U.S. patent application number 09/930848 was filed with the patent office on 2002-06-06 for containment system for encapsulating a sharp medical instrument.
Invention is credited to Attarwala, Shabbir, Montenieri, Robert E., Vakiener, Brian R..
Application Number | 20020066686 09/930848 |
Document ID | / |
Family ID | 22846607 |
Filed Date | 2002-06-06 |
United States Patent
Application |
20020066686 |
Kind Code |
A1 |
Montenieri, Robert E. ; et
al. |
June 6, 2002 |
Containment system for encapsulating a sharp medical instrument
Abstract
A containment system encapsulates a sharp medical instrument.
The containment system includes a container having an upper end for
insertably accommodating the medical instrument. The container
supports a pair of liquid components of a two-part hardenable
compound which are separated by a rupturable divider. The
components are mixed upon rupture of the divider caused by
insertion of the medical instrument thereinto. The hardenable
compound thereby hardens around the medical instrument, quickly and
permanently encapsulating the inserted instrument.
Inventors: |
Montenieri, Robert E.;
(Southington, CT) ; Vakiener, Brian R.; (Rocky
Hill, CT) ; Attarwala, Shabbir; (Simsbury,
CT) |
Correspondence
Address: |
Daniel A. Scola, Jr., Esq.
HOFFMANN & BARON, LLP
6900 Jericho Turnpike
Syosset
NY
11791
US
|
Family ID: |
22846607 |
Appl. No.: |
09/930848 |
Filed: |
August 15, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60225874 |
Aug 17, 2000 |
|
|
|
Current U.S.
Class: |
206/365 ;
206/219 |
Current CPC
Class: |
A61M 2005/328 20130101;
A61M 5/3205 20130101; A61M 5/3213 20130101 |
Class at
Publication: |
206/365 ;
206/219 |
International
Class: |
B65D 083/10; B65D
025/08 |
Claims
What is claimed is:
1. A containment system for encapsulating a sharp medical
instrument comprising: a container having an end for insertably
receiving said medical instrument, said container supporting a pair
of liquid components of a two-part hardenable compound separated by
a rupturable divider, said components being mixed upon rupture of
said divider by said insertion of said medical instrument
thereinto.
2. A containment system of claim 1, wherein said container further
includes an open ended container base containing one of said pair
of liquid components, and an open ended container cap for
insertably receiving said medical instrument and containing the
other of said pair of liquid components, said cap being positioned
over said open end of said base with said rupturable divider
positioned therebetween.
3. A containment system of claim 2, wherein said container cap
further includes a puncturable cover closing said open end thereof
for receiving said medical instrument upon said insertion.
4. A containment system of claim 3, wherein said base contains a
hardenable resin and wherein said cap contains a resin
hardener.
5. A containment system of claim 3, wherein container cap is
cup-shaped and is inserted within said container base.
6. A containment system of claim 5, wherein said cup-shaped cap
includes a side wall and a breakaway bottom wall forming said
rupturable divider, said side wall having a wall thickness
resisting puncture by said inserted instrument.
7. A containment system of claim 3, wherein said rupturable divider
includes said bottom wall being detachable from said side wall upon
instrument insertion.
8. A containment system of claim 3, wherein said rupturable divider
is shatterable glass.
9. A containment system of claim 4, wherein said hardenable resin
is selected from the group consisting of anaerobically curable
resins, cyanoacrylates, vinyl resins, epoxy resins, silicone
resins, silicone-acrylate resins and combinations thereof.
10. A containment system of claim 9, wherein said resin hardener is
selected from the group consisting of initiators, metal catalysts,
acidic catalysts, basic catalysts and accelerators and combinations
thereof.
11. A container for enclosing a sharp medical instrument
comprising: a container base having an open upper end for
accommodating a first component of a two component hardenable
compound; a container cap positioned over said open upper end of
said base and insertably receiving said instrument, and for
accommodating a second component of said two component hardenable
compound; and a rupturable divider positioned between said cap and
said base for maintaining separation between said first and second
components, said divider being rupturable upon said instrument
insertion to cause said first and second components to mix and
harden around said inserted instrument.
12. A container of claim 11, wherein said cap has an opposed open
lower end closed by said rupturable divider.
13. A container of claim 11, wherein said cap is snap fitted over
said base.
14. A container of claim 13, wherein said container cap is a
generally cup-shaped member insertable into said container base,
said cup-shaped member having a side wall and a breakaway bottom
wall forming said rupturable divider, said side wall having a wall
thickness resisting puncture by said inserted medical
instrument.
15. A container of claim 14, wherein said base is attached to said
side wall by a releasable snap fit.
16. A container of claim 13, wherein said rupturable divider is a
glass wafer supported between said cap and said base.
17. A container of claim 11, wherein said components of said two
component hardenable compound are mutually miscive liquids.
18. A container of claim 11, wherein said first component is a
hardenable resin selected from the group consisting of
anaerobically curable resins, cyanoacrylates, epoxy resins, vinyl
resins, silicone resins, silicone-acrylate resins and combinations
thereof.
19. A container of claim 18, wherein said second component is a
resin hardener selected from the group consisting of radical
initiators, metal catalysts, acid catalysts, basic catalysts and
accelerators and combinations thereof.
20. A container of claim 11, wherein said upper end of said
container cap is closed by a puncturable cover.
21. A method of encapsulating a sharp medical instrument comprising
the steps of: inserting said instrument into a container supporting
a pair of liquid components of a two-part hardenable compound
separated by a rupturable divider, said components being mixed upon
rupture of said divider during insertion of said instrument to
cause said compound to harden around said instrument.
22. A method of claim 21, further including the step of shattering
a glass wafer forming said rupturable divider upon said inserting
step.
23. A method of claim 21, further including the step of breaking
away a portion of a wall defining said divider.
24. A method of claim 21, wherein one part of said two-part
hardenable compound is a hardenable resin and the other part as a
resin hardener.
25. A container for enclosing a medical instrument having a sharp
extent, comprising a container housing having an upper chamber, a
middle chamber and a lower chamber, said upper chamber having an
upper end for insertably receiving said instrument and for
accommodating a first component of a two-component hardenable
compound, said middle chamber accommodating a second component of
said two-component hardenable compound, a rupturable divider
disposed between said upper chamber and said middle chamber, said
divider being rupturable upon said instrument insertion to cause
said first and second components to mix in said middle chamber and
harden around a portion of said inserted instrument, a penetrable
wall disposed between said middle chamber and said lower chamber,
said wall being penetrable by a sharp extent of said instrument,
said lower chamber being configured to receive and accommodate the
sharp extent of said inserted instrument.
26. A container according to claim 25, wherein said middle chamber
is defined by a first cup received in said container housing, said
first cup having side walls and a lower wall, and an open upper
end, said lower wall defining said penetrable wall.
27. A container according to claim 26, wherein said container
housing is generally elongate and includes a closed lower end
opposite said open upper end, said first cup being disposed in said
container housing such that said lower wall and said housing closed
end bound said lower chamber.
28. A container according to claim 27, wherein said container
housing tapers toward said lower closed end and flares outwardly
toward said upper open end.
29. A container according to claim 28, wherein said first cup
tapers toward said lower wall and is received in said housing
flared portion.
30. A container according to claim 27, wherein said upper chamber
is defined by a second cup received in said container housing, said
second cup having side walls and a bottom wall, and an open upper
end, said bottom wall defining said rupturable wall.
31. A container according to claim 30, wherein said second cup is
disposed relative to said first cup such that said bottom wall of
said second cup and said lower wall of said first cup bound said
middle chamber.
32. A container according to claim 30, wherein said rupturable wall
comprises a plurality of weakened score lines in said bottom wall
that are adapted to break open upon insertion of said sharp extent
of said instrument.
33. A container according to claim 30, wherein said rupturable wall
comprises a breakable hinged floor in said bottom wall including a
plurality of weakened score lines and a flexible hinged portion,
said score lines being adapted to break upon insertion of said
sharp extent of said instrument, with said floor being hingedly
openable as a result thereof.
34. A container according to claim 30, wherein said rupturable wall
comprises a plug that is separable from said bottom wall upon
insertion of said sharp extent of said instrument.
35. A container according to claim 30, wherein said first cup, said
second cup and said container housing are assembled in interference
fit.
36. A container according to claim 30, wherein said second cup
comprises a pierceable foil sealing lid disposed over said upper
chamber.
37. A container for enclosing a hypodermic needle supported by a
hub, comprising: an elongate container housing having an interior
space, a lower closed end and an upper open end, said interior
space adjacent said closed end of said housing defining a first
chamber; a first cup having side walls, a bottom wall and an upper
opening and defining a second chamber therein, said first cup being
received in said upper open end of said housing with said bottom
wall communicating with said first chamber, said second chamber
configured to accommodate a first component of a two-component
hardenable compound; a second cup having side walls, a lower wall
and an upper opening and defining a third chamber therein, said
second cup being received in said upper open end of said housing
adjacent said first cup, the lower wall of said second cup
communicating with said second chamber, said third chamber
configured to accommodate a second component of said two-component
hardenable compound; said lower wall of said second cup being
rupturable upon insertion of said hypodermic needle into said
housing to cause said first and second components to mix and harden
substantially in said second chamber; and said bottom wall of said
first cup being penetrable upon insertion of said hypodermic needle
to allow said needle to pass therethrough and be accommodated
within said first chamber, with said hub being accommodated in said
second chamber for encapsulation by the hardening of said compound
therearound.
38. A container according to claim 37, further including a cover
disposed over said third chamber.
39. A container according to claim 38, wherein said cover comprises
a pierceable foil sealing lid.
40. A containment system for encapsulating a sharp medical
instrument comprising: means for separably containing two liquid
components of a two-part hardenable compound and for insertably
receiving a sharp medical instrument to be encapsulated; and means
supported by said containing means for separating said two liquid
components being and responsive to said insertable receipt of said
sharp medical instrument for rupturing, thereby causing mixture of
said two components into a hardenable compound that hardens around
and thereby encapsulates said sharp medical instrument.
41. An apparatus for enclosing a medical instrument having a sharp
extent, comprising: means for holding a first component of a
two-part hardenable compound; means for separably holding a second
component of a two-part hardenable compound; means between said
first component and said second component for rupturing upon
engagement by said sharp extent of said medical instrument to
thereby allow said first component and said second component to mix
and thereby harden around a portion of said medical instrument; and
means separate from said means for holding said first component and
said means for holding said second component for enclosably
accommodating said sharp extent of said medical instrument.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to Provisional Application,
Serial No. 60/225,874, filed on Aug. 17, 2000 and entitled
"Containment System For Encapsulating A Sharp Medical
Instrument".
FIELD OF THE INVENTION
[0002] The present invention relates generally to a containment
system for disposal of a sharp medical instrument such as a
hypodermic needle. More particularly, the present invention relates
to a containment device which quickly and permanently seals, plugs
and encapsulates an inserted needle, making it unusable and
allowing the safe disposal thereof.
DISCUSSION OF THE RELATED ART
[0003] The handling and disposal of used medical instruments,
particularly sharp medical instruments such as hypodermic needles,
suture needles, lancets, trocars, scalpel blades and the like is a
major problem facing healthcare professionals. Blood-born pathogens
can be easily transmitted by inadvertent contact with the used
medical instrument such as by accidental needle sticks.
[0004] In order to avoid such accidental needle sticks, especially
immediately after using the medical instrument, the healthcare
professional will attempt to cover the needle with a protective cap
or sheath so that the instrument can be safely transported for
disposal. The provision for caps and sheaths affords some degree of
protection, however many accidental needle sticks occur while
trying to place the cap or sheath back on the needle in preparation
for transport for disposal.
[0005] In the absence of re-capping or re-sheathing, quite often
the used medical instrument is transported uncovered to a sharps
container which ideally is located proximate to the site. The
sharps container holds several used medical instruments in a hard
puncture-resistant package which is subsequently collected for
final disposal. However, this still requires the healthcare
professional to handle and transport the unprotected needle after
use. Also, the collected used instruments remain on site in the
sharps container until collected for final disposal.
[0006] The art has seen many devices for capping, closing and
sheathing used sharp medical instruments for disposal. Many of
these devices simply enclose the entire medical instrument, or at
least the sharp portion thereof in a protective enclosure. Other of
these devices attempt to encapsulate or surround the used medical
instrument with a composition which hardens around the sharp
portion of the instrument, providing permanent containment and
protection.
[0007] One such encapsulation system is shown in U.S. Pat. No.
5,322,165 where a two-part hardenable compound is provided in a
container which accepts a sharp medical instrument such as a
hypodermic needle. The container of the '165 patent supports a
hardenable resin such as a cyanoacrylate ester and a filler of
particulate matter in spaced separation. The filler includes an
accelerator which is used to speed up the hardening of the resin.
The resin and the filler accelerator are separated by a rupturable
partition such as thin glass. The used medical instrument, such as
a needle, is inserted into the container, rupturing the glass
membrane between the two components, thereby causing the components
to come together and harden around the needle.
[0008] Another encapsulation system for a sharp object is depicted
in U.S. Pat. No. 4,845,923 wherein a container holds a first liquid
reactive agent and a porous foam impregnated with a second reactive
agent. A pierceable membrane separates the porous impregnated foam
from the first reactive agent. Upon piercing the membrane, the
first reactive agent is absorbed by the foam which then, as a
result of hardening, encapsulates the sharp object.
[0009] As may be appreciated, the length of time it takes for the
resin and accelerator to react and harden around the needle is of
particular importance. If, upon insertion of the needle into the
container, the hardening process takes too long, there is risk that
the needle can be removed from the container, thereby exposing the
healthcare professional to an increased risk of accidental needle
stick. Further, if the components in the container require some
form of agitation to assure complete hardening, such as may be the
case where one of the components is a particulate matter such as a
filler, the subsequent mixing operation by the healthcare
professional may present additional risks or, as significantly, if
done improperly, may result in incomplete hardening around the
inserted needle and failure to plug the needle itself.
[0010] It is, therefore, desirable to provide an improved
containment system for supporting a two-part hardenable compound
which is quickly mixed so that hardening can occur upon simple
insertion of the sharp medical device into the container to harden
around the needle as well as plug the needle making it
unusable.
SUMMARY OF THE INVENTION
[0011] The present invention provides a containment system for
encapsulating a sharp medical instrument. The containment system
includes a container having an end for insertably receiving the
sharp medical instrument. The container supports a pair of liquid
components of a two-part hardenable resin material. The two liquid
components include a hardenable resin first part and a resin
hardener second part, each of which are separated by a rupturable
divider which is ruptured upon instrument insertion. The components
are mixed upon rupture of the divider and harden to encapsulate the
inserted medical instrument.
[0012] In one particular embodiment of the present invention, the
container includes an open ended container base which accommodates
one of the pair of liquid components, and an open ended container
cap which insertably receives the medical instrument and
accommodates the other of the pair of liquid components. The cap is
positioned and secured over the open end of the base with the
rupturable divider being positioned therebetween. The rupturable
divider may be a glass wafer which is shatterable upon instrument
insertion.
[0013] The compounds may include a hardenable resin and a resin
hardener. The hardenable liquid resin may be selected from a
variety of resins which can be cured rapidly (meth)acrylates,
cyanoacrylates, vinyls, epoxies and combinations thereof. For
example, anaerobically curable resins, polyurethane polyacrylate
resins, epoxy resins, cyanoacrylates, vinyl resins, silicones,
silicone-acrylate resins may be employed. The liquid resin hardener
may be selected in accordance with the type of hardenable resin
employed. For example, free radical initiators, metal catalysts,
acidic or basic catalysts and/or accelerators may be employed. For
purposes of this invention, the term "liquid resin hardener" will
include any material, such as initiators, catalysts, accelerators,
and promoters, which when mixed with the hardenable resin causes
the resin to harden.
[0014] In further embodiments, the rupturable divider may include a
break-away wall which is snap-fitted onto the container cap and is
broken away by instrument insertion.
[0015] In a method aspect of the present invention, a method of
encapsulating a sharp medical instrument is provided. The method
includes inserting the instrument into a container supporting a
pair of liquid components of a two-part hardenable compound. The
components are separated by a rupturable divider. Upon inserting
the instrument into container, the divider is ruptured and the
components become mixed so as to cause the compound to harden
around the instrument.
[0016] In a further particular aspect of the present invention, a
container for enclosing a medical instrument having a sharp extent
comprises a container housing having an upper chamber, a middle
chamber and a lower chamber. The upper chamber has an upper end for
insertably receiving the instrument and for accommodating a first
component of a two-component hardenable compound. The middle
chamber accommodates a second component of the two-component
hardenable compound. A rupturable divider is disposed between the
upper chamber and the middle chamber, the divider being rupturable
upon instrument insertion to cause the first and second components
to mix in the middle chamber and harden around a portion of the
inserted instrument. A penetrable wall is disposed between the
middle chamber and the lower chamber, the wall being penetrable by
a sharp extent of the instrument, the lower chamber being
configured to receive and accommodate the sharp extent of the
inserted instrument.
BRIEF DESCRIPTION OF DRAWINGS
[0017] FIG. 1 is an exploded vertical section of one embodiment of
the containment system of the present invention.
[0018] FIG. 2 is a vertical sectional showing of the assembled
containment system of FIG. 1.
[0019] FIGS. 3, 4 and 5 are sectional showings of containment
system of FIG. 1, including two-part liquid encapsulate
accommodated therein, with the figures showing progressively the
insertion of a needle thereinto.
[0020] FIG. 6 is a vertical section of a further embodiment of the
containment system of FIG. 1.
[0021] FIGS. 7-10 are vertical sections of additional embodiments
of the containment system of the present invention.
[0022] FIG. 11 is a schematic showing of a tray used to support a
plurality of containment devices shown in FIGS. 1-10.
[0023] FIG. 12 is a perspective view of a further particular form
of a container for encapsulating a sharp medical instrument in
accordance with the present invention.
[0024] FIG. 13 is a perspective vertical sectional view of the
container of FIG. 12.
[0025] FIG. 14 is a vertical sectional view of the container of
FIG. 12.
[0026] FIG. 15 is a perspective view of an upper cup component of
the container of FIG. 14 for accommodating one component of a
two-component hardenable compound.
[0027] FIGS. 15(a) and 15(b) are perspective views of variations of
the upper cup component of FIG. 15.
[0028] FIG. 16 is a vertical sectional view of the container of
FIG. 12 shown in encapsulating assembly with a hypodermic
needle.
DETAILED DESCRIPTION OF THE INVENTION
[0029] The present invention provides a containment system for the
encapsulation of a sharp medical instrument such as a hypodermic
needle. The containment system is easy to use and quickly
encapsulates the needle after use, thus reducing the incident of
accidental needle stick by making it non-reusable.
[0030] With reference to FIGS. 1 and 2, one embodiment of the
present invention provides a containment assembly for supporting
and separating two liquid components of a two-part hardenable
compound. A first liquid component is supported in spaced
separation from second liquid component. In the present invention,
first component may be a liquid hardenable resin of the type
selected from the group consisting of anaerobically curable resins,
epoxy resins, cyanoacrylates, vinyl resins, silicones,
silicone-acrylate resins and combinations thereof. A second
component may include a liquid resin hardener selected from the
group consisting of free radical initiators, metal catalysts,
acidic or basic catalysts or combinations thereof. The two liquid
components forming the liquid hardenable resin and the liquid resin
hardener are miscible. Thus, upon mixing the liquid hardenable
resin with the liquid resin hardener, the liquid components rapidly
harden, and, as will be disclosed in further detail hereinbelow,
completely encapsulate an inserted sharp medical instrument such as
a hypodermic needle.
[0031] The containment assembly 10 preferably includes three
assembled components. A base 16 supports a liquid resin hardener 12
while a cap 18 supports a liquid resin 14. A rupturable divider in
the form of a membrane or wafer 20 is supported between cap 18 and
base 16, so as to contain hardener 14 in the cap and to separate
resin hardener 12 from liquid resin 14. As may be appreciated,
alternatively, the base may support the resin while the cap
supports the hardener.
[0032] While the components forming containment assembly 10 may
take various shapes and configurations, base 16 is generally a
cup-shape member having a closed bottom surface 22 and an opposed
open end 24, with a circumferential sidewall 26 extending
therebetween. Base 16 defines an interior 17 for accommodating
liquid hardenable resin 12 at the lower end thereof. The distal
extent of sidewall 26 defines a rim-like seat 30 for supporting
rupturable wafer 20 thereon. Also, base 16 includes an outwardly
extending lip 31, which as will be described in detail hereinbelow,
provides for securement of cap 18 thereto.
[0033] Cap 18 is generally an elongate member having an enlarged
lower open end 32 and an opposed upper end 34, closed by a
transverse puncturable wall 36. An elongate circumferential
sidewall 38 extends between lower end 32 and upper end 34 of cap
18.
[0034] Base 16 and cap 18 may be formed of any suitably rigid
material, preferably molded plastic which, with the exception of
transverse wall 36, is resistant to puncture by a sharp medical
instrument such as a hypodermic needle. It is also preferable that
base 16 and cap 18 be formed of a transparent or translucent
material so as to permit viewing of the components of the two-part
compound, as well as the insertion of the sharp medical instrument
therein.
[0035] As shown in FIGS. 1 and 2, cap 18 is attachable to base 16,
with wafer 20 being secured therebetween. The enlarged lower end 32
of cap 18 fits in a frictionally secured relationship with the
extending lip 31 of the upper end of base 16. By such securement
wafer 20, seated on rim 30, is captively secured between base 16
and cap 18. While frictional securement of cap 18 to base 16 is
shown, other securement techniques such as interfitting snap rings
and/or screw securement may also be employed. Wafer 20 with cap 18
defines a cap interior 19 for accommodating resin 14.
[0036] Wafer 20 is preferably formed of shatterable material, such
as glass. As such, upon contact with the sharp medical instrument
during insertion thereof, the glass wafer 20 will shatter.
Shattering of wafer 20 assures that the interior 19 of cap 18 is
placed in communication with the interior 17 of base 16 so as to
cause the liquid resin 14 to flow from interior 19 into interior 17
and mix with resin hardener 12 in base 16. While shatterable glass
is preferred, the present invention may be employed with any
rupturable membrane supported between cap 18 and base 16.
[0037] Transverse wall 36, extending across and closing the upper
end 34 of cap 18, may be integrally formed therewith or may be
formed by a separate component placed therein. Transverse wall 36
is readily puncturable by the insertion of a hypodermic needle or
other sharp medical instrument. The puncturability of transverse
wall 36 is provided by the thinness of wall 36, where the wall is
formed integrally with cap 18. Where wall 36 is formed separately
from cap 18, the puncturability of wall 36 may be provided by its
thinness or by the particular material from which it is formed,
such as thin metal foil. Prior to puncturing, however, transverse
wall 36 serves to enclose the interior 19 of cap 18, providing
containment of liquid resin 14 therein.
[0038] Having described the components of containment assembly 10
of the present invention, its operation in encapsulating an
inserted medical device may now be described with respect to FIGS.
3-5. In the description hereinbelow, the inserted sharp medical
device is shown as a needle 40, such as a hypodermic needle.
However, it may be appreciated that any other sharpened medical
device may also be employed in combination with the containment
assembly 10 of the present invention.
[0039] As shown in FIG. 3, after using needle 40, the needle may be
inserted into the open upper end 34 of cap 18. The sharp point 42
of needle 40 punctures puncturable transverse wall 36. Due to the
thinness and/or material forming wall 36, the wall is in close
contact with needle 40 which may assist in providing a wiping
action as the needle is inserted thereinto. The needle progresses
until the sharpened tip 40 makes contact with glass wafer 20.
[0040] As shown in FIG. 4, upon the contacting of tip 42 with glass
wafer 20 and upon continued insertion, the needle shatters glass
wafer 20. The shattering of the glass wafer 20 causes an immediate
opening of the passage between interior 19 of cap 18 and the
interior 17 of base 16. This places the liquid resin hardener 12 in
communication with the liquid resin 14. Once in contact, and with
the liquid hardenable resin and the liquid resin hardener being
miscible, immediate mixing and hardening of the combined materials
takes place. The hardening occurs as the needle 40 is pushed fully
into the base 16 until it approaches or is stopped by the bottom
wall 22 thereof. The risk of puncturing the bottom wall is
prevented by forming the base of a suitably rigid plastic.
[0041] Since the materials forming the compound are liquid, some of
the combined material 50 will actually flow into the hollow
interior channel of needle 40. This results in plugging the
interior channel rendering the needle non-reusable. The admixing of
the liquid hardened resin with the resin hardener causes
encapsulation of the needle 40 within base 16 rapidly, and
desirably in a matter of seconds. The needle 40 is thereby
permanently encapsulated and contained within the containment
assembly 10, preventing removal of the needle therefrom. Such
containment prevents any occurrence of an accidental needle stick.
The containment assembly 10 with the needle permanently
encapsulated therein may now be safely transported for
disposal.
[0042] Useful hardenable resins include any liquid resin which when
admixed with the liquid resin hardener cures in a sufficiently
rapid time to be commercially acceptable for the device of the
present invention. Usually, an acceptable hardening time is about
20 seconds to about 40 seconds. More desirably, the hardening time
is about 20 seconds. Useful resins include anaerobically curable
resins, polyurethane polyacrylate resins, epoxy resins,
cyanoacrylates, vinyl resins, silicone resins, and
silicone-acrylate resins. Combinations and copolymers of such resin
materials are also useful.
[0043] More specifically, useful anaerobically curable resins
include those based on mono- and poly(meth)acrylate monomers. Such
resins are described, for example, as U.S. Pat. Nos. 3,043,820 and
3,046,262 to Loctite Corporation, which are incorporated herein by
reference.
[0044] Resin hardeners particularly useful with anaerobic curing
resins include solutions of metal salts. The use of salt solutions
facilitates the mixing of the resin hardener with the hardenable
resin to obtain rapid hardening. Virtually any transition metal
salt solution may be employed, but salt solutions of copper, iron,
nickel and zinc are most desirable. Examples of useful copper salts
include copper octonate and the diketone salts of copper.
Accelerators typically employed with anaerobic systems may also be
incorporated in the resin hardener component. Amines are frequently
used as accelerators in compatible organic carriers, such as
tetraethylene glycol esters. Amines may be effectively combined
with saccharin. Hydrazine derivatives and sulfonamides are also
useful as accelerators. A description of various useful
accelerators can be found in U.S. Pat. Nos. 3,203,941; 3,218,305;
4,180,640 and 4,287,330 to Loctite Corporation.
[0045] Useful cyanoacrylate resins include those described in U.S.
Pat. Nos. 2,784,215 to Joyner and 3,742,018 to Loctite which are
incorporated herein by reference. These resins typically employ
amines, thiols, or benzothiazole sulfenamide derivatives as resin
hardeners, as described in U.S. Pat. Nos. 3,742,018 and 3,836,377,
also incorporated herein by reference.
[0046] Epoxy resins useful in the present invention includes those
described in Epoxide Resins and Their Formulations, Plastics for
Electronics, 2.sup.nd Edition, Edited by Martin Gossey, Academic
Publisher (1999). Typical resin hardeners for epoxies, such as
amines or thiol compounds may be employed.
[0047] The relative proportions of the two parts of various curable
compositions may be chosen to ensure rapid cure. For example, in
cases where epoxy compositions are employed, generally the resin
and hardener components are admixed in approximately equimolar
proportions. In instances where anaerobic compositions or
cyanoacrylate compositions are employed, amounts of about 0.05 to
about 1 gram of resin is generally used for every 0.05 to about
0.025 grams of the resin hardener. Conventional proportions of
resin to resin hardener may be employed, depending on the
particular
[0048] Referring now to FIG. 6, further embodiment of the
containment assembly 10 of the present invention is shown.
Containment assembly 60 includes a base 62 which supports
hardenable resin and a cap 64 which supports the liquid resin
hardener. It should be understood that, in the alternative, base 62
may support the hardener and cap 64 may support the resin. Base 62
is generally a cup-shaped member having a closed bottom surface 66
and an open upper end 68 with a cylindrical side wall 70 extending
therebetween. In the present embodiment, cap 64 is also generally
cup-shaped, having an open upper end 72, a closed bottom wall 74,
and a side wall 76 extending therebetween. In the present
embodiment, bottom wall 74 may be formed by a shatterable material
such as glass, or shatterable plastic which is easily shattered
upon needle insertion as described above with respect to the
embodiment of FIGS. 1-5.
[0049] Also, in order to assure that inserted needle contacts the
shatterable bottom wall 74, side wall 76 includes a conical wall
portion 76. The conical shape of wall portion 76 helps guide the
inserted needle towards the shatterable bottom wall 74, which is
generally positioned at the apex thereof. To further assure proper
contact between bottom wall 74 and the inserted needle, the bottom
wall includes an upwardly extending annular ridge 75. Ridge 75
accommodates the needle as it is inserted. Further, in order to
prevent the needle from prematurely puncturing side wall 76, the
cup-shaped cap 64 is formed of rigid plastic which resists needle
puncture.
[0050] Cap 64 is inserted in position within the interior 71 of
base 70, and includes a radially extending annular lip 78 which
sits atop a rim-like seat 73 adjacent to the open upper end 68 of
base 62. The securement of cap 64 to base 62 may be by frictional
engagement or may be provided by other mechanical securement
techniques such as a snap-fit. The engagement of lip 78 with seat
73 may be established such that a seal is provided
therebetween.
[0051] The embodiment shown in FIG. 6 operates in a substantially
similar manner to the embodiments shown in FIGS. 1-5 whereupon
shattering of the bottom wall 74, the liquid resin hardener is
placed in immediate communication with the hardenable resin. The
extremely miscive nature of the components provides for hardening
around the inserted instrument.
[0052] Referring now to FIG. 7, a further embodiment of the present
invention is shown. Containment assembly 80, shown in FIG. 7,
includes a base 82 referred to as a lower reservoir and a cap 84
referred to as an upper reservoir which are substantially identical
to those shown and described with respect to FIG. 6. The bottom
wall 86 of cap 84 is formed of a separate member which is attached
to the conical portion 89 of side wall 88 by a releasable snap fit.
In the present illustrative embodiment, bottom wall 86, which is
itself conical in shape, includes an outwardly extending annular
rib 90 which is snap-fitted into a corresponding groove 92 at the
distal end of side wall 88. The rib and groove snap-fit arrangement
between bottom wall 86 and side wall 88 provides for releasable
securement thereof. Upon insertion of the medical instrument,
bottom wall 86 is detached from side wall 88 so as to place the
components respectively contained in base 82 and cap 84 in
immediate communication. As with the embodiment of FIG. 6, the side
wall 88 is formed of rigid plastic to assure that the inserted
instrument is guided toward conical bottom wall 86 so as to effect
detachment thereof.
[0053] As shown particularly in the embodiment of FIG. 7, cap 84
may include a puncturable transverse covering 95 which encloses the
interior of cap 84. Covering 95 functions similar to transverse
wall 36 of the embodiment of FIGS. 1-5.
[0054] FIG. 8 shows a further embodiment of the present invention
which is substantially similar to the embodiment shown in FIG. 7
having a base 91 and cap 93. However, in the embodiment shown in
FIG. 8, bottom wall 97 is a generally flat member having an
internally directed annular groove 98 which is attachable to an
outwardly extending annular rim 99 on the side wall 95 of cap 93.
As with the embodiment of FIG. 7, insertion of the medical device
serves to detach bottom wall 97 from the side wall so as to place
the respective component in communication.
[0055] With respect to FIG. 9, an additional embodiment of the
present invention is shown. This embodiment, which is substantially
similar to the embodiments of FIGS. 6-8, includes a base 100 and a
cap 102. Cap 102 has a sidewall 106 defining at the bottom thereof,
and an opening 103. Opening 103 is fitted with a releasable plug
104, which may be attached to the circumferential inner edge of
opening 103 by inwardly directed detents 108. The plug 104, which
may be formed of impenetrable plastic, is dislodged from the
sidewall 106 upon instrument insertion so as to allow communication
between the respective materials held in the cap and the base.
[0056] The concept of the funnel or conical shape may be practiced
with an embodiment of the invention similar to that shown in FIGS.
1-6.
[0057] FIG. 10 shows a further embodiment of the invention where a
base 116 and a cap 118 are separated by a glass wafer 120. The cap
118 may include a funnel or conically shaped interior cavity 117.
Similarly, base 116 may include a conically shaped upper interior
section 119 which serves to funnel the contents of cap 118 to the
bottom of the base 116 after glass wafer 120 is shattered.
[0058] In a typical laboratory or other medical setting, it is
often necessary to use multiple needles at one time. The present
invention contemplates placing or arranging plural containment
assembly of the types shown in FIGS. 1-9 in a mutually supported
array.
[0059] As an example, the containment assemblies may be held in a
10.times.10 arrangement in a tray 150 shown in FIG. 11. Tray 150
includes compartments 152 which may each support one containment
assembly. As may be appreciated, other number arrays may also be
employed. Further, other techniques may also be used in supporting
plural containment assemblies in a grid-like array.
[0060] Referring now to drawings FIGS. 12, 13 and 14, there is
shown a particular arrangement of a container 200 for encapsulating
a hypodermic needle. In this particular arrangement, container 200
is a three-component structure, comprising a container housing 202,
a first cup 204 and second cup 206. While each of the housing 202,
first cup 204 and second cup 206 is formed of molded plastic, it
should be appreciated that other materials suitable for
encapsulation purposes may be used.
[0061] Container housing 202 is of generally elongate, vial-like
configuration having a closed lower end 208 and an open upper end
210 and an interior space 212. In one form of the housing
configuration as shown particularly in FIGS. 12 and 13, the lower
end of the housing 202 tapers downwardly to a narrowing interior
space toward the closed end 208 while the upper end of the housing
202 flares outwardly to an expanding interior surface toward the
upper end 210. Adjacent the upper end of the housing 202 a
circumferential recess 214 is provided for receipt therein of the
first cup 204, as will be described.
[0062] First cup 204 comprises sidewalls 216, a lower wall 218 and
an open upper end 220. First cup 204 is particularly formed to have
a tapering configuration narrowing toward the lower wall 218 and is
adapted for insertion into the flared upper end of container
housing 202 as shown. First cup 204 is formed to have an outwardly
extending flange 222 that is particularly configured to be received
in interference fit in housing recess 214.
[0063] In assembly with the housing 202, first cup 204 is disposed
therein such that lower wall 218 is axially spaced from the closed
end 208 defining thereby a lower chamber 224 for receipt therein of
the sharp extent of a hypodermic needle as will be detailed. First
cup 204 further defines in assembly with the container housing 202,
a middle chamber 226. Middle chamber 226 is adapted to accommodate
therein a first component of a two-component hardenable compound.
In one arrangement, a liquid resin 14 of the type described herein
is accommodated in middle chamber 226 of first cup 204. Lower wall
218 of first cup 204, while supporting the liquid resin 14 therein,
is formed to be penetrable by the sharp extent of a hypodermic
needle or other sharp object for receipt therethrough. While some
seepage of compound may occur through the lower wall 218, it is
intended that the hardenable compound be substantially retained in
the middle chamber 226. First cup 204 is further formed at its
upper end 220 to have a circumferential recess 228 for receipt
therein of the second cup 206.
[0064] Referring now also to FIG. 15, the details of second cup 206
are described. Second cup 206 is of generally cylindrical
configuration having circumferential side walls 230, a rupturable
bottom wall 232 and an open upper end 234. Second cup 206 further
includes an outwardly projecting circumferential flange 236
particularly configured for interference fit with recess 228 of
first cup 204. It should be appreciated that while assembly of the
first cup 204 in housing 202 and the assembly of the second cup 206
in the recess of the first cup 204 are described as being in
interference fit, other suitable techniques for assembling these
components may be used within the context of the invention. In
assembly with the first cup 204 and the housing 202, the second cup
206 defines an upper chamber 238 that particularly accommodates a
liquid resin hardener 12, of the type described herein. It should
be appreciated that while a liquid resin 14 is shown and described
as being accommodated in middle chamber 226 and a liquid resin
hardener 12 is described as being contained in upper chamber 238,
the resin 14 and hardener 12 may be reversed. A pierceable foil lid
240 is provided over the upper chamber 238 to hold the liquid resin
hardener 12 therein.
[0065] In assembly, the bottom wall 232 of the second cup 206 is
disposed above the middle chamber 226. In one particular aspect,
the bottom wall 232 is formed to have a series of radially
projecting weakened score lines 242 that are adapted to break upon
the insertion of the sharp extent of an object to be encapsulated
in the container 200.
[0066] In another form of the second cup 206a as shown in FIG.
15(athe rupturable bottom wall 232a formed to have a rupturable
hinged door 244. Hinged door 244 in one particular arrangement, is
rectangular and is defined by three weakened score lines 245
forming three edges of the hinged door 244 and one non-scored edge
defining a hinge for door 244. Upon insertion of the sharp extent
of an object such as a hypodermic needle to be encapsulated, the
weakened score lines 245 are adapted to break open and the door 244
is rotatably openable about the non-scored edge which effectively
provides a flexible hinge.
[0067] A further example of the second cup 206b is illustrated with
reference to FIG. 15(b). The bottom wall 232b is provided with a
plug 246 that is adapted to fully break and separate from the
rupturable bottom wall 232b upon insertion of the sharp extent of
the object to be encapsulated. Having described three particular
configurations of a rupturable bottom wall of the second cup 206,
it should be appreciated that other variations may be made within
the contemplated scope of the invention.
[0068] Turning now to FIG. 16, the encapsulation of a hypodermic
needle by the container of the present invention is described.
Hypodermic needle 248 comprises a hub 250 and an elongate sharp
extent 252. After assembly of the first cup 204 and second cup 206
with container housing 202 as described herein, the hypodermic
needle is protected as follows. The sharp extent 252 first pierces
through foil lid 240 and then through the rupturable bottom wall
232 of the second cup 206. Upon rupturing of the bottom wall 232,
the liquid resin hardener 12 flows under gravity completely out
from the upper chamber 238 into the middle chamber 226 wherein it
mixes with the liquid resin 14 to form hardenable compound 254.
Insertion of the hypodermic needle 248 continues with the sharp
extent 252 penetrating through the lower wall 218 of the first cup
204 until the hub 250 lies substantially within the middle chamber
226. Once the hub is fully disposed in middle chamber 226, the
compound 254 hardens around the hub 250 for suitable encapsulation.
The sharp extent 252, having penetrated through lower wall 218,
projects into the lower chamber 224 wherein it is completely
surrounded within the housing 202 and protected thereby. As
described herein, the encapsulated syringes may be deposited in a
tray or the like for suitable transport and disposal.
EXAMPLES
[0069] Example 1 is an example of an anaerobically curable two-part
composition useful in the present invention. Part 1 and Part 2 of
the compositions are set for the below in weight percent based on
the total weight of each part.
Example 1
[0070]
1 Part 1 Components (Resin) Wt % Poly(ethylene
glycol)dimethacrylate 79.32 Hydroxy methacrylate 10 Acrylic acid 6
1,4-Naphtaquinone 0.01 Pentasodium diethylenetriamine pentaacetic
acid (PTDA) 0.07 Deionized water 0.2 Propylene glycol 0.6 100%
[0071]
2 Part 2 Components (Liquid Hardener) Wt % 2-Ethylhexonic acid 29.0
Copper carbonate 3.5 Poly (ethylene glycol) 200 Di (2-ethyl
hexoate) 57.5 Tri butyl amine 10 100%
[0072] About 0.5 to about 1.0 grams of part 1 of the anaerobic
composition were placed in the cap of the inventive device. About
0.05 to about 0.025 grams of part 2 (resin hardener) of the
anaerobic composition were placed in the base. The barrier of the
present device was then removed, permitting each of the parts to be
combined and rapidly cure around the needle inserted therein. The
curing time was within the range of about 20 to about 40
seconds.
[0073] Example 2 demonstrates a cyanoacrylate composition used in
the present invention. The cyanoacrylate composition was formulated
into a two-part composition, each of the parts being described in
percent weight of the individual parts.
Example 2
[0074]
3 Part 1 Components (Resin) Wt % Ethyl cyanoacrylate monomer 99.899
Boron trifluoride 0.001 Hydroquinone 0.100 100%
[0075]
4 Part 2 Components (Liquid Hardener) Wt % N,N'-Dimethyl
p-toluidine 5.0 Poly(ethylene glycol)dimethacrylate 95.0 100%
[0076] Part 1 was placed in the cap of the inventive device in an
amount of about 0.5 grams. Part 2 was placed in the base of the
device in amounts of about 0.025 grams. The barrier was removed,
permitting combination of Part 1 and Part 2 and subsequent curing
to fully encapsulate the needle therein.
[0077] Example 3 demonstrates a cyanoacrylate composition used in
the present invention. The cyanoacrylate composition was formulated
into a two-part composition, each of the parts being described in
percent weight of the individual parts.
Example 3
[0078]
5 Part 1 Components (Resin) Wt % Ethyl cyanoacrylate monomer 94.898
Polymethyl Methacrylate 5.000 Boron trifluoride 0.002 Hydroquinone
0.100 100%
[0079]
6 Part 2 Components (Liquid Hardener) Wt % Glycerol Triacetate 93.0
N-Oxydiethylene Benzothiazole-2-Sulfenamide 7.0 100%
[0080] Part 1 was placed in the cap of the inventive device in an
amount of about 0.5 grams. Part 2 was placed in the base of the
device in amounts of about 0.025 grams. The barrier was removed,
permitting combination of Part 1 and Part 2 and subsequent curing
to fully encapsulate the needle therein.
[0081] In any of the Examples 1-3 set forth herein, the Part 1
(Resin) and the Part 2 (Liquid Hardener) may be placed in either
the cap or the base of the encapsulant container.
[0082] The invention being thus described, it will be evident to
those skilled in the art that the same may be varied in many ways.
Such variations are not to be regarded as a departure from the
spirit and scope of the invention and all such modifications are
intended to be included within the scope of the claims.
* * * * *