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| United States Patent |
6,019,218
|
|
Racicot
, et al.
|
February 1, 2000
|
Disposal of contaminated medical products
Abstract
A disposed system for medical waste, and particularly sharp ended waste,
includes a sharps receptacle and a companion needle holder. The needle
holder has an actuation mechanism capable of detachably mounting an
externally threaded hub of a needle assembly to the holder. The sharps
receptacle has a top with an automatic release structure disposed thereon
for engagement with the actuation mechanism of the needle holder. The
automatic release structure cooperates with the actuation mechanism of the
needle holder to automatically detach a mounted needle assembly from the
holder into the sharps receptacle in response to placement of the holder
into the automatic release structure.
| Inventors:
|
Racicot; Douglas A. (Tolland, CT);
Kinsey; P. Spencer (Newington, CT);
Holdaway; Richard G. (Storrs, CT);
Edmond; Gary L. (Canterbury, CT);
Biancardi; Gregory F. (South Windsor, CT)
|
| Assignee:
|
Bio-Plexus, Inc. (Vernon, CT)
|
| Appl. No.:
|
963283 |
| Filed:
|
November 3, 1997 |
| Intern'l Class: |
A61M 005/32 |
| Field of Search: |
206/364,366,367,368,369,370
128/763
220/908
|
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Other References
U.S. application No. 08/904,811, Racicot et al., filed Aug. 1, 1997.
|
Primary Examiner: Ackun; Jacob K.
Attorney, Agent or Firm: Libert; Victor E.
Parent Case Text
This application is a continuation of application Ser. No. 08/670,270 filed
on Jun. 21, 1996 now abandoned.
Claims
What is claimed is:
1. A sharps disposal system for automatic detachment of the hub of a
medical device from a holder comprising:
a holder, said holder including movable actuator means for detachably
mounting a hub to said holder; and
a sharps receptacle having a generally hollow base with an open end and a
generally rigid cover for closing said open end of said base, said cover
having an aperture sized and shaped to permit passage of a hub into the
interior of the receptacle, said cover also having engagement means for
engaging said actuator means of said holder, said engagement means
operating said actuator means to cause detachment of a mounted hub from
said holder, said engagement means being in spaced relationship to said
aperture in said cover whereby a hub detached from said holder by
operation of said engagement means will pass into said sharps receptacle
as a result of placement of said holder is placed into said engagement
means.
2. A sharps disposal system as recited in claim 1, wherein said actuator
means comprises a linearly movable actuation mechanism, wherein said
aperture in said cover is smaller than said holder and larger than the
largest portion of the hub, and wherein said engagement means further
comprises:
first and second guide walls for aligning said holder with said aperture,
said guide walls extending substantially perpendicularly from said cover
and being in spaced relation to said aperture; and
an actuator means engaging projection extending from said cover, said
projection engaging said actuation mechanism of said holder to thereby
cause detachment of a hub from said holder.
3. A sharps disposal system as recited in claim 2 wherein said projection
is integral with one of said guide walls.
4. A sharps disposal system as recited in claim 2 wherein said guide walls
and projection comprise separate, spatially displaced members extending
upwardly from said cover.
5. A sharps disposal system as recited in claim 2, wherein said cover
further comprises:
a hub unwinder aperture extending through said cover, said unwinder
aperture being sized and configured to engage and impede rotation relative
to a holder of a threaded hub;
an oversized aperture extending through said cover for inserting medical
waste into said sharps receptacle;
a first lid pivotably mounted to said cover for selectively opening and
closing said hub passage aperture and said unwinder aperture
simultaneously; and
a second lid pivotably mounted to said cover for selectively opening and
closing said oversized aperture.
6. A sharps disposal system as recited in claim 2,
wherein each of said first and second guide walls includes a top, an outer
surface, an inner surface which faces the inner surface of the other of
said guide walls and a chamfered edge at said top, said chamfered edge
extending downwardly from said outer surface toward said inner surface to
assist placement of said holder between said first and second guide walls.
7. A sharps disposal system as recited in claim 2, wherein said holder
includes an end cap having a recess, through which said projection can
pass, wherein said actuation mechanism includes an actuator element
slidably mounted to said holder, said actuator element having a camming
surface positioned to be contacted by a projection which passes through
said recess, and wherein said projection is sized and shaped to pass
through said recess whereby said projection will engage said camming
surface as said holder is placed between said first and second guide
walls.
8. A sharps disposal system for automatic detachment of a cannula assembly
from a holder, said cannula assembly including a hub and a cannula
extending through the hub and affixed thereto, said system comprising:
holder means for releasably holding a cannula assembly through cooperation
with the hub thereof; and
a sharps receptacle having a hollow base and a cover on said base, said
cover having a cannula assembly passage aperture and engagement means for
engaging said holder means such that the cannula assembly detaches from
said holder means and enters into said sharps receptacle via said aperture
as said holder means is placed into said engagement means.
9. A sharps disposal system as recited in claim 8, wherein said holder
means includes means for detachably mounting the cannula assembly hub to
said holder means, wherein said aperture is provided in said cover, said
aperture being smaller than said holder means and larger than the cannula
assembly hub and wherein said engagement means further comprises:
first and second guide walls for contacting said holder means to align a
cannula assembly mounted thereon with said aperture, said guide walls
extending upwardly substantially perpendicularly from said cover and being
in spaced relation to said aperture; and
a projection extending from said cover, said projection being configured
and positioned to engage said means for detachably mounting a cannula
assembly hub to said holder means, cooperation between said projection and
mounting means causing detachment of the cannula assembly hub from said
holder means in response to placement of said holder means between said
guide walls whereby the cannula assembly may fall into said base solely
under the influence of gravity.
10. A sharps disposal system as recited in claim 9, wherein said projection
is integral with one of said guide walls.
11. A sharps disposal system as recited in claim 9, wherein said guide
walls and said projection are equidistant from the center of said aperture
and are uniformly spaced about said aperture, said guide walls and
projection also being similarly configured, whereby each can perform
either a guiding or detachment causing function.
12. A sharps disposal system as recited in claim 8, wherein said cover
further comprises:
a needle unwinder aperture extending through said cover the cannula
assembly may be manually detached, said unwinder aperture being sized and
shaped to engage a cannula assembly hub to prevent rotation thereof in a
first direction;
an oversized aperture extending through said cover for inserting medical
waste into said sharps receptacle; and
lid means pivotably mounted to said cover for selectively opening and
closing said apertures.
13. A sharps disposal system as recited in claim 9,
wherein each of said first and second guide walls includes a top, an outer
surface, an inner surface which faces the inner surface of the other of
said guide walls and a chamfered edge at said top, said chamfered edge
extending downwardly and inwardly from said top to said inner surface to
guide said holder between said first and second guide walls.
14. A sharps disposal system as recited in claim 9, wherein said holder
includes an end cap having a recess with a size and shape complementary to
said projection, wherein said means for detachably mounting the cannula
assembly includes an actuator element slidably mounted to said holder,
said actuator element having a channel which is in part defined by an
inclined cam surface, said channel being sized and positioned so as to be
entered by said projection after passage thereof through said recess, and
wherein said projection is shaped to operatively engage said cam surface.
15. A sharps disposal system for automatic detachment of a needle assembly
from a holder, the needle assembly including an elongated member affixed
to said hub, said system comprising:
a needle holder, said needle holder having a hollow body with an end wall
at a closed first end thereof, said end wall having an aperture
therethrough, said hollow body also having an open second end disposed
opposite to said first end for receiving a fluid container within said
hollow body;
housing means abutting said first end of said hollow body for maintaining
at least a portion of an actuation mechanism within said holder, said
housing means including means defining an aperture therethrough which is
generally coaxial with said aperture of said needle holder end wall; and
an actuation mechanism for releasably mounting a threaded needle assembly
hub to said holder with one end of the needle extending forwardly of said
actuation mechanism for venipuncture and the other end extending
rearwardly into said hollow body for cooperation with a fluid container
received in said body, said actuation mechanism including:
first and second threaded halves mounted within said housing means for
removably mounting the needle assembly hub upon threading of the hub into
said actuation mechanism, at least one of said first and second threaded
halves being pivotable between a hub-mounting position, and a retracted
position;
means for pivotably mounting at least one of said first and second threaded
halves within said housing means; and
actuation means slidably mounted to said housing means for movement between
an initial position wherein at least one of said first and second threaded
halves is urged into said cannula-mounting position, and a secondary
position wherein at least one of said first and second threaded halves is
urged into said retracted position; and
a sharps receptacle having a base and a cover on said base, said cover
having engagement means for operatively engaging said actuation means such
that the needle assembly detaches from said actuation mechanism and enters
into said sharps receptacle as a result of placement of said holder into
said engagement means.
16. A sharps disposal system as recited in claim 15, wherein said cover
includes a needle passage aperture, said needle passage aperture being
smaller than said holder and larger than the largest portion of the needle
assembly and wherein said engagement means further comprises:
first and second guide walls for aligning said holder with said needle
passage aperture, said guide walls extending upwardly substantially
perpendicularly from said cover and being in spaced relation to said
aperture; and
a projection for engaging said actuation mechanism of said holder to detach
the needle assembly from said holder into said sharps receptacle as said
holder is placed between said first and second guide walls.
17. A sharps disposal system as recited in claim 16, wherein said cover
further comprises:
an oversized aperture extending through said cover for inserting medical
waste into said sharps receptacle; and
lid means pivotably mounted to said cover for selectively opening and
closing said aperture.
18. A sharps disposal system as recited in claim 16,
wherein said projection is integral with one of said guide walls and
wherein each of said first and second guide walls includes a top, an outer
surface, an inner surface which faces the inner surface of the other of
said guide walls and a chamfered edge at said top, said chamfered edge
extending downwardly and inwardly from said top to said inner surface to
assist placement of said holder between said first and second guide walls.
19. A sharps disposal system as recited in claim 16 wherein said guide
walls and projection comprise separate, spatially displaced members
extending upwardly from said cover.
20. A sharps disposal system as recited in claim 16, wherein said holder
includes an end cap having a recess sized and shaped to permit passage of
said projection therethrough, wherein said actuation means includes an
actuator element slidably mounted to said holder, said actuator element
having a channel with an inclined bottom surface which is substantially
aligned with said recess, and wherein said projection has a cross-section
and shape complementary to said recess, said projection passing through
said recess and engaging said channel bottom surface as said holder is
placed between said first and second guide walls.
21. A sharps disposal system for automatic detachment of a cannula assembly
from a holder, the cannula assembly including a hub, said system
comprising:
a needle holder, said needle holder having a hollow body with an end wall
at a closed first end thereof, said end wall having an aperture
therethrough, said hollow body also having an open second end opposite to
said first end for receiving a fluid container within said hollow body;
housing means affixed to and abutting said first end of said hollow body
for maintaining at least a portion of an actuation mechanism within said
holder, said housing means including means defining an aperture
therethrough which is generally coaxial with said aperture of said holder
end wall; and
an actuation mechanism positioned in said housing means for detachably
mounting a cannula assembly hub to said holder in with one end of the
cannula extending forwardly of said actuation mechanism for venipuncture
and the other end extending rearwardly into said hollow body for
engagement with a fluid container received therein, said actuation
mechanism including:
first and second mounting jaws rotatably mounted within said housing means
for removably mounting the cannula assembly hub upon insertion of the hub
into said actuation mechanism, said first and second mounting jaws being
pivotable between a mounting position wherein said mounting jaws cooperate
to define a passageway complementary in cross-sectional shape to the
cross-sectional shape of the cannula assembly hub, and a retracted
position wherein said mounting jaws cooperate to define an opening larger
than the cannula assembly hub;
a pivot axle for rotatably mounting said first and second mounting jaws
within said housing means; and
actuation means for urging said first and second mounting jaws between said
cannula assembly-mounting and retracted positions, said actuation means
being slidably mounted to said housing means for linear reciprocal
movement between an initial position wherein said first and second
mounting jaws are urged into said mounting position, and a second position
wherein said first and second mounting jaws are urged into said retracted
position; and
a sharps receptacle having a base and a cover, said cover having engagement
means for engaging said actuation means such that the cannula assembly
detaches from said holder in response to placement of said holder into
said engagement means.
22. A sharps disposal system as recited in claim 21, wherein said cover
includes a needle passage aperture, said needle passage aperture being
smaller than said holder and larger than the largest cross-section of the
cannula assembly and wherein said engagement means further comprises:
first and second guide walls for aligning said holder with said needle
passage aperture, said guide walls extending substantially perpendicularly
from said cover and being in spaced relation to said aperture; and
an actuation means operating projection extending from said cover, said
projection engaging said actuation means of said holder to cause
detachment of the cannula assembly from said holder.
23. A sharps disposal system as recited in claim 21 wherein said guide
walls and projection comprise separate, spatially displaced members
extending upwardly from said cover.
24. A sharps disposal system as recited in claim 22, wherein said cover
further comprises:
an oversized aperture extending through said cover for inserting medical
waste into said sharps receptacle; and
lid means pivotably mounted to said cover for selectively opening and
closing said oversized aperture.
25. A sharps disposal system as recited in claim 22,
wherein said projection is integral with one of said guide walls and
wherein each of said first and second guide walls includes a top, an outer
surface, an inner surface which faces the inner surface of the other of
said guide walls and a chamfered edge at said top, said chamfered edge
extending downwardly from said outer surface toward said inner surface to
assist placement of said holder between said first and second guide walls.
26. A sharps disposal system as recited in claim 22, wherein said holder
includes an end cap having a recess sized and shaped for passage of said
projection therethrough, wherein said actuation means includes an actuator
element slidably mounted to said holder, said actuator element having a
channel with an inclined cam surface which is substantially aligned with
said recess, and wherein said projection has a substantially constant
cross-section of substantially the same cross-section and size as said
recess, said projection passing through said recess and engaging said
channel cam surface as said holder is placed between said first and second
guide walls.
27. A sharps receptacle for use with a companion needle holder of the type
having a movable actuation mechanism for detachably mounting a needle
assembly therein, said receptacle comprising:
a generally hollow base with one open end;
a generally rigid cover mounted on said open end of said base, said cover
including engagement means for engaging the actuation mechanism of the
needle holder, said engagement means operating the actuation mechanism to
cause detachment of the needle assembly from the holder into said base of
said sharps receptacle as the needle holder is placed into said engagement
means.
28. A sharps receptacle as recited in claim 27, wherein said engagement
means comprises:
a needle passage aperture extending through said cover, said aperture being
smaller than the needle holder and larger than the largest portion of the
needle assembly;
first and second guide walls for aligning the needle holder with said
needle passage aperture, said guide walls extending substantially
perpendicularly from said cover and being in spaced relation to said
aperture; and
a projection extending from said guide cover, said projection engaging and
imparting movement to the actuation mechanism of the holder to detach the
needle assembly from the holder into said sharps receptacle as the holder
is placed between said first and second guide walls.
29. A sharps disposal system as recited in claim 28 wherein said projection
is integral with one of said guide walls.
30. A sharps disposal system as recited in claim 28 wherein said guide
walls and projection comprise separate, spatially displaced members
extending upwardly from said cover.
31. A sharps receptacle as recited in claim 28, wherein said cover further
comprises:
a needle unwinder aperture extending through said cover for engaging a
threaded needle assembly whereby the threaded needle assembly may be
manually detached from a holder into said sharps receptacle, said unwinder
aperture permitting rotation of an engaged assembly in only one direction;
an oversized aperture extending through said cover for inserting medical
waste into said sharps receptacle;
a first lid pivotably mounted to said cover for selectively opening and
closing said needle passage aperture and said unwinder aperture; and
a second lid pivotably mounted to said cover for selectively opening and
closing said oversized aperture.
32. A sharps receptacle as recited in claim 28,
wherein each of said first and second guide walls include a top, an outer
surface, an inner surface which faces the inner surface of the other of
said guide walls and a chamfered edge at said top, said chamfered edge
extending downwardly and inwardly from said outer surface toward said
inner surface to assist placement of said holder between said guide walls.
33. A sharps receptacle as recited in claim 28, adapted for use with a
needle holder having an actuation mechanism for detachably mounting a
cannula therein and an end cap having a recess sized and shaped for
passage of said projection therethrough, wherein said actuation means
includes an actuator element slidably mounted to said holder, said
actuator element having a channel with an inclined cam surface which is
substantially aligned with said recess, and wherein said projection has a
substantially constant cross-section of substantially the same
cross-section and size as said recess, said projection passing through
said recess and engaging said channel cam surface as said holder is placed
between said first and second guide walls.
34. Apparatus for significantly impeding rotation in only one direction of
the hub of a needle subassembly which is threadably engaged by a needle
holder, said apparatus comprising:
a container for receiving detached needle subassemblies after disengagement
thereof from the holder;
a top affixed to said container; and
an unwinder aperture in said top, said unwinder aperture being elongated
and having a centerline which extends between a pair of oppositely
disposed narrow ends, said narrow ends being interconnected by a pair of
oppositely disposed arcuate sides having the same radius, each of said
arcuate sides including a segment which defines a plurality of teeth, said
toothed segments adjoining respective narrow ends of said aperture on
opposite sides of the centerline, said toothed segments extending from
said respective opposite narrow aperture ends along opposite sides of said
aperture for a distance which is less than half of the length of the
included side.
35. The apparatus of claim 34 wherein said top further comprises:
a rim region of increased thickness which extends about at least a portion
of the periphery of said aperture.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to safely disposing of medical waste,
particularly needles and the like, in a manner which minimizes the danger
of transmission of infectious diseases. More specifically, this invention
is directed to a disposal system and, especially, to such a system which
comprises a receptacle for contaminated medical products of the type which
comprise a hub, the products also typically including a needle, the system
additionally comprising a holder which cooperates with the products so as
to cause a product mounted to the holder may be automatically detached
from the holder and deposited within the receptacle. Accordingly, the
general objects of the present invention are to provide novel and improved
methods and apparatus of such character.
2. Description of the Related Art
A wide variety of blood collection/fluid injection devices are used by the
health care industry. These devices include a hollow bored member,
hereinafter a "hub", for transferring fluid materials via a cannula,
hyopodermic needle or via the hub itself thereby providing a connective
conduit for the fluid path. The hub may be tapered, and/or may be
externally threaded or may have some other external configuration to
faciliate and provide attachment means. These hub based devices include
hypodermic syringes and blood collection/fluid injection systems. While
hypodermic syringes normally have a fluid chamber integrally formed with
the needle holder, blood collection/fluid injection systems typically
include a needle holder having a hub detachably mounted thereon so that a
needle is disposed at one end of the holder and a fluid collection tube
may be inserted in the other end of the holder.
For both economic and safety reasons a wide variety of venipuncture devices
have been developed. Economic factors have favored designs having
associated holders which allow hub removal whereby reuse of the holder is
permitted. Safety concerns, however, have pointed away from the use of
such devices because the hub removal procedure creates an increased risk
of inadvertent contact between the health care worker and a patient's
bodily fluids and, particularly, an accidental needle stick. In recent
years, increased concern about the transmission of infectious diseases,
such as HIV and HBV, has renewed interest in developing safer methods and
apparatus for disposing of infectious medical waste. Most of the
development efforts to date have been directed toward simplifying the
process of removing a hub from a holder while simultaneously minimizing
the health care worker's contact with the "sharp" which is affixed to or
integral with the hub. In particular, these efforts have been directed
toward improving both hub retaining mechanisms and complementary hub
removing means which are integrated with sharps disposal receptacles.
Sharps receptacles designed for removing a standard externally threaded hub
from a holder typically possess a hollow base portion, for receiving the
detached devices, and a cover having various shaped slots, known in the
art as unwinder apertures, for engaging a hub during needle removal. To
dispose of a previously used hub with attached needle using a conventional
sharps receptacle, a health care worker must carefully position the hub in
the appropriate slot and then grip and rotate the holder to unthread the
hub so that it and the attached needle may fall through the slot into the
underlying body of the receptacle. When using these devices, it is often
difficult to tell when the hub has been fully unwound from the holder.
Since the health care worker may be simultaneously performing other tasks,
there exists a serious danger that a hub may "hang-up" and the associated
needle inadvertently contact an unsuspecting health care worker. A further
deficiency of prior art devices of the type being discussed stems from the
lack of any product misuse prevention features. For example, the use of
hubs which only appear to be compatible with a given unwinder slot may
cause a malfunction. Where the hub is attached to a double-ended needle,
i.e., a cannula, a further danger arises after the hub is disengaged from
a holder because the hub may remain lodged in the slot, causing exposure
of the upstanding posterior end of the cannula. In such a case, the user
must physically handle the hub to remove it from the slot and permit the
cannula hub assembly to drop into the sharps receptacle.
Aside from hub-engaging unwinder slots, other medical "sharps" removal
schemes have been developed. These include the use of sharps receptacles
having movable jaws which engage the standard externally threaded hub of a
needle assembly. Such devices allow a user to unthread the hub/needle
combination from a holder by (1) inserting the hub into a sharps box
having such jaws; (2) operating the jaw mechanism to lock the hub; (3)
rotating the holder to unthread the hub from the holder; and (4) releasing
the locking mechanism to allow the now threadably removed hub and needle
combination to fall into the sharps container base. While some sharps
disposal containers of this nature can effectively remove threaded hubs,
with associated needles or cannulas from holders, they are typically
complex and costly devices, the complexity having a deleterious effect on
reliability. Additionally, such sharps receptacles still require the
health care worker to follow a relatively lengthy and complex manual
hub-unwinding procedure. As with less complicated devices having unwinder
slots, these receptacles periodically suffer from the problem of
incomplete hub unwinding. Finally, safety is again compromised by the lack
of any means for preventing operator misuse.
A similar style of disposal system, which has both increased safety and a
simplified hub removal procedure, includes a sharps receptacle with an
electric hub-unwinding mechanism. Sharps receptacles of this nature allow
a health care worker to simply insert a holder having a hub/needle
combination received therein into an aperture whereby the hub is
unthreaded from the holder by means of an electric motor. Deficiencies
associated with these mechanical sharps disposal systems include the facts
that the receptacles are (1) very expensive to build and maintain; and (2)
not easily transportable because they require some kind of electric power
supply. Further, while incomplete hub unwinding is less of a problem with
these systems, none of these power driven systems include any type of
operator misuse prevention feature.
Finally, sharps disposal systems have been proposed wherein the sharps
disposal container cooperates with a custom hub holder to effect needle
release. Some of these proposed disposal systems are allegedly compatible
with cannula assemblies having an externally threaded hub. While such a
system would theoretically increase the safety of the "sharps" removal
procedure, a rather complex series of steps would be required to achieve
removal. Thus, increased safety is achieved at the expense of simplicity
of operation. One proposed system for use with a custom holder requires
that an adapter be placed on the hub, the hub of a cannula assembly for
example, in order to make the cannula assembly compatible with the holder.
The need for a hub adaptor obviously results in a cost increase. Finally,
neither the holder nor the sharps container of the proposed systems have
any means to prevent a health care worker from using them with other,
potentially incompatible, devices. Thus, safety is again sacrificed by the
lack of operator misuse prevention features.
Co-pending U.S. patent application Ser. No. 08/580,322, filed on Dec. 28,
1995, is directed to an improved holder for a fluid collection and/or
injection system. That application has been assigned to the assignee of
the present invention and the information disclosed therein is hereby
incorporated by reference. The holder shown and described in application
Ser. No. 08/580,322 possesses an actuation mechanism at one end of the
holder. The actuation mechanism enables the mounting of the externally
threaded hub of a cannula assembly on the holder and the maintaining of
the attachment of the cannula assembly to the holder during use.
Initially, the threaded hub will be threadably engaged by the actuation
mechanism of the holder in the same manner as the hub/needle combination
would be installed in any other medical device holder which accepts a
threaded hub. Upon operation of an external actuator of the actuation
mechanism, the hub is released from the actuation mechanism whereby the
hub/needle combination will fall from the holder under the force of
gravity. In one embodiment of the holder, the actuator is in the form of a
push-button which is capable of being depressed by the operator's finger.
Thus, this medical sharps holder configuration offers both compatibility
with standard threaded hubs and a safe and simple means of removing a hub,
particularly a hub which is integral with a cannula or needle, from the
holder. However, while the holder of the co-pending application represents
a substantial advance in the sharps disposal field, some methods and
apparatus of safely disposing of used hubs from such a holder are beyond
the scope of the incorporated application. Thus, some aspects of the
sharps disposal system of the present application represent improvements
on the holder shown and described in the incorporated application.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a sharps disposal
system which will permit simple, safe and effective disposal of hubs, and
particularly hubs integrated or associated with needles and cannulas.
Another object of the invention is to provide a sharps disposal system
comprising a holder for releasably engaging a hub and a cooperating sharps
receptacle which is capable of permitting more precise and reliable
single-handed remote disposal of a standard threaded hub or hub/needle
combination.
It is yet another object of the present invention to provide such a
disposal system which permits more precise and reliable detachment of a
standard threaded cannula assembly, i.e., an externally threaded hub and
associated cannula, from a holder by simply placing the holder into a
complementary structure of a sharps disposal receptacle.
It is still another object of the present invention to provide a medical
sharps disposal system which is of simple, durable construction and is
economical to manufacture.
Another object of the present invention is to provide a sharps disposal
receptacle having a safer means for removing a hub from a cooperating
needle holder than has characterized the prior art.
Still another object of the present invention is to provide a sharps
disposal receptacle having an operator misuse prevention feature.
These and other objects and advantages of the present invention are
achieved in one embodiment by providing a holder with an actuation
mechanism capable of detachably mounting a hub, and particularly the
standard threaded hub of a needle assembly, onto the holder and a sharps
disposal receptacle having a cover with an automatic release structure for
engagement with and operation of the actuation mechanism of the holder.
In a preferred embodiment of the present invention, the actuation mechanism
of the holder component of the sharps disposal system includes an actuator
element, extending outwardly from, and slidably mounted to, the body of
the holder. The actuator element is operably associated with other
components of the actuation mechanism such that the actuation mechanism is
normally biased to a position capable of engaging the external threads on
a hub having a cannula extending therethrough for fluid transfer purposes.
The actuator element includes a release structure guide channel extending
through at least a portion of the actuator element which projects
laterally outwardly from the holder body. This channel is oriented
substantially parallel to the axis of the holder body and possesses a
sloped face. Upon operation of the actuator element, the hub of an engaged
needle assembly becomes detached from the actuation mechanism and the hub
and needle are free to fall as a unit from the holder under the force of
gravity. The holder includes an end cap for maintaining the actuation
mechanism in the holder. The end cap includes a guide channel-access
recess aligned with actuator element channel for permitting access to the
sloped face of the guide channel.
A system in accordance with the present invention also includes a sharps
disposal receptacle. In a first embodiment, this receptacle has a hollow
base (or, alternatively, body) for receiving medical waste therein and a
receptacle cover for covering the open end of the base. The cover includes
an automatic release (also referred to as "auto-release") structure which
is designed to cooperate with the holder such that a standard threaded hub
will be detached from the holder upon the establishment of operative
engagement between the automatic release structure and the actuator
element of the holder. The automatic release structure includes, in the
embodiment being described, an aperture located between, and at a spaced
distance from, a pair of holder guide walls which extend from the cover of
the sharps receptacle. The guide walls guide one end of the holder between
the inner surfaces of the guide-walls such that the hub of a hub/needle
combination received within the holder may pass through the aperture. A
shoulder on one of the guide walls is sized and shaped to pass through the
channel-access (or, alternatively shoulder-access) recess of the end cap
and mate with the sloped face of the channel in the actuator element of
the holder. Thus, as the holder moves downwardly, the shoulder imparts
linear motion to the actuator element. This, in turn, imparts motion to
the hub engaging components of the actuator mechanism, and the, now
detached, hub and needle combination passes through the aperture and into
the base of the sharps receptacle.
In accordance with a second embodiment of a sharps receptacle for use in
practice of the invention, the automatic release structure includes an
aperture located between, and at a spaced distance from, a plurality of
uniformly spaced elevated protrusions. Any pair of these protrusions may
function as the guide structure for the holder while a third protrusion
functions as the release actuation structure. As a holder is contacted by
the guide structure, and then moved downwardly, the actuation protrusion
imparts linear motion to the actuator element of the holder. This, in
turn, imparts motion to the hub engaging components of the actuator
mechanism, and the now detached hub, typically with a needle affixed
thereto, passes through the aperture and into the base of the sharps
receptacle.
A sharps receptacle in accordance with the present invention preferably
also includes novel means for manually unwinding a hub from a holder. Such
a sharps receptacle also has an oversized aperture for inserting various
other types of medical waste into the base of the sharps receptacle.
Finally, a sharps receptacle in accordance with the invention is
additionally provided with plural lids for selectively opening and closing
the various apertures in the cover of the receptacle.
The present invention offers enhanced safety characteristics relative to
prior art devices and methods. This increase in safety is partially due to
the simple operation of the auto-release feature of the sharps disposal
system. To dispose of a used hub/needle or hub/cannula combination with
the present invention, the health care worker simply orients a holder with
an engaged hub above the auto-release structure of the sharps disposal
receptacle and then places the holder into the auto-release structure. As
the actuator channel of the holder actuator element engages the shoulder
on one of the guide walls or one of the protrusions, the hub previously
mounted in the holder becomes detached and drops into the base of the
sharps receptacle.
In some embodiments of the present invention, overall safety is further
enhanced by the inclusion of user misuse prevention features. For example,
misuse prevention is achieved in the present invention by forming the
sharps receptacle with an automatic release structure which unambiguously
mates with and exclusively operates the actuation mechanism of a companion
holder. Similarly, the configuration of the holder prevents actuation of
the actuation mechanism by any other sharps receptacle. Therefore, system
safety is enhanced by minimizing the possibility that a health care worker
will cause incomplete needle release by attempting to use experimental
combinations of system components.
Some embodiments of the present invention also include a sharps receptacle
with a novel unwinder aperture which is incapable of inadvertently being
used to tighten the hub of a hub/needle combination to a holder.
Another significant advantage, relative to various prior art methods and
devices for disposing of standard threaded medical sharps, offered by the
present invention is an optimal combination of reduced cost and efficient
usage.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will now be described with reference to the
accompanying drawings wherein like numerals represent like structures and
in which:
FIG. 1 is a perspective view of a first embodiment of a sharps disposal
system in accordance with a first embodiment of the present invention;
FIG. 2 is a perspective view of the needle holder of the embodiment of FIG.
1;
FIG. 3 is a top plan view of the sharps disposal receptacle of FIG. 1;
FIG. 4 is a partial cross-sectional view of the top of the sharps
receptacle of FIG. 3, taken along line 4--4 of FIG. 3, FIG. 4 also
schematically showing the holder of FIGS. 1 and 2;
FIGS. 5A and 5B are respectively enlarged partial top plan and
cross-sectional side elevation views of the top of the receptacle which
show details of the unwinder aperture;
FIG. 6 is a view similar to FIG. 1 which depicts a sharps disposal
receptacle in accordance with a second embodiment of the invention; and
FIG. 7 is a partial top plan view of the receptacle of FIG. 6, FIG. 7
showing details of the auto-release structure of the receptacle.
DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENT
Referring to the drawings, and particularly FIG. 1, a sharps disposal
system, indicated generally at 10, includes a holder 80 and a sharps
disposal receptacle 20. Although not a part of system 10, an externally
threaded hub 83, having a needle affixed thereto, is shown detachably
mounted to needle holder 80. Sharps receptacle 20 includes a generally
hollow base 30 for receiving contaminated sharps. Base 30 is a unitary
structure and is provided with a cover 40. Each of base 30 and cover 40
have been individually injection molded to an appropriate thickness using
a puncture resistant and leak-proof material such as polypropylene. Base
30, in a preferred embodiment, has a medical waste receiving capacity of
approximately one quart. Referring jointly to FIGS. 1, 3 and 4, cover 40
includes a first lid 42, a second lid 46, an unwinder aperture 50, an
oversized aperture 49, and an auto-release structure which has been
indicated generally at 60. Auto-release structure 60, in accordance with a
first embodiment, includes first and second guide walls, 61 and 65
respectively, extending substantially perpendicularly from cover 40 and
positioned in spaced relation to a needle passage aperture 64. As may best
be seen from FIGS. 3 and 4, a generally rectangular shoulder 69 extends
from one side of second guide wall 65. As illustrated in FIG. 1, holder 80
has been positioned relative to auto-release structure 60 such that, upon
downward movement of holder 80, shoulder 69 and first and second guide
walls 61, 65 will orient needle holder 80 so that the needle affixed to
hub 83 will extend through aperture 64.
The auto-release structure in accordance with a second embodiment may be
seen from FIGS. 6 and 7. This alternative auto-release structure,
indicated generally at 60', includes three protruding posts 66, 67, 68
extending substantially perpendicularly from cover 40 and positioned in a
circular, evenly spaced relation to needle passage aperture 64. The height
of posts 66-68 is sufficient to establish an operative relationship with
the holder activation mechanism. As illustrated in FIG. 6, holder 80 has
been positioned relative to auto-release structure 60' such that, upon
downward movement of holder 80, two posts 66, 67 will guide and orient the
holder 80 so that the needle affixed to hub 83 will extend through
aperture 64. The third post 68 will engage the needle release mechanism.
Three possible orientations of holder 80 onto posts 66, 67, 68 will result
in actuation of the release mechanism.
An enlarged perspective view of holder 80 is shown in FIG. 2. As
illustrated therein, holder 80 consists of a body 81, an actuation
mechanism 82 and an end cap 90. End cap 90 is used to retain actuation
mechanism 82 in holder 80 and is itself retained in holder 80 by flanges
89. End cap 90 includes an aperture which permits hub/needle combinations
to be inserted into actuation mechanism 82. Additionally, end cap 90
includes a recess 92 at one end thereof. As shown, recess 92 is generally
rectangular.
Actuation mechanism 82 includes an actuator 84 and which is normally biased
outwardly, with respect to body 81, to the position shown in FIG. 2. In
this position, a guide channel 85 in the actuation mechanism is, at its
deepest point, substantially aligned with the base of recess 92 in end cap
90. Channel 85 has a constantly and smoothly decreased depth and, in part,
is defined by a pair of facing side walls 86 and 88, which are preferably
in alignment with the side walls of recess 92. Channel 85 also includes a
sloped face, i.e., a cam surface, 87 which slopes away from the axis of
holder body 81. As shown in FIG. 2, both end cap 90 and actuator 84
possess a bevelled outer surface at one end thereof which assists with
appropriate alignment of the needle holder during venipuncture. While end
cap 90 is preferably fixedly attached to holder 80, actuator 84 is
slidably mounted to holder 80 for reciprocal movement in a direction
generally perpendicular to the axis of body 81. The various other
components of actuation mechanism 82, and their interaction with a hub 83
(see FIG. 1), are described in greater detail in above-referenced
co-pending U.S. patent application Ser. No. 08/580,322.
As shown in FIG. 2, when actuator 84 is in the outward position, actuation
mechanism 82 is biased to a hub engaging position. In this position, a
standard threaded hub, for example a hub integrate with a needle to form a
hub/needle combination, can be threaded into actuation mechanism 82 and
firmly supported by holder 80. Upon movement of actuator 84 toward the
axis of body 81, hub 83 detaches from actuation mechanism 82 such that, if
holder 84 were inverted from the FIG. 2 orientation, hub 83 and the
associated needle would be free to fall from holder 80 under the influence
of gravity.
Also as shown in FIG. 2, channel 85 preferably extends through a relatively
small central region of actuator 84 so that actuator 84 can be,
optionally, operated by using a finger. The extension of end cap 90
outwardly in substantial alignment with actuator 84 minimizes the
possibility of inadvertent operation of actuator 84 whereby the rigid
support for hub 83 would be disrupted at an inopportune moment. Similarly,
end cap 90 cooperates with actuator 84 to ensure, as will be discussed in
more detail below, that hubs are automatically detached from holder 80
only by the action of the complementary auto-release structure of sharps
receptacle 20 (FIG. 1).
Referring to FIG. 3, a top plan view of sharps receptacle 20 of system 10
is shown. Cover 40 of receptacle 20 includes a generally cat's-eye shaped
unwinder aperture 50. Undulating portions 52 and 54, of generally
sinusoidal shape, are included in the opposite elongated sides of the
perimeter of aperture 50 as shown. The central region of aperture 50 is
sized and shaped to comfortably receive a hub of a needle/hub combination,
such as hub 83. As a result of movement of the hub either to the left or
to the right from the insertion position, i.e., movement away from the
central region of aperture 50, the undulating portions 52 or 54 will
engage the hub and impede counter-clockwise rotation thereof. This
engagement allows an operator to manually unthread hub 83 from holder 80.
Thus, using unwinder aperture 50, a health care worker has the option of
manually unscrewing hub 83 from holder 80 in the conventional manner. The
positioning undulating portions 52 and 54 as shown in FIG. 3 precipitates
the advantage that undulating portions 52 and 54 will only mechanically
engage a hub as the hub is unwound, i.e., rotated in the counter-clockwise
direction, from a holder. Thus, a health care worker cannot inadvertently
over-tighten a hub to a holder when attempting to unwind the hub from the
holder.
FIGS. 5A and 5B show the unwinder aperture 50 in greater detail. The
opposite, narrow ends 90 and 91 of aperture 50 interconnect, and thus
define the ends of, a pair of opposed aperture sides 95, 96. Sides 95 and
96 are in the form of substantially equal radii arcs. The central portions
of arcuate sides 95 and 96 are spaced sufficiently to permit the free
passage of hubs, such as hub 83, therethrough. The undulating portions 52
and 54 are located between the central or free drop portions of the
aperture defined by arcuate sides 95 and 96 and respective of the ends 90
and 91. Each undulating portion is located opposite from a smoothly curved
wall. As may clearly be seen in FIG. 5B, top 40 is provided with regions
of increased thickness which extend at least part way about the periphery
of aperture 50, these enlarged width portions increasing the strength of
the top.
As shown in FIG. 3, top 40 also includes oversized aperture 49 for
receiving assorted infectious medical waste such as hypodermic syringes,
winged infusion sets and catheters of appropriate size. While aperture 49
is shown as being generally rectangular, it can, of course, also be any
one of many other shapes as long as aperture 49 is sufficiently large to
easily receive the aforementioned medical products. Aperture 49 may have a
notch along one side thereof to facilitate disposal of waste products have
standard Luer fittings or adapters. Once these products have passed
through aperture 49, second lid 46 may be used to seal aperture 49 and
prevent inadvertent spillage of infectious medical waste.
Second lid 46 is pivotably mounted to one end of cover 40 via a second
hinge 48. Second lid 46 is preferably integrally formed with cover 40 and
second hinge 48 is preferably sized and shaped to provide a durable, yet
flexible, hinge for repeated usage. Thus, to provide access to oversized
aperture 49, second lid 46 is pivoted away from aperture 49. Similarly,
aperture 49 can be closed by pivoting second lid 46 toward cover 40. For
allowing temporary closure, second cover 46 may have any suitable means,
such as detents, which snap-fit into complementary elements on cover 40.
Aperture 49 can be permanently closed by pivoting second lid 46 toward
cover 40 and slipping a lock-tab 47 into a lock-slot 47'. This would be
done, for example, once the infectious medical waste has substantially
filled sharps receptacle 20.
Cover 40, as noted above, also includes auto-release structure 60.
Structure 60 preferably includes needle passage aperture 64 disposed
between, and in spaced relation to, guide walls 61 and 65 or posts 66-68.
As can be seen from FIG. 3, which is a further showing of the receptacle
of FIG. 1, first guide wall 61 is preferably generally arc-shaped and
second guide wall 65 is preferably generally U-shaped. The concave
portions of first and second guide walls 61 and 65 face one another and
are sized and shaped to receive one end of holder 80. Needle passage
aperture 64 is preferably large enough to easily pass hub 83, but small
enough to prevent holder 80 from passing therethrough. First guide wall 61
has a concave inner surface 62 which faces inner surface 66 on second
guide wall 65. Further, as clearly shown in FIG. 4, first guide wall 61
has a chamfered edge 63 which extends downwardly and inwardly from the top
of guide wall 61. Similarly, second guide wall 65 has a generally U-shaped
chamfered edge 73 extending downwardly and inwardly from the top of guide
wall 65. First and second chamfered edges 63 and 73 function as guides to
insure proper orientation of holder 80 when holder 80 is initially
inserted into auto-release structure 60. Upon further downward movement of
holder 80, shoulder 69, which is preferably of uniform rectangular
cross-section passes through recess 92 (FIG. 2) of end cap 90 thus
positioning guide wall inner surfaces 62 and 66 adjacent the outer surface
of holder 80. Since shoulder 69 only extends up to the bottom chamfered
edge 73, release of actuation mechanism 82 only begins at this point. Upon
further downward movement of holder 80, shoulder 69 enters actuator
channel 85. This keyed alignment between shoulder 69 and channel 85
further ensures appropriate and exclusive operation between auto-release
structure 60 and holder 80. Still further downward movement of holder 80
forces the top edge shoulder 69 to ride along sloped face 87 of channel 85
whereby actuator 84 is cammed toward body 81 of holder 80 in a direction
which is substantially perpendicular to the axis of holder body 81. This
camming action may be achieved, after contact is established between
shoulder 69 and face 87 of actuator channel 85, by imparting a rocking
motion to holder 80. The holder thus does not have to be moved axially
with respect to aperture 64 but, rather, needs merely to engage guide wall
surface 62 to permit the hub release action to be initiated. The inward
movement of actuator 84 causes actuation mechanism 82 to detach a hub 83
previously mounted to holder 80. Thus, hub/needle combination is free to
fall through needle passage aperture 64 into sharps receptacle base 30
under the force of gravity.
Central needle passage aperture 64 is preferably large enough to easily
pass hub 83, but small enough to prevent holder 80 from passing
therethrough. In the embodiment of FIGS. 6 and 7, positioned in a circular
spaced relation to needle passage aperture 64, three protruding posts 66,
67, 68 extend substantially perpendicularly from cover 40. The height of
these posts is sufficient to operatively engage the holder activation
mechanism. The width of each of posts 66, 67, 68 is sufficiently narrow to
pass through recess 92 of end cap 90, into actuator channel 85. This keyed
alignment between the posts 66, 67, 68 and the channel 85 further ensures
appropriate and exclusive operation between the auto-release structure 60
and holder 80. As illustrated in FIG. 7, holder 80, shown in hatching, has
been positioned relative to auto-release structure 60 such that, upon
downward movement of holder 80, two posts 66, 68 will guide and orient the
holder 80 so that hub 83 will extend through aperture 64 while the third
post 67 enters channel 85 and contacts the hub actuator 84 on its sloped
cam surface 87.
Similar to second lid 46, first lid 42 is pivotably mounted to cover 40 via
first hinge 44. First lid 42 can be used to selectively open and close
both needle passage aperture 64 and unwinder aperture 50 by rotation about
first hinge 44. For allowing temporary closure, first cover 42 may have
any suitable means such as detents which snap-fit into complementary
elements on cover 40. As with second lid 46, first lid 42 includes a
lock-tab 43 which is sized and shaped to engage lock-slot 43' to
permanently seal needle passage aperture 64 and unwinder aperture 50. Lid
42 is preferably integrally formed with cover 40 and hinge 44 is sized and
shaped to provide a durable, yet flexible, hinge for repeated usage.
Cover 40 is preferably permanently affixed to base 30 (FIG. 1) at a rim 41
in snap-fit fashion. Cover 40 is engaged by base 30, preferably at rim 41,
with sufficient strength that cover 40 cannot be removed from base 30
without causing substantial damage thereto. Cover 40 and base 30 are
individually injection molded from a suitable plastic material. These
components may, however, vary in certain respects. For example, base 30 is
preferably formed of a red opaque material. By contrast, cover 40 is
preferably formed of either a translucent or transparent material. This
allows health care workers to monitor the amount of accumulated waste
material inside sharps receptacle 20. Medical waste level monitoring may
be further assisted by the presence on base 30 of a fill-line (not shown)
extending around the surface of base 30. Thus, by forming cover 40 of
translucent material, and by the inclusion of a fill line on base 30, a
health case worker may easily determine when sharps receptacle 20 is
sufficiently full. When sharps receptacle 20 has become sufficiently full
with waste material, a health care worker may permanently seal sharps
receptacle 20 by closing covers 42 and 46 and slipping lock-tabs 43 and 47
into lock-slots 43' and 47' respectively. Thereafter, the sealed sharps
receptacle 20 can be discarded in an appropriate manner as a single unit.
It should be noted that, since guide walls 61 and 65 preferably extend
upwardly from cover 40, more medical waste may be received within base 30
relative to prior art sharps receptacles having release mechanisms located
within the interior of the sharps receptacle. Thus, the present invention
more efficiently utilizes the space available for receiving medical waste.
Referring again to FIG. 4, the cooperation between needle holder 80 and
auto-release structure 60 in the embodiment of FIGS. 1 and 3 will be
described in still greater detail. In FIG. 4, cover 40 is depicted in
partial cross-section taken along line 4--4 of FIG. 3. Holder 80, by
contrast, is shown in side elevation view. As shown in FIG. 4, holder 80
has been partially placed into auto-release structure 60 in the direction
of arrow A. Channel 85 and shoulder-access recess 92, shown in phantom,
are in engagement with shoulder 69 such that actuator 84 has experienced
some minimal movement in the direction of arrow B. In this position, hub
83 has not yet become detached from actuation mechanism 82. Upon further
movement of holder 80 in the direction of arrow A, end cap 90 will come
into abutting relationship with cover 40 at the bottom of first and second
guide walls 61 and 65. At this time, actuator 84 will have moved in the
direction of arrow B, i.e., channel 85 will have moved to the position
where shoulder 69 has reached the end of channel 85. In this position, hub
83 is detached from actuation mechanism 82 and is free to fall from holder
80 into base 30 of sharps receptacle 20 (FIG. 1) in the direction of arrow
A. Upon removal of holder 80 from auto-release structure 60 in a direction
opposite of that of arrow A, holder 80 resumes its normal configuration,
as shown in FIG. 2, and is ready for reuse. The operation of the
embodiment of FIGS. 6 and 7 is, of course, substantially identical to the
above-described operation of the FIGS. 1 and 3 embodiment.
It will be readily appreciated by one of ordinary skill that the present
invention incorporates a number of safety features not present in the
prior art. First and foremost is that holder 80 and both disclosed
embodiments of auto-release structure 60 are specifically designed for use
with one another. For example, end cap 90 of holder 80 effectively
precludes movement of actuator 84 when holder 80 is inserted into
non-compatible disposal containers, such as containers of the type having
a generally conical opening. Thus, health care workers are effectively
prevented from attempting to use holder 80 with incompatible sharps
containers. Similarly, the arrangement of first and second guide walls 61
and 65, or the array of posts 66-68, and rectangular shoulder 69
effectively prevents auto-release structure 60 from being used with other
needle holders. Thus, while holder 80 can be hand-operated, the exclusive
compatibility between holder 80 and auto-release structure 60 ensures that
experimental combinations of components is precluded.
The cooperation between holder 80 and auto-release structures 60
significantly improves the reliability of the hub detachment operation.
For example, the sizing, spacing and arrangement of first and second guide
walls 61 and 65 or posts 66-68 and rectangular shoulder 69 ensures that
actuator 84 is sufficiently, but not overly, depressed each time holder 80
is fully placed into auto-release structure 60. This ensures proper
detachment of hub 83 from holder 80 while extending the life of holder 80
by preventing over-stressing of actuation mechanism 82. Similarly, the
sizing and location of needle passage aperture 64 ensures that holder 80
will never pass into or become lodged in sharps receptacle 20. This
arrangement also ensures that a health care worker can easily recognize
when the needle detaching procedure has been completed. Similarly, the
first and second chamfered edges 63 and 73 in the embodiment of FIGS. 1
and 3 help ensure proper alignment between holder 80 and first and second
guide walls 61 and 65. This feature further enhances the speed and
accuracy of the hub detachment operation. Thus, successful hub detachment
is virtually ensured using the methods and apparatus of the present
invention.
Having described two preferred embodiments of the present invention with
reference to the accompanying drawings, it will be appreciated that
various changes and modifications can be effected therein by one of
ordinary skill in the art without departing from the spirit and scope of
the invention as defined in the appended claims.
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