Non-vented vial drug delivery

• US 10,434,299 B2
• Filed: 04/19/2018
• Issued: 10/08/2019
• Est. Priority Date: 06/19/2015
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Beiriger, Michael James
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US15/957,350
• Publication Number:
  US 20180236216A1
• Time in Patent Office: 537 Days
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2205/507 Head Mounted Displays [HMD]
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/1411 Drip chambers A61M5/162, A61M5/1689, A61M5/40 take precedence
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066

Abstract

This disclosure relates to fluid line sets and related methods. In certain aspects, the fluid line sets include a vial adapter connected to a first end of a fluid line, and a cap removably attached to a second end of the fluid line such that the cap seals the second end of the fluid line. The vial adapter includes a base, a spike extending from a central region of the base, and a sidewall extending from the base and substantially surrounding the spike. The base and the side wall at least partially define a cavity configured to receive a portion of a vial. The cap includes a deformable portion at least partially defining a gas chamber, and the cap is configured so that deformation of the deformable portion causes gas to be forced from the gas chamber to the vial adapter via the fluid line.

Claims

1. A method comprising:

causing a gas to flow through a fluid line of a dialysis system until the gas enters a drug vial connected to a vial adapter assembly causing a pressure within the drug vial to increase; and

clamping the fluid line after increasing the drug vial pressure,

wherein the fluid line comprises a first end connected to the vial adapter assembly and a second end, and a cap removably attached to the second end of fluid line such that the cap seals the second end of the fluid line, the cap comprising;

a deformable portion at least partially defining a gas chamber, the deformable portion being a bistable diaphragm configured to be activated by depression so that deformation of the deformable portion causes gas to be forced from the gas chamber to the vial adapter assembly via the fluid line.

2. The method of claim 1, further comprising fluidly connecting a drug vial with the fluid line via the vial adapter assembly, the vial adapter assembly comprising a vial adapter having a spike extending from a central region of a base.

3. The method of claim 2, wherein the drug vial includes an initial internal pressure equal to an ambient pressure.

4. The method of claim 3, wherein the drug vial includes an initial gas volume of 0.3 ml to 2 ml.

5. The method of claim 2, wherein the gas flowing through a delivery line introduces gas into the drug vial.

6. The method of claim 5, wherein the introduced gas volume within the drug vial is 1 ml to 2 ml.

7. The method of claim 5, wherein the introduced gas within the drug vial increases a pressure within the drug vial.

8. The method of claim 1, further comprising removing the cap from the second end of the fluid line.

9. The method of claim 8, further comprising connecting the second end of the fluid line to an extracorporeal blood circuit.

10. The method of claim 9, further comprising delivering drug from the drug vial to the extracorporeal blood circuit via a drug delivery line.