U.S. patent application number 10/141538 was filed with the patent office on 2003-07-03 for medical needle assemblies.
Invention is credited to Alchas, Paul G., Prais, Alfred W., Sprieck, Terry L..
Application Number | 20030121812 10/141538 |
Document ID | / |
Family ID | 26839208 |
Filed Date | 2003-07-03 |
United States Patent
Application |
20030121812 |
Kind Code |
A1 |
Sprieck, Terry L. ; et
al. |
July 3, 2003 |
Medical needle assemblies
Abstract
A shielded, sterile, single-use unit dose needle assembly
includes a unit dose needle with a hub and a packaging shield. The
unit dose needle has a handle end and a prong end configured to
hold a unit dose of a vaccine. The hub is fixedly attached to the
handle end of the unit dose needle and includes a tapered mating
surface. The packaging shield includes a tubular housing having an
open end and a closed end with an internal opening extending
therebetween. The open end of the packaging shield can be removably
attached to the tapered mating surface of the hub to form an
air-tight seal, with the unit dose needle contained within the
internal opening.
Inventors: |
Sprieck, Terry L.;
(Columbus, NE) ; Prais, Alfred W.; (Hewitt,
NJ) ; Alchas, Paul G.; (Wayne, NJ) |
Correspondence
Address: |
Kirk M. Miles
WEBB ZIESENHEIM LOGSDON ORKIN & HANSON, P.C.
700 Koppers Building
436 Seventh Avenue
Pittsburgh
PA
15219-1818
US
|
Family ID: |
26839208 |
Appl. No.: |
10/141538 |
Filed: |
May 9, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60344304 |
Dec 28, 2001 |
|
|
|
Current U.S.
Class: |
206/365 ;
604/263 |
Current CPC
Class: |
A61B 17/205 20130101;
A61M 5/3286 20130101; A61M 5/3243 20130101; A61M 2205/6063
20130101; A61M 5/002 20130101 |
Class at
Publication: |
206/365 ;
604/263 |
International
Class: |
B65D 083/10 |
Claims
What is claimed is:
1. A shielded, sterile, single-use needle assembly for
administering a unit dose of a vaccine comprising: a unit dose
needle having a handle end and a prong end configured to hold a
unit dose of a vaccine; a hub fixedly attached to the handle end of
the unit dose needle and including a tapered mating surface; and a
packaging shield comprising a tubular housing having an open end
and a closed end with an internal opening extending therebetween,
the open end of the packaging shield being removably attached to
the tapered mating surface of the hub to form an air-tight seal,
with the unit dose needle contained within the internal
opening.
2. The needle assembly of claim 1, wherein the unit dose needle
comprises a bifurcated needle, wherein the prong end includes two
pointed prongs which are capable of penetrating or abrading the
skin of a patient, and wherein the prongs are separated by a
U-shaped channel capable of holding the unit dose of a vaccine.
3. The needle assembly of claim 1, wherein the unit dose of a
vaccine is a liquid.
4. The needle assembly of claim 1, wherein the handle end is
fixedly attached to the hub by an adhesive joint.
5. The needle assembly of claim 4, wherein the adhesive joint
comprises an epoxy adhesive.
6. The needle assembly of claim 14, wherein the hub includes means
for attachment to a medical device.
7. The needle assembly of claim 6, wherein the hub includes an
internal luer taper.
8. The needle assembly of claim 1, wherein the hub includes a
profile for accommodating a user's fingers.
9. The needle assembly of claim 1, wherein the shield comprises one
or more moldable plastics.
10. The needle assembly of claim 9, wherein the plastics are one or
more selected from the group consisting of polyethylenes,
polypropylenes, polyamides, polyesters and fluorinated
polyethylenes.
11. The needle assembly of claim 1, further comprising a
blister-type package comprised of a top web having a perimeter edge
and a bottom web having a perimeter edge and comprising a pocket
suitable for receiving the needle assembly therein, wherein the
perimeter edge of the top web and the perimeter edge of the bottom
web are sealed together along their respective lengths.
12. The needle assembly of claim 11, wherein the bottom web has an
embossing area capable of receiving printed images.
13. The needle assembly of claim 11, wherein the top web comprises
one or more of paper and a polymer film.
14. The needle assembly of claim 11, wherein the bottom web
comprises one or more of paper and a polymer film.
15. A shielded, sterile, single-use bifurcated needle assembly for
administering a vaccine comprising: a hub including a tapered
mating surface; a bifurcated needle fixedly adhered to the hub and
including two pointed prongs which are capable of penetrating or
abrading the skin of a patient, and which are separated by a
U-shaped channel which contains a unit dose of a vaccine; and a
packaging shield surrounding the bifurcated needle and removably
attached to the tapered mating surface of the hub to form an
air-tight seal between the hub and the packaging shield, thereby
maintaining the bifurcated needle in a sterile environment within
an interior of the packaging shield.
16. The bifurcated needle assembly of claim 15, wherein the hub
includes means for attachment to a medical device.
17. The bifurcated needle assembly of claim 15, wherein the hub
includes an internal luer taper.
18. The bifurcated needle assembly of claim 15, wherein the hub
includes a profile for accommodating a user's fingers.
19. A method of packaging a single-use unit dose needle assembly
comprising: (a) providing a sheet of top web material, wherein the
top web material comprises a plurality of rows, each row comprising
a plurality of covers for a blister pack, each cover comprising a
perimeter area; (b) providing a sheet of bottom web material,
wherein the bottom web material comprises a plurality of rows, each
row comprising a plurality of bottoms for a blister pack, each
bottom comprising a perimeter area and a pocket; (c) providing a
plurality of single-use unit dose needle assemblies comprising: (i)
a single-use unit dose needle including a prong end configured to
hold a unit dose of a vaccine, and a handle end attached to a hub;
and (ii) a cylindrical needle shield having a closed end and an
open end having a circumferential edge, the open end of the shield
being capable of receiving the unit dose needle such that the
circumferential edge securely engages a tapered surface of the hub;
(d) placing one of the single-use unit dose needle assemblies in
(c) in each of the pockets in the bottom web material in (b); and
(e) sealing the perimeter areas in the top web material in (a) to
the perimeter areas in the bottom web material in (b) to form a
plurality of sealed single-use unit dose needle assembly
packages.
20. The method of claim 19, wherein the bottom web (b) has an
embossing area capable of receiving printed images.
21. The method of claim 19, wherein the top web material in (a) and
the bottom web material in (b) comprises one or more of paper and a
polymer film.
22. The method of claim 19, further comprising cutting each row of
sealed single-use unit dose needle assembly packages from the
plurality of sealed single-use unit dose needle assembly packages.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority from U.S. Provisional
Patent Application Serial. No. 60/344,304, filed Dec. 28, 2001, and
entitled "Bifurcated Needle Assembly."
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to needles for use in medical
procedures and in particular to safety shielded needles and needle
assemblies for use in medical procedures.
[0004] 2. Description of Related Art
[0005] Bifurcated or forked end needles are well-known for
providing a simple and effective means for a doctor to administer a
vaccine. During use, the bifurcated tip of the bifurcated needle is
put into contact with either a dried or liquid substance, which
adheres to the bifurcated needle tip. The bifurcated needle tip is
then put into contact with the skin of the patient who is being
administered the vaccination. The skin is either scratched or
pierced with the needle tip so that the vaccination material may be
absorbed into the skin of the patient. An alternative method of
delivering the vaccination includes placing a drop of the vaccine
onto the skin of the patient and contacting the skin of the patient
with the bifurcated needle tip through the drop of vaccination.
Alternatively, a standard pointed needle tip may also be used when
the drop of vaccination is applied directly to the skin of the
patient.
[0006] The bifurcated needle is considered a significant medical
advancement because it has allowed more people to be vaccinated
with less serum. This has been especially important for those
living in less developed areas because of the efficient and easy to
use design, as well as the ease of replication.
[0007] Vaccination effectiveness, however, is reduced if the
bifurcated needle is reused too many times. Moreover, reuse of such
vaccination needles exposes patients to the risk of transmission of
infectious diseases through percutaneous contact through the skin.
Additionally, medical care workers using traditional vaccination
needles are at an increased risk of exposure to infectious diseases
due to the design of such needles, which makes them difficult to
handle, as well as due to the repeated use of such needles.
[0008] In particular, bifurcated needles used to administer
vaccinations are not traditionally sterilized or packaged in a
single-use container that would enable convenient storage and
subsequent use. Additionally, such needles have traditionally been
difficult to handle in that they typically do not include a hub
attached to the opposite end of a needle from the tip, and do not
typically include any sort of shield for protection from the needle
prior to and during use.
[0009] For example, U.S. Pat. No. 3,194,237 to Rubin discloses a
vaccinating needle having a main shank with a pair of prongs at one
end that define a slot of predetermined length, width and depth
therebetween to hold an amount of liquid by capillary action. The
shank of the needle is of sufficient length so that the non-prong
end will function as a handle. U.S. Pat. No. 3,948,261 to Steiner
discloses a reusable unit dose container for vaccines contained
within a rigid receptacle, with a compressible closure for
supporting a bifurcated needle bearing dried vaccine. The closure
is adapted to support the needle in the container during a
lyophilizing process while liquid vaccine is dried on the needle.
The closure has grooves which permit the vaporized liquid from the
vaccine to be withdrawn from the receptacle during lyophilizing,
and can further seal the container.
[0010] There exists a need for a safety assembly for use with a
unit dose vaccination needle that is easily manufactured, that is
simple to use, that is easily sterilized and maintained in a
sterile condition until used, that can be safely disposed of, and
that does not interfere with normal practices of bifurcated needle
use.
SUMMARY OF THE INVENTION
[0011] The present invention is directed a shielded, sterile,
single-use needle assembly for administering a unit dose of a
vaccine. The assembly includes a unit dose needle with a hub and a
packaging shield. The unit dose needle has a prong end configured
to hold a unit dose of a vaccine and a handle end. The hub is
fixedly attached to the handle end of the unit dose needle and
includes a tapered mating surface. The packaging shield includes a
tubular housing having an open end and a closed end with an
internal opening extending therebetween. The open end of the
packaging shield can be removably attached to the tapered mating
surface of the hub to form an air-tight seal, with the unit dose
needle contained within the internal opening. Desirably, the hub
includes means for attaching the assembly to a medical device, such
as a standard needle cover.
[0012] The present invention is further directed to a method of
packaging the present single-use unit dose needle assembly. The
packaging method includes providing a sheet of top web material,
providing a sheet of bottom web material, and providing a plurality
of the present single-use unit dose needle assemblies. The top web
material includes a plurality of rows, each row including a
plurality of covers for a blister pack, each cover including a
perimeter area. The bottom web material includes a plurality of
rows, each row including a plurality of bottoms for a blister pack,
each bottom including a perimeter area and a pocket. The single-use
unit dose needle assemblies are placed in each of the pockets in
the bottom web material, which are then sealed joining the
perimeter areas in the top web material to the perimeter areas in
the bottom web material to form a plurality of sealed single-use
unit dose needle assembly packages.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of a shielded, sterile
single-use needle assembly of the present invention;
[0014] FIG. 2 is a side cross section view of the needle assembly
shown in FIG. 1;
[0015] FIG. 3 is an exploded perspective view of the needle
assembly of FIG. 1;
[0016] FIG. 4 is a perspective view of a needle assembly in
accordance with an alternate embodiment of the present
invention;
[0017] FIG. 5 is an exploded perspective view of a packaged needle
assembly of the present invention;
[0018] FIG. 6 is an exploded perspective view demonstrating
packaging of the packaged needle assembly of the present
invention;
[0019] FIG. 7 is an exploded perspective view of the needle
assembly of the present invention packaged in a plurality of strips
of blister packages and a carton;
[0020] FIG. 8 is a perspective view of a plurality of cartons and a
case as packaged;
[0021] FIG. 9 is a perspective view of a sealed case;
[0022] FIG. 10 is a perspective view of a plurality of cases shrink
wrapped on a pallet; and
[0023] FIG. 11 is a perspective view of two stacked shrink wrapped
pallets of cases.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] In the following description and accompanying drawings, like
reference numbers, as used in the various figures, refer to like
features or elements. The terms top and bottom, as used herein,
refer to the orientation of a given element as shown in the
drawings.
[0025] Referring to the drawings in which like reference characters
refer to like parts throughout the several views thereof, FIGS. 1-3
depict a shielded, sterile, single-use unit dose needle assembly 10
in accordance with the present invention and the related features.
The unit dose needle assembly 10 is intended for use for the
administration of vaccines applied to or through the skin of the
patient, and is intended as a single-use vaccination needle
assembly including features to maintain sterility of the needle
during packaging and to provide ease of use for the medical
practitioner, as will be described in more detail herein.
[0026] The unit dose needle assembly 10 generally includes a unit
dose needle for administering a unit dose of a vaccine, such as
bifurcated needle 12, which is supported by a hub 22, and enclosed
within a needle shield 40. While unit dose needle assembly 10 is
described herein in terms of a preferred embodiment including
bifurcated needle 12, unit dose needle assembly 10 may include any
unit dose needle capable of administering a unit dose of a vaccine,
such as in a dry powder or liquid form, as is well known in the
art.
[0027] Bifurcated needle 12 includes a handle end or a non-patient
end at proximal end 14, and an opposed prong end or patient end at
distal end 16. Bifurcated needle 12 is provided with two sharp
prongs 18 positioned at a distal end 16 of the needle. The prongs
18 are separated by a U-shaped channel 20 configured to hold a unit
dose of vaccine. The prongs 18 are intended to penetrate or abrade
the skin of the patient to administer the vaccine disposed in the
U-shaped channel 20. Bifurcated needle 12 may be constructed of any
material known in the art, such as metal or plastic, and is
desirably constructed of a medical grade surgical steel.
[0028] Hub 22 is fixedly attached to the proximal end 14 of
bifurcated needle 12, such as through an adhesive joint 24.
Adhesive joint 24 may be provided through any adhesive capable of
fixedly attaching or adhering bifurcated needle 12 to hub 22, such
as an epoxy or equivalent adhesive. Hub 22 includes a hub housing
26 including a proximal end 28 and a distal end 30, with the
external surface of hub housing 26 defining an outer tapered
surface 32 extending therealong. Desirably, distal end 30 of hub 22
includes an internal bore having an internal diameter of
approximately the same size as the outer diameter of the proximal
end 14 of bifurcated needle 12, for accommodating and fixedly
adhering bifurcated needle 12 within such an internal bore of hub
22.
[0029] The hub 22 may further include means for attachment with a
medical device, such as luer lugs 34 extending at the proximal end
thereof, with an internal luer taper 36 which extends internally
within a portion of hub housing 26. Internal luer taper 36 and luer
lugs 34 are designed to engage a medical device, such as a
hypodermic syringe or a standard needle holder, for particularly
desired uses of the unit dose needle assembly. Such attached
medical devices can act as a handle portion for the assembly,
thereby facilitating ease of use of the assembly. In addition, such
means for attachment may accommodate attachment of a safety shield
which can be used to shield the needle after use thereof. Threads
(not shown) may further be provided within internal luer taper 36,
for establishing threaded engagement with a corresponding threaded
surface of a medical device.
[0030] Unit dose needle assembly 10 further includes a needle
shield 40 extending about bifurcated needle 12. Needle shield 40 is
of a generally tubular hollow construction, including tubular
shield housing 42 extending between a proximal end 44 and a distal
end 46, with the tubular shape of shield housing 42 forming an
internal opening 48 extending through needle shield 40. Proximal
end 44 of needle shield 40 is generally open ended, forming a
passage for access to internal opening 48, while distal end 46 is
closed ended, forming a wall. Needle shield 40 extends about
bifurcated needle 12, thereby containing bifurcated needle 12
within internal opening 48. Proximal end 44 may further be provided
with a lip extending circumferentially about the open ended
passage. Proximal end 44 removably engages the hub 22 along the
tapered surface 32 to form an air-tight seal, completely concealing
the bifurcated needle 12 and associated prongs 18 therein in a
sterile, air-tight manner.
[0031] The needle shield 40 serves to protect the bifurcated needle
12 from damage and exposure to soils or other contaminants during
shipping and storage, and prior to use of the unit dose needle
assembly. The needle shield 40 also provides protection to
personnel from needle sticks prior to removing the needle shield 40
for use.
[0032] The hub 22 and needle shield 40 may be constructed of any
material, and are desirably constructed of a moldable plastic
material. Suitable moldable plastics include, but are not limited
to polyethylenes, polypropylenes, polyamides, polyesters and
fluorinated polyethylenes. Preferably, hub 22 is constructed of a
rigid material, while needle shield 40 may be formed from a
non-rigid material. By non-rigid material, what is meant is a
material that is sufficiently flexible to conform to the tapered
surface 32 of the hub 22 to form an air-tight seal. While needle
shield 40 may be desirably formed from polypropylene, any material
known by those of skill in the art to facilitate sterilization of
the unit dose needle 10 may also be used. Needle shield 40 may
further include external ribs 50 integrally molded with shield
housing 42 and extending longitudinally along the outer surface of
shield housing 42 between proximal end 44 and distal end 46. Such
external ribs 50 provide further structural integrity to needle
shield 40, which is particularly useful during packaging and
storage.
[0033] FIG. 4 depicts a further embodiment of the present
invention, in which the hub may also include a profile for
accommodating a user's fingers. FIG. 4 includes many components
which are substantially identical to the components of FIGS. 1-3.
Accordingly, similar components are numbered identically to those
of FIGS. 1-3, except that a suffix "a" will be used to identify
those components in FIG. 4.
[0034] As shown in FIG. 4, hub 22a may include a profile for
accommodating a user's fingers, such as arcuate surface 38a which
extends circumferentially about hub 22a. Such a profile extends
from the proximal end 28 of hub 22, thereby providing ease of use
with a user's fingers, and providing a significant surface for a
user to grasp during removal of needle shield 40 for exposure of
the bifurcated needle 12, as well as during use of bifurcated
needle 12 during administration of the vaccine.
[0035] The vaccine may be in any suitable physical form. Suitable
physical forms for the vaccine include, but are not limited to
liquids, such as solutions, emulsions, and dispersions, or dry
powders. Typically, the vaccine will be in a liquid form. Moreover,
the vaccine is desirably associated with unit dose needle assembly
10 during storage, and may therefore be contained within the
U-shaped channel 20 prior to removal of needle shield 40.
Alternatively, the vaccine may be provided as a separate component,
with bifurcated needle 12 being contacted with the vaccine after
removing needle shield 40 therefrom just prior to use of the needle
for administration of the vaccine.
[0036] As noted, needle shield 40 sealingly mates with hub 22 to
provide an airtight connection therebetween, with bifurcated needle
12 contained within the air-tight environment in internal opening
48 of needle shield 40. Such an air-tight arrangement provides unit
dose needle assembly 10 as a self-contained assembly, in the form
of a complete, shielded, sterile, single-use unit dose needle
assembly, which can be shipped in this form. Alternatively, this
unit dose needle assembly 10 may be further packaged to provide
additional sterility to the assembly.
[0037] For example, referring to FIG. 5, a packaged needle assembly
52 is shown. In the packaged assembly 52, a blister-type package
including a top web 54 having a perimeter edge 56 and a bottom web
58 having a perimeter edge 60 and a pocket 62 suitable for
receiving the unit dose needle assembly 10 therein. The perimeter
edge 56 of the top web 54 and the perimeter edge 60 of the bottom
web 58 are sealed together along their respective lengths. Thus,
the unit dose needle assembly 10 may be sealed between the top web
54 and the bottom web 58 to provide further sterility to the unit
dose needle assembly 10. In this manner, a blister-type packaged
assembly 52 conceals the unit dose needle assembly 10 in a sterile
environment. The bottom web 58 may include an embossing area 64
capable of receiving printed images such as lot numbers or other
identifying information. The top web 54 and the bottom web 58 may
comprise any suitable material. Suitable materials include, but are
not limited to paper and polymer films, and combinations
thereof.
[0038] Packaging of unit dose needle assembly 10 within packaged
assembly 52 may be accomplished through any known packaging
technique. For example, as shown in FIG. 6, packaging of the unit
dose needle assembly 10 may include providing a sheet of top web
material 66, where the top web material 66 includes a plurality of
rows 68, each row including a plurality of individual units forming
individual covers in the form of top web 54 of packaged assembly
52. Each of the covers of top web 54 includes a perimeter edge 56.
A roll of bottom web material 70 is further provided, where the
bottom web material 70 includes a plurality of rows, each row
including a plurality of bottom webs 58 for the blister pack of
packaged assembly 52. Each of the bottom webs 58 includes a
perimeter edge 60 and a pocket 62. The pocket 62 is adapted to
receive the unit dose needle assembly 10.
[0039] The top web 54 is formed from a roll of top material 66 in a
sectionalized fashion. Likewise, the bottom web 58 may be formed
from a roll of bottom material 70 in a similar manner. During
production, one unit dose needle assembly 10 is inserted into each
pocket 62 and the rolls of material 66, 70 are mated so that a
plurality of assemblies 52 may be interconnected between the rolls
of material 66, 70. The perimeter edges 56 in the top web material
54 are sealed to the perimeter edges 60 in the bottom web material
58 to form a plurality of sealed packaged assemblies 52.
[0040] Turning to FIGS. 7-11, a plurality of the blister packaged
assemblies 52 may be removed from the interconnected rolls so that
a strip 72 comprising a row of packaged assemblies 52 may be
packaged in a carton 80 to provide a packaged carton 82. Strips 72
of packaged assemblies 52 may optionally be perforated so that a
single blister package 60 may be removed from the strip 72 when
needed for use. A plurality of strips 72 may be placed in a single
carton 80 for shipment to an end use destination. A plurality of
packaged cartons 80 may be placed in a case 84 (FIG. 8) that may be
taped and labeled for shipping (FIG. 9). A plurality of shipping
cases 84 may be secured to a pallet 88, as shown in FIG. 10.
Stretch wrap 90 or an equivalent may be wrapped around the
plurality of shipping cases 84 on pallet 88 for further
sterilization and shipment.
[0041] A plurality of pallets 88 may be stacked upon each other for
shipment in bulk as shown in FIG. 11. Each pallet 88 preferably is
separated by a slip sheet 92 to prevent the pallets 88 from sliding
upon one another during shipment.
[0042] While the present invention is satisfied by embodiments in
many different forms, there is shown in the drawings and described
herein in detail, the preferred embodiments of the invention, with
the understanding that the present disclosure is to be considered
as exemplary of the principles of the invention and is not intended
to limit the invention to the embodiments illustrated. Various
other embodiments will be apparent to and readily made by those
skilled in the art without departing from the scope and spirit of
the invention. The scope of the invention will be measured by the
appended claims and their equivalents.
* * * * *