Drug vial spikes, fluid line sets, and related systems

• US 8,425,487 B2
• Filed: 06/30/2010
• Issued: 04/23/2013
• Est. Priority Date: 07/01/2009
• 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, Kaintz, Ryan
• Primary Examiner(s): Stephens, Jacqueline
• Assistant Examiner(s): Mensh, Andrew J
• Application Number:
  US12/827,207
• Publication Number:
  US 20110004145A1
• Time in Patent Office: 1,028 Days
• Field of Search: 604/403, 604/411, 604/414, 604/86, 604/506
• US Class Current: 604/411
• CPC Class Codes: A61G 7/0503 Holders, support devices for receptacles, e.g. for drainage or urine bags hanging-up devices for infusion A61M5/1414
• 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 1/2089 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: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 39/14 : for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1408 : in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• 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 5/16827 : 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: 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
• CPC Class Codes: A61M 5/19 : having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

This disclosure relates to drug vial spikes, fluid line sets, and related systems. In some aspects, a fluid line set includes a frame, multiple spikes extending from the frame, and multiple fluid lines connected to the frame. The frame is configured to hold the fluid lines in a spaced apart configuration.

Claims

1. A drug vial spiking device, comprising:

a cup-shaped member having a base and a sidewall, the base and the sidewall at least partially forming a recess configured to receive at least a portion of a drug vial;

a spike extending from a central region of the base, the spike defining a channel extending therethrough; and

a plurality of springs extending from the base of the cup-shaped member into the recess, the springs configured to apply a force to the drug vial in a direction away from the base of the cup-shaped member when at least a portion of the drug vial is positioned in the recess such that a seal of the drug vial bulges away from the drug vial and forms a concave shape.

2. The drug vial spiking device of claim 1, wherein the springs are leaf springs.

3. The drug vial spiking device of claim 2, wherein at least one of the leaf springs comprises a projection extending from a surface thereof, the projection being arranged to contact a cap of the drug vial when the drug vial is inserted into the recess.

4. The drug vial spiking device of claim 3, wherein the projection and the at least one leaf spring are configured in a manner such that the projection dents a cap of the drug vial when the drug vial is inserted into the recess.

5. The drug vial spiking device of claim 1, wherein the base defines a plurality of openings configured to receive the plurality of springs when the drug vial is fully inserted into the recess.

6. The drug vial spiking device of claim 1, wherein at least one of the springs comprises a projection extending therefrom, the at least one of the springs and the projection being configured such that the projection dents a cap of the drug vial when the drug vial is inserted into the recess with sufficient force to cause the cap of the vial to contact the base of the cup-shaped member.

7. The drug vial spiking device of claim 1, further comprising at least one bi-stable member attached to the base, the bi-stable member positioned above an aperture defined in the base.

8. The drug vial spiking device of claim 7, wherein the bi-stable member is configured to be stably positioned in a first position and a second position, and at least a portion of the bi-stable member is visible to a user when the bi-stable member is in the second position.

9. The drug vial spiking device of claim 8, wherein the bi-stable member in the second position indicates that a drug vial has been fully inserted into the recess.

10. The drug vial spiking device of claim 8, wherein the portion of the member visible to the user protrudes from an outer surface of the base.

11. The drug vial spiking device of claim 8, wherein the bi-stable member comprises a projection extending from its upper surface.

12. The drug vial spiking device of claim 11, wherein the projection is configured to push the bi-stable member from the first position to the second position when the drug vial is fully inserted into the recess such that the vial contacts the base of the cup-shaped member.

13. The drug vial spiking device of claim 1, wherein the spike comprises a portion configured to engage an inner surface of a seal of a drug vial after the spike is inserted into the drug vial.

14. The drug vial spiking device of claim 13, wherein the portion of the spike extends laterally in at least one direction to a greater extent than a remainder of the spike.

15. The drug vial spiking device of claim 14, wherein the portion of the spike is substantially conical.

16. The drug vial spiking device of claim 14, wherein the portion of the spike comprises a barb.

17. The drug vial spiking device of claim 1, wherein the spike defines a plurality of openings along an outer surface of the spike, and each of the openings is in fluid communication with the channel.

18. The drug vial spiking device of claim 1, wherein a portion of the sidewall forms a flange that retains the portion of the vial within the recess.

19. The drug vial spiking device of claim 18, wherein the flange is configured to contact a cap of the vial.

20. A fluid line set, comprising:

a plurality of fluid lines;

a plurality of drug vial spiking devices, each of the drug vial spiking devices being connected to one of the fluid lines, and each of the drug vial spiking devices comprising

a cup-shaped member having a base and a sidewall, the base and the sidewall at least partially forming a recess configured to receive at least a portion of a drug vial;

a spike extending from a central region of the base, the spike defining a channel extending therethrough; and

a plurality of springs extending from the base of the cup-shaped member into the recess, the springs configured to apply a force to the drug vial in a direction away from the base of the cup-shaped member when at least a portion of the drug vial is positioned in the recess such that a seal of the drug vial bulges away from the drug vial and forms a concave shape.