Patent Publication Number: US-2021178060-A1

Title: Tube Crimping Arrangement for Drug Delivery Device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 16/160,184 filed Oct. 15, 2018, entitled “Tube Crimping Arrangement for Drug Delivery Device”, which claims priority to U.S. Provisional Application Ser. No. 62/572,692 filed Oct. 16, 2017, entitled “Tube Crimping Arrangement for Drug Delivery Device”, the entire disclosures of each of which are hereby incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Disclosure 
     The present disclosure relates generally to a drug delivery or injector device and method for delivering a fluid into the body of a patient by injection and, in particular, to a drug delivery device configured to automatically provide a fluid lock to prevent fluid from leaking from the device after fluid delivery is completed. 
     Description of the Related Art 
     Various types of automatic injection 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 
     According to an aspect of the disclosure, a drug delivery system for injecting a medicament is provided. The system includes: a container configured to receive a medicament; a drive assembly which, upon actuation, is configured to expel the medicament from the container; a needle for injecting the medicament to a patient; a fluid path assembly comprising a tube in fluid communication with the container and the needle for conducting fluid from the container to the needle; and a tube crimping arrangement configured to engage the tube to block fluid flow through the tube. The drive assembly causes the tube crimping arrangement to engage the tube after a dose of the medicament has been delivered to the patient through the needle. 
     In some examples, upon actuation, the drive assembly automatically causes the tube crimping arrangement to engage the tube. Optionally, the system further comprises a housing enclosing at least a portion of the container, drive assembly, needle, fluid path assembly, and tube crimping arrangement. The housing can include a top cover engaged to a bottom cover. 
     In some examples, the system further includes a needle actuator assembly having a movable portion biased by a biasing member and configured to move the needle between a pre-use position, a use position for delivery of the medicament to the patient, and a post-use position after delivery of the medicament is completed. Optionally, the system further includes a housing enclosing at least a portion of the container, drive assembly, needle, fluid path assembly, and tube crimping arrangement. The needle can be retracted into the housing in the pre-use and post use positions. At least a portion of the needle can be extended from the housing in the use position. 
     In some examples, transition of the needle actuator assembly between the use position and the post-use position causes the tube crimping arrangement to engage the tube. For example, upon actuation, the drive assembly can automatically cause the needle actuator assembly to transition the needle between the use position and the post-use position. 
     In some examples, the tube crimping arrangement includes at least one tube crimping member configured to be driven toward the tube by contact with the movable portion of the needle actuation assembly. Optionally, the system further includes a housing enclosing at least a portion of the container, drive assembly, needle, and fluid path assembly. The at least one crimping member can include one or more flexible blades pivotally mounted to a portion of the housing. The movable portion of the needle actuator assembly can include one or more pins extending therefrom. The pins can be configured to contact the flexible blades to drive the flexible blades towards the tube. 
     In some examples, the system further includes a housing enclosing at least a portion of the container, drive assembly, needle, and fluid path assembly. The at least one crimping member can include two flexible blades pivotally mounted to a portion of the housing and defining a gap therebetween. The movable portion of the needle actuator assembly can include a first set of pins positioned to deflect the two flexible blades away from one another to expand the gap and a second set of pins positioned to drive the two flexible blades towards one another to contact the tube. Optionally, the movable portion of the needle actuator assembly includes a ridge configured to press the tube into the gap when the gap is expanded by contact between the first set of pins and the flexible blades. 
     In some examples, the biasing member of the needle actuator assembly exerts a force of 1N or less on the tube crimping arrangement. In some examples, the tube is a flexible single walled tube having a diameter of 0.7 mm or less. 
    
    
     
       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 top view of the drug delivery system of  FIG. 1  according to one aspect of the present invention, showing a top cover of the housing removed and the drug delivery system in a pre-use position. 
         FIG. 3  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. 4  is a top view of the drug delivery system of  FIG. 1  according to one aspect of the present invention, showing a top cover of the housing removed and the drug delivery system in an initial actuation position. 
         FIG. 5  is a top view of the drug delivery system of  FIG. 1  according to one aspect of the present invention, showing a top cover of the housing removed and the drug delivery system in an in 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 an in 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 cover of the housing removed and the drug delivery system in a post-use position. 
         FIG. 8  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. 9A  is a cross-sectional view of a drive assembly of the drug delivery system of  FIG. 1  according to one aspect of the present invention, showing a pre-use position of the drive assembly. 
         FIG. 9B  is a cross-sectional view of the drive assembly of  FIG. 9A  according to one aspect of the present invention, showing a use position of the drive assembly. 
         FIG. 9C  is a cross-sectional view of the drive assembly of  FIG. 9A  according to one aspect of the present invention, showing a post-use position of the drive assembly. 
         FIG. 10  is another top view of the drug delivery system of  FIG. 1  according to one aspect of the present invention, showing a top cover of the housing removed and the drug delivery system in a post-use position. 
         FIG. 11  is a left side perspective view of a needle shuttle of a needle actuator assembly of the drug delivery system of  FIG. 1  according to one aspect of the present invention. 
         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 fluid path assembly and the drug delivery system in a pre-use position 
         FIG. 13  is a cross-sectional view of a portion of a drug delivery system including a tube crimping arrangement according to an aspect of the present invention. 
         FIG. 14  is a perspective view of a portion of an interior surface of a top cover of the drug delivery system of  FIG. 13  according to an aspect of the invention. 
         FIG. 15  is a perspective view of a portion of the needle actuator assembly of the drug delivery system of  FIG. 13  according to an aspect of the present invention. 
         FIG. 16  is another cross-sectional view of the drug delivery system of  FIG. 13  according to an aspect of the present invention with the system in a post-use position. 
         FIG. 17  is a perspective view of a portion of an interior surface of the top cover of the drug delivery system of  FIG. 13  according to an aspect of the present invention. 
         FIG. 18  is another perspective view of a portion of an interior surface of the top cover of the drug delivery system of  FIG. 13  according to an aspect of the present invention. 
         FIG. 19  is a perspective view of the interior surface of the top cover of the drug delivery system of  FIG. 13  according to an aspect of the present invention. 
         FIG. 20  is a cross-sectional view of a portion of another exemplary drug delivery system including a tube crimping arrangement according to an aspect of the present invention. 
         FIG. 21  is another cross-sectional view of a portion of the drug delivery system of  FIG. 20  including a tube crimping arrangement according to an aspect of the present invention. 
         FIG. 22  is a schematic drawing of another exemplary drug delivery system including a tube crimping arrangement according to an aspect of the present invention. 
         FIG. 23  is a cross-sectional view of a portion of a drug delivery system including another exemplary tube crimping arrangement according to an aspect of the present invention. 
         FIGS. 24A and 24B  are schematic drawings of a similar tube crimping arrangement as shown in  FIG. 23  according to aspects of the present invention. 
         FIG. 25  is a cross-sectional view of a portion of a drug delivery system including another exemplary tube crimping arrangement according to an aspect of the invention. 
         FIG. 26  is another cross-sectional view of a portion of the drug delivery system of  FIG. 25  taken at line  26  according to an aspect of the present invention. 
     
    
    
     Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary aspects of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner. 
     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. 
     A drug delivery system including an injector device for injecting a fluid medicament to a patient is provided. The injector device can be configured to provide injection of a fluid substance over a predetermined time period. The injector device can be wearable and configured to be affixed to a patient. In some examples, the injection can occur automatically meaning that, once the user actuates the system or device, the injection occurs without further action by the patient. In some instances, the injector device includes a drive mechanism that transitions the device between a pre-use position, a use-position, and a post-use position. For example, transitioning the injector device through the various positions can include causing a needle to extend from the device and to be inserted into the patient, expelling fluid medicament from a container or reservoir of the injector device to the patient through the needle, and retracting the needle back into the device for safe disposal. The injector device can include a cover or pad for covering the tip of the needle after the injection is completed to prevent fluid leaks. 
     In some examples, the injector device includes a fluid path assembly for transporting fluid through the injector device. The fluid path assembly can include a flexible tube or conduit for transporting fluid from the container or reservoir to the needle. In some examples, the injector device includes a tube crimping arrangement that is configured to achieve fluid lock of the tube or conduit after the injection is completed (e.g., end-of-dose). The fluid lock can supplement protection provided by the needle pad or cover and, in particular, can prevent fluid from leaking or flowing from the injector device once an injection is completed. The tube crimping arrangement can be integrated with other biasing or movement mechanisms of the injector device, such that the tube is automatically crimped to prevent fluid leak at the end-of-dose. For example, movement of the drive mechanism to transition the device between the use and post-use positions can actuate the tube crimping mechanism, as discussed herein, by driving crimping or clamping structures against the tube or conduit to compress the tube or conduit and to prevent fluid flow therethrough. 
     Exemplary Fluid Delivery System 
     As shown in  FIGS. 1-12 , a drug delivery system  10  according to one aspect of the present invention includes an injector device  2  having a drive assembly  12  (shown in  FIGS. 2-8 ), a container  14 , a valve assembly  16  (shown in  FIGS. 2, 4, 5, 7, and 10 ), a needle actuator assembly  18  (shown in  FIGS. 2-8 , and a fluid path assembly  200  (shown, example, in  FIG. 12 ) for conducting fluid from the valve assembly  16  to a needle  28  (shown in  FIGS. 3, 6, and 8 ) of the needle actuator assembly  18 . The drive assembly  12 , the container  14 , the valve assembly  16 , the needle actuator assembly  18 , and the fluid path assembly  200  are at least partially positioned within a housing  20 . 
     As shown in  FIG. 1 , the housing  20  is formed from a top cover  22  and a bottom cover  24 , although other suitable arrangements for the housing  20  may be utilized. In one aspect, the injector device  2  is 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 to the patient. The drug delivery system  10  and injector device  2  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  and injector device  2  may deliver the medicament at a fixed pressure to the user with the rate being variable. 
     The injector device  2  is configured to operate by engagement (e.g., depressing and/or sliding) of an actuation button  26  by a patient. Engagement of the button  26  causes the needle  28  (shown in  FIGS. 3, 6, and 8 ) of the needle assembly  18  to extend from the housing  20  and to pierce the skin of the patient. Engagement of the button  26  also actuates the drive assembly  12  via the needle actuator (shown in  FIGS. 2-12 ), which places the needle  28  in fluid communication with the container  14  through a flexible tube  210  of the fluid path assembly  200  (shown, for example, in  FIG. 12 ). Once the container  14  is in fluid communication with the needle  28 , the drive assembly  12  expels fluid or medicament from the container  14  and to the patient through the needle  28 . Once a total desired dose is delivered to the patient, the drive assembly  12  in conjunction with the needle actuator, needle actuator spring, and release flipper causes the needle  28  to withdraw from the user and to recede into the housing  20 . General operation of an exemplary drug delivery system is shown and described in International Publication Nos. WO 2013/155153 and WO 2014/179774, which are hereby incorporated by reference in their entirety. Additionally, in some configurations, the container  14  and valve assembly  16  may be the container and valve assembly shown and described in International Publication No. WO 2015/081337, which is also hereby incorporated by reference in its entirety. 
     With continued reference to  FIG. 1 , in some examples, 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 . In some examples, the indicator arrangement  32  moves along with the needle actuator assembly  18  during use of the system  10  to indicate a pre-use position, use position, and post-use position of the system  10  and device  2 . The indicator arrangement  32  provides a visual indication regarding the device status. As will be appreciated by those of ordinary skill in the art, other suitable indicators, such an auditory or tactile indicators, may be provided as an alternative or in addition to the visual indication provided by the indicator arrangement  32 . 
     As shown in  FIGS. 2 and 3 , during a pre-use position of the injector device  2 , the container  14  is spaced from the drive assembly  12  and the valve assembly  16  and the needle  28  is in a retracted position. The drive assembly  12  is configured to engage a stopper  34  of the container  14  via a spacer component, which will initially move the entire container  14  into engagement with the valve assembly  16 , in the direction of arrow A 1  (shown in  FIG. 2 ) due to the incompressibility of the fluid or medicament within the container  14 . 
     More specifically, during the initial actuation of the injector device  2 , as shown in  FIG. 4 , 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 the fluid path assembly  200  (shown in  FIG. 12 ). The initial actuation of the system  10  is caused by engagement of the actuation button  26  by a user (e.g., the patient or a caregiver), 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 . 
     When the device  2  transitions to the use position, as shown in  FIGS. 5 and 6 , 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 patient. In the use position, the valve assembly  16  has already pierced the 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 , as shown by arrow A 2  (in  FIGS. 4 and 5 ) since fluid is able to be dispensed from the container  14 . 
     At the post-use position of the injector device  2 , shown in  FIGS. 7 and 8 , the needle  28  (shown in  FIG. 8 ) 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 . In addition, as discussed hereinafter, a tube crimping mechanism  202  (shown in  FIGS. 13-18 ) of the fluid path assembly  200  (shown, for example, in  FIG. 12 ) crimps or clamps against the tube  210  to provide a fluid lock, which blocks fluid from passing through the tube  210  and to the needle  28 . In some examples, the tube crimping arrangement  202  is driven by the drive mechanism  12  and/or by movement of other portions of the device which translate through the housing  20  as the device  2  transitions from the use-position to the pose-use position. 
     Drive Assembly 
     Referring to  FIGS. 2-8 , the drive assembly  12  according to one aspect of the present invention is shown. As discussed above, the drive assembly  12  is configured to move the container  14  in the direction of arrow A 1  (shown in  FIG. 2 ), to pierce the closure  36  of the container  14  and also to move the stopper  34  within the container  14  in the direction of arrow A 2  (shown in  FIGS. 4 and 5 ) to dispense fluid or medicament from the container  14 . In some examples, the drive assembly  12  can be configured to dispense a plurality of discrete fill volume ranges. For example, the drive assembly  12  can include a number of stops or spacers for restricting or limiting translation of the drive assembly  12  through the housing  20 , thereby limiting the amount of fluid expelled from the container  14 . In one example, the injector device  2  can be capable of delivering thirteen discrete fluid volumes or doses to the patient. A desired injection volume can be selected prior to device assembly and the drive assembly assembled in this configuration. 
     With reference to  FIGS. 9A-9C , elements of the drive assembly  12  which advance a plunger member  52  through the container  14  are shown in detail. In some examples, the drive assembly  12  includes the first plunger member  52 , a second plunger member  54  received by the first plunger member  52 , a first biasing member  56 , a second biasing member  58 , a plunger actuation member  60 , and an index member  70 . The first plunger member  52  is moveable from the pre-use position (shown in  FIG. 9A ), to the use position (shown in  FIG. 9B ), to the post-use position (shown in  FIG. 9C ) with the first plunger member  52  configured to move the stopper  34  (shown in  FIGS. 2-8 ) within the container  14  to dispense medicament from the container  14 . The first plunger member  52  is configured to move axially. The second plunger member  54  and the first plunger member  52  form a telescoping arrangement with the second plunger  54  configured to move axially after the first plunger member  52  moves a predetermined axial distance. The movement of the first and second plunger members  52 ,  54  is provided by the first and second biasing members  56 ,  58 , which are compression springs, although other suitable arrangements for the biasing members  56 ,  58  may be utilized. 
     A drive surface  40  of the plunger actuation member  60  is configured to be engaged by a portion of the needle actuator assembly  18  (shown in  FIGS. 2-8 ) to effect movement of the needle actuator assembly  18  through the housing  20  (shown in  FIGS. 2-9 ) as the injector device  2  transitions from the pre-use position, to the use position, to the post use position. For example, after engagement of the actuator button  26  and release of the needle actuator assembly  18 , the needle actuator assembly  18  moves within the housing  20  in the direction of arrow A 3  (in  FIGS. 9A-9C ). During the initial movement of the needle actuator assembly  18 , a portion of the needle actuator assembly  18  engages the drive surface  40  of the plunger actuation member  60  to move the plunger actuation member  60  from the first rotational position to the second rotational position. 
     With reference again to  FIG. 7 , the second plunger member  54  is configured to engage a restriction member  86  of the system  10 . The restriction member  86  cooperates with the needle actuation assembly  18  and restricts movement of the needle actuator assembly  18  from the use position to the post-use position until a predetermined end-of-dose position of the stopper  34  is reached. Such engagement between the restriction member  86  and the needle actuation assembly  18  is released by rotation of the restriction member  86  when the stopper  34  reaches its end-of-dose position. During the use position of the needle actuator assembly  18 , the restriction member  86  is biased in a rotational direction with the rotation of the restriction member  86  being prevented through engagement with the second plunger member  54 . 
     With reference to  FIG. 10 , in some examples, the restriction member in conjunction with the needle actuator is also configured to adjust the position of the indicator arrangement  32  to identify for the user or patient the status of the injection (e.g., pre-use, injection occurring, post-use or end-of-dose). Movement of the indicator arrangement  32  can be viewed through the window  30 . More specifically, as shown in  FIG. 10 , the indicator arrangement  32  engages a portion of the restriction member  86  and moves along with the restriction member  86  to reach the first state and then the indicator arrangement engages a portion of the needle actuator and moves along with the needle actuator to reach the final state of the system. Movement of the restriction member  86  can, for example, rotate the indicator arrangement  32  to provide an indication to the user regarding the state of the system  10 . 
     Needle Actuator Assembly 
     Referring to  FIGS. 2-10 , the needle actuator assembly  18  according to one aspect of the present invention is shown. The needle actuator assembly  18  includes a needle actuator body  62  having guide surfaces  64 , a needle shuttle  102  having cam surfaces  104  (shown in  FIG. 11 ), and the needle  28  received by the needle shuttle  102  and configured to be in fluid communication with the container  14  through the fluid path assembly  200  (shown in  FIG. 12 ). The needle actuator body  62  is generally rectangular with the guide surfaces  64  protruding radially inward. The needle shuttle  102  is received within the needle actuator body  62 . The needle actuator body  62  is moveable within the housing  20 , as the system transitions from the pre-use position (shown in  FIGS. 2 and 3 ), an initial actuation position ( FIG. 4 ), a use position ( FIGS. 5 and 6 ), and a post-use position ( FIGS. 7 and 8 ). The needle actuator body  62  is biased from the pre-use position to the post-use position via a biasing member, such as an extension spring  106 , although other suitable biasing arrangements may be utilized. The needle actuator body  62  is released and free to move from the pre-use position to the use position upon engagement of the actuator button  26  and engagement with the drive mechanism  12  and restriction member  86  as discussed herein. 
     The needle shuttle  102  is moveable along a vertical axis between a retracted position where the needle  28  is positioned within the housing  20  and an extended position where at least a portion of the needle  28  extends out of the housing  20 . The needle shuttle  102  is configured to move between the retracted position and the extended position through engagement between the guide surfaces  64  of the needle actuator  62  and the cam surfaces  104  (shown in  FIG. 11 ) of the needle shuttle  102 . As shown, for example, in  FIG. 11 , the cam surface(s)  104  is provided by first and second cam members  108 ,  110 , with the first cam member  108  spaced from the second cam member  110 . The housing  20  includes a guide post having recess configured to receive a T-shaped projection  114  on the needle shuttle  102 , although other shapes and configurations may be utilized for the guide post and T-shaped projection  114 . The needle shuttle  102  moves along the guide post between the retracted and extended positions. The guide post  112  is linear and extends about perpendicular from the housing, although other suitable arrangements may be utilized. The guide surfaces  64  of the needle actuator body  62  may be non-linear and may each include a first side and a second side positioned opposite from the first side. 
     The guide surfaces  64  of the needle actuator body  62  cooperate with the cam members  108 ,  110  of the needle shuttle  102  to move the needle shuttle  102  vertically between the retracted and extended positions as the needle actuator body  62  moves axially from the pre-use position to the post-use position. The needle shuttle  102  also includes a shuttle biasing member  120  configured to engage the housing  20  or the actuator button  26 . In particular, the shuttle biasing member  120  engages the housing  20  or actuator button  26  and provides a biasing force when the needle actuator body  62  is transitioning from the use position to the post-use position. 
     As shown in  FIGS. 7 and 8 , when the needle actuator body  62  is fully transitioned to the post-use position, the cam members  108 ,  110  (shown in  FIG. 11 ) of the needle shuttle  102  are disengaged from the guide surfaces  64  of the needle actuator body  62  and the shuttle biasing member  120  biases the needle shuttle  102  downward such that the needle  28  engages the pad  38 , as discussed above. The needle actuator body  62  may interact with the actuator button  26  to prevent the actuator button  26  from popping back up until the post-use position is reached. 
     Fluid Path Assembly 
     As shown in  FIG. 12 , the injector device  2  also includes the fluid path assembly  200 . In general, the fluid path assembly  200  includes the elements of the injector device  2  that contact the medicament fluid plus the tube crimping mechanism  202  (shown in  FIGS. 13-19 ). For example, the fluid path assembly  200  can include portions of the container  14  (shown in  FIGS. 1-10 ), the stopper  34  (shown in  FIGS. 2-10 ), the valve assembly  16 , and an adapter for connecting the container  14  with the valve assembly  16 . The fluid path assembly  200  also includes the connecting tube  210  (shown in  FIG. 12 ), a port or needle hub  212  for connecting the tube  210  to the needle shuttle  102 , and the needle  28 . The fluid path assembly  200  can be provided separately from other components of the injector device  2  and can be inserted into the injector device  2  prior to use. In that case, the fluid path assembly  200  can be provided with a disposable retainer for holding the components of the fluid path assembly  200  prior to installation in the bottom cover  24  of the housing  20 . 
     To install or assemble the fluid path assembly  200  into the housing  20 , the installer unwinds the flexible tube  210  from the disposable retainer. The installer then connect the needle hub or port  212  to an end of the tube  210  and connects the other end of the tube  210  to the container  14  and/or valve assembly  16 . The installer then secures the needle hub or port  212  at the end of an arm portion of the needle shuttle  102  and inserts the container  14  and valve assembly  16  into the respective portions of the bottom cover  24  of the housing  20 . The installer then positions or secures portions of the tube  210  against a top surface  214  of the needle actuator body  62 , as shown in  FIG. 12 . It is noted that the valve module is not physically linked to the primary container, as the fluid path of the valve module is a sub-assembly and is assembled into the bottom case, which can be done independently of the assembly of the primary container. 
     Tube Crimping Arrangement 
     With reference to  FIG. 13 , the top case also includes structures for crimping the tube  210  (shown in  FIG. 12 ) to produce a fluid-block in the tube  210  as the injector device  2  transitions to the post-use or end of dose position. Collectively, these structures are referred to herein as the tube crimping arrangement  202 . In some examples, as shown in  FIGS. 13 and 14 , the tube crimping arrangement  202  includes one or more crimping members configured to be driven toward a portion of the tube  210  by movement of the needle actuator assembly  18 . As discussed herein, the needle actuator assembly  18  is released to travel to the post-use state by the button and then drive assembly  12  and restriction member (shown in  FIGS. 2-8 ) and translates through the housing  20  to extend and retract the needle  28  (shown in  FIGS. 2-8 ). In some examples, the crimping members are flexible fins or blades  216  extending from an interior surface  218  of the top cover  22  of the housing  20 . A molded living hinge  220  can be disposed along the base of the fins or blade  216  to allow the fins or blades  216  to rotate or pivot towards the tube  210 . Additional views of the top cover  22  of the housing and blades  216  are shown in  FIGS. 17-19 . In some examples, flexible blades  216  can be provided in a side-by-side arrangement to form a swinging gate as shown, for example, in  FIGS. 14 and 19 . The tube  210  is pushed into the gap between the opposing fins or blades  216 , such that, when the blades  216  are driven together as the device  2  transitions to the post-use position, the tube  210  is clamped or compressed between the blades  216 . The flexible blades  216  can be angled relative to the axis X 1  of the top cover  22  of the housing  20 , such that the blades  216  both bend and pivot toward the tube  210 . For example, the blades  216  can be angled by about 10 degrees so that the blades  216  move both axially and radially inwardly toward the tube  210 . 
     As shown in  FIGS. 13, 15, and 16 , the flexible blades  216  can be configured to be driven by protrusions, such as pins  222 ,  224 , extending from a top surface  214  of the needle actuator body  62 . The pins  222 ,  224  are positioned such that as the needle actuator body  62  translates through the housing  20 , the pins  222 ,  224  contact the flexible blades  216 , causing the blades  216  to cinch or clamp around the tube  210  to block fluid flow therethrough. 
     In some examples, the top surface  214  of the actuator body  62  includes two pairs of pins (e.g., front pins  222  and rear pins  224 ) disposed on the top surface  214  of the needle actuator body  62  and positioned to contact the blades  216  in a sequential fashion. The top surface  214  of the needle actuator body  62  can also include a ridge  226  (shown in  FIG. 15 ) extending along the surface between the front pins  222  and the rear pins  224 . In some cases, front pins  222  can be disposed on an extension portion  228  of the top surface  214  so that the spacing between the pins  222 ,  224  is sufficient to crimp the tube  210  in the desired manner. The front pins  222  can include angled surfaces  230  positioned to open or splay apart the blades  216  as shown, for example, in  FIG. 16 . The angled surfaces  230  can be angled relative to the longitudinal axis X 2  (shown in  FIG. 15 ) of the needle actuator body  62 , such that opposing blades  216  are pushed apart to increase the gap therebetween. 
     During actuation of the injector device  2 , which is caused by depressing and/or translating the actuation button  26 , the needle actuator body  62  is directed along the guide surface  64 , such that a front portion of the needle actuator body  62  rocks up at one of its ends in the direction of arrow B 1  in  FIG. 16 . As a result of the rocking motion, the front pins  222  are effectively lifted up to contact the flexible blades  216 . For example, the angled surface  230  of the pins  22  can contact the blades  216  as discussed herein. Contact between the front pins  222  and flexible blades  216  causes the blades  216  to splay apart to expand the gap between the blades  216 . As the gap between the blades  216  increases, the tube  210  is pushed up by the ridge  226  on the needle actuator body  62  and into the gap. In some examples, the gap can be about 0.5 mm prior to actuation of the injector device  2 . The gap can be expanded to about 0.7 mm when the blades  216  are splayed apart by the front pins  222 . 
     After the dose of fluid is delivered to the patient in the manner described hereinabove, the injector device  2  transitions from the use position to the post-use position. During the transition to the post-use position, the needle actuator body  62  translates through the housing  20  along the guide surface  64  to retract the needle  28 . In some examples, the last movement (e.g., the last few millimeters of movement) of the needle actuator body  62  along the guide surface  64  causes the rear pins  224  to deflect the flexible blades  216  forward and radially inward causing the blades  216  to pinch or clamp against the flexible tube  210 . Desirably, the force required to maintain the pinch or clamp of the tube  210 , as a result of the pressure applied on the blades  216  from the rear pins  224 , is minimized and, preferably is less than or equal to about 1N. 
     Force exerted by the biasing member or extension spring  106  may be minimized in the following manner. Under force of the extension spring  106 , the blades  216  may be moved a distance of 1 mm to 2 mm to minimize the gap between the blades  216 . In this position, each blade  216  exerts a force of about 0.5 N on the tube needle actuator body  62 , meaning that a total force of about 1N is provided by the needle actuator body  62  and the extension spring  106 . Movement of the blades  216  to clamp or cinch the tube  210  causes the tube  210  to compress, which produces a transverse or side load on the tube  210 . The force of the transverse or side load can be about 3N. As the blades rotate and flex inwards to pinch the tube the transverse or side loads increase but the axial force reduces, this reducing force must be provided through the blades  216  by the needle actuator body  62  and the extension spring  106 . This reduction in force applied by the extension spring  106  for cinching or clamping the tube  210  suggests a toggling action. For example, the tube  210  can be positioned to permit over-centering or toggle action of the flexible blades  216  so that the residual force required by the needle actuator body  62  and extension spring  106  to maintain the cinch or clamp of the tube  210  is minimal. 
     It is believed that the 3N transverse or side load is sufficient to seal off flow of a thin wall tube having a double wall thickness of about 0.7 mm. In other examples, a thick walled tube having a double wall thickness of about 1.3 mm may be used. However, when using a thick walled tube, slightly more force or compression may be required to seal off the flow through the tube. Care must also be taken to ensure that the living hinge  220  of the blades  216  maintains sufficient flexibility so that the blades  216  contact and cinch the tube  210 . Element analysis demonstrates that maximum shear rate for the injection should be below 40,000. In some cases, injections performed using the drug delivery device should be performed slightly faster than standard injections to prevent the living hinge  220  on the flexible blades  216  from freezing off due to shear. 
     Additional Exemplary Tube Crimping Arrangements 
     Another example of an injector device  300  with a tube crimping arrangement  302  for a flexible tube  310  is illustrated in  FIGS. 20 and 21 . As in previously described examples, the device  300  includes a housing  320  formed from a top cover  322  and bottom cover  324 . The tube crimping arrangement  302  is simplified by replacing the pins and flexible blades of previously described embodiments with a sharp edge  316 , which extends inwardly from an interior surface  318  of the top cover  322 , and wedge  326  of a needle actuator body  362 . The wedge  326  is positioned to drive the tube  310  toward the sharp edge  316  to compress the tube  310 , thereby blocking fluid flow therethrough. As previously described, at the end-of-dose, the needle actuator body  362  translates through the housing  20  in the direction of arrow Cl. Movement of the needle actuator body  362  through the housing  320  pushes the tube  310  toward the sharp edge  316 . A small bore tube only requires about 1 mm of compression. As such, the needle actuator body  62  needs to move the tube  310  toward the sharp edge  316  by about 0.5 mm to close the gap between the wedge  326  of the needle actuator body  362  and the edge  316  of the top cover  322 . 
     Another example of an injector device  400  including a tube crimping arrangement  402  for a flexible tube  410  is illustrated in  FIG. 22 . The tube crimping arrangement  402  can be configured to kink the tube  410  to block fluid flow therethrough. The tube  410  can be placed in a housing  420  of the injector device  400  such that a portion  411  of the tube  410  is curved about guide structure(s)  416  to impart a bend to the tube  410 . For example, the guide structure(s)  416  can be posts or protrusions which direct the tube  410  in a curved path. As a needle actuator body  462  translates through the housing  420  at end-of-dose, a portion  426  of the needle actuator body  462  is pressed against the curved portion  411  of the tube  410  to place a kink in the tube  410 . Specifically, the curved portion  411  of the tube  410  is pressed, in the direction of arrow D, against the guide structure  416  to produce the kink. 
     Another example of an injector device  500  including a tube crimping arrangement  502  for a flexible tube  510  is illustrated in  FIGS. 23-24B . As shown in  FIG. 23  and as previously described, the injector device  500  includes a housing  520  formed from a top cover  522  and a bottom cover  524 . The tube crimping arrangement  502  may include a wedge shaped portion  516  extending from an inner surface  518  of the top cover  522  of the housing  520 . A needle actuator body  562 , which translates through the housing  520  as the injector device  500  transitions to the post use position, may include a pinching portion  526  configured to press against the tube  510 . Specifically, as shown in  FIGS. 24A and 24B , as the needle actuator body  562  is driven through the housing  520  in the direction of arrow E 1 , the wedge  516  directs the pinching portion  526  of the needle actuator body  562  toward the tube  510 , in the direction of arrow E 2 . The movement of the needle actuator body  562  compresses the tube  510  against a portion of the bottom cover  524  of the housing  520 . In some examples, the bottom cover  524  can include a protrusion  564  (shown in  FIG. 24A ) or retention structure for maintaining the position of the tube  510  when the pinching portion  526  of the needle actuator body  562  is pressed against it. In other examples, the bottom cover  524  can include a curved surface  566  (shown in  FIG. 24B ) or depression for receiving the tube  510 . Other pinching or camming structures for compressing the tube  510  as the needle actuator body  562  translates through the housing  520  may also be constructed within the scope of the present disclosure, as will be apparent to those of ordinary skill in the art. 
     Another example of an injector device  600  including a tube crimping arrangement  602  for a flexible tube  610  is shown in  FIGS. 25 and 26 . As in previously described examples, the injector device  600  includes a housing  620  formed from a top cover  622  and a bottom cover  624 . A needle actuator body  662  is disposed in the housing  620  and configured to translate through the housing  620  as the device  600  transitions from its use position to a post-use position. The tube crimping arrangement  602  includes a clamp  626  extending from the needle actuator body  662 . As shown in  FIG. 26 , the clamp  626  includes a channel  630  formed from opposing walls  632 . Element  628  is a rigid feature of the needle actuator and the tube  610  is positioned with element  628  during use. When the needle actuator moves to the post-use position, the tube is wedged up into the features on the top of the case thereby pinching the tube and blocking flow. These are two channels to accommodate two different pinches required for different inner tube diameters. The tube may be assembled in the one relating to its appropriate inner diameter during assembly. 
     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.