needle and moving the now used needle back into the needle array. 
         [0039]      FIGS. 5A and 5B  show one configuration. In  FIG. 5A , a cylinder  180  contains a plurality of needles. The cylinder  180  is double staged. In the first stage, the cartridge connect  182  on cartridge  103  is coupled to the needle  204  as the cartridge  103  and cartridge connect  182  are moved from a neutral position to the first stage by depressing activation input  128 . In the second stage of extension, the cartridge  103  and cartridge connect  182  with the coupled needle  204  are moved out of the cylinder  180  through the cover plate bore  191  in the cover plate  190  and the end cap bore  194  in the end cap  192  thereby exposing the needle for use. An antiseptic reservoir  127  may be used to apply an antiseptic or sterilizing solution prior to injection or after transfer of the used needle. 
         [0040]    In the first stage of retraction, the needle  204  is retracted back into the cylinder bore  196  by depressing activation input  128 . Then in the second stage of retraction, the needle  204  is decoupled from the cartridge connect  182 . The needle  204  may be decoupled from the cartridge connect  182  by a detent  208  within the cylinder bore  196  that snags a catch on the needle  204 . Alternatively, an oversized gasket/grommet could be positioned within the cylinder bore  196  which permits the needle  204  to move from stage 1 to stage 2, but decouples the needle  204  from the cartridge connect  182  when the needle  204  is moved from stage 2 to stage 1. 
         [0041]    To rotate the cylinder  180  and align a new needle  204  with the cartridge connect  182 , the activation input  128  is depressed. The rotation of the cylinder  180  may be either manual or automatic. Similarly, the cylinder  180  could be rotated to align a clean needle  204  with cartridge connect  182  during stage 2 after the cartridge connect  182  is decoupled from the used needle  204  and withdrawn from the cylinder  180 . Alternatively, the cylinder  180  could be rotated to align a clean needle  204  with cartridge connect  182  at the outset of stage 1 upon extension of the cartridge connect  182 , but prior to movement of the cartridge connect  182  into the cylinder  180 . Upon rotation of the cylinder  180 , the used needle  204  is then secured within the cylinder bore  196  at stage 2 between the detent  208  and the cover plate  190 . Similarly, when all clean needles  204  within the cylinder  180  have been used, the cylinder  180  may align the cover plate bore  191  between two cylinder bores  182  to keep used needles  204  from passing through the cover plate bore  191  to thereby prevent exposure or reuse of the used needles  204 . In another embodiment, the detent  208  or oversized gasket/grommet could be adapted to lock the used needle  204  in stage 2 of the cylinder  180  so that the used needle could not be advanced despite depression of the activation input  128 . Thus, used needles can not be reused. Once the cylinder  180  is full of used needles  204 , the user can safely dispose of the cylinder  180  and reload the medication delivery pen  100  with a new cylinder  180  with clean needles  204 . The number of needles present should be related to the amount of medication, so that in some instances both will be depleted at or about the same time. Alternatively, if  180  and  103  are built as a single unit, the unit can be disposed of entirely. 
         [0042]      FIG. 5C  illustrates one embodiment of the cartridge portion  103  of the medication delivery pen  100 . In this embodiment, the cartridge connect  182  extends from the cartridge  103 . The cartridge  103  contains a reservoir of medication. Thus, when medication is depleted, the cartridge  103  can be replaced. 
         [0043]    As previously explained, either a mechanical or electromechanical system may be used. The activation button  128  may be operatively connected a double action plunger. When the activation button  128  is pressed a first time, the cartridge  103  moves the cartridge connect  182  into the first stage within the cylinder  180  for coupling to the needle  204 . The activation button  128  may then be depressed again to move the cartridge  103  with the cartridge connect  182  coupled to the needle  204  out of the end cap  192  to the second stage for injection. A third click then retracts the needle  204  to the second stage, detaches it from the cartridge connect  182 , moves the cartridge connect  182  through the first stage into the neutral position, and rotates the cylinder  180  so that the cartridge connect  182  is aligned with a clean needle  204  in an adjacent cylinder bore  196 . The cartridge  103  may be biased toward a neutral position by a spring or other biasing means. 
         [0044]    The embodiment shown in  FIG. 5A  through  FIG. 5C  attaches the needle  204  to the cartridge connect  182  using a quick coupler. The embodiment in  FIG. 6A  to  FIG. 6G  provides for a non-coupling embodiment where the needle  204  is threaded onto the cartridge connect  182 .  FIG. 6A  shows an end view of the cylinder  180 .  FIG. 6B  shows the cylinder  180  with a thumbwheel  230  on the outside of the cylinder  180 .  FIG. 6C  is another view of the cylinder  180  with the thumbwheel  230  positioned over the cartridge connect  182 .  FIG. 6D  is a top view of the cylinder  180 .  FIG. 6E  is a perspective view of the cylinder  180  within the medication delivery pen  100 , with the exterior surface of the medication delivery pen  100  having an opening to allow access to the thumbwheel  230 .  FIG. 6F  illustrates a clean needle  204  in the cartridge connect which can be threaded in place through use of the thumbwheel. In operation, rotation of the thumbwheel  230  imparts rotation to the needle  204 . A single thumbwheel  230  may be configured in the cylinder  180  for rotating/threading the clean needle  204  onto the cartridge connect  182 . 
         [0045]      FIG. 7  illustrates an alternative embodiment where breaks are in the cylinder bore  196  of the cylinder  180  so that a portion of the cylinder bore  196  rotates separate from the rest of the cylinder bore  196 . The rotatable section of the cylinder bore  196  may be rotatably supported by needle bearings or ball bearings positioned on opposite ends of the rotatable section of the cylinder bore  196  so that rotation of the thumbwheel  230  imparts rotation to the freely rotatable cylinder bore  196  section, which rotates and threads the needle  204  onto the cartridge connect  182 . 
         [0046]      FIG. 8A  is an alternative embodiment which could incorporate either quick-connect, quick-coupling, manual, or automatic threading of the needle  204  onto the cartridge connect  182 . In the embodiment of  FIG. 8A , note that the path of the needle  204  is connected from one side and disconnected from the other side. Thus, the used needles  204  are separated from the clean needles  204 .  FIG. 8B-8E  shows this embodiment with a manually threaded embodiment (through operation of a thumbwheel  230 ).  FIG. 8D  illustrates how the needle cartridge may be a unitary piece with clean needles  204  on one side and used needles  204  on the opposite side. 
         [0047]    In operation, in a first stage, a plunger moves the medicine cartridge connect  182  to couple or be threaded to a clean needle  204 . In a second stage, the plunger moves the coupled/threaded needle  204  into the end cap  192  for use. In a third stage, the cartridge connect  182  retracts and decouples the now used needle  204  from the cartridge connect  182  or into the position to be unthreaded. If coupling is used, after the cartridge connect  182  is decoupled from the needle  204 , the used needle  204  is ejected along arrow  240  from the loading stage into the used needle cartridge  232  and a new needle is moved from the clean needle cartridge  234  along arrow  238  into the loading stage. If threading is used, in the third stage, unthreading of the needle from the cartridge connect  182  takes place. In a fourth stage, movement (ejection) of the used needle from the loading stage into the used needle cartridge  232  occurs and new needle movement into the loading stage from the clean needle cartridge  234  occurs. The threading stage can be performed manually or by automatic operation. For example, a low-voltage servo motor  236  could be used to rotate thumbwheel  230  to thread and unthread needle  204  onto cartridge connect  182 .  FIG. 9A-D  and  10  is another alternative embodiment of the medication delivery pen  100 .  FIG. 9A  shows a cylinder  180  having a rotatable array of double-sided needles  242  (shown in  FIG. 9D ) carried by belt  250 . Armature  244  is pivotably actuated, mechanically, electromechanically or otherwise, to sweep side-to-side within the cylinder  180 . In one embodiment, armature  244  pivots toward belt  250  to pick up double-sided needle  242  using grip  248  positioned on the armature  244 . In an alternative embodiment, each double-sided needle  242  could have a grip  248  that quick-couples to the armature  244  to pick up a clean double-sided needle  242  from the belt  250  (shown in  FIG. 9B ) and de-couples from the armature  244  to release the used double-sided needle  242  in the same or another position on the belt  250  (shown in  FIG. 9C ). 
         [0048]      FIG. 9A-D  and  FIG. 10  show a double-sided needle  242  in the neutral position. In the neutral position, the double-sided needle  242  is ready for use. Depressing the activation button  128  causes the cartridge  103  or the cylinder  180  to move together whereby one of the needle spikes of the double-sided needle  242  is inserted into the needle valve  246  on the cartridge  103 . The medication delivery pen  100  then may be pressed against the skin whereby the double-sided needle  242  and cartridge  103  are then moved together to extend the other needle spike on the double-sided needle  242  out of the end cap  192  to puncture the skin at which point the medication delivery pen  100  dispenses the specified dosage from the cartridge  103  through needle valve  246  and double-sided needle  242  into the body. After delivery of the medication, the used double-sided needle  242  is drawn back inside the cylinder  180 , withdrawn out of the needle valve  246 , and moved by the armature  244  into a stored position in the belt  250 . The armature  244  then picks up a clean double-sided needle  242  and moves it from the belt  250  to the neutral position within the cylinder  180  for subsequent use. 
         [0049]    In addition to the embodiments provided herein, the present invention contemplates numerous additions, variations, options, and alternatives. For example, instead of a single needle being used, multiple needles may be used as a part of an injection. An alcohol skin preparation may be performed prior to injection with the medication delivery pen facilitating the antiseptic, through an antiseptic reservoir. Such cleaning may also occur after the used needle is brought back into the assembly through bore  110 . 
         [0050]    In one embodiment, multiple containers may be used so that a medication delivery pen can deliver more than one type of medication. In such an embodiment, multiple configurations may be used, such as the ring configuration shown where one ring may be placed outside of another ring or above or below another ring. In addition, a device such as a glucometer may be incorporated into the device. Where the glucometer is present, the intelligent control of the medication delivery pen can set the dosage level. 
         [0051]    The preferred embodiments of the present invention has been set forth in the drawings and specification and although specific terms are employed, these are used in the generically descriptive sense only and are not used for the purposes of limitation. Changes in the formed proportion of parts as well in the substitution of equivalence are contemplated as circumstances may suggest or are rendered expedient without departing from the spirit and scope of the invention as further defined in the following claims.