Note: Descriptions are shown in the official language in which they were submitted.
CA 02325428 2000-11-07
TITLE OF THE In'VENTION
OCULAR IONTOPHORETIC APPARATUS HANDLE
This application claims the priority of U.S. Provisional Application Serial
No. 60/184,498 filed
February 23, 2000.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed to ocular iontophoretic apparatuses, and
more
particularly, to a handle for an ocular iontophoretic apparatus to facilitate
the grasping,
positioning and placement thereof.
2. Background Art
The use of ocular iontophoretic devices has been known in the art. Such
devices have
been used in an attempt to administer a drug through an electromotive force
which drives ionic
chemicals through the eye tissue so that they can be absorbed by adjacent
tissues and blood
vessels.
Among other problems, difficulties can be incurred with the placement of these
devices
onto the surface of the eye of a patient. Specifically, inasmuch as certain of
these devices are
intended for use on only a portion of the eye, they are rather small in size.
Accordingly, it is
difficult for a doctor to carefully position the device in the proper
orientation. Moreover, once
placed on the patient's eye, it is often difficult to reposition or to adjust
the positioning of the
device.
Accordingly, it is an object of the invention to provide for a handle member
~~hich
facilitates the grasping, positioning and placement of ocular iontophoretic
apparatuses.
It is likewise an object of the invention to facilitate the repositioning of
an ocular
1
CA 02325428 2000-11-07
iontophoretic apparatus after placement onto the surface of the eye.
It is a further object of the invention to provide for a handle member which
can be
pinched so as to flex the iontophoretic apparatus during placement onto an eye
and during
removal from the eye of the patient.
These and other objects of the invention will become apparent in light of the
specification
and claims appended hereto.
2
CA 02325428 2000-11-07
SUMn'IARY OF THE INVENTION
The application comprises an iontophoretic apparatus which includes a housing
member,
a current distribution member, a medicament containment member and a handle
member. The
current distribution member is associated with the housing member. The
medicament
containment member is associated with the current distribution member. The
handle member is
associated with the housing member, and the handle member serves to facilitate
the positioning
and/or placement of the iontophoretic apparatus.
In a preferred embodiment, the handle member comprises a first handle region
and a
second handle region extending outwardly from the handle member. Each of the
first and second
handle regions are preferably co-molded with the housing member and distally
spaced apart a
predetermined distance. In one such embodiment, the first and second handle
regions extend
away from each other. In another embodiment, the handle member may be
releasably associated
with the housing member.
In another preferred embodiment, at least one of the first and second handle
regions
1 S includes a gripping region. The gripping region facilitates the overall
gripping of the handle
region by a user during the positioning and/or placement of the apparatus. In
another such
embodiment, the first and second handle regions include a grasping region
which joins the
handle regions together to, in turn, render a single unitary handle region.
In another preferred embodiment, the first and second handle regions include
means for
flexing the housing member. In one such embodiment, the first and second
handle regions further
include means for limiting the flexing of the housing member. In one
embodiment, the flexing
limiting means may comprise the positioning of a portion of the first and
second handle regions
in a spaced apart orientation. The spaced apart orientation substantially
corresponds to the
3
CA 02325428 2000-11-07
desired maximum flex of the housing member.
In another such embodiment, the flexing limiting means further includes means
for
aligning the first and second handle regions. The aligning means precludes
inadvertent
misalignment of the first and second handle regions during flexing.
S In another preferred embodiment, the apparatus further includes means for
maintaining
the registered placement of the apparatus in the desired orientation. In one
such embodiment, the
registered placement maintaining means may comprise a receiving region
associated with one or
both of the handle member and the housing member. In one such embodiment, the
receiving
region comprises at least one notch. Preferably, the apparatus may further
include means for
biasing at least a portion of the receiving region against the soft tissue of
a user.
4
CA 02325428 2000-11-07
BRIEF DESCRIPTION OF THE DR.AVfINGS
Fig. 1 of the drawings is a perspective view of the first embodiment of the
apparatus of
the present invention;
Fig. 2 of the drawings is a perspective view of the first embodiment of the
apparatus of
S the present invention;
Fig. 3 of the drawings is a perspective view of the first embodiment of the
apparatus of
the present invention;
Fig. 4 of the drawings is a perspective view of the first embodiment of the
apparatus of
the present invention;
Fig. 5 of the drawings is a perspective view of the first embodiment of the
apparatus of
the present invention;
Fig. 6 of the drawings is a perspective view of the first embodiment of the
apparatus of
the present invention;
Fig. 7 of the drawings is a perspective view of a second embodiment of the
apparatus of
the present invention;
Fig. 8 of the drawings is a perspective view of a third embodiment of the
apparatus of the
present invention;
Fig. 9 of the drawings is a perspective view of a fourth embodiment of the
apparatus of
the present invention; and
Fig. 10 of the drawings is a perspective view of the fourth embodiment of the
apparatus
of the present invention.
5
CA 02325428 2000-11-07
BEST MODE FOR PRACTICING THE INVENTION
While this invention is susceptible of embodiment in many different forms,
there is
shown in the drawings and will be described in detail, several specific
embodiments with the
understanding that the present disclosure is to be considered as an
exemplification of the
principles of the invention and is not intended to limit the invention to the
embodiments
illustrated.
Iontophoretic apparatus 10 is shown in Figs. 1 and 2 as comprising housing
member 12,
current distribution member 14, medicament containment member 16 and handle
member 18.
The housing member, the current distribution member and the medicament
containment member
are each described in detail in co-pending application serial number
09/318,181 entitled
"Methods and Apparatus for Ocular Iontophoresis," the complete specification
of which is
incorporated herein by reference. As described therein in greater detail, the
housing member
includes outer surface 40, first end 42, second end 44, upper region 4~ and
rim 47. Generally,
the housing comprises a plastic material which is molded into a desired
configuration for the
positioning thereof on the eye of a patient.
As will be understood, housing member 12 may be of any number of sizes and
shapes.
Various embodiments of the housing member may include various configurations
depending on
the medicament to be dispensed, as well as the specific shape of the soft
tissue surrounding the
eye of the patient, and the particular region of the eye to which it is to be
applied. Of course, the
handle member is not limited to any particular housing member configurations
and may be used
with a wide variety of such devices. Additionally, the medicament that is
retained in
medicament containment member 16 for dispensing is not limited to any
particular medicament,
and virtually any medicament that can be applied iontophoretically through the
eye can be used
6
CA 02325428 2000-11-07
in association with the iontophoretic apparatus.
Handle member 18 is shown primarily in Figs. l and 5 as comprising first
handle region
20, second handle region 22, means 24 for flexing the handle member, means 26
for limiting the
flexing of the handle member and means 2~ for maintaining registered placement
of the
apparatus. Generally, handle member 18 is co-molded with housing member 12,
however, it is
likewise contemplated that the handle member may comprise a separate component
~~hich may
be welded, adhered or otherwise joined to housing member 12. In addition, the
handle member
is generally associated with the upper region 4~, which, in turn, facilitates
placement of the
device along, for example, the lov~~er edge of the patient's eye under the
lower eyelid. In
addition, such handle positioning minimizes the intrusiveness of the handle
member and the
discomfort to the patient receiving treatment, while maximizing the
versatility thereof.
First handle region 20 of the handle member is shown in Figs. 3 and 4 as
including first
end 46, second end 48 and first gripping portion ~0. First end 46 is
associated with outer surface
40 proximate first end 42 of the housing member. Second end 48 extends
outwardly therefrom
and in a direction which is generally away from second handle region 22 of the
handle member.
First ripping portion ~0 is positioned proximate second end 48 of first handle
region 20.
Generally, first gripping portion 50 comprises a region which is sized and
shaped so as to
promote the gripping thereof by a doctor or other professional during
placement of the
iontophoretic apparatus in the eye of a patient. As can be seen in Figs. 5 and
6, first gripping
portion 50 is substantially planar and spaced apart from the housing member a
distance sufficient
to insure that the doctor can easily grip the gripping portion without
inadvertently striking or
touching the patient. In certain embodiments the gripping region comprises a
substantially flat
pod region 51 (Fig. 7).
7
CA 02325428 2000-11-07
It will be understood that second handle region 22 is substantially similar to
first handle
region 20, and comprises first end 52, second end ~4 and second gripping
portion ~6. While
various configurations are contemplated, generally, the first and second
handle regions are
substantial mirror images of each other (and are substantially symmetrical)
about central axis 101
(Fig. 2) of the housing member.
In the embodiment shown in Fig. 8, gripping portion 50 of first handle region
20 and
gripping portion ~6 of second handle region 22 are integrally associated with
each other, to, in
turn, define a single loop like configuration for the ripping portion. In such
an embodiment, the
integrated gripping portion extends from second end 48 of first handle region
20 to second end
~4 of second handle region 22. The integrated gripping portion is
substantially parallel to the
housing member and generally follows the surface configuration of the outer
surface 40 of
housing member 12.
In the embodiment shown in Figs. 9 and 10, handle member 18 may be removably
associated with housing member 12. Specifically, in such an embodiment, handle
member 18
includes means 74 for releasably retaining the handle member to the housing
member.
Releasable retaining means 74 includes hoop 76 which is releasably
positionable within grooved
recess 78 of the housing member. As v~~ill be understood, once the apparatus
is positioned as
desired in the eye, the handle member can be removed by pulling thereon, to,
in turn, release
hoop 76 from within recess 78 of the housing member. Additionally, it will be
understood that
while the removable handle member is shown as including a single gripping
region, other handle
members, including, but not limited to, those shown in Figs. 1, 7 and 8 are
likewise
contemplated.
In the embodiment shown in Figs. S and 6, gripping portion 50 of first handle
region 20
8
CA 02325428 2000-11-07
and gripping portion ~6 of second handle region 22 are spaced apart a
predetermined distance
from each other, to essentially provide a means for flexing the housing.
Specifically, and as will
be explained in more detail below with respect to the operation, as the doctor
or professional
pinches the first and second gripping portions ~0, 56, about the respective
second ends of handle
regions 20, 22, toward each other, the force, in turn, flexes the housing
member. By flexing the
housing member during insertion and positioning on the surface of the eye, an
improved fit, and
an improved positioning can be achieved. Indeed, as long as the first and
second gripping
portions are not united to form a single integrated gripping portion, by
positioning the first and
second handle regions at opposite ends of the housing member, the pinching
thereof will
facilitate the flexing of the housing member.
Placement of a gap between the first and second gripping portions defines
means 26 for
limiting the flexing of the housing member. Specifically, gripping portion 50
and gripping
portion 56 extend from the respective second ends of the respective handle
regions so as to be
substantially parallel to outer surface 40 of housing member 12. The two
gripping portions
essentially extend toward each other until end 62 of first gripping portion ~0
is separated from
end 64 of second gripping portion 56 by a gap. Thus, as the user pinches the
gripping members,
the distance separating the two gripping portions becomes smaller until end 62
of first gripping
portion is in abutment with end 64 of second gripping portion 56. At such
time, the respective
gripping portions can be pinched no further and additional flexing of the
housing member is not
possible.
As shown in Figs. ~ and 6, the flexing limiting means further includes means
32 for
aligning the respective ends of the gripping portions. In particular, aligning
means 32 includes
first alignment member 68 which is associated with end 60 of gripping portion
50 and second
9
CA 02325428 2000-11-07
alignment member 70 which is associated with end 62 of gripping portion 52. As
will be
understood, as the user flexes the ends, the alignment members insure that end
60 of gripping
portion 50 is aligned with end 62 of gripping portion ~2, so that the flexing
can be limited by the
interaction and abutment of the two ends. Indeed, without the alignment
members, inadvertent
misalignment of the ends would permit the flexing of the respective ends
without limitation and
beyond that which is desirable.
Placement registration means 2~ is shown in Fig. 1 as including retaining
regions 70, 72
and means 73 for biasing the retaining region against the soft tissue of a
patient. Retaining
region 70 is associated with one or both of first end 46 of first handle
region 20 and first end 42
of housing member 12. Similarly, retaining region 72 is associated with one or
both of first end
52 of second handle region 22 and second end .~4 of housing member 12. The
retaining regions
comprise structures, such as notches that are configured to cooperate with the
corner area of the
soft tissue surrounding the eye of the user. Biasing means 73 comprises the
natural resilience of
the material surrounding retaining region 70 to return to its original
configuration upon flexing
thereby biasing the retaining regions against the soft tissue of a patient. As
will be explained, the
corner areas of the eye, the retaining regions and the biasing means cooperate
to maintain the
registered placement of the apparatus in the desired orientation, and
substantially preclude
movement of the apparatus once positioned. It is also contemplated that the
placement
registration means is not limited to cooperation with the corners of the eyes;
rather, it can also
cooperate with other surrounding tissues that remain substantially static
during movement of the
eye.
It is additionally contemplated that the electrical leads which attach the
power supply to
the electrodes which drive the medicament may be molded into the handle
member.
CA 02325428 2000-11-07
In operation, the doctor, physician's assistant or other professional first
selects the
appropriate apparatus from among various apparatuses of different size, shape
and medicament.
As explained above, the apparatus is not limited to any particular shape and
any particular
medicament. Once selected and prepared for placement by the doctor or
assistant on the
patient's eye, the apparatus is Grasped by the gripping members and positioned
onto the surface
of the eye.
In particular, in the embodiment shorn in Fig. 1, the doctor first pinches the
respective
GrippinG portions 50, ~6 toward each other so as to flex housing member 12.
Once flexed as
desired, the user positions the housing member on the surface of the patient's
eye. As the initial
contact with the surface of the eye is attained, the doctor slowly releases
the pinching Grip on the
Gripping reGions, and housinG member 12 returns to its original orientation at
which time the
entire outer rim 46 is in contact with the surface of the eye. By pinching the
gripping regions
prior to positioninG, improved surface matinG between the outer rim and eye
and improved
comfort to the patient is achieved. Moreover, better control can be maintained
over the
1 ~ apparatus, which, in turn, facilitates improved accuracy relative to
placement on the surface of
the eye.
In addition, as the doctor releases the handle member, the corner regions of
the eye are
positioned into and accepted by retaininG regions 70 and 72 of registered
placement maintaining
means 25 so as to achieve registered placement of the apparatus in the desired
orientation.
Furthermore, biasing means 73 of registered placement maintaining means 25
cooperates
with the retaining regions to bias and, in turn, maintain the corner of the
eye and the retaining
regions in cooperative enGagement. The cooperation of the registered placement
maintaining
means and the biasing means can also compensate for size variation in the
dimensions of the soft
11
CA 02325428 2000-11-07
tissue surrounding the eye. In certain embodiments, biasing means 73 and the
flexing means of
the handle member may be integrated into a single structure. -
Once fully positioned, the doctor initiates current delivery from the current
distribution
member. The current forces medicament retained in the medicament containment
member
S through the tissue of the patient's eye. The treatment continues for a
predetermined period of
time which is determined by the type and quantity of medicament that is to be
transmitted to the
patient.
Once the treatment is complete, current ceases to be delivered by the current
distribution
member. At such time, passage of medicament through the patient's tissue
ceases. Vv'hen the
treatment is complete, the apparatus can be removed from the patient.
Specifically, the doctor
main grasps the gripping regions of handle member 12 and pulls the housing
from the surface of
the e~~e.
In the embodiment shown in Fig. l, the user pinches gripping portions ~0 and
~6 until
housing member 12 flexes. The flexing of the housing member likewise
facilitates the release of
the housing member from the surface of the eye in a controlled manner.
In the embodiment shown in Fig. 7, the user may individually grasp each of the
separate
gripping members to release the housing member from the surface of the eye.
Similarly, in the
embodiment of Fig. 8, the doctor can grab the unitized gripping member to
release the housing
member from the surface of the eye.
The foregoing description merely explains and illustrates the invention and
the invention
is not limited thereto except insofar as the appended claims are so limited,
as those skilled in the
art who have the disclosure before them will be able to make modifications
without departing
from the scope of the invention.
12
