Non-vented vial drug delivery

• US 9,974,942 B2
• Filed: 06/19/2015
• Issued: 05/22/2018
• 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): Schmidt, Emily
• Assistant Examiner(s): STILES, AMBER R.
• Application Number:
  US14/744,304
• Publication Number:
  US 20160367746A1
• Time in Patent Office: 1,068 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 fluid line set comprising:

a vial adapter comprising;

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 sidewall at least partially defining a cavity configured to receive a portion of a vial;

a fluid line having a first end connected to the vial adapter and a second end; and

a cap removably attached to the second end of the 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 from a first position having a convex shape moves the deformable portion to a second position having a concave shape and causes gas to be forced from the gas chamber to the vial adapter via the fluid line.

2. The fluid line set of claim 1, wherein the cap further comprises a one-way valve.

3. The fluid line set of claim 2, wherein the one-way valve is disposed between the second end of the fluid line and the gas chamber to prevent fluid from passing into the gas chamber from the fluid line.

4. The fluid line set of claim 1, wherein the chamber includes a volume of sterile gas.

5. The fluid line set of claim 4, wherein the sterile gas is air.

6. The fluid line of claim 4, wherein the volume of sterile gas comprises less than 2 ml of sterile gas.

7. The fluid line of claim 4, wherein the volume of sterile gas comprises 1 to 2 ml of sterile gas.

8. A dialysis system comprising:

a dialysis machine comprising;

a blood pump; and

a drug pump;

a blood line set comprising a blood line that can be operably connected to the blood pump and a drip chamber in fluid communication with the blood line;

a fluid line set comprising a fluid line including a first end connected to a vial adapter 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 so that it is activated by depression to cause deformation of the deformable portion from a first position having a convex shape moves the deformable portion to a second position having a concave shape and causes gas to be forced from the gas chamber to the vial adapter via the fluid line.

9. The dialysis system claim 8, wherein the cap further comprises a one-way valve.

10. The dialysis system claim 8, wherein the one-way valve is disposed between the second end of the fluid line and the gas chamber to prevent fluid from passing into the gas chamber from the fluid line.

11. The dialysis system claim 8, wherein the chamber includes a volume of sterile gas.

12. The dialysis system claim 11, wherein the sterile gas is air.

13. The dialysis system claim 11, wherein the volume of sterile gas comprises less than 2 ml of sterile gas.

14. The dialysis system claim 11, wherein the volume of sterile gas comprises 1 to 2 ml of sterile gas.

15. The dialysis system claim 8, further comprising a drug vial connected to the vial adapter, such that deformation of the deformable portion causes gas to be forced into the drug vial.

16. The dialysis system of claim 15, wherein the drug vial includes an initial gas volume of 0.3 to 2 ml.

17. The dialysis system of claim 16, wherein additional gas introduced by the deformation of the deformable portion increases the gas volume to 1 to 3 ml.