Patent Publication Number: US-2016228634-A1

Title: Aseptic drug delivery system and methods

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims priority benefit under 35 U.S.C. §119(e) to U.S. provisional application No. 62/112,716 filed Feb. 6, 2015, which is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to drug delivery systems for administering medication. More specifically, but not exclusively, the present invention concerns an aseptic drug delivery system. 
     BACKGROUND OF THE INVENTION 
     Currently many auto injectors use glass or rigid plastic vials, syringes, cartridges, or barrels to store the medication for delivery to a patient. Many of these containers include additional parts, such as, flex tubing, transfer IVS, plungers, pistons, stoppers, and the like to push the medication out of the container through a needle for delivery to the patient. These containers are generally coated with chemicals, such as, silicone, to assist the plunger motion during use. The chemicals may be sprayed onto the barrel in liquid form or sprayed as an emulsion and baked onto the glass wall. Although these coatings assist in plunger motion, they cause concerns for chemical compatibility to the medication contained in the containers. In addition, the chemicals and additional components provide additional sources for potential contamination and breakage of the sterile environment. For example, the coatings could leach into the medication, break, or flake off and be injected into the patient. 
     In addition, many auto injectors use small pieces of tubing to connect the needle to the bottle or container holding the medication. The addition of tubing between the container and needle provides an additional source of potential contamination of the sterile environment. Glass syringes can also introduce contaminates into the drug delivery stream if they chip, crack, or otherwise break during production filling, which may result in glass chards being injected into the patient. Further, anytime a patient or medical professional refills a multiple use auto injector whether by refilling the container or replacing the used cartridge with a pre-filled cartridge, the patient or medical professional must thoroughly clean all components of the system as well as components used to refill the auto injector to maintain a sterile environment. The requirement to sterilize the auto injector system when refilling provides another opportunity for contamination and may also be time consuming and difficult for some patients. 
     Thus, a drug delivery system that ensures a sterile environment without the risk of contamination is needed. 
     SUMMARY OF THE INVENTION 
     Aspects of the present invention provide an aseptic drug delivery system. The present invention also provides methods for manufacturing, assembling and using the aseptic drug delivery system. 
     In one aspect provided herein is a drug delivery system that includes a housing, a motion plate coupled to the housing, and a module moveably coupled to the motion plate. 
     In another aspect, provided herein is a drug delivery module that has a plate with a first end and a second end, a cartridge positioned on the plate, and a cover positioned over the cartridge and coupled to the plate. 
     In yet another aspect, provided herein is a method of manufacturing a drug delivery cartridge, the method includes obtaining a first cartridge layer and a second cartridge layer. The method also includes forming edge holes in the first cartridge layer and forming a plurality of cavities in the first cartridge layer. The method further includes inserting an injection mechanism into each cavity and forming edge holes in the second cartridge layer. In addition, the method includes aligning the edges holes of the first cartridge layer with the edge holes of the second cartridge layer and sealing the first cartridge layer to the second cartridge layer on at least three edges to form a plurality of cartridges. 
     These, and other objects, features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the detailed description herein, serve to explain the principles of the invention. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the invention. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. The foregoing and other objects, features and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which: 
         FIG. 1  is a perspective transparent view of an aseptic drug delivery cartridge, in accordance with an aspect of the present invention; 
         FIG. 2  is a perspective view of the assembled aseptic drug delivery module including the transparent cartridge of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 3  is an exploded view of an aseptic drug delivery module including the transparent cartridge of  FIG. 1  with a portion of the plate cut away to show the drive plate, in accordance with an aspect of the present invention; 
         FIG. 4  is an exploded view of an aseptic drug delivery system including the module of  FIG. 3 , in accordance with an aspect of the present invention; 
         FIG. 5  is a perspective view of the assembled aseptic drug delivery system of  FIG. 4 , in accordance with an aspect of the present invention; 
         FIG. 6  is a top view of a portion of a roll of aseptic drug delivery cartridges, in accordance with an aspect of the present invention; and 
         FIG. 7  depicts one embodiment of a method of manufacturing an aseptic drug delivery system, in accordance with an aspect of the present invention. 
     
    
    
     DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION 
     Generally stated, disclosed herein are an aseptic drug delivery cartridge, module, and system. Further, methods of manufacturing, assembling, and using the aseptic drug delivery system are discussed. 
     In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part of a device according to the relative disposition of the device with respect to a body or directional terms of reference. For example, “proximal” means the portion of a device nearest the point of attachment, while “distal” indicates the portion of the device farthest from the point of attachment. As for directional terms, “anterior” is a direction towards the front side of the device, “posterior” means a direction towards the back side of the device, “medial” means towards the midline of the device, “lateral” is a direction towards the sides or away from the midline of the device, “superior” means a direction above and “inferior” means a direction below another object or structure. 
     Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to  FIG. 1 , there is illustrated an aseptic drug delivery cartridge  100 . The cartridge  100  includes a first layer  102  coupled to a second layer  104 . The first and second layers  102 ,  104  may be, for example, rigid films or flexible films, and the layers  102 ,  104  may be the same film material or different film materials. The layers  102 ,  104  may be made of, for example, a number of different polymers based on their chemical compatibility with the medication that will be stored in the cartridges  100  formed of the layers  102 ,  104 . The cartridge  100  may also be, for example, a blow fill seal container, a form fill seal container, or the like. The first layer  102  and second layer  104  may each include a plurality of edge holes  106  extending along the first edges and second edges of the layers  102 ,  104 . The first layer  102  and second layer  104  may each also include fastener holes  108 . The fastener holes  108  may include, for example, a first fastener hole  108  positioned near the top edge and a second fastener hole  108  positioned near the bottom edge on each layer  102 ,  104 . The fastener holes  108  may also be positioned, for example, so that the first fastener holes  108  are positioned near the first edge and the second fastener holes  108  are positioned near the second edge. The layers  102 ,  104  may be attached together by aligning the holes  106 ,  108  and, for example, heat sealing, gluing, or otherwise bonding the two layers  102 ,  104  to each other, as described in greater detail below with reference to the method of manufacture. The cartridges  100  may also be formed using, for example, blow fill seal or form fill seal technology. 
     The cartridge  100  may further include a cavity  110  positioned between the first layer  102  and second layer  104 . The cavity  110  may be formed by, for example, the first layer  102  and second layer  104  each being formed to provide half the cavity  110 , the first layer  102  being flat and the second layer  104  being formed to create the cavity  110 , or the first layer  102  being formed to create the cavity  110  and the second layer  104  being flat. The cavity  110  may be formed by, for example, thermoforming the first layer  102  and/or second layer  104  to create the cavity  110 . The cavity  110  may include a first portion  112  and a second portion  114  connected by a pathway  116 . The first portion  112  may be, for example, filled with a fluid or medication to be administered to a patient. The second portion  114  may have, for example, at least one flexible surface for moving the medication from the first portion  112  out of the cartridge  100 . 
     It is also contemplated that the first portion  112  of the cavity  110  may, for example, be split into at least two sections, one section may contain a liquid and the other section may contain a second liquid or a powder. The at least two sections of the first portion  112  would have a divider mechanism that could be mechanically removed by, for example, a pull tab or other externally activated mechanism to remove the divider mechanism for mixing of the liquid and powder prior to or during injection into the patient. Alternatively, an external force could be applied to the first portion  112  to break the divider mechanism and allow the at least two sections of the first portion  112  to mix prior to or during injection. The at least two sections could be positioned, for example, parallel to each other and in line with the pathway  116  or in series with each other so one section is at a first end of the first portion  112  and the second section is at a second end of the first portion  112 . It is also contemplated that there may be at least two first portions  112  that may either share a pathway  116 , second portion  114  and injection mechanism  120  or have separate pathways  116 , second portions  114  and injection mechanisms  120  that are adjacent to each other on a single cartridge  100 . The first portion  112  of the cavity  110  having at least two sections allows for onsite drug mixing to occur just prior to being administered to the patient. A divided first portion  112  may include, for example, a freeze-dried or lyophilized drug product in the first section, which is reconstituted when mixed with a liquid in a second section of the first portion  112 . 
     The cavity  110  may also include a tip  118  extending out from the second portion  114 . The tip  118  may receive an injection mechanism  120 , for example, a needle, micro-needle, cannula, or the like. The injection mechanism  120  may be coupled in a fluidic manner to the cavity  110  by, for example, a cannula (not shown). The injection mechanism  120  may be, for example, a needle that may extend out of the cartridge  100  at a first end and the second end of the needle may be fluidically coupled to the cavity  110  by, for example, a cannula. The cartridge  100  may further include a cover or cap  122  for insertion over the injection mechanism  120 . 
     Referring now to  FIGS. 2 and 3 , with continued reference to  FIG. 1 , an aseptic drug delivery module  130  including the cartridge  100  is shown. The module  130  also includes a plate  132  and a cover  134 . The cover  134  may be made of, for example, a flexible material to allow for the cover  134  to be depressed or crushed to allow for the cartridge  100  to be moved forward and the drug contained in the cartridge  100  to be delivered to a patient. The plate  132  and cover  134  may be, for example, shaped to include a rectangular portion with a triangular portion extending out from the first end. The cartridge  100  is attached to the module  130  by, for example, positioning the cartridge  100  on the plate  132 . The cover  134  may then be positioned and applied over the cartridge  100 . Once the cover  134  is in the desired position, the cover  134  may be attached to the plate  132  forming a seal  136  around the outside edge of the cover  134 . The cover  134  may also be secured to the plate  132  through the fastener holes  108  forming a dot seal  138  to hold the cartridge  100  in the desired position. The plate  132  and cover  134  may form, for example, a sterile housing surrounding the cartridge  100 . The plate  132  may also include an extension  140  projecting out from a top side of the plate  132 . The extension  140  and the plate  132  may be, for example, planar. The extension  140  may include at least one opening  142 . The cover  134  may also include a through hole  144  positioned near the tip of the triangular portion of the cover  134 . At least a portion of the cap  122  may extend through the hole  144  in the cover  134 . The module  130  may also include a tab  146  which may be positioned over and cover the entire hole  144 . The tab  146  may optionally be coupled to the cap  122 , such that when the tab  146  is removed, the cap  122  will also be removed to expose the injection mechanism  120 . 
       FIG. 3  also shows a motion plate  150  which the module  130  may be coupled to for injecting medication into a patient. It is also contemplated that the cartridge  100  may be coupled directly to the motion plate  150  with the necessary sterilization of the cartridge  100  and injection mechanism  120  to maintain the same sterile environment as provided by the module  130 . The motion plate  150  may include a first track  152  positioned near a first end of the motion plate  150  and a second track  154  positioned near a second end of the motion plate  150 . The first track  152  may include, for example, a first portion slanted from a top position near the first end of the motion plate  150  toward a center point of the motion plate  150  and a second portion then slanted toward a bottom position near the first end of the motion plate  150 . The second track  154  may be, for example, angled from the second end toward the center point of the motion plate  150 . The aseptic drug delivery module  130  may be attached to the motion plate  150  using translating members  158 ,  160 . For example, a first translating member  158  may couple the module  130  to the first track  152  and a second translating member  160  may couple the module  130  to the second track  154 . The translating members  158 ,  160  may slide within the first and second tracks  152 ,  154 , respectively, allowing for the module  130  to move with respect to the motion plate  150 . The translating members  158 ,  160  may be, for example, cams, bar linkages, slides and the like. The motion plate  150  may also include a movement mechanism  162 , which is moved proximally in  FIG. 3  for ease of illustration. The movement mechanism  162  may be coupled to the translating member  158  to move the module  130  for injection. The movement mechanism  162  may be, for example, a motor, drive spring, cylinder, cable, or the like to move the module  130  along the tracks  152 ,  154 . 
       FIGS. 4 and 5  show another embodiment of an aseptic drug delivery system  200 . The aseptic drug delivery system  200  may include the motion plate  150  and the aseptic drug delivery module  130  with the aseptic drug delivery cartridge  100 . The aseptic drug delivery system  200  may also include a housing with a first portion  202  and a second portion (not shown). The first portion  202  of the housing may also include an activation button  204  to start the medication delivery. The aseptic drug delivery system  200  may further include a controller  210 , power source  212 , and a delivery mechanism  214 . The controller  210  may also be positioned within the housing  102  and may be, for example, a printed circuit board, including a processing circuit, which may also be referred to as a processor and/or a microprocessor. The controller  210  may be coupled to the activation button  204 , the movement mechanism  162 , and the delivery mechanism  214  for activation and deactivation. The power source  212  may include, for example, at least one battery or other power supply. The delivery mechanism  214  is positioned external to the cavity  110  of the cartridge  100 . The delivery mechanism  214  may be, for example, an excitation device, vibrating mechanism, solenoid, magnetic mechanism, plunger, rolling pump, circular pump, stroking pump, peristaltic pump, diaphragm pump, magnetic u-shaped pump, linear pump, constant force springs, motors, rotary actuators, piezo electronics, fluid pressure, and the like. 
     The first portion  202  and second portion (not shown) may be secured together to form a housing surrounding the cartridge  100 , module  130 , motion plate  150 , movement mechanism  162 , controller  210 , power source  212 , and delivery mechanism  214 . The first portion  202  may also include an opening  206  for the injection mechanism  120  to pass through for injection into the patient, as shown in  FIG. 5 . The aseptic drug delivery system  200  may also optionally include a pull strip  216 . The pull strip  216  may be attached over the opening  206  in the first portion  202  of the housing prior to injection. The pull strip  216  may optionally be coupled to the tab  146 . The aseptic drug delivery system  200  may be, for example, an aseptic patch pump. 
     The aseptic drug delivery cartridge  100  may be manufactured as a roll  180  including a plurality of aseptic drug delivery cartridges  100 .  FIG. 6  shows a portion of the roll  180  of cartridges  100 . The cartridges  100  may be, for example, connected at a separation line  182 . The separation line  182  may indicate where one cartridge  100  ends and the next cartridge  100  begins. The separation line  182  may also indicate where the cartridges  100  should be separated to form individual cartridges  100 . Before separation, the roll  180  may be sterilized, filled with the desired medication, and sealed, as described in greater detail below. 
     The method of manufacturing the aseptic drug delivery cartridges  100 , as shown in  FIG. 7 , may include obtaining a first cartridge layer and a second cartridge layer  300 . The method may also include forming edge holes in the first cartridge layer  302  and forming cavities in the first cartridge layer for receiving medication and the injection mechanisms  304 . Injection mechanisms may then be obtained and inserted into each cavity  306 . Next, edge holes may be formed in the second cartridge layer  308  and the edge holes of the first and second cartridge layers may be aligned  310 . Once the edge holes are aligned the first and second cartridge layers are sealed together to form a plurality of cartridges  312 . The first and second layers may be sealed together by, for example, an adhesive or heat. The seal may be formed using, for example, ultrasonic, thermal or other methods to form the seal. Covers may then be placed over the injection mechanisms of each of the plurality of cartridges  314 . The plurality of cartridges may be formed into rolls for additional processing. For example, after the cartridges are formed and covers applied, the cartridges may be sterilized  316  and then the cavities of the cartridges filled with the desired fluid or medication  318 . After the cartridges are filled, the remaining opening of the cartridge may be sealed to close the cavities  320 . Finally, the sealed first and second cartridge layers may be separated into individual cartridges for use  322 . If desired or necessary, the filled cartridges may once again be sterilized. 
     The second cartridge layer may also optionally have cavities formed in the layer prior to aligning the first and second cartridge layers  310  during the method of manufacturing. The individual cartridges  100  each include components that were sterilized prior to being filled with the medication creating an aseptic environment for the medication. As no additional components come into contact with the medication within the cartridges  100  after they are sealed, there is a reduced risk of contamination of the medication while in the cartridges  100  awaiting injection into the patient. Thus, the cartridges  100  maintain an aseptic environment for the medication from the time of filling the cartridges  100  until injection into the patient. 
     The aseptic drug delivery system  200  may be assembled by obtaining a cartridge  100 , a module  130 , a motion plate  150 , a movement mechanism  162 , a housing with a first portion  202  and a second portion, a controller  210 , a power source  212 , and a delivery mechanism  214 . The movement mechanism  162 , motion plate  150 , controller  210 , and power source  212  may all be secured to the interior of the first portion  202  of the housing. The cartridge  100  may be coupled to the module  130  by inserting the translating members  158 ,  160  through the openings  142  in the plate  132  and the first and second tracks  152 ,  154 , respectively. The translating member  158  may extend through the first track  152  and be moveably secured to a portion of the movement mechanism  162  inside the first housing portion  202 . The translating member  160  may extend through the second track  154  and be moveably secured on the back side of the motion plate  150 , as shown in  FIG. 5 . Next, the delivery mechanism  214  may be positioned with respect to the cavity  110  of the cartridge  100  to allow for the delivery mechanism  214  to expel the fluid from the cavity  110 . The delivery mechanism  214  may optionally be secured to the second portion (not shown) of the housing. It is also contemplated that the delivery mechanism  214  may be secured to the first housing portion  202  or alternatively, attached directly to the cartridge  100 . After all of the internal components of the aseptic drug delivery system  200  are positioned within the first housing portion  202 , the second portion (not shown) may be aligned and coupled to the first portion  202  to close the system  200 . A pull strip  216 , as shown in  FIG. 5 , may then be applied over the opening  206  in the first housing portion  202 . The pull strip  216  may optionally be secured to the tab  146 . 
     Once assembled, the aseptic drug delivery system  200  may be used to deliver a fluid or medication from the cavity  110  to a patient by first positioning the system  200  on the patient&#39;s body at the site for administering the medication. The system  200  may be laid or held on the patient&#39;s body or alternatively, secured to the patient&#39;s body by, for example, an adhesive, bandage wrap, Velcro wrap, or the like. When the patient is ready for administration of the medication, the pull strip  216  may be removed. The pull strip  216  may be attached to the tab  146  which is in turn secured to the cap  122 , which allows for the removal of the cap  122  to expose the injection mechanism  120  when the pull strip  216  is removed. Alternatively, the pull strip  216  may not be secured to the tab  146  and after removal of the pull strip  216 , the tab  146  would then need to be removed to remove the cap  122  and expose the injection mechanism  120 . 
     Next, the patient, medical professional, or caregiver may push the activation button  204 . When the button  204  is pressed it may activate the movement mechanism  162 . The movement mechanism  162  in turn moves the module  130  along the tracks  152 ,  154  to position the injection mechanism  120  for insertion into the patient. For example, the module  130  sliding along tracks  152 ,  154  may move the module  130  to an insertion position of, for example, approximately 45 degrees, by sliding the first pointed end of the module  130  down the first portion of the track  152  toward the middle of the motion plate  150 . Next, the movement mechanism  162  may exert additional force on the module  130  to drive the injection mechanism  120  into the patient at a desired insertion distance. Alternatively, the injection mechanism  120  may be deployed from the system  200  just above the patient&#39;s skin for a topical application. To drive the injection mechanism  120  into the patient or position the injection mechanism  120  above the patient&#39;s skin, the module  130  is translated down the second portion of the first track  152  at a first end and down the second track  154  at a second end to move the injection mechanism  120  through opening  206  and to or into the patient. 
     Once the injection mechanism  120  is inserted into the patient or positioned for medication delivery, the delivery mechanism  214  may be activated to move the medication from the first portion  112  of the cavity  110  through the pathway  112  and second portion  114  and out of the tip  118  to the injection mechanism  120  for delivery to the patient. As the medication is delivered to the patient, the cavity  110  may be formed of layers  102 ,  104  that are elastic to allow the cavity  110  to collapse in upon itself as the pressure changes in the cavity  110 . Alternatively, if the cavity  110  is formed of rigid layers  102 ,  104 , the cavity  110  may include, for example, a filter to allow for air to escape from the cavity  110  as the medication is delivered to the patient. The filter, while allowing air to escape, will also prevent fluid from escaping from the cavity  110 . In addition, layers  102 ,  104  of the cavity  110  may include a mechanism to assist with the delivery of the medication, for example, a pumping membrane may be integral to at least one of layers  102 ,  104  in the second portion  114  of the cavity  110  to allow for the delivery mechanism  214  to pump the medication out of the injection mechanism  120  to the patient. 
     After the medication delivery is complete, which may be determined based on, for example, sensors which measure time, pressure drop, or the like, the delivery mechanism  214  is turned off. Then, the injection mechanism  120  may be retracted back into the system  200 . To retract the injection mechanism  120 , the movement mechanism  162  may reverse and slide the module  130  back along the tracks  152 ,  154  to the starting position where the injection mechanism  120  is positioned entirely within the housing. When retraction of the injection mechanism  120  is complete, the system  200  may optionally send a notification signal to the patient, medical professional, or caregiver, such as a sound indication, light indication, or the like. After the medication delivery is complete, the patient, medical professional or caregiver may remove the system  200  from the patient. If the system  200  is a single use system, the system  200  may then be properly discarded. However, if the system  200  is reusable, the housing may be opened and the empty module  130  may be removed allowing for a new module  130  to be inserted into the system  200 . The pull strip  216  may be reinserted over the opening  206  after the new module  130  is inserted into the housing. The pull strip  216  may optionally be attached to the tab  146  of the new module  130 . Although the pull strip  216  is preferably reusable, it is also contemplated that the pull strip  216  could be replaceable. The system  200  is then ready for administering the next dosage of medication. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. 
     The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.