Patent Publication Number: US-2016228648-A1

Title: Shoulder adapter and methods of use and assembly

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims priority benefit under 35 U.S.C. §119(e) to U.S. provisional application No. 62/113,157 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 a shoulder adapter and injection system. 
     BACKGROUND OF THE INVENTION 
     Currently many syringes, injectors and assisted injection systems apply a force on the flange of a syringe during injection. The force applied to the syringe flange may cause the flange to break or the syringe to shatter. If the syringe and/or flange breaks during the injection, the syringe pieces may cut the patient and/or the medical professional. In addition, the syringe may break before the injection is complete which may result in the medication or fluid flowing out of the syringe. If the syringe breaks such that the medication or fluid is lost, this may result in loss of expensive medications or difficulties in determining how much medication was administered to the patient. Thus, reduction or elimination of syringe flange breakage during the injection cycle is needed. 
     SUMMARY OF THE INVENTION 
     Aspects of the present invention provide a syringe shoulder adapter and injection system. The present invention also provides methods for assembling and using the syringe shoulder adapter and injection system. 
     In one aspect provided herein is a syringe shoulder adapter including a housing with a first end and a second end opposite the first end. The housing including a cavity defined by an exterior surface between the first end and the second end and a first slot positioned near the second end of the housing and extending into the cavity. 
     In another aspect, provided herein is an injection system including a shoulder adapter, a syringe positioned within the shoulder adapter, and an injector coupled to the shoulder adapter. 
     In yet another aspect, provided herein is a method of assembling an injection system, the method includes obtaining a syringe shoulder adapter, a syringe, and an injector device. The method also includes inserting the syringe into a cavity in the shoulder adapter. The method further includes attaching the injector device to a coupling mechanism on a first end of the shoulder adapter. 
     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 view of a shoulder adapter from a first end, in accordance with an aspect of the present invention; 
         FIG. 2  is a top perspective view of the shoulder adapter of  FIG. 1  from the first end, in accordance with an aspect of the present invention; 
         FIG. 3  is a top perspective view of the shoulder adapter of  FIG. 1  from a second end, in accordance with an aspect of the present invention; 
         FIG. 4  is a top view of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 5  is a side view of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 6  is a bottom view of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 7  is a first end view of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 8  is a second end view of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 9  is a perspective view of the housing of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 10  is a perspective view of the retaining member of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 11  is a perspective view of the deformable member of the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 12  is a perspective view of an exploded injection system including the shoulder adapter of  FIG. 1 , in accordance with an aspect of the present invention; 
         FIG. 13  is a perspective view of the assembled injection system, in accordance with an aspect of the present invention; and 
         FIG. 14  is a perspective view of another shoulder adapter, in accordance with an aspect of the present invention. 
     
    
    
     DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION 
     Generally stated, disclosed herein is a syringe shoulder adapter and injection system. Further, methods of assembling and using the syringe shoulder adapter and injection 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  FIGS. 1-11 , there is illustrated a syringe shoulder adapter  100 . The shoulder adapter  100  includes a housing  110 , a retaining member  140 , and a deformable member  150 . The housing  110  may include a first end  112  and a second end  114  with a sidewall  115  extending between the first end  112  and the second end  114 . The housing  110  may also include a cavity  116  extending into the housing  110  from an exterior surface. The cavity  116  may extend from the first end  112  to the second end  114 . The cavity  116  may be sized to receive a medication storage and delivery device, such as a syringe  160  shown in  FIGS. 12-13  or a cartridge (not shown). When the syringe  160  is inserted into the cavity  116 , the cavity  116  creates a window to view the syringe  160  during the injection cycle. The cavity  116  may include a first slot  118  near the first end  112  of the housing  110  and a second slot  120  near the second end  114  of the housing  110 . The second slot  120  may receive the deformable member  150  and a portion of the syringe  160 . The deformable member  150  may act, for example, to cushion the interface between the syringe  160  and the second end  114  of the housing  110 . Although not shown, it is also contemplated that a second deformable member  150  may be positioned in the first slot  118 . The housing  110  may also include a groove  122  extending around the exterior surface of the sidewall and into the cavity  116 . The groove  122  may be sized to receive the retaining member  140 . Alternatively, the retaining member  140  may be, for example, integral with the housing  110  and positioned where the groove  122  is shown. 
     With continued reference to  FIGS. 1-9 , the housing  110  may include a coupling mechanism  124  extending away from the first end  112 . The coupling mechanism may include a neck  126  and a lip  128 , as best shown in  FIGS. 4-6 . The neck  126  may be, for example, generally cylindrical and extend out from the first end  112  of the housing  110 . The lip  128  may extend out relatively perpendicular from the neck  126 . The lip  128  of the coupling mechanism  124  may have, for example, two planar sides and two rounded or curved sides with the two planar sides positioned opposite each other and the two rounded sides positioned opposite each other, as shown in  FIG. 7 . The lip  128  may be shaped to function, for example, in positioning and/or locking the shoulder adapter  100  to the injection mechanism. The housing  110  may also include an opening  130  extending through the coupling mechanism  124  and into the cavity  116  at the first end  112 . The opening  130  may be positioned, for example, centered in the first end  112  of the housing  110 , such that the opening  130  extends into the center of the cavity  116 . The housing  110  may further include a projection  132  extending away from the second end  114 . In addition, the housing  110  may include a channel  134  recessed in the projection  132  and extending through the second end  114  of the housing  110  into the cavity  116 . The projection  132 , as shown in  FIGS. 1-6 and 8-9 , may be sized, for example, to act as a needle length gauge to limit the depth of needle penetration into the skin. Thus, the adapter  100  may come with varying length projections  132  to ensure the injection mechanism is inserted to the proper depth for injection of a given medication into the patient. It is also contemplated that the projection  132  may, for example, cover the entire injection mechanism to allow for topical application of medications. 
     Referring now to  FIG. 10 , an example retaining member  140  is shown. The retaining member  140  may be, for example, a unitary piece or have at least two pieces coupled together. The retaining member  140 , as illustrated in  FIGS. 1-6 and 10 , may be a spring clip and include a cylindrical body portion  142  and at least two engagement members  144 . The cylindrical body portion  142  may include a first end  146  and a second end  148 . The cylindrical body portion  142  may be sized to fit around the housing  110  in the groove  122 . The cylindrical body portion  142  may also include a gap between the first end  146  and the second end  148  and the gap may be, for example, the width of the cavity  116 . A first engagement member  144  may extend away from the first end  146  into the gap and a second engagement member  144  may extend away from the second end  148  into the gap. When the retaining member  140  is inserted onto the housing  110 , the at least two engagement members  144  may extend into the cavity  116  to secure a syringe in the cavity  116  of the housing  110 . Alternative retaining members  140  are also contemplated and may include, for example, a spring clip, at least one elastomeric element, an elastic member, a rubber band, soft rubber bumpers, elastomeric extrusions of low durometer, and the like. As shown in  FIGS. 12 &amp; 13 , the retaining member  140  may be, for example, a rubber band like structure that may be positioned in a groove  122 , which is sized to receive the rubber band. If bumpers are used they may be positioned, for example, at the top of the cavity  116  and will deform to allow a syringe to be inserted into the cavity  116  and assist in retaining the syringe in the cavity during the injection cycle. It is also contemplated that the retaining member  140  may be, for example, integral to the housing  110  and include an opposing first engagement member  144  and second engagement member  144  which each extend out from the housing  110  into the cavity  116 . 
     Referring now to  FIG. 11 , an example deformable member  150  is shown. The deformable member  150  may be, for example, a gasket, spacer, or the like. The deformable member  150  may be fabricated from, for example, a thermoplastic, elastomer, or thermoset elastomer, such as, silicone, polyvinylidene fluoride (PVDF), elvax, butyl rubber, natural rubber, nitride rubber, fluoro-elastomer, vinyl, nylon, polyurethane elastomer, halo-butyl rubber, neoprene, and the like. The deformable member  150  may conform to the shape of a syringe or cartridge inserted into the housing  110  to spread the compressive load across the deformable member  150 . The deformable member  150  may include a body  152  and a channel  154 . The body  152  may be, for example, generally cylindrical and sized to fit in the second slot  120  of the housing  110 . The channel  154  may be sized to match the size of the channel  134  in the housing  110 . The deformable member  150  may be removable or placed permanently in the second slot  120  of the housing  110 . If the deformable member  150  is removable, the deformable member  150  may optionally be attached to the second slot  120  at the second end  114  by, for example, by an adhesive material. 
     An example injection system  200  is shown in  FIGS. 12-13 . The injection system  200  may include the syringe shoulder adapter  100 , a syringe  160 , and an injector device  210 . The syringe  160  may include a body  162  with a flange  164  at a first end and a shoulder  166  at a second end. An injection mechanism (not shown) may extend out from the second end of the body  162  and may optionally include a cover  168  over the injection mechanism. The terms “cover,” “cap,” “needle cover” and “shield” may be used interchangeably herein as they each refer to a structure used to maintain a sterile field and protect the patient and medical professional from accidentally being stuck by the injection mechanism. The injection mechanism may be, for example, a needle, microneedle, cannula, or the like for a subcutaneous injection or a tube, dispensing needle, or the like for topical application to the skin, a patch, or the like. The first end of the body  162  may also include an opening  170  for receiving a fluid or medication  172  and a piston head  174  for injection into a patient. The terms “piston head,” “plunger” and “plunger head” may be used interchangeably herein as they each refer to the same structure used for injecting a medication into the patient. In the embodiments shown in  FIGS. 12-13 , the piston head  174  is illustrated in a nearly complete injection position. In the syringe  160 , that is full of medication  172  which has not yet been administered, the piston head  174  will be positioned near the first end closer to the flange  164  of the syringe  160 . The cavity  116  of the adapter  100  may be sized to receive the syringe  160 . 
     The injector device  210  may include a housing  212  with an adapter end  214  and an activation end  216 , as shown in  FIGS. 12 and 13 . The adapter end  214  may include a coupling portion  218  with a recess  220  and an opening  222 . The recess  220  may extend into the housing  212  from an exterior surface in a direction perpendicular to the longitudinal axis of the housing  212 . The recess  220  may be sized to receive the lip  128  of the coupling mechanism  124  of the housing  110 . The opening  222  may extend from the second end into the housing  212  in a direction along the longitudinal axis of the housing  212 . The opening  222  may be sized to receive the neck  126  of the coupling mechanism  124  of the housing  110 . The coupling portion  218  may be, for example, generally horseshoe or C shaped. The adapter end  214  may also include a plunger rod  224  recessed within the housing  212 . The plunger rod  224  may be positioned such that upon release from the housing  212  the plunger rod  224  extends through the opening  222  to contact the piston head  174  in the syringe  160  to inject the medication or fluid  172 . As shown in  FIG. 13 , the activation end  216  may include a deployment means  226  allowing for the deployment or the pushing of the plunger rod  224  out of the housing  212 . The deployment means  226  may be, for example, a compressed air or gas line for an assisted injection system or alternatively, a manual injection mechanism coupled to the plunger rod  224  or an opposite end of the plunger rod  224  may be used for manual injection system. The housing  110  may also include, for example, a door or moveable portion (not shown) at the first end  112  which may be opened to access the opening  130  and a portion of cavity  116 . The door or moveable portion (not shown) of housing  110  would allow for the syringe shoulder adapter  100  to be removed from an injection system  200  without damage by providing a passage for removal of the plunger rod  224  after injection. By allowing for the removal of the plunger rod  224  from the adapter  100  after injection, the adapter  100  may be reusable. 
     The injection system  200  may be assembled by first obtaining a syringe shoulder adapter  100 , a syringe  160  filled with the desired fluid or medication  172  for injection, and an injector device  210 . The syringe shoulder adapter  100  should be selected to correspond to the size of the syringe  160  being used. If the deformable member  150  is not permanent, then the deformable member  150  may be inserted into the second slot  120  and optionally, attached to the housing  110  using, for example, an adhesive material. The adhesive material may be, for example, temporary or permanent in nature. Once the deformable member  150  is positioned within the second slot  120 , the syringe  160  may be inserted into the housing  110 . 
     To insert the syringe  160  into the housing  110 , the syringe flange  164  may be aligned with the first slot  118  of the syringe shoulder adapter  100  and the syringe cover  168  may be aligned with the channel  134 . Next, a force may be applied to the syringe  160  to insert the syringe  160  into the cavity  116 . Once the syringe  160  is positioned in the cavity  116 , a retaining member  140 , for example, the spring clip of  FIG. 10  or the elastic member of  FIGS. 12-13 , may optionally be inserted into the groove  122  to secure the syringe  160  into the housing  110 . The size of the groove  122  may correspond to the size of the retaining member  140 , such that the groove  122  for receiving the spring clip  140  of  FIG. 10  will be larger than the groove  122  for receiving the elastic member  140  of  FIGS. 12-13 . If a spring clip  140  is used, the spring clip  140  may be pressed into the housing  110  at the groove  122 . Alternatively, if an elastic member  140  is used, the elastic member  140  may be inserted over the first or second end  112 ,  114  of the housing  110  and moved into position within the groove  122 . 
     Next, the injector device  210  may be attached to the coupling mechanism  124  of the syringe shoulder adapter  100 , as shown in  FIG. 13 . The injector device  210  may be attached by aligning the lip  128  of the adapter coupling mechanism  124  with the recess  220  in the adapter end  214  of the injector  210 . Once the lip  128  is aligned with the recess  220 , a force may be applied by the user to insert the lip  128  into the recess  220  and the neck  126  into the opening  222 . The recess  220  may be, for example, sized to secure the coupling mechanism  124  to the injector device  210  such that a force is required to release the coupling mechanism  124  from the recess  220 . Finally, if necessary, an actuation mechanism may be attached to the deployment means  226  of the injector device  210 . 
     Once assembled, the injection system  200  may be used to deliver a fluid or medication  170  to a patient. To initiate the injection cycle, the cap or cover  168  would be removed from the syringe  160  to expose the needle (not shown). Next, the needle may be inserted into the patient for injection or positioned over the area of application for a topical application. Once the needle (or patch) is in the desired position, the deployment means  226  may be activated. As the deployment means  226  is activated, a force is applied to the plunger rod  224  to move the plunger rod out of the housing  212  of the injector device  210 . As the plunger rod  224  moves it passes through the opening  222  in the injector device  210  and into the opening  130  in the syringe shoulder adapter  100 . The opening  130  acts to align the plunger rod  224  with the inner diameter of the syringe body  162  to avoid uneven pressure and point loading on the flange  164 . The plunger rod  224  continues through the opening  130  and into the opening  170  in the syringe  160 . As the plunger rod  224  passes into the syringe  160 , the plunger rod  224  contacts the piston head  174 . The force of the plunger rod  224  on the piston head  174  causes the piston head  174  to begin to move toward the shoulder  166 . As force is applied to the plunger rod  224  and in turn the piston head  174 , the first slot  118  provides support to the flange  164  to prevent breakage of the flange  164 . In addition, the syringe shoulder adapter  100  transfers the force being applied to the plunger rod  224  and piston head  174  to the syringe shoulder  166  which contacts the deformable member  150  and assists in minimizing the resultant load on the flange  164 . As the piston head  174  moves, the medication or fluid  172  is forced out of the syringe  160  and through the needle (not shown) into the patient. The deployment means  226  will continue to apply a force on the plunger rod  224  until the desired amount of fluid or medication  172  is administered to the patient. As the injection cycle occurs, the cavity  116  provides a window to view the syringe  160  to allow the medical professional or user to confirm that the desired amount of fluid or medication  172  injected into the patient. Once the desired amount of medication or fluid  172  is administered, the needle may be removed from the patient and the cap  168  may be replaced to cover the needle. 
     Referring now to  FIG. 14 , another shoulder adapter  250  is shown. The shoulder adapter  250  is shaped to receive, for example, a cartridge or other tube-like medication storage device without a flange. The shoulder adapter  250  may include a housing  260 , a retaining member  140 , and a deformable member  150 . The housing  260  may be of the type described above with reference to housing  110  without the slot  118  near the first end  112 . For brevity sake, the housing  260  will not be described again here in detail. The housing  260  may also include a cavity  266  extending into the housing  110  from an exterior surface. The cavity  266  may extend from the first end  112  to the second end  114 . The cavity  266  may be sized to receive a medication storage and delivery device, such as a cartridge without a flange. When the cartridge (not shown) is inserted into the cavity  266 , the cavity  266  creates a window to view the cartridge during an injection. The cavity  266  may also include a first slot  270  near the second end  114  of the housing  260 . The first slot  270  may be of the type described above with reference to second slot  120  which will not be described again here for brevity sake. The housing  260  may also include groove  122 , coupling mechanism  124 , lip  128 , opening  130 , projection  132 , and channel  134  as described above with reference to housing  110  which will not be described again here for brevity sake. 
     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.