SYSTEMS AND METHODS FOR RESERVOIR FILLING

• US 20080269680A1
• Filed: 04/29/2008
• Published: 10/30/2008
• Est. Priority Date: 04/30/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Lee, Mike, Kavazov, Julian D., Ibranyan, Arsen, Miller, Thomas, Griffin, Christopher G., Shen, Benjamin X., Hezzell, David
• Granted Patent: US 8,434,528 B2
• Time in Patent Office: Days
• US Class Current: 604/122
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2062 with directional valves
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

Systems and methods allow for limiting a presence of air bubbles in a fluidic medium filled into a reservoir. A fluidic medium may be forced from a vial into a reservoir. A vial may be degassed prior to being used to fill a reservoir. A filling process may be automated and a membrane may be located in a fluid flow path to trap air bubbles in a fluidic medium being filled into a reservoir.

Claims

1. A system for use in filling one or more reservoirs, the system comprising:

a vial having a diaphragm that separates a fillable volume of the vial from a pressurizable volume of the vial, the diaphragm inflatable to reduce the fillable volume in a case where a pressure within the pressurizable volume is increased.

2. The system of claim 1,

said diaphragm deflatable to increase the fillable volume in a case where the pressure within the pressurizable volume is decreased.

3. The system of claim 1,

said diaphragm attached to an inner surface of the vial.

4. The system of claim 1, further comprising:

a pressure providing device for changing a pressure within the pressurizable volume.

5. The system of claim 4,

said pressure providing device including a syringe;

said syringe connectable to the vial such that in a case where the syringe is filled with air and is connected to the vial and a plunger head within the syringe is advanced, a pressure within the pressurizable volume is increased so as to cause the diaphragm to inflate and reduce the fillable volume.

6. The system of claim 1,

said fillable volume fillable with a fluidic medium.

7. The system of claim 1, further comprising:

a reservoir having an interior volume;

said diaphragm deflatable to evacuate air from the interior volume of the reservoir into the fillable volume of the vial in a case where the interior volume of the reservoir and the fillable volume of the vial are connected by a needle and a vacuum is applied to the pressurizable volume of the vial.

8. The system of claim 1, further comprising:

a reservoir having an interior volume;

said diaphragm inflatable to force a fluidic medium out of the fillable volume of the vial and into the interior volume of the reservoir in a case where the fillable volume of the vial is holding the fluidic medium and the fillable volume of the vial is connected to the interior volume of the reservoir by a needle and the pressure within the pressurizable volume is increased.

9. The system of claim 8, further comprising:

a membrane located in a flow path between the fillable volume of the vial and the interior volume of the reservoir for trapping air bubbles in the fluidic medium in a case where the fluidic medium is transferred from the fillable volume of the vial to the interior volume of the reservoir.

10. The system of claim 1, said vial further comprising:

a first port for allowing a fluidic medium to flow out of the fillable volume of the vial; and

a second port for allowing a gas to be injected into the pressurizable volume of the vial.

11. A method for filling a reservoir, comprising:

providing a fluid flow path between a fillable volume of a vial and an interior volume of the reservoir; and

applying a pressure to a pressurizable volume of the vial so as to inflate a diaphragm to cause a fluidic medium to be expelled from the fillable volume of the vial into the interior volume of the reservoir.

12. The method of claim 11, said applying the pressure comprising:

injecting at least one of a gas and a liquid from a pressure providing device into the pressurizable volume of the vial.

13. The method of claim 12,

said pressure providing device including a syringe;

said injecting comprising injecting the at least one of the gas and the liquid from the syringe into the pressurizable volume of the vial by advancing a plunger head within the syringe.

14. The method of claim 11, further comprising:

applying a vacuum to the pressurizable volume of the vial so as to deflate the diaphragm to cause air to be evacuated from the interior volume of the reservoir into the fillable volume of the vial.

15. The method of claim 14,

said applying the vacuum occurring before said applying the pressure.

16. The method of claim 11, further comprising:

trapping air bubbles in the fluidic medium by a membrane when the fluidic medium is transferred from the fillable volume of the vial to the interior volume of the reservoir.

17. A system for use in filling one or more reservoirs, the system comprising:

a vial having an interior volume for containing a fluidic medium; and

a moveable element located within the vial, said moveable element advancable within the vial to reduce the interior volume.

18. The system of claim 17,

said moveable element retractable within the vial to increase the interior volume.

19. The system of claim 17,

said vial having a barrel portion and a curved portion;

said moveable element having a barrel portion with an outer contour that substantially matches an inner contour of the barrel portion of the vial; and

said moveable element having a curved portion with an outer contour that substantially matches an inner contour of the curved portion of the vial.

20. The system of claim 17, further comprising:

a transfer guard for providing a fluid flow path from the vial to a reservoir, said transfer guard including a membrane in the fluid flow path for trapping air bubbles.

21. A method for filling a reservoir, comprising:

providing a fluid flow path between an interior volume of a vial and an interior volume of the reservoir; and

advancing a moveable element within the vial to cause a fluidic medium within the interior volume of the vial to be transferred to the interior volume of the reservoir through the fluid flow path.

22. The method of claim 21, wherein said advancing comprises:

advancing the moveable element within the vial until a curved portion of the moveable element contacts a curved portion of the vial.

23. The method of claim 21, further comprising:

trapping air bubbles in the fluidic medium by a membrane located in the fluid flow path.

24. A method of degassing a vial with a degassing tool, the method comprising:

piercing a septum of the vial with an insertion member of the degassing tool that is connected to a port of a plunger housing of the degassing tool; and

pivoting a first handle of the degassing tool toward a second handle of the degassing tool so as to pivot a first arm of the degassing tool to move a plunger arm of the degassing tool to cause a plunger head of the degassing tool to retract within the plunger housing so as to increase a volume in the plunger housing between the plunger head and the port;

wherein gas is extracted from the vial and into the plunger housing through the insertion member when the volume in the plunger housing between the plunger head and the port is increased.

25. A method for filling a reservoir from a vial using an apparatus, the apparatus including a transfer guard, a plunger housing connected to the transfer guard, a plunger head within the plunger housing, a plunger arm connected to the plunger head, and a pressure providing device, the method comprising:

connecting the vial and the reservoir to the transfer guard to provide a fluid flow path from the vial to the reservoir;

connecting the plunger arm of the apparatus to a reservoir plunger arm that is connected to a reservoir plunger head within the reservoir; and

providing pressure by the pressure providing device to the plunger head within the plunger housing to move the plunger head within the plunger housing so as to move the plunger arm;

wherein, when the plunger arm is connected to the reservoir plunger arm and the plunger arm is moved, the reservoir plunger arm moves so as to move the reservoir plunger head within the reservoir to allow a fluidic medium to flow from the vial to the reservoir through the fluid flow path.

26. A method for filling a reservoir from a vial using an apparatus, the apparatus including a transfer guard, a pressure channel connected to the transfer guard, a plunger head moveable within the pressure channel, and an air path member, the method comprising:

inserting an end of the air path member into the vial;

connecting the vial and the reservoir to the transfer guard to provide a fluid flow path from the vial to the reservoir; and

advancing the plunger head within the pressure channel to force air from the pressure channel into the vial through the air path member so as to increase a pressure within the vial to force a fluidic medium from the vial to the reservoir through the fluid flow path.

27. A transfer guard, comprising:

a reservoir nest for receiving a port of a reservoir;

a vial nest for receiving a port of a vial;

a vacuum plunger nest for receiving a port of a vacuum plunger;

a first valve moveable between at least an open position and a closed position for selectively opening and closing a fluid path to the reservoir nest;

a second valve moveable between at least an open position and a closed position for selectively opening and closing a fluid path to the vial nest; and

a third valve moveable between at least an open position and a closed position for selectively opening and closing a fluid path to the vacuum plunger nest.

28. A method, comprising:

connecting a filter to a port of a reservoir;

providing an air path between a pressure source and a vial;

providing a fluid path between the vial and the filter; and

forcing air from the pressure source to the vial through the air path so as to cause a fluidic medium in the vial to be expelled from the vial to the reservoir through the fluid path and the filter.

29. A system, comprising:

a vial having an interior volume for containing a fluidic medium;

an air sack for holding air;

an air line connected between the air sack and the interior volume of the vial;

a one-way valve for allowing air to pass from the air sack to the interior volume of the vial through the air line when the air sack is compressed; and

a drive mechanism controllable to compress the air sack.

30. A system, comprising:

a reservoir sack for containing a fluidic medium, the reservoir sack having an outlet path;

a one-way valve; and

a pressure sack for forcing air through the one-way valve and into the reservoir sack so as to cause the fluidic medium to be expelled from the reservoir sack through the outlet path.

31. A system, comprising:

a reservoir having a septum;

a plunger head, the plunger head including a plunger head septum;

a plunger rod connected to the plunger head, the plunger rod including a pressurized vessel that contains air under pressure; and

a needle having a first end for piercing a septum of a vial, and having a second end for piercing the septum of the reservoir and the plunger head septum so as to provide an air path between the pressurized vessel in the plunger rod and the vial.

32. A system, comprising:

a reservoir;

a plunger head moveable within the reservoir, the plunger head having a channel from a first surface of the plunger head to a second surface of the plunger head;

a plunger head septum located within the channel of the plunger head;

a plunger rod connected to the plunger head, the plunger rod having a hollow interior for allowing a needle to pass within the plunger rod and through the plunger head septum.