Abstract:
An adapter assembly for connecting a cartridge of medication (or any other substance) to a catheter and for securely housing the cartridge within a base or housing, comprising: a body having a bore dimensioned to receive a head of a cartridge therein; a retaining mechanism disposed within the bore in the body, the retaining mechanism dimensioned to hold onto the head of the cartridge; and a double ended hollow needle passing through the first body, the needle having a first end projecting into the bore in the first body; or alternatively; a bottom portion having a bore dimensioned to receive a head of a cartridge therein; a top portion coupled to the bottom portion; a needle hub coupled to the top portion; and a double ended hollow needle passing through the needle hub; wherein an outer surface of the cap is dimensioned to be received into a base.

Description:
RELATED APPLICATION  
       [0001]    The present application claims the benefit of priority under 35 U.S.C. Section 119 to U.S. provisional patent application Ser. Nos. 60/278,256 filed Mar. 23, 2001 and 60/279,014 filed Mar. 26, 2001. 
     
    
     
       TECHNICAL FIELD  
         [0002]    The present invention is related to systems for connecting catheters to medication cartridges.  
         SUMMARY OF THE INVENTION  
         [0003]    In various embodiments, the present invention provides an adapter assembly comprising: a first body having a bore dimensioned to receive a head of an ampule therein; a retaining mechanism disposed within the bore in the first body, the retaining mechanism dimensioned to hold onto the head of the ampule; a double ended hollow needle passing through the first body, the needle having a first end projecting into the bore in the first body; a second body having a bore dimensioned to receive the first body therein; and a retaining mechanism disposed within the bore in the second body, the retaining mechanism dimensioned to hold onto the first body; and wherein an outer surface of the second body is dimensioned to be received into a base.  
           [0004]    In various embodiments, the second body further optionally comprises a septum received therein which is penetrated by a second end of the double ended hollow needle when the first body is received into the bore in the second body.  
           [0005]    In alternate embodiments, the present invention provides an adapter assembly comprising: a body having a bore dimensioned to receive a head of an ampule therein; a retaining mechanism disposed within the bore in the body, the retaining mechanism dimensioned to hold onto the head of the ampule; and a double ended hollow needle passing through the body, the needle having a first end projecting into the bore in the body, wherein an outer surface of the body is dimensioned to be received into a base.  
           [0006]    In further alternate embodiments, the present invention provides an adapter assembly comprising: a bottom portion having a bore dimensioned to receive a head of an ampule therein; a top portion coupled to the bottom portion; a needle hub coupled to the top portion; and a double ended hollow needle passing through the needle hub; wherein an outer surface of the cap is dimensioned to be received into a base.  
           [0007]    In its various embodiments, the present invention provides a system for connecting a medication cartridge (or ampule) to a catheter, while securely holding the medication cartridge (or ampule) in a base or housing such as, for example, an insulin pump.  
           [0008]    In accordance with the present invention, the flow path from the medication cartridge (or ampule) to the catheter is opened prior to positioning the cartridge (or ampule) in the base or housing. Although not so limited, thus the present invention is particularly well suited for use with cartridges (e.g. standard ampules) of insulin, wherein the ampule of insulin is conveniently stored in the base or housing of an insulin pump.  
           [0009]    As mentioned, the flow path from the medication cartridge (or ampule) to the catheter can be opened prior to positioning the cartridge (or ampule) in the base or housing. Thus, an operator can conveniently view the ampule, and ensure that proper fluid flow is occurring, prior to placing the ampule into the base or housing of the pump (where the ampule cannot be seen). Moreover, in accordance with the present invention, an operator is free to remove the ampule from the base or housing of the infusion pump without having to interrupt the flow of medication from the ampule to the catheter. Thus, the operator may conveniently monitor the amount of fluid remaining in the ampule at different times during use.  
           [0010]    In contrast, in pre-existing systems, the flow path from the medication cartridge to the catheter is opened only when the cartridge is positioned within the housing of the infusion pump. Therefore, a user is unable to observe fluid flow from the ampule. Moreover, with such systems, the user is unable to observe fluid level within the ampule without having to first interrupt fluid flow. Such fluid flow interruptions are extremely undesirable for many reasons. For example, continuous delivery of medication (especially insulin) is therapeutically desired. Also, interrupting fluid flow by disconnecting system components increases the risk of contamination.  
           [0011]    The present invention also provides a method of connecting an ampule to a catheter, comprising: pushing a top end of an ampule into a bore in a body, the body having a retaining mechanism disposed therein such that the top end of the ampule is held within the bore of the body, the body having a double ended hollow needle passing therethrough such that a first end of the double ended hollow needle passes into the ampule, wherein a second end of the double ended needle is in fluid communication with the catheter; and subsequently, fastening the body into a base. Fastening the body into a base may comprises fastening the body directly into a base, or fastening the body to a second body and then fastening the second body to the base. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]    [0012]FIG. 1 is a sectional side elevation view of an embodiment of the present invention.  
         [0013]    [0013]FIG. 2 is a sectional side elevation view of another embodiment of the present invention.  
         [0014]    [0014]FIG. 3 is a perspective view corresponding to either of the embodiments of the present invention shown in FIG. 1 or  2 .  
         [0015]    [0015]FIG. 4 is a sectional side elevation view of another embodiment of the present invention.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0016]    Before the present articles ad methods are disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. It must be noted that, as used in the specification and the appended claims, the singular forms of “a ”, “an” and “the” include plural referents also unless the context clearly dictates otherwise.  
         [0017]    In its various embodiments, the present invention provides adapter assemblies for use with medication cartridges, including pre-filled medication cartridges.  
         [0018]    [0018]FIGS. 1 and 2 illustrate embodiments of the present invention, showing alternate internal designs. The perspective view of FIG. 3 is an illustration of embodiments of the present invention. Lastly, FIG. 4 illustrates another embodiment of the present invention.  
         [0019]    In its various embodiments, the present invention may be used to connect a catheter to an ampule of pre-filled medication such that the flow path from the ampule to the catheter can be opened prior to placing the ampule in a body or housing such as an infusion pump.  
         [0020]    An “ampule” is a standard type of cartridge which is typically pre-filled with medication prior to, or during, operation. Such medication may optionally comprise insulin, but is not so limited. Typically, an ampule simply comprises a glass tube having a top end resembling a bottle neck which is sealed by a rubber membrane covering which is in turn held in position by an external flange which wraps partially over the rubber membrane and around the “neck” of the ampule. The external flange has a hole disposed over the center of the rubber membrane, thereby allowing a needle to pass through the rubber membrane and withdraw fluid from inside the ampule. The opposite end of the ampule may be sealed by a piston which is used to expel the contents of the ampule out through the needle passing through the rubber membrane sealing the top of the ampule. However, other systems for sealing the ampule are also contemplated. It is to be understood that the present invention is not limited solely to insulin ampules, or any other sort of ampules. Rather, the present invention is suited for use with any form of medication or substance delivery cartridge. Thus, the present references to an “ampule” are defined to include references to any form of cartridge.  
         [0021]    Referring to FIG. 1, an embodiment of the present invention is shown. Adapter assembly  10  is a “two-part” embodiment of the present invention, comprising a first body  20  and a second body  30 . The top end of a standard ampule  40  is received into bore  21  in first body  20 .  
         [0022]    Ampule  40  comprises a tube having a neck  41 . As is common with standard ampules, a rubber membrane  42  covers its top end. Rubber membrane  42  is held in position by a metal flange  44  which covers rubber membrane  42  and wraps around neck  41  (with the exception of a small hole  45  at the center of rubber membrane  42 ).  
         [0023]    First body  20  comprises a retaining mechanism, which may comprise an O-ring  22  therein. In accordance with the present invention, O-ring  22  provides a frictional grip on the top end of ampule  40  such that ampule  40  is held in position within first body  22  when it is pushed therein. It is to be understood that O-ring  22  is merely an exemplary restraining mechanism for holding the top end of ampule  40  within first body  20 . The present invention is not so limited. Rather, any suitable system (friction-based interference fit, or otherwise) can be used for holding the top end of ampule  40  within first body  20 , all keeping within the scope of the present invention.  
         [0024]    Second body  30  has a bore  31  which is dimensioned to receive first body  20  therein. Second body  30  comprises a retaining mechanism such as O-ring  32  therein. In accordance with the present invention, O-ring  32  provides a frictional grip between first body  20  and second body  30  such that first body  20  is held within second body  30  when it is pushed therein. It is to be understood that O-ring  32  is an exemplary restraining mechanism for holding first body  20  and second body  30  together. The present invention is not so limited. Rather, any suitable system (friction-based, or otherwise) can be used for holding first body  20  and second body  30  together, all keeping within the scope of the present invention.  
         [0025]    First body  20  further comprises a double ended hollow needle  25  passing therethrough. A tubular projection  36  extends from second body  30 . A catheter  50  is connected to tubular projection  36 . Second body  30  may optionally comprise a septum  35  which covers a narrow portion  34  of bore  31 .  
         [0026]    Thus, when the top end of ampule  40  is press-fit into first body  20  and first body  20  is press-fit into second body  30 , a first end of needle  25  will pass through rubber membrane  42  into ampule  40 , and a second end of needle  25  will pass through septum  35 , and be disposed in narrow portion  34  of bore  31  in second body  30 . At this time, an open fluid flow path with be created from ampule  40  through first body  20  and second body  30  into catheter  50 . Thus, an operator can view the contents in ampule  40 .  
         [0027]    Thereafter, adapter assembly  10  can be positioned within a base  60 . In various embodiments, base  60  comprises the housing of an insulin pump. In various embodiments, an outer surface of second body  30  is threaded such that it can conveniently be screw-fit into base  60 , (as shown in FIG. 3.). Other systems of fastening second body  30  into base  60  are also contemplated. For example, a detent-fitting system may be used.  
         [0028]    Referring next to FIG. 2, a “one-part” embodiment of the present invention is provided. Specifically, adapter assembly  100  comprises a body  120 , having a bore  120  into which the top end of a standard ampule  40  is received.  
         [0029]    Body  120  comprises a retaining mechanism such as O-ring  122  therein. In accordance with the present invention, O-ring  122  provides a frictional grip on the end of ampule  40  such that ampule  40  is held in position within body  120  when it is pushed therein. It is to be understood that O-ring  122  is an exemplary restraining mechanism for holding the top end of ampule  40  within first body  120 . The present invention is not so limited. Rather, any suitable system (friction-based, or otherwise) can be used for holding the top end of ampule  40  within body  120 , all keeping within the scope of the present invention.  
         [0030]    Body  120  further comprises a double ended hollow needle  125  passing therethrough. A tubular projection  136  extends from body  120 . A catheter  50  is connected to tubular projection  136 .  
         [0031]    Thus, when the top end of ampule  40  is press-fit into body  120 , a first end of needle  125  will pass through rubber membrane  42  and into ampule  40 , with the second end of needle  125  disposed in tubular projection  136 . At this time, an open flow path with be created from ampule  40  through body  120  into catheter  50 .  
         [0032]    Thereafter, adapter assembly  100  can be positioned within a base  60 . In various embodiments, base  60  comprises the housing of an insulin pump. In various embodiments, an outer surface of body  120  is threaded such that it can conveniently be screw-fit into base  60 , (as shown in FIG. 3.) Other systems of fastening body  120  into base  60  are also contemplated. For example, a detent-fitting system may be used.  
         [0033]    Referring next to FIG. 4, a third “three-part” embodiment of the present invention is shown. Specifically, adapter assembly  200  comprises a bottom portion  210 , a top portion  220  and a needle hub  230  which are assembled together. Needle hub  230  further comprises a double ended needle  235  passing therethrough.  
         [0034]    Bottom portion  210  may have an outer surface which is threaded, and top portion  220  may have an inner surface which is threaded such that top portion  220  may be screw-fit onto the top of bottom portion  210 . Similarly, in various embodiments, an outer surface of top portion  220  is threaded such that it can conveniently be screw-fit into base  60 . Other systems of fastening top portion  220  and bottom portion  210  together are also contemplated. For example, a detent-fitting system may be used.  
         [0035]    Top portion  220  has an optional lip  224  and needle hub  320  has an optional lip  324  which mate together such that needle hub  320  and top portion  220  can be fastened together. In various embodiments, needle hub  320  is made from a soft, flexible material such that it can be snap-fit under lip  224  and onto the top of top portion  220 .  
         [0036]    When ampule  40  is received into bottom portion  210 , and bottom portion  210  is connected to top portion  220 , and top portion  220  is connected to needle hub  230 , and a catheter  50  is connected to the hollow tubular extension  326 , an open flow path from ampule  40  into catheter  50  is provided.  
         [0037]    Thereafter, adapter assembly  200  can be positioned within a base  60 . In various embodiments, base  60  comprises the housing of an insulin pump. In various embodiments, an outer surface of top portion  220  is threaded such that it can conveniently be screw-fit into base  60 . Other systems of fastening top portion  220  into base  60  are also contemplated. For example, a detent-fitting system may be used.