Drug Vial Spikes, Fluid Line Sets, And Related Systems

• US 20110004145A1
• Filed: 06/30/2010
• Published: 01/06/2011
• Est. Priority Date: 07/01/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Beiriger, Michael James, Kaintz, Ryan
• Granted Patent: US 8,425,487 B2
• Time in Patent Office: Days
• US Class Current: 604/6.11
• 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 a 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.

2-19. -19. (canceled)

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 a 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.

21. A fluid line set, comprising:

a frame comprising a top member, a manifold, and at least one connecting member that extends between and is attached to the top member and the manifold, the manifold defining a fluid passage extending therethrough;

a plurality of spikes extending from the top member, each of the spikes defining a fluid channel;

a plurality of fluid lines connected to the top member and the manifold, each of the fluid lines being in fluid communication with the channel of one of the spikes, and each of the fluid lines being in fluid communication with the fluid passage extending through the manifold,

wherein the frame is configured to hold the fluid lines in a spaced apart configuration.

22. The fluid line set of claim 21, wherein the frame comprises two connecting members that extend between and are attached to the top member and the manifold.

23. The fluid line set of claim 22, wherein the frame is rectangular.

24. The fluid line set of claim 22, wherein the frame further comprises a cross bar that extends between and is connected to the two connecting members.

25. The fluid line set of claim 24, wherein the cross bar defines a plurality of spaced apart recesses, and each of the recesses is configured to retain one of the fluid lines.

26. The fluid line set of claim 21, wherein a projection extends from a surface of the frame, and the projection is configured to mate with a matching hole in a drug delivery device.

27. The fluid line set of claim 26, wherein the projection is configured to engage the matching hole in the drug delivery device in a manner to releasably secure the fluid line set to the drug delivery device.

28. The fluid line set of claim 26, wherein the projection and the matching hole are hexagonal.

29. The fluid line set of claim 21, wherein each of the top member, the manifold, and the at least one connecting member has a greater rigidity than the fluid lines.

30. The fluid line set of claim 21, further comprising a cover disposed over at least one of the spikes.

31. A drug delivery system, comprising:

a drug delivery device having a surface from which a plurality of pumps extend; and

a fluid line set comprising

a frame comprising a top member, a manifold, and at least one connecting member that extends between and is attached to the top member and the manifold, the manifold defining a fluid passage extending therethrough;

a plurality of spikes extending from the top member, each of the spikes defining a fluid channel;

a plurality of fluid lines connected to the top member and the manifold, each of the fluid lines being in fluid communication with the channel of one of the spikes, and each of the fluid lines being in fluid communication with the fluid passage extending through the manifold,

wherein the frame is configured to hold the fluid lines in a spaced apart configuration, and the fluid line set is configured to be secured to the drug delivery device in a manner such that each of the fluid lines is operably connected to one of the pumps.

32. The drug delivery system of claim 31, wherein the drug delivery device comprises a door, and the door and the surface of the drug delivery device form a cassette compartment configured to receive the frame and the fluid lines of the fluid line set therein when the door is closed.

33. The drug delivery system of claim 32, wherein an inner surface of the door defines a recessed region configured to receive the frame of the fluid line set.

34. The drug delivery system of claim 32, wherein an inner surface of the door defines a hole configured to receive a projection that extends from a surface of the support frame.

35. The drug delivery system of claim 34, wherein the hole and the projection are configured to engage one another in a manner to releasably secure the fluid line set to the door of the drug delivery device.

36. The drug delivery system of claim 31, wherein the pumps are peristaltic pumps.

37. The drug delivery system of claim 31, wherein the drug delivery device further comprises a plurality of air bubble detectors positioned on the surface, and the fluid line set is configured to be disposed adjacent the surface of the dialysis machine in a manner such that each fluid line is aligned with one of the air bubble detectors.

38. The drug delivery system of claim 31, wherein the drug delivery device further comprises a drug vial holder that is movable in a manner such that, when a drug vial is disposed in the drug vial holder, the drug vial can be moved with respect to the fluid line set to cause one of the spikes of the fluid line set to penetrate the vial.

39. A dialysis system, comprising:

a dialysis machine comprising

a blood pump; and

a drug delivery device having a surface from which a plurality of drug pumps extend;

a fluid line set comprising

a frame comprising a top member, a manifold, and at least one connecting member that extends between and is attached to the top member and the manifold, the manifold defining a fluid passage extending therethrough;

a plurality of spikes extending from the top member, each of the spikes defining a fluid channel; and

a plurality of fluid lines connected to the top member and the manifold, each of the fluid lines being in fluid communication with the channel of one of the spikes, and each of the fluid lines being in fluid communication with the fluid passage extending through the manifold, wherein the frame is configured to hold the fluid lines in a spaced apart configuration, and the fluid line set is configured to be secured to the drug delivery device in a manner such that each of the fluid lines is operably connected to one of the pumps; and

a blood line set comprising a blood line that is operably connected to the blood pump,

wherein the fluid line set is configured to be placed in fluid communication with the blood line set such that, when one of the spikes of the fluid line set is disposed within a drug vial and the drug pump operably connected to the fluid line that is in fluid communication with the channel of that spike is operated, a drug is delivered from the drug vial to the blood line set via the fluid line set.

40. 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.

41-57. -57. (canceled)

58. 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.