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Publication Number
US-8720501-B2
Publication Date
2014-05-13
Expiration Date
Abstract
A hollow needle comprising a shaft having a distal portion suitable for passing through an elastomer closure of a container, said shaft extending in a longitudinal direction and having a central longitudinal axis, and having an internal longitudinal conduit therein for the flow of liquid and one or more orifices communicating between the conduit and the exterior of the needle, the distal portion of the shaft being provided with a pointed end that has a profile comprising a cutting edge in the form of two part cutting edges converging in the longitudinal direction to meet at the needle point, each part cutting edge extending in a straight line in a widthways direction across a plane including the central longitudinal axis, on both widthways sides of the cutting edge the pointed end having a profile which is a non-cutting surface, wherein the pointed end of the needle tapers from an outer surface of said distal portion toward the point of the needle, and the distance, measured in a further plane defined by said two part cutting edges between the outermost ends of said part cutting edges, is smaller than the largest outer dimension of said distal portion, measured perpendicular to said central axis in said further plane.
Core Innovation
The invention discloses a hollow container filling needle having a shaft extending in a longitudinal direction with a central longitudinal axis, an internal longitudinal conduit for the flow of liquid, one or more orifices communicating between the conduit and the exterior, and a vent groove in an outer surface to allow displaced atmosphere to be vented out of the container when liquid is introduced. The needle point is suitable for passing through an elastomer closure of a container having a sterile interior, and is formed from a profile in the pyramidal part including two part cutting edges converging in the longitudinal direction to meet at the needle point.
The needle point profile further defines non-cutting surfaces on both widthways sides of each part cutting edge, so the pointed end has a cutting structure with non-cutting rounded edges. The pointed end tapers from an outer surface of the distal portion toward the point, where the needle changes from a first cylindrical part to a second conical part and then into a third pyramidal part, thereby creating a two-stage taper region leading into the more steeply tapering region at the point.
A dimensional relationship is enforced in the needle point geometry by measuring, in a further plane defined by the two part cutting edges, the distance between the outermost ends of the part cutting edges and requiring it to be smaller than the largest outer dimension of the distal portion at the cylindrical part. This relationship produces a slit-shaped puncture hole with a shorter slit length that is easier to seal during needle withdrawal, while reducing elastomer tearing by using non-cutting rounded edges on the pointed end.
The document also describes a process for introducing liquid into a sterile container by puncturing a puncturable wall part with the filling needle, delivering liquid into the container through the conduit and one or more orifices, and withdrawing the needle from the punctured area. The vent groove enables displaced atmosphere to be vented out of the container, and the document further describes optional heat fusing of a residual puncture hole, for example using a focused laser beam.
Claims Coverage
The partial content provides one independent claim and multiple dependent claims, with at least one additional independent/process-type claim identified in the family summary as including a method of introducing liquid into a sterile container. The main inventive features relate to the needle’s vent groove and internal conduit/orifices, the multi-part tapered pyramidal cutting tip with non-cutting rounded edges, and a specific dimensional relationship between the cutting-edge outermost ends and the distal portion outer dimension.
Vent groove for displaced atmosphere venting with internal conduit
A hollow container filling needle having a vent groove in an outer surface for allowing displaced atmosphere to be vented out of a container when liquid is introduced, together with a central longitudinal axis, an internal longitudinal conduit for liquid flow, and one or more orifices communicating between the conduit and the exterior.
Multi-part tapered pyramidal needle point with converging part cutting edges
A needle point profile in the pyramidal part comprising a cutting edge in the form of two part cutting edges converging in the longitudinal direction to meet at the needle point.
Non-cutting rounded surfaces on pointed end adjacent to cutting edges
The pointed end has, on both widthways sides of the cutting edge, a non-cutting surface so that the pointed end includes non-cutting rounded edges together with the two part cutting edges.
Size relationship between cutting-edge outermost ends and distal portion outer dimension
A dimensional relationship where the distance measured between the outermost ends of the part cutting edges is smaller than the largest outer dimension of the distal portion at the cylindrical part.
Two-stage taper from cylindrical part through conical to pyramidal part
The needle changes from a first cylindrical part into a second conical part, which changes into a third pyramidal part, with the pointed end tapering toward the needle point and a defined taper profile that includes a two-stage taper region.
Across the provided material, the coverage centers on a hollow container filling needle combining vent groove displaced-atmosphere venting with an internal conduit and exterior orifices, and a pyramidal multi-part tapered needle point in which two part cutting edges converge to the tip while adjacent surfaces are non-cutting and rounded, along with a defined dimensional relationship between the cutting-edge outermost ends and the distal portion outer dimension. Process coverage includes puncturing a sterile container wall, delivering liquid through the conduit, and withdrawing the needle.
Stated Advantages
Reduces elastomer tearing during withdrawal due to non-cutting rounded edges and resulting shorter slit-shaped puncture hole.
Reduces penetration force relative to a conical needle tip.
Provides better wipe/cleaning of residual liquid during withdrawal.
Produces a shorter slit length that is easier to seal.
Documented Applications
Introducing liquid into a sterile container through an elastomer closure using the hollow container filling needle, with displaced atmosphere venting and optional heat fusing of a residual puncture hole.
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