U.S. patent application number 10/351665 was filed with the patent office on 2003-07-17 for method for using dispensation and disposal container for medical devices.
This patent application is currently assigned to OmniSonics Medical Technologies, Inc.. Invention is credited to Hare, Bradley A., Loper, James H., Rabiner, Robert A..
Application Number | 20030132131 10/351665 |
Document ID | / |
Family ID | 25105906 |
Filed Date | 2003-07-17 |
United States Patent
Application |
20030132131 |
Kind Code |
A1 |
Rabiner, Robert A. ; et
al. |
July 17, 2003 |
Method for using dispensation and disposal container for medical
devices
Abstract
The invention is directed to a container for storage,
dispensation, transport and disposal of a medical device such a
disposable ultrasonic surgical probe, that allows its dispensation
for use, and for its safe storage and disposal after use, thereby
protecting the user from the hazards of needle pricks and possible
contamination from small-diameter probes. The container of the
present invention also provides a mechanism for restricting access
to the probe to prevent its reuse, and a method for its safe
attachment to and detachment from an ultrasonic medical device. The
container comprises a cylindrical tube having two ends and an inner
surface defining a space for containing the probe. The probe is
held within the cylindrical section of the container by a locking
means that allows a single dispensation for its use and enables its
disposal after use in an inaccessible manner, so as to enable its
attachment and detachment to the non-disposable segment of the
device such as an ultrasonic probe handle without requiring direct
handling by the user. The user, is therefore protected from against
accidental sticks from a possibly contaminated probe. The container
also prevents re-use of the probe, and provides a means for its
safe disposal.
Inventors: |
Rabiner, Robert A.;
(Chelmsford, MA) ; Hare, Bradley A.; (Chelmsford,
MA) ; Loper, James H.; (Wales, MA) |
Correspondence
Address: |
PALMER & DODGE, LLP
RICHARD B. SMITH
111 HUNTINGTON AVENUE
BOSTON
MA
02199
US
|
Assignee: |
OmniSonics Medical Technologies,
Inc.
|
Family ID: |
25105906 |
Appl. No.: |
10/351665 |
Filed: |
January 27, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10351665 |
Jan 27, 2003 |
|
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09775908 |
Feb 2, 2001 |
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6527115 |
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Current U.S.
Class: |
206/438 ;
206/365 |
Current CPC
Class: |
A61B 2050/0081 20160201;
A61M 5/3213 20130101; A61B 50/36 20160201; A61B 50/30 20160201;
B65D 43/20 20130101 |
Class at
Publication: |
206/438 ;
206/365 |
International
Class: |
A61B 017/06; B65D
085/24 |
Claims
We claim:
1. A container for dispensation, storage, transportation and
disposal of medical articles comprising a hollow cylindrical
section comprising at least one open end comprising a closure
assembly adapted to said open end, including means for mounting
thereto, comprising an access opening adapted to dispense, receive
and retain medical articles; an access controlling means adapted to
the said closure assembly interacting with the container and said
access opening; said access control means comprising of at least
one locking mechanism formed integrally with said closure assembly
and movable under the action of an actuating means from a
non-locked position to a locked position; said actuation means
further comprising an articulation apparatus whereby application of
pressure on said apparatus results in movement of said locking
mechanism from a non-locked to a locked position, and means for
positively retaining the said locking mechanism in said locked
position after movement thereto from said non-locked position.
2. A container of claim 1 wherein the closure assembly comprises a
collar having at least two non-detachable segments, a first segment
proximal to the cylindrical section of said container and a second
segment distal to the said cylindrical section, said segments have
access openings that communicate with the cylindrical section of
said container, further having at least one locking mechanism
disposed between said segments, and an articulation means to
activate said locking mechanism.
3. The locking mechanism of claim 2 comprising a rectangular plate
having a slot capable of moving over a pin attached to the collar
segment proximal to the cylindrical section, said pin seated on a
spring capable of exerting a unidirectional force enabling said pin
to make intimate contact with said plate, whereby movement of the
said plate causes said pin to be forced into the slot in causing
said mechanism to lock in an irreversible manner.
4. A container of claim 2 wherein the locking mechanism is attached
to an articulation means extending externally from the collar,
capable of moving said locking mechanism from a non-locked position
to a locked position.
5. The container of claim 2 wherein the collar has an inside
diameter that is greater than the inside diameter of said tube.
6. The container of claim 2 wherein the inner diameter collar is
large at the terminal end of said container, and tapers to a
smaller diameter approaching the access opening proximal to the
cylindrical section of said container.
7. The container of claim 2 wherein the collar comprises an
additional extended structural assembly positioned around the said
collar to provide a means of shielding the hand of a user from the
medical article during its dispensation from or disposal into said
container.
8. A container of claim 1 wherein the medical article is a medical
device.
9. A container of claim 8 wherein the medical device is a
disposable sharp.
10. A container of claim 8 wherein the medical device selected from
the group consisting of ultrasonic surgical probes, needles,
scalpels, picks, blades and guide-wires.
11. A container of claim 10 wherein the medical device is an
ultrasonic surgical probe
12. The container of claim 1 containing at least two locking
mechanisms, a first locking mechanism capable of engaging the
medical article in the locked position and disengaging from said
probe in the unlocked position upon activation, and a second
locking mechanism capable of engaging an ultrasonic probe in the
unlocked position and disengaging from said medical article in the
locked position upon activation.
13. The container of claim 12 wherein the medical article is an
ultrasonic surgical probe.
14. The container of claim 12 capable of dispensing an unused
medical article upon activation of first locking mechanism, and
receiving said medical article after use through the second locking
mechanism upon activation in a manner that renders said medical
article inaccessible.
15. A container of claim 14 wherein the medical article is
dispensed from said container for its use and disposed within said
container after use without requiring direct handling of said
article.
16. A container of claim 15 wherein the medical article is an
ultrasonic probe.
17. A container of claim 1 comprising a single open end for
disposal of used medical articles
18. The container of claim 2 wherein the locking mechanism
comprises of at least two locking assemblies at the same end,
thereby enabling dispensation and disposal of a medical device from
the said end.
19. The container of claim 2 wherein the locking mechanism secures
the medical device disposed within in an immovable manner relative
to the container, thereby providing a mechanism for communicating
torsional forces applied to said medical device to effectuate
assembly or disassembly of the said device or a segment thereof
from the body of main body of the device.
20. The container of claim 19 wherein the medical device is an
ultrasonic probe.
21. A method of dispensation of a disposable medical device or a
segment thereof prior to its use and subsequent disposal thereof
after use, without substantial direct handling of the said
disposable device or segment comprising providing a container
comprising a disposable medical device or segment thereof,
attaching said device or segment thereof to a non-disposable
segment of the device articulating a locking means to enable
detachment said device or segment from locking means in container
to effect dispensation inserting said disposable device or segment
thereof after use into container articulating a locking means to
secure said device, and providing a sufficient torsional force to
the non-disposable segment of device relative to the container,
thereby enabling detachment said disposable device or segment
thereof causing their disposal in an inaccessible manner.
22. A method of claim 21 wherein the disposable medical device is
an ultrasonic probe.
23. A kit comprising of a medical device contained within container
of claim 1 having suitable packaging materials and instructions for
use.
24. A kit of claim 23 wherein the medical device is an ultrasonic
probe.
25. A kit of claim 24 wherein the ultrasonic probe further
comprises an accessory selected from a sheath assembly and a
balloon catheter that is adapted to said probe.
26. The kit of claim 23 wherein said container further comprises a
shielding fixture, thereby providing a means for protection from
injury.
27. The kit of claim 23 wherein the contents of said kit is
supplied sterile.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to a container for
storage, dispensation, transport and disposal of a medical device.
More particularly, this invention is directed to a container for
storing a sterile ultrasonic surgical probe that allows its
dispensation for use, and for its safe storage and disposal after
use, thereby protecting the user from the hazards of accidental
needle sticks and possible contamination from small-diameter
probes. The container of the present invention also provides a
mechanism for restricting access to the probe to prevent its reuse,
and a method for its safe attachment to and detachment from an
ultrasonic medical device.
BACKGROUND OF THE INVENTION
[0002] The increased utilization of disposable medical devices such
as scalpels, syringes, lances needles, and the like, commonly
referred to as "sharps" is raising concern with regard to the safe
disposal of such devices. Improper handling of sharps by medical
and healthcare personnel is attributed to being the leading cause
of accidental skin puncture wounds. The consequences of such
injuries can be life threatening, since used medical devices that
are contaminated with blood and other biological media can result
in transmission of dangerous infectious diseases such as hepatitis
and AIDS. Furthermore, conventional disposal units for such devices
do not normally allow for positive neutralization of the biological
hazard at the site of the surgical procedure. Such devices,
therefore, may contain contaminating bacterial and viral species
that remain viable as the device is transported from the site
through a waste hauling system to a decontamination facility.
Additionally, a number of currently used disposal devices,
especially sharps, do not A affirmatively lock when closed,
resulting in their being accidentally or intentionally reopened
thereby exposing medical and waste disposal personnel to
potentially dangerous biological contaminants.
[0003] Various devices have been proposed in the art for disposal
of sharps. Sharps containers in the art typically include a valved
opening, and a closure mechanism (see, e.g., model 5400 series
available from Becton Dickinson and Company of Rutherford, N.J.) or
non-valved openings (see, e.g., U.S. Pat. No. 4,569,554). The
containers typically can be filled with multiple sharp objects.
Other sharps containers (Model 8600, Becton Dickinson and Company
of Rutherford, N.J.) include a mechanism to disable a sharp object
being disposed of (e.g., a needle), but also invites filling with
multiple sharp objects. A great majority of sharp containers
disclosed in the art (for example in U.S. Pat. Nos. 4,666,538,
4,804,090, 4,842,138 and 5,281,391, 5,630,506) are limited to the
disposal of needles, more particularly syringe needles, and are
designed to be disposal containers capable of accepting and
containing several units, after which the container is sealed and
transported for disposal. Since these containers are designed for
disposal only, they offer only a limited advantage, since they do
not obviate the need for the healthcare professional to manipulate
the needle manually to detach it from the syringe prior to
discarding them in such containers. The aforementioned risks of
accidental injury are, therefore, not precluded.
[0004] While many of the prior art devices have provided innovative
and improved, disposal methods for sharps, more particularly,
needles, these devices suffer from some of the following
disadvantages:
[0005] i) inadequate design for disposal of single use specialty
devices such as probes, catheters, guide-wires and other
non-permanent implants. Although such devices that have to be
disposed of taking the same precautionary steps as needles to
prevent accidental contamination, they are presently discarded
using conventional disposal devices that require physical handling
by the healthcare personnel.
[0006] ii) they require direct handling of sharps by medical
personnel to remove them from manufacturers sterile packaging for
attachment to ancillary devices such as a handle of a surgical
device or a dispensing syringe, and for their subsequent detachment
from said ancillary device for discarding into a disposal
container. Such handling can result in inadvertent microbiological
contamination of the sharp prior to use that can pose risk of
infecting the patient, and pose concerns of health hazard to the
healthcare provider arising from contact with contaminated
biological materials such as blood or tissue from the used device
during the process of detaching them from the ancillary device for
their disposal.
[0007] iii) they do not offer efficient means to remove new sharps
from sterile packaging, their attachment and detachment to device
ancillary units, and disposal without substantial human contact,
thereby eliminating inadvertent injury caused by handling the
sharps and associated concerns such as contaminating unused sharps
prior to use on a patient, or contracting contagious diseases from
used contaminated sharps.
[0008] Due to the recent advent of disposable forms of devices such
as endoscopes, ultrasonic tissue ablation probes, and the like,
previously only being envisioned as reusable devices, there exists
a significant need for an improved apparatus for containing devices
(herein referred to as "container") and methods for dispensation,
storage and safe disposal of such devices, that allows their easy
removal for use substantially without direct human contact, and
subsequent placement of the device in the same container after its
use again without requiring such direct contact. It is also
desirable for the container to maintain used devices contained in
them such that they are substantially isolated from further access
during handling for disposal. There is also a need for the
container to be able to preclude retrieval of used medical devices
placed in them, thereby discouraging their unauthorized reuse.
Additionally, it is desirable to have the ability to package new
unused medical devices such as "sharps" in the multi-functional
container that enables dispensation, storage and disposal of the
device. Presently, new sharps are typically packaged and
transported in one type of container and disposed in another
container after use. Furthermore, it is generally recognized by
those skilled in transport and delivery of medical instruments and
devices that it is critically important to provide evidence of
tampering for each user immediately prior to opening a container of
new medical instruments and devices.
[0009] Ultrasonic surgical probes, especially those operating in
transverse mode described in applicants co-pending provisional
applications U.S. Ser. No. 60/178,901 and 60/225,060, have a
plurality of regions of maximum energy referred to as nodes, along
the length of the probe. This results in a plurality of regions of
high stress, resulting in potential for degradation of structural
integrity of the probe. Repetitive use of the probe can potentially
worsen this problem, with inadequate means by the user to determine
the residual life of the probe. Stress fractures may develop,
creating a greater tendency for the probe to shatter with the
potential of foreign bodies being induced into the patient, or
resulting in microscopic irregularities in the surface that may
render the probe difficult to decontaminate between uses. As such,
ultrasonic probes should be treated as single use, single patient
contact medical devices, and after each use be considered medical
waste. Where a probe sheath is also used in conjunction with the
probe, the small sheath lumen will incorporate blood and cellular
debris during use, which due to their small diameter, render them
extremely difficult to clean. For safety purposes they should be
discarded.
[0010] Medical waste disposal devices also do not normally allow
visual inspection and counting of enclosed sharps or other devices
after the devices is closed, thereby precluding an accounting means
to ensure the number and type of medical waste included in such
sealed containers. Furthermore current medical-waste disposal
methods typically require large treatment systems involving complex
operation that are non-portable and highly expensive. Such systems
include autoclaving, incineration and bulk chemical treatment of
the medical device waste. It is therefore, desirable to provide an
improved portable disinfecting and disposal device for such medical
device waste.
[0011] Based on the aforementioned limitations in the current
disposal containers for medical devices disclosed in the art, and a
lack of an efficient container that functions both as a dispensing
as well as a disposal container for a disposable surgical device in
the art. There is a need for such a dispensing and disposal
container for sharp disposable medical devices, such as a small
diameter ultrasonic probe used for tissue ablation. Such probes are
described in the Applicant's co-pending provisional applications
U.S. Serial Nos. 60/178,901, and 60/225,060 which further describe
the design parameters for an ultrasonic probe operating in a
transverse mode and the use of such a probe to remodel tissues, as
well as the Applicants co-pending utility application entitled
"Ultrasonic medical device operating in a transverse mode for
removing occlusions" (Attorney Docket No. 20563/1010) which
describes the use of such probes combined with probe sheath
assemblies that modulate the cavitation energy emitted by the
probe, and catheter balloon assemblies for removing blood vessel
occlusions. The entirety of these applications are herein
incorporated by reference.
SUMMARY OF INVENTION
[0012] It is therefore an object of the present invention to
provide a tamper-resistant light-weight container for safely
holding a medical-surgical device, allowing its dispensation of the
device from the container for use, and for it's disposal after use,
without requiring direct touching or handling of the probe itself
The device containment segment of the container may be rigid, or
flexible with rigid ends to accommodate devices that are
flexible.
[0013] It is yet another object of the present invention to provide
such a container to hold, dispense and dispose of medical sharps
safely, particularly thin ultrasonic probes utilized for tissue
ablation and removal of occlusion materials from vascular
occlusions in blood vessels.
[0014] It is yet a further object of the invention to provide a
container for an ultrasonic probe that is capable of dispensing a
new probe or probe assembly for attachment to an ultrasonic
surgical device, and for detaching the probe from the said device,
without requiring direct handling of the probe or probe
assembly.
[0015] It is another object of the present invention to provide a
container for a medical device such as an ultrasonic probe,
consisting of a tamper resistant locking mechanism that prevents
reuse of a used device disposed within by precluding access to said
device.
[0016] It is yet another object of the invention to provide a
container for a medical device such as an ultrasonic probe which
may be disposed of simultaneously with the disposal of the used
medical-surgical device, thereby obviating the need for sterilizing
the container itself.
[0017] Briefly summarized, the foregoing objects are achieved by a
container assembly which is utilized for both storing and
dispensing new sharps such as a small diameter ultrasonic probes
and accompanying accessories, if any, such as sheath assemblies,
balloon catheters, etc. prior to use, and receiving such
contaminated or used devices for storage, transport and
disposal.
[0018] The preferred embodiment comprises a container for an
ultrasonic probe which prevents the probe's reuse and provides a
method for dispensing and disposing an ultrasonic probe. The
container is designed for containing a probe or probe assembly, a
means for attaching the probe to an ultrasonic medical device, a
means for simultaneously containing the used probe while detaching
the probe from the ultrasonic medical device, without requiring
direct handling of the probe.
[0019] The container comprises a hollow cylindrical tube having two
collar assemblies (herein referred to as "Collar") at the open ends
that function as lids. The inner diameter and length of the
cylinder with an inner dimension defining a space for the probe and
its accompanying accessories, if any. The collars are designed to
be adaptable to cylinders with varied lengths and diameters to
accommodate probes and probe assemblies of different dimensions.
Each collar comprises of two segments, both of which have apertures
centrally located, having diameters that correspond to the
dimension of the probe or probe assembly for which the container is
adapted. The said apertures in the collars permit access to the
cylindrical segment of the container. The collars are also designed
such that they are securely affixed to the container body in a
manner that provides evidence of tampering when removed. A
complement of tamper resistant mechanisms, including locking
assemblies in the collars, are provided that render opening of the
container relatively restricted. The locking mechanism within the
collars are configured to function in a manner complementary with
respect to each other, thereby enabling the collar at the
dispensing end to permit a one-time dispensation of a new, unused
device, whereas the collar at the disposal end permits receipt of
used or contaminated device. The said locking mechanisms in the
collar assemblies prevent the reuse of the container by
substantially preventing the removal or re-dispensation of a
previously disposed device in the associated container. The collar
at the disposal end includes an area for placement of a used or
contaminated device, wherein a person may then deposit the article
into the container body without directly touching the device being
disposed of. Additionally, the collar assembly prevents further
handling of the used devices by medical personnel subsequent to
disposal.
[0020] In a preferred embodiment, the collar assemblies have a
larger diameter than the cylindrical tube section of the container.
The interior surface of the collar assemblies are arcuate or
conical shaped, tapering from a larger diameter at the end distal
to the cylindrical section to a smaller diameter approaching the
aperture, thereby providing a means of guiding or directing the
used probe into the device, and also providing clearance for
attaching or detaching the probe to or from the transducer. In
another embodiment of the invention, an extended rigid or
semi-rigid structure located around the collar provides a means of
shielding the hand of the operator that holds the container while
the probe is inserted.
[0021] Between the first and second segments of the collar is a
locking mechanism capable of manipulation by the user. The first
locking mechanism can be, for example a plate that slides along a
groove in a direction perpendicular to the longitudinal axis of the
container. Alternatively the locking mechanism can be a rod or an
extrusion. The locking means is adapted for engaging the medical
article or device stored or disposed within the container. In a
preferred embodiment, the locking mechanism is capable of engaging
the proximal end an ultrasonic probe at one or more grooves or
threads located at proximal end of said probe or at a depression,
aperture, or a raised surface designed on the probe at its proximal
end. At one end of the container (herein referred to as "dispensing
end"), articulation of the locking means by the operator,
disengages the locking mechanism from the probe, thereby allowing
its release from within the container for dispensation. At the end
opposite from the dispensing end of the container (herein referred
to as "disposal end"), articulation of the locking mechanism by the
operator engages the probe thereby securing the probe irreversibly
within the container, thereby preventing further access. The
locking mechanisms are capable of securing the probe immovably
within the container, thereby providing a mechanism for
communicating torsional forces applied to the probe, for example,
when the probe is affixed to or detached from an ultrasonic medical
device. The attachment the probe and its detachment from the
medical device can be accomplished for example, by screwing the
probe on to, or off of the device, by rotating the device handle
after affixing it to the proximal end of the probe. In other
embodiments of the invention the locking mechanism can be threaded,
or a ratcheting means, or other such ways of constraining the probe
in a unidirectional manner while torsional forces are applied to
the container to effectuate attachment or detachment of the probe
from the ultrasonic medical device.
[0022] In another embodiment, the container of the invention
comprises a single open end having a plurality of locking
assemblies, thereby enabling the dispensation and disposal of a
medical device from the same end of said container. In a further
embodiment, the container of the invention comprises of a single
open end having a single locking assembly, thereby enabling its
utilization exclusively for safe disposal of used medical devices
and articles.
[0023] In one aspect, the container of the present invention is
provided together with an ultrasonic probe contained therein in the
form of a kit. In another aspect, container of the present
invention is provided together with a probe comprising accessories
such as a sheath assembly, balloon catheter, and the like contained
therein, as required for specific surgical procedures. In yet
another aspect of the invention, the container within the kit with
the probe and accessories, if any contained therein, further
comprises packaging, whereby said container and its contents are
pre-sterilized, and sealed against environmental contaminants. In
another aspect, the container comprising the probe and accessories
are provided in a manner complying with regulations governing
packaging, storage, handling, transport and disposal of sharp
medical devices.
[0024] In a preferred embodiment, the container provides a means of
attaching the ultrasonic probe together with its accessories to an
ultrasonic medical device, and further provides a means for
detaching them from the said device, without necessitating direct
manipulation or handling of the probe (and its accessories if any),
and a means for removing the said probe and assembly from the
ultrasonic medical device after use. In one aspect, container
having a probe contained within provided a sterile kit, comprises
single use locking mechanisms located at the dispensing and
disposal ends of said container, wherein said locking mechanism at
the dispensing end enables attachment of the probe to an ultrasonic
medical device solely through the said container, thereby allowing
its dispensation from within the container, and wherein the said
locking mechanism at the disposal end allows its disposal into the
container in a manner preventing re-insertion of the probe through
the dispensing end and re-extracting the used probe from the
disposal end.
[0025] The foregoing specific objects and advantages of the
invention are illustrative of those that can be achieved by the
present invention, and are not intended to be exhaustive of the
possible advantages that can be realized. Thus these, and other
objects and advantages of the invention will be apparent from the
specifications and drawings, herein or can be learned by practicing
the invention, both as embodied herein or as modified in the view
of any variations which may be apparent to those skilled in the
art. Accordingly, the present invention resides in the novel parts,
construction, configurations, improvements and utility herein shown
and described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 shows the container for single use medical articles
comprising a dispensing end and a disposal end.
[0027] FIG. 2 shows a medical device comprising a disposable
ultrasonic probe that is dispensed from and disposed into the
container.
[0028] FIG. 3 shows the ultrasonic probe of the surgical device
inserted into the container for disposal
[0029] FIG. 4 shows a cross-sectional view of the collar assembly
comprising the locking mechanisms enabling irreversible
dispensation and disposal respectively of a medical article.
[0030] FIG. 5 depicts the container with a cross-sectional view of
the collar assemblies at the dispensation and disposal ends showing
the articulation handles for engaging the locking mechanism within
the collars.
[0031] FIG. 6 shows a sectional view the locking mechanisms within
the collar at the disposal end (6a and 6b).
[0032] FIG. 7 shows a sectional view the locking mechanisms within
the collar at the dispensing end (7a and 7b).
DETAILED DESCRIPTION OF THE INVENTION
[0033] "Container" as used herein refers to an apparatus used for
safe dispensation, storage and disposal of a medical article or
device, in most particularly, sharp medical devices.
[0034] Throughout this description, the terms "distal" and
"proximal" when pertaining to description of a probe or probe
assembly are relative to the operator, i.e. distal is away from the
operator and indicates the forward end of the device, whereas
proximal is nearest to the operator and relates to the rear end of
the device.
[0035] When aforementioned terms are used pertaining to description
of collar assemblies of the container, they are relative to the
hollow cylindrical portion of the container wherein a medical
device such as an ultrasonic probe is stored, i.e. "distal" is the
segment of the collar that is furthest from the cylindrical
section, whereas "proximal" refers to the segment that nearest to
said cylindrical section.
[0036] "Dispensing end" and "Disposal end" as used herein refers to
the ends of the container that allow dispensation and disposal
respectively of a medical article or medical device
[0037] "Probe" as used herein refers to a device capable of being
adapted to an ultrasonic generator means, which is capable of
propagating the energy emitted by the ultrasonic generator means
along its length, and is capable of acoustic impedance resulting in
transformation of ultrasonic energy into mechanical energy.
[0038] "Sharps" as used herein refers to an elongated medical
instrument or medical device with a small diameter, for example,
less than 2 mm. A "Sharps Container" as used herein is a container
capable of retaining a sharp medical device or the sharp portion
thereof, such that a handler is not exposed to the sharp portion of
the device.
[0039] "Sheath assembly" as used herein refers to a device for
covering, encasing, or shielding in whole or in part, a probe or
portion thereof connected to an ultrasonic generation means.
[0040] In the drawings, like reference characters generally refer
to the same parts throughout the different views. Also, the
drawings are not necessarily to scale, emphasis instead generally
being placed upon illustrating the principles of the invention.
[0041] FIG. 1 shows a "sharps" container 30 of the present
invention for dispensing and disposal of an ultrasonic probe.
Container 30 comprises a cylindrical section 32 capable of
accommodating probe 18 (shown partially) terminally connected to
collars 36 and 38 that form the dispensing and disposal ends
respectively of container 30. Articulation levers 43 enable
engagement of the locking mechanisms (not shown) within
collars.
[0042] FIG. 2 shows a transverse mode ultrasonic medical device 1
comprising a disposable elongated probe 6 designed for a one time
use, which is coupled to a device handle 66 that contains a source
or generation means for the production of ultrasonic energy (shown
in phantom in the figure as 66) that is transmitted to said probe
to enable its function. In the example shown, the probe diameter
decreases at defined intervals 14, 18, 20, and 22. In this example,
probe interval 18 has at least one groove 45 at the end proximal to
probe handle 66. Groove 45 is capable of being engaged by the
locking mechanisms at the dispensing and disposal ends of the
container 30, so as to constrain the probe within the cylindrical
volume of said container, thereby enabling its dispensation and
disposal without requiring direct handling of the probe itself.
[0043] FIG. 3 shows a cross-sectional view of collar 34 comprising
of two segments, a first segment 42 proximal to the cylindrical
section (not shown) and a second segment 44 distal to the tube.
Between the first and second segments is a locking mechanism
capable of being engaged by the user. In one embodiment, the
locking means can be engaged by a lever, not shown in this view.
The lever extends laterally to the outside of the collar assembly,
allowing articulation by the user. The lever engages the locking
mechanism, causing it to slide laterally within a groove in segment
42 of the collar. In a preferred embodiment, the locking mechanism
comprises a locking assembly, such as for example, a plate 48
having a keyhole shaped slot 50, both shown partially, and a
pin-hole (not shown) capable of sliding over a pin 46 seated on a
spring 52 that exerts a unidirectional force on the pin. Upon
engaging the locking mechanism, for example with a lever, plate 48
is capable of sliding over pin 46 so as to align pin-hole in the
plate with the pin, thereby rendering it capable of receiving the
pin. The pin is forced into the pinhole by spring so as to "lock"
the plate, rendering it incapable of further lateral movement since
it is constrained within the collar assembly. The locking assembly,
once engaged by the pin, is therefore prevented from retrograde
articulation. The keyhole shaped slot 50 in the plates at the
dispensing and disposal ends of the container are aligned inversely
with respect to one another, so as to permit dispensation and
disposal of the probe respectively, upon activation of the locking
mechanisms at the respective ends, by engaging or disengaging
groove 45 in the probe.
[0044] FIG. 4 shows, a used ultrasonic probe 18 (shown partially)
that is still connected to probe handle 66 inserted into the
disposal end of the container through collar 38 prior to its
disposal within cylindrical section 32. Disposal of the probe is
accomplished by depressing lever (not shown) that articulates
locking assembly 48 within the collar assembly 34, causing said
locking assembly to move to a irreversibly to a "locked" position
wherein pin 46 is aligned with a slot in the locking assembly 48,
further causing pin 46 to be forced into the slot by the
unidirectional force exerted by a spring (not shown) on said pin.
The locking action of assembly 48 engages a groove or set of
grooves (not shown) in probe 18 located at the end proximal to
probe handle 66, thereby causing said probe to be restrained
irreversibly within container 31. The probe is subsequently
disengaged from the handle 66 by turning the latter in a counter
clockwise direction, thereby releasing the probe into container for
safe disposal.
[0045] FIG. 5 shows container 31 and a cross-sectional view of
collars 34 illustrating the locking assembly plates 48 connected to
articulation handles 43 at disposal end 36 and dispensing end 38 of
the container. The locking mechanism of container 31 at disposal
end 36 is adapted to engage probe 18 in a specific manner to enable
its disposal as shown, such as for example, by engaging one or more
set of grooves in the probe proximal to the probe handle 66.
Engaging the locking mechanism by depressing lever 43, causes plate
48 to slide laterally within the space defined by collar assembly
over pin (not shown in this view), forcing the pin to align with
and engage a pinhole in plate 48, thereby "locking" the plate.
Rendering the plate "locked" further causes said locking mechanism
to engage probe 18 in an irreversible manner, thereby preventing
its re-dispensation. Upon disengagement of the probe from device
handle (not shown in figure), the probe is deposited within
container for disposal. The irreversible engagement of the locking
mechanism, therefore, prevents access to the probe disposed within
the container.
[0046] FIG. 6 shows sectional views of collar segment 42 at the
disposal end 36 comprising of a central aperture 36 capable of
communicating with the cylindrical section of container (not shown
in this view). A locking assembly comprising plate 48 having a key
hole shaped slot 50 is capable of being articulated by lever 43,
thereby causing it to slide laterally over aperture 36. Plate 48
further comprises pinhole 54 capable of aligning with pin 46 seated
on a spring (not shown in this view) within collar segment 42 such
that it exerts a unidirectional force on pin 46, thereby causing
the pin to remain in intimate contact with plate 48. When locking
mechanism is in the non-locked position (FIG. 6a), the circular
section of the key hole slot 50 in plate 48 is aligned with
aperture 36, thereby enabling insertion of a used probe for
disposal. Articulation of the locking mechanism by depressing lever
43 causes plate 48 to slide laterally over aperture 36, thereby
causing the circular segment of keyhole shaped slot 50 to be
displaced from aperture 36. The lateral movement of plate 48
further causes pinhole 54 to aligned with pin 46 such that pin 46
irreversibly enters pinhole 54 by action of the spring, thereby
causing plate 48 to remain in the "locked" position, wherein the
rectangular segment of keyhole slot 50 engages a groove or set of
grooves on the probe at the end proximal to the device handle. The
irreversible action of the locking mechanism, therefore, precludes
subsequent retraction of the probe after its disposal into the
container and activation said locking mechanism.
[0047] FIG. 7 shows sectional views of collar segment 42 at the
dispensing end. The arrangement of components and articulation of
the locking mechanism is identical to that at the disposal end
illustrated in FIG. 6 as described in the foregoing section, with
the exception of the orientation of key hole slot 50, which is
inverse to that at the disposal end (FIG. 6). The inverse
orientation of slot 50 causes an unused probe to be restrained in a
non-retractable manner when the plate 48 of locking mechanism is in
a non-locked position (FIG. 6a), and allows retraction of the said
probe for dispensation upon moving plate 48 to a locked position by
articulation of lever 43. Dispensation of the probe is accomplished
by attachment of the probe handle of a medical device to the
proximal end of the probe, following which engaging the locking
assembly by articulation of lever 43 to cause plate 48 to move
irreversibly into a "locked" position further causes alignment of
aperture 38 with the circular segment of keyhole 50, thereby
enabling retraction of probe from the container. The irreversible
movement of plate 48 in a locked position precludes re-insertion of
probe into container for re-dispensation.
[0048] Dispensation and disposal of an ultrasonic probe using the
container of the invention is accomplished in the following manner.
A new unused probe packaged in the container with the locking
mechanism at the dispensation in the non-locked position so as to
constrain the probe within said container is, dispensed by
inserting probe handle into collar at dispensing end, affixing
probe to the handle by clockwise rotation causing threads on the
probe handle to engage complementary threads in the device handle,
depressing the lever at that end results in articulation of the
locking mechanism 48 thereby disengaging the said locking mechanism
from the grooves on the probe and allowing the operator to withdraw
the probe from the container. After the probe has been used and is
ready for disposal, the operator inserts the probe at the disposal
end of the container. Engaging the locking mechanism at the
disposal end causes the used probe to be secured within the
container, thereby enabling detachment of the probe handle by
counter clockwise rotation to disengage the threads on the probe
from the complementary threads on the handle. The used probe is
permanently engaged by and contained within the container, and can
be disposed of in compliance with the provisions governing the
disposal of medical waste. Because the probe assembly is contained
by the invention, the sharp probe tip does not present a safety
hazard, and can be safely handled and disposed of as medical
trash.
[0049] Materials useful for the present invention include any
material rigid or semi-rigid materials that are substantially
resistant to puncture from a sharp medical instrument, and capable
of being sterilized by, for example, gamma irradiation or ethylene
oxide gas (ETO), without losing their structural integrity. Such
materials include but are not limited to, rubber, or plastics such
as polytetrafluoroethylene (PTFE), polyethylene, polypropylene,
silicone, polyetherimide or other similar plastics. Ceramic,
metallic, and glassy materials can also be used, and have the added
benefit being sterilizable by autoclaving. Where sterilization by
ultraviolet irradiation is contemplated the materials for
construction of the container must be substantially
UV-transmissible. Combinations of the aforementioned materials can
be used. The proportions of the device depend on the probe that
will be contained within the device. A container that is designed
to accommodate a probe of for example, eight inches long, would
utilize a tube approximately the same length. The diameter of the
tube must be sufficient to accommodate the probe, which will vary
depending on the shape of the probe tip, for example, straight,
rounded, curved, crescent, or "U" shaped, or the presence of a
probe sheath. Glass or clear high-density plastic is preferred as
the probe itself can be visualized in the container. The collar
assembly has an inside diameter at least as wide as the tube, with
an outside diameter greater than the inside diameter. In the
preferred embodiment, the outside diameter of the collar is at
least two to five times the inside diameter, and the inside surface
tapers in width from the widest point at the terminus of the
collar, and narrows proximally to the cylindrical section of the
container. This taper provides a means to guide the probe into the
tube, and it also provides clearance between the inside surface of
the collar, allowing attachment to the ultrasonic medical device. A
large outer diameter for the collar provides greater shielding
capability to protect the hand of the operator from accidental
pricks when a used probe is inserted into the container. The collar
assembly may be manufactured out of any substantially rigid
material that will not deform, crack, or shatter under the
torsional forces generated from attaching or detaching the probe to
the ultrasonic medical device, for example, high density plastic,
metal, ceramic, or hard rubber, and the like.
[0050] It should be obvious to those of ordinary skill in the art
that the individual features described herein may be combined.
Variations, modifications, and other implementations of what is
described herein will occur to those of ordinary skill in the art
without departing from the spirit and scope of the invention as
claimed. Accordingly, the invention is to be defined not by the
preceding illustrative description but instead by the spirit and
scope of the following claims.
* * * * *