Abstract:
Medical devices and methods for delivering therapeutic fluids transcutaneously to a body of a patient via a fluid delivery device and an adapter is provided. A Luer slip connector is provided at a first connecting end of the adapter. A therapeutic fluid container is connected with the second connecting end such that the container&#39;s neck is received in the second connecting end and a hollow penetrating member provided in the adapter punctures the septum of the container to admit the therapeutic fluid into a needle-less syringe from the container. After, fluid emerges from the tip of the penetrating member, the second connecting end of the adapter is attached to the fluid delivery device, thereby filling the reservoir with the fluid and pushing the syringe plunger forward to inject fluid into reservoir.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims benefit under 35 U.S.C. §119(e) to U.S. provisional patent application No. 60/838,660, filed Aug. 18, 2006, the entire disclosure of which is herein incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    Embodiments of the present invention relate to medical devices, and more particularly to medical devices for delivering therapeutic fluids transcutaneously to a body of a patient, e.g. infusion pumps, disposable infusion pumps, etc. 
       BACKGROUND OF THE INVENTION 
       [0003]    Prior art devices to facilitate transfer of a dose of a fluid from a bulk container are well known in the art. Usually, these devices are used to transfer a dose of a medicament from a vial or a bulk container of a medicament into a syringe for injection or administrating the dose to a patient. Examples of such devices are documented in U.S. Pat. Nos. 6,238,372 and 6,379,340 to Zinger. More advanced adapters, as documented in U.S. Patent Application Publication No. 2005/0131357 to Denton, are capable of receiving several discharge orifices. 
         [0004]    U.S. Patent Application Publication No. 2005/0021000 to Adair et al. discloses an adapter for connecting between a reservoir, a syringe, infusion set tubing, and an infusion pump. According to this disclosure, the reservoir is a detachable component, which is first filled using the adapter and is later inserted into the infusion pump. 
         [0005]    Accordingly, the prior art adapters are generally suitable for use between a syringe and vial or other medicament container, which has an orbicular neck. Such devices are not suitable for the filling of fluid infusion devices which have a non-orbicular end at which is disposed an inlet port for filling reservoir of the fluid infusion device, as disclosed in Israel Patent Application No. 171813 and U.S. patent application Ser. No. 11/397,115. 
         [0006]    Specifically, due to the miniature size of such infusion devices, it is often difficult for a patient to locate and pierce the seal covering the orifice of the fluid reservoir. Furthermore, the use of unshielded needle to pierce the medicament container septum or the sealed orifice of the reservoir might be associated with inadvertent punctures. 
       SUMMARY OF THE EMBODIMENTS 
       [0007]    Embodiments of the present invention address the above-noted concerns and provide methods and apparatuses to allow the filling of the reservoir of an infusion device having a non-orbicular end, with a medicament fluid withdrawn from a medicaments fluid container. Such methods and apparatuses may be used with small, low-cost, portable infusion devices/systems comprising disposable and reusable parts. Examples of such devices can be found in Israel Patent Application No. 171813, and U.S. patent application Ser. No. 11/397,115, filed Apr. 3, 2006, both disclosures of which are herein incorporated by reference in their entirety. 
         [0008]    According to some embodiments of the present invention, such methods and devices are designed and manufactured to be inexpensive and preferably eliminate the occurrence of punctures associated with using unshielded needles. 
         [0009]    According to some embodiments of the present invention, an adapter for establishing fluid communication between a syringe and a medicament container, and/or between a syringe and reservoir of a fluid infusion device are provided. Such an adapter is preferably intended for withdrawal of medicament fluid from a container and filling the reservoir within the disposable part of the infusion device with the extracted fluid. 
         [0010]    In an embodiment of the present invention, the adapter may include an elongated body made of a medical plastic and consisting of two opposite connecting ends. A fluid communication is enabled between the first connecting end and the second connecting end via a hollow needle or sharpened cannula. 
         [0011]    In an embodiment of the present invention, the first connecting end may be provided with a cavity adapted to receive a male half connector (e.g., Luer slip connector) of a needle less syringe. The cavity is in fluid communication with the second end via a hollow piercing member, which can be either a needle provided in a female half of the connector (e.g., Luer slip connector) or a sharpened cannula secured in the cavity so as to extend therefrom towards the second connecting end. 
         [0012]    In an embodiment of the present invention, the second connecting end may include a depression, which is adapted to receive therein at least one of an outlet of a therapeutic fluid container (e.g., an orbicular neck), and an inlet (e.g., a non-orbicular end) of the housing of a fluid infusion device (e.g., the disposable part). The second connecting end may also be provided with an abutment wing, which may be configured and dimensioned to support the adapter against the housing wall after the adapter has been attached to the housing. 
         [0013]    In an embodiment of the present invention, the piercing member may be used to pierce either the sealing cover of a therapeutic fluid container or the sealing cover of the reservoir of the fluid infusion device. 
         [0014]    According to some embodiments of the present invention, a method for filling a reservoir of a fluid delivery device is provided. The method includes connecting a male half of a connector of a needle-less syringe to the first connecting end, pushing a syringe&#39;s plunger to a protracted position, connecting a medicament fluid container with the second connecting end such that the container&#39;s outlet is received in the second connecting end and the piercing member punctures the outlet (e.g., septum) of the container to admit the fluid into syringe from the container, pulling the syringe&#39;s plunger (preferably while holding the syringe in a vertical position) whereas the medicament container is preferably on top (e.g., at a higher vertical level), to permit the withdrawal of the fluid from the container to the syringe, and detaching the medicament fluid container from the second connecting end. Further, some of the embodiments includes the priming of air from the syringe by holding the syringe in a vertical position while the second connecting end is on top (at a higher vertical position) and slightly pushing the plunger until a first drop(s) of fluid emerges from the tip of the piercing member. In addition, some methods may include attaching the second connecting end of the adapter to the housing of disposable part of the fluid infusion device so as to enable the piercing member to puncture the seal which covers the orifice of the reservoir, to admit the fluid into reservoir from the syringe. The reservoir may be filled with the fluid by holding the assembly in a vertical position, whereas the exit port of the disposable part is preferably on top (e.g., at a higher vertical position), and pushing the syringe plunger forward and inject fluid into reservoir, until a first drop(s) of medicament fluid emerges from the exit port of the fluid infusion device. The adapter is thereby detached from the disposable part of the fluid infusion device. 
         [0015]    The foregoing and other features, aspects, and advantages of the present invention will be more apparent from the following detailed description, which illustrates exemplary embodiments of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    For a better understanding of the present invention, reference is made to the following description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which: 
           [0017]      FIG. 1  is a perspective view of a fluid delivery device in accordance with some embodiments of the present invention. 
           [0018]      FIG. 2  is a fragmented perspective view of the fluid delivery device detailing the reusable portion in accordance with some embodiments of the present invention. 
           [0019]      FIG. 3  is perspective side view of an adapter in accordance with some embodiments of the present invention. 
           [0020]      FIG. 4  is a side view of the adapter of  FIG. 3  in accordance with some embodiments of the present invention. 
           [0021]      FIG. 5  is a bottom view of the adapter of  FIG. 3  in accordance with some embodiments of the present invention. 
           [0022]      FIG. 6  is a side, cross-section view of the adapter of  FIG. 3  in accordance with some embodiments of the present invention. 
           [0023]      FIG. 7  is a side, cross-sectional view of an adapter connecting to a needle-less syringe in accordance with some embodiments of the present invention. 
           [0024]      FIG. 8  is a side, cross-sectional view of the adapter connecting to a needle-less syringe in accordance with some embodiments of the present invention. 
           [0025]      FIG. 9A  is a side view of an adapter attached to a fluid container and a syringe in accordance with some embodiments of the present invention. 
           [0026]      FIG. 9B  is a side, partial, cross-sectional view of the adapter attached to the fluid container and syringe of  FIG. 9A . 
           [0027]      FIG. 10A  is a top view of the assembly of a fluid delivery device, an adapter and a syringe in accordance with some embodiments of the present invention. 
           [0028]      FIG. 10B  is a cross-sectional, side view of a portion of the assembly shown in  FIG. 10A , in accordance with some embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0029]    The foregoing and other features, aspects, and advantages of the present invention will be more apparent from the following detailed description, which illustrates exemplary embodiments of the present invention. 
         [0030]    Referring now to  FIG. 1 , there is illustration of an exemplary embodiment of a fluid delivery device  100  constructed in accordance with some of the embodiments of the present invention, also referred to as a patch unit, which may be adherable to a patient&#39;s body, and a remote control unit (not shown), which communicates with the patch unit  100 . The patch unit may comprise a disposable portion  10 , which is detachably connectable to a reusable portion  12 . The configuration of the fluid delivery device comprising such a patch unit is disclosed in Applicants Israel Patent Application No. 171813 as well as in U.S. patent application Ser. No. 11/397,115, both disclosures herein incorporated by reference in their entireties. 
         [0031]    One of the advantageous of such a fluid delivery device  100  configuration is that the relatively expensive components may be deployed within the reusable portion  12  while less expensive components might be accommodated within the disposable portion  10 . By virtue of this provision, the use of the device is significantly more economical for the patient. 
         [0032]    Reusable portion  12  of a fluid delivery device  100  may be removably coupled to a disposable portion  10  in operative association, as shown in  FIG. 1 . In  FIG. 2 , only the disposable portion  10  of the fluid delivery device is shown. The disposable portion  10  may include a U-shaped housing defined by lateral walls LW 1  and LW 2 , by bridging section BS and by butt ends BE 1  and BE 2 . One of ordinary skill in the art would recognize that the U-shaped housing may vary in shape in perspective to a non-formal U-shape. Additional components of the disposable portion  10  may include a reservoir  14  situated between lateral walls and butt end BE 2 . The reservoir  14  preferably includes a therapeutic fluid, e.g. insulin. The reservoir  14  is in fluid communication with a delivery tube  16 , terminating by an outlet port  18 . Through this port the fluid can be delivered to a cannula (not shown), which is subcutaneously inserted in a patient. 
         [0033]    The reservoir  14  can be filled with the therapeutic fluid through an inlet port  20 , which may be made in butt end BE 2 . The butt end BE 2  may include a rectangular configuration terminating by a face  22 . A sealing cover  24  preferably seals the inlet port  20 . 
         [0034]    In accordance with the design of the patch fluid delivery device unit  100 , a portion of the delivery tube  16 , which extends along the bridging section BS may be placed between a stator plate and wheels of a peristaltic pump of the reusable portion  12  (not shown). When these wheels rotate, they depress the tube  16  to the plate and squeeze it. Accordingly, the fluid is periodically pumped from the reservoir  14  to exit port  18  and further to the cannula. 
         [0035]    With reference to  FIGS. 3-5  adapter  26  of the invention is generally illustrated, which may be suitable for connecting the reservoir  14  with a syringe filled with a therapeutic fluid. Preferably, the adapter  26  is configured as an elongated tubular structure made of a plastic suitable for medical use, which in a preferred embodiment is of inexpensive material. The adapter  26  may include a first connecting end  28 , and may also include an opposite second connecting end  30 , with an intermediate body portion  32 . The first connecting end  28  may be attachable to a needle-less syringe  50 , as seen in  FIG. 8 . The second connecting end  30  may be releasably attachable either to a circular neck of container for therapeutic fluid or to an end (e.g., rectangular butt end BE 2 ) of a housing of a fluid delivery device (e.g., that of the patch unit  100 ). 
         [0036]    The second connecting end  30  may be provided also with an abutment wing  34 , which may be used to rest on lateral wall LW 2  of the housing when the second connecting end  30  is connected to the butt end BE 2  of the housing. 
         [0037]    Referring to  FIGS. 4 and 5 , it is seen that the second connecting end  30  may be provided with a border wall  36  delimiting a depression. The contour of the border wall  36  comprises a circular portion  38  and a non-circular portion  40 . The non-circular portion  40  may be a rectangular shape or any other shape which would be understood by one of ordinary skill in the art. The circular portion  38  of the border wall  36  may define a circular region D 1  of the depression. This region D 1  is preferably intended for receiving the circular neck of the fluid container. The non-circular portion  40  of the border wall may define a non-circular region D 2  of the depression. This region D 2  can be used for receiving butt end BE 2  of the housing. The circular  38  and non-circular  40  regions may be configured and dimensioned to allow a tight fit with the received items irrespective whether it is circular neck of the fluid container or butt end of the housing. 
         [0038]    Circular portion of the border wall is provided with gaps G 1 , G 2 , G 3 , to provide a discontinuous arrangement, which preferably provides a degree of elasticity. It is understood by one of ordinary skill in the art that the number of gaps G 1 -G 3  may vary accordingly between alternative embodiments. Seen in the center of the region D 1  is a sharpened end  42  of a penetrating member, which is secured at the first connecting end of the adaptor  26 . 
         [0039]    The sharpened end is preferably fully concealed within depression delimited by the border wall  36  and therefore is preferably not accessible. By virtue of this provision inadvertent puncture may be prevented. 
         [0040]    As shown in  FIG. 6 , the first connecting end  28  may be provided with a core  44 , in which a cavity  46  may be provided. The shape of the core and of the cavity may be selected to constitute a female half of Luer slip connector. A hollow penetrating member  48  is secured within the core such that sharp end  42  of the penetrating member protrudes inside region D 1  of the depression made in the second connecting end  30  of the adapter  26 . By virtue of this provision, fluid communication is provided between cavity  46  and the depression in the second connecting end  30 . As a suitable penetrating member, one can use a hollow needle or a cannula, according to one embodiment. Instead of dedicated core with cavity  46 , one can use ready-to-use female half of Luer connector, which would be suitably embedded in the first connecting end  28 . 
         [0041]    Referring to  FIGS. 7 and 8  it is shown how a needle-less syringe  50  is connected to the first connecting end  28  of the adapter  26 . It is seen that male half  52  of Luer slip connector provided at the syringe  50  is inserted within female half  46  of the Luer connector associated with the first connecting end  28 . 
         [0042]    Referring to  FIGS. 9A and 9B  it is shown how the second connecting end  30  may be attached to a fluid container  54 . It is seen in  FIG. 9   b , that when a neck  56  of the container is fully received within circular depression region D 1  of the second connecting end  30 , the penetrating member  48  pierces a cover  58  of the container and protrudes inside the container. One of skill in the art can readily appreciate that since there is provided fluid communication between the first  28  and second  30  connecting ends, the therapeutic fluid could be withdrawn from the container through the penetrating member into the syringe  50 . 
         [0043]    Referring now to  FIGS. 10   a  and  10   b  it is shown the second connecting end  30  of the adapter  26  being attached to rectangular butt end BE 2  of the housing, while first connecting end  28  is attached to syringe  50  such that reservoir  14  can be filled or replenished by the therapeutic fluid from the syringe  50 . 
         [0044]    It is seen that the butt end BE 2  is received within depression in the second connecting end  30  such that it is embraced by non-circular portion  38  of the border wall and by abutment wing  34  juxtaposed with lateral wall LW 2  of the housing. In this position piercing member  48  pierces sealing cover  24  of the reservoir  14  such that therapeutic fluid can be delivered through inlet port  20  to the reservoir from syringe  50 . 
         [0045]    Below is an exemplary method, according to some embodiments of the present invention, of how a reservoir of a fluid infusion device can be filled with the aim of adapter of the invention. 
         [0046]    When filling the reservoir of the fluid infusion device, the first connecting end of the adapter may be attached to the male half of Luer connector of a needle-less regular syringe as illustrated in  FIG. 7 . Typically, such syringes are supplied with separate therapeutic fluid containers in a pharmacy store. The second connecting end of the adapter may then be firmly attached to the fluid container until circular portion of the border wall engages the orbicular neck of the fluid container and piercing member pierces sealing cover of the container. 
         [0047]    In one embodiment, in order to eliminate entering of air into syringe, the syringe connected to adapter is held in a vertical position whereas the second connecting end is on top, as illustrated in  FIG. 8A . By pulling the syringe&#39;s plunger backward, fluid from the container can be withdrawn through the piercing member into the syringe. 
         [0048]    When the syringe is filled with the desired dose, the fluid container is detached from the second connecting end. 
         [0049]    It is worth noting that entrapment of air bubbles during the withdrawing process should preferably be prevented. For this purpose, according to an embodiment of the invention, air is primed from the syringe before withdrawal of the medicament fluid. During the priming, the syringe is preferably held in a vertical position whereas the second connecting end is on top. Then, the plunger of the syringe may be slightly pushed inwardly until a first drop(s) of the fluid appears at the tip of the penetrating member. 
         [0050]    After the syringe is filled with the fluid, the second connecting end of the adapter may be separated from the container and then attached to the housing of the disposable portion of the fluid infusion device as illustrated in  FIG. 10A  and  FIG. 10B . The therapeutic fluid can be now transferred from the syringe to the reservoir of the fluid infusion device. It is worth noting that during attachment and filling of the reservoir, the adapter and the housing are preferably held in a vertical position such that the outlet port of the housing is on top. Then, the plunger may be slowly pushed inwardly until first drop(s) of fluid appears at the outlet port, indicating that reservoir is full and that air in delivery tube was primed. 
         [0051]    The adapter can then be detached from the housing and the fluid infusion device is ready to operate. 
         [0052]    Although particular embodiments have been disclosed herein in detail, this has been done by way of example for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, it is contemplated that various substitutions, alterations, and modifications may be made without departing from the spirit and scope of the invention as defined by the claims. Other aspects, advantages, and modifications are considered to be within the scope of the following claims. The claims presented are representative of the inventions disclosed herein. Other, unclaimed inventions are also contemplated. The applicant reserves the right to pursue such inventions in later claims.