U.S. patent application number 11/406657 was filed with the patent office on 2006-08-24 for ocular iontophoretic apparatus with handle.
Invention is credited to Jon E. Beck, Alex Koss.
Application Number | 20060189919 11/406657 |
Document ID | / |
Family ID | 36913714 |
Filed Date | 2006-08-24 |
United States Patent
Application |
20060189919 |
Kind Code |
A1 |
Beck; Jon E. ; et
al. |
August 24, 2006 |
Ocular iontophoretic apparatus with handle
Abstract
An iontophoretic apparatus comprising a housing member, a
current distribution member, a medicament containment member and at
least one of a lateral and medial straddling member. The straddling
members are configured to correspond to the external surrounding
soft tissue of the eye.
Inventors: |
Beck; Jon E.; (Salt Lake
City, UT) ; Koss; Alex; (Salt Lake City, UT) |
Correspondence
Address: |
FACTOR & LAKE, LTD
1327 W. WASHINGTON BLVD.
SUITE 5G/H
CHICAGO
IL
60607
US
|
Family ID: |
36913714 |
Appl. No.: |
11/406657 |
Filed: |
April 19, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09922559 |
Aug 3, 2001 |
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11406657 |
Apr 19, 2006 |
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09318181 |
May 25, 1999 |
6319240 |
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09922559 |
Aug 3, 2001 |
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09599245 |
Jun 22, 2000 |
6728573 |
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09922559 |
Aug 3, 2001 |
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60184498 |
Feb 23, 2000 |
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Current U.S.
Class: |
604/20 ;
604/294 |
Current CPC
Class: |
A61N 1/303 20130101;
A61N 1/30 20130101; A61N 1/0448 20130101; A61N 1/306 20130101; A61N
1/0428 20130101; A61N 1/044 20130101; A61F 9/00 20130101 |
Class at
Publication: |
604/020 ;
604/294 |
International
Class: |
A61N 1/30 20060101
A61N001/30; A61M 35/00 20060101 A61M035/00 |
Claims
1. An ocular apparatus for medically treating an eye, the ocular
apparatus being capable of cooperating with soft tissue proximate
the eye, the ocular apparatus comprising: a medicament containment
member; a handle operably connected to the medicament containment
member, the handle including a lateral straddling member and a
medial straddling member, the lateral straddling member including a
first end and a second end, the medial straddling member including
a first end and a second end, the first end of the lateral
straddling member connected to the medicament containment member
and the first end of the medial straddling member connected to the
medicament containment member, wherein placement of the medicament
containment member directly on the eye being maintained by the
operable cooperation of the handle and soft tissue proximate the
eye; and, a current distribution member in electrical communication
with the medicament containment member.
2. The ocular apparatus of claim 1 wherein maintaining placement of
the medicament containment member directly on the eye being
facilitated by abutment of lateral straddling member proximate
lateral soft tissue of the eye and the medial straddling member
proximate medial soft tissue of the eye.
3. The ocular apparatus of claim 1 further comprising: a first grip
portion attached to the second end of the lateral straddling
member; and, a second grip portion attached to the second end of
the medial straddling member wherein the first and second grip
portions facilitate grasping of the handle.
4. The ocular apparatus of claim 2 wherein the medial and lateral
straddling members each include a width such that opening and
closing of the eye is substantially unobstructed.
5. The ocular apparatus of claim 1 wherein at least one of the
lateral or medial straddling members includes a width to retain an
eyelid in an open position.
6. The ocular apparatus of claim 1 further comprising: a means for
biasing abutment of the handle with soft tissue proximate the
eye.
7. The ocular apparatus of claim 6 wherein the means for biasing
simultaneously maintains abutment of the lateral straddling member
with lateral soft tissue proximate the eye and abutment of the
medial straddling member with medial soft tissue proximate the
eye.
8. The ocular apparatus of claim 1 wherein the handle including a
wire.
9. The ocular apparatus of claim 1 wherein the handle being
unitarily configured with the medicament containment member and
extending there from.
10. The ocular apparatus of claim 1 wherein the handle comprising:
a first member including a first end and a second end, the first
end of the first member being affixed to the medicament containment
member; and, a second member including a first end and a second
end, and the first end of the second member being affixed to the
medicament containment member.
11. The ocular apparatus of claim 10 further comprising: a first
grip portion attached to the second end of the first member of the
handle; and, a second grip portion attached to the second end of
the second member of the handle, wherein the first and second grip
portions facilitate grasping of the handle.
12. An ocular apparatus for medically treating an eye, the ocular
apparatus being capable of cooperating with soft tissue proximate
the eye, the ocular apparatus comprising: a medicament containment
member; a handle being affixed to the medicament containment
member; a registration member attached to the medicament
containment member and extending outwardly there from, wherein
placement of the medicament containment member directly on the eye
being maintained by operable cooperation of the registration member
and soft tissue proximate the eye; and, a current distribution
member in electrical communication with the medicament containment
member.
13. The ocular apparatus of claim 12 wherein maintaining placement
of the medicament containment member directly on the eye being
facilitated by abutment of the registration member proximate soft
tissue of the eye.
14. The ocular apparatus of claim 12 wherein the registration
member includes a width such that opening and closing of the eye is
substantially unobstructed.
15. The ocular apparatus of claim 12 wherein the registration
member includes a width to retain an eyelid in an open
position.
16. The ocular apparatus of claim 12 further comprising: a means
for biasing abutment of the registration member with the soft
tissue proximate the eye.
17. The ocular apparatus of claim 12 wherein the registration
member comprising: a lateral member including a first end and a
second end, the first end of the lateral member being affixed to
the medicament containment member and extending outwardly there
from; and, a medial member including a first end and a second end,
the first end of the medial member being affixed to the medicament
containment member and extending outwardly there from.
18. The ocular apparatus of claim 12 further comprising: a means
for biasing abutment of the registration member with soft tissue
proximate the eye.
19. The ocular apparatus of claim 18 wherein the means for biasing
simultaneously maintains abutment of the lateral member with
lateral soft tissue proximate the eye and abutment of the medial
member with medial soft tissue proximate the eye.
20. The ocular apparatus of claim 12 wherein at least one of the
lateral and medial members of the registration member includes a
width such that opening and closing of the eye is substantially
unobstructed.
21. The ocular apparatus of claim 12 wherein at least one of the
lateral and medial members of the registration member includes a
width to retain an eyelid in an open position.
22. The ocular apparatus of claim 12 wherein the handle including a
wire.
23. The ocular apparatus of claim 12 wherein the registration
member including a wire.
24. The ocular apparatus of claim 12 wherein the handle being
unitarily configured with the medicament containment member and
extending there from.
25. The ocular apparatus of claim 12 wherein the registration
member being unitarily configured with the medicament containment
member and extending there from.
26. The ocular apparatus of claim 12 wherein the handle being
connected to the registration member.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of pending U.S.
application Ser. No. 09/922,559 filed on Aug. 3, 2001, which, is a
continuation-in-part of U.S. application Ser. No. 09/318,181 filed
May 25, 1999 and is a continuation-in-part of U.S. application Ser.
No. 09/599,245 filed Jun. 22, 2000, which, in turn, claims priority
from U.S. Provisional Application Ser. No. 60/184,498 filed Feb.
23, 2000.
BACKGROUND OF THE INVENTION
[0002] The present invention is directed to ocular iontophoretic
apparatuses, and more particularly, to a handle for an ocular
iontophoretic apparatus (or ocular passive delivery apparatus) to
facilitate the grasping, positioning and placement thereof, as well
as a retaining member to facilitate the retention thereof in a
desired orientation.
[0003] 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.
[0004] 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. Further
still, it is often difficult to retain the ocular apparatus in the
desired orientation for application of medicament.
[0005] It will be understood that substantially the same problems
and difficulties are associated with passive medicament or fluid
delivery devices which are intended for ocular use.
[0006] Accordingly, it is an object of the invention to provide for
a handle member which facilitates the grasping, positioning and
placement of ocular iontophoretic apparatuses (or passive
apparatus).
[0007] It is a further object of the invention to facilitate the
registered maintenance of the ocular apparatus in a desired
orientation of the eye.
[0008] It is likewise an object of the invention to facilitate the
repositioning of an ocular apparatus after placement onto the
surface of the eye.
[0009] 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.
[0010] These and other objects of the invention will become
apparent in light of the specification and claims appended
hereto.
SUMMARY OF THE INVENTION
[0011] The invention comprises an iontophoretic apparatus. The
apparatus comprises 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. The handle member includes a lateral straddling
member and a medial straddling member. The straddling members
cooperate with the soft tissue of the eye to retain the apparatus
in a desired orientation.
[0012] In a preferred embodiment, the handle member comprises a
first handle region and a second handle region extending outwardly
from the handle member. The first and second handle regions are
distally spaced apart a predetermined distance. The lateral
straddling member is associated with the first handle region and
the medial straddling member is associated with the second handle
region.
[0013] In another preferred embodiment, at least one of the first
and second handle regions includes a gripping region. The gripping
region facilitates the grasping of the handle region by a user.
[0014] In another preferred embodiment, the straddling members have
a width which is such that the opening and closing of an eye is
substantially unobstructed.
[0015] In another embodiment, at least one of the straddling
members includes a width which facilitates retention of an eyelid
of a patient in an open position.
[0016] Preferably, at least one of the medial and lateral
straddling members is substantially flexible so as to facilitate
the biasing of the straddling members against respective soft
tissue.
[0017] In a preferred embodiment, the lateral straddling member is
configured to straddle the region encompassed by the lateral
angle.
[0018] In yet another preferred embodiment, the medial straddling
member is configured to straddle the region encompassed by the
medial angle, the lacus lacrimalis and the caruncula
lacrimalis.
[0019] In yet another preferred embodiment, for biasing the
straddling members against the soft tissue of an eye.
[0020] In another aspect of the invention, the invention comprises
an ocular apparatus. The ocular apparatus is similar to the
iontophoretic apparatus; however, the delivery of medicament or
other fluid is not achieved by way of an electric current, rather,
by way of passive delivery. Such an apparatus comprises a housing
member, a medicament containment member associated with the housing
and at least one of a lateral straddling member and a medial
straddling member. The at least one straddling member cooperates
with the soft tissue of the eye to retain the apparatus in a
desired orientation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 of the drawings is a perspective view of the
apparatus of the present invention showing, in particular, the
apparatus placed upon an eye;
[0022] FIG. 2 of the drawings is another perspective view of the
apparatus of the present invention showing, in particular, the
apparatus placed upon an eye;
[0023] FIG. 3 of the drawings is a top plan view of the apparatus
of the present invention showing, in particular, the apparatus
placed upon an eye;
[0024] FIG. 4 of the drawings is a front elevational view of an
apparatus of the present invention;
[0025] FIG. 5 of the drawings is a front elevational view of an
apparatus of the present invention showing, in particular,
application thereof within an eye; and
[0026] FIG. 6 of the drawings is a front elevational view of an
apparatus of the present invention showing, in particular,
application thereof within an eye.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0027] While this invention is susceptible of embodiment in many
different forms, there is shown in the drawings and will be
described in detail, one specific embodiment 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 embodiment illustrated.
[0028] It will be understood that like or analogous elements and/or
components, referred to herein, are identified throughout the
drawing by like reference characters. In addition, it will be
understood that the drawing is merely a representation, and some of
the components may have been distorted from actual scale for
purposes of pictorial clarity.
[0029] Iontophoretic apparatus 10 is shown in FIGS. 1 and 2 as
comprising housing member 12, current distribution member 14,
medicament containment member 16, handle member 18. The housing
member, the current distribution member and the medicament
containment member are each described in detail in related U.S.
Pat. No. 6,319,240 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 45 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. It will be
understood that the medicament containment member can be used to
contain medicament, as well as other fluids (lubricating agent,
wetting agent, etc.).
[0030] It is likewise contemplated that the apparatus may comprise
a passive delivery device which includes housing and a medicament
containment member. Such an embodiment has a similar appearance but
does not include a current distribution member. As such the
medicament is not driven through the surface of the eye; rather,
the medicament (or other fluid to be delivered) is permitted to
passively be absorbed by the eye. Moreover, it is likewise
contemplated that the handle and registration maintaining means
described below can be adapted for use in association with other
applications to the eye, such as, ERG, Electroretinography, among
others.
[0031] 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 (i.e. under the
cornea, above the cornea, in the corners of the eye proximate the
medial and lateral angles, etc). 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 in association with the iontophoretic
apparatus.
[0032] Handle member 18 is shown primarily in FIGS. 1 and 2 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 25 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 which may be welded, adhered or otherwise joined to
housing member 12. Of course, as shown in FIG. 4, the registration
placement maintaining means 25 can comprise a separate structure
which is associated with the housing or with the handle member.
[0033] First handle region 20 of the handle member is shown in
FIGS. 1 and 2 as including first end 46, second end 48 and first
gripping portion 50. 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
gripping portion 50 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 on the eye of a patient. As can be seen in
FIGS. 1 and 2, first gripping portion 50 is 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. It will be understood that second handle
region 22 is substantially similar to first handle region 20, and
comprises first end 52, second end 54 and second gripping portion
56.
[0034] Gripping portion 50 of first handle region 20 and gripping
portion 56 of second handle region 22 are spaced apart a
predetermined distance from each other, to essentially provide a
means for flexing at least one of registration maintaining means 25
and the housing itself. 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 50, 56,
about the respective second ends of handle regions 20, 22, toward
each other, the force, in turn, flexes the registration maintaining
means 25 to facilitate the proper placement of same relative to the
external soft tissue surrounding the eye that is to receive
treatment. Additionally, the housing member may be flexed by the
doctor or professional during insertion and positioning on the
surface of the eye, so that an improved fit and an improved
positioning can be achieved.
[0035] 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 50 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 registration
maintaining means and/or the housing member is not possible. As the
respective gripping portions are rather large, it would be
difficult to over flex the gripping members as eventual abutment is
difficult to avoid.
[0036] Placement registration means 25 is shown in FIGS. 1 through
5 as including lateral straddling member 70, medial straddling
member 72 and biasing means 73. Lateral straddling member 70
straddles the region encompassed by the lateral angle of the eye.
The medial straddling member straddles the region encompassed by at
least one of the medial angle, lacus lacrimalis and caruncula
lacrimalis.
[0037] Most preferably, and as shown in FIGS. 1 and 5, lateral
straddling member includes a single straddling region 91 and medial
straddling member includes a first and second straddling region 92,
93, respectively. As such, single straddling region 91 of the
lateral straddling member 70 straddles the lateral angle of the
eyelid. The first straddling region of the medial straddling member
72 is configured to straddle the medial angle and the second
straddling region 93 is configured to straddle at least one of the
lacrus lacrimalis and caruncula lacrimalis.
[0038] In the embodiment shown in FIG. 5, each of the straddling
members comprise a narrow wire-like member having a small
thickness. Such a narrow member is suitable for receipt proximate
the lateral and medial regions such that the patient ability to
open and close the eyelid is substantially unaffected. In other
embodiments, such as the embodiment shown in FIG. 6, the straddling
members may have a larger width which would encompass a wider
region around the respective medial and lateral angles. Such an
embodiment can spread the force applied by the straddling members
along a wider soft tissue surface area and can likewise maintain
the eyelids in an open position, if such a maintenance is desirable
or necessary.
[0039] The configuration of each of the respective straddling
members is such that they are spaced apart a distance that is
slightly greater than the distance between the medial and lateral
angles of the eye. As such, upon application, one of the soft
tissue of the eye and the straddling members must be flexed (i.e.
manipulated) to achieve the desired registered positioning of the
straddling members relative to the eye. Once positioned, the soft
tissue is generally biased against the straddling members such that
the two are retained in substantial abutment. This cooperation and
respective dimensioning of components forms biasing means 73
referred to in the claims as a means for biasing medial and lateral
straddling members against the corner of the eye.
[0040] It is contemplated that in certain embodiments, only one of
a medial and lateral straddling member can be utilized. For
example, a medial straddling member can be utilized proximate the
medial angle, and a lateral straddling member can be omitted.
Similarly, a lateral straddling member can be utilized proximate
the lateral angle, and the medial straddling member can be omitted.
Such configurations are useful in association with particularly
shaped housings (i.e., housings that are configured to be placed on
the eye to cover regions proximate the medial and lateral angle
regions).
[0041] 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.
[0042] It is contemplated that the registration maintaining means
25 may comprise a structure separate from the handle member or a
structure which is not directly a portion of the handle member.
Such a structure is shown in FIG. 4, wherein the registration
maintaining means 25 include registration regions which cooperate
with the soft tissue of the eye. Such an apparatus further includes
a separate handle member which is used by the operator to
manipulate the apparatus. Such a separate handle member can be
associated with either the housing or it may branch from the
registration maintaining means. The registration maintaining means
25 can, in such an embodiment, be manipulated independent of the
handle members. It is also contemplated that the registration
maintaining means 25 can be incorporated with only one of the two
handle regions, and omitted with respect to the other of the handle
regions.
[0043] 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 external surface of the eye.
[0044] In particular, in the embodiment shown in FIG. 1, the doctor
first pinches the respective gripping portions 50, 56 toward each
other so as to flex registration maintaining means 25 (and to also
flex housing member 12 if configured for same). Once the
registration maintaining means is flexed as desired, the user can
position the housing member on the external surface of the
patient's eye. As the initial contact with the surface of the eye
is attained, the medical professional manipulates the registering
regions into the desired configuration relative to the external
soft tissue surrounding the eye. In particular, the lateral
straddling member is positioned to straddle the region encompassed
by the lateral angle. Similarly, the medial straddling member is
positioned to straddle the region encompassing the medial angle,
the lacus lacrimales and the carincula lacrimales. Each of the
straddling regions 91, 92 and 93 are configured to matingly
straddle these soft tissue regions.
[0045] Furthermore, once fully released, due to the relative
spacing between the straddling members, the straddling members are
generally biased against the respective soft tissue surrounding the
eye due to the biasing means.
[0046] Once fully positioned, the doctor initiates current delivery
from the current distribution member. The current forces medicament
retained in the medicament containment member 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.
[0047] 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. When the
treatment is complete, the apparatus can be removed from the
patient. Specifically, the doctor again grasps the gripping regions
of handle member 12 and pulls the housing from the external surface
of the eye.
[0048] 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.
* * * * *