U.S. patent application number 10/862694 was filed with the patent office on 2004-12-09 for method and apparatus for sharps protection.
Invention is credited to Alcouloumre, Eric, Lenker, Jay Alan, Reedy, Richard E..
Application Number | 20040245134 10/862694 |
Document ID | / |
Family ID | 33493613 |
Filed Date | 2004-12-09 |
United States Patent
Application |
20040245134 |
Kind Code |
A1 |
Alcouloumre, Eric ; et
al. |
December 9, 2004 |
Method and apparatus for sharps protection
Abstract
Devices and methods are disclosed for protecting individuals
from the sharp ends of medical objects following use on a patient.
Such sharp objects include hypodermic needles, scalpel blades,
cannulae, trocars, and the like. The invention utilizes a
disposable protective cover for the used sharp. The protective
cover is designed to surround and embed the sharp in a permanent
cover that is blunt and will not permit further puncture or cutting
with the sharp. In an embodiment, the protective cover also absorbs
any fluids on or in the used sharp. A refillable or replaceable
dispenser dispenses the protective covers at points of use. A
disposable receptacle receives the used sharp embedded in the
protective cover. When the receptacle is full, the entire
receptacle may be discarded in a medical waste container.
Inventors: |
Alcouloumre, Eric; (Laguna
Beach, CA) ; Reedy, Richard E.; (Laguna Beach,
CA) ; Lenker, Jay Alan; (Laguna Beach, CA) |
Correspondence
Address: |
ERIC ALCOULOUMRE
2385 HILLVIEW DRIVE
LAGUNA BEACH
CA
92651
US
|
Family ID: |
33493613 |
Appl. No.: |
10/862694 |
Filed: |
June 7, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60477121 |
Jun 9, 2003 |
|
|
|
Current U.S.
Class: |
206/364 |
Current CPC
Class: |
A61B 17/06114 20130101;
A61B 50/362 20160201; A61B 2050/185 20160201; B65D 83/0847
20130101; A61B 50/3001 20160201; A61B 17/3217 20130101; B65D
83/0888 20130101 |
Class at
Publication: |
206/364 |
International
Class: |
B65D 083/10 |
Claims
What is claimed is:
1. An apparatus adapted for entrapment of medical sharps
comprising: a shell having an upper portion and a lower portion; an
expandable hinge connecting the upper portion to the lower portion;
and a first pad affixed to an inside surface of the lower portion,
the first pad comprising: a first adhesive layer; and a first
gap-filling deformable layer disposed between the first adhesive
layer and the inside surface of the lower portion; wherein a
medical sharp set on the first adhesive layer is trapped between
the upper portion and the lower portion when the shell is
closed.
2. The apparatus of claim 1 wherein the pad further comprises a
first absorbent layer disposed between the first adhesive layer and
the inside surface of the lower portion.
3. The apparatus of claim 2 wherein the first adhesive layer
comprises openings to allow fluid to pass to the first absorbent
layer.
4. The apparatus of claim 1 wherein the first pad further comprises
absorbent material.
5. The apparatus of claim 1 further comprising a cover strip over
the first adhesive layer.
6. The apparatus of claim 1 further comprising a second pad affixed
to an inside surface of the upper portion, the second pad
comprising a second adhesive layer.
7. The apparatus of claim 6 wherein the second pad further
comprises a second gap-filling deformable layer disposed between
the second adhesive layer and the inside surface of the upper
portion.
8. The apparatus of claim 7 wherein the second pad further
comprises a second absorbent layer disposed between the second
adhesive layer and the inside surface of the upper portion.
9. The apparatus of claim 6 further comprising a cover strip over
the first adhesive layer and the second adhesive layer, the cover
strip comprising a pull tab, wherein pulling the pull tab removes
the cover strip from the first adhesive layer and the second
adhesive layer.
10. The apparatus of claim 1 wherein the lower portion further
comprises a puncture resistant lip wherein the lip substantially
surrounds the inside surface of the lower portion.
11. The apparatus of claim 10 wherein the lip further comprises an
opening to permit a non-sharp portion of the medical sharp to
protrude out of the shell.
12. The apparatus of claim 1 further comprising a lock to maintain
closure of the shell.
13. The apparatus of claim 1 packaged in an aseptic package,
wherein the aseptic packaged apparatus is sterilized.
14. The apparatus of claim 13 wherein the aseptic package is a
double aseptic package.
15. The apparatus of claim 1 wherein the shell comprises a polymer
layer and a puncture resistant layer.
16. The apparatus of claim 1 wherein the expandable hinge allows
the upper portion to be parallel with the lower portion while the
medical sharp with a thickness between approximately 0.1 inch and
approximately 2 inches is embedded within the shell.
17. The apparatus of claim 1 wherein the expandable hinge is a
z-folded hinge.
18. A method of disposal for a used medical sharp, the method
comprising: providing an open disposable sharps containment device
at a point-of-use of a medical sharp; placing the medical sharp
onto the open disposable sharps containment device at the
point-of-use, wherein the medical sharp comprises a sharp portion
and a blunt portion; closing the open disposable sharps containment
device at the point-of-use, wherein the sharp portion of the
medical sharp is embedded within the closed disposable containment
device, and the blunt portion of the medical sharp protrudes from
the closed disposable sharps containment device; and transporting
the closed disposable sharps containment device including the
embedded medical sharp to a medical waste disposal container
remotely located from the point-of-use of the medical sharp.
19. The method of claim 18 further comprising preventing fluid
leakage from the closed disposable sharps containment device having
the embedded medical sharp.
20. The method of claim 18 further comprising locking the closed
containment device having the embedded medical sharp to prevent
re-opening of the closed disposable sharps containment device and
to prevent removal of the used medical sharp from the disposable
containment device.
21. An apparatus adapted for entrapment of medical sharps
comprising: a means for adhering a sharp portion of a used medical
sharp within a puncture resistant container; a means to fill gaps
between the sharp portion adhered within the puncture resistant
container and the puncture resistant container; a means to absorb
fluids from the used medical sharp to prevent fluid leakage from
the container; and a means to lock the puncture resistant container
containing the sharp portion of the used medical sharp in a closed
position to prevent re-opening of the closed puncture resistant
container, wherein the sharp portion of the used medical sharp is
embedded within the puncture resistant container and a blunt
portion of the used medical sharp protrudes from the container.
22. An apparatus adapted for entrapment of medical sharps at a
point-of-use comprising: a dispenser at a point-of-use of a medical
sharp, the dispenser containing a plurality of medical sharp
containment devices, wherein each medical sharp containment device
comprises: a bi-folded puncture resistant shell; and at least one
adhesive pad attached to the inside of the shell; wherein the
dispenser presents the medical sharp containment device to a user
for placement of a used medical sharp therein, and wherein the
dispenser presents a second medical sharp containment device only
upon removal of a first medical sharp containment device.
23. The apparatus of claim 22 wherein removal of the medical sharp
containment device from the dispenser closes the medical sharp
containment device and embeds the used medical sharp within the
medical sharp containment device.
24. The apparatus of claim 23 wherein closure of the medical sharp
containment device around the used medical sharp occurs without the
user touching the medical sharp containment device.
25. A pad for entrapment of a medical sharp comprising: an adhesive
layer; and a gap-filling deformable layer disposed below the
adhesive layer, wherein the gap-filling deformable layer
substantially deforms to a contour of a medical sharp to fill
substantially all gaps around the contour of the medical sharp when
the medical sharp is pressed into the adhesive layer.
26. The pad of claim 25 further comprising absorbent material
disposed below the adhesive layer.
27. The pad of claim 26 wherein the adhesive layer comprises
openings to permit fluids to flow to the absorbent material.
28. The pad of claim 25 further comprising a cover strip over the
adhesive layer.
29. The pad of claim 25 wherein the gap-filling deformable layer
comprises spun polyester.
30. The pad of claim 25 wherein the pad is affixed to a
puncture-resistant support such that the adhesive is disposed on
the side of the pad opposite the support.
Description
RELATED APPLICATIONS
[0001] This application claims priority benefit under 35 USC .sctn.
119(e) from U.S. Provisional Application No. 60/477,121, filed on
Jun. 9, 2003, entitled "METHOD AND APPARATUS FOR SHARPS
PROTECTION", the entirety of which is hereby incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] This invention relates to devices to protect individuals
from infectious disease spread due to puncture wounds made by
sharp, contaminated objects. More particularly, the invention
relates to a protective container for safely sequestering and
disposing of used medical sharps.
BACKGROUND OF THE INVENTION
[0003] Pathogenic microorganisms may be present in human blood,
body fluids or other infected materials and can cause infection and
disease in persons who are percutaneously or mucocutaneously
exposed. These pathogens include, but are not limited to, hepatitis
B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency
virus (HIV). In this context, contaminated blood, body fluids or
other infected materials means the presence or reasonably
anticipated presence of pathogenic microorganisms on the surface or
in a device.
[0004] A medical sharp is an object that can penetrate the skin and
includes devices such as, but not limited to, needles, scalpels,
tubes, wires, and other medical procedure objects, devices or
instruments. Accidental puncture with contaminated, sharp needles
or surgical instruments, referred to as medical sharps or sharps,
remains a significant risk to healthcare workers. All healthcare
workers, such as physicians, nurses, paramedics, emergency medical
technicians, ambulance staff, airmedics, airmedic staff
technicians, janitorial staff, office staff, and even patients and
their families, are potentially at risk from this dangerous
situation.
[0005] Typically, injuries resultant from accidental needle and
scalpel sticks occur after the instruments have been used. As a
result, healthcare workers are subject to serious diseases,
including but not limited to hepatitis B virus (HBV), hepatitis C
virus (HCV) and human immunodeficiency virus (HIV).
[0006] Most often, needle and scalpel punctures occur during the
handling of used sharp instrumentation prior to permanent disposal.
Healthcare workers can accidentally stick themselves or others in
the vicinity while carrying contaminated instruments to a centrally
located disposal container for used sharps. Often, needles
dangerously protrude from the designated container, often located
on a peripheral wall of a given room and often located behind
furniture, fixtures, and medical equipment. This increases the risk
of puncture to the healthcare worker placing the sharp in the
container, or emptying the used sharps container.
[0007] The true cost of the problem is difficult to measure. For
every "needlestick" exposure, the health care worker and source
patient, if known, is subjected to batteries of tests that are
repeated 3 to 4 times over the following year. If the risk is
determined to be substantial, in terms of exposure to known or
likely HIV, Hepatitis, or other pathogens, there may also be
medication costs involved. There are side effects to medications
administered for suspected disease transmission and the costs, both
societal and monetary, are significant for such treatments. If a
disease is actually transmitted by the event, the costs, both
personal and financial, are staggering, and the event can prove to
be career ending as well as adversely affecting the family and
social life of the healthcare worker. Disease transmission, in the
worst scenario, can be life ending for the exposed healthcare
worker. Bearers of these costs--both tangible and intangible,
include health care organizations, their insurers, governmental
agencies, the health care workers and their families, and society
as a whole.
[0008] Current solutions in the prior art include needle guards and
covers, retractable needles, scalpel protectors and needleless
connecting systems for intravenous solutions.
[0009] Although needle guards and covers, needles and needleless
systems address part of the solution to the problem, they do not
offer a universal solution that will manage the risks posed by
other types of medical sharps, including scalpel blades, trocars,
and the like.
[0010] The prior art includes protective devices for sharps. These
are intended to enclose and blunt the used sharp, which prevents
anyone from coming into contact with the contaminated sharp.
[0011] Current portable sharps containment devices accommodate
needles, but may not accommodate thick sharps, such as cannulae,
trocars, scalpels, hypodermic needles with an attached syringe
barrel, and the like. It is generally against hospital policy and
good medical practice to attempt to remove a sharp from its handle
or syringe barrel because of the risk of needlestick or skin
puncture and resultant contamination. Typically, sharps containment
devices comprise a soft enveloping material having inadequate
puncture resistance. In addition, current sharps containment
devices may leak contaminated bodily fluids from the used sharp.
Medical care facilities typically locate the sharps receptacle at a
peripheral location within an area or room, and not at the
point-of-use. There may be significant obstacles between the user
and the sharps receptacle, including patient gurneys, beds, or
examining tables; persons, such as patients, family members,
visitors, and other health care workers; medical equipment such as
IV poles and lines, monitors, wires, tubes, and other devices; or
other furniture, fixtures, and equipment. This again creates the
problem of the healthcare worker sticking a co-worker while moving
the contaminated sharp to the disposal receptacle.
[0012] A typical sharps collector and disposal device is
mailbox-style container with or without a pull-down opening
allowing access to the container. The user pulls the lid open,
deposits the used sharp, and releases lid, which swings shut, much
like mailing a letter. Mailbox-style containers without the
pull-down opening have a tortuous path that the sharp must traverse
to enter the container. The mailbox-style containers can be found
in a variety of sizes and uses, such as in-hospital room
containers, multi-purpose containers, mail-away containers, large
volume and pharmacy containers, specialized containers,
transportable containers, and the like.
[0013] A typical problem with mailbox-style receptacles is that
they are frequently overfilled with needles, such that the needles
stick out of the containment container. In addition, it may be
difficult to put certain types of sharps, such as butterfly
needles, needles attached to syringes, suture needles, trocars,
cannulae, and the like, into them. An overfilled mailbox-style
receptacle may result in healthcare workers becoming cut and
infected by an already disposed-of sharp when they try to insert a
new sharp into the receptacle and force their hand on the
protruding sharp object, or by the new sharp itself. An additional
risk of the mailbox-style receptacle includes the user being stuck
as the sharp is being placed into the unit due to the difficulty of
inserting the sharp into the tortuous pathway opening.
[0014] Not only are health care workers themselves at risk because
of inadequate or unsafe disposal systems, but there are significant
risks to housekeeping personnel within healthcare institutions and
even to the public, who may encounter an improperly disposed,
contaminated, unprotected, medical sharp device. Areas at risk
include in-patient hospitals, outpatient facilities, emergency or
ambulatory facilities, patient homes, offices, public restrooms,
physician's offices, nursing homes, laboratories, emergency medical
facilities, military facilities, helicopters, airplanes, airmedic
facilities, employer facilities, hospice care facilities, needle
dispensing facilities for heroin addicts and diabetics, and the
like. Unprotected contaminated medical sharps are occasionally
found in public areas such as public beaches, parks, and children's
play areas.
[0015] New devices, procedures, systems, and methods are needed for
guarding, dispensing, and collecting contaminated sharps to
minimize the risk of accidental wounding of healthcare workers and
others by infectious, sharp devices. Such devices and procedures
are particularly important in any medical setting including
in-hospital, pre-hospital, outpatient, military, and the emergency
department.
SUMMARY OF THE INVENTION
[0016] This invention relates to devices to minimize the risk of
infectious disease spread from one individual to another due to
puncture wounds made by sharp, contaminated objects.
[0017] An embodiment of the invention is a guard for sharps, or a
sharp guard. Another embodiment of the invention is an integrated
receiver and container assembly for point-of-use medical sharps
containment and disposal. In one embodiment, a solid sheet of
material is bi-folded to irreversibly, seal, blunt, sequester,
entrap, or render useless, medical sharps. The bi-folded sharp
guard structure includes optional tabs for grasping and removal
from storage as well as optional tabs that may be folded over and
adhered to further secure the entrapped medical sharp. The folding
tabs may further comprise incomplete labeling that becomes complete
when the tabs are folded over the sequestered sharp. The complete
labeling indicates the presence of an entrapped contaminated
medical sharp object. In an embodiment, the sharp guard is a single
use, disposable device, which is not intended to be reprocessed by
cleaning, disinfection, sterilization, or the like.
[0018] In an embodiment, the sharp guard can be used at the
point-of-use to protect or sequester sharp medical devices. The
sharp guard may be used for most of the sharps commonly encountered
in hospital, lab, ambulance, or office practice. These sharps
include scalpel blades, hypodermic needles with or without an
attached syringe barrel, trocars, cannulae, and the like. The sharp
guard includes protection of the healthcare worker from the moment
subsequent to use of a medical sharp on a patient until the point
where it is physically placed in the disposal receptacle.
Additionally, the sharp guard can be implemented economically using
techniques such as thermoforming, injection molding, die stamping,
and the like.
[0019] In one embodiment of the invention, an apparatus adapted for
entrapment of medical sharps comprises a shell having an upper
portion and a lower portion, an expandable hinge which connects the
upper portion to the lower portion, and a pad affixed to the inside
surface of the lower portion. The pad comprises an adhesive layer,
and a gap-filling deformable layer disposed between the adhesive
layer and the inside surface of the lower portion where a medical
sharp set on the adhesive layer is trapped between the upper
portion and the lower portion when the shell is closed.
[0020] In another embodiment, the apparatus adapted for entrapment
of medical sharps also comprises another pad affixed to the inside
surface of the upper portion. In another embodiment, a pad for
entrapment of a medical sharp comprises an adhesive layer; and a
gap-filling deformable layer disposed below the adhesive layer,
where the gap-filling deformable layer substantially deforms to the
contour of the medical sharp to fill substantially all gaps around
the contour of the medical sharp when the medical sharp is pressed
into the adhesive layer.
[0021] In another embodiment, a method of disposal for a used
medical sharp comprises providing an open disposable sharps
containment device at a point-of-use of a medical sharp, and
placing the medical sharp onto the sharps containment device at the
point-of-use, where the medical sharp comprises a sharp portion and
a blunt portion. The method further comprises closing the sharps
containment device at the point-of-use, where the sharp portion is
embedded within the containment device, and the blunt portion
protrudes from the closed containment device. The method further
comprises transporting the containment device including the
embedded medical sharp to a medical waste disposal container
remotely located from the point-of-use of the medical sharp.
[0022] In a further embodiment, an apparatus adapted for entrapment
of medical sharps comprises a dispenser at the point-of-use of the
medical sharp, where the dispenser contains a plurality of medical
sharp containment devices. Each medical sharp containment device
comprises a bi-folded puncture resistant shell; and at least one
adhesive pad attached to the inside of the shell. The dispenser
presents the medical sharp containment device to a user for
placement of a used medical sharp therein, and the dispenser
presents another medical sharp containment device only upon removal
of the first medical sharp containment device.
[0023] Another embodiment of the invention is a system comprising a
sharp guard, a distributed sharp guard dispenser for dispensing
unused sharp guards, and a sharp guard receptacle for receiving
sharp guards containing a sharp.
[0024] In an embodiment, a sharp guard can be obtained from one of
numerous dispensers affixed to walls or counter surfaces. The sharp
guard, in another embodiment, is obtained from a transportable kit
and is dispensed at the point of use. The dispensers work either
manually or automatically. The sharp guard is used to safely render
the sharp object unable to puncture another individual. Finally, in
an embodiment, the protected sharp and sharp guard are discarded
into a specially designed sharps receptacle. The sharp guard, in
another embodiment, is included in prepackaged sterile surgical,
suture, or procedure kits. Both the dispenser and the receptacle
include optional visual monitoring, through windows or other
indicators, so that the contents and fill level can be determined
easily. The receptacle further includes a closure or seal for final
disposal.
[0025] The sharp guard is comprised of a sheet or sheets of
material that are capable of embedding, entrapping, folding over,
sequestering, and otherwise rendering the sharp object harmless,
unusable, and blunt. The sharp guard is, in an embodiment, a sheet
of bi-folded material such as, but not limited to, cardboard,
polystyrene, foamed polymer, or the like, that is folded in half
over the sharp object and sealed permanently so that the sharp
object cannot be removed, exposed, or otherwise used. The sharp
guard includes, in an embodiment, tabs that close over the
bi-folded sheet and lock or adhere to complete the closure.
Labeling affixed to the surface of the sharp guard indicates when
the sharp guard is undeployed, and when it is in its deployed and
sealed state with biological waste entrapped therein.
[0026] In another embodiment, the sharp guard system comprises a
bi-folded sheet of protective material that is presented to the
medical caregiver by its dispenser. When one sharp guard is used
and removed from the dispenser, another sharp guard protective,
automatically or, is positioned for use in protecting another
sharp. The medical caregiver places the contaminated sharp against
the protective sheet of material and presses the sharp against the
fold. The dispenser causes the protective cover to fold over the
sharp under the influence of downward manual pressure and coercion
from side compression members on the dispenser. The protective
cover finally closes and irreversibly seals over the sharp. The
disabled sharp and its protective cover are removed from the
dispenser and placed in a receptacle. Another sharp protective
cover moves into place for ready to receive another sharp.
[0027] Materials for the protective cover for the sharp guard
include, but are not limited to, foamed polymers, cardboard,
polymer sheets, and the like. The internal surfaces of the sharp
protective cover are preferably fabricated from adhesive materials
that entrap and grab the sharp and cause the closed sharp
protective cover to remain sealed over the sharp. Active foaming
materials are also desirable so that the presence of the metal
sharp or any liquids causes a catalytic reaction that actively
foams the side of the protective cover toward the sharp and encases
the sharp in foam which seals to the other side of the bi-folded
protective cover or simply seals the sharp. In yet another
embodiment of the invention, the fold of the bi-folded protective
sheet comprises multiple creases to accommodate sharp devices of
various thicknesses. Such multiple creases may comprise, for
example, an accordion, "U", "Z", "V", or "W" shaped
configuration.
[0028] In a preferred embodiment, the same device is used for
dispensing and disposal of the Sharp Guard, and is easily, and
quickly replaced when empty of new, unused product or full of used
product. A user has a visual indication that the receptacle is full
and that no additional sharps can be added to the receptacle. The
system is foolproof and clear even to an untrained user that no
additional sharps, even protected sharps, can be added. The
receptacle is designed so that users can easily tell when it is
full so they will not inadvertently cut themselves trying to stuff
an already full container with yet another sharp. In yet another
embodiment, the receptacle opening is rendered closed when it has
been loaded with enough protected sharps to fill it. The sharp
guard system is, preferably, a completely disposable system and is
an acceptable end-receptacle for medical sharps that can be placed
directly into the medical waste system without requiring an
intermediate sharps container as is required by most current
systems and devices. The protective covers are disposable, the
dispenser is disposable, and the receptacle is disposable. All
items are fabricated from materials that may be incinerated in the
medical waste system.
[0029] Both the dispenser and the receptacle are preferably
configured to permit access to a sharp guard with only one hand and
further, to dispose of a sharp guard and entrapped sharp with only
one hand. The one-handed functionality is preferably achieved by
opening the dispenser or receptacle with only one hand and then
placing the sharp guard within the receptacle with one hand only.
This one-handed functionality relies on dispenser and receptacle
opening systems that store energy and use the stored energy to open
the dispenser or receptacle lid using hand or finger pressure. If
the user prefers, two-handed operation is equally safe and
effective.
[0030] In yet another embodiment of the sharp guard system, a
healthcare provider may carry around a portable encapsulator. The
portable encapsulator may be hooked to the belt, placed in a
pocket, hung around the neck, etc., of the healthcare provider. The
portable encapsulator comprises an openable shell, a reservoir of
encapsulation material, an activation mechanism, and a hardening
system. In this embodiment, the lid of the shell is opened, the
sharp is placed into the shell and the lid is closed. Encapsulation
material flows around the sharp and into a pre-configured mold
area. The encapsulation material is then hardened to form a rigid
blunt barrier around the sharp. The encapsulation system comprises
material such as, but not limited to, ultra-violet (UV) curable
adhesives such as those made from polyurethane, two-part epoxies,
hardening foams, gels, and the like. The hardening system
comprises, for example, an ultraviolet light that activates
hardening of the UV curable adhesive. The key feature of this and
other embodiments is that the sharp guard is available at the
point-of-use.
[0031] Because the sharp guard is simple to use, there is minimal
training involved and very low risk of error that could cause
inadvertent injury. Its design makes it very difficult to use it
incorrectly, and its correct use minimizes the risk of injury to
healthcare workers. By product design, contaminated sharps are
directed away from potential contact with users until the sharp is
enclosed in the device. Once enclosed, accidental contact with the
sharp is virtually impossible during normal use and activity.
Hospital and healthcare workers can be trained and policies can be
set to ensure that all workers are fully aware of the procedures
necessary to make the sharp guard system functional. The
implementation cost of the sharp guard system is minimal and the
time to train is less than 30 minutes per trainee and, preferably,
less than 10-15 minutes per trainee.
[0032] The policy to use the sharp guard comprises making the
policy available on a proactive basis to all primary and ancillary
personnel involved with sharps. The policy emphasizes the need to
keep sharp guard systems near the point of use, including available
in or around the sterile or operative field. The policy further
requires that all sharps are encased or protected within a sharp
guard prior to placing them in a sharps receptacle, or directly
into the hospital medical waste system without an intermediate
sharps receptacle. The policy preferably comprises the step of not
moving your feet, as a sharps user, between when the sharp is used
and when it is encased or entrapped within a sharp guard. The
policy further requires that the medical sharp be encapsulated
prior to turning or rotating the body when a used medical sharp is
in a user's hand. Reinforcement of the policy will be an ongoing
effort. The policy further comprises steps to ensure that sharp
guard dispensers are maintained with unused sharp guards always
available and that sharp guard receptacles never become completely
full before they are emptied or disposed of. In addition, a label
is preferably provided on the receptacle that indicates that the
receptacle is for placement of sharp guard protected sharps
only.
[0033] For purposes of summarizing the invention, certain aspects,
advantages and novel features of the invention are described
herein. It is to be understood that not necessarily all such
advantages may be achieved in accordance with any particular
embodiment of the invention. Thus, for example, those skilled in
the art will recognize that the invention may be embodied or
carried out in a manner that achieves one advantage or group of
advantages as taught herein without necessarily achieving other
advantages as may be taught or suggested herein.
[0034] These and other objects and advantages of the present
invention will be more apparent from the following description
taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] A general architecture that implements the various features
of the invention will now be described with reference to the
drawings. The drawings and the associated descriptions are provided
to illustrate embodiments of the invention and not to limit the
scope of the invention. Throughout the drawings, reference numbers
are re-used to indicate correspondence between referenced
elements.
[0036] FIG. 1A illustrates an oblique view of a flat un-deployed
sharp guard, according to an embodiment of the invention.
[0037] FIG. 1B illustrates an oblique view of the sharp guard in
its open, deployed state, according to an embodiment of the
invention.
[0038] FIG. 1C illustrates an oblique view of the sharp guard in
the closed state with a hypodermic needle trapped therein,
according to an embodiment of the invention.
[0039] FIG. 2A illustrates a top view of the sharp guard in its
undeployed flat configuration, according to another embodiment of
the invention.
[0040] FIG. 2B illustrates a side cutaway view of a folded sharp
guard showing additional details of an entrapment pad, according to
an embodiment of the invention.
[0041] FIG. 3 illustrates an oblique view of a stack or plurality
of un-deployed, flat sharp guards, according to an embodiment of
the invention.
[0042] FIG. 4A illustrates an oblique view of a sharp guard
dispenser with a plurality of un-deployed sharp guards loaded
therein, according to an embodiment of the invention.
[0043] FIG. 4B illustrates an oblique cut away view of the sharp
guard dispenser filled with a plurality of un-deployed sharp
guards, according to an embodiment of the invention.
[0044] FIG. 4C illustrates an oblique view of the sharp guard
dispenser with a sharp guard being removed, according to an
embodiment of the invention.
[0045] FIG. 5 illustrates an oblique view of another embodiment of
a dispenser for sharp guards comprising a single central opening on
the top of the dispenser and a one-hand operated spring-loaded
lid.
[0046] FIG. 6A illustrates an oblique view of a sharp guard
dispenser attached to the rail of a hospital bed, according to an
embodiment of the invention.
[0047] FIG. 6B illustrates an oblique view of the sharp guard
dispenser attached to a bed stand, according to an embodiment of
the invention.
[0048] FIG. 7A illustrates an oblique view of the sharp guard
receptacle with a sharp guard being inserted, according to an
embodiment of the invention.
[0049] FIG. 7B illustrates an oblique view of the sharp guard
receptacle, which has become full and can no longer accept new
sharp guards, according to an embodiment of the invention.
[0050] FIG. 8 illustrates an oblique view of another embodiment of
a receptacle for sharp guards comprising a single opening and a
single area to hold the sharps.
[0051] FIG. 9A illustrates a sharp guard delivery system, according
to an embodiment of the invention.
[0052] FIG. 9B illustrates another embodiment of a sharp guard
delivery system comprising a bracket to hold the dispenser and the
receptacle.
DETAILED DESCRIPTION OF THE INVENTION
[0053] In accordance with one or more embodiments of the present
invention, a plurality of embodiments of a sharp guard system is
described herein. In order to fully specify this preferred design,
various embodiment specific details are set forth, such as the
shape and size of the receptacle as well as the dispenser. It
should be understood, however that these details are provided only
to illustrate the presented embodiments, and are not intended to
limit the scope of the present invention.
[0054] FIG. 1A illustrates an oblique view of an embodiment of a
sharp guard 10 in the fully open or flat configuration. The sharp
guard 10 comprises an upper support 12, a hinge area 14, a lower
support 16, a plurality of optional folding tabs 18, and a pull-tab
20. The upper support 12, the hinge area 14, the lower support 16,
the optional folding tabs 18 and the pull-tab 20 of the sharp guard
10 are permanently affixed to each other and are, preferably,
fabricated from the same piece of material in a unitary
structure.
[0055] In an embodiment, the upper support 12, the hinge area 14,
the lower support 16, the optional folding tabs 18 and the pull-tab
20 are fabricated from puncture resistant thermoplastic materials
including, but not limited to, polyethylene terephthalate,
polystyrene, polyethylene, polypropylene, or the like. In another
embodiment, other puncture resistant materials, including, but not
limited to, cardboard, paper, polyurethane foam, polyvinyl chloride
foam, cork, synthetic composites, polyester, and the like, may be
used. Because of its minimal cost and easy manufacturability,
polystyrene sheet is the preferred material for fabrication of the
upper support 12 and the lower support 16, including any tabs
18.
[0056] In another embodiment, the upper support 12, the hinge area
14, the lower support 16, the optional folding tabs 18 and the
pull-tab 20 are laminated with puncture resistant materials, such
as ceramics, metals, or polymers. Exemplary laminate materials
include, but are not limited to, low density polyethylene,
polyester, polyimide, polyamides, stainless steel, stainless steel
mesh, Kevlar, aluminum, and the like.
[0057] Fabrication processes for upper support 12, the hinge area
14, the lower support 16, the optional folding tabs 18 and the
pull-tab 20 include, but are not limited to, extrusion, injection
molding, insert molding, thermoforming, and the like.
[0058] The sharp guard 10 further comprises an upper adhesive
region 24 and a lower adhesive region 26. The upper and lower
adhesive regions 24 and 26, respectively, are permanently adhered
to the upper support 12 and the lower support 16 and comprise an
embedding adhesive material. The upper adhesive region 24 and the
lower adhesive region 26 are configured to permanently and
irreversibly bond to each other and entrap or sequester the sharp
therein when the sharp guard 10 is folded closed over a sharp.
Further, the embedding adhesive of the upper adhesive region 24 and
the lower adhesive region 26 not only sticks to itself and an
entrapped sharp, but deforms and completely conforms to and
surrounds the sharp. The adhesive is malleable and deforms to
surround and fill any gaps or spaces that may be created around a
large diameter sharp. The adhesive regions 24 and 26 preferably do
not extend into the hinge area 14. The gap-filling nature maximizes
adhesive contact surface area on the sharp and seals the sharp to
prevent fluid leakage or spillage.
[0059] In an embodiment, the upper adhesive region 24 and the lower
adhesive region 26 are thick and flowably or malleably deformable.
Thus, when a thick sharp is enclosed within the sharp guard 10, the
adhesive regions 24 and 26 flow aside and permit full entrapment of
the large sharp with no air gaps extending to the exterior of the
upper support 12 or lower support 16.
[0060] Further, such prevention or minimization of air gaps will
prevent smaller sharps that are placed within the sharp guard 10
from inadvertently falling out through the air gap route to the
exterior of the sharp guard 10.
[0061] The upper adhesive region 24 and the lower adhesive region
26 are fabricated from adhesives that permanently adhere to the
upper support 12 and the lower support 16, respectively. Examples
of the embedding adhesive utilize or comprise base materials of
acrylics, acrylate polymers, polychloroprenes, cyanoacrylates, and
the like. In an embodiment, the upper adhesive region 24 and the
lower adhesive region 26 are approximately 0.01 inch to
approximately 2.0 inches thick, and preferably 0.1 inch to
approximately 0.5 inch thick.
[0062] In another embodiment, the embedding adhesive is laminated
onto a foam, which is preferably malleably deformable to
accommodate sharps of varying size and thickness. This is to
enhance bond strength, which is dependent upon the amount of
adhesive-to-surface contact developed. Examples of the foam are
closed cell polyvinyl chloride foam (vinyls), styrene block
copolymer (SBC), polyurethane, polyester, open cell polyvinyl
chloride foam (vinyls), styrene block copolymer (SBC), and the
like. In an embodiment, the foam is approximately 0.1 inch to
approximately 2.0 inches thick, and preferably 0.25 inch to
approximately 1.5 inches thick.
[0063] In another embodiment, the embedding adhesive is laminated
onto a gel, which is preferably malleably deformable to accommodate
sharps of varying size and thickness. Examples of the gel are
sealant type materials utilizing a base material of epoxy, acrylic,
nitrile, hydrophilic hydrogel, collagen, and the like. In an
embodiment, the gel is approximately 0.1 inch to approximately 2.0
inches thick, and preferably 0.25 inch to approximately 1.5 inches
thick.
[0064] In yet another embodiment, the adhesive, gel or foam is
affixed only at or near the exterior of the sharp guard 10 to
prevent exit routes for the sharps while maintaining a lower
overall device cost.
[0065] In another embodiment, the upper adhesive region 24 and the
lower adhesive region 26 comprise an absorbent material, such as,
but not limited to, carboxymethyl cellulose, cotton, paper, sea
sponge, hydrophilic hydrogel, wood cellulose fiber,
cellulosic-based fiber granules, absorbent polyacrylate, wood
pulp/polypropylene/cellulose, wood pulp and other fiber blends with
polypropylene, polyester and polyethylene, and the like. In
addition, specialized absorbent and foaming materials such as, but
not limited to, encapsulated monosodium citrate and an alkali metal
or alkaline earth metal salt thereof could also be utilized.
Specific applications may contain any combination of components
such as carboxy-methyl cellulose, polypropylene, non-woven
polyethylene film laminate, cellulose/polyester, non-woven
polyester microfiber, polyethylene coated film or paper and
polyester packing pouches.
[0066] The sharp guard 10 further comprises an adhesive cover strip
28 on the exposed surface of the adhesive regions 24 and 26. The
adhesive cover strip 28 further comprises an adhesive cover strip
pull-tab 34. The adhesive cover strip 28 and its integral adhesive
cover strip pull-tab 34 cover the adhesive regions 24 and 26 until
such time as the adhesive cover strip 28 is removed and the sharp
guard 10 is ready for a medical sharp object to be adhered and
sandwiched between the upper adhesive region 24 and the lower
adhesive region 26. The adhesive cover strip pull-tab 34 is
designed to facilitate easy grasping by the user and enables the
user to lift the adhesive cover strip 28 to fully uncover the
adhesive regions 24 and 26. It is preferable that the adhesive
cover strip 28 be removed from both the upper adhesive region 24
and the lower adhesive region 26 using a single motion on the part
of the user. Thus, in an embodiment, a single pull-tab 34 controls
the cover strips 28 over both the upper adhesive 24 and the lower
adhesive 26.
[0067] The adhesive cover strip 28 and the adhesive cover strip
pull-tab 34 are preferably a unitary structure and comprise
materials that do not adhere to the upper adhesive region 24 and
the lower adhesive region 26. Such materials depend on the nature
of the embedding adhesive material used in the upper adhesive
region 24 and the lower adhesive region 26. In an embodiment,
polytetrafluoroethylene, other fluoropolymers, metal foils, and the
like, are suitable materials for the adhesive cover strip 28 and
the adhesive cover strip pull-tab 34.
[0068] The pull-tab 20 is designed to facilitate easy grasping of
the sharp guard 10 by the user and enables the user to remove the
sharp guard 10 from a sharp guard dispenser.
[0069] The flat configuration illustrated in FIG. 1A is the
configuration in which the sharp guard 10 is manufactured and most
compactly stored prior to use. The sharp guard is sized so that it
can encapsulate the majority of medical sharps. In an embodiment,
the length of the sharp guard 10 from the upper support 12 to the
tab 20 is between approximately 0.5 inch and approximately 10
inches, preferably is between approximately 2 inches and
approximately 7 inches and most preferably is between approximately
3 inches and approximately 5 inches. In an embodiment, the width of
the sharp guard 10 from an outside edge of one tab 18 to an outside
edge of an opposite tab 18 is between approximately 0.5 inch and
approximately 10 inches, preferably is between approximately 2
inches and approximately 7 inches and most preferably is between
approximately 3 inches and approximately 5 inches.
[0070] FIG. 1B illustrates an oblique view of an embodiment of the
sharp guard 10 in a partially folded and partially open
configuration. The sharp guard 10 comprises the upper support 12,
the hinge area 14, the lower support 16, optional folding tabs 18,
and the pull-tab 20.
[0071] In an embodiment, the hinge area 14 is integrated with the
upper support 12 and the lower support 14, and is height
adjustable. The hinge area 14 is height adjustable to permit the
sharp guard 10 to accommodate sharps of varying thickness.
Typically, a medical sharp comprises a sharp portion connected to a
blunt portion. Sharp portions are, for example, needles, scalpel
blades, trocars, tubes, wires and other medical procedure devices,
objects or instruments, which can penetrate the skin, and the like.
Blunt portions are, for example, handles, syringe bodies, tubing,
connectors, catheters, specialized containers, and the like.
Typically, once used, the entire medical sharp is thrown away.
[0072] The hinge area 14 is preferably fabricated by creating
creases or thin areas in the upper support 12 and the lower support
14, which are, preferably, fabricated from the same piece of
material. In an embodiment, the hinge area 14 comprises a complex
hinge or multiple hinges. In an embodiment, the hinge area 14
comprises a single crease or region of material thinness. In
another embodiment, the hinge area 14 is a doubly creased area
forming a "U" shape or a book hinge. In a further embodiment, the
hinge area 14 is a "W" folded or tri-folded configuration capable
of expanding substantially. In another embodiment, the hinge area
14 is an accordion fold or z-fold that comprises a plurality of
hinges to allow the hinge area 14 to expand substantially or
compress substantially. Since the thickness of a sharp to be
embedded is variable, the hinge 14 accommodates a wide range of
thicknesses and still allows the upper support 12 and the lower
support 16 to be substantially parallel to each other when the
sharp guard 10 is closed around the sharp. The accordion fold or
other multiply creased hinge 14 provides for such parallelism in
the closure of the upper support 12 and the lower support 16.
[0073] In an embodiment, the thickness of the folded, unexpanded
hinge area 14 is between approximately 0.1 inch and 0.25 inch. When
expanded, the hinge 14 is between approximately 0.1 inch and 2
inches, and preferably is between 0.25 inch and 1.5 inches.
[0074] FIG. 1C illustrates an oblique view of an embodiment of the
sharp guard 10 in a closed configuration with a sharp medical
object 30 embedded therein. Typically, a healthcare worker places
the used medical sharp 30 into the lower adhesive region 26 and
folds the upper support 12 over the lower support 16. The upper
adhesive region 24 and the lower adhesive region 26 adhere
together, embedding the sharp 30. The upper support 12, the hinge
area 14, and the lower support 16 form a puncture resistant shell
or case around the embedded sharp 30.
[0075] In an embodiment, the health care worker can also fold the
optional tabs 18 over the upper support 12 to provide additional
sealing of the sharp guard 10.
[0076] In an embodiment, the optional tabs 18 comprise snaps or
locks to provide audible and tactile feedback that the sharp guard
10 is closed around the sharp. The snaps or locks preferably
irreversibly lock the sharp guard 10 closed. These locks may be
molded into the structure and comprise tapers that facilitate
intermeshing of the sharp guard 10 surfaces and overhangs or
catches that prevent disengagement of the locked sharp guard
10.
[0077] Thus, the sharp guard 10 protects the healthcare worker from
needlesticks, punctures, and cuts caused by the contaminated sharp
30. The sharp guard 10 is applied to the contaminated sharp 30 at
the point of use, which may, in an embodiment, generally be
described as a location wherein the user does not have to move
their feet or turn to apply the sharp guard 10 to the contaminated
sharp 30.
[0078] The sharp guard 10 further comprises a label 22. The label
22 preferably comprises a standard biohazard symbol and a notation
that the contents may be pathogenic or contaminated with medical
waste. In one embodiment, the label 22 is affixed to the outer
surface of the upper support 12. In yet another embodiment, the
label 22 affixed to the underside of the plurality of optional
folding tabs 18 so that when the tabs are folded over the upper
support 12, their edges are adjacent and a complete statement is
legible. When the tabs 18 are open, the part of the label 22 on
each tab 18 is incomplete and does not display a coherent message.
In an embodiment, the lower adhesive area 26 extends onto the upper
surfaces of the tabs 18 and serves as a permanent and irreversible
closure for the tabs 18 when they are folded over the outside of
the upper support 12.
[0079] The sharp guard 10, in another embodiment, further comprises
an adhesive catalyst 32. In an embodiment, the adhesive catalyst 32
is located on the outer surface proximate to the hinge area 14. In
another embodiment, the adhesive catalyst 32 is proximate to and
over the hinge area 14. The adhesive catalyst 32 promotes adhesion
between the employed sharp guard 10 and a sharp guard receptacle
when the employed sharp guard 10 is placed in the sharp guard
receptacle.
[0080] FIG. 2A illustrates another embodiment of the sharp guard
10. The sharp guard 10 comprises the upper support 12, the hinge
area 14, and the lower support 16. The upper support 12 further
comprises a plurality of protrusions 106, and a flat area 108
having an optional raised stiffening rim 110. The raised rim 110 is
slightly raised to maximize structural stiffness and rigidity. The
lower support 16 further comprises a plurality of circular
depressions 104, and a raised area 100 having an optional recess
102.
[0081] The protrusions 106 and the raised stiffening rim 110 on the
upper support 12 are aligned with the circular depressions 104 and
the recess 102 on the lower support 16 such that when the sharp
guard 10 is folded over the sharp 30, the protrusions 106 and the
raised stiffening rim 110 fit snugly within and intermesh with the
circular depressions 104 and the recess 102, respectively. In an
embodiment, the protrusions 106 latch into the depressions 104 when
the sharp guard 10 is closed. In an embodiment, the protrusions
irreversibly 106 latch into the depressions 104 when the sharp
guard 10 is closed.
[0082] In another embodiment, the flat area 108 comprises slots,
wells, or cutouts that accept the raised area 100 and permit the
raised area 100 to project beyond the plane of the flat area 108 of
the bi-folded surfaces.
[0083] The sharp guard 10 further comprises the upper adhesive
region 24 and the lower adhesive region 26. The upper adhesive
region 24 is level with the flat area 108. The lower adhesive
region 26 sets in a depression surrounded by the raised area 100.
In an embodiment, the upper adhesive region 12 and the lower
adhesive region 16 comprise an embedding adhesive material such as
polyurethane-based adhesives, acrylics, acrylate polymers,
polychoroprenes, cyanoacrylates, and the like. The lower adhesive
region 26 optionally comprises holes, openings, or fenestrations
158 which permit diffusion or absorption of fluid from the embedded
sharp 30 into a region separated from the sharp 30 by the lower
adhesive region 26.
[0084] In an embodiment, the lower adhesive region 26 further
comprises an absorbent spun material, such as, for example
compounds of methyl cellulose, cotton, paper, polyester,
polypropylene non-woven/polyethylene film laminate,
cellulose/polyester, non-woven polyester microfiber, polyethylene
coated film or paper, polyester packing pouches, and the like,
under the embedding adhesive material. In another embodiment, the
spun material comprises absorbent additives, such as, for example,
carboxymethyl cellulose, hydrophilic hydrogel, sea sponge, wood
cellulose fiber, cellulosic-based fiber granules, absorbent
polyacrylate, wood pulp/polypropylene/cellulose, wood pulp and
other fiber blends with polypropylene, polyester and polyethylene,
and the like. In addition, special absorbent materials may be added
such as, but not limited to, encapsulated monosodium citrate and an
alkali metal or alkaline earth metal salt thereof and the like. In
an embodiment, the upper adhesive region 24 and the lower adhesive
region 26 further comprise the absorbent spun material.
[0085] In yet another embodiment, the lower adhesive region 26
further comprises a foaming material, such as, but not limited to,
encapsulated monosodium citrate and an alkali metal or alkaline
earth metal salt thereof, and the like, under the embedding
adhesive material. The foaming material foams in the presence of
the metal sharp 30 or any liquids present with the used metal sharp
30, to further contain the used sharp 30. In another embodiment,
the upper adhesive region 24 and the lower adhesive region 26
further comprise the foaming material.
[0086] In yet another embodiment, the lower adhesive region 26
further comprises a cover. The cover facilitates contact with the
deformable and/or absorptive material of the upper and/or lower
adhesive regions 24, 26. In an embodiment, the cover may be treated
with an adhesive. In an embodiment, the cover material may be a
fine denier woven or non-woven spinable polyester. In yet another
embodiment, the upper adhesive region 24 and the lower adhesive
region 26 further comprise the cover.
[0087] In another embodiment, the sharp guard 10 further comprises
a lower opening 112. The lower opening 112 is located along an edge
of the lower support 16 at a break in the raised area 100. The
lower adhesive region 26 extends into the lower opening 112. The
upper adhesive region 24 extends into the flat area 108. The lower
opening 112 and the upper adhesive region 24 which extends into the
flat area 108 are aligned such that the upper adhesive region 24
which extends into the flat area 108 sets over the lower opening
112 when the user closes the sharp guard 10.
[0088] In another embodiment, the lower adhesive region 26
comprises a pad 150. FIG. 2B illustrates a cross section of the
sharp guard 10 comprising the pad 150. The pad 150 comprises an
adhesive layer 152 comprising materials such as acrylics, acrylate
polymers, polychoroprenes, cyanoacrylates, and the like. The
adhesive layer 152 adheres to the sharp 30, the upper adhesive
region 24, and itself when the sharp guard 10 is closed around the
sharp 30 to embed and entrap the sharp 30 within the sharp guard
10.
[0089] In another embodiment the pad 150 further comprises a
gap-filling deformable layer 154 disposed between the adhesive
layer 152 and an inside surface of the lower support 16. Examples
of a gap-filling deformable material include, but are not limited
to hydrogel, soft foams of polyvinyl chloride, polyurethane, or
polyester, closed cell polyvinyl chloride foams (vinyls),
polystyrenes, styrene block copolymer (SBC), polyurethanes,
polyesters, or the like. The gap-filling deformable layer 154
deforms when the sharp 30 is embedded or pressed into the pad 150
to substantially fill any gaps surrounding the sharp 30. The
deformation is either resilient or the result of irreversible
crushing of the gap-filling material. This further contains sharps
30 of varying sizes and diameters within the sharp guard 10 when
the sharp guard 10 is closed. The gap-filling deformable layer 154
expands to fill an interior space of the closed sharp guard 10
having the embedded sharp 30 such that there are substantially no
gaps in the closed, employed sharp guard 10.
[0090] In an embodiment, the pad 150 further comprises an absorbent
layer 156 disposed below the adhesive layer 152, comprising
materials such as, for example, wood cellulose fiber,
cellulosic-based fiber granules, absorbent polyacrylate, wood
pulp/polypropylene/cellulose, wood pulp, or the like. In another
embodiment, the pad 150 comprises a composite, an integrally
distributed, or an itemized absorbent material, such as, for
example, particles of carboxymethyl cellulose suspended in
open-celled polyurethane foam, air-laid paper, wood cellulose
fiber, cellulosic-based fiber granules, absorbent polyacrylate,
wood pulp/polypropylene/cellulose- , wood pulp and other fiber
blends with polypropylene, polyester and polyethylene, or the like.
The absorbent layer 156 or the absorbent materials substantially
absorb any fluids contained on and/or in the used sharp 30 to
prevent fluids from leaking from the closed sharp guard 10. The
adhesive layer 152, in an embodiment, is perforated or fenestrated
with openings 158 to permit fluid flow or diffusion into the layers
below.
[0091] In another embodiment, the upper adhesive region 24
comprises the pad 150. In a further embodiment, the upper adhesive
region 24 and the lower adhesive region 26 each comprise the pad
150.
[0092] In an embodiment, the sharp guard 10 has a orientation edge
or guide to assist the healthcare professional with proper
alignment of a syringe body and other pharmaceutical injection or
infusion devices into the sharp guard 10. This ensures that
needles, catheters and other elongated medical sharps are properly
orientated for maximum containment with the sharp guard 10.
[0093] The raised area 100 forms a raised ridge with respect to the
lower adhesive region 26 to prevent the sharp from inadvertently
being poked out of the edge of the sharp guard 10. The ridge or
raised edge forms a material barrier to the sharp 30 around much of
the perimeter of the folded sharp guard 10. The ridge or raised
edge preferably does not extend through the lower opening 112 where
the medical sharp 30 is inserted and a handle or other blunt
portion may project out of the sharp guard 10. This is especially
useful in the context of large syringes or scalpels. The
intermeshing of the raised rim 110 and protrusions 106 with the
recess 102 and the depressions 104 provides a barrier against
sharps penetration.
[0094] Referring to FIG. 2A, the hinge area 14 is preferably
fabricated by creating creases or thin areas in the upper support
12 and the lower support 16, which are, preferably, fabricated from
the same piece of material. In an embodiment, the hinge area 14 is
an accordion fold that comprises a plurality of hinges to allow the
hinge area 14 to expand substantially or compress substantially.
Since the thickness of the sharp 30 to be embedded is variable, the
hinge 14 accommodates a wide range of thicknesses and still allows
the upper support 12 and the lower support 16 to be substantially
parallel to each other when the sharp guard 10 is closed around the
sharp 30. The accordion fold or other multiply creased hinge area
14 provides for such parallelism in the closure of the upper
support 12 and the lower support 16.
[0095] In an embodiment, the thickness of the hinge area 14 is
between approximately 0.1 inch and 0.25 inch. When expanded, the
thickness of the hinge area 14 is between approximately 0.1 inch
and 2 inches, and preferably is between 0.25 inch and 1.5
inches.
[0096] In another embodiment of the sharp guard 10, a pouch
fabricated from materials including, but not limited to, Tyvek,
polyethylene, polypropylene, or the like is heat sealed around the
sharp guard 10 and the sharp guard 10 is sterilized using ethylene
oxide, gamma irradiation, or the like. The sharp guards 10 are
preferably separately bagged or pouched and irradiated for single
use in a sterile environment. In an embodiment, the pouch is a
typical heat-sealed chevron-style or other style pouch known in the
art as aseptic packaging that may be opened and the sterile sharp
guard 10 contents spilled or dumped into the sterile field using
aseptic procedure. By this method, the sharp guards 10 may be
deployed onto a sterile field for use when needed.
[0097] In yet another embodiment, the sharp guards 10 are double
pouched in a manner known as double aseptic packaging. A
double-pouched sharp guard is a sterile safeguard 10 pouched in a
first sterile pouch, and then the pouched safe guard 10 is pouched
in a second sterile pouch.
[0098] FIG. 3 illustrates an oblique view of a stack 36 sharp
guards 10. In an embodiment, the stack 36 comprises between 1 and
100 sharp guards 10. In another embodiment, the stack 36 comprises
between 5 and 50 sharp guards 10, and in yet another embodiment,
the stack 36 comprises between 10 and 30 sharp guards 10. In a
further embodiment, the stack 36 comprises more than 100 sharp
guards 10. The stack 36 facilitates shipping, storage, and
dispensing of the sharp guards 10. The sharp guards 10 may be
non-sterile or they may be bagged or pouched and sterile.
[0099] FIG. 4A illustrates an oblique view of a dispenser 40 for
sharp guards 10. The dispenser 40 comprises a case 42, a mount 44,
a window 46, and an opening 48. The dispenser 40 is loaded with a
plurality of sharp guards 10.
[0100] The mount 44 is affixed to the case 42 and is used to
removably affix the case 42 to another object such as a table, bed,
wall, or the like. The window 46 is affixed to the case 42 and
permits viewing of the sharp guards 10 or other contents of the
case 42. The opening 48 is a penetration through the case 42 and
may be located on the front of the case 42, on the top of the case
42, or it may be positioned partially on the top and partially on
the front of the case 42, as shown in FIG. 4A.
[0101] In an embodiment, the case 42 of the dispenser 40 is
fabricated from materials such as, but not limited to, polyvinyl
chloride, polyethylene, polypropylene, polyester terephthalate
(PET), acrilonitrile butadiene styrene (ABS), polystyrene,
copolymers of the aforementioned, metal, sealed wood, cardboard, or
any other material suitable for a container. In an embodiment, the
preferred material is PET, cardboard, or polystyrene because of the
low manufacturing cost of these materials. Preferred manufacturing
methods for the case 42 include, but are not limited to,
lamination, blow molding, extrusion, injection molding,
thermoforming, and the like.
[0102] The mount 44 comprises non-permanent adhesives, magnets,
clips, clamps, or the like. The mount 44 is configured to allow the
case 42 to be mounted to a wall, tabletop, bed rail, or any other
surface or structure commonly found in a hospital, ambulance, or
other medical facility.
[0103] FIG. 4B illustrates a cut-away image of an oblique view of
the dispenser 40. The dispenser 40 comprises a plurality of sharp
guards 10. Referring to FIGS. 3 and 4B, the sharp guards 10 are
arranged in the stack 36. The sharp guards 10 in the stack 36 may
be sterile and separately pouched or they may be non-sterile. In an
embodiment, the sharp guards 10 are labeled with full Food and Drug
Administration (FDA), Occupational Safety and Health Administration
(OSHA) and International Standards Organization (ISO) specified
labeling to characterize the device and the sterile or non-sterile
nature of the device.
[0104] FIG. 4C illustrates an oblique view of the dispenser 40 with
the sharp guard 10 being removed through the opening 48. The
dispenser 10 further comprises an optional lid closure 50. The lid
closure 50 is hinged to the case 42 so that it may be opened and
closed. The lid closure 50 further comprises an optional lock to
hold the lid closure 50 closed against the case 42. In an
embodiment, the lid closure 50 comprises a spring to bias the lid
closure 50 in the open position. The lock holding the lid closure
50 closed comprises a release button that may be depressed with a
single finger. Depressing the lock releases the lid closure 50 and
the spring causes the lid closure 50 to open, thus the lid closure
50 is operable with a single press of the hand or finger. The same
hand may be used to remove the sharp guard 10 from the dispenser
40. The lid closure 50 may then be closed by a single hand or
finger and the lock holds the lid closure 50 closed.
[0105] FIG. 5 illustrates another embodiment of the dispenser 40
for sharp guards 10 comprising the case 42, the opening 48, the lid
closure 50, a latch or lock 49, and the plurality of undeployed
sharp guards 10. In this embodiment, the opening 48 is arrayed
generally centrally on a top surface of the case 42. The lid
closure 50 is preferably biased open by a spring. The spring may be
a leaf spring, a coil spring, or any other type of spring. The
latch or lock 49 is operable by simple pressure with a single
finger and depression of the lock 49 causes the lid closure 50 to
open by stored force in the spring and permits access to the
contents of the case 42. The latch or lock 49 is, in an embodiment,
a simple molded catch or protrusion that engages with a feature on
the case 42 and prevents the lid closure 50 from opening.
Depression of the latch or lock 49 causes the catch or protrusion
to become disengaged with the case 42 and allows the spring to move
the lid closure 50 to the open position. The lid closure 50 may
then be closed with a single hand and the latch or lock 49 engages
with the case 42 when the lid closure 50 is pushed closed. The
stored force to open the lid closure 50 may be generated by methods
such as, but not limited to, a spring, a magnet, a motor, hydraulic
or pneumatic pressure, and the like.
[0106] In an embodiment, the dispenser 40 presents the user with
the open sharp guard 10. The medical caregiver places the
contaminated sharp 30 against the lower adhesive region 26 and
presses the sharp 30 against the fold or hinge area 14. The
dispenser 40 causes the protective covers of the upper and lower
supports 12, 14 to fold over the sharp 30 under the influence of
downward manual pressure and coercion from side compression members
on the dispenser 40. The sharp guard 10 finally closes and
irreversibly seals over the sharp 30. The disabled sharp 30 and its
protective cover or sharp guard 10 are removed from the dispenser
40 and placed in a receptacle. Another sharp guard 10 moves into
place to contain another sharp 30. In another embodiment, the
closing action for the sharp guard 10 may be derived from an active
source such as a motor, pneumatic or hydraulic cylinder, or the
like.
[0107] FIG. 6A illustrates a hospital bed 90 comprising a plurality
of bed rails 92 and a plurality of bed posts 94. The sharp guard
dispenser 40 is attached to one of the bed rails 92 for easy access
by medical personnel.
[0108] FIG. 6B illustrates a bed stand 100 with the sharp guard
dispenser 40 attached thereto. Attachment to the bed stand 100 is
performed by means of a clamp, clip, Velcro, adhesive, or other
fastening method. The attachment is reversible in that the
dispenser 40 is removed once it is empty and the dispenser 40 is
replaced by one containing at least one sharp guard 10.
[0109] FIG. 7A illustrates a receptacle 60 for used sharp guards
10, comprising a case 62, a plurality of openings 64, an optional
window 66, a bracket or mount 67, and a lid closure 68. The sharp
guard 10 is shown comprising the medical sharp object 30. The
receptacle 60 is sized to fit sharp guards 10 and used entrapped
medical sharps 30.
[0110] In an embodiment, the case 62 of the receptacle 60 is
fabricated from materials including, but not limited to, polyvinyl
chloride, polyethylene, polypropylene, polyester terephthalate
(PET), acrilonitrile butadiene styrene (ABS), polystyrene,
copolymers of the aforementioned, metal, sealed wood, cardboard, or
any other material suitable for a container. The preferred material
is PET, cardboard, or polystyrene because of the low manufacturing
cost of these materials. Preferred manufacturing methods for the
case 42 include, but are not limited to, lamination, blow molding,
extrusion, injection molding, or the like. The bracket or mount 67
comprises releasable or non-permanent adhesives, magnets, Velcro,
clips, clamps, snaps, bayonet mount, screw mounts, or the like.
[0111] In an embodiment, the optional window 66, which can be
either open or sealed with transparent polymer, allows the user to
visually monitor the contents and fill level.
[0112] In another embodiment, the receptacle 60 further comprises a
seal 124. In an embodiment, the seal 124 is located on the lid
closure 68. When the medical sharps receptacle 60 is full, the user
closes the lid 68 and enables the seal 124 to prevent the
receptacle 60 from opening. The receptacle 60 is then discarded. By
this means, a user cannot attempt to discard a used sharp guard 10
in the full receptacle 60, as the opening 64 is sealed shut.
[0113] FIG. 7B illustrates the receptacle 60 with the sharp guard
10 inserted into every opening 64. Not only can the user see that
each opening 64 is filled with the sharp guard 10, but it is
impossible to put additional sharp guards 10 into the receptacle 60
because all the openings 64 are obstructed by the sharp guard 10.
In an embodiment, the receptacle 60 further comprises an optional
permanent adhesive on its interior wall opposite the openings 64.
Once the user inserts the sharp guard 10 into the receptacle 60,
the adhesive adheres the sharp guard 10 to the wall, and prevents
removal of the sharp guard 10.
[0114] Referring to FIG. 1C, in another embodiment, the adhesive
catalyst 32 promotes bonding between the sharp guard 10 and the
adhesive within the receptacle 60 to further prevent removal of the
used sharp guard 10 from the receptacle 60.
[0115] FIG. 8 illustrates another embodiment of the receptacle 60
for sharp guards 10, comprising the case 62, a single opening 120,
the window 66, the bracket or mount 67, and the lid closure 68. The
lid closure 68 further comprises a latch or lock 122. The sharp
guard 10, shown comprising the medical sharp object 30, is being
inserted into the opening 120. The window 66 permits viewing of the
contents of the receptacle 60 when the lid closure 68 is closed.
The case 62 constrains an internal chamber that is accessed by the
opening 64 and permits storage of sharp guards 10 with embedded
medical sharps 30.
[0116] The lid closure 68 is preferably biased open by a spring.
The spring may be a leaf spring, a coil spring, or any other type
of spring. The latch or lock 122 is operable by simple pressure
with a single finger. Depression of the lock 122 causes the lid
closure 68 to open by stored force in the spring and permits used
sharp guards 10 with embedded sharps 30 to be placed or disposed of
within the case 62. Such a latch or lock 122 is, in a preferred
embodiment, a simple molded catch or protrusion that engages with a
feature on the case 62 and prevents the lid closure 68 from
opening. Depression of the latch or lock 122 causes the catch or
protrusion to become disengaged with the case 62 and allows the
spring to move the lid closure 68 to the open position. The lid
closure 68 may then be closed with a single hand and the latch or
lock 122 engages with the case 62 when the lid closure 68 is pushed
closed. The stored force to open the lid closure 68 may be
generated by methods such as, but not limited to, a spring, a
magnet, a motor, hydraulic or pneumatic pressure, or the like.
[0117] In another embodiment of the receptacle 60, a specialized
lid is configured to clamp to the top of a trashcan or standard
medical sharps container. The specialized lid is designed to allow
the single sharp guard 10 and encased sharp 30 to be inserted into
the receptacle 60. The specialized lid prevents overfilling of the
receptacle 60 by becoming unable to open when the interior space of
the case 62 is full.
[0118] In another embodiment, the user can discard the used,
employed sharp guard 10 in any standard biohazard waste disposal
container.
[0119] FIG. 9A illustrates an oblique view of a sharp guard
delivery system 80 comprising the dispenser 40 and the receptacle
60. The dispenser 40 further comprises the plurality of sharp
guards 10 and the receptacle 60 is shown with the single used sharp
guard 10 being inserted therein. The used sharp guard 10 further
comprises the contaminated medical sharp object 30. The delivery
system 80 allows for access to sharp guards 10 and a convenient
place for storage of used sharp guards 10 so that the medical
practitioner or user does not have to travel across the room to
dispose of the medical sharp object 30 or sharp guard 10. The
unitary design of the sharp guard delivery system 80 occupies
minimum space in the medical facility. In an embodiment, the sharp
guard delivery system 80 is unitary. In another embodiment, the
sharp guard delivery system 80 comprises the dispenser 40 and the
receptacle 60 as separate units. In an embodiment, the sharp guard
receptacle 60 holds at least as many sharp guards 10 and
contaminated medical sharp objects 30 as the dispenser 40 contains
when full. The dispenser 40 presents one sharp guard 10 at a time,
and upon removal of the presented sharp guard 10, the dispenser 40
presents another sharp guard 10 for use.
[0120] FIG. 9B illustrates another embodiment of the sharp guard
delivery system 80 comprising the dispenser 40, the receptacle 60,
and a bracket 126 to hold the dispenser 40 and the receptacle 60.
The bracket 126 further comprises a plurality of recesses 128 to
hold the receptacle 60 and the dispenser 40. In addition, the
bracket 110 comprises a clamp 130. The clamp 130 is configured to
hold the bracket 126 to a wall, bed stand, bed rail, ambulance
wall, tabletop, or other hospital or medical location. The clamp
130 is configured in various ways including, but not limited to, a
releasable adhesive, Velcro, C-clamp, permanent or electromagnet,
bracket with spring-loaded closure, and the like.
[0121] In yet another embodiment of the invention, a bracket is
provided that holds the dispenser 40 and the receptacle 60. The
bracket allows each of the dispenser 40 and the receptacle 60 to be
inserted and locked into place. Removal of the empty dispenser 40
and the full receptacle 60 is accomplished by releasing the lock
and removing either the dispenser 40 or the receptacle 60 from the
bracket. The bracket may be attached to a bed, bed stand, table,
wall or the like and reversibly accept the dispenser 40 and/or the
receptacle 60. The bracket may also allow the dispenser 40 to be
coupled to a commercially available receptacle.
[0122] In an embodiment, this invention comprises the methods of
placing a sharp guard 10 or other medical sharps receiver at a
location proximate to where it will be used medically, or at the
point-of-use. It is preferable that such proximate location is no
further than 15 feet from where the sharp 30 is used and, more
preferably, the location is less than 5 feet from where the medical
sharp is used. Most preferably, such proximate locations is such
that the medical professional does not have to move his feet or
even turn to reach a sharp guard 10 from where the medical sharp 30
is used on a patient.
[0123] The receptacle 60 is preferably located proximate to the
patient use of the medical sharp 30. The sharp guard 10 is provided
by the dispenser 40 affixed proximate to where the medical sharp 30
is used on the patient. The sterile sharp guard 10 may also be
taken from another location and moved to the sterile field where it
is available for use immediately after using the sharp 30 on a
patient. The person disposing of the sharp 30 entraps the medical
sharp 30 within the sharp guard 10 at or near the point-of-use so
that the medical sharp 30 is not moved around the room in such a
way as it might cut or puncture another person. Once entrapped
within the sharp guard 10, the healthcare worker transports the
medical sharp 30 to the receptacle 60 where it is safely
discarded.
[0124] Application of the sharp guard system and methods reduces
the risk that a medical caregiver will use a hypodermic needle,
scalpel, or the like on a patient, turn around and accidentally
stab a co-worker while trying to put the sharp into its receptacle.
Such a scenario is particular disadvantageous when the patient is a
vector for highly pathogenic organisms such as those for hepatitis,
human immunodeficiency virus (HIV), and the like. The sharp guard
system is universal and does not require that each individual sharp
is specially designed to retract or self-blunt. The sharp guards
and the methods of using the sharp guards reduce the risk of an
inadvertent contamination in the medical environment.
[0125] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. For example, the sharp guard can, instead, be
configured as a single monolithic slab of gel material that entraps
the sharp and hardens to embed the sharp. The sharp guard
receptacle and dispenser may also be configured to accept such
hardenable gel sharp guards. The described embodiments are to be
considered in all respects only as illustrative and not
restrictive. The scope of the invention is therefore indicated by
the appended claims rather than the foregoing description. All
changes that come within the meaning and range of equivalency of
the claims are to be embraced within their scope.
* * * * *