U.S. patent application number 13/206200 was filed with the patent office on 2011-12-01 for system for packaging and handling an implant and method of use.
This patent application is currently assigned to ReVision Optics, Inc.. Invention is credited to Alok Nigam.
Application Number | 20110290681 13/206200 |
Document ID | / |
Family ID | 27098073 |
Filed Date | 2011-12-01 |
United States Patent
Application |
20110290681 |
Kind Code |
A1 |
Nigam; Alok |
December 1, 2011 |
System for Packaging and Handling an Implant and Method of Use
Abstract
A system designed to store an implant together with the tools
necessary to implant the stored implant, and a method of using such
system. Such system includes an implant storage tool adapted to
retain the implant within a storage container. The implant storage
tool is operable to provide an implant applicator.
Inventors: |
Nigam; Alok; (Trabuco
Canyon, CA) |
Assignee: |
ReVision Optics, Inc.
Lake Forest
CA
|
Family ID: |
27098073 |
Appl. No.: |
13/206200 |
Filed: |
August 9, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11422815 |
Jun 7, 2006 |
7992906 |
|
|
13206200 |
|
|
|
|
11054639 |
Feb 9, 2005 |
7128351 |
|
|
11422815 |
|
|
|
|
10463091 |
Jun 17, 2003 |
6893461 |
|
|
11054639 |
|
|
|
|
09843547 |
Apr 26, 2001 |
6581993 |
|
|
10463091 |
|
|
|
|
09660371 |
Sep 12, 2000 |
6543610 |
|
|
09843547 |
|
|
|
|
Current U.S.
Class: |
206/229 |
Current CPC
Class: |
A61F 2/14 20130101; A61F
2/0095 20130101; A61F 9/0017 20130101; A61F 9/007 20130101; A61F
2/1662 20130101; A61F 2/1691 20130101; G02C 7/021 20130101; A61B
50/30 20160201; A61F 2/147 20130101; A61F 2/16 20130101; A61F 2/148
20130101 |
Class at
Publication: |
206/229 |
International
Class: |
B65D 69/00 20060101
B65D069/00 |
Claims
1. A packaging and handling system, comprising: a storage container
having a fluid contained in said container; and an implant
applicator tool contained in said container, said applicator tool
comprising: an applicator first end, and an applicator second end,
said applicator second end having a concave surface contoured to
hold an implant for application of the implant to the eye; and a
retaining member, said retaining member adapted to detachably
engage to said applicator second end surface so as to define an
enclosure to retain an implant.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. application Ser. No.
11/422,815, filed Jun. 7, 2006, now U.S. Pat. No. 7,992,906; which
is a continuation of U.S. application Ser. No. 11/054,639, filed
Feb. 9, 2005, now U.S. Pat. No. 7,128,351; which is a continuation
of U.S. application Ser. No. 10/463,091, filed Jun. 17, 2003, now
U.S. Pat. No. 6,893,461; which is a divisional of U.S. application
Ser. No. 09/843,547 filed Apr. 26, 2001, now U.S. Pat. No.
6,581,993; which is a continuation-in-part of U.S. application Ser.
No. 09/660,371, filed Sep. 12, 2000, now U.S. Pat. No. 6,543,610;
all disclosures of which are incorporated herein by reference in
their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to a system for packaging,
handling and applying implants. Additionally, this invention
relates to a method for introducing a corneal implant to the
corneal surface.
BACKGROUND OF THE INVENTION
[0003] Current methods and devices used to store small, delicate,
and normally transparent implants entail free-floating the implant
in a volume of storage fluid contained within a storage bottle or
other container. This manner of storage is oftentimes used to
preserve retinal transplants, brain tissue transplants, corneal
implants, tissue biopsies and any other delicate biological
specimen. Free-floating storage, however, subjects a stored
specimen or implant to fluid agitation, which can severely and
irreparably damage the integrity of the stored material. In
addition, isolating transparent specimens from the storage fluid is
difficult to achieve.
[0004] Corneal implants are especially susceptible to the above
described problem. Corneal implants are used to correct visual
disorders such as Myopia or near-sightedness, Hyperopia or
farsightedness, Presbyopia or difficulty in accommodating a change
in focus, and Astigmatism. To correct these disorders, the implant
is introduced into the body of the cornea in known ways, such as
after a flap is formed and an under surface of the cornea is
exposed. The implant, changes the shape of the cornea and alters
its refractive power. These implants are generally made of various
types of hydrogels, but can include other polymers, tissue
implants, or the like. In the past, storing the corneal implant
required free-floating the implant in a volume of storage fluid
contained within a storage container. To retrieve the implant, one
had to first locate the implant within the fluid, and then remove
the implant using a filter device or sequestering tool. In the case
of a corneal implant, locating the implant is complicated by both
the size and transparency of the implant. For instance, a corneal
implant generally has a diameter of about 4.0 to 7.0 mm and a
center that is normally fabricated having a thickness ranging from
25 to 50 microns. Due this minuscule size, physically grasping the
implant from the storage fluid using tweezers, or the like, is
simply not practical.
[0005] Successful isolation of a corneal implant, or other
specimen, generally requires the use of a sieve to separate the
implant from the fluid. Isolating the implant in this manner,
however, subjects the implant to mechanical forces, which could
lead to a loss of the implant. If not damaged, the transparent
implant must still be located-on the sieve surface and retrieved.
The implant must therefore be grasped using tweezers, forceps, or
the like. Imparting such force upon the implant, however, can also
damage the implant. Using force imparting tools to hold the implant
is therefore not desirable. Current isolation techniques are
therefore difficult, time-consuming and create additional steps,
which can also lead to implant contamination. Thus, it is desired
to have an implant storage and handling system, which allows the
user to rapidly and successfully retrieve the implant for prompt
implantation.
[0006] Current devices used to deposit an implant onto the cornea
surface generally deposit the corneal implant onto the cornea
surface in a bunched or folded conformation. Aligning the implant
in planar relation to the cornea surface requires the surgeon to
manipulate or tease the implant so as to remove any folds or bends
in the implant. Problematically, the step of unfolding the implant
on the cornea surface can cause serious trauma to the cornea
surface. This trauma can lead to the formation of edema, or other
deleterious responses that lead to rejection or displacement of the
implant.
[0007] Thus, there is believed to be a demonstrated need for a
unitary packaging and handling system that provides the desired
storage capabilities, easy retrieval of the specimen from that
storage, and tools that are operable to retrieve and utilize the
specimen without causing damage to the specimen or an implantation
site. There is also an additional need for a more effective method
for implanting a corneal implant onto a cornea surface.
SUMMARY OF THE INVENTION
[0008] The present invention relates to an implant packaging and
handling system which includes a storage bottle having an opening
to receive a volume of implant storage fluid, and an implant
holding tool designed to retain the implant in fluid communication
with the implant storage fluid. A storage bottle stopper holds the
implant holding tool, so that a portion of the implant holding tool
is immersed within the storage fluid upon placement of the stopper
into the bottle, placing the implant in fluid communication with
the storage fluid. The implant holding tool includes a retaining
member detachably mounted to an implant applicator tool. Together
they define an enclosure for retaining the implant in a secure,
known storage position.
[0009] The implant applicator tool has an arcuate-shaped applicator
surface with a plurality of openings. The arcuate shaped surface is
contoured to correspond to the curvature of the cornea surface,
which aids in the proper implantation of the implant to the cornea
surface. In one embodiment, the applicator surface has one or more
recessed surfaces designed to hold and center the implant on the
applicator surface. One or more recessed grooves are also provided
to allow fluid to flow between the implant and the applicator
surface.
[0010] The openings have numerous advantages. The openings provide
continuous fluid communication between a retained implant and the
implant storage fluid. Upon removal from storage, the openings
enable the user to unfold and orient the implant by gently passing
fluid through the openings so as to float the implant into a
desired central position on the applicator tool surface. Once so
positioned, the user is then able to aspirate the fluid/from
between the implant and the applicator tool, the applicator tool
surface. The applicator tool also includes a central opening
providing the user with a reference point for centering the
applicator surface, and thus, the implant onto the surface of the
cornea.
[0011] The present invention also relates to a method of implanting
a corneal implant using the implant packaging and handling system.
The initial step includes surgically preparing the cornea surface
for implantation. Next, the implant and implant holding tool are
retrieved from the storage bottle, and the retaining member removed
so as to provide an applicator tool together with implant. The
applicator can then be attached to a handle for ease of use. The
implant is then properly aligned on the applicator tool and
deposited onto the surgically prepared cornea surface. Finally, the
cornea is restored.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] A better understanding of the invention can be obtained from
the detailed description of exemplary embodiments set forth below,
when considered in conjunction with the appended drawings, in
which:
[0013] FIG. 1 is a partial sectional view of the implant packaging
and handling system of the present invention;
[0014] FIG. 2 is a schematic representation of the implant
applicator tool fastened to a retaining member, providing the
implant storage tool of the present invention;
[0015] FIG. 3 is a schematic representation of the implant
applicator tool of the present invention;
[0016] FIG. 4 is a schematic representation of the retaining member
adapted to form an implant retaining enclosure when fastened to the
implant applicator tool of FIG. 3;
[0017] FIG. 5 is a bottom view of a stopper used to seal the
storage bottle of the present invention, showing the implant
storage tool engagement slot in an open position;
[0018] FIG. 6 is a cross-sectional view through the stopper of FIG.
5 taken on line 10-10;
[0019] FIG. 7 is a partial sectional view of the bottle stopper
positioned within the storage bottle, showing the implant storage
tool engagement slot in a closed position;
[0020] FIG. 8 is a cross-section at view through the stopper and
storage bottle of FIG. 7 taken on line 20-20;
[0021] FIG. 9 is a schematic illustration of the implant applicator
tool secured to a handle;
[0022] FIG. 10 is a side view of the implant applicator tool
secured to a handle, showing the curved surface of the implant
applicator tool, which corresponds with the contour of the cornea
surface;
[0023] FIG. 11 is a schematic representation of an implant
applicator tool having a central opening for aligning the
applicator tool with the visual or pupillary axis of the eye;
[0024] FIG. 12 is a schematic representation of an implant
applicator tool having a recessed surface defining a central
opening and adjacent alignment slot;
[0025] FIG. 13 is a schematic representation of a retaining member
adapted to engage with the applicator tools shown in FIGS. 9 and
12, and FIG. 13a shows the retaining member in a planar
configuration, i.e., before tabs 26 and 28 have been folded down as
shown in FIG. 13;
[0026] FIGS. 14a, 14b, 14c, 14d and 14e are cross-sectional views
of a human eye illustrating the method of introducing an implant to
the cornea surface using the implant applicator tool of the present
invention;
[0027] FIG. 15a is a side view of the presently preferred
embodiment of implant packaging and handling system of the present
invention;
[0028] FIG. 15b is a cross-sectional view of the implant packaging
and handling system shown in FIG. 15a illustrating the relation
between the upper lens carrier member and the lower lens support
member;
[0029] FIG. 16a is a top view of the upper lens carrier member of
the implant packaging and handling system of the present
invention;
[0030] FIG. 16b is a side view of the upper lens carrier member of
the implant packaging and handling system of the present
invention;
[0031] FIG. 16c is a cross-sectional view across line B-B of the
upper lens carrier member shown in FIG. 16a;
[0032] FIG. 17a is a top view of the lower lens support member of
the implant packaging and handling system of the present
invention;
[0033] FIG. 17b is a side view of the lower lens support member of
the implant packaging and handling system of the present
invention;
[0034] FIG. 17c is a cross-sectional view of the lower lens support
member shown in FIGS. 17a and 17b;
[0035] FIG. 18 is a top view of a lens implant of the present
invention showing an asymmetrical mark for proper orientation of
the lens on the cornea surface;
[0036] FIG. 19 is a top view of a lens implant of the present
invention showing asymmetrical markings for proper orientation of
the lens on the cornea surface;
[0037] FIG. 20 is a top view of a lens implant of the present
invention showing the posterior surface of the lens implant having
the letter "a" imprinted on the anterior surface.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0038] FIGS. 1-17b of the drawings show an implant packaging and
handling system 10 of the present invention. As illustrated in FIG.
1, the preferred system 10 includes a cylindrical storage bottle 11
for holding implant storage fluid (not indicated). The bottle 11 is
sealed by a stopper 12 having an upper cap portion 14 and a plug
portion 13, which is adapted to detachably couple to an implant
storage tool 15. A protective safety seal 17 provides tamper
resistance and maintains the stopper 12 in sealed relation to the
bottle 11.
[0039] FIGS. 2-4 show a retaining member 16 and implant applicator
tool 19, which together define the implant storage tool 15. As
illustrated, the retaining member 16 is adapted to detachably
engage the implant applicator tool 19, thereby defining an
enclosure 41 operable to retain the implant. Both the retaining
member 16 and the applicator tool 19 include a plurality of
openings 18 and 22, respectively, which allow storage fluid to
communicate into the implant retaining enclosure 41. As shown in
FIG. 1, the implant retaining enclosure 41 is located on the end of
storage tool 15 that is distal to the stopper 12 such that the
enclosure 41 is immersed in implant storage fluid when the storage
tool 15 is inserted into the bottle 11. When the implant is stored,
the enclosure 41 of storage tool 15 holds the implant in the
storage fluid, while also providing a user with ready access to the
implant. The user simply removes the stopper 12, thereby removing
the storage tool 15 from the bottle 11, and detaches the retaining
member 16 from the applicator 19 to access the implant.
[0040] As illustrated in FIG. 3, applicator tool 19 has a handle
attachment arm 20 connected through a body portion 21 to an implant
applicator member 45. The body portion 21 is preferably shaped to
provide a broad handling surface. For instance, FIGS. 2 and 3 show
a body portion 21 having a broad elliptical shape, which allows a
user to more easily manipulate the applicator tool 19. As shown,
the implant applicator member 45 includes an applicator surface 42
having a plurality of openings 22 to provide fluid communication
between the applicator surface 42 and an implant resting thereon.
Openings 22 further allow the user to release the implant from the
applicator surface 42. More particularly, the user can impart force
upon the implant by passing through the opening 22 either a flow of
fluid or a cantilever so as to forcibly separate the implant from
the applicator member surface 42 (as is shown in FIG. 14).
[0041] In a preferred embodiment, the applicator surface 42 has a
central opening 23 to help the user align the applicator surface 42
along the visual or optical axis of the eye. As shown, the
centrally positioned opening 23 defines a circular opening having a
diameter greater than the diameter of the surrounding openings 22.
In this way, the user is provided with a central point of
reference, which enables the user to align the applicator surface
42 with the optical axis of the eye, and thus, properly position
the implant.
[0042] In another embodiment, the applicator tool 19 may include an
applicator alignment notch 24 positioned integral to the surface 42
of the applicator member 45. For instance, FIGS. 3 and 12 show the
notch 24 extending inwardly towards the centrally positioned
alignment opening 23. In this embodiment, the notch 24 is used to
align the implant on the cornea surface 39, as well as release the
implant from the applicator surface 42. Specifically, the notch 24
is dimensioned to allow a cantilever, or like instrument, to pass
through the notch, thereby allowing the user to impart force
against an implant held on the applicator surface 42. Specifically,
the user lifts the application tool 19 away from the cornea surface
while simultaneously imparting downward force on the implant
through the notch 24 so as to release the implant. One skilled in
the art will understand that various notch positionings can be
incorporated into the applicator member 45 without departing from
the scope of the present invention.
[0043] As shown in FIG. 2, the retaining member 16 has an outer
surface 44 defining a plurality of openings 18 that provide fluid
communication to an implant retained by the enclosure 41. FIG. 4
shows a retaining member 16 disengaged from the applicator tool 19
shown in FIG. 3. To secure the retaining member 16 to the
applicator tool 19, the retaining member 16 is provided with
attachment tabs 26a-c adapted to insert into corresponding
attachment slots 25a-c integral to the applicator tool 19. In use,
the retaining member 16 is attached to the applicator tool 19 by
simply inserting the tabs 26a-c into the respective corresponding
slots 25a-c, and then positioning the bottom surfaces 28 of
retaining member side walls 43 against the applicator surface 42.
In a preferred embodiment, at least one side wall 43 has an
overlapping flexible portion 27 adapted to bend about the distal
edge of the applicator surface 42, thereby securely clamping the
retaining member 16 to the applicator tool 19. To remove the
retaining member 16, the user merely unclamps the flexible portion
27 by bending it away from the applicator tool 19, and lifting the
member 16 so as to disengage tabs 26a-c from slots 25a-c.
[0044] As illustrated in FIGS. 9, 11, 12 and 13, an alternative
attachment tab 26 and attachment slot 25 can also be used with the
present invention. For instance, FIG. 12 shows an applicator tool
19 having four separate attachment slots 25, while in comparison
FIG. 3 shows an applicator tool 19 having three separate attachment
slots 25a-c. It will be understood by those skilled in the art that
various embodiments for attachment slots 25 and tabs 26 can be
incorporated into the applicator tool 19 and retaining member 16
without deviating from the scope of the present invention.
[0045] As illustrated in FIGS. 5-8, a preferred embodiment of
system 10 includes a bottle stopper 12 adapted to receive and
securely hold the handle attachment arm 20 of the applicator tool
19. The stopper 12 preferably includes an upper cap portion 14 and
a plug portion 13 dimensioned to insertably seal the bottle 11.
FIG. 5 shows the stopper plug portion 13, which is not inserted
into a storage bottle opening 46 (shown in FIG. 8). In comparison
to FIG. 5, FIG. 7 shows the plug 13 inserted into the storage
bottle opening 46. As illustrated by FIGS. 5 and 7, plug portion
13, when removed from bottle opening 46, adopts an elliptical shape
by distending in an outwardly direction along line the 10-10.
Likewise, inserting stopper 12 into bottle opening 46 causes the
outer diameter of plug portion 13 to conform to the inner diameter
of the inner bottle surface 34. In this way, the plug portion 13
becomes inwardly compressed along line 30-30. Referring to FIGS. 6
and 8, cross-section views are shown of stopper plug portion 13 in
an out-of-bottle elliptical shape and an in-bottle compressed
circular shape, respectively. The utility of this embodiment is
described in more detail below.
[0046] An engagement slot 32 is located integral to plug portion 13
in an orientation perpendicular to line 10-10. As illustrated in
FIGS. 5-8, the engagement slot 32 opens or closes in response to
either the removal or insertion of the plug portion 13 from the
bottle opening 46, respectively. Referring to FIGS. 5 and 6, the
engagement slot 32 is shown in an open position. More particularly,
when the user removes the stopper 12 from bottle opening 46, the
plug portion 13 adopts an unrestrained elliptical shape by
distending outwardly along the line 10-10 for opening slot 32. In
this way, the engagement arm 20 of the applicator tool 19, which is
held by the engagement the slot 32, is easily separated from slot
32 once the stopper 12 is removed from the storage bottle 11. By
way of comparison, FIGS. 7 and 8 show the engagement slot 32
adopting a closed conformation upon insertion of the stopper 12
into the bottle opening 46. As shown in FIG. 7, insertion of the
stopper 12 into the bottle 11 causes the outer surface 47 of the
plug portion 13 to conform to the inner diameter of the bottle
opening surface 34, which imparts force in the direction of the
line 30-30. In this way, the slot 32 is forced into a tight, closed
conformation. Thus, the engagement arm 20 of the applicator tool 19
is held by a slot 32 in a secure position when the stopper 12 is
inserted into the bottle 11. The stopper 12 is preferably made of
silicone rubber, or other elastomeric material.
[0047] FIGS. 9 and 10 show an applicator tool 19 attached to a
handle 30. The applicator tool attachment arm 20 detachably mounts
to the handle 30 through a handle fastener 31. It will be
understood by those skilled in the art that numerous types of
handles and handle fasteners are available that can be used with
the applicator tool 19 without departing from the scope of the
present invention.
[0048] As illustrated by FIG. 10, the implant applicator member 45
has a curved applicator surface 42, which corresponds to the
curvature of the cornea implant site. This curved surface allows
the user to position the curved applicator surface 42 evenly across
the cornea surface, enabling the implant to be more evenly
deposited onto the cornea surface. Referring to FIGS. 9 and 12,
each applicator member 45 is shown having a recessed applicator
surface 29. As shown, the recessed surface 29 is preferably
circular, thereby allowing a substantially circular implant to be
centrally positioned on the applicator member 45. In addition, the
central opening 23 which is centered relative to the perimeter of
the circular recess 29, provides the user with a reference point
for alignment of the applicator member 45 with the pupil diameter.
In this way, the implant can be properly aligned on the cornea
surface.
[0049] FIG. 11 shows an applicator tool 19 having an applicator
surface 42 with recessed grooves 29 to allow fluid to flow between
the applicator surface 42 and an implant supported on the surface
42. It should be understood by one skilled in the art that
alternatively dimensioned recesses and grooves can be formed in the
applicator surface 42 without departing from the scope of the
present invention. It is advantageous to provide fluid flow between
the surface 42 and the implant to enable the user to more easily
manipulate the implant while it is on the applicator surface 42.
During storage, for example, the implant may come to rest in
various folded and bunched conformations. Once the retaining member
16 is removed, the user can manipulate the implant into its desired
conformation by gently passing a volume of fluid through the
openings 22 and 23. More particularly, the implant will overlap a
small volume of fluid, thereby allowing the user to floatingly
realign the implant on the applicator surface 42. After the implant
is aligned, the fluid can be removed by simply touching the
underside of the applicator member 45 with a cotton swab, or like
absorbent material.
[0050] FIGS. 12 and 13 show an alternative embodiment of an
applicator tool 19 and a retaining member 16, respectively. In this
embodiment, the retaining member 16 includes four attachment tabs
26 that detachably insert into four corresponding applicator tool
attachment slots 25. As shown, the tool 19 and the retaining member
18 include fluid communication openings 22 and 18, respectively. It
should be understood that various combinations of tabs, slots,
alignment and openings can be incorporated into the tool 19 and the
member 16 without deviating from the scope of the present
invention.
[0051] FIGS. 14a-14e illustrate the steps of the claimed method of
implanting an implant to an exposed surface of the cornea using the
system of the present invention. The first step, shown in FIG. 14a,
involves the surgical preparation of a portion of the outer surface
of the cornea 38 of the eye to form a corneal flap 37, which
remains attached to the cornea 38 by way of a hinge 36. This
surgical step is commonly known in the art as a lamellar
dissectomy, and is typically performed using a keratome (not
shown). In a preferred embodiment, the flap is cut deeply enough to
dissect the Bowman's membrane portion of the cornea 38. Surgically
preparing a corneal flap of 100 to 200 microns, typically 160 to
180 microns, operates to eliminate tension caused by the Bowman's
membrane. This step reduces the possibility of implant extrusion
due to pressure generated within the cornea 38, which may be caused
by the implant. As illustrated, it is preferable to leave the
corneal flap 37 attached by way of a hinge 36, thereby allowing the
flap 37 to be replaced in the same orientation as before the
cut.
[0052] After the surface 39 is prepared, the surgeon deposits the
implant 40 onto the surface 39 using the applicator 19. To retrieve
the applicator tool 19, the surgeon first removes the protective
seal 17 from around the bottle opening. The implant holding tool 15
is then removed from within the bottle 11 by removing the stopper
12, which holds the storage tool 15. The storage tool 15 is easily
separated from the stopper 12 by holding the tool 15 about the body
portion 21 and disengaging the tool 15 from the now opened slot 32.
Next, the tool arm 20 can be attached to a handle 30, and the
retaining member 16 removed. Removing the member 16 presents the
implant 40 to the surgeon for implantation. The surgeon is able,
therefore, to retrieve an implant 40 from a storage bottle 11
without having to use, at the risk of damaging or losing the
implant, a grasping tool, such as tweezers or surgical forceps.
[0053] The surgeon then properly aligns the implant 40 on the
applicator surface 42 by preferably passing liquid through the
openings 22. At this step, the surgeon may gently guide the implant
40 to its proper alignment on the surface 42 using a cannula 35, or
other similar device. The implant 40 is positioned on the
applicator surface 42 by drawing off the fluid located intermediate
to the implant 40 and the applicator surface 42. This can be done
by placing a cotton swab, or other absorbent material, against the
underside of applicator member 45, which draws off the fluid
through openings 22.
[0054] As shown in FIG. 14b, the corneal flap 37 is pulled away
from the cornea implantation surface 39. The implant 40 is then
positioned over the cornea implantation surface 39 by holding the
applicator tool 19 in a generally horizontal position over the
surface 39 with the implant 40 facing the surface 39. As shown, the
applicator member 45 has an arcuate shaped applicator surface 42,
which matches the curved shaped of the cornea surface 39. In this
way, as illustrated in FIG. 14c, the applicator member 45 can be
evenly placed over the cornea surface 39, reducing trauma to the
surface 39. Specifically, the implant 40 is evenly adhered to the
surface 39, reducing the need for any manipulation of the implant
40 on the surface 39, which could traumatize the eye as is
described above.
[0055] Referring to FIG. 14d, the implant 40 is deposited onto the
surface 39 by gently lifting the applicator tool 19 away from the
surface 39. As shown, the implant 40 remains adhered to the surface
39. The use of a cannula 35 operable to pass a volume of fluid flow
through opening 22, however, can be used to ensure proper
deposition of the implant 40 onto surface 39. As shown in FIG. 14e,
once the implant is deposited onto the surface 39, the corneal flap
37 is replaced.
[0056] As shown in FIGS. 15a-19, there is illustrated a presently
preferred embodiment for an implant packaging and handling system
48 used to apply a corneal implant to the corneal surface.
Referring to FIG. 15a, the preferred embodiment includes an implant
carrier member 80 having a handle portion 50 joined at an angle to
a implant applicator portion 58. The system 48 further includes an
implant carrier member 80, which is specially contoured to
detachably connect to the implant support member 78. As
illustrated, the implant support member 78 is also provided with a
handle portion 52 joined at an angle to an implant support portion
56.
[0057] As illustrated in FIG. 15b, fastening the carrier 80 and
support 78 members together operably aligns the implant applicator
portion 58 and implant support portion 56. In this embodiment, the
handle portions 50 and 52 are adjacently positioned so as to form a
support handle 54 having an end 96 that is held within by an
opening 32 in a vial stopper 12 during storage conditions, as
illustrated by FIG. 1. In this way, the concave surface 70 of the
applicator portion 58 overlaps the upper implant support surface
76, which is preferably a convex surface, of the support portion
56. This overlapping arrangement forms a chamber 88 between the two
surfaces, 70 and 76, which provides a storage space to hold an
implant therein.
[0058] Referring to FIG. 16c, which is shown a cross-sectional view
of the preferred implant applicator portion 58. The applicator
portion 58 includes a recessed or domed portion having an upper
surface 86 and lower surface 70. The lower surface 70 is specially
contoured to have a radius of curvature that is greater than the
radius of curvature of an implant that is being packaged. Such
design is advantageous in assisting with the release of the lens
implant from the applicator surface 70. More particularly, a
corneal implant generally includes a posterior surface that is
applied directly to the corneal surface and an anterior surface
that is covered by a corneal flap following the application of the
implant to the corneal surface. Similar to the method described in
detail above, applying the implant to the corneal surface is
achieved by setting the applicator surface 70 of the applicator
portion 58 in contact with the corneal surface and then lifting the
applicator portion 58 away from the corneal surface, wherein the
anterior surface of the implant remains adhered to the corneal
surface and the posterior surface of the implant releases from the
applicator surface 70. To both enhance deposition of the implant
onto the corneal surface and prevent the implant from remaining
adhered to the applicator lower surface 70, the applicator lower
surface 70 is provided with a radius of curvature that is greater
than the curvature of the anterior surface of the particular
implant that is packaged and held in the chamber 88 between the
implant applicator portion 58 and the support portion 56. In this
way, the anterior surface of the implant and the applicator lower
surface 70 are not complementary, and, thus, are more easily
separated.
[0059] In another embodiment, the applicator surface 70 is provided
with an indented ring or recessed applicator surface (as is shown
in FIG. 12 and indicated by numeral 29). The recessed surface is
preferably circular, thereby allowing a substantially circular
implant to be centrally positioned on the applicator surface
70.
[0060] To further enhance displacement of the implant from the
applicator surface 70, a plurality of openings 64 are provided
through the applicator surface 70 through which a volume of fluid
can be passed or withdrawn away from the implant resting against
the applicator surface 70. Particularly, the openings 64 provide a
fluid passage for drawing fluid away from the implant using a
cotton swab, or other absorbent material, placed against the upper
surface 86 of the applicator portion 58. Additionally, a central
opening 66 is provided on the applicator surface to assist with the
proper alignment of the implant and the deposition of the implant
onto the cornea surface. Specifically, a cannula or like instrument
can be inserted through the central opening 66 to depress and
assist the release of the implant from the applicator surface 76,
as is described in greater detail above. As is also described
above, the central opening 66 defines a circular opening having a
diameter greater than the diameter of the surrounding openings 64.
In this way, the user is provided with a central point of
reference, which enables the user to align the applicator surface
70 with the optical axis of the eye, and, thus, properly position
the implant.
[0061] Referring to FIGS. 17a-17c, there is shown the implant
support member 78. As illustrated, the implant support member 78
has a handle portion 52 joined to an implant support portion 56.
The implant support portion 56 comprises a platform portion 82
disposed about an upper implant support surface 76 having an
opposing lower surface 90 that is recessed relative to the lower
surface of the platform portion 82. The support 76 and lower 90
surfaces define a plurality of openings therethrough to facilitate
the passage of liquid to and away from the implant.
[0062] Referring to FIG. 16b the support portion 56 is shown as
being angularly connected to the handle portion 52. In the present
embodiment, it is advantageous to provide an angle between the
handle portion 52 and the lower surface of the platform portion 52
of between about 30.degree. and about 60.degree.. Likewise, and as
illustrated in FIG. 17b, the angular connection between the
applicator portion 58 and handle portion 50 forms is generally
between about 30.degree. and about 60.degree. relative to the lower
surface of platform portion 84. A preferable angular connection
between the handle portions 50 and 52 and platform portions 84 and
82, respectively, is about 45.degree.. Though preferred angles are
provided, it is to be understood that a range of angular
connections can be used without deviating from the scope of the
present invention.
[0063] Referring to FIGS. 15b, 16a and 17a, there is illustrated a
preferred embodiment to maintain the implant support member 78
detachably connected to the implant carrier member 80.
Specifically, as illustrated by FIG. 16a, the carrier member 80 is
provided with a pair of notches or grooves, 68a and 68b, along
opposite edges of the carrier member 80. More particularly, the
notches or grooves, 68a and 68b, are located on opposite sides of
the implant applicator portion 58. Likewise, the support member 78
is provided with a pair of notches or grooves, 68c and 68d, located
on opposite sides of the implant support portion 56 of the support
member 78. In this way, the carrier member 80 can be securely
fastened to the support member 78 by aligning notch 68a with 68c,
and 68b with 68d, and then positioning a fastening means about the
two members and securely within the matched notches. Referring to
FIG. 15b, a fastening means can include an elastic band 69, which
is placed about each member, 78 and 80, and secured within each of
the respective notches (68a-d) to secure the members together in a
detachable manner. Alternatively, metal or plastic clips could be
used to fasten together the two members, 78 and 80. It should be
understood, however, that various ways can be utilized to fasten
the two members together in a detachable manner without deviating
from the scope of the present invention.
[0064] Referring to FIG. 17a, a preferred embodiment of the present
invention comprises a space or slot 74 through the handle portion
52 of the support member 78 for receiving and interlocking with a
tab portion 72. As shown in FIG. 16b, there is illustrated a tongue
or tab portion 72 extending from the lower surface of the handle
portion 50 of the carrier member 80. In use, the carrier member 80
is positioned in overlapping relation to the support member 78 such
that the tap portion 72 is inserted into the slot 74. Once
inserted, the tab portion 72 holds the carrier member 80 together
with the support member 78. To provide further attachment, the band
69 is then place about the implant applicator portion 58 and
implant support portion 56, as is described in more detail above.
In its preferred use, the user initially removes the band 69 or
other attachment means from about the adjacently fastened members,
78 and 80. Once removed, the user simply slides the handle portion
50 in the direction indicated by the arrow 98 or other similar
indicia. In this way, the tab 72 is slidably disengages from the
slot 74 and the two members, 78 and 80, are separated. Once
separated, the top carrier member 80 is used to apply the implant
to the cornea surface. The handle portion 50 of the carrier member
80 can be attached to a surgical-style handle 30 as illustrated in
FIGS. 9 and 10. The user is then able to easily manipulate the
carrier member 80 for depositing the implant onto the cornea
surface.
[0065] Because of the special design of the support surface 76, the
lens implant will preferably remain adhered to the carrier
applicator surface 70 on the carrier member 80 upon separation of
the two members, 78 and 80. More particularly, a preferred
embodiment for the support surface 76 comprises fabricating the
surface 76 to have a more uneven or rough contour than the adjacent
applicator surface 70. Specifically, the applicator surface 70 is
provided as a smooth or polished surface, while the support surface
76 is provided as a more rough or uneven surface 76. In this
embodiment, it is not critical that the surface 70 be
microscopically smooth, though it is preferred; however, it is
critical that the surface 70 be more smooth than the corresponding
support surface 76. In this manner, the applicator surface 70
provides a smoother surface area for directly contacting and
adhering to the lens implant. The support surface 76, however, is
preferably fabricated so as to have a contour characterized by
minute bumps or rounded portions along the surface 76. This
contoured surface can be fabricated by manufacturing the support
surface 76 from polypropylene comprising polytetrafluoroethylene
beads embedded in the polypropylene surface.
Polytetrafluoroethylene is sold under the trade name TEFLON. In
this embodiment, the beads maintain their general conformation when
embedded, which results in the surface 76 having raised bumps,
rounded portions, or the like. Alternatively, the support surface
76 can be roughened, etched, notched, scored or made to be
imperfect using any one of molding, stamping or other mechanical
techniques generally known in the art. In this way, the surface 76
is less able to adhere to the surface of the implant than is the
more smooth applicator surface 70, and the implant will
preferentially remain adhered to the applicator surface 70 upon
separation of the two members, 78 and 80.
[0066] As described above, the implant can be further directed to
maintain an adhering position on the applicator surface 70 by
removing the system 48 from the storage bottle 11 and turning the
system 48 such that the carrier member 80 is facing downwards.
Next, the user simply places an absorbent material against the top
surface 60 of the applicator portion 58 so as to draw fluid from
within the chamber 88 through the openings 64. This results in the
implant being lowered to a resting position against the applicator
surface 70 as the storage fluid is withdrawn from the chamber
88.
[0067] In another presently preferred embodiment, one or more of
the various members of the system 48 is made from a polymer or
plastic material. For instance, the system 48 components could be
made from one or a combination of the following polymers:
Polytetrafluoroethylene (sold under the trade name TEFLON),
Polypropylene, or Polysulfone (sold under the trade name UDEL).
Alternatively, portions of each component member could be made from
a polymer or plastic together with a portion comprising stainless
steel or other metal or semi-metal material. For instance, the
handle portion 50 of the implant carrier member 80 could be
manufactured from stainless steel, and the applicator portion 58
could be manufactured from a polymer material. The handle and
applicator portions could then be welded or interlocked together
using various fabrication techniques known in the art. It should
also be understood that various other polymers or polymer
combinations can be utilized without deviating from the scope of
the present invention.
[0068] As described above, the present system 48 is used to
maintain an implant in a hydrated condition during storage and
shipping. More particularly, and as is shown in FIG. 15a, the
handle portions 50 and 52 of each member when positioned together
form a support handle 54 adapted to insert into a vial stopper. As
described above, and illustrated in FIGS. 5-8, a means for holding
the system 48 in a storage vial comprises inserting the end 96 of
the support handle 54 into an opening 32 provided in a stopper 12.
Once inserted into the opening 32, the stopper 12 is placed in the
vial opening thereby positioning the implant within the vial and in
contact with a volume of storage fluid in the vial. It should be
understood that the presently described system 48 for holding and
applying the implant to the corneal surface is readily adapted for
use with the storage vial and stopper described in more detail
above. In this way, the implant is contained within the chamber 88
and maintained in a hydrated condition by the passage of fluid
through the respective openings 62, 64 and 66.
[0069] In the present embodiment, the lens implant 92 is packaged
within the chamber 88 defined by the applicator surface 70 and
carrier support surface 76. It is to be understood that the height
of this space is designed to be sufficiently narrow that the
implant 92 remains properly oriented within the chamber 88 during
storage and handling conditions. In this way, the user simply
detaches the upper implant member 80 from the implant support
member 78 and deposits the implant to the corneal surface by
placing the applicator surface 70, on which the implant is adhered
to, directly to the corneal surface. To ensure that the implant is
properly oriented, however, the implant is provided with special
asymmetric markings, which the user views to make a determination
that the implant is resting against the corneal surface in a proper
orientation. Referring to FIGS. 18-20, there are shown three
exemplary embodiments of asymmetric markings 94 that can be
utilized to properly orient the lens implant. As shown by FIGS. 18
and 19, the markings are preferably positioned in a clockwise
orientation. In another embodiment, shown in FIG. 20, a letter can
be placed on the posterior surface of the implant. In this way, if
the implant's posterior surface is placed onto the cornea surface,
then the letter will not read properly. For instance, FIG. 20 shows
the letter "a" on the posterior surface of the implant 92. If the
implant 92 is not positioned right side up on the cornea surface,
then the letter will read backwards. In this embodiment, any letter
can be used so long as it has an asymmetric design. For instance,
"R", "P", "C", etc. It is to be understood, however, that other
symmetrical or asymmetric markings and orientations can be used
without deviating from the scope of the present invention.
[0070] In this embodiment, the markings 94 can be positioned onto
the lens using laser engraving, and/or printing with ink.
Alternatively, openings through the lens can be asymmetrically
positioned about the lens. It is important, however, that the
markings 94 be positioned as far from the optical zone as possible
to prevent optical distortion. It is to be further understood that
various methods and techniques for placing the mark on the lens can
be used without deviating from the scope of the present invention.
For instance, notches could be positioned in an asymmetric
orientation about the edge of the lens implant.
[0071] In another embodiment, the system 48 is provided as a
component of a kit used to store, handle and implant the implant
onto the cornea surface. Specifically, the system 48 is provided
within a storage bottle (as illustrated above in FIG. 1) having a
volume of storage fluid contained therein. In this way, the handle
end 96 is inserted into the opening 32 (FIG. 5) in the stopper, and
the stopper is placed into the bottle 11, which positions the
implant holding chamber 88 located opposite the handle end 96
within the bottle. In this way, the implant 92 is positioned in
communication with the storage fluid. The implant 92 is provided
having the markings 94 shown in FIGS. 18 and 19 to assist the user
with properly orienting and/or to ensure that the implant is
positioned right side up on the cornea surface.
[0072] Various embodiments of the present invention have been
described herein. It should be understood by those of ordinary
skill in the art, however, that the above described embodiments of
the present invention are set forth merely by way of example and
should not be interpreted as limiting the scope of the present
invention, which is defined by the appended claims. Many other
alternative embodiments, variations and modifications of the
foregoing embodiments that embrace various aspects of the present
invention will also be understood upon a reading of the detailed
description in light of the prior art. For instance, it will be
understood that features of one embodiment may be combined with
features of other embodiments while many other features may be
omitted (or replaced) as being nonessential to the practice of the
present invention.
* * * * *