Patent Publication Number: US-2023133017-A1

Title: Connector for Aseptic Transfer of Fluid

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application is a continuation of U.S. patent application Ser. No. 16/160,081 filed Oct. 15, 2018, entitled “Connector for Aseptic Transfer of Fluid”, which claims priority to U.S. Provisional Application Ser. No. 62/572,730 filed Oct. 16, 2017, entitled “Connector for Aseptic Transfer of Fluid”, the entire disclosures of each of which are hereby incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present disclosure relates generally to a drug delivery device and, in particular, to a connector arrangement for aseptic transfer of fluid within the drug delivery device. 
     Description of Related Art 
     Various types of automatic injection or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered by untrained personnel or to be self-injected. Generally, these devices include a reservoir that is pre-filled with the liquid therapeutic preparation, and some type of automatic needle-injection mechanism that can be triggered by the user. When the volume of fluid or drug to be administered is generally below a certain volume, such as 1 mL, an auto-injector is typically used, which typically has an injection time of about 10 to 15 seconds. When the volume of fluid or drug to be administered is above 1 mL, the injection time generally becomes longer resulting in difficulties for the patient to maintain contact between the device and the target area of the patient&#39;s skin. Further, as the volume of drug to be administered becomes larger, increasing the time period for injection becomes desirable. The traditional method for a drug to be injected slowly into a patient is to initiate an IV and inject the drug into the patient&#39;s body slowly. Such a procedure is typically performed in a hospital or outpatient setting. 
     Certain devices allow for self-injection in a home setting and are capable of gradually injecting a liquid therapeutic preparation into the skin of a patient. In some cases, these devices are small enough (both in height and in overall size) to allow them to be “worn” by a patient while the liquid therapeutic preparation is being infused into the patient. These devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic preparation to flow out of a reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism to cause the liquid therapeutic preparation to begin to flow at the proper time and a triggering mechanism to initiate the injection. 
     SUMMARY OF THE INVENTION 
     In one aspect, a drug delivery system for injecting a medicament includes a housing defining a cavity, a container received within the cavity and configured to receive a medicament with the container including a closure, a valve assembly received within the cavity and including a piercing configured to pierce the closure of the container, and a connector arrangement provided between the container and the valve assembly, the connector arrangement movable between a first, pre-use position maintaining sterility between the closure of the container and the valve assembly and a second, use position permitting fluid communication between the container and the valve assembly. 
     In another aspect, the connector arrangement may include at least one membrane held between the container and the valve assembly. The connector arrangement may include two membranes held between the container and the valve assembly. The at least membrane may include flashspun high-density polyethylene fibers. At least a portion of the connector arrangement may extend through and outside of the housing. The connector arrangement may be pulled out of the housing to move the connector arrangement from the first position to the second position. 
     In another aspect, a fluid transfer system utilizing a connector arrangement for aseptic transfer of fluid between a cannula arrangement and a container includes the cannula arrangement, the container, at least one membrane held between the cannula arrangement and the container, and at least one clip configured to clamp the at least one membrane between the cannula arrangement and the container. 
     In another aspect, the at least one membrane may include two membranes. The at least one clip may include two clips. The cannula arrangement may include a flange extending around a portion thereof. The container may include a flange extending around a portion thereof. The at least one clip may be configured to engage the flanges on the cannula arrangement and the container to clamp the at least one membrane between the cannula arrangement and the container. The cannula arrangement may include a housing and a cannula slidably positioned within the housing. The at least one membrane may include one of the following: a foil, rubber, or polymer. The at least one membrane may be pulled out of the housing to establish fluid communication between the cannula arrangement and the container. The container may include a syringe barrel. A joint member may be provided on a proximal end of the cannula arrangement and a joint member may be provided on a distal end of the container. The joint members may be configured to engage one another after the at least one membrane has been removed from between the cannula arrangement and the container. At least a portion of the at least one membrane may extend through the at least one clip. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein: 
         FIG.  1    is a perspective view of a drug delivery system according to one aspect of the present invention. 
         FIG.  2    is a perspective, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention. 
         FIG.  3    is a front, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention. 
         FIG.  4    is a top view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing a top portion of the housing removed and the drug delivery system in a pre-use position. 
         FIG.  5    is a top, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in a pre-use position. 
         FIG.  6    is a front, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in a pre-use position. 
         FIG.  7    is a top view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing a top portion of the housing removed and the drug delivery system in an initial actuation position. 
         FIG.  8    is a top, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in an initial actuation position. 
         FIG.  9    is a front, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in an initial actuation position. 
         FIG.  10    is a top view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing a top portion of the housing removed and the drug delivery system in a use position. 
         FIG.  11    is a top, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in a use position. 
         FIG.  12    is a front, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in a use position. 
         FIG.  13    is a top view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing a top portion of the housing removed and the drug delivery system in a post-use position. 
         FIG.  14    is a top, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in a post-use position. 
         FIG.  15    is a front, cross-sectional view of the drug delivery system of  FIG.  1    according to one aspect of the present invention, showing the drug delivery system in a post-use position. 
         FIG.  16    is a side view of a connector for aseptic transfer of fluid in the drug delivery system of  FIG.  1    according to one aspect of the present invention. 
         FIG.  17 A  is a side view of a connector for aseptic transfer of fluid in the drug delivery system of  FIG.  1    according to another aspect of the present invention, the connector being shown in an inactive state. 
         FIG.  17 B  is a side view of the connector of  FIG.  17 A , shown in an active state. 
         FIG.  18    is a side view of a connector for aseptic transfer of fluid in the drug delivery system of  FIG.  1    according to another aspect of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention. 
     For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. 
     Referring to  FIGS.  1 - 15   , a drug delivery system  10  according to one aspect of the present disclosure includes a drive assembly  12 , a container  14 , a valve assembly  16 , and a needle actuator assembly  18 . The drive assembly  12 , the container  14 , the valve assembly  16 , and the needle actuator assembly  18  are at least partially positioned within a cavity defined by a housing  20 . The housing  20  includes a top portion  22  and a bottom portion  24 , although other suitable arrangements for the housing  20  may be utilized. In one aspect, the drug delivery system  10  is an injector device configured to be worn or secured to a user and to deliver a predetermined dose of a medicament provided within the container  14  via injection into the user. The system  10  may be utilized to deliver a “bolus injection” where a medicament is delivered within a set time period. The medicament may be delivered over a time period of up to 45 minutes, although other suitable injection amounts and durations may be utilized. A bolus administration or delivery can be carried out with rate controlling or have no specific rate controlling. The system  10  may deliver the medicament at a fixed pressure to the user with the rate being variable. The general operation of the system  10  is described below in reference to  FIGS.  1 - 15   . 
     Referring again to  FIGS.  1 - 15   , the system  10  is configured to operate through the engagement of an actuation button  26  by a user, which results in a needle  28  of the needle assembly  18  piercing the skin of a user, the actuation of the drive assembly  12  to place the needle  28  in fluid communication with the container  14  and to expel fluid or medicament from the container  14 , and the withdrawal of the needle  28  after injection of the medicament is complete. The general operation of a drug delivery system is shown and described in International Publication Nos. 2013/155153 and 2014/179774, which are hereby incorporated by reference in their entirety. The housing  20  of the system  10  includes an indicator window  30  for viewing an indicator arrangement  32  configured to provide an indication to a user on the status of the system  10  and a container window  31  for viewing the container  14 . The indicator window  30  may be a magnifying lens for providing a clear view of the indicator arrangement  32 . The indicator arrangement  32  moves along with the needle actuator assembly  18  during use of the system  10  to indicate a pre-use status, use status, and post-use status of the system  10 . The indicator arrangement  32  provides visual indicia regarding the status, although other suitable indicia, such an auditory or tactile, may be provided as an alternative or additional indicia. 
     Referring to  FIGS.  4 - 6   , during a pre-use position of the system  10 , the container  14  is spaced from the drive assembly  12  and the valve assembly  16  and the needle  28  is in a retracted position. During the initial actuation of the system  10 , as shown in  FIGS.  7 - 9   , the drive assembly  12  engages the container  14  to move the container  14  toward the valve assembly  16 , which is configured to pierce a closure  36  of the container  14  and place the medicament within the container  14  in fluid communication with the needle  28  via a tube (not shown) or other suitable arrangement. The drive assembly  12  is configured to engage a stopper  34  of the container  14 , which will initially move the entire container  14  into engagement with the valve assembly  16  due to the incompressibility of the fluid or medicament within the container  14 . The initial actuation of the system  10  is caused by engagement of the actuation button  26  by a user, which releases the needle actuator assembly  18  and the drive assembly  12  as discussed below in more detail. During the initial actuation, the needle  28  is still in the retracted position and about to move to the extended position to inject the user of the system  10 . 
     During the use position of the system  10 , as shown in  FIGS.  10 - 12   , the needle  28  is in the extended position at least partially outside of the housing  20  with the drive assembly  12  moving the stopper  34  within the container  14  to deliver the medicament from the container  14 , through the needle  28 , and to the user. In the use position, the valve assembly  16  has already pierced a closure  36  of the container  14  to place the container  14  in fluid communication with the needle  28 , which also allows the drive assembly  12  to move the stopper  34  relative to the container  14  since fluid is able to be dispensed from the container  14 . At the post-use position of the system  10 , shown in  FIGS.  13 - 15   , the needle  28  is in the retracted position and engaged with a pad  38  to seal the needle  28  and prevent any residual flow of fluid or medicament from the container  14 . The container  14  and valve assembly  16  may be the container  14  and valve assembly  16  shown and described in International Publication No. WO 2015/081337, which is hereby incorporated by reference in its entirety. 
     Referring to  FIGS.  16 - 17 B , in one aspect, a connector arrangement  50  is provided between two mating components to provide a sterile connection between the two components during fluid transfer. In one aspect, the connector arrangement  50  is provided between a syringe barrel or container  51 ,  52  and a cannula arrangement  54 . The cannula arrangement  54  includes a cannula  53  surrounded by a housing  56  with a flange  58 . The container  51 ,  52  also includes a corresponding flange  60 . The container  51 ,  52  and the housing  56  each include a membrane  62 ,  64  to provide a sterile seal of the mating portions of the container  51 ,  52  and the housing  56 . The membranes  62 ,  64  are made of any suitable material, such as a foil, rubber, or polymer, to maintain sterility of the container  51 ,  52 , the cannula  53 , and the housing  56  while allowing the membranes  62 ,  64  to be removed. 
     Referring again to  FIGS.  16 - 17 B , during assembly of the connector arrangement  50 , a clip  66  or other similar type of connector is fitted to engage the respective flanges  58 ,  60  of the container  51 ,  52  and the housing  56  such that the membranes  62 ,  64  are brought into contact with one another. In one aspect, a single clip  66  is provided to clamp the flanges  58 ,  60  together with one another. In another aspect, two clips  66  are provided to clamp the flanges  58 ,  60  together with one another. The membranes  62 ,  64  may extend through one of the clips  66  once the connector arrangement  50  has been assembled. Prior to use of the cannula arrangement  54 , the membranes  62 ,  64  are removed from the connector arrangement  50  to permit fluid communication between the container  51 ,  52  and the cannula  53 . The membranes  62 ,  64  may be pulled away from the connector arrangement  50  to permit the container  51 ,  52  and the housing  56  to move into engagement with one another. In one aspect, a distal end of the container  51 ,  52  and a proximal end of the housing  56  may include joints  68 ,  70  to facilitate engagement between the container  51 ,  52  and the housing  56 . The joints  68 ,  70  may be any type of engagement and locking mechanism that connects the distal end of the container  51 ,  52  with the proximal end of the housing  56 . 
     Referring to  FIG.  18   , the connector arrangement  50  is shown in use with the drug delivery system  10  shown in  FIG.  1 - 15   . The connector arrangement  50  is provided between the container  14  and the valve assembly  16 . In particular, the membranes  62 ,  64  are held between a distal end of the container  14  and a proximal end of a valve member  72  of the valve assembly  16 . In this aspect, the membranes  62 ,  64  form a pull tab that extends through and outside of the housing  20  of the system  10 . The valve assembly  16  is configured to pierce a septum  74  held in the closure  36  of the container  14 . During the drug delivery process of the system  10 , the container  14  is pressed against the valve member  72  to expose a piercing member  76  housed in the valve member  72 . The piercing member  76  pierces the septum  74  of the container  14  to establish fluid communication between the container  14  and the valve assembly  16 . Prior to use of the system  10 , however, the membranes  62 ,  64  are positioned between the container  14  and the valve assembly  16  to maintain the sterility of the components before use of the system  10 . A portion of the membranes  62 ,  64  may extend out of the housing  20  of the system  10  to allow a user to grasp the membranes  62 ,  64 . Before use of the system  10 , the membranes  62 ,  64  are pulled from the housing  20  to allow the container  14  and the valve assembly  16  to move towards one another during the drug delivery process of the system  10 . In this aspect, the membranes  62 ,  64  are made of flashspun high-density polyethylene fibers to allow pulling of the membranes  62 ,  64  without breaking or tearing the membranes  62 ,  64 . It is contemplated, however, that other suitable materials may also be used for the membranes  62 ,  64 . 
     Elements of one disclosed aspect can be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the present invention. 
     While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.