Abstract:
A system for administering an injection is described. The invention consists of an adhesive patch with an integrated injector that controllably insets an injection needle and delivers the medication contained within the patch. Variations of the system may also subsequently and automatically retracts the needle, rendering the patch safely inert. In additional variations, a portion of the system may remain on the patient and function as a bandage.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to an injection system for administering medical substances into tissue. Variations of the device and method described herein allow for an automated injector for administration of medications under the skin or into the muscle of patients. Further variations include injection systems designed to reside on an individual where injection of the substance can occur when needed and on-demand. 
       BACKGROUND 
       [0002]    Several medications are frequently administered by injection into or under the skin with a syringe and needle system. Preferably, such injections require cleansing of the skin with alcohol or another antiseptic to prevent infection. The needle is then exposed and often visible to the patient. Next, the medical caregiver inserts the needle into the patient to a certain depth to inject the medication. The injection is then administered and the needle is withdrawn from the patient, leaving an exposed needle. Subsequently a bandage may be placed on the injection site. 
         [0003]    Significant populations of individuals requiring such injections are frightened and/or react badly to the sight of needles. “Needle-less” pneumatic injectors were developed to obviate the need for needles. These systems are expensive and require regular maintenance. They have generally found application only in large-scale vaccination programs. If a patient moves during the administration of a pneumatic injection, failure of the injection and possible injury can result. Skin preparation prior to the injection and bandage application are still required as separate steps.. 
         [0004]    Standard needle/syringe injections are technique dependant. Both the rate of needle insertion as well as the rate of injection of the medication greatly affect the pain associated with the injection. Often, the needle is not inserted to the same depth resulting in bleeding, swelling, pain and potential ineffectiveness of the medication. 
         [0005]    A syringe-loaded injection system is available currently for use primarily with emergency medications such as epinephrine. This “Epi-Pen” requires skin cleansing, uncapping, and forceful thrusting into the skin to actuate the spring firing mechanism. This injection system is rather large and awkward and is not easily carried, although it must be readily available in case the need for use arises. Users also complain that the spring-loaded mechanism sometimes fires accidentally and can result in an inadvertent injection with resultant injury. 
         [0006]    Children receive multiple injections for vaccination against diseases and may require physical restraint in order to accomplish the injections. In view of the above, there remains room for improvement to injection systems, particularly medicinal injection systems. 
     
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0007]      FIG. 1A  shows a variation of an actuator/injection system. 
           [0008]      FIG. 1B  shows the needle residing within the system. 
           [0009]      FIG. 1C  shows the needle exiting the system. 
           [0010]      FIG. 2A  shows a cross sectional view of a variation of the system prior to actuation. 
           [0011]      FIG. 2B  shows the system after the gas generation compound activates to increase the pressure within the first chamber. 
           [0012]      FIG. 2C  shows pressurization of a second chamber causing a drug delivery piston to compress the substance or medication. 
           [0013]      FIG. 2D  shows gas being vented throug a venting port. 
       
    
    
     DETAILED DESCRIPTION 
       [0014]    The present invention includes a simple self-contained injection system that can be applied to a patient. Although the system may be applied with traditional cleaning of the skin surface, variations include systems that, automatically prepare the skin with antiseptic. In a further variation of the system, the system allows injection of medication without further intervention at a standard rate of injection after a standard and optimal needle deployment, and can act as a bandage all in one application. Variations of the present system allow for safe and convenient carrying of the device prior to use. Variations of the system may include a self-retracting needle that leaves the used system safely inert. 
         [0015]      FIG. 1A  shows a variation of the invention. In this variation, the system  10  includes an actuator/injection system  10  where the system  10  includes an adhesive patch or section that is coated with an adhesive  12 . Typically, the adhesive surface is initially covered with a removable backing. When applying the system  10  to an individual the backing is removed so that the system  10  adheres to the skin or clothing of the individual. As mentioned above, the adhesive section  12  may optionally be impregnated with any type of agent that may be required (e.g., an antiseptic agent, an anesthetic agent, clotting agent, etc., or a combination of agents if so desired). In the variation shown in  FIG. 1 , the system  10  contains an adhesive coating  12  on a portion of the system  10 . In this case, the uncoated section of the system  10  may be unattached to the individual while the section with the needle opening  14  contains the adhesive. As discussed below, such a configuration may be desirable when repositioning the system  10  to prepare for an injection. Although other variations are possible, in such a variation the area of the system that delivers the needle is affixed to the injection area. 
         [0016]    Next, the actuator/injection system  10  is activated to prepare for the injection. This activation may be initiated by manually repositioning part of the device (e.g., pulling the unaffixed portion perpendicular to the injection site). Alternatively, the system may be designed to reposition automatically (e.g., by pushing a button that electrically, chemically, or via a combination of means repositions the system to deliver the injection). Regardless, repositioning of the system may not be necessary. 
         [0017]    Variations of the invention may be configured to deliver the injection upon repositioning of the system  10 . However, the injection process may occur as a separate step as well. As shown in  FIG. 1B , prior to injection, the needle  16  resides within the system  10 . During actuation of the needle, but prior to the injection process, the needle  16  a needle/injection port  14  as shown in  FIG. 1C . The needle/injection port maybe a thin membrane that is penetrated by the needle upon actuation. In additional variations, the needle/injection port may be a valve-type member or simply an opening in the system. 
         [0018]    As shown in  FIGS. 1C  or  1 D, needles  16  of the present system may be inclined, angled, or curved as well as straight. Such configurations may facilitate systems  10  that lay flat against the skin. 
         [0019]    It is understood that in variations of the device, the needle port as well as the exit path of the needle-may vary as required for the particular application. Furthermore, during the injection process can be triggered to automatically inject the medication. Such triggering mechanisms may be electrical, magnetic, manual, or fluid powered. In one variation, the injection process may be a gas generation process that is started when an activator is added to the gas generation compound. An example of such a compound is sodium bicarbonate with an activator consisting of, for example, acetic acid solution. For example, the two agents may be placed in separate compartments of the system  10  where actuation causes a separating member or wall to rupture to mix the agents. 
         [0020]      FIG. 2A  shows a cross sectional view of a variation of the system  10  prior to actuation. As shown, the system  10  includes a first chamber  20 , a second chamber  22  and a port  24  that allows for eventual equalization of pressure between the two chambers. The needle  16  resides in the first chamber  20  and is coupled to a sealing piston  26  that temporarily blocks the port  24 . To actuate the system  10  the gas generation compound  30  drives the sealing piston  26  and needle  16 . Eventually, the needle  16  exits the system  10  via the needle port  14  as discussed below. The second chamber  22  contains the injection or therapeutic substance  34 , an exhaust port  32  and a venting port  36 . A spring  28  is affixed to the sealing piston  26  so that after the chamber decreases in pressure, the sealing piston  26  retracts causing the needle to withdraw. As the gas moves the sealing piston and needle assembly toward the skin, the spring stretches. Alternatively, the spring. could be placed on the opposite side of the piston as a compression spring. The therapeutic substance may be held in a container or may be placed directly into the chamber  22 . 
         [0021]      FIG. 2B  shows the system of  FIG. 2B  after the gas generation compound activates to increase the pressure within the first chamber  20 . As shown, the increase in pressure causes the sealing piston  26  and needle  16  to advance (e.g., into the tissue  2 ). Once the proximal end of the sealing piston  26  moves past the chamber port  24 , the second chamber  22  pressurizes. 
         [0022]    As shown in  FIG. 2C , pressurization of the second chamber  22  causes a drug delivery piston  36  to compress the substance or medication  34 . As shown, the medication is in fluid communication with the needle  16 . Accordingly, compression of the medication  34  results in injection of the substance  34  into tissue (as shown.) In another variation, the system may not require a piston  36  to compress the substance  34  (or a container holding the substance). Instead, the system will be configured so that pressure generated within the second chamber  22  compresses the substance  34  moving it through the needle  16 . 
         [0023]    As shown in  FIG. 2D , the delivery piston  36  includes a venting port  38 . Once the pressure drives the piston  38  a sufficient distance to inject the substance  34 , the venting port  38  becomes exposed to the atmosphere via an exhaust port  32 . Accordingly, gas  40  from the system  10  exhausts from the port  32  to cause a pressure decrease in the first and second chambers  20  and  22 . As the pressure decreases, insertion force exerted against the sealing piston  26  decreases as well. Once this insertion force drops below the return force exerted by the spring  28  on the sealing piston  26 , the return force or spring causes the sealing piston  26  to return. It should be noted that the back of the first chamber  20  may include a deformable one-way valve located between the first and second chambers. The deformable valve could permanently open after injection of the medicine to prevent residual pressure from impeding retraction of the sealing piston  26  and needle  16 . 
         [0024]    The rate of needle deployment can be controlled as desired. For example, the rate of deployment may be controlled by selecting substances having varying rates of gas creation. Alternatively, the rate of deployment may be altered by changing the force of the return spring or the frictional force acting on the needle piston. Likewise, the rate of medication delivery can be manipulated and controlled by adjusting the resistance of the chamber port between the first and second chambers  20  and  22 , by the resistance to flow through the fluid channel into and through the needle, and/or by the friction and momentum of the drug delivery piston and the force needed for drug reservoir compression. The system may be designed to delay the injection to allow the anesthetic/analgesic time to work before needle deployment but after actuation. 
         [0025]    The system  10  can be configured so the sound of the exhaust  40  is audible, such as a whistle. The audible signal provides the patient and/or staff completion of the injection. 
         [0026]    In addition to the above discussion, the invention includes, but is not limited to the following: 
         [0027]    A method of beginning an injection consisting of placing an adhesive patch with or without antiseptic and/or anesthetic components, onto an area of the skin, activating the injection system and delivering the medication through said injection system, after which the needle is retracted into the system to render it inert. 
         [0028]    In the above method the event may comprise generating a signal in response the completion of the injection process. 
         [0029]    The devices described herein generally automatically administer an injection into the skin where they are placed without the need for additional intervention on the part of the patient or medical practitioner. These devices generally include an adhesive patch. The patch may have an agent such as an antiseptic and/or anesthetic agent. The injection component includes a movable needle and a drug reservoir with a force-generating component such as a gas generator that is activated after or about the time of the desired injection. 
         [0030]    In additional variations of the invention, the actuation mechanism may include a winding mechanism that stores energy via winding. The energy is then dissipated by the injection process. Alternatively, or in combination, an expandable polymer or hydrogel may be placed into the first and/or second chambers  20 ,  22 . To activate the device, and expanding agent such as water or expanding foam is added to complete the injection process. In yet another variation, the pistons  26 ,  36  may be fabricated from the expandable polymer or hydrogel. In another variation, the device may use a hydrophilic material that allows the device to self-actuate after the backing is removed from the adhesive. This feature may allow for injection soon after the device is placed on an individual. 
         [0031]    Naturally, the system may include a variation of the above configurations. Variations of the device may include systems that have various decorations on the outer surface to make the system more child-friendly and alleviate apprehension of getting an injection. In these devices and methods, the conditions may be those as described above, or other conditions as required by the specific treatment sought. 
         [0032]    While embodiments and applications of this invention have been shown and described, it would be apparent to those skilled in the art having the benefit of this disclosure that many more modifications than mentioned above are possible without departing from the inventive concepts herein. The invention, therefore, is not to be restricted except in the spirit of the appended claims.