US-12622846-B2 - Components of a fluid transfer apparatus

US12622846B2US 12622846 B2US12622846 B2US 12622846B2US-12622846-B2

Abstract

A syringe that is configured for use in a syringe pump. The syringe has a flange at the proximal end of a barrel and a sealing element at its proximal end. The sealing element has of a disk shaped annular sealing assembly having a hole in its center through which a piston rod passes. The sealing assembly has an upper part and a lower part that are pressed together to hold an O-ring that seals around the piston rod. The sealing assembly is placed inside the barrel of the syringe; thereby not disturbing the external shape of the syringe and allowing the syringe to fit into dedicated grooves on syringe pumps.

Inventors

Marino Kriheli

Assignees

EQUASHIELD MEDICAL LTD.

Dates

Publication Date: 20260512
Application Date: 20201125
Priority Date: 20150611

Claims (4)

1 . A syringe configured for use in a syringe pump, the syringe comprising a flange at a proximal end of a barrel and a sealing element at a proximal end of the syringe, the sealing element comprised of a disk shaped annular sealing assembly having a hole in its center through which a piston rod passes, the sealing assembly comprised of an upper part and a lower part that are pressed together towards each other between the barrel and the piston rod at least in a direction transverse to the barrel to hold therebetween an O-ring that seals around the piston rod, the sealing assembly comprising a gap between at least a portion of the upper part and at least a portion of the lower part in the direction transverse to the barrel; wherein the sealing assembly is placed inside the barrel of the syringe and is fixedly held in place at the proximal end of the barrel; thereby not disturbing the external shape of the syringe and allowing the syringe to fit into dedicated grooves on syringe pumps, said fixed holding of the sealing assembly at the proximal end of the barrel being independent of the flange, wherein at least one of the upper part and the lower part is held in place and sealed to the inside of the barrel of the syringe by at least one of: press fitting, laser welding, ultrasound welding, heat welding, and gluing, and wherein the sealing assembly has a barrel facing surface facing an internal volume of the barrel, and an opposite exterior facing surface, the exterior facing surface being free of overlay by the barrel as well as the flange.
2 . The syringe of claim 1 , wherein the syringe can be used for either closed or open transfer systems.
3 . The syringe of claim 1 , wherein said at least one of the upper part and the lower part is pressed against the inside of barrel, and at least the other one of the upper part and lower part is pressed against the piston rod.
4 . The syringe of claim 1 , wherein at least one of the upper part and the lower part is held in place and sealed to the inside of the barrel of the syringe by at least one of: laser welding, ultrasound welding, heat welding, and gluing.

Description

FIELD OF THE INVENTION The present invention relates to the field of fluid transfer apparatuses. Particularly, the invention relates to apparatus for the contamination-free transfer of a hazardous drug from one container to another or to a patient. More particularly, the invention relates to improvements to syringes and to connectors and adapters that are used in fluid transfer apparatuses. BACKGROUND OF THE INVENTION Advances in medical treatment and improved procedures constantly increase the need for improved valves and connectors. The demands relating to a variety of types, quality, needle safety, microbial ingress prevention and leak prevention are constantly growing. Additionally, advances in sampling or dose dispensing technologies, automated and manual, aseptic or non-aseptic applications, call for new safe concealing solutions for the sampling needle. One extremely demanding application exists in the field where medical and pharmacological personnel that are involved in the preparation and administration of hazardous drugs suffer the risk of being exposed to drugs and to their vapors, which may escape to the surroundings. As referred to herein, a “hazardous drug” is any injectable material the contact with which, or with the vapors of which, may constitute a health hazard. Illustrative and non-limitative examples of such drugs include, inter aka, cytotoxins, antiviral drugs, chemotherapy drugs, antibiotics, and radiopharmaceuticals, such as herceptin, cisplatinum, fluorouracil, leucovorin, paclitaxel, etoposide, cyclophosphamide and neosar, or a combination thereof, in a liquid, solid, or gaseous state. Hazardous drugs in liquid or powder form are contained within vials, and are typically prepared in a separate room by pharmacists provided with protective clothing, a mouth mask, and a laminar flow safety cabinet. A syringe provided with a cannula, i.e. a hollow needle, is used for transferring the drug from a vial. After being prepared, the hazardous drug is added to a solution contained in a bag which is intended for parenteral administration, such as a saline solution intended for intravenous administration. Since hazardous drugs are toxic, direct bodily contact thereto, or exposure to even micro-quantities of the drug vapors, considerably increases the risk of developing health problems that can result in fatalities such as skin cancer, leukemia, liver damage, malformation, miscarriage and premature birth. Such exposure can take place when a drug containing receptacle, such as a vial, bottle, syringe, and intravenous bag, is subjected to overpressure, resulting in the leakage of fluid or air contaminated by the hazardous drug to the surroundings. Exposure to a hazardous drug also results from a drug solution remaining on a needle tip, on a vial or intravenous bag seal, or by the accidental puncturing of the skin by the needle tip. Additionally, through the same routes of exposure, microbial contaminants from the environment can be transferred into the drug and fluids; thus eliminating the sterility with possibly fatal consequences. U.S. Pat. Nos. 8,196,614 and 8,267,127 to the inventor of the present invention describe closed system liquid transfer devices designed to provide contamination-free transfer of hazardous drugs. FIG. 1 and FIGS. 3a to 3b are schematic cross-sectional views of an apparatus 10 for transferring hazardous drugs without contaminating the surroundings, according to one embodiment of the invention described in U.S. Pat. No. 8,196,614. The main features of this apparatus that are relevant to the present invention will be described herein. Additional details can be found in the aforementioned patent. The proximal section of apparatus 10 is a syringe 12, which is adapted to draw or inject a desired volume of a hazardous drug from a fluid transfer component, e.g. a vial 16 or an intravenous (IV) bag in which it is contained and to subsequently transfer the drug to another fluid transfer component. At the distal end of syringe 12 is connected a connector section 14, which is in turn connected to vial 16 by means of vial adapter 15. Syringe 12 of apparatus 10 is comprised of a cylindrical body 18 having a tubular throat 20 that has a considerably smaller diameter than body 18, an annular rubber gasket or stopper assembly 22 fitted on the proximal end of cylindrical body 18, hollow piston rod 24 which sealingly passes through stopper 22, and proximal piston rod cap 26 by which a user can push and pull piston rod 24 up and down through stopper 22. A piston 28 made of an elastomeric material is securely attached to the distal end of piston rod 24. Cylindrical body 18 is made of a rigid material, e.g. plastic. Piston 28, which sealingly engages the inner wall of, and is displaceable with respect to, cylindrical body 18 defines two chambers of variable volume: a distal liquid chamber 30 between the distal face of piston 28 and connector section 14 and a proximal air chamber 32 between