Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-04-17
2003-10-07
Hirsch, Paul J. (Department: 3754)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S506000, CD24S114000
Reexamination Certificate
active
06629962
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to improved needle designs for live vaccines and, in particular, live vaccines for Marek's and other diseases affecting chicken and other avian species, as well as for live microorganisms in general. More specifically, the present invention relates to a pair of needle assemblies having a needle and needle retainer which minimizes turbulence and damage to the live cells during transfer of vaccine fluids into and out of a standard syringe.
2. Prior Art
Marek's disease is a viral disease of chickens resulting in a type of cancer, and is one of the most serious threats to poultry health. This virus lies latent in T-cells, which are a type of white blood cells. T-cells are an integral part of the immune system response which is the bird's natural defense against disease. Within three weeks of infection, the fatal virus manifests as aggressive tumors in the spleen, liver, kidney, gonads, skin and muscle of the infected bird.
Marek's disease is a herpesvirus-induced lymphoprolifertive disease that occurs naturally in chickens. Since the advent of the turkey herpesvirus vaccine (HVT), newly hatched chicks have been routinely inoculated against the disease prior to being placed in the brooder houses. Although HVT vaccine is generally quite effective, occasionally inoculated flocks experience heavy Marek's disease losses. More recently, it has been found that by proper selection of both the site and time of inoculation, embryonic vaccination can be effective in the control of poultry diseases. It is essential that the egg be injected during the final quarter of the incubation period, and that the inoculate be injected within either of the regions defined by the amnion or the yolk sac. Under these conditions, the embryo will favorably respond immunologically to the vaccine with no significant impairment of its prenatal development.
A live cell-associated virus vaccine of tissue culture origin typically contains the Rispens strain, the SB1 strain of the chicken herpes-virus and the FC 126 HVT strain of the turkey herpes virus alone or in combination. The vaccine is presented in glass ampules containing concentrated vaccine, typically 1000 doses each, with a specified titer defined as Plaque Forming Units (“PFUs”). The vaccine product is stored in a frozen condition typically in liquid nitrogen freezer and shipped in liquid nitrogen. A special sterile diluent is supplied in a separate package, typically a sealed plastic bag with appropriate injection port and delivery tube opening. The vaccine is reconstituted by thawing the frozen vaccine in the glass ampule. The ampule is then broken open and the liquid vaccine product is withdrawn from the ampule using a standard needle and syringe. The diluent is stored at room temperature until use when the concentrated vaccine product withdrawn from the ampule by the needle and syringe is then injected into the diluent contained in the sealed plastic bag through the bag injection port. The reconstituted vaccine is then ready for delivery from the sealed bag through the delivery tube.
There are various factors that affect the level of PFUs delivered by a live cell associated vaccine, such as Marek's vaccine, to an inoculated specimen. Most of these factors occur during the vaccine reconstitution and in the delivery process and both have to do with vaccine handling, temperature, turbulence in the syringe, air pressure, friction, pH, vaccine delivery tube, length and diameter, needle length and diameter, needle shape and delay in vaccine consumption after thawing. Elimination or reduction of the adverse effects arising from any one of these noted factors would greatly improve the inoculation process for Marek's vaccine, specifically, and for live vaccines, generally.
A conventional needle configuration for drawing a vaccine fluid into a syringe and subsequently delivering the vaccine from the syringe to a vaccine delivery system, such as an automated injection system for avian embryos as disclosed in U.S. Pat. No. 4,681,063, is illustrated in FIG.
1
. As shown, a conventional syringe needle, generally designated by reference numeral
110
, is attached to a conventional syringe, generally designated by reference numeral
112
. The syringe
112
has a hollow tubular barrel
114
having a chamber
116
for retaining fluid, such as the live vaccine. The syringe
112
also has a plunger with a flexible plug (not shown). As is common in the art, the plug will sealingly engage against an inner surface
118
of the syringe barrel
114
, with the plunger being pulled out of the chamber
116
to draw fluid into the chamber and being pushed into the chamber
116
to inject fluid out of the chamber.
The syringe
112
has a standard tubular extension
120
projecting from end
122
of the barrel
114
. The tubular extension
120
has a cylindrical axial passageway
126
which communicates with the syringe chamber
116
and needle assembly
110
, when attached. The tubular extension
120
is surrounded by a collar
124
which has internal male threads
125
so that the needle assembly
110
can be sealingly attached in a conventional manner by outwardly extending flange
138
screwing downwardly on threads
125
.
The needle assembly
110
includes an injection needle or cannula
133
and a needle retainer
128
. The retainer
128
is mounted on the forward end of the syringe
112
as previously described to retain the needle assembly
110
in generally axial alignment with the syringe
112
and tubular extension
120
. The needle
133
is made of conventional needle materials, such as stainless steel for strength and chemical compatibility, and the retainer
128
is preferably made of a suitable plastic material which can be easily molded around the end
136
of needle
133
.
The needle
133
includes a hollow central passageway or lumen
134
and a sharpened tip
130
at its outer end
132
formed by an angled cut of the hollow needle. The needle
133
is preferably surrounded by a cap or sheath (not shown) before the needle is used for sterility, and the sheath is easily removed in a conventional manner when the needle and syringe are ready for use.
To hold the needle assembly
110
in generally axial alignment with the syringe, the retainer
128
has an axial bore
141
and an outwardly projecting rim or flange
138
at the syringe receiving end. The axial bore
141
is sized to fit in sealing engagement over the tubular extension
120
, while the outer circumference of the rim or flange
138
engages the threads
125
on the inner wall of surrounding collar
124
. As assembled, the outwardly projecting rim or flange
138
snugly fits down into space
139
between the outer surface
142
of the tubular extension
120
and the inner surface of the collar
124
. Thus, mounted on the syringe
112
, the hollow central passageway or lumen
134
of the needle portion
133
aligns with the passageway
126
of the tubular extension
120
and the chamber
116
of the syringe
112
.
The conventional syringe and needle assembly as previously described and shown in
FIG. 1
is commonly used and well known. The assembly is particularly intended for single dosage use, and for storage, transportation, and injection while filled with fluid. It is also the standard assembly for transferring concentrated live virus vaccines, such as Marek's vaccine, from supply ampules to diluent storage containers or bags where it is appropriately diluted for delivery to a specimen to be vaccinated, such as chicken egg embryos and the like, by known vaccine delivery machines or systems. It has been surprisingly discovered that the use of this conventional syringe and needle assembly for transferring live vaccines creates unexpected problems in the destruction of the live cells caused by turbulence of the vaccine during both the drawing of the vaccine into the syringe chamber
116
and the discharge of the vaccine from the chamber
116
, through the passageway
126
of exten
Correa Rafael S.
Quiroz Marco A.
Samson William D.
Buechner Patrick
Hirsch Paul J.
Jacobson & Holman PLLC
Machining Technologies, Inc.
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