Methods and devices for multiple fluid transfer

• US 9,180,242 B2
• Filed: 05/17/2012
• Issued: 11/10/2015
• Est. Priority Date: 05/17/2012
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Saint, Sean, Michaud, Michael, Rosinko, Mike, Swanson, Vance, Metzmaker, Thomas
• Primary Examiner(s): Maust, Timothy L
• Assistant Examiner(s): KELLY, TIMOTHY PATRICK
• Application Number:
  US13/474,032
• Publication Number:
  US 20130306191A1
• Time in Patent Office: 1,272 Days
• Field of Search: 141/2, 141/9, 141/100, 141/104, 141/383, 141/386, 141346-354, 604/151, 604/500
• US Class Current: 1/1
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 2039/1094 at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like

Abstract

Devices and methods are disclosed for transferring multiple fluids from multiple supply reservoirs to multiple corresponding receptacle reservoirs. The devices and methods may be configured to prevent or reduce the incidence of a user transferring a fluid to an incorrect receptacle reservoir.

Claims

1. A fluid transfer system, comprising:

A. a first pump reservoir including;

(i) a first pump reservoir body,

(ii) a first reservoir interior volume disposed within the first pump reservoir body, the first reservoir interior volume being capable of containing fluid,

(iii) an input port comprising a first reservoir septum disposed within the first pump reservoir body and being in fluid communication with the first reservoir interior volume, and

(iv) a first output port in fluid communication with the first reservoir interior volume;

B. a second pump reservoir including;

(i) a second pump reservoir body,

(ii) a second reservoir interior volume disposed within the second pump reservoir body, the second reservoir interior volume being capable of containing a fluid, and

(iii) a second output port comprising a second output port adapter in fluid communication with the second reservoir interior volume;

C. a syringe hub assembly comprising;

(i) a syringe body,

(ii) a syringe interior volume disposed within the syringe body,

(iii) a first fluid contained within the syringe interior volume, and

(iv) a hub assembly coupled to the syringe body, the hub assembly including a needle in fluid communication with the syringe interior volume, the needle capable of piercing the first reservoir septum in order to create a first fluid communication junction between the syringe interior volume and the first reservoir interior volume, the needle being mechanically incompatible with the second output port adapter so as to prevent a fluid communication junction therebetween; and

D. a diabetic pen reservoir assembly including;

(i) a diabetic pen reservoir body,

(ii) a pen interior volume disposed within the diabetic pen reservoir body,

(iii) a second fluid contained within the pen interior volume, and

(iii) a diabetic pen reservoir adapter coupled to the diabetic pen reservoir body and in fluid communication with the pen interior volume, the diabetic pen reservoir adapter being capable of coupling with the second output port adapter in order to create a second fluid communication junction between the pen interior volume and the second reservoir interior volume, the diabetic pen reservoir adapter being mechanically incompatible with the input port so as to prevent a fluid communication junction therebetween.

2. The fluid transfer system of claim 1 wherein the second output port adapter comprises a male luer adapter and the diabetic pen reservoir adapter comprises a female luer adapter.

3. The fluid transfer system of claim 2 wherein the input port comprises a channel disposed within the pump reservoir body, the channel diameter being too small to accept the female luer adapter thereby preventing a fluid communication junction between the diabetic pen reservoir and the first pump reservoir.

4. A method for transferring fluids, comprising:

a. creating a first fluid communication junction between a first pump reservoir and a syringe reservoir by a piercing a first reservoir septum of a first input port of the first pump reservoir with a needle of a syringe hub assembly, the needle being mechanically incompatible with a second adapter of a second output port of a second pump reservoir so as to prevent a fluid communication junction therebetween;

b. transferring a first fluid from the syringe reservoir to the first pump reservoir through the first fluid communication junction;

c. creating a second fluid communication junction between a second pump reservoir and a diabetic pen reservoir by coupling the second adapter of the second output port to a diabetic pen reservoir adapter, the diabetic pen reservoir adapter being mechanically incompatible with the first input port so as to prevent a fluid communication junction therebetween; and

d. transferring a second fluid from the diabetic pen reservoir to the second pump reservoir through the second fluid communication junction.

5. The method of claim 4 wherein the second adapter comprises a male luer adapter and the diabetic pen reservoir adapter comprises a female luer adapter and wherein creating the second fluid communication junction includes coupling the male luer adapter to the female luer adapter.

6. The method of claim 5 wherein coupling the male luer adapter with the female luer adapter comprises coupling the male luer adapter with the female luer adapter which is too large to insert into a channel of the input port thereby preventing a viable fluid communication junction therebetween.

7. The method of claim 4 wherein piercing the first reservoir septum with the syringe reservoir needle comprises piercing the first reservoir septum with the syringe reservoir needle which has an outer transverse dimension which is too small to form a seal with an inner transverse dimension of the male luer adaptor thereby preventing a viable fluid communication junction therebetween.

8. A fluid transfer system, comprising:

A. a first pump reservoir including;

(i) a first pump reservoir body,

(ii) a first reservoir interior volume disposed within the first pump reservoir body, the first reservoir interior volume being capable of containing fluid,

(iii) an input port comprising a first reservoir septum, the first reservoir septum sealing the first reservoir interior volume, and

(iv) a first output port in fluid communication with the first reservoir interior volume;

B. a second pump reservoir including;

(i) a second pump reservoir body,

(ii) a second reservoir interior volume disposed within the second pump reservoir body, the second reservoir interior volume being capable of containing a fluid, and

(iii) a second output port comprising a second output port adapter being in fluid communication with the second reservoir interior volume;

C. a syringe hub assembly comprising;

(i) a first syringe body,

(ii) a first syringe interior volume within the first syringe body,

(iii) a first fluid contained within the first syringe interior volume, and

(iv) a hub assembly coupled to the first syringe body, the hub assembly including a needle in fluid communication with the first syringe interior volume, the needle capable of piercing the first reservoir septum in order to create a first fluid communication junction between the first syringe interior volume and the first reservoir interior volume, the needle being mechanically incompatible with the second output port adapter so as to prevent a fluid communication junction therebetween; and

D. a second syringe reservoir comprising;

(i) a second syringe body,

(ii) a second syringe interior volume within the second syringe body,

(iii) a second fluid contained within the second syringe interior volume, and

(iv) a second syringe port in fluid communication with the second syringe interior volume, the second syringe port capable of coupling to the second output port adapter in order to create a second fluid communication junction between the second syringe interior volume and the second reservoir interior volume, the second syringe port being mechanically incompatible with the input port so as to prevent a fluid communication junction therebetween.

9. The fluid transfer system of claim 8 wherein the second output port adapter comprises a female luer adapter and the pen port comprises a male luer adapter.

10. The fluid transfer system of claim 9 wherein the input port comprises a channel disposed within the pump reservoir body, the channel diameter being too small to accept the second syringe port thereby preventing a fluid communication junction between the diabetic pen reservoir and the second pump reservoir.

11. A method for transferring fluids comprising:

a. creating a first fluid communication junction between a first pump reservoir and a first syringe reservoir by piercing a first reservoir septum of a first input port of the first pump reservoir with a needle of a syringe hub assembly, the needle being mechanically incompatible with a second adapter of a second output port of a second pump reservoir so as to prevent a fluid communication junction therebetween;

b. transferring a first fluid from the first syringe reservoir to the first pump reservoir through the first fluid communication junction of the first syringe reservoir needle and the septum;

c. creating a second fluid communication junction between a second pump reservoir and a second syringe reservoir by coupling the second adapter with a syringe port of the second syringe reservoir, the syringe port being mechanically incompatible with the first input port so as to prevent a fluid communication junction therebetween; and

d. transferring a second fluid from the second syringe reservoir to the second pump reservoir through the fluid communication junction of the syringe port and the second adapter.

12. The method of claim 11 wherein the second adapter comprises a female luer adapter and the syringe port comprises a male luer adapter and wherein creating the second fluid communication junction includes coupling the female luer adapter to the male luer adapter.

13. The method of claim 12 wherein creating the second fluid communication junction includes coupling the female luer adapter with the male luer adapter which is too large to insert into the input port thereby preventing a viable fluid communication junction therebetween.

14. The method of claim 11 wherein piercing the first reservoir septum with the needle comprises piercing the first reservoir septum with the needle which has an outer transverse dimension which is too small to form a seal with an inner transverse dimension of the female luer adaptor thereby preventing a viable fluid communication junction therebetween.

15. A fluid transfer system, comprising:

A. a first vial adapter assembly including;

1. a first hub assembly including;

(i). a first hub comprising a first hub body, a proximal section capable of mating with a syringe port, and a first key feature disposed on a perimeter of the first hub body that is mechanically compatible with a first keyed port of a first receptacle reservoir and is mechanically incompatible with a second keyed port of a second receptacle reservoir; and

(ii). a first needle comprising an elongate tubular member of high strength material including a sharpened distal end and a proximal end sealingly secured to the distal section of the first hub body; and

2. a first vial adapter including a first vial adapter body comprising a first distal cavity which has an inner transverse dimension configured to couple to a first spigot of a first vial reservoir but not couple to a second spigot port of a second vial reservoir and which includes a first hooked clip configured to engage the first spigot port but not the second spigot port, and

3. a first engagement feature which releasably secures the first hub body to the first vial adapter body such that the first needle of the first hub assembly may be disposed within and in axial alignment with the first distal cavity of the first vial adapter; and

B. A second vial adapter assembly comprising;

1. a second hub assembly including;

(i). a second hub comprising a second hub body, a proximal section capable of mating with a syringe port, and a second key feature disposed on a perimeter of the second hub body that is mechanically compatible with the second keyed port of the second receptacle reservoir and is mechanically incompatible with the first keyed port of the first receptacle reservoir, and

(ii). a second needle comprising an elongate tubular member of high strength material including a sharpened distal end and a proximal end sealingly secured to the distal section of the second hub body,

2. a second vial adapter including a second vial adapter body comprising a second distal cavity which has an inner transverse dimension configured to couple to a second spigot of a second vial reservoir but not couple to a first spigot port of a first vial reservoir and which includes a second hooked clip configured to engage the second spigot port but not the first spigot port, and

3. a second engagement feature which releasably secures the second hub body to the second vial adapter body such that the second needle of the second hub assembly may be disposed within and in axial alignment of the second distal cavity of the second vial adapter.

16. The fluid transfer system of claim 15 wherein the first hub body comprises a polymer.

17. The fluid transfer system of claim 15 wherein the second hub body comprises a polymer.

18. The fluid transfer system of claim 15 wherein the first needle comprises stainless steel.

19. The fluid transfer system of claim 15 wherein the second needle comprises stainless steel.

20. The coupling system of claim 15 wherein the first vial adapter comprises a polymer.

21. The fluid transfer system of claim 15 wherein the second vial adapter comprises a polymer.

22. The fluid transfer system of claim 15 wherein the first key feature comprises a plurality of elongated bosses disposed parallel to a longitudinal axis of the first needle lumen and spaced around a perimeter of the first hub body and the second key feature comprises a plurality of elongated bosses disposed parallel to a longitudinal axis of the second needle lumen and spaced around a perimeter of the second hub body.

23. The fluid transfer system of claim 15 wherein the first distal cavity comprises a substantially cylindrical configuration and the second distal cavity comprises a substantially cylindrical configuration.

24. The fluid transfer system of claim 15 wherein the first vial adapter body includes about 1 first hooked clip to about 3 first hooked clips and the second vial adapter body includes about 1 second hooked clip to about 3 second hooked clips.

25. The fluid transfer system of claim 15 wherein the first engagement feature comprises a break away rib connected between the first hub body and the first adapter body.

26. The coupling system of claim 15 wherein the second engagement feature comprises a break away rib connected between the second hub body and the second adapter body.

27. A method for transferring fluids, comprising:

A. providing a first vial adapter assembly, including ;

1. a first hub having a tubular needle extending therefrom and a first key feature which is mechanically compatible with a first keyed port of a first pump reservoir and which is mechanically incompatible with a second keyed port of a second pump reservoir,

2. a first vial adapter including a first distal cavity which is configured to couple to a first spigot of a first vial reservoir but mechanically incompatible with a second spigot port of a second vial reservoir, and

3. a first engagement feature which releasably secures the hub to the first vial adapter with the tubular needle disposed within the first distal cavity;

B. providing a first vial reservoir including a first vial internal volume containing a first fluid, a first spigot port in fluid communication with the first vial internal volume, and a first vial septum disposed within and sealing the first spigot port;

C. providing a second vial adapter assembly, including ;

1. a second hub having a tubular needle extending therefrom and a second key feature which is mechanically compatible with the second keyed port of the first pump reservoir and which is mechanically incompatible with the first keyed port of the second pump reservoir,

2. a second vial adapter including a second distal cavity which is configured to couple to the second spigot of the second vial reservoir but mechanically incompatible with the first spigot port of the first vial reservoir, and

3. a second engagement feature which releasably secures the second hub to the second vial adapter with the tubular needle disposed within the second distal cavity;

D. providing a second vial reservoir including a second vial internal volume containing a second fluid, a second spigot port in fluid communication with the second vial internal volume, and a second vial septum disposed within and sealing the second spigot port;

E. coupling the first vial adapter assembly to the first vial reservoir by inserting the first spigot port into the first distal cavity such that the first tubular needle punctures the first vial septum and such that the first vial adapter assembly is mechanically captured to the first vial reservoir;

F. coupling a first syringe to the first hub;

G. transferring the first fluid from the first vial reservoir to a first syringe reservoir of the first syringe through a lumen of the first tubular needle;

H. detaching the first hub from the first vial adapter by disengaging the first engagement feature;

I. coupling the second vial adapter assembly to the second vial reservoir by inserting the second spigot port into the second distal cavity such that the second tubular needle punctures the second vial septum and such that the second vial adapter assembly is mechanically captured to the second vial reservoir;

J. coupling a second syringe to the second hub;

K. transferring the second fluid from the second vial reservoir to a second syringe reservoir of the second syringe through a lumen of the second tubular needle; and

L. detaching the second hub from the second vial adapter by disengaging the second engagement feature.

28. The method of claim 27 wherein coupling the first vial adapter assembly to the first vial reservoir by inserting the first spigot port into the first distal cavity comprises inserting the first spigot port which has a diameter which is too small to form a seal with the second distal cavity thereby preventing the creation of a fluid communication junction therebetween into the first distal cavity.

29. The method of claim 27 wherein coupling the second vial adapter assembly to the second vial reservoir by inserting the second spigot port into the second distal cavity comprises inserting the second spigot port which has a diameter which is too large to fit within the second distal cavity thereby preventing the creation of a fluid communication junction therebetween into the second distal cavity.

30. A fluid transfer system, comprising:

A. a first hub assembly including;

(i). a first hub comprising;

a. a first hub body including a proximal section configured to mate with a syringe port, and

b. a first hub key feature which is disposed on a perimeter of the first hub body, which is configured to couple to a first keyed port of a first receptacle reservoir but which is mechanically incompatible with a second keyed port of a second receptacle reservoir, and

(ii). a first needle comprising an elongate tubular member of high strength material, a sharpened distal end and a proximal end sealingly secured to a distal section of the first hub body;

B. a first keyed port in fluid communication with an interior volume of a first receptacle reservoir, comprising;

(i). a first channel which is in fluid communication with an interior volume of a first receptacle reservoir and which is configured to accommodate insertion of the first hub body,

(ii). a first septum disposed within and sealing the first channel at a depth substantially equal to or greater than a distance that the first needle extends from the first hub, and

(iii). a first port key feature which is disposed on an inner perimeter of the first channel, which is configured to couple with the first hub key feature but which is mechanically incompatible with a second hub key feature;

C. a second hub assembly including;

(i). a second hub comprising;

a. a second hub body including a proximal section configured to mate with a syringe port, and

b. a second hub key feature which is disposed on a perimeter of the second hub body, which is configured to couple to a second keyed port of a second receptacle reservoir but which is mechanically incompatible with the first keyed port of the first receptacle reservoir, and

(ii). a second needle comprising an elongate tubular member of high strength material, a sharpened distal end and a proximal end sealingly secured to a distal section of the second hub body; and

D. a second keyed port in fluid communication with an interior volume of a second receptacle reservoir, comprising;

(i). a second channel which is in fluid communication with the interior volume of a second receptacle reservoir and which is configured to accommodate insertion of the second hub body,

(ii). a second septum disposed within and sealing the second channel at a depth substantially equal to or greater than a distance that the second needle extends from the second hub, and

(iii). a second port key feature which is disposed on an inner perimeter of the second channel, which is configured to couple with the second hub key feature but which is mechanically incompatible with the first hub key feature.

31. The fluid transfer system of claim 30 wherein the first hub key feature comprises a plurality of oblong bosses disposed parallel to a longitudinal axis of the first hub body and the first port key feature comprises a plurality of oblong slots which correspond in circumferential spacing to the circumferential spacing of these oblong bosses and which extend substantially parallel to a longitudinal axis of the first channel.

32. The fluid transfer system of claim 30 wherein the second hub key feature comprises a plurality of oblong bosses disposed parallel to a longitudinal axis of the second hub body and the second port key feature comprises a plurality of oblong slots which correspond in circumferential spacing to the circumferential spacing of these oblong bosses and which extend substantially parallel to a longitudinal axis of the second channel.

33. A fluid transfer system, comprising:

A. a first vial adapter assembly comprising;

1. a first hub assembly including;

(i). a first hub comprising;

a. a first hub body,

b. a proximal section capable of mating with a syringe port, and

c. a first hub key feature which is disposed on a perimeter of the first hub body, which is mechanically compatible with a first keyed port of a first receptacle reservoir and which is mechanically incompatible with a second keyed port of a second receptacle reservoir; and

(ii). a first needle comprising an elongate tubular member of high strength material including a sharpened distal end and a proximal end sealingly secured to the distal section of the first hub body; and

2. a first vial adapter including;

(i). a first vial adapter body, and

(ii). a first distal cavity which has an inner transverse dimension configured to couple to a first spigot of a first vial reservoir but not couple to a second spigot port of a second vial reservoir, the first distal cavity including a hooked clip configured to engage a first spigot port but not a second spigot port, and

3. a first engagement feature which releasably secures the first hub body to the first vial adapter body such that the first needle of the first hub assembly is disposed within and in axial alignment with the first distal cavity of the first vial adapter;

B. a first vial reservoir comprising a first vial reservoir body, a first vial internal volume disposed within the vial reservoir body, a first spigot port in fluid communication with the first vial internal volume, a first vial septum disposed within the first spigot port, and a first fluid disposed within the first vial internal volume;

C. a first receptacle reservoir comprising an interior volume and a first keyed port including a first channel in fluid communication with the interior volume of the receptacle reservoir, a first septum which is disposed within and seals the first channel at a depth which is greater than or equal to a distance which the first needle extends from the first hub body and a first port keyed feature which is disposed on a perimeter of the first channel and mechanically compatible with the first hub key feature;

D. a second vial adapter assembly comprising;

1. a second hub assembly including;

(i). a second hub comprising;

a. a second hub body,

b. a proximal section capable of mating with a syringe port, and

c. a second hub key feature which is disposed on a perimeter of the second hub body, which is mechanically compatible with a second keyed port of a second receptacle reservoir and which is mechanically incompatible with the first keyed port of the first receptacle reservoir; and

(ii). a second needle comprising an elongate tubular member of high strength material including a sharpened distal end and a proximal end sealingly secured to the distal section of the second hub body; and

2. a second vial adapter including;

(i). a second vial adapter body, and

(ii). a second distal cavity which has an inner transverse dimension configured to couple to a second spigot of a second vial reservoir but not couple to the first spigot port of the first vial reservoir, the second distal cavity including a second hooked clip configured to engage the second spigot port but not the first spigot port, and

3. a second engagement feature which releasably secures the second hub body to the second vial adapter body such that the second needle of the second hub assembly may be disposed within and in axial alignment with the second distal cavity of the second vial adapter;

E. a second vial reservoir comprising a second vial reservoir body, a second vial internal volume disposed within the second vial reservoir body, a second spigot port in fluid communication with the second vial internal volume, a second vial septum disposed within the second spigot port, and a second fluid disposed within the second vial internal volume; and

F. a second receptacle reservoir comprising an interior volume and a second keyed port including a second channel in fluid communication with the interior volume of the second receptacle reservoir, a second septum which is disposed within and seals the second channel at a depth which is greater than or equal to a distance which the second needle extends from the second hub body and a second port keyed feature which is disposed on a perimeter of the second channel and mechanically compatible with the second hub key feature.

34. A fluid transfer system, comprising:

A. a first pump reservoir including;

(i) a first reservoir body,

(ii) a first reservoir interior volume which is disposed within the first reservoir body and which is capable of containing fluid,

(iii) a first input port including a first channel which is in fluid communication with the first reservoir interior volume, a first septum disposed within and sealing the first channel and a tubular bayonet needle inserted through the first septum such that an inner lumen of the first bayonet needle is in fluid communication with the first interior volume, and

(iv) a first output port comprising a first fluid line which is in fluid communication with the first interior volume and a first output port adapter which is secured to and in fluid communication with the first fluid line;

B. a second pump reservoir including;

(i) a second reservoir body,

(ii) a second reservoir interior volume which is disposed within the second reservoir body and which is capable of containing fluid,

(iii) a second input port including a second channel which is in fluid communication with the second reservoir interior volume, a second septum disposed within and sealing the second channel, and a key feature disposed on a perimeter of the second channel, and

(iv) a second output port comprising a second fluid line which is in fluid communication with the second interior volume and a second output port adapter which is secured to and in fluid communication with the second fluid line;

C. a diabetic pen reservoir assembly including;

(i) a diabetic pen reservoir body;

(ii) a pen interior volume disposed within the diabetic pen reservoir body;

(iii) a first fluid contained within the pen interior volume; and

(iv) a pen port which is in fluid communication with the pen interior volume, which is configured to couple to the bayonet needle in order to create a second fluid communication junction between the pen interior volume and the first interior volume and which is mechanically incompatible with the first channel of the first input port so as to prevent a fluid communication junction therebetween; and

D. a syringe hub assembly comprising;

(i) a syringe including a syringe body, a syringe interior volume disposed within the syringe body, a second fluid contained within the syringe interior volume and a syringe port; and

(ii) a hub assembly comprising;

a. a hub body including a proximal section secured to a syringe port of the syringe;

c. a hub key feature which is disposed on a perimeter of the hub body, which is mechanically compatible with the second input port so as to allow for the coupling of the hub assembly to the second input port and which is mechanically incompatible with the first input port; and

d. a tubular needle which includes an inner lumen in fluid communication with the syringe interior volume, which is configured to pierce the second reservoir septum in order to create a second fluid communication junction between the syringe interior volume and the second interior volume and which is mechanically incompatible with the second output port adapter so as to prevent a fluid communication junction therebetween.

35. The fluid transfer system of claim 34 wherein the second output port adapter comprises a female luer adapter and the pen port comprises a male luer adapter.

36. A method for transferring fluids, comprising:

a. creating a first fluid communication junction between a first pump reservoir and a diabetic pen reservoir by coupling a diabetic pen adapter of the diabetic pen reservoir, which is mechanically incompatible with a second keyed input port, to a bayonet needle adapter which is secured to the first pump reservoir and which includes a bayonet needle disposed through a first reservoir septum of a first port of the first pump reservoir;

b. transferring a first fluid from the diabetic pen reservoir to the first pump reservoir through the first fluid communication junction;

c. inserting a keyed hub assembly coupled to a syringe reservoir, which is mechanically incompatible with the first input port, into the second keyed input port of a second pump reservoir such that a hub needle of the keyed hub assembly penetrates a second reservoir septum which seals the second pump reservoir thereby creating a second fluid communication junction between the second pump reservoir and the syringe reservoir; and

d. transferring a second fluid from the syringe reservoir to the second pump reservoir through the second fluid communication junction.

37. The method of claim 36 wherein the bayonet needle adapter comprises a male luer adapter and the diabetic pen reservoir adapter comprises a female luer adapter and wherein creating the first fluid communication junction includes coupling the male luer adapter to the female luer adapter.

38. The method of claim 37 wherein creating the first fluid communication junction includes coupling the male luer adapter with the female luer adapter which is too large to insert into the second keyed port thereby preventing a viable fluid communication junction therebetween.

39. The method of claim 36 wherein creating the second fluid communication junction includes piercing the second reservoir septum with the hub needle including an outer transverse dimension which is too small to form a seal with an inner transverse dimension of the female luer adaptor of the bayonet needle thereby preventing a fluid communication junction therebetween.