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Publication Number
US-8100867-B2
Publication Date
2012-01-24
Expiration Date
Abstract
A needle (1, 100, 110) for precision filling of dosage containers, such as vials, ampoules etc. is provided. The needle ideally comprises an elongate plastics body (2) having a through channel (5) extending between inlet (3) and outlet (4) openings. A tip portion (7b) at the outlet opening (4) has a chamfer (8) tapering towards the outlet opening (4) and an end surface (9) around the opening so that the tip portion (7b) is frusto-conical. The surface area of the end surface (9) is sufficiently smaller than the area of the cross-section of the needle body (2) so that in use the needle (1) is capable of providing for formation of smaller droplets of liquid at the outlet (4) compared to needles without such body thickness reduction at the time when the liquid flow through the needle is shut off. The end surface (9) may be so narrow as to take the form of a sharp rim.
Core Innovation
The invention provides a needle for transfer of liquid comprising an elongate body having a liquid inlet end, a liquid outlet end, and a through passage defined by a wall and extending between the ends. The body comprises a tip portion at the outlet end, where the wall thickness of the tip portion is reduced compared to that of the body, and this reduced wall thickness renders the needle capable of providing for formation of smaller droplets at the outlet end when liquid flows from the inlet end towards the outlet end and quicker separation of the droplets from the needle.
The needle material is a polymeric material selected from a silicone or a plastics material, and the diameter of the through passage is uniform along the length of the through passage in the body and in the tip portion, with the external diameter of the body uniform along the length of the body. A ratio between the thickness of the wall material of the body and the diameter of the through passage is selected at least 0.5 or greater, providing the needle with the same strength and flexibility characteristics as those of a metal needle having substantially the same body length and substantially the same cross-sectional dimensions of the through passageway.
In dependent embodiments, the reduced wall thickness at the outlet end is formed by a chamfer having an outer surface that tapers toward the outlet opening, so that the chamfer leads to a frusto-conical end surface around the outlet opening, or the needle tip is shaped as a sharp rim. The arrangement is described in the context of a precision filling needle for vials and ampoules to reduce droplet separation and accuracy errors when flow is shut off.
An associated filling system is also described, comprising at least one liquid source vessel with an outlet opening and at least one discharge manifold with a first end connected to the liquid source vessel outlet opening and a second end connected to the liquid inlet end of the needle, wherein the discharge manifold further comprises a liquid flow control means. In addition, a liquid-transfer method is described where the polymeric components of the filling system are subjected to sterilisation using gamma-rays, with the irradiation dose selected to provide through-sterilisation of the liquid source vessel, the polymeric material of the discharge manifold, the liquid flow control means, and the needle without damaging the polymeric material.
Claims Coverage
The provided claim set includes three independent claims: a needle claim, a filling-system claim, and a method claim. Across these claims, the core inventive coverage centers on polymeric needles with reduced tip wall thickness that generate smaller droplets and enable quicker droplet separation, while maintaining strength and flexibility via uniform geometrical constraints and a wall-thickness-to-passage-diameter ratio of at least 0.5.
Polymeric needle with reduced tip wall thickness for smaller droplets and quicker separation
An elongate body having a liquid inlet end, a liquid outlet end and a through passage, where a tip portion at the outlet end has wall thickness reduced compared to that of the body, thereby rendering the needle capable of providing for formation of smaller droplets of liquid at the outlet end when liquid flows and quicker separation of the droplets from the needle compared to needles without such body thickness reduction.
Uniform passage and body diameters with wall thickness to passage diameter ratio at least 0.5
The diameter of the through passage is uniform along the length of the through passage in the body and in the tip portion, and the external diameter of the body is uniform along the length of the body; and the ratio between the thickness of the wall material of the body and the diameter of the through passage is selected at least 0.5 or greater thereby providing the needle with the same strength and flexibility characteristics as those of a metal needle having substantially the same body length and substantially the same cross-sectional dimensions of the through passageway.
Chamfered outlet tip forming a frusto-conical end surface or a sharp rim
The reduced tip wall thickness is provided by forming a chamfer whose outer surface tapers toward the outlet opening; and an end surface around the outlet opening forms a frusto-conical needle tip, or the needle tip is shaped as a sharp rim.
Filling system using the reduced-tip polymeric needle with discharge manifold flow control
A filling system comprising at least one liquid source vessel with an outlet opening, at least one discharge manifold with a first end connected to the outlet opening and a second end connected to the needle liquid inlet end, where the needle is as defined with reduced tip wall thickness for smaller droplets and quicker separation; wherein the needle geometry includes uniform through passage diameter and uniform external body diameter and a wall-thickness-to-through-passage-diameter ratio selected at least 0.5; and wherein the discharge manifold further comprises a liquid flow control means.
Gamma-ray sterilisation of polymeric filling system components without damaging the polymer
A method of transferring liquid into a vessel by providing the polymeric filling system, directing the outlet end of the needle into the vessel, adjusting the liquid flow control means to cause liquid flow at a selected flow rate, and selecting a liquid source vessel, a discharge manifold, a liquid flow control means and a needle being made from a polymeric material; and prior to directing the outlet end, subjecting the filling system to sterilisation using gamma-rays with an irradiation dose selected to provide through-sterilisation of the liquid source vessel, the polymeric material of the discharge manifold, the liquid flow control means and the needle without damaging the polymeric material.
Across the independent claims, the patent protects a polymeric liquid-transfer needle with reduced wall thickness at a tip portion to generate smaller droplets and quicker droplet separation, combined with uniform through-passage and body diameters and a wall-thickness-to-passage-diameter ratio of at least 0.5 to maintain strength and flexibility comparable to a metal needle. The filling-system and method claims additionally require a discharge manifold with liquid flow control and gamma-ray sterilisation of polymeric components without damaging them.
Stated Advantages
Formation of smaller droplets of liquid at the outlet end.
Quicker separation of the droplets from the needle.
Same strength and flexibility characteristics as those of a metal needle having substantially the same body length and substantially the same cross-sectional dimensions of the through passageway.
Through-sterilisation of the liquid source vessel, the polymeric discharge manifold, the liquid flow control means, and the needle without damaging the polymeric material.
Documented Applications
Precision filling of vials and ampoules using the disclosed needle and filling system to reduce droplet separation and accuracy errors when flow is shut off.
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