U.S. patent application number 10/419422 was filed with the patent office on 2004-10-21 for safety shield needle protector.
Invention is credited to Paradis, Joseph R..
Application Number | 20040206416 10/419422 |
Document ID | / |
Family ID | 33159303 |
Filed Date | 2004-10-21 |
United States Patent
Application |
20040206416 |
Kind Code |
A1 |
Paradis, Joseph R. |
October 21, 2004 |
Safety shield needle protector
Abstract
Method and apparatus for needle protection provided by a
container having opposed ends, with one end permitting the
container to be positioned on a receptacle, and the opposite end
for the attachment of a fillable member. A needle is positioned
within the container, which can be tubular, between the opposed
ends. The attachment of a fillable member can be by the attachment
of an empty syringe, and the container can be positioned on a
receptacle for attaching a serum vial. A needle removably extends
within the container near the end where the receptacle is
attachable. The empty syringe is removably connected to the needle
within the container, and is used to withdraw serum from the vial.
After the filled syringe is withdrawn, the serum is dispensed, and
the empty syringe, with the needle is returned to the container,
which is disposed of.
Inventors: |
Paradis, Joseph R.; (Hilton
Head Island, SC) |
Correspondence
Address: |
George E. Kersey
P.O. Box 1073
Framingham
MA
01701
US
|
Family ID: |
33159303 |
Appl. No.: |
10/419422 |
Filed: |
April 21, 2003 |
Current U.S.
Class: |
141/2 ; 141/27;
141/329 |
Current CPC
Class: |
A61J 1/2055 20150501;
A61J 1/201 20150501; A61J 1/2096 20130101 |
Class at
Publication: |
141/002 ;
141/329; 141/027 |
International
Class: |
B65B 001/04 |
Claims
1. A safety shield comprising: a container having opposed ends;
means at one end for permitting said container to be positioned on
a receptacle; means at the opposite end of said container for the
attachment of a fillable container; and a needle positioned within
said container between said opposed ends.
2. A safety shield as defined in claim 1 wherein said container is
tubular.
3. A safety shield as defined in claim 1 wherein said means for the
attachment of a fillable container comprises means for attaching an
empty syringe thereto.
4. A safety shield as defined in claim 1 wherein said means for
permitting said container to be positioned on a receptacle
comprises means for attaching a serum vial to said container.
5. A safety shield as defined in claim 1 wherein said needle
extends within said container near the end where said receptacle is
attachable.
6. A safety shield as defined in claim 1 wherein said needle is
removably connectable to said end where a fillable container is
attachable.
7. A safety shield as defined in claim 4 wherein said serum vial
has a tamper-evident cap which is removed and discarded before said
vial is attached to said container and is penetrated by said
needle.
8. A safety shield as defined in claim 3 wherein said empty syringe
is removably connected to said needle within said container.
9. A safety shield as defined in claim 3 wherein said empty syringe
is returnably connectable with said needle into said container
after removal therefrom; thereby to prevent exposure to said needle
after the use thereof.
10. A safety shield as defined in claim 1 wherein said container
including said needle is placed in sealed package before being used
to attach a vial at one end and a syringe at the opposite end.
11. A method of providing a safety shield for a needle comprising
the steps of: (a) positioning a needle within a container having
opposed ends; (b) providing means at one end of said container for
permitting it to be positioned on a receptacle; and (c) providing
means at the opposite end of said container for the attachment of a
fillable container.
12. The method as defined in claim 11 further including the step of
providing said container as a tubular member.
13. The method as defined in claim 12 further including the step of
providing means for the attachment of a fillable container to said
tubular member.
14. The method as defined in claim 12, further including the step
of providing means for the attachment of an empty syringe to said
tubular member.
15. A method of employing a safety shield to protect users of
medications dispensable by needles comprising the steps of (a)
positioning an empty syringe at one end of a tubular member
containing a needle; and (b) positioning a serum vial at another
end of said tubular member.
16. The method as defined in claim 15 further including the step of
depressing said serum vial into said tubular member until said vial
is penetrated by said needle.
17. The method as defined in claim 16 further including the step of
withdrawing serum from said vial by said syringe.
18. The method as defined in claim 17 further including the step of
withdrawing said syringe with said needle attached from said
tubular member.
19. The method as defined in claim 18 further including the step of
repositioning said needle in said tubular member thereby to protect
users of said needle from injury therefrom.
20. The method as defined in claim 15 further including the step of
sealing said tubular member with said needle therein in a sterile
package.
Description
DETAILED DESCRIPTION
[0001] This invention relates to a safety shield for protecting
users of medical needles in performing medical procedures, such as
the injection of a serum by a syringe into a patient.
BACKGROUND OF THE INVENTION
[0002] Because of the presence of highly infectious diseases,
syringes, scalpels and other sharp devices have caused numerous
injuries to the medical personnel. Many states have enacted
legislation seeking to protect medical personnel from "needle
stick" injuries.
[0003] Unfortunately, many of the devices and protective techniques
that have been proposed are not only complicated and expensive, but
have not been able to provide the desired degree of protection.
[0004] For example, in the use of a syringe with a needle, a
practitioner, unsheathes the needle, inserts into a vial of
medication, removes the syringe and inserts the needles into a
patient. After the needle has been unsheathed, before being
inserted, it presents a hazard to the user. Typically, two hands
are used to prepare a patient for an injection. One hand is used to
clean the area to be injected, while the other hand is used to
inject the needle into tissue. After removing the needle from the
patient, the nurse must press the site of injection and hold a
syringe in place with the other hand. A needle stick safety syringe
includes a outer tubular protective cover or sleeve for the inner
syringe body where a concentric coil spring is compressed against
the normal flange of the inner syringe body and retained there by a
stop which is cantilevered from a collar affixed to the distal end
of the inner syringe body. This cantilevered stop also includes a
convenient button which may be easily depressed by a finger of one
hand holding the outer tubular body to allow the sleeve to be slid
over the needle under the bias of the spring. The cantilevered
button and stop rides in a groove in the inner diameter of the
tubular outer protective body and is captured by a slot which
effectively prevents reuse, which is a very cumbersome releasable
retaining device to retract the needle syringe where it will not
cause harm.
[0005] Accordingly, it is the principal object of the invention to
provide a non-cumbersome, releasable retaining device for needle
syringes to avoid harm to the user.
[0006] In U.S. Pat. No. 6,322,540 issued Nov. 27, 2001 to Grabis,
et al. for "Safe-Shield Needle Protector" a needle stick safety
syringe includes a outer tubular protective cover or sleeve for the
inner syringe body where a concentric coil spring is compressed
against the normal flange of the inner syringe body and retained by
a stop which is cantilevered from a collar affixed to the distal
end of the inner syringe body. This cantilevered stop also includes
a button which may be depressed by a finger of one hand holding the
outer tubular body to allow the sleeve to be slid over the needle
under the bias of the spring. The cantilevered button and stop
rides in a groove in the inner diameter of the tubular outer
protective body and is captured by a slot to prevent reuse.
[0007] The invention avoids the complexity of this kind of
device.
[0008] In U.S. Pat. Nos. 6,146,362 and 5,833,674, issued to
Turnbull, et al., Nov. 14, 2000 and Nov. 10, 1998, for "Needleless
IV Medical Delivery System", an injection site and drug transfer
spike are used for facilitating coupling a syringe to a fluid line.
The injection site has a housing and septum comprised of two parts.
The drug transfer spike has a positive locking member for
restricting retraction from the injection site once it is inserted
for injecting a medicament. The positive locking member preferably
comprises an annular ridge defined about the shaft of the drug
transfer spike. The septum includes a pair of axially aligned,
oppositely oriented conical recesses with adjacent apices either
separated by a thin membrane or intersecting at the time of
manufacture. The housing has an inlet for receiving the septum and
comprises a plurality of fingers with inwardly extending tabs for
constraining the septum therewithin. The septum is ideally adapted
to be applied to injection sites, Y-connectors, vial adaptors,
single or multi-dose vials and blood collection tubes. When the
drug transfer spike is made to penetrate the septum, the walls of
the septum or the inwardly extending tabs tightly engage the shaft
of the spike to preclude inadvertent withdrawal. The invention
avoids the complexity of this kind of device.
[0009] In U.S. Pat. No. 5,899,886, issued to Cosme, May 4, 1999,
for "Puncture Safe Needle Assembly", a needle sleeve encloses a
needle holder and is manually extendable and retractable in a
telescopic manner to enclose or expose respectively the distal
sharp portion of a needle without the aid of a spring or
spring-like device. An interlocking member that clamps or slips
into the needle holder locks or releases the needle sleeve from the
needle holder. In this assembly, the needle is attached to a
protruding body to prevent movement of the needle during use. At
the proximal end of the needle assembly is a connector for
communicating the needle assembly to a hypodermic syringe or other
fluid delivery device.
[0010] In U.S. Pat. No. 5,685,860, issued to Chang, et al., Nov.
11, 1997, for, "Self-Capping Needle Assembly", the self-capping
needle assembly is used in combination with skin puncture apparatus
and contains a pleated sleeve made from any natural or synthetic
fiber material. The fiber materials employed as the pleated sleeve
may be treated with a suitable agent that provides the fiber
material with a hydrophobic coating and prevents fluids such as
blood from seeping therefrom.
[0011] In U.S. Pat. No. 5,658,259, issued to Pearson, et al., Aug.
19, 1997, for "Dental Cartridge Assembly Auto-Injector With
Protective Needle Cover", an injection device includes a generally
tubular outer body and a medicament cartridge assembly carried
within the outer body. The cartridge assembly includes a glass
container, a charge medicament disposed within the glass container,
iii) a plunger member rearwardly confining the medicament, and iv)
seal for sealing the forward portion of the glass container. A
needle has a rearward end disposed proximate the seal, with the
seal and needle being movable with respect to one another. A rigid
needle cover member is maintained in an inoperative position and is
movable relative to the tubular body to a protective position
wherein the needle cover member extends forwardly to cover the
forward end of the needle. A releasable spring responds to a
predetermined actuating procedure to drive a collet member
forwardly within the outer body and enable i) the cartridge
assembly to move relative to the needle so that the rearward end of
the needle pierces the seal to establish communication with the
medicament, ii) the needle to move with respect to the body so that
the needle projects outwardly from the forward end of the body, and
iii) the needle cover to move relative to the body from the
inoperative position to the protective position so that the needle
cover member extends beyond the forward end of the needle.
[0012] In U.S. Pat. No. 5,601,536, issued to Crawford, et al., Feb.
11, 1997, for "Needle Tip Cover", there is a cover with a needle
having an elongate shank and a tip with a sharpened point. The
cover is coaxially associated with the elongate shank for movement
therealong toward the tip and includes a part for extending beyond
the sharpened point when the cover is positioned near the tip. A
lock associated with the needle and cover cooperates with and holds
the cover to prevent axial movement relative to the needle tip
after positioning the cover near the tip. A retaining member on the
adapter, and on the cover, releasably attach the cover and adapter,
while on the elongate shank of the needle, allowing the needle and
cover to be disengaged from the catheter and adapter after
placement.
[0013] In U.S. Pat. No. 5,591,138, issued to Vaillancourt, et al.,
Jan. 7, 1997, for "Protected Needle Assembly", a V-shaped slot is
provided at the rear of a guide slot so that a retractable sheath
can be locked in a retracted position. In another embodiment, a cam
surface at the front of the guide slot directs the projection on
the sheath into a position to lock the sheath in an extended
position. An additional inclined guide portion may be provided at
the forward end of the guide slot for intramuscular injection use.
The movable sheath may also be mounted on a syringe without need
for a resilient bias or may incorporate a coiled spring or rubber
strip to bias the sheath into an extended position.
[0014] In U.S. Pat. No. 5,472,430, issued to Vaillancourt, et al.,
Dec. 5, 1995, for "Protected Needle Assembly", a retractable sheath
can be moved from an unextended protected position over a hollow
needle to a retracted position exposing the hollow needle. A
projection carried on the sheath is disposed in a guide slot having
a circumferentially directed portion for receiving the projection.
In addition, a spring or resilient sleeve is provided between the
movable sheath and the housing to bias the sheath longitudinally of
the hollow needle and also circumferentially. In order to release
the sheath, the needle assembly is brought into contact with a
patient's skin or a septum and twisted. Thereafter, an axial force
on the needle assembly causes the sheath to be retracted while the
hollow needle penetrates through the skin or septum. Other
embodiments are provided wherein a blunt needle can be moved within
a hollow needle from an extended position protecting the hollow
needle and a retracted position permitting exposure of the hollow
needle.
[0015] In U.S. Pat. No. 5,462,533, issued to Daugherty, Oct. 31,
1995, for "Self-Contained Needle And Shield", a surgical needle is
made up of two concentric tubes. The inner tube has a sharp tip
like a conventional hypodermic or intravenous needle. The inner
tube can be retracted into the outer tube after use. In one
embodiment, the needle forms part of a catheter assembly. A
catheter is mounted coaxially around the both tubes. The inner tube
has a latching member attached to the end without the sharp tip.
The latching member engages detents on a housing to hold the sharp
tip in an extended position or a retracted position. The latching
member is provided with a porous plug to assist in venting gases
during catheter introduction.
[0016] In U.S. Pat. Nos. 5,312,366 and 5,290,254, issued to
Vaillancourt, May 17, 1994 and Mar. 1, 1994, for "Shielded Needle
Assembly", a tubular shield of latex rubber is mounted over the
needle of the assembly. The shield includes a resilient collapsible
tubular portion which is able to collapse in an accordion-like
manner when a longitudinal force is imposed. The shield also has a
cap at the distal end which seals off a chamber in which the needle
is contained in a sterile manner. The cap includes a transverse
wall which may be pierced by the needle when the needle is passed
into a vial of medication or into a connector of an administration
set.
[0017] In U.S. Pat. No. 4,982,842, issued to Hollister, Jan. 8,
1991, for "Safety Needle Container", a safety adapter is usable
with different types of needles and syringes, with integral first
and second sections and a housing flexibly connected to one of the
sections. The first section is adaptable to be mated with the hub
of a needle assembly, with the housing flexibly connected thereto
by way of a living hinge. The needle assembly is threadedly mated
with an internally threaded annular collar surrounding a protrusion
which is coupled to the hub of the needle assembly. The second
section of the safety adapter includes a female luer that is
adaptable to be mated with different types of syringes, such as a
luer slip syringe or a luer lock syringe. Once the needle assembly
has been threadedly mated to the first section of the safety
adapter, to ensure that the needle of the needle assembly is not
exposed so as to preclude accidental pricking by the needle, the
housing is pivoted to a position where it completely envelops the
needle. One integral retainer mechanism in the housing prevents
relative movement between the needle and the housing once the
housing has been pivoted to envelop the needle. The dead space
volume at the junction where the needle is connected to the syringe
can be reduced by an embodiment of the safety adapter which
includes a male extension within the female luer.
[0018] In U.S. Pat. No. 4,892,525, issued to Hermann, Jr., et al.,
Jan. 9, 1990, for "Hypodermic Needle Protective Barrel and Cap
Packaging", improvements are made in conventional protection barrel
and cap packagings for hypodermic needles by a structural guard
that encourages a user's fingers to locate directly behind the
guard, and around the outer surface of an opening into the
protected barrel. A person inserting a needle into a barrel
automatically seeks to grasp the barrel proximate its open end, to
avoid yawing of the barrel during the manipulative process. A
laterally expanded barrel opening defines a transition ramp surface
into the barrel open end and towards the barrel closed end, even if
the needle insertion step included an initial lateral misalignment,
off the axial centerline of the barrel cap which extends the guard
protections of the barrel needle barrel protector, through a cap
which forms an extending boss from the exterior surface of the cap,
so that both needles will be guided away from accidental,
manipulative stabbing. A protective barrel and extended cap
packaging for enclosing a hypodermic needle and syringe assembly
also is provided, wherein a disposable axially extending housing
can be discarded, leaving a protective needle barrel when
reinserting only the barrel onto the needle.
[0019] In U.S. Pat. No. 4,838,863, issued to Allard, et el., Jun.
13, 1989, for "Safe Needle System for Collecting Fluidse", a
hypodermic syringe having a cylindrical outer body is adapted to
accept a smaller fluid storage vial within its inner walls. A
removable cap on one end of the cylinder provides access in order
to insert and remove the vial with a spring-loaded, double-headed
needle assembly integrated into the other end, and held in place by
a retainer until the storage has been punctured by one end of the
needle, the vial filled and removed and the needle assembly
retracted into the space vacated by the vial.
[0020] In U.S. Pat. No. 4,725,267, issued to Vaillancourt, Feb. 16,
1988, for "Post Injection Needle Sheath", the sheath encloses the
sharpened end of a needle used with a syringe, without spring
actuation. The sheath is initially in a compact and secured
condition on the needle hub and has a substantial portion exposed
for insertion into a patient or vial. Some embodiments employ a
compression spring, and other embodiments avoid a spring, but have
a corrugated portion and a flange that are manipulated by an
attendant to urge the sheath forward to enclose the sharpened end
of needle. In all embodiments, the forward end includes a
transverse wall with an aperture that is slightly larger than the
shank of the needle. Protection to the exposed needle before use is
provided by a conventional shield which is removed at time of use.
After withdrawal of the needle from the patient, the sheath, with
the cap or end portion, is moved forward to enclose the sharpened
needle.
[0021] In U.S. Pat. No. 4,592,744, issued to Jagger, et al., for
Jun. 3, 1986, "Self-Resheating Needle Assembly", a sheath has a
case with a small closed end and a large open end. A needle
assembly within the case has the needle projecting through the
small closed end. A hub is connected to the needle assembly inside
the case and a connector on the hub cooperates with a receiver in
the small end to hold the needle assembly in the case. A flange on
the hub cooperates with an inward projection in the case spaced
from the small end to prevent movement of the needle out of the
case when the needle is withdrawn from the opening in the small
end. The nozzle of a syringe pushed into the hub withdraws the
needle when the syringe is withdrawn. A rubber stopper on a vacuum
tube withdraws the needle after the rubber stopper turns the flange
to release the connector from the receiver.
[0022] In U.S. Pat. No. 4,240,427, issued to Akhavi, Dec. 23, 1980,
for "Needle With Protector", an intermitting rib structure on a
hypodermic needle and its protector have beveled ends to
rotationally shift the needle and protector into proper alignment
during high speed assembly.
[0023] In U.S. Pat. No. 3,934,722, issued to Goldberg, Jan. 27,
1976, for "Sterile Needle Package", a sterile needle package
includes a rigid cartridge supporting a hypodermic needle for
aseptic removal. After the cartridge is opened, the needle is
removed by tipping the cartridge body and spilling the
loosely-supported needle onto a sterile surface. When sealed within
the cartridge, the needle and its tip are protected against damage
and contamination despite the loose fit between the parts. The
cartridge includes a cover with an integral lever which is lifted
to pry the cover free of the body, without contaminating of either
the needle or the mouth of the cartridge, when removal of the
needle is desired.
[0024] In U.S. Pat. No. 3,306,290, issued to H. S. Weltman, Feb.
28, 1967, for "Automatically Retractable Needle Syringe",
hypodermic syringes of the type employed by dentists and physicians
for injecting drugs, and other fluids into body tissues employ
disposable capsules to inject a local anesthetic.
[0025] In U.S. Pat. No. 3,021,942, issued to Donald A. Hamilton,
Feb. 20, 1962, for "Needle Package", a container protects the
needle and can be used to put the needle on a syringe and to remove
it.
[0026] Accordingly, it is a further object of this invention to
provide an improved safety shield device for needle syringes which
device is an improvement over the foregoing prior art devices.
SUMMARY OF THE INVENTION
[0027] In accomplishing the foregoing and related objects, the
invention provides a safety shield formed by a container having
opposed ends, with means at one end for permitting the container to
be positioned on a receptacle, and means at the opposite end for
the attachment of a tillable container. A needle is positioned
within the container between the opposed ends.
[0028] In accordance with one aspect of the invention, the
container is tubular, and the means for attachment of a fillable
container is of an empty syringe. The means for permitting the
container to be positioned on a receptacle is by attaching a serum
vial to the container. A needle extends near the end of the
container where the receptacle is attachable, and needle is
removably connectable to the end where the fillable container is
attachable.
[0029] The serum vial may have a tamper-evident cap which is
removed and discarded before the vial is attached to the container
and penetrated by the needle. The empty syringe is removably
connected to the needle within the container. The empty syringe is
returnable connectable, with the needle, into the container to
prevent exposure to the needle after its use. The container,
including the needle, can be placed in a sealed package before
being used to attach a vial at one end, and a syringe at the
opposite end.
[0030] In a method of the invention for providing a safety shield
for a needle, steps include (a) positioning a needle within a
container having opposed ends; (o) providing means at one end of
the container for permitting it to be positioned on a receptacle,
and (c) providing means at the opposite end of the container for
the attachment of a fillable vial.
[0031] The method further includes the step of providing the
container as a tubular member, and the step providing means for the
attachment of a fillable container to the tubular member.
[0032] The method also includes the step of providing for the
attachment of an empty syringe to the tubular member.
[0033] A safety shield to protect users of medications dispensable
by needles includes the steps of (a) positioning an empty syringe
at one end of a tubular member containing a needle; and (b)
positioning a serum vial at another end of the tubular member.
[0034] The method further includes the step of depressing the serum
vial into the tubular member until the vial is penetrated by the
needle. The method also further includes the step of withdrawing
serum from the vial by the syringe. The step of withdrawing the
syringe from the tubular member with the needle attached.
[0035] A further step is repositioning the needle in the tubular
member to protect users of the needle from injury. Another step is
sealing the tubular member with the needle in a sterile
package.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] FIG. 1A is a diagram of a needle and protector cap in a
sterile package in accordance with the prior art.
[0037] FIG. 1B is diagram of the needle and protector cap removed
from the sterile package of FIG. 1A.
[0038] FIG. 1C is diagram of an empty syringe for use with the
needle removed from the sterile package of FIG. 1A.
[0039] FIG. 2A is a diagram of the needle and protector cap of FIG.
1B attached to an empty syringe in accordance with the prior
art.
[0040] FIG. 2B is a diagram showing the protector cap of FIG. 2A
removed for discard, exposing in FIG. 2C a sharp needle attached to
the empty syringe.
[0041] FIG. 3A is a serum vial with a tamper evident cap in
accordance with the prior art.
[0042] FIG. 3B is a diagram showing the serum vial of FIG. 3A with
its tamper-evident cap removed to expose the septum of the vial in
preparation for penetration by the needle of a syringe in FIG. 3C
after a disinfectant is used prior to the entrance of the
needle.
[0043] FIG. 4A is a diagram showing the penetration of the septum
vial of FIG. 3B, by the needle of the syringe of FIG. 3C, for
transfer of serum from the vial into the syringe.
[0044] FIG. 4B is a diagram showing the removed needle after
extraction of serum from the vial, which is discarded, and the
syringe with its exposed sharp needle is ready for patient
injection, following which the syringe with its exposed sharp
needle will be discarded, causing potential injury to the user by
virtue of the exposure of the sharp needle at the end of the
syringe.
[0045] FIG. 5A is a diagram of a needle and safety shield protector
of the invention in a sterile package.
[0046] FIG. 5B is diagram of the needle and safety shield protector
of the invention removed from the sterile package of FIG. 5A.
[0047] FIG. 5C is a diagram of an empty syringe for use with the
needle and safety shield protector of FIG. 5B.
[0048] FIG. 6A is a diagram of the needle and safety shield
protector of FIG. 5B attached to an empty syringe in accordance
with the invention.
[0049] FIG. 6B is a diagram showing the needle and safety shield
protector, with attached empty syringe positioned for receiving a
serum vial.
[0050] FIG. 6C is a diagram showing the serum vial inserted into
the safety shield protector of FIG. 6B.
[0051] FIG. 7A is a diagram showing the syringe of FIG. 6C removed
from its safety shield protector.
[0052] FIG. 7B is a diagram showing the syringe of FIG. 6C returned
to the safety shield protector after use with a patient and ready
for proper disposal.
[0053] FIG. 8A is a cross-sectional view of the needle cap
protector 20 of the invention with its needle removed.
[0054] FIG. 8B is a distal end view of the fill sectional needle
cap protector 20 of FIG. 8A
[0055] FIG. 8C is a proximal end view of the full sectional needle
cap protector 20 of FIG. 5A.
[0056] FIG. 9A is a cross-sectional view of the needle cap
protector 20 of the invention with an included needle, taken along
the lines A-A of FIG. 5B.
[0057] FIG. 9B is a partial cross-sectional view of a standard vial
for insertion into the needle cap protector 20 of FIG. 9A.
[0058] FIG. 9C is a partial view, partially in cross-section
showing a syringe for connection to the protected needle in the cap
protector of FIG. 9A.
[0059] FIG. 9D is a composite view showing the standard vial of
FIG. 9B and the syringe of FIG. 9C connected to the protector of
FIG. 10A.
[0060] FIG. 10A is a full scale drawing of the needle cap protector
20 of the invention.
[0061] FIG. 10B is an end view of the needle cap protector 20 of
FIG. 10A.
[0062] FIG. 10C is side view of the needle, partially in section,
removed from the needle cap protector 20 of FIG. 10A.
[0063] FIG. 11A is an enlarged view of the needle cap protector 20
of the invention with the needle removed.
[0064] FIG. 11B is an end view of the needle cap protector 20 of
FIG. 1I A taken along the lines B-B.
[0065] FIG. 11C is an end view of the needle cap protector 20 of
FIG. 11A taken along the lines C-C.
[0066] FIG. 12A is a sectional view of the needle cap protector 20
of FIG. 11A.
[0067] FIG. 12B is a full sectional view taken along the lines B-B
of FIG. 12A.
[0068] FIG. 12C is a full section view taken along the lines C-C of
FIG. 12A.
DETAILED DESCRIPTION
[0069] With reference to FIG. 1A, a sterile package 10, in
accordance with the prior art, contains a needle 11 and a protector
cap 12. Access to the needle 11, shown within its protector cap 12,
as pictured in FIG. 1B, is obtained by tearing the tab T of the
package 10, and removing the assemblage of FIG. 1B.
[0070] A typical, empty commercial syringe 13 of the "TB" type,
with a 3 cc capacity and a tubular body 14 is shown in FIG. 1C with
a plunger 15 that slides within the tubular body 14 and operates in
standard fashion. The empty syringe 13 is for use with the needle
11 that has been removed from the sterile package 10 of FIG.
1A.
[0071] The empty syringe 13 of FIG. 1C is attached to the needle 11
within the protector cap 12 in accordance with the prior art as
shown in FIG. 2A. In order to use the syringe 13, the protector cap
12 of FIG. 2B is removed for discard, exposing the sharp needle 11
attached to the empty syringe as shown in FIG. 2C. At this stage of
the procedure, the exposure of the sharp needle 11 exposes the user
to inadvertent needle sticks.
[0072] Once the protector cap 12 is removed, the empty syringe 13
can be used with a serum vial 16 of FIG. 3A, which has a tamper
evident cap 17, in accordance with the prior art.
[0073] In FIG. 3B, the serum vial 16 of FIG. 3A has its
tamper-evident cap 17 removed to expose the septum 18 of the vial
16 in preparation for penetration by the needle 11 of the syringe
13, shown in FIG. 3C, after a disinfectant is used on the septum 18
prior to the entrance of the needle 1I through the septum 18 into
the vial 16 to obtain access to the serum within the vial 16, as
illustrated in FIG. 4A.
[0074] In order to transfer serum into the syringe 13, the plunger
15 is extended, withdrawing serum into the syringe 13 in accordance
with extent to which the plunger 15 is extended.
[0075] After the serum is withdrawn from the vial 16, the syringe
13, now containing the serum transferred from the vial 16, is
withdrawn as shown in FIG. 4B, exposing the sharp needle 11, which
is ready for injection of the serum into a patient. After
extraction of serum from the vial 16, the vial is discarded. Once
again the act of discarding the vial 16 can result in inadvertent
needle sticks.
[0076] In order to eliminate the possibility of inadvertent needle
sticks at the time the syringe 13 is to be used to withdraw serum
from the vial 16, the invention provides a safety shield protector
20 containing a needle 11 within a sterile package 21 shown in FIG.
5A.
[0077] As shown in FIG. 5B, the needle 11 and safety shield
protector 20 of the invention have been removed from the sterile
package 21 of FIG. 5A, and the needle 11 and protector 20 are
attached to an empty syringe 13 shown in FIG. 5C, in standard
fashion.
[0078] In preparation for further usage of the assemblage of FIG.
6A, the tamper evident cap 17 of a serum vial 16, as shown in FIG.
3A is removed, and the vial 16 shown in FIG. 3B is positioned, as
shown in FIG. 6B, for placement within the safety shield protector
20.
[0079] After the serum vial 16 is inserted into the protector 20,
the needle 11 within the protector 20 penetrates the septum 18,
with the result shown in FIG. 6C. The contents of the serum vial 16
can then be extracted by withdrawing the plunger 15 of the syringe
13 and then removing the syringe 13 with the extended plunger 15,
as shown in FIG. 7A in preparation for injection of the serum into
a patient, following which the syringe 13 is returned to the safety
shield protector 20, as shown in FIG. 7B.
[0080] A further view of the safety shield protector 20' of the
invention, in section with its needle removed, is shown in FIG. 8A,
and a distal view of the full sectional protector 20' is shown in
FIG. 8B, while a proximal view is shown in FIG. BC. The protector
20' includes a plurality of flexible fingers 21 of which one finger
21-1 is shown in section, and another finger 21-2 is shown in full
in the interior of the protector 20'. Each of the fingers 21-1
through 21-3 includes a trapezoidal end 22 for gripping the collar
16-C of the vial 16, illustrated in FIG. 9B. In addition, the
fingers 21-1 through 21-3 include a recessed portion 23 for
engaging the collar 16-C of the vial 16 after it has passed the
trapezoidal ends 22. Extending from the proximal end 24 of the
protector 20', is an internal funnel 25 for housing a needle within
the protector 20'. The funnel 25 has an extended portion 25-E for
encircling that portion of the needle away from its sharpened end
to the hub position 25-H, where the hub of a needle is encircled
and gripped by fingers 26-1 through 264. The entry portion of the
funnel 25 extends conically to the hub 25-H to facilitate guidance
of a needle to within the protector 20'.
[0081] A cross-sectional view of the needle cap protector 20 of the
invention with an included needle 11, taken along the lines A-A of
FIG. 5B, is shown in FIG. 9A. A partial cross-sectional view of a
standard vial 16 for insertion into the safety shield protector 20
of FIG. 9A is shown in FIG. 9B, while FIG. 9C is a partial view,
partially in cross-section showing a syringe 13 for connection to
the needle in the safety shield protector 20 of FIG. 9A.
[0082] FIG. 9D is a composite view showing the standard vial 16 of
FIG. 9B, inserted into the distal end of the protector 20 after the
collar 16-C of the vial 16 has passed the trapezoidal ends 22 and
the collar 16-C has engaged the recesses 23 of the fingers 21-1
through 21-3, so that the sharpened end of the needle 11 has
penetrated the septum 18 of the vial 16 positioned within the
protector 20. In addition, as shown in FIG. 9D, the tip 13-T of the
syringe 13 has been inserted into the cylindrical opening 11-C of
FIG. 9A and the Luer threads 13-L have engaged the disk end 11-D of
the needle 111 by a threadable connection. After the syringe 13 has
been used to remove serum from the vial 16 in FIG. 9D, the syringe
13 with its attached needle 11, is withdrawn against the function
fit of the fingers 26-1 through 264 and the serum-loaded syringe 13
is ready for use with a patient following which the syringe 13 and
needle 11 are returned to the protector 20 of FIG. 9D, and the
syringe 13, the protector 20 with the used needle, as shown in FIG.
9D for disposal without any danger of a needle stick. The disposal
may be made with or without the empty serum vial 16 attached to the
protector 20.
[0083] Full scale drawings of the safety shield protector 20 of the
invention, and its component needle 11, partially in section, are
shown in FIGS. 10A through 10C.
[0084] FIG. 11A is an enlarged view of the safety shield protector
20 of the invention with the needle 11 removed. The safety shield
protector 20 has flexible tabs 21-1 through 21-3, of which one tab
21-3 is shown in FIG. 11A, for the purpose gripping the vial 16
when inserted into the distal end of the protector 20. The
remaining flexible tabs 21-1 and 21-3 are pictured in FIG. 1I B,
which is an end view of the safety shield protector 20 of FIG. 11A
taken along the fines B-B. The proximal end view of the safety
shield protector 20 of FIG. 11A taken along the lines C-C, is shown
in FIG. 11C.
[0085] In FIG. 12A, which is a sectional view of the safety shield
protector 20 of FIG. 11A, a housing 25 in the form of a funnel is
shown extending from the distal end where the needle 11 enters and
is held in position so that a syringe 13 can be attached.
[0086] A full sectional view taken along the lines B-B of FIG. 12A,
is shown in FIG. 12B, and a full section view taken along the lines
C-C of FIG. 12A, is shown in FIG. 12C
[0087] It will be understood that the foregoing description is
illustrative only and that adaptations and modifications may be
made without departing from the spirit and scope of the invention
as defined in the claims.
* * * * *