KeraMed v. Network Medical Products Et. Al.

Case 1:14-cv-01397-VSB Document 2
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EXHIBIT 1
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US008029515B2
(12) Ulllted States Patent

Shiuey
(54) CORNEAL IMPLANTS AND METHODS AND
SYSTEMS FOR PLACEMENT
(10) Patent N0.:

(45) Date of Patent:
2 * lg;
5,919,197 A
6,050,999 A
US 8,029,515 B2
Oct. 4, 2011
ghfilst 6t
rc ows iet
a1
. ......... ..
606m
(75) Inventor: Yichieh Shiuey, Cupertino, CA (U S)

(73) Assignee: Yichieh Shiuey, San Jose, CA (US)
5,702,441 A 5,868,752 A
12/1997 Zhou 2/1999 Makk
7/1999 McDoifaid
tal.
4/2000 Paraschac et al.
6,162,229 A
6,454,800 B2
12/2000 Feingold et 31.

9/2002 Dalton et al.
( * ) Notice:
Subject' to any disclaimer, the term of this

patent is extended or adjusted under 35 6,689,165 B2
gilgnmet a1
2/2004 Jacob et a1
U.S.C. 154(b) by 319 days.
6,712,848 B1
6,786,926 B2
3/2004 Wolfetal.
9/2004 Peyrnan
(21) Appl. No.: 11/741,496

_
6,855,163 B2
6,858,033 B2
6,976,997 B2
2/2005 Peyman
2/2005 Kobayashi
12/2005 Noolandi et al.
(22)
Med
Apr- 27 2007
7,276,071 B2 * 10/2007 Lin et al. ..................... .. 606/107
2002/0022881 A1
2/2002 Figueroa et al.
(65)
Prior Publication Data

Us 2007/0244559A1 001 18> 2007
2002/0055753 A1 2003/0025873 A1
2003/0050646 A1*
5/2002 Silvestrini 2/2003 Ocampo

3/2003 Kikuchietal. ............. .. 606/107
2003/0054109 A1
3/2003 Quinn et al.
Related US. Application Data
(Continued)
OTHER PUBLICATIONS
(63) Continuation-in-part of application No. 11/341,320,

?led on Jan. 26, 2006, noW abandoned.
(60)
Provisional application NO 60/648949 ?led on Jan 31 2005'
International Search Report andWritten Opinion of PCT Application No. PCT/US06/02918, dated May 1,2008, 11 pages total.
(51) Int. Cl.

A61F 9/00
(58)
(
(200601)
Assislanl Examiner i
Continued
Primary Examiner * S. Thomas Hughes

Simpson
U.S. Cl- ..................................... ..
Field of Classi?cation Search ................ .. 606/107;
(74) Anomeyl Agent) OrFirm i Wilson sonsini G00drich&
623/511, 6.12
Rosati
See application ?le for complete search history.
(57)
(56) References Cited
U.S. PATENT DOCUMENTS 4,706,666 A 11/1987 Sheets 4,919,130 A 4/1990 Stoyetal.
5,211,660 A
5,269,812 A *
ABSTRACT
A system comprising a holloW member is used to deliver a
constrained corneal implant into a corneal pocket. The holloW member may be tapered and the system may further include
an implant deformation chamber and an axial pusher to
5/1993 Grasso
12/1993 White ......................... .. 128/898
advance the implant through the holloW member.

12 Claims, 12 Drawing Sheets
5,300,116 A
4/1994 Chirilaetal.
_/,206
205/
21,0
A
210
/ A
202
204 "
212
204
204
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U.S. PATENT DOCUMENTS
2003/0093083 2003/0173691 2004/0199174 2004/0243159 2004/0243160 2006/0235430 2006/0252981
A1 A1
A1 *
OTHER PUBLICATIONS
5/2003 Peyrnan 9/2003 Jethmalani et al.

10/2004 Herberger et al. .......... .. 606/107
A1 A1 A1 A1
12/2004 Shiuey 12/2004 Shiuey et a1. 10/2006 Le et al. 11/2006 Matsuda et al.
International Search Report and Written Opinion of PCT Application No. PCT/US08/61656, dated Sep. 16, 2008, 9 pages total. Final Rejection ofU.S. Appl. No. 11/341,320, mailed Nov. 19, 2009,
12 page total.
* cited by examiner
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MG. 3%
ER
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MG 3Q
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1
CORNEAL IMPLANTS AND METHODS AND SYSTEMS FOR PLACEMENT CROSS-REFERENCES TO RELATED APPLICATIONS
2
grafts). Recently tWo neW surgical techniques for placement
of a lamellar corneal stromal endothelial transplant grafts have been devised. These surgical techniques are useful in the
treatment of endothelial diseases of the cornea such as Fuchs
endothelial dystrophy and pseudophakic bullous keratopathy.

One of these techniques is referred to as deep lamellar endot
The present application is a continuation-in-part of US. application Ser. No. 11/341,320, ?led on Jan. 26, 2006, Which claims the bene?t of Provisional Application No. 60/648,949, ?led Jan. 31, 2005, the full disclosures of Which are incorpo rated herein by reference.
BACKGROUND OF THE INVENTION
helial keratoplasty (DLEK). In this technique a pocket is

made Within the cornea and diseased corneal endothelium is
excised along With a layer of corneal stroma. Healthy lamellar corneal stromal endothelial tissue is then transplanted into the space left by the excised diseased tissue. Another technique is called Descemets stripping automated endothelial kerato plasty (DSAEK). In this technique, a lamellar corneal stromal
endothelial transplant graft is automatically created using

either a microkeratome or a laser. The diseased corneal endot
Field of the Invention
helium is stripped aWay With surgical instruments and then the lamellar corneal stromal endothelial transplant graft is
inserted into the anterior chamber through a full thickness
There are many different types of corneal implants that have been developed for the treatment of refractive error and
disease. Because of limitations in the methods of creating
corneal pockets, these implants have all been designed for

placement in the cornea by creation of a corneal incision Which is either similar in siZe to the smallest dimension of the
20
corneal incision. The graft is then held in place against the stripped posterior corneal stromal surface by an air bubble until the graft is able to heal in position.
In both DLEK and DSAEK it is advantageous to be able to
insert a relatively large transplant atraumatically through a

small corneal or scleral incision. A larger transplant has more corneal endothelial cells and should produce better results in
25
implant or larger. Recently, tWo methods of corneal pocket

creation have been devised Which can create a pocket With an
external opening Width that is less than the maximum internal Width of the pocket. These tWo methods are pocket creation
the treatment of corneal endothelial diseases. HoWever, a
by the femtosecond laser and, of particular interest, cornea

cutting, as described in US 2004/ 0243159 and 0243160, invented by the inventor herein, the full disclosure of Which is
signi?cant problem With prior art methods of inserting cor neal transplants into the anterior chamber through a small
30
incorporated herein by reference.

It is advantageous to have a biocompatible corneal implant that can be placed through an external incision that is less than the Width of the implant, especially an external incision that is less than half of the Width of the implant. A small external
incision is that they all involve folding of the transplant and grasping of the transplant With forceps. Moreover, the trans plant is typically severely compressed as it passes through the
corneal incision. It has been demonstrated through the use of
vital staining techniques that many of the delicate corneal

endothelial cells of a transplant are killed during the prior art
35
incision decreases induced surgical astigmatism and speeds

up the recovery time for the patient. Moreover, it is useful to have a relatively large implant that can be placed through a relatively small incision. For example a lens implant that is
insertion process. Like corneal transplant grafts for DSAEK or DLEK, synthetic corneal implants e. g. corneal inlay pros
theses are also very delicate. In many cases, these corneal inlays may be as thin as 30 to 40 microns, Which make them
larger is more likely to give good quality vision especially in

a patient With large pupils. It is also advantageous to have a
40
very easily torn by forceps. Therefore, there is also a need for an improved method to place these corneal inlays atraumati cally through a small incision.
simple and reliable delivery system for the corneal implant.

Intraocular lenses for cataract surgery have been designed to be placed through a small incision. These small incision
cataract surgery lenses cannot practically be used Within a
Delivery systems for placement of intraocular lenses (IOLs) into the posterior chamber through a small incision have been described. HoWever, these delivery systems
45
corneal pocket. Most small incision cataract surgery lens implants are usually too thick to be placed Within a corneal pocket. For example the typical thickness of a cataract sur
gery lens implant is 1 mm or more Which is substantially
designed for small incision cataract surgery IOLs are not Well adapted for use as a delivery system for corneal implants
through a small incision. For example, a typical intraocular

lens implant may be 1 mm or more in thickness, Whereas the
typical corneal transplant for DLEK or DSAEK is betWeen

0.1 to 0.15 mm in thickness. Moreover, as has been noted
50
thicker than the human cornea, Which is usually betWeen 0.5 to 0.6 mm. Some corneal implants that have been designed only have a thickness of about 0.05 mm. Moreover, the cata ract surgery lens implants have haptics, Which are extensions
from the lens implant designed to keep the lens implant ?x

ated Within the capsular bag. Haptics are not present and not necessary for corneal implants. Finally, the cataract surgery lens implants are not designed to be biocompatible With the
cornea and Would not be tolerated as corneal implants.
55
before, the thickness of a corneal inlay prosthesis may be as little as 30 to 40 microns. In addition, the siZe and shape of an IOL is different from that of a corneal transplant. An IOL is typically 12 to 13 mm in length and 5 to 6 mm Wide, Whereas a corneal transplant Would typically be circular in shape and
Would have a diameter of 8 to 9 mm. In the case of a corneal
prosthesis inlay, the diameter may range from 1 mm to 10
The delivery systems designed for small incision cataract

surgery lens implants are not Well adapted for use as a deliv
ery system for small incision corneal implants. These delivery systems have been designed for cataract surgery lens implants
that are much thicker than the usual corneal implant. The delivery systems for small incision cataract surgery lens
60
mm. Finally, IOL delivery systems are designed to greatly compress the IOL during the insertion process, Whereas this type of compression Would be likely to either damage or destroy a living corneal transplant. The amount of compres sion used for IOL delivery systems could also damage the much thinner corneal implants.
BRIEF SUMMARY OF THE INVENTION
implants are designed to accommodate haptics, Which Would

not be present on a corneal lens implant.
65
Corneal implants can be made of either synthetic materials
(e. g. prostheses) or can be biological in origin (e. g. transplant
Improved systems and methods for implanting corneal implants are provided by the present invention. The phase
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3
corneal implant refers to any natural (biological) or syn thetic implant or graft that may be implanted into a human
cornea. These systems and methods can place a corneal
4
implants are useful in restoring optical clarity or structural integrity to the cornea in lieu of corneal transplantation. The corneal prosthesis may be used to replace only a partial thick
ness portion of the cornea or a full thickness portion of the
implant through a corneal incision that is substantially less than the Width of the implant. The placement of the implant
may be Within or betWeen any of the layers of the cornea
including epithelium, BoWmans membrane, stroma,

Descemets membrane, and endothelium. In preferred
aspects, the corneal incision is equal or less than half of the
cornea. In preferred aspects, the corneal implant may be coated With extracellular matrix proteins such as collagen,
?bronectin, laminin, substance P, insulin-like groWth factor

I, or peptide sequences such as ?bronectin adhesion-promot
Width of the implant. In additional preferred aspects, the system alloWs the placement of a corneal implant through an
incision that is less than or equal to 3 mm, Which advanta
ing peptide (FAP). In additional preferred aspects, these

extracellular matrix proteins and peptides are tethered or
geously avoids the need for suturing of the incision in most cases and also greatly decreases the chance of unWanted
otherWise bound to the epithelial side of the corneal implant by the methods described in US. Pat. No. 6,689,165, to Jacob
et al. Such surface treatments are intended to promote epithe lialiZation on the surface of a corneal implant.
induced astigmatism.
In accordance With a ?rst aspect of the present invention,
the corneal implant is reversibly deformable in shape to alloW

its passage through a corneal incision that is equal or less than
half of the Width of the implant. The corneal implant is bio compatible With the cornea, the eye, and the body. In certain embodiments, synthetic material Which can meet these crite ria may potentially be used for the implant. Suitable synthetic
materials include one or more compounds selected from the
20
In alternate preferred embodiments, the surface of the cor neal implant may have a texture that promotes epithelialiZa tion on the surface of the corneal implant. Textures, such as surface indentations, may be applied to the surface of the corneal implant to promote epithelialiZation, as described in
US. Pat. No. 6,454,800 to Dalton et al.
In yet other alternate preferred embodiments, the corneal

implant may be manufactured from a material that promotes epithelialiZation on the surface of the corneal implant.
25
group consisting of collagen, polyurethanes, poly(2-hy
droxyethylmethacrylate), polyvinylpyrolidone, polyglycer olmethacrylate, polyvinyl alcohol, polyethylene glycol, poly

methacrylic acid, silicones, acrylics, poly?uorocarbons, and
polymers With phosphocholine. In other embodiments, the
grafts may comprise human corneas harvested for use in
Examples of such materials include polymers selected from the group consisting of collagen and N-isopropylacrylamide,
collagen and l-ethyl-3,3'(dimethyl-aminopropyl)-carbodi

imide as Well as collagen and N-hydroxysuccinimide (EDC/
NHS). In further preferred aspects, the polymer may addi

30
transplants. In the future, biological cornea implants may be

obtained from other sources such as animals, genetically
tionally contain extracellular matrix proteins such as
?bronectin, laminin, substance P, insulin-like groWth factor

I, or peptide sequences such as ?bronectin adhesion-promot
modi?ed animals, in vitro cell culture, or the like. In a preferred embodiment, the material comprises a
ing or peptide (FAP).

Optionally, at least a portion of the device may contain
35
hydrogel. In additional preferred embodiments, the material
comprises polymethacrylic acid-co hydroxyethyl methacry

late (PHEMA/MAA). In other preferred embodiments, holes
or pores may be provided in the implant to increase biocom
holes or be porous in nature so as to promote groWth of
corneal tissue into and through the implant in order to pro mote retention and biocompatibility. Such porous implants
may be fabricated as described in US. Pat. No. 6,976,997 to Noolandi et al. and US. Pat. No. 5,300,116 to Chirila et al. Optionally, at least a portion of the lens or other corneal implant may be colored. Coloration can be useful for cos metic purposes or for therapeutic purposes e.g. treatment of
patibility of the implant by alloWing nutritive substances and gasses (e.g., Water, glucose, and oxygen) to pass easily through the implant in order to maintain healthy metabolism
in the cornea. In still other preferred embodiments, the poly mer material may have thermoplastic properties such that the
implant Will have one desired shape at one temperature and then deform into another desired shape at a second tempera
40
aniridia. For example, methods of applying biocompatible

inks, Which are Well knoWn in colored contact lens manufac
45
ture. In yet other preferred aspects, the corneal implant may

comprise one or more separate, smaller components that can
be assembled in situ placed inside the corneal pocket. Such in situ assembly advantageously minimiZes the incision siZe
needed to insert a corneal implant.
The corneal implant may be of any shape that alloWs it to be
50
turing, may be used to color the corneal implant. Particular coloring methods are described in US. Patent Applications 2003/0054109 and 2003/0025873, the disclosures of Which are incorporated herein by reference. In alternate preferred aspects, the corneal implant may be colored With photosen sitive inks that change color With exposure to electromagnetic
Waves. This alloWs the color of the corneal implant to be
placed Within a corneal pocket. In preferred embodiments, the corneal implant is substantially round. In alternate pre
ferred embodiments, the corneal implant is not round. A corneal implant Which is not round has the advantage that it is less likely to rotate Within a corneal pocket. This property is useful in the implants Which correct for astigmatism. In preferred other embodiments, the corneal implant is a lens. The lens can be a monofocal, multifocal, Fresnel, dif fractive, prismatic, or other type of lens that can be used to treat refractive error (such as myopia, hyperopia, or astigma tism) presbyopia, or ocular disease eg macular degenera
tion. The lens may also be made of a polymer that can have its
55
adjusted permanently or reversibly by exposure to electro

magnetic Waves in vivo. Optionally, the corneal implant may also contain an ultra
violet ?lter compound of the benZophenone type such as 3-(2
BenZyotriaZolyl)-2-Hydroxy-5-Tert-Octyl-BenZyl acryl Amide.

60
Meth
In yet other alternate preferred embodiments, the corneal implant may be a device. Examples of potential implant
devices include miniature cameras and aqueous glucose monitors. The improved corneal implants of the present invention are deformable into a reduced Width shape that alloWs passage through a corneal incision that is substantially less than the Width of the implant When undeformed or unconstrained. In preferred aspects, the incision Will be less than or equal to one-half of the Width of the implant.
refractive properties adjusted permanently or reversibly by

electromagnetic energy as described in US. Patent Applica
tion 2003/0173691 to Jethmalani.
65
The corneal implant usually comprises a prosthesis that is

used to replace or augment a portion of the cornea. Such
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5
A system according to the present invention comprises a hollow member and implant mover or other axial pusher used
to deliver a corneal implant that has been constrained to ?t inside an axial holloW passage of the holloW member. The implant may be deformed or constrained in any shape or con?guration having a reduced Width that alloWs it to be ?t inside of the holloW member e. g., rolled or folded. By reduced Width it is meant that a maximum Width of the implant, such as a diameter of a circular lens, is reduced by
reuse.
6
assembly of the disposable component, but Which are easily
destroyed if there is an attempt to disassemble the system for
Optionally, the system may be designed so that the corneal implant is pre-loaded inside of the holloW member prior to use by the surgeon. This advantageously minimiZes the need for manipulation of the delicate corneal implant by the sur geon, Which could result in damage to the corneal implant. Once the corneal implant is inside the holloW member, the
implant mover or other axial pusher is used to engage and
some threshold amount, typically by at least one-half (50%),

often by at least 60%, and sometimes by 65% or more.
push the implant into the corneal pocket. Optionally, the

system may further comprise a deformation chamber Where the implant is deformed into a shape and siZe that Will ?t inside the holloW member. In other preferred aspects, the
A system according to the present invention comprises a

holloW member and implant mover used to deliver a corneal
implant that has been restrained to ?t inside of the holloW member. Once the corneal implant is inside the holloW mem ber, the implant mover is used to move the implant into a corneal pocket or the anterior chamber.
deformation chamber may contain ridges, protrusions, inden

tations, or recesses Which help to maintain orientation of the
corneal implant Within the deformation chamber during the deformation process. Optionally, the holloW member is
tapered, i.e., narroWer at a distal end than at a proximal end.
20
Optionally, the system may further comprise a deformation chamber Where the implant is deformed into a shape and siZe that Will ?t inside the holloW member. In preferred aspects,
the deformation chamber may contain ridges, protrusions,

indentations, or recesses Which help to maintain and guide the orientation of the corneal implant Within the deformation
Such tapering alloWs additional deformation (siZe or Width reduction) of the implant as it is advanced through the holloW member and passes out through a smaller distal opening. The interior of the holloW member may contain ridges, protru
sions, indentations, or recesses Which help to maintain orien tation of the corneal implant as it travels inside of the holloW
chamber during the deformation process. In further preferred

aspects the deformation chamber Will be a siZe that is appro
25
member. The system for implant placement is designed to

alloW an implant to be placed into a corneal pocket With an entry incision that is equal or less than one-half of the Width
30
priate for the type of corneal implant Which is being used. For
example in the case of a corneal transplant, the minimum internal dimensions of an open deformation chamber should be betWeen 6 and 10 mm, more preferably betWeen 8 and 9 mm. In the case of a corneal implant prosthesis, the minimum internal dimensions of an open deformation chamber dimen sions should be betWeen 1 mm and 10 mm, more preferably betWeen 2 .0 mm and 7 mm. In additional preferred aspects the deformation area may be tapered or funnel shaped, i.e. nar
roWer one end than on the other end. The tapered or funnel
of the implant, hoWever, the system can also be used to place an implant through a corneal incision that is greater than one-half of the Width of the implant.
BRIEF DESCRIPTION OF THE DRAWINGS
35
FIGS. 1A, 1B, 1C, and 1D illustrate prior art corneal
implants.
FIGS. 2A through 2C illustrates a ?rst embodiment of
shape advantageously facilitates the corneal implant to be

restrained to a smaller diameter con?guration. In other preferred aspects, the interior of the holloW mem ber may contain ridges, protrusions, indentations, or recesses Which help to maintain and guide the orientation of the cor neal implant as it travels inside of the holloW member. In additional preferred aspects, the interior of the holloW mem ber may contain ridges, protrusions, indentations, or recesses Which guides a lamellar corneal stromal endothelial trans plant to deform in a Way Which alloWs it to travel through a
40
apparatus of the present invention.

FIGS. 3A through 3C illustrate side vieWs of a corneal
implant as it is advanced and constrained by the apparatus of

FIGS. 2A-2C. FIGS. 4A through 4D illustrate a second embodiment of
the apparatus of the present invention.

FIGS. 5A through 5D illustrate side vieWs of a corneal
45
implant as it is advanced and constrained by the apparatus of

FIGS. 4A-4D. FIGS. 6A through 6C illustrate a third embodiment of the
small incision Without the need for folding or being grasped by forceps. The system is designed to alloW a corneal trans
plant to be placed through an incision equal or less than 3 mm. HoWever, the system can also be used to place an implant through an incision that is greater than 3 mm.
50
apparatus of the present invention.

FIGS. 7A and 7B illustrate use of the apparatus of FIGS. 6A-6C in implanting an implant in a cornea.
FIGS. 8A through 8D illustrate preferred corneal implants

in accordance With the present invention. FIGS. 9A through 9F illustrate a further implantation pro tocol in accordance With the present invention. FIGS. 10A through 10F illustrate a further implantation protocol in accordance With the present inventions. FIGS. 11A through 11F illustrate a further implantation protocol in accordance With the present inventions.
FIGS. 12A and 12B illustrate a tool in accordance With the
60
Optionally, the system may be designed to be sterile and disposable for single use. This advantageously decreases the
chance for contamination and infection. It also obviates the need for the surgeon to autoclave or to provide other methods of steriliZation such as ethylene oxide. To insure that the system Will be both sterile and single use only We can add one or more of the folloWing features. In preferred aspects one or more components of the system may be made of a polymer Which Will melt or deform into an unusable shape upon auto
55
claving. In additional preferred aspects, the system may have

a one Way locking mechanism, such that once the tip of the implant mover travels to a certain distance, the implant mover
principles of the present invention for collapsing and advanc ing a corneal implant.
FIGS. 13A and 13B illustrate an alternative tool in accor
is locked in position inside of the holloW member, thus pre
dance With the principles of the present invention for collaps ing and advancing a corneal implant.
65
venting reloading of another corneal implant. In alternative preferred aspects, the system may be assembled through the
use of breakable tabs or snaps, Which alloWs the secure
FIGS. 14A and 14C are cross-sectional vieWs of the tool of 13A and 13B shoWing the implant as it is advanced as shoWn
in FIGS. 15A through 15C.
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7
FIGS. 15A through 15D illustrate use of the tool of FIGS.
8
implant 15 into a folded or rolled corneal implant 17. FIG. 4C
13A and 13B for advancing and reducing the cross-section of an implant in accordance With the principles of the present invention.
DETAILED DESCRIPTION
FIG. 1A shows a top vieW of a cataract surgery lens implant
2. A round optic 5 of the implant 2 has haptics 10 Which extend from the periphery of the optic. The haptics 10 are used to help the optic center and ?xate Within the capsular
bag. FIG. 1B shoWs a side vieW of a cataract surgery lens
implant optic 5. Note that the thickness tl of the optic 5 is

typically 1 mm or more and is substantially greater than the
0.5 to 0.6 mm thickness of the human cornea. The thickness
of the optic 5 makes it inappropriate for use as a corneal lens implant. FIG. 1C shoWs a top vieW of a corneal implant 15. Note there are no haptics on the corneal implant. FIG. 1D shoWs a side vieW of corneal implant 15. Note that the thick
shoWs axial pusher 30 engaging deformed corneal implant 17 by implant mover tip 35. FIG. 4D shoWs deformed and folded corneal implant 17. Axial pusher 30 engages corneal implant 17 to push the deformed constrained implant inside holloW passage 25. FIG. 4D shoWs that corneal implant 17 has been advanced by axial pusher 30 out of the holloW passage 25 While retaining a constrained shape. The constrained con?gu ration of corneal implant 17 alloWs passage into the corneal pocket (not shoWn) through a small incision. The presence of the optional deformation chamber 27 and deforming member 28, advantageously alloWs the corneal implant 15 to be easily deformed into a con?guration that Will alloW it to be placed through a small corneal incision into a corneal pocket. FIGS. 5A-5D shoW side vieWs of the corneal implant 15 being deformed into an exemplary deformed and folded or
pleated corneal implant 17.

FIGS. 6A-6C shoW a top vieW of an alternative corneal
implant delivery system 100. In this embodiment a corneal

20
ness t2 is substantially less than cataract surgery lens implant 5. The thickness t2 of corneal implant 15 Would in general be
less than the thickness of the human cornea.
implant 115 is placed into a deformation area 122. When the Wings 123 of the deformation area are closed, a deforma
FIG. 2A shoWs a corneal implant delivery system 18 in partial section. A holloW member 20 having a distal tip 21 (Which is preferably beveled or chamfered) de?nes holloW axial passage 25 (eg an axial lumen). Axial pusher 30 has a tip 35 that engages a corneal implant 15 that has been deformed in shape and constrained to ?t inside the holloW
axial passage 25 of the holloW member 20, as shoWn in FIG. 2B. The cross-section of holloW passage 25 may be circular, polygonal, or any other shape that is conducive to constrain
25
tion chamber 124 (FIG. 6B) is formed Which deforms the corneal implant 115. In this embodiment, the corneal implant 115 is folded in half. A tip 132 of an axial pusher 130 engages corneal implant 115. The holloW member 120 is tapered so
that holloW passage 126 is narroWer at a distal end 121 that
inserts into the corneal pocket. This alloWs the corneal

implant 115 to be deformed into an even smaller cross-section
30
ing the corneal implant 15. The holloW axial passage 25 of the holloW member 20 may contain ridges, protrusions, indenta tions, or recesses (noW shoWn) Which help to maintain orien tation of the corneal implant as it advances distally of the holloW member (not shoWn). Axial pusher 30 engages one
end of the constrained corneal implant 15 to advance the constrained implant through holloW passage 25. FIG. 2C shoWs the constrained corneal implant 15 emerging from a distal end of the holloW passage 25 still in its deformed and
as the implant is advanced distally and through the distal end 121. Advantageously in this embodiment, the implant mover tip 132 may also be deformable to ?t Within the narroWing holloW passage 126.
FIG. 7A shoWs a side cross-sectional vieW of corneal
35
implant 115 being inserted into corneal pocket 140. FIG. 7B shoWs the ?nal shape of corneal implant 115 after it has been
inserted into corneal pocket 140 and unfurled or otherWise expanded back to its unconstrained siZe Within cornea 145.
FIG. 8A illustrates a cross-sectional vieW of a corneal
implant prosthesis 50 Corneal implant 50 is meant to replace

40
constrained con?guration. By placing the tip of the holloW

member 20 through an incision in the cornea, the corneal
implant 15 may be advanced into the corneal pocket (not

shoWn) through even a very small incision. In preferred aspects, the corneal implant is able to pass through an entry incision that is less than one-half the Width of the corneal
implant. In those cases, the holloW member Will have an external Width from 0.5 mm to 5 mm, preferably from 1 mm
45
a portion of the anterior layers of the cornea. In this embodi ment there is a central optic 52 that protrudes anteriorly from a rim 54. In preferred aspects, the central optic Would pro trude anteriorly from the rim by 1 to 600 microns. More
preferably, the central optic Would protrude anteriorly from

the rim by 50 to 400 microns. The central optic 52 Will replace diseased anterior corneal tissue that has been removed. The rim 54 is designed to partly or fully around the center of optic
and to ?t Within the peripheral recesses of a corneal pocket in
order to anchor the corneal implant prosthesis to the cornea. to 3 mm and an internal Width from 0.3 mm to 4.8 mm, 50 The rim may be a continuous skirt as illustrated or may be preferably from 0.8 mm to 2.8 mm.
FIG. 3A shoWs a side vieW of corneal implant 15 in its
crenellated or otherWise distributed in sections about the
non-deformed, non-constrained shape. FIGS. 3B and 3C

shoWs an end on vieW of the corneal implant 15 as it is moved
periphery of the center optic. FIG. 8B shoWs a top vieW of
corneal implant prosthesis 50 Which shoWs the central optic

55
Within the holloW member 20. Note that the corneal implant 15 has been deformed and constrained into a rolled con?gu ration. The rolled con?guration Will preferably have a diam
eter in the range from 0.3 mm to 4.8 mm, more preferably from 0.6 mm to 2.6 mm, to ?t into the holloW passage 25 of the
52 and the rim 54. The rim 54 may optionally contain holes or be porous in nature so as to promote groWth of corneal tissue
into and through the implant, in order to promote retention
and biocompatibility.
60
holloW member 20.
FIGS. 4A-4D shoWs a corneal implant delivery system

With a deformation chamber 27 and a deforming member 28.
FIG. 8C shoWs a cross-sectional vieW of corneal implant prosthesis 60 Which is meant to replace a full-thickness area of the cornea. In this embodiment there is an anterior portion
In this embodiment of the invention, the corneal implant 15 is placed into the chamber 27 in an unconstrained and unde
formed con?guration and is then deformed into a folded or
of central optic 62 Which protrudes anteriorly from a rim 64. The anterior portion of central optic 62 Will replace diseased anterior corneal tissue that has been removed. In preferred
aspects, the central optic Would protrude anteriorly from the

65
rolled corneal implant 17 Within deformation chamber 27 by deforming member 28. Deforrning member 28 is moved
Within deformation chamber 27 to deform and fold corneal
rim by 1 to 600 microns. More preferably, the central optic Would protrude anteriorly from the rim by 50 to 400 microns. In addition corneal implant prosthesis 60 has a posterior
Filed 03/03/14 Page 30 of 54
US 8,029,515 B2
10
portion of central optic 66 Which protrudes posteriorly from rim 64. In preferred aspects, the central optic Would protrude
posteriorly from the rim by 1 to 900 microns. More prefer
63 is optional and is not necessarily required for the corneal implant to properly function. It is to be understood that the relative dimensions, shapes, and angles of the anterior central
ably, the central optic Would protrude posteriorly from the rim by 50 to 800 microns. The posterior portion of central optic 63 Will replace diseased posterior corneal tissue that has been removed. The rim 64 Will anchor corneal implant prosthesis
60 Within the peripheral recesses of the corneal pocket and provide a Water-tight seal. The rim 64 may optionally contain
holes or be porous in nature so as to promote growth of
optic 62, posterior central optic 63, and rim 64, may each be
modi?ed to promote improved retention as Well as optical
qualities all in keeping Within the scope of the present inven

tion.
FIGS. 11A-11F shoW an embodiment of a corneal implant that can be assembled Within the corneal pocket. By assem
corneal tissue into and through the implant, in order to pro mote retention and biocompatibility. The rim may be formed from any of the lens materials described above.
FIGS. 9A-9F shoW a method of treating an anterior corneal
bling individual smaller pieces of the corneal implant Within the corneal pocket, a relatively large corneal implant can be
constructed While using a relatively small external incision. The top portion of FIGS. 11A and 11B shoW a cross-sectional
vieW of a cornea With an intra-stromal pocket. The bottom portion of FIG. 11A shoWs a top doWn vieW of a cornea With
disease process using the methods and apparatus of the

present invention. In each FIGS. 9A-F, a cross-sectional vieW
of the cornea is seen above and a top vieW is seen beloW. In
an intra-stromal pocket. In both FIGS. 11A and 11B, it can be seen that the ?rst half of the rim 70 has already been inserted
FIG. 9A it is shoWn that pocket 40 has been created posterior

to anterior diseased cornea 43. FIG. 9B shoWs that anterior diseased cornea 43 has been excised With a circular trephine
20
inside the pocket. A second half of the rim 74 is being inserted through the small external incision. Note that because the corneal tissue is partially elastic, the rim may be made of a
(not shoWn) to create an open top having a peripheral pocket.

The edge of the excision is shoWn as 45. FIG. 9B also shoWs corneal implant 50 resting in the deformation area 122. In FIG. 9C the holloW member 120 has been inserted into pocket
relatively rigid material e. g. polymethylmethacrylate (PMMA) and still be inserted through the external opening 42
that is less than half of the diameter of the assembled corneal
implant. The vertical dashed lines in the top of the ?gure and
25
40 through external opening 42 and corneal implant 50 has

been folded in half Within deformation chamber 124. FIG. 9D shoWs that corneal implant 50 has been further deformed into
a more compact shape by its movement through narroWing holloW passage 126 and is being extruded into pocket 40. FIG. 9E shoWs that corneal implant 50 has been restored to its
30
the circular dashed lines in the bottom ?gure represent an opening 76 left by a circular disk of anterior stromal tissue that has been excised (eg with a trephine). FIGS. 11C and 11D shoW that the optic 72 may ?t into opening 76. FIGS. 11E and 11F shoW that the optic 72 has been attached to the tWo halves of the rim 70 and 74 to complete assembly of the
original shape Within corneal pocket 40. Central optic 52 ?lls

the space left by excised diseased anterior cornea 43 and restores optical clarity to the cornea. HolloW member 120 and implant mover 30 have been WithdraWn from corneal pocket 40. FIG. 9F shoWs the ?nal appearance of corneal implant 50 ?xated Within corneal pocket 40.
FIGS. 10A-10F shoW a method of treating a full-thickness
corneal implant. The individual pieces of the corneal implant may be attached to each other by interlocking ?ttings (not
shoWn), by glue, or any other appropriate mechanical or
35
chemical method of ?xation. In this embodiment of the inven tion the corneal implant is shoWn as a three piece prosthesis that replaces part of the cornea. HoWever, it is to be under stood that the invention includes any corneal implant that can
be assembled as tWo or more pieces Within a corneal pocket. FIGS. 12A-12B are end vieWs of the back of a deformation chamber 86 on a holloW member 80 Which shoW hoW the
corneal disease (e. g. pseudophakic bullous keratopathy)

through the use of the present invention. In each FIGS. 1 0A-F,
a cross-sectional vieW of the cornea is seen above and a top 40
vieW is seen beloW. In FIG. 10A it is shoWn that pocket 40 has been created Within the layers of the diseased cornea 41. The pocket divides the cornea into diseased anterior cornea 43 and diseased posterior cornea 44. FIG. 10B shoWs that anterior diseased cornea 43 has been excised With a circular trephine
presence of a protrusion 82 Within the deformation chamber can help to maintain the orientation of a corneal implant 90 as it is pushed in an axial direction. Deformation chamber 86
includes three hinged sections 80a, 80b, and 800 Which make
45
(not shoWn). The edge of the excision is shoWn in dashed lines

as 45. FIG. 10B also shoWs corneal implant 60 resting in the
deformation charter or area 122. In FIG. 10C the holloW
up a holloW member Which opens in order to receive corneal implant 90. At the lateral aspects of deformation area 80 are
tWo protrusions 82, Which help to hold the rim 94 of corneal implant 90 in place. FIG. 12B shoWs hoW sections 80a, 80b,
member 120 has been inserted into pocket 40 through exter nal opening 42 and corneal implant 60 has been folded in half
Within deformation chamber 122. FIG. 10D shoWs that cor neal implant 60 has been further deformed into a more com
and 800 can be closed by putting together the Wings 84 (Which

50
pact shape by its movement through narroWing holloW pas

sage 126 and is being extruded into pocket 40. FIG. 10E shoWs that corneal implant 60 has been restored to its original shape Within corneal pocket 40. Anterior optic 62 ?lls the
space left by the excised diseased anterior cornea 43. In
55
together form an axial pusher or implant mover) to create holloW member 80 and deformation chamber 86. Corneal implant 90 is noW securely ?xated Within the holloW defor mation chamber 86 by the protrusions 82 and can be manipu lated. The corneal implant 90 can thenbe moved axially along holloW member 80 by an axial pusher or other implant mover
(not shoWn) Without inadvertent rotation of the corneal
implant.
Please note at least some portion of the corneal implant could be colored in any of the embodiments of the invention
60
preferred aspects, after corneal implant 60 has been posi

tioned in the pocket, the posterior diseased cornea 44 can be excised With loW pro?le curved corneal scissors or some other
to enhance the aesthetic appearance of the eye or to decrease
cutting tool (e. g. plasma blade) inserted through external

opening 42. FIG. 10F shoWs the ?nal appearance of corneal implant prosthesis 60. Note that the rim 64 anchors corneal implant prosthesis 60 Within the peripheral recesses of the corneal pocket and provides a Water-tight seal. In this
the amount of light exposure to the eye (eg for treatment of
aniridia).
Referring noW to FIGS. 13A and 13B, a corneal implant insertion device 200 includes a deformation chamber 202
65
embodiment, posterior optic 63 protrudes through the space

left by exicised diseased cornea 44. HoWever, posterior optic
de?ned by tWo-circular hinged sections 204. The hinged sec tions 204 are attached to Wings 206 Which permit the hinged sections to be closed in order to capture the corneal implant C,
Filed 03/03/14 Page 31 of 54
US 8,029,515 B2
11
after the implant has been introduced into the deformation
chamber, as shown in FIG. 13B. Protrusions 210 having interior arcuate surfaces 212 are attached to the hinged sections 204 so that the surfaces 212
12
the biological corneal implant remain everted but do not touch the interior surface of the biological corneal implant such that damage to the implant is reduced. 2. A method as in claim 1, Wherein constraining comprises
closing semi-circular halves of a deformation chamber on the
form radially inwardly directed ramps, as illustrated in FIG. 14A. Thus, after the corneal implant C is introduced into the deformation chamber 202, as illustrated in FIG. 13B, closure of the chamber using the Wings 206 Will curl the corneal implant C into a C-shaped pro?le, as shoWn in FIG. 14A. This
can be an advantage over the corneal insertion tool embodi
implant, Wherein each half carries an inWardly directed ramp to evert the edges of the implant inWardly as the halves are closed. 3. A method as in claim 1, Wherein advancing comprises pushing a pusher member against a rear edge of the corneal
ment of FIGS. 12A and 12B Where the edges of the implant are held in a generally open con?guration by the outWardly
implant.
4. A method as in claim 3, Wherein a forWard portion of the
facing surfaces of protrusions 82.

In a speci?c embodiment of the corneal implant insertion device of the present invention, the corneal implant C com prises a lamellar corneal stromal endothelial transplant graft of approximately 9 mm in diameter and 100 pm in thickness.
The deformation chamber 220 has a diameter or Width D of
pusher member conforms to the interior of the tapered cham ber as the pusher member is pushed. 5. A method as in claim 1, Wherein the biological implant comprises a lamellar corneal stromal endothelial transplant. 6. A method as in claim 1, Wherein the protrusion extends over the entire length of the chamber and remains betWeen the
approximately 9 mm in order to receive the corneal implant C such that its edges are disposed beneath the arcuate surfaces 212 of the protrusions 210, as illustrated in FIG. 13B. Referring noW to FIGS. 15A through 15C, a pusher shaft 230 having a forWard member 232 may be advanced into the deformation chamber 202 of the corneal implant insertion device 200. The forWard element 232 Will have a pro?le Which is similar to the shape of the holloW passage so that it can pass over the protrusions 210 and Will typically be com pressible so that it can pass into a tapered region 240 of the insertion device, as shoWn in FIG. 15D. Thus, the forWard member 232 Will ?rst be introduced into the constant-diam eter portion of the deformation chamber 202, as shoWn in
opposed edges until the constrained implant is released.

20
7. A method as in claim 6, Wherein the chamber is tapered

to a reduced Width in the direction of advancement of the
implant.
8. A system for delivering corneal implants, said system
comprising:
25
a deformation chamber having a proximal end, a distal end, and a pair of semi-circular halves hinged to each other along a common side, each semi-circular half having an
inWardly oriented arcuate surface along an opposite
side, said surfaces being adapted to evert opposite edges

30
of an implant having an exterior surface and an interior
surface When said implant is placed betWeen the surfaces

of the deformation chamber as the halves are closed; a holloW member having a proximal end and a distal end con?gured for insertion into a pocket Within a cornea and having an axial holloW passage Which tapers in the distal direction, Wherein the axial holloW passage is attached to a distal end of the deformation chamber, receives the implant in an arcuate con?guration, and includes inWardly oriented arcuate surfaces Which fur
FIG. 15B, and used to advance the corneal implant C for Wardly. The shaft 30 and forWard member 232 Will continue
to be advanced so that the corneal implant C is pushed from the distal tip of the tapered region 240, as shoWn in FIG. 15C.
35
As the corneal implant C is advanced, its edges Will be

curved or everted inWardly, as illustrated in FIGS. 14A
through 14C. In FIG. 14A, the corneal implant C is shoWn as it is in FIG. 15A. As it advances forWardly, as shoWn in FIG. 15B, the corneal implant C is reduced in diameter With the
40
edges being pushed radially inWardly, as shoWn in FIG. 14B.

Finally, as the corneal implant C is released from the proximal tip of the tapered region 240, it has a signi?cantly reduced
diameter, as shoWn in FIG. 14C. It is particularly desirable that the corneal implant C be reduced in siZe to as great an extent as possible but that the leading tips of the implant not touch the interior surface, just as shoWn in FIG. 14C. This reduces the damage or trauma to the delicate corneal endot
45
ther evert the opposite edges of the corneal implant radially inWardly as the insert is axially advanced through the passage, Wherein the inWardly oriented
arcuate surfaces of the holloW member are disposed on
opposite sides of a protrusion Which extends axially through the holloW passage to form inWardly directed ramps to curl the opposite edges of the implant into a C-shape Wherein the opposite edges are everted but do
not touch the interior surface of the implant as the
helial cells during the implantation protocol.

While the above is a complete description of the preferred embodiments of the invention, various alternatives, modi? cations, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention Which is de?ned by the appended claims.
What is claimed is:
50
implant is advanced; and

an axial pusher disposed to be advanced through the defor mation chamber and the holloW axial passage of the
holloW member to engage and axially advance the cor
neal implant through the holloW passage.

55
9. A system as in claim 8, further comprising a corneal implant constrained Within the deformation chamber on a
1. A method for delivering a biological corneal implant having an exterior surface, an interior surface, and laterally opposed edges to a cornea, said method comprising:
distal side of the axial pusher. 10. A system as in claim 8, Wherein the axial pusher is
tapered in a distal direction. 11. A system as in claim 10, Wherein the axial pusher is deformable so that it Will reduce in diameter as it is distally
constraining the implant so that the laterally opposed edges evert inWardly to provide a C-shaped pro?le;
advancing the implant through a chamber With a protrusion
60
advanced through the tapered holloW passage.

12. A system as in claim 11, Wherein the axial pusher has a cross-sectional pro?le Which is similar in shape to the cross sectional pro?le of the deformation chamber and the holloW passage.
disposed betWeen the laterally opposed edges to further

evert the edges and reduce the Width of the implant; and
releasing the constrained biological corneal implant into

the cornea or anterior chamber at the reduced Width,
65
Wherein prior to release the laterally opposed edges of
Filed 03/03/14 Page 32 of 54
EXHIBIT 2
Filed 03/03/14 Page 33 of 54
CORNEAL GRAFT
CORONET
Filed 03/03/14 Page 34 of 54
EndoGlide System
A new DSAEK donor delivery system with reduced endothelial cell loss.
DSAEK Corneal transplantation is undergoing a paradigm shift with the development of Endothelial Keratoplasty. The main focus today is to reduce iatrogenic damage of donor endothelium caused by manipulation and insertion of the donor through a small incision. The EndoGlide is a device for surgeons to use which consistently delivers a donor lenticule through a small incision, with minimal endothelial loss, whilst making the insertion procedure relatively reliable and consistent, with the surgeon in full control of the donor at all stages of insertion.
Introducer and Glide Cartridge

Advantages
Minimal endothelial damage double coiling of the donor, no contact with wound, endoforceps grip stromal edge only
PATENT APPLIED
Minimal endothelial touch during donor coiling - double coil Minimal endothelial touch when the donor is pulled through the wound
Stable anterior chamber throughout insertion procedure closed eye system Reliable consistent results Supplied sterile for single use only.
Developed with:
Professor Donald Tan FRCSE FRCSG FRCOphth FAMS Medical Director, Singapore National Eye Centre. Chairman, Singapore Eye Research Institute, Department of Ophthalmology, National University of Singapore.
No folding assists with unfolding and orientation in the anterior chamber Can be used in small eyes with shallow anterior chambers or high vitreous pressure Transparent cartridge allows for good visualisation
Page 1
Filed 03/03/14 Page 35 of 54
51-820 EndoGlide Classic

Standard DSAEK procedures
Designed to deliver Donor Endothelium in a controlled manner with minimum endothelial cell loss. To accept both anterior and posterior lenticules. Accommodates donor material up to 9.50mm diameter and 130-250 microns in thickness.
Supplied one per box Supplied sterile for single use only
51-823 EndoGlide Ultrathin

Ultrathin and standard DSAEK procedures
Designed to deliver Ultrathin Donor Endothelium in a controlled manner with minimum endothelial cell loss. Accommodates donor material up to 9.50mm diameter and 70-250 micron in thickness.
Supplied one per box Supplied sterile for single use only
Modern technology, materials and design are at the heart of the Coronet programme and drives our product innovation.
Page 2
Filed 03/03/14 Page 36 of 54
The most important part of a trephine is the blade. All CORONET trephines utilise the unique CORONET blade technology to create an ultra-sharp cutting edge of reliable and repeatable quality. The ultra-sharp, thin-profile cutting edge minimises damage to the endothelial cells and reduces undercut and tissue distortion.
Page 3
Filed 03/03/14 Page 37 of 54
51-840 Recipient Vacuum Trephine

Trephine Size (mm)
6.50 6.75 7.00 7.25 7.50 7.75 8.00 8.25 8.50 8.75 9.00 9.50 Patent Applied
Code
51-840-6.50 51-840-6.75 51-840-7.00 51-840-7.25 51-840-7.50 51-840-7.75 51-840-8.00 51-840-8.25 51-840-8.50 51-840-8.75 51-840-9.00 51-840-9.50
Blade progresses 63 microns downward per quarter turn and 250 microns per full rotation Marker pin allows the operator to calculate the quarter and full turns through which the blade has progressed.
Supplied one per box Supplied sterile for single use only Sterilisation by Ethylene Oxide (EO) Declared 3-year shelf life
Page 4
Filed 03/03/14 Page 38 of 54
51-835 Donor Trephine Vacuum Punch

Trephine Size (mm)
6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75 8.00 8.25 8.50 8.75 9.00 9.25 9.50 9.75 Patent Protected The CORONET Donor Trephine Vacuum Punch has all the benefits of the donor trephine punch with the additional vacuum function. Supplied one per box Supplied sterile for single use only Sterilisation by Ethylene Oxide (EO) Declared 3-year shelf life
Code
51-835-6.00 51-835-6.25 51-835-6.50 51-835-6.75 51-835-7.00 51-835-7.25 51-835-7.50 51-835-7.75 51-835-8.00 51-835-8.25 51-835-8.50 51-835-8.75 51-835-9.00 51-835-9.25 51-835-9.50 51-835-9.75
51-850 Donor Trephine Punch

Trephine Size (mm)
6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75 8.00 8.25 8.50 8.75 9.00 9.25 9.50 9.75 Patent Protected
Code
51-850-6.00 51-850-6.25 51-850-6.50 51-850-6.75 51-850-7.00 51-850-7.25 51-850-7.50 51-850-7.75 51-850-8.00 51-850-8.25 51-850-8.50 51-850-8.75 51-850-9.00 51-850-9.25 51-850-9.50 51-850-9.75
The unique CORONET Donor Trephine Punch has been designed to award the surgeon with best approach and visualisation. 100% visualisation of the graft at all times Graft tissue may be manipulated through the windows for optimal positioning The ultra-sharp, thin profile blade minimises damage to the endothelial cells and reduces undercut Cover protects the graft from contamination during transfer Marker holes in base assist when centering the tissue and reduces the likelihood of bubbles forming under the epithelial tissue
Supplied one per box Supplied sterile for single use only Sterilisation by Ethylene Oxide (EO) Declared 3-year shelf life
Page 5
Filed 03/03/14 Page 39 of 54
51-860 Guarded Trephine (300 micron) 51-865 Guarded Trephine (400 micron)
Size (mm) Code
300 micron 7.00 7.50 8.00 8.50 51-860-7.00 51-860-7.50 51-860-8.00 51-860-8.50
Code
400 micron 51-865-7.00 51-865-7.50 51-865-8.00 51-865-8.50
The CORONET Guarded Trephine has been designed to meet the requirements of the surgeon when performing a lamellar keratoplasty. The fixed blade depth awards the surgeon control over the blade penetration.
Supplied one per box Supplied sterile for single use only Sterilisation by Gamma Irradiation Declared 5- year shelf life
Suitable for both recipient and donor Especially useful for any lamellar technique
300 micron
Choice of two fixed-depth blades; 300 microns or 400 microns Cross hair to assist with centralisation
51-900 Standard Trephine

Size (mm)
6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75 8.00 8.25 8.50 8.75 9.00 9.25 9.50 9.75 Supplied one per box Supplied sterile for single use only Sterilisation by Gamma Irradiation Declared 5-year shelf life
Code
51-900-6.00 51-900-6.25 51-900-6.50 51-900-6.75 51-900-7.00 51-900-7.25 51-900-7.50 51-900-7.75 51-900-8.00 51-900-8.25 51-900-8.50 51-900-8.75 51-900-9.00 51-900-9.25 51-900-9.50 51-900-9.75
Page 6
Filed 03/03/14 Page 40 of 54
51-901 Standard Trephine with cross hair

Size (mm)
6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75 8.00 8.25 8.50 8.75 9.00 9.25 9.50
Code
51-901-6.00 51-901-6.25 51-901-6.50 51-901-6.75 51-901-7.00 51-901-7.25 51-901-7.50 51-901-7.75 51-901-8.00 51-901-8.25 51-901-8.50 51-901-8.75 51-901-9.00 51-901-9.25 51-901-9.50 Supplied one per box Supplied sterile for single use only Sterilisation by Gamma Irradiation Declared 5-year shelf life
51-903 Long-handled Trephine

Size (mm)
6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75 8.00 8.25 8.50 8.75 9.00 9.25 9.50
Code
51-903-6.00 51-903-6.25 51-903-6.50 51-903-6.75 51-903-7.00 51-903-7.25 51-903-7.50 51-903-7.75 51-903-8.00 51-903-8.25 51-903-8.50 51-903-8.75 51-903-9.00 51-903-9.25 51-903-9.50
Larger Sizes (mm)

10.00 10.50 11.00 11.50
Code
51-903-10.00 51-903-10.50 51-903-11.00 51-903-11.50
Supplied one per box Supplied sterile for single use only Sterilisation by Gamma Irradiation Declared 5-year shelf life
Page 7
Filed 03/03/14 Page 41 of 54
51-935 Artificial Anterior Chamber

The CORONET Artificial Anterior Chamber has been designed to be used with any of the CORONET standard hand held trephines and is unique in concept in that one chamber fits all sizes of donor graft ONE SIZE FITS ALL. Suitable for use with both manual dissection and femto-second lasers. Supplied one per box Supplied sterile for single use only Sterilisation by Ethylene Oxide (EO) Declared 3-year shelf life
The chamber is suitable for any size

donor graft tissue from 14.5mm through to 18mm Two tissue retaining heads are supplied with the chamber: Small to accommodate graft tissue 14.50mm - 16.00mm Large to accommodate graft tissue 16.00mm - 18.00mm
16.00mm - 18.00mm Large
14.50mm - 16.00mm Small
Page 8
Filed 03/03/14 Page 42 of 54
51-905 Exactor Trephine

Size (mm)
15 17 18
Code
51-905-15 51-905-17 51-905-18 Supplied one per box Supplied sterile for single use only Sterilisation by Gamma Irradiation Declared 5-year shelf life
The Exactor trephine is the only stainless steel ground blade trephine in the CORONET range. Designed for the preparation of the donor tissue in the eye bank, the trephine is available in three sizes; 15mm, 17mm and 18mm diameters.
51-915 Corneal Marker

Size (mm)
7.00 8.00
Code
51-915-7.00 51-915-8.00 Supplied five per box Supplied sterile for single use only Sterilisation by Gamma Irradiation
Eight-blade marker Available in two sizes; 7.00mm and 8.00mm
Declared 5-year shelf life
Page 9
Filed 03/03/14 Page 43 of 54
53-920 EndoGlide Support Platform

Re-usable construction
Ergonomic design to assist loading of the EndoGlide. The platform is useful to support the EndoGlide or donor trephine punch. Re-usable and can be sterilised by conventional autoclave procedures.
53-951 Tan EndoGlide Placement Forceps
Titanium forceps specifically designed to grasp and pull the endothelium into the anterior chamber of the recipient.
53-952 Tan EndoGlide Loading Forceps
Titanium forceps specifically designed to grasp endothelium and load into the endoglide cartridge.
Page 10
Filed 03/03/14 Page 44 of 54
CORONET is the Ophthalmic Division of Network Medical Products Ltd.
Network Medical Products Ltd. Coronet House, Kearsley Road, Ripon, North Yorkshire, HG4 2SG, UK. Tel: (44) 01765 609555 Fax: (44) 01765 608476 email: marketing@networkmedical.co.uk www.networkmedical.co.uk
Distributed by:
All the products in this catalogue have been manufactured in accordance with the requirements of ISO 13485:2003 and the Medical Devices Directive 93/42/EEC and, where appropriate, are authorised to bear the CE mark.
CAT. REF. NO: CL_COR_001 Rev. 01 08/12
Filed 03/03/14 Page 45 of 54
EXHIBIT 3
Filed 03/03/14 Page 46 of 54
DSAEK / DSEK Donor Delivery System

CORONET is the Ophthalmic Division of Network Medical Products Ltd.
Network Medical Products Ltd. Coronet House, Kearsley Road, Ripon, North Yorkshire, HG4 2SG, UK. Tel: (44) 01765 609555 Fax: (44) 01765 608476 email: marketing@networkmedical.co.uk www.networkmedical.co.uk
Accepts single lenticule 250 - sub 100 donor* Minimises endothelium damage Sealed system Best operator control
Distributed by:
Easy to load
All the products in this brochure have been manufactured in accordance with the requirements of ISO 13485:2003 and the Medical Devices Directive 93/42/EEC and, where appropriate, are authorised to bear the CE mark.
REF:CL_COR_002
Filed 03/03/14 Page 47 of 54
1
The well is wetted with BSS and the endothelium is placed, endothelium side up, into the donor well (the donor endothelium may be a single lenticule*).
2
The donor endothelium is eased forward towards the cartridge, a small amount of dispersive viscoelastic may be applied to the endothelial surface.
3
Tan EndoGlide Loading Forceps are introduced through the cartridge to grasp the stromal edge of the donor lenticule. The lenticule is pulled into the cartridge, the saddle naturally rolls the tissue into the cartridge reducing any tendency to curl out.
4
Remove the saddle using a rocking motion.
5
The introducer is attached, LOADING facing upwards.
6
The assembled EndoGlide is removed from the base and inverted with INSERTION facing upwards.
7
An AC maintainer can be used to stabilise
8
Continue to hold the donor in the anterior chamber and withdraw the EndoGlide. The donor will naturally uncoil in the AC without any risk of donor inversion. Simple manipulation can be used to assist the deployment.
9
A small air bubble is injected beneath the donor to position it on the cornea and the forceps are removed.
Preparation base
Cartridge Saddle
the chamber, the flow angled away from the 4.5mm scleral incision. The EndoGlide is carefully inserted through the scleral tunnel, the EndoGlide Placement Forceps are introduced through the nasal paracentesis, the stromal edge of the donor is grasped and
Introducer
pulled completely into the AC.
EndoGlide Forceps
53-951 TAN EndoGlide Placement Forceps
Product Code: 51-823
53-952 TAN EndoGlide Loading Forceps
* Donor endothelium may be between 250 - 70 , single or double lenticule, and up to 9.50mm diameter.
For more information please visit www.networkmedical.co.uk/ultrathin
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EXHIBIT 4
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C o r n e a Tr a n s p l a n t P r o d u c t s
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DSAEK Insertion Device
A clinical study completed with the EndoGlide technique resulted in an

1
average endothelial cell loss of only 13%

In separate studies, the Busin Glide technique has resulted in an average endothelial cell loss of 20%2 and the taco folding technique has resulted in an average endothelial cell loss of 34%3
EndoGlide - Ultrathin DSAEK Insertion Device*

Design facilitates the insertion of thinner donor tissue measuring as low as 70 microns thickness Features a removable saddle designed to encourage the curling effect for very thin, sub 100 micron tissue Double-coiling of the donor tissue results in minimal endothelial damage and the closed system results in a stable anterior chamber throughout the insertion procedure Supplied sterile for single use only
Removable Saddle Glide Cartridge Preparation Base
Item Number
11823
Description
EndoGlide - Ultrathin
Glide Introducer
Design Features
Oval diameter designed to fit through a 4.5mm scleral or 4.9mm Clear Corneal wound to fully protect the donor from the wound margins Designed with an integral glide platform in front for ease of device insertion Transparent cartridge allows for good visualization
* Available only in North & South America (except Brazil), where approved
Note: Additional clinical studies are needed comparing taco folding technique, Busin Glide technique and EndoGlide technique to further assess and compare endothelial cell loss. Reference: 1. Khor WB, Mehta JS, Tan DTH, Descemet stripping automated endothelial keratoplasty with a graft insertion device: surgical technique and early clinical results. American Journal of Ophthalmology. doi:10.1016/j.ajo.2010.08.027. Reference: 2. Busin M, Bhatt PR, Scorcia V. A modied technique for descemet membrane stripping automated endothelial keratoplasty to minimize endothelial cell loss. Arch Ophthalmol 2008;126(8):11331137. Reference: 3. Price MO, Price FW Jr. Endothelial cell loss after descemet stripping with endothelial keratoplasty inuencing factors and 2-year trend. Ophthalmology 2008;115(5): 857 865.
Forceps*
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Item Number
53-951
Description
Curved Placement Forceps
Item Number
53-952
Description
Straight Loading Forceps
Support Platform*
Item Number
11920
Description
Support Platform
For more information or to place an order, contact your local Sharpoint sales representative or our customer service team at: 877.991.1110 (USA and Canada only), +1.610.404.3520 (International), or visit Sharpoint.com
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Trephines
Trephines*
The trephine product line consists of disposable vacuum trephines, donor punch sets, and short or long handled trephines in sizes ranging from 6.00mm through 9.75mm, in 0.25mm increments. Advanced trephine blade technology provides an exquisitely sharp cutting edge to achieve the critical fit needed for successful cornea transplants.
Item Number
11840 11850
Description
Vacuum Trephine - All metal, ergonomic design and ultra sharp blade with cross hairs. Designed for full-penetrating keratoplasty; Sterile; Single use; 1 piece/box Donor Punch Set - Unique design providing precise control and full visualization throughout the procedure; Sterile; Single use; 1 set/box
11901
X-Hair Trephine - Hand held; Sterile; Single use; 1 piece/box
11903
Long Handled Trephine - Hand held; Sterile; Single use; 1 piece/box
Item Code
11840 11850 11901 11903
Description
Blade Sizes (mm)

6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75 8.00 8.25 8.50 8.75 9.00 9.25 9.50 9.75
Vacuum Trephine Donor Punch Set X-Hair Trephine
Long Handled Trephine
Knives
Clear Corneal Knife, Double-Bevel
The Sharpoint 4.9mm Clear Corneal Knife is designed to create a 4.9mm clear corneal incision needed for insertion of the EndoGlide cartridge. This knife features tapered bevel cutting edges designed to compensate for corneal curvature, creating a self-sealing linear incision. Patented incision depth indicators (1.5mm, 1.75mm, 2.0mm) are visible on each blade. 6 per box.
Knife Description
72-4963 4.9mm Angled, double-bevel, depth indicators
Slit Knife, Bevel-Up

The Sharpoint 4.5mm angled, bevel up slit is designed to create an accurate 4.5mm scleral incision needed for insertion of the EndoGlide cartridge. 6 per box.
Knife Description
72-4561 4.5mm Angled, bevel-up
ClearPort Paracentesis Knife

The Sharpoint 1.1mm ClearPort Paracentesis knife is designed to create a consistent, self-sealing paracentesis incision for insertion of the EndoGlide curved placement forceps. 6 per box.
Knife
78-2010
Description
1.1mm Angled
Maximum Instrument Size

20g
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UltraGlide Sutures
UltraGlide Sutures
UltraGlide sutures are a perfect choice for corneal transplant procedures, offering the surgeon reliable sharpness, pass after pass. The tips ultra-sharp point and concave facets ensure precise placement, smooth penetration and dependable strength. Complementing this superior cutting geometry is an innovative lift and cut ramp that counters the corneal tissues tendency to roll under and follow the needle. An added benefit of this cutting geometry is the ability to bury suture knots more easily. Unique lift and cut design action Reduced tissue drag Effortless penetration with each pass Non-glare finish
UltraGlide
Needle Description
Bicurve Length 4.88mm
AU-8 CSB-6
Material
Black Monolament Black Monolament Black Monolament Black Monolament
Length
12/30cm
11-0
10-0
AA-2675N
9007G
9-0
8-0
BGL5 DGL6
NU-1, CU-1 CS140-6 SE-140-6
Radius 1.52/2.79mm Chord 3.71mm Wire 1.5mm Radius 2.54mm Chord 4.82mm Wire .15mm Radius 2.54mm Chord 4.82mm Wire .15mm Radius 2.03mm Chord 4.06mm Wire .15mm Radius 2.03mm Chord 4.06mm Wire .15mm
Curvature 90/50 3/8 Circle Length 6.15mm Curvature 135 3/8 Circle Length 6.15mm Curvature 135 1/2 Circle Length 5.51mm Curvature 160 1/2 Circle Length 5.51mm Curvature 160
AA-2673N
4/10cm
9060G
DGL6
NU-1, CU-1 CS140-6 SE-140-6
AA-2627N
12/30cm
9003G
HGL5
CU-5 CS160-6 SE-160-6
AA-2674N
4/10cm
9061G
HGL5
AA-2713N
AA-2712N
9001G
6/15cm Black Monolament 12/30cm
9016G
AA-2626N
9000G
CU-5 CS160-6 SE-160-6
HGL7
CU-2 CS175-8
1/2 Circle Length 6.99mm Curvature 175
Radius 2.29mm Chord 4.57mm Wire .15mm
Black Monolament
AA-2714N
12/30cm
9032G
Product numbers are color coded respectively as Sharpoint (blue), Alcon (brown), Ethicon (black), and Syneture (aqua blue). B or N denotes a box of 12; D denotes a box of 36.
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EndoGlide - Ultrathin Procedure**
1
Place a small amount of BSS in the well of the preparation base for lubrication. Inject BSS into the inner chamber of the cartridge, which can be completely filled. Carefully place the donor cornea endothelial surface up in the well of the preparation base and place a very thin stream of dispersive viscoelastic onto the donor surface.
2
Using the straight loading forceps grasp the edge of the donor, and gradually pull it into the cartridge chamber. As the donor tissue enters the cartridge, the sides of the donor tissue will naturally curl upwards and form a double coil configuration in the cartridge.
3
Remove the saddle by lifting off vertically, and attach the introducer with the word LOADING facing uppermost, into the posterior end of the cartridge until it fully engages with a hard stop. Remove the loaded cartridge and introducer from the preparation base by sliding the assembly backwards and out of the grooves of the base. After removing the introducer and cartridge from the base, turn the assembly right-side up, with the word INSERTION facing uppermost.
4
With the AC maintainer on a low flow, gently slide the anterior glide of the cartridge through the temporal wound. With one hand still holding the introducer and cartridge in position, insert the curved placement forceps into the anterior chamber through the nasal paracentesis with the other hand. Grasp the donor and gently pull the donor tissue out of the cartridge.
5
While still holding onto the donor tissue with the curved placement forceps, retract the cartridge and introducer out of the eye. The donor tissue will automatically uncurl in the anatomically correct endothelial down position.
6
Inject a small amount of air beneath the donor tissue, and release the donor tissue from the curved forceps and retract the forceps out of the eye. Full wound closure, air tamponade and completion of the DSAEK procedure should then be performed in the usual manner.
**Always refer to the full instructions for use supplied with the product before use.
For more information or to place an order, contact your local Sharpoint sales representative or our customer service team at: 877.991.1110 (USA and Canada only), +1.610.404.3520 (International), or visit Sharpoint.com
Surgical Specialties Corporation, 100 Dennis Drive, Reading, PA 19606, U.S.A. 610.404.3520 877.991.1110 (USA and Canada only) Fax: 610.404.4010 OPG-PM-425R1 10/13 SHARPOINT, THE SURGEONS EDGE, CLEARPORT, and ULTRAGLIDE are trademarks of Surgical Specialties Corporation. ENDOGLIDE is a trademark of Coronet Medical Technologies Ltd. 2012-2013 Surgical Specialties Corporation. All Rights Reserved.

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(12) Ulllted States Patent

(10) Patent N0.:

(75) Inventor: Yichieh Shiuey, Cupertino, CA (U S)

12/1997 Zhou 2/1999 Makk

4/2000 Paraschac et al.

12/2000 Feingold et 31.

Subject' to any disclaimer, the term of this

U.S.C. 154(b) by 319 days.

(21) Appl. No.: 11/741,496

7,276,071 B2 * 10/2007 Lin et al. ..................... .. 606/107

2/2002 Figueroa et al.

Prior Publication Data

5/2002 Silvestrini 2/2003 Ocampo

3/2003 Quinn et al.

Related US. Application Data

(63) Continuation-in-part of application No. 11/341,320,

Provisional application NO 60/648949 ?led on Jan 31 2005'

(51) Int. Cl.

Primary Examiner * S. Thomas Hughes

U.S. Cl- ..................................... ..

Field of Classi?cation Search ................ .. 606/107;

(74) Anomeyl Agent) OrFirm i Wilson sonsini G00drich&

See application ?le for complete search history.

A system comprising a holloW member is used to deliver a

advance the implant through the holloW member.

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5/2003 Peyrnan 9/2003 Jethmalani et al.

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