Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
PCT/AU02/01644
~ ' CA 02468998 2004-06-07
_ _ Received 23 January 2004
-' P \OPER\Axd\2597243.wriucn opinion responsc.doc-22/01/04
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ATTACHMENT FOR LASER EMITTING DEVICE
The present invention relates to an attachment for use on a laser emitting
device.
More particularly, the invention provides an attachment which is adapted to
engage a laser
emitting device and thereby facilitate activation of the device to enable
firing of the device.
The invention also relates to a laser ablation system which involves the use
of such an
attachment.
The laser ablation of the skin of a patient in order to increase permeability
of the
skin and thereby allow permeation of a drug containing solution through the
skin is known.
Laser emitting devices may take any suitable form. Recent trends see such
devices
becoming more portable and more easily operated. Activation of laser emitting
devices is
generally achieved through a trigger mechanism. In this regard, the devices
are generally
aimed at the area of skin to be ablated and fired by a user as desired at the
site.
During the ablation process, debris is produced in the form of particles of
the
stratum corneum which has been ablated and/or interstitial fluid permeating
through the
ablated skin. Such debris can cause contamination of the laser emitting device
during
firing of the device. As such, it is generally considered desirable to provide
the device
with a protective cap or attachment for protecting the firing end of the
device.
The present invention advantageously provides an attachment for use on a laser
emitting device which is disposable and which protects the device from
contamination by
debris and which facilitates activation of the device to minimize the risk of
misfiring of the
emitting device.
According to one aspect of the invention there is provided an attaclunent for
a laser
emitting device, including: a body having a first end configured to detachably
engage the
laser emitting device and further having a second end; and a cap associated
with the
second end of the body, wherein said body includes engagement means adapted to
facilitate preliminary engagement with the laser emitting device which enables
energising
of the device and secondary engagement with the laser emitting device which
enables
firing of the device.
In a preferred embodiment, a first tab, preferably having a bevelled face, is
located
on the first end of the body of the attaclunent which, on initial engagement
of the
attachment on the laser ablation device, engages a lever of the laser emitting
device. It is
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preferred that a second tab is located on an opposing side of the first end of
the body
relative to the first tab, the second tab engaging a switch of the laser
emitting device as the
attachment is inserted into the laser emitting device to a final operating
position so as to
activate the laser emitting device.
The engagement of the disposable attachment with the laser emitting device
facilitates activation of the device. Generally, it is preferable that some
form of electronic
recognition be provided between the disposable attachment and the laser
emitting device
such that when the attachment is engaged with the device, the device is
electronically
activated to facilitate firing of the device. More particularly, in a
preferred embodiment
the body includes electronic identification means, preferably an electronic
chip, which in
use cooperates with a sensor of the laser emitting device. That is, the
cooperation of the
electronic identification means with the sensor facilitates firing of the
laser emitting
device.
More particularly, it is preferred that the second tab of the body, as
discussed
above, includes electronic identification means which is readable by the laser
emitting
device on insertion of the attaclnnent into the device to the final operating
position.
In an alternative embodiment the engagement means includes an annular
retaining
lip, preferably with a bevelled face, on the first end of the body of the
attachment.
Given that debris is produced during the ablation process and that this debris
may
collect on the disposable attachment, it is preferred that the disposable
attachment be a
"single use" attachment. That is, when ablation is complete, either on halting
firing of the
emitting device or on the removal of the attachment from the device, the
attachment is
altered so that it cannot be reused.
Single use may be achieved by any suitable means. For example, the disposable
attachment may be mechanically altered on removal from the emitting device so
that it
cannot be re-engaged with the device. However, in a preferred embodiment the
electronic
identification means is adapted to be altered on firing of the laser emitting
device, such as
by the application of reverse voltage, such that the electronic identification
means no
longer cooperates with the sensor, thereby preventing further firing of the
laser emitting
device. The disposable attachment may also, or alternatively be encoded to
ensure single
use of the attachment. That is, on engagement with the emitting device the
attachment
effectively registers with the device whereby any subsequent engagement will
not activate
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the device.
The body and cap may be integral with each other. Alternatively, the body may
be
adapted to engage the cap. In this regard, whether the two portions are
integral or whether
they engage each other, it is preferred that the body includes a passage
extending between
the first and second ends and the cap includes a substantially central
aperture, the passage
and aperture being commensurate so as to enable passage of the laser beam of
the laser
emitting device through the attachment. Preferably, a transparent membrane or
lens is
positioned between the passage of the body and the aperture of the cap. The
lens may take
any suitable form and is made from any suitable material. For example, the
lens may have
a layered structure. However, the lens is preferably formed from teflon.
In many instances, the laser is advantageously directed to a very specific
site on the
skin to be ablated. In this regard, it is preferable that the laser beam
emanating from the
emitting device be well defined without any substantial halo effect. With this
in mind, in a
preferred embodiment, the aperture of the cap is such that the laser beam of
the laser
emitting device is clipped on firing of the laser beam through the aperture.
As will be
understood by those skilled in the art, the term "clipped" refers to the
masking of the laser
beam to ensure that the beam which is emitted from the end of the attachment,
and
therefore the device, to the target area is well defined.
As mentioned above, it is preferred that the body engage the cap, such as by a
mechanical engagement. In this regard, in a preferred embodiment the body
includes at its
second end a flange which is received by the cap of the attachment. The flange
may be
retained within the cap by any suitable means. For example, the flanges may be
adhered or
welded within the cap. Preferably, the flange is ultrasonically welded within
the cap.
It may be desirable in some instances to provide a mark on the skin to clearly
indicate the target site for ablation. This may be so as to ensure that any
further ablation is
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carried out on the same site, or to clearly indicate the area of ablation for
drug
administration or interstitial fluid collection. In this regard, in a
preferred embodiment the
proximal end of the body of the attachment includes a recess which houses an
inlc pad, the
inlc pad including an aperture which is aligned with the apertures of the body
and the cap
and including a plurality of projections which, when the body is engaged by
the cap,
project through a plurality of complimentary apertures in the cap. It will be
appreciated
that the marlcing material need not be limited to ink, but may be any material
which can
apply a marls to the skin.
Although references made to an inkpad above, it will be appreciated that any
other
suitable marking means may be provided to facilitate marking of the skin as
desired. In
any event, it is preferred that the plurality of apertures of the cap include
a plurality of slits
which extend outwardly from the substantially central aperture of the cap.
In a preferred embodiment the body of the attachment further includes a
control
device that is configured to control the operation of the laser emitting
device when the first
end of the body is engaged with the laser emitting device. The control device
may be
associated with or separate to the engagement means of the attachment. In a
preferred
embodiment, the control device comprises an electric circuit.
The electric circuit may be configured to allow a laser element located in the
laser
emitting device to draw an electric charge from a power source associated with
the laser
emitting device when the first end of the body is engaged with the laser
emitting device.
Furthermore, the electric circuit may comprise a fuse element configured to
cease
operating after a predetermined amount of electric charge has passed through
the electric
circuit to prevent the laser element from drawing electric charge from the
power source.
In a particularly preferred embodiment, the electric circuit comprises a
memory
containing a predetermined code sequence. More preferably, the electric
circuit is
configured to communicate the predetermined code sequence to the laser
emitting device.
Still further, the electric circuit may be configured to delete the
predetermined code
sequence from the memory upon operation of the laser emitting device.
As previously stated, the body includes a first end that is configured to
detachably
engage a laser emitting device. In a preferred embodiment, the body is
configured to
detachably engage the laser emitting device for movement therein when at least
a
PCT/AU02/01644
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mechanism in the laser emitting device for operation of the laser emitting
device. In
particular, it is preferred that the cap is positionable substantially in a
focal plane of the
laser emitting device when at least the minimum amount of pressure is applied
to the cap
by contact with the skin.
In an alternative embodiment of the invention there is provided an attachment
for a
laser emitting device, comprising: engagement means configured to detachably
engage the
laser emitting device; a contact surface attached to the engagement means and
configured
to contact the skin of a patient; and control means configured to control the
operation of
the laser emitting device when the attachment is engaged with the laser
emitting device,
wherein said engagement means is adapted to facilitate preliminary engagement
with the
laser emitting device which enables energizing of the device, and secondary
engagement
with the laser emitting device which enables firing of the device.
Embodiments of the invention will now be described with reference to the
accompanying drawings in which:
Figure 1 illustrates a first embodiment of the disposable attachment;
Figure 2 illustrates a second embodiment of the disposable attachment;
Figures 3A and 3B illustrate third and fourth embodiments of the disposable
attachment;
Figure 4 illustrates a first stage of insertion of the attachment into a laser
emitting
device;
Figure 5 illustrates a second stage of the attachment inserted into the laser
emitting
device; and
Figure 6 illustrates the attachment being ejected by the laser emitting
device.
Referring to Figure 1, the disposable attachment 10 is illustrated in its
assembled
form and in an exploded view. The disposable attaclnnent 10 includes a body 11
and a cap
12 which cooperate with each other. As mentioned above, these portions may be
integral
with one another.
The body 11 includes a first tab 13 located on the distal end 14 of the body
11. As
best illustrated in Figure 4, the tab 13 is provided to engage a laser
emitting device to
facilitate engagement of the disposable attachment with the device. In this
embodiment,
the first tab 13 is located on a longitudinally extending ridge 15 of the body
11.
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The body 11 also includes a second tab 16 located on an opposing side of the
body
side 11 relative to the first tab 13. The second tab 16 extends longitudinally
along the
underside of the body 11 and is adapted to engage the laser emitting device to
activate the
device (as best illustrated in Figure 5).
The body 11 includes an aperture 17 which is aligned with an aperture 18 of
the
cap 12. A lens 19 is also provided and is housed between the aperture 17 of
the body 11
and the aperture 18 of the cap 12. This arrangement facilitates firing of the
laser through
the body 11 and cap 12 and also ensures firing through the lens 19. In certain
embodiments, the aperture 17 of the body 11 and/or the aperture 18 of the cap
12 may be
sized so as to facilitate clipping of the laser beam as it is fired through
the disposable
attachment 10. Generally, the cap 12 will provide a comfortable and effective
contact
surface with the slcin of the patient. Also, the attachment 10 is
advantageously designed to
allow the passage of at least 92% of the laser burst energy.
Referring to Figure 2, in an alternative embodiment the disposable attachment
20
includes a smart chip 21 which cooperates with a sensor of the laser emitting
device. The
smart chip 21 may be incorporated to ensure that the firing of the laser
emitting device is
prevented if the disposable attachment is damaged, or it may act as a
registration device so
that only attachments including a smart chip 21 can be used in conjunction
with a
particular laser emitting device. The smart chip 21 may further provide a
means of
ensuring single use of the disposable attachment. In this regard, as
previously mentioned,
on firing of the laser emitting device the smart chip 21 may be electronically
altered to
prevent refiring of the laser emitting device.
As illustrated in Figure 2, the disposable attachment 20 is also provided with
an
inkpad 22 which includes a plurality of projections 23. The projections 23 are
positioned
so that they can protrude through apertures 24 of the cap 12 when the body 11
engages the
cap 12. In this embodiment, the disposable attachment may be used to marls the
skin at the
target area during the ablation process, thereby ensuring that the target site
is easily
identified on removal of the laser emitting device from the skin. The
disposable
attachment 20 may also be provided with a cap 25 which is removable from the
cap 12.
Referring to Figures 3A and 3B, further embodiments of the disposable
attaclunent
are illustrated. In these embodiments, the cap 12 is integral with the body
11. The integral
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form of the attachment as illustrated may be formed by conventional moulding
techniques
and includes a lens 19 which may be positioned and set during moulding of the
disposable
attachment.
Figures 4-6 illustrate the initial engagement, full engagement and ejection of
the
disposable attachment relative to a laser ablation device 30 in cross section.
Referring firstly to Figure 4, the disposable attachment 10 initially engages
the
device 30 as the first tab 13 of the body 11 engages a lever arm 31 of the
device 30. The
lever arm 31 includes a press button 32 which is biased by a spring 33.
Therefore, as the
attachment 10 is forced into the end of the device 30, the first tab 13
engages the lever arm
31 compressing the spring 33 until the first tab 13 is engaged by the lever
arm 31.
Advantageously, the attachment 10 is configured such that it can only be
inserted into the
device 30 in one position or orientation. Even in the initial engagement
position illustrated
in Figure 3, the attachment 10 is securely held on the device 30, minimizing
the risk of the
attaclnnent 10 becoming detached during charging of the laser emitting device
30.
At this initial engagement, the smart chip 21 is located in a front portion of
the
device 30. At this position, a sensor 34 of the device 30 cannot read the
smart chip 21.
However, in particular embodiments the attaclnnent 10 may be provided with an
identification means which is electronically accessible by the emitting device
on initial
engagement. This may be physically embedded in the attachment 10. Further, the
identification means, such as a code, may advantageously be electronically
wiped or
altered on use to ensure that the attachment 10 can be identified by the
device 30 and used
only once, thus rendering the attachment with a "single-use" functionality.
~n further insertion of the disposable attachment 10 into the laser emitting
device
30, as illustrated in Figure 5, the attachment 10 may be moved into a final
engagement
position. During this movement, the second tab 16 of the attachment 10 forces
a shutter 41
to rotate away from the attachment, while the smart chip 21 slides over the
sensor 34
allowing the sensor 34 access to the chip 21. The attachment method
advantageously
ensures reliable connection between the sensor and the chip. The rotation of
the shutter 41
allows the second tab 16 to engage an ejector plate 42 which moves baclcwards
to
compress an interlock switch 43. This action and further insertion of the
attachment 10
into the device 30 facilitates activation of the device 30. Thus, on full
insertion of the
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_$_
attachment 10 into the device 30 to the position illustrated in Figure 5,
enables firing of the
device 30. That is, the movement of the ejector plate opens a laser shutter
(not shown) of
the device 30. The laser shutter, when closed, is capable of absorbing a
substantial amount
of the laser operating wavelength of the laser emitting device 30. For
example, the shutter
is preferably capable of absorbing 99.9% of the operating wavelength of the
laser.
From Figures 4 and 5 it will be readily understood that on initial engagement,
as
illustrated in Figure 4, the attachment can be maintained in position while
the laser
emitting device 30 remains deactivated. It is only on movement to the second
position
illustrated in Figure 5 that the full engagement of the attachment 10 with the
laser emitting
device 30 enables firing of the device 30. In certain embodiments, there may
be a firing
time limit, that is firing must occur within, for example, 5 seconds after
full engagement of
the attachment 10 with the device 30. The time limit may of course be selected
as desired.
The attachment protrudes from the end of the device at a desired distance,
such as about
6mm at a minimum. This advantageously ensures that the laser focal point is
correct and
that subsequent ablation is performed as desired.
Once the firing of the device has been conducted, the attachment 10 can be
released
and ejected from the laser emitting device 30 by pushing on the exposed button
32 of the
lever arm 31. Advantageously, removal of the attachment 10 is achieved without
requiring
the user to touch the attachment. On ejection, the shutter 41 returns to its
original position.
When there is no attachment inserted into the laser emitting device, the
ejector plate 42 and
shutter 41 are in their resting position. In this position, the end of the
laser emitting device
which acts as the attachment lcey hole is closed off. This advantageously
prevents
access to the interior of the laser emitting device and excess dust
contamination. A
transparent membrane may also be provided inside the attachment itself to
ensure that the
25 interior of the laser emitting device is not contaminated when the
attachment is in position
on the device.
In certain embodiments, the laser emitting device may include an LED which may
indicate, for example, laser charge status, engagement of the attachment with
the device
and power status of the laser emitting device.
30 The material of construction of the attachment is of no particular
importance, but it
is preferred that the attachment be manufactured from material which is
biocompatible and
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which maximizes ease of use while minimizing and rislc of adverse reactions,
such as
allergic reactions.
The reference to any prior art in this specification is not, and should not be
taken
as, an acknowledgment or any form of suggestion that that prior art forms part
of the
common general lcnowledge in Australia.
Those skilled in the art will appreciate that the invention described herein
is
susceptible to variations and modifications other than those specifically
described. It is to
be understood that the invention includes all such variations and
modifications which fall
within its spirit and scope. The invention also includes all the steps,
features, compositions
and compounds referred to or indicated in this specification, individually or
collectively,
and any and all combinations of any two or more of said steps or features.