Drug vial spikes, fluid line sets, and related systems

• US 9,132,061 B2
• Filed: 03/26/2013
• Issued: 09/15/2015
• Est. Priority Date: 07/01/2009
• Status: Expired due to Fees

• 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): Zalukaeva, Tatyana
• Assistant Examiner(s): Mensh, Andrew J
• Application Number:
  US13/850,473
• Publication Number:
  US 20130218123A1
• Time in Patent Office: 903 Days
• Field of Search: 604/411, 604/263, 604/198
• US Class Current: 1/1
• 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 assembly, comprising:

a drug vial spike device comprising a spike extending from a base, the spike having a tip opposite the base; and

a cover secured to the drug vial spike device, the cover being movable toward the base from a first position in which the cover at least partially covers the tip of the spike to a second position in which the tip of the spike is fully exposed,

wherein a plurality of circumferentially spaced projections extend from a surface of the cover, and the circumferentially spaced projections and one or more portions of a cap of a drug vial are configured to dent a rubber seal of the drug vial when the drug vial is pressed against the cover with sufficient force to cause the cover to move from the first position to the second position.

2. The drug vial spiking assembly of claim 1, wherein the cover is resilient such that when a force applied to the cover to move the cover from the first position to the second position is removed, the cover returns to approximately the first position.

3. The drug vial spiking assembly of claim 1, wherein a length of the cover is greater than a length of the spike when the cover is in the first position, and the length of the cover is less than the length of the spike when the cover is in the second position.

4. The drug vial spiking assembly of claim 1, wherein the cover comprises an upper member, a lower member, and at least one elongate structure connecting the upper member to the lower member.

5. The drug vial spiking assembly of claim 4, wherein each of the upper and lower members defines an aperture configured to receive the spike therein.

6. The drug vial spiking assembly of claim 4, wherein the at least one elongate structure comprises a plurality of circumferentially spaced, resilient columns.

7. The drug vial spiking assembly of claim 6, wherein each of the resilient columns defines a channel along its peripheral surface that facilitates collapse of the column when a force is applied to the column along a longitudinal axis of the column.

8. The drug vial spiking assembly of claim 4, wherein the at least one elongate structure comprises a foam tube.

9. The drug vial spiking assembly of claim 4, wherein the elongate structure comprises a spring.

10. The drug vial spiking assembly of claim 9, wherein the spring is a coil spring that at least partially surrounds the spike.

11. The drug vial spiking assembly of claim 1, wherein the cover is an inflated member.

12. The drug vial spiking assembly of claim 11, wherein the inflated member is an inflated balloon.

13. The drug vial spiking assembly of claim 11, wherein the inflated member at least partially surrounds the spike.

14. The drug vial spiking assembly of claim 13, wherein the inflated member and the spike are configured such that the spike punctures the inflated member when a force is applied to the inflated member in a direction along the spike.

15. The drug vial spiking assembly of claim 1, wherein the cover is a coil spring that at least partially surrounds the spike.

16. The drug vial spiking assembly of claim 1, wherein the cover comprises an elongate tubular member that fits over the spike.

17. The drug vial spiking assembly of claim 16, further comprising a structure that is fixed relative to the spike and is configured to contact the elongate tubular member and resist further movement of the elongate tubular member when the elongate tubular member has been moved to the second position.

19. The drug vial spiking assembly of claim 1, wherein the circumferentially spaced projections are further configured to penetrate the rubber seal.

20. The drug vial spiking assembly of claim 1, wherein the circumferentially spaced projections are pointed.

21. The drug vial spiking assembly of claim 1, wherein each of the circumferentially spaced projections is further configured to dent a discrete portion of the drug vial cap into the rubber seal.

18. A fluid line set, comprising:

a plurality of fluid lines;

a plurality of drug vial spike devices, each of the drug vial spike devices connected to one of the fluid lines, and each of the drug vial spike devices comprising a spike extending from a base, the spike of each drug vial spike device having a tip opposite the base; and

a plurality of covers, each of the covers secured to one the drug vial spike devices, each cover being movable toward the base from a first position in which the cover at least partially covers the tip of the spike of the spike device to which the cover is secured to a second position in which the tip of the spike of the spike device to which the cover is secured is fully exposed,

wherein a plurality of circumferentially spaced projections extend from each of the covers, and the circumferentially spaced projections and one or more portions of a cap of a drug vial are configured to dent a rubber seal of the drug vial when the drug vial is pressed against each of the covers with sufficient force to cause the cover to move from the first position to the second position.

22. The fluid line set of claim 18, wherein the circumferentially spaced projections are further configured to penetrate the rubber seal.

23. The fluid line set of claim 18, wherein the plurality of the circumferentially spaced projections are pointed.

24. The fluid line set of claim 18, wherein each of the circumferentially spaced projections is further configured to dent a discrete portion of the drug vial cap into the rubber seal.