U.S. patent application number 14/793965 was filed with the patent office on 2016-03-10 for conformable therapeutic shield for vision and pain.
The applicant listed for this patent is NexisVision, Inc.. Invention is credited to YAIR ALSTER, ENRIQUE BARRAGAN, DEAN CARSON, MATT CLARKE, EUGENE DE JUAN, JR., BRIAN LEVY, K. ANGELA MACFARLANE, CARY J. REICH, DOUG RIMER, DOUGLAS SUTTON, ASHLEY TUAN.
Application Number | 20160067109 14/793965 |
Document ID | / |
Family ID | 43900724 |
Filed Date | 2016-03-10 |
United States Patent
Application |
20160067109 |
Kind Code |
A1 |
DE JUAN, JR.; EUGENE ; et
al. |
March 10, 2016 |
CONFORMABLE THERAPEUTIC SHIELD FOR VISION AND PAIN
Abstract
A conformable covering comprises an outer portion with rigidity
to resist movement on the cornea and an inner portion to contact
the cornea and provide an environment for epithelial regeneration.
The inner portion of the covering can be configured in many ways so
as to conform at least partially to an ablated stromal surface so
as to correct vision. The conformable inner portion may have at
least some rigidity so as to smooth the epithelium such that the
epithelium regenerates rapidly and is guided with the covering so
as to form a smooth layer for vision. The inner portion may
comprise an amount of rigidity within a range from about
1.times.10-4 Pa*m3 to about 5.times.10-4 Pa*m3 so as to deflect and
conform at least partially to the ablated cornea and smooth an
inner portion of the ablation with an amount of pressure when
deflected.
Inventors: |
DE JUAN, JR.; EUGENE; (SAN
FRANCISCO, CA) ; REICH; CARY J.; (LOS GATOS, CA)
; ALSTER; YAIR; (PALO ALTO, CA) ; MACFARLANE; K.
ANGELA; (WOODSIDE, CA) ; RIMER; DOUG; (LOS
ALTOS HILLS, CA) ; SUTTON; DOUGLAS; (PACIFICA,
CA) ; CARSON; DEAN; (MOUNTAIN VIEW, CA) ;
BARRAGAN; ENRIQUE; (MONTERREY, MX) ; CLARKE;
MATT; (MENLO PARK, CA) ; TUAN; ASHLEY; (MENLO
PARK, CA) ; LEVY; BRIAN; (NEW YORK, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NexisVision, Inc. |
Menlo Park |
CA |
US |
|
|
Family ID: |
43900724 |
Appl. No.: |
14/793965 |
Filed: |
July 8, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13555056 |
Jul 20, 2012 |
9107773 |
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14793965 |
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13503842 |
Dec 4, 2012 |
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PCT/US10/53975 |
Oct 25, 2010 |
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13555056 |
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61322206 |
Apr 8, 2010 |
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61279613 |
Oct 23, 2009 |
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Current U.S.
Class: |
602/43 |
Current CPC
Class: |
A61F 2250/0029 20130101;
A61F 9/0017 20130101; A61F 9/00 20130101; A61F 9/00802 20130101;
A61L 2430/16 20130101; A61F 9/00804 20130101; A61L 27/18 20130101;
A61F 13/124 20130101; G02C 7/047 20130101; A61F 2009/00893
20130101; A61F 2/147 20130101; A61F 2/145 20130101; A61F 2009/00853
20130101; A61F 9/0136 20130101; A61F 9/008 20130101; G02C 2202/06
20130101; A61F 9/04 20130101; G02C 7/048 20130101; G02C 7/049
20130101; A61F 9/013 20130101; A61L 27/18 20130101; C08L 83/04
20130101 |
International
Class: |
A61F 13/12 20060101
A61F013/12 |
Claims
1. (canceled)
2. A covering for an eye of a patient, the eye comprising a cornea
having an optical portion, wherein the covering comprises: an inner
portion having an inner rigidity and at least one inner radius of
curvature; and an outer portion having an outer rigidity and at
least one outer radius of curvature; wherein the inner rigidity is
greater than the outer rigidity; and wherein the covering, when
applied to the eye, is configured to flex, with the inner portion
configured to at least partially conform to the cornea and to
provide a chamber between the inner portion and the cornea, and
with the outer portion configured to engage the eye.
3. The covering of claim 2, wherein the outer portion is configured
to provide engagement with the eye sufficient to resist movement of
the inner portion relative to the optical portion of the
cornea.
4. The covering of claim 2, wherein the inner portion comprises a
first curved portion and the outer portion comprises a second
curved portion and a third curved portion, wherein, the first
curved portion comprises a first lower surface having a first
radius of curvature; the second curved portion comprises a second
lower surface having a second radius of curvature; and a third
curved portion comprises a third lower surface having a third
radius of curvature; wherein the third curved portion is configured
to inhibit movement of the inner portion relative to the optical
portion of the cornea by deforming the third curved portion during
the applying of the covering so as to promote motion-inhibiting
engagement of the third lower surface against the eye.
5. The covering of claim 2, wherein, the inner portion comprises a
substantially uniform thickness; and the inner portion comprises an
index of refraction that substantially corresponds to the index of
refraction of the cornea.
6. The covering of claim 2, wherein the covering is formed from a
material selected from silicone, silicone hydrogel, and a
combination thereof.
7. The covering of claim 2, wherein the inner portion comprises a
radius of curvature less than the optical power of the cornea, and
is configured to deform during the application of the covering so
that the inner radius of curvature of the inner portion at least
partially conforms to the cornea.
8. The covering of claim 2, wherein a lower surface of the inner
portion comprises an aspherical surface.
9. The covering of claim 2, wherein the inner portion is
characterized by a thickness from about 50 .mu.m to about 250
.mu.m.
10. The covering of claim 2, wherein the material forming the
covering is characterized by a water content of no more than 1%; an
Ionoton Ion Permeability Coefficient of no more than about
2.6.times.10.sup.-6 mm.sup.2/min; and an oxygen permeability Dk of
100 or more.
11. The covering of claim 2, wherein, the inner rigidity is from
2.5E-6 Pa-m.sup.3 to 6.41E-3 Pa-m.sup.3; and the outer rigidity is
no more than 4E-5 Pa-m.sup.3.
12. The covering of claim 2, wherein, inner modulus comprises a
modulus in a range from 1 MPa to 35 MPa; and the outer portion
comprises a modulus of no more than 5 MPa.
13. The covering of claim 2, wherein, the inner portion is centered
on the optical portion of the cornea.
14. A method of treating an eye of a patient, comprising applying
the covering of claim 2 to an eye of a patient.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present PCT application claims priority to the following
U.S. provisional applications: U.S. App. Ser. No. 61/279,613 filed
23 Oct. 2009, entitled "Conformable Therapeutic Shield for Vision
and Pain" (attorney docket no. 26322A-000200US); U.S. App. Ser. No.
61/322,206 filed 8 Apr. 2010, entitled "Conformable Therapeutic
Shield for Vision and Pain" (attorney docket no. 26322A-000210US);
the full disclosures of which are incorporated herein by
reference.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED
RESEARCH AND DEVELOPMENT
[0002] Not Applicable
BACKGROUND OF THE INVENTION
[0003] The present invention is generally directed to visual
rehabilitation and treatment of pain for patients with epithelial
defects on the cornea of the eye. Although specific reference is
made to epithelial defects following photorefractive keratectomy,
embodiments of the present invention can be used to treat
epithelial defects from other causes, for example corneal
abrasions, trauma, keratoconus, penetrating keratoplasty and
dystrophies.
[0004] The eye includes several tissues that allow patients to see.
The cornea of the eye is an anterior tissue of the eye that is
clear in healthy eyes and refracts light so as to form an image on
the retina. The retina is a posterior tissue of the eye that senses
light from the image formed thereon and transmits signals from the
image to the brain. The cornea includes an outer layer of tissue,
the epithelium, which protects the underlying tissues of the
cornea, such as Bowman's membrane, the stroma and nerve fibers that
extend into the stroma and Bowman's. The healthy eye includes a
tear film disposed over the epithelium. The tear film can smooth
small irregularities of the epithelium so as to provide an
optically smooth surface. The tear film is shaped substantially by
the shape of the underlying epithelium, stroma, and Bowman's
membrane, if present. The tear film comprises a liquid that is
mostly water and does include additional components, such as
mucoids and lipids. The many nerve fibers of the cornea provide
sensation to promote blinking that can cover the cornea with the
tear film. The never fibers also sense pain so that one will
normally avoid trauma to the cornea and also avoid direct contact
of an object to the cornea so as to protect this important
tissue.
[0005] In the healthy cornea, the proper amount of hydration of the
cornea, sometimes referred to as dehydration of the cornea, is
maintained such that the cornea remains clear. The cornea includes
a posterior endothelial layer that pumps water from the cornea into
the adjacent anterior chamber. The epithelium minimizes flow of
water from the tear liquid into the cornea, such that the corneal
stroma can be maintained with the proper amount of hydration with
endothelial pumping. The endothelial pumping of water from the
cornea to maintain the proper hydration and thickness of the eye is
often referred to as deturgescence.
[0006] In patients with epithelial defects, the barrier function of
the epithelium is compromised, such that water can enter the cornea
through the epithelial defect so as to cause swelling of the
corneal stroma. As a result, excessive hydration of the cornea may
occur in eyes with epithelial defects. In some instances, excessive
hydration that swells the corneal stroma can result in light
scattering, or haze, such that an image seen by a patient is
degraded. The scattering of light by the corneal stroma can be seen
with a slit lamp examination to diagnose the patient, and is
sometimes referred to as corneal haze. In addition to potentially
causing excess hydration of the cornea, an epithelial defect can
expose the nerve fibers of the cornea such that the patient feels
pain.
[0007] Several known techniques exist to treat corneal epithelial
defects, including bandage therapeutic lenses, non-steroidal
anti-inflammatories (hereinafter NSAIDS), steroids, antibiotics and
analgesics. These known techniques may be somewhat effective in
reducing symptoms associated with the epithelial defect. However,
many of these known techniques may not provide a barrier to water
entry into the corneal stroma, such that the cornea may swell with
water and may affect patient vision in at least some instances. For
example, a bandage therapeutic lens may be placed over the
epithelial defect to cover and protect the corneal tissues under
the defect, such as the corneal stroma and nerve fibers. However,
in at least some instances the bandage therapeutic lens may not
prevent water of the tear from leaking through the epithelial
defect into the stroma. Also, a bandage therapeutic lens may slide
over the epithelial defect when positioned on the eye in at least
some instances, potentially decreasing the therapeutic benefit when
the lens slides along the delicate underlying tissue, for example
when a patient blinks.
[0008] Work in relation to embodiments of the present invention
suggests that at least some of the known therapeutic bandage lenses
used to treat epithelial defects may actually contribute to corneal
edema and pain in at least some instances. At least some of the
current bandage lenses may provide less oxygen than would be ideal,
and decreased oxygen to the cornea may be related pain and corneal
edema in at least some instances. Also, in at least some instances,
bandage lenses may be fit loosely on the cornea, such that water
can go around the bandage lens and may penetrate the stroma through
the epithelial defect.
[0009] As the post-ablation cornea may have a complex shape, many
of the prior commercially available lenses may not fit the ablated
cornea as well as would be ideal, and in at least some instances
fitting of lenses can be time consuming and awkward. Commercially
available contact lenses having a rigid central RGP portion and a
soft peripheral skirt can be difficult and/or time consuming to fit
to the ablated cornea and may not fit very well in at least some
instances. The ablated cornea may comprise an abrupt change in
curvature near the edge of the ablation, and in at least some
instances it can be difficult to fit such lenses near the edge of
the ablation. Also, at least some of the commercially available
contact lenses may not be suitable for extended wear and may be
removed each day which can be awkward for a patient.
[0010] Although anesthetics such as lidocaine and proparacaine may
reduce pain, the overuse of these treatments can delay regeneration
of the epithelial tissue over the defect, such that the defect may
last longer. Consequently many people with epithelial defects may
feel pain and have degraded vision while the epithelial defect
heals.
[0011] Many people elect to undergo laser vision correction surgery
to treat refractive error of the eye, such as near sightedness.
With one form of this surgery known as photorefractive keratectomy
(hereinafter "PRK"), a large area of the epithelium is removed, for
example a 6 to 9 mm area. Following ablation of the underlying
tissues such as the corneal stroma and/or Bowman's membrane, the
epithelium grows back over the ablated zone and the
de-epithelialized area to cover the area where the epithelium was
removed. This re-growth of the epithelium can take three to four
days, and at least some of the patients who undergo this surgery
may feel pain. In addition, the epithelium may be somewhat
irregular while growing back over the corneal stroma, and the
irregularities may degrade patient vision in at least some
instances. Further, work in relation to embodiments of the present
invention suggests that anterior stromal edema, ablated surface
irregularities and necrotic cells in the ablated surface area may
decrease vision in some instances. Therefore, improved treatment of
epithelial defects may result in improved patient comfort and
vision following PRK, and possibly other surgeries that remove the
corneal epithelium.
[0012] In light of the above, it would be desirable to provide
improved treatments for epithelial defects of the cornea, such as
epithelial defects following PRK. Ideally, these treatments would
avoid at least some of the deficiencies of known techniques while
providing improved patient comfort and/or vision while the
epithelial defect heals.
BRIEF SUMMARY OF THE INVENTION
[0013] Embodiments of the present invention provide an improved
covering to treat an eye having an epithelial defect, for example
an epithelial defect subsequent to refractive surgery such as PRK.
The covering can improve regeneration of the epithelium, such that
the epithelium can regenerate smoothly and rapidly. The covering
may be configured in many ways to encourage regeneration of the
epithelium, can resist movement when placed on the eye, and may
seal the cornea to restore deturgescence, so as decrease
irregularities of the cornea and improve vision. The covering may
comprise an inner portion having a modulus and a thickness so as to
conform at least partially to the ablated stromal surface and so as
to smooth irregularities of the epithelium and ablated stroma, such
that the patient can receive the optical benefit of the ablation.
The covering may comprise an outer portion that can contact the
epithelium or the conjunctiva so as to resist movement and in many
embodiments so as to seal the covering to decrease swelling of the
cornea. The outer portion can be configured in many ways to contact
the cornea or the conjunctiva so as to resist movement and in many
embodiments seal the cornea. The outer portion may extend to at
least an outer portion of the cornea and may extend to at least the
limbus and beyond the cornea so as to contact the conjunctiva and
couple to the sclera so as to resist movement.
[0014] The inner portion of the covering can be configured in many
ways so as to conform at least partially to an ablated stromal
surface so as to correct vision. As the inner portion can conform
at least partially to the ablated surface, the patient can receive
the benefit of the ablation profile that corrects vision. The
conformable inner portion may have at least some rigidity so as to
smooth the epithelium such that the epithelium regenerates rapidly
and is guided with the covering so as to form a smooth layer for
vision. The inner portion may comprise a modulus and a thickness
corresponding to an amount of rigidity so as to provide pressure on
the cornea and smooth irregularities when the inner portion is
deflected and conforms at least partially to the cornea. The inner
portion may comprise an amount of rigidity within a range from
about 1.times.10.sup.-4 Pa*m.sup.3 to about 5.times.10.sup.-4
Pa*m.sup.3 so as to deflect and conform at least partially to the
ablated cornea and smooth an inner portion of the ablation with
pressure when deflected. The inner portion may comprise a modulus
within a range from about 1 MPa to 35 MPa, for example from 4 MPa
to about 20 MPa, and may conform at least partially to the ablated
surface and smooth corneal irregularities such as stromal and
epithelial irregularities. The covering having the inner portion
configured to conform at least partially to the ablated stroma can
fit many sizes and shapes of the cornea very effectively such that
the covering can be easier for a practitioner to fit to the patient
and provide a better fit. The inner portion can provide an
environment to promote epithelial regeneration and guide
regeneration of the epithelium along the covering and ablated
surface. The covering may comprise a material having high oxygen
permeability, for example silicone, with a wettable coating
disposed on at least an upper surface of the covering to inhibit
coupling of the covering the eyelid and improve adherence of the
covering to the epithelium or the conjunctiva.
[0015] In a first aspect, embodiments of the present invention
provide, a covering to treat an eye of a patient, in which the eye
has an epithelium with a defect and an ablated stroma. The covering
comprises an inner portion comprising an inner rigidity to contact
the stroma, and an outer portion comprising an outer rigidity to
define an enclosure with the inner portion and the ablated stroma
to promote growth of the epithelium.
[0016] In many embodiments, the enclosure provides an environment
to promote growth of the epithelium over the defect within about 2
days of ablation.
[0017] In many embodiments, the enclosure comprises a terrarium to
promote growth of the epithelium over a defect. For example, the
enclosure may comprise a terrarium to promote growth of the
epithelium over a defect at least about 6 mm across within about 2
days of a PRK ablation.
[0018] In many embodiments, the enclosure comprises a chamber to
promote growth of the epithelium over the defect within about 2
days of ablation.
[0019] In many embodiments, the inner portion comprises an oxygen
permeability Dk parameter of at least about 300. For example, the
inner portion may comprise an oxygen permeability Dk parameter of
at least about 400, for example, at least about 450.
[0020] In many embodiments, the inner portion comprises a wettable
surface on at least an upper surface and wherein the inner portion
comprises an oxygen permeability Dk parameter of at least about
300. The inner portion may comprise a wettable surface on at least
an upper surface, and the inner portion may comprise an oxygen
permeability Dk parameter of at least about 400. The inner portion
may comprises a wettable surface on at least an upper surface and
the inner portion may comprise an oxygen permeability Dk parameter
of at least about 450.
[0021] In many embodiments, the outer rigidity comprises a rigidity
to indent the epithelium when the outer portion is adhered to the
cornea.
[0022] In many embodiments, the outer rigidity comprises a rigidity
to conform to a boundary of the epithelium with the epithelial
defect and to indent the epithelium.
[0023] In many embodiments, the outer portion comprises a perimeter
and wherein the outer rigidity comprises a rigidity to conform to a
boundary of the epithelium inward of the perimeter and to indent
the epithelium with at least a portion of the perimeter.
[0024] In many embodiments, the outer portion comprises a perimeter
and wherein the outer rigidity comprises a rigidity to cover at
least a portion of the perimeter with the epithelium when the
covering is adhered to the cornea. The at least the portion of the
perimeter may correspond to an inferior portion of the epithelium
disposed at an inferior location of the cornea. The at least the
portion of the perimeter may comprise the inferior portion of the
epithelium and a superior portion of the epithelium, and the at
least the portion of the epithelium may extend over the perimeter a
greater distance on the inferior portion of the covering than a
superior portion of the covering.
[0025] In many embodiments, the outer portion comprises a modulus
to remodel the epithelium with an indentation and retain at least a
portion of the perimeter of the covering at least partially within
the indentation.
[0026] In many embodiments, the covering comprises a modulus within
a range from about 4 to 20 MPa such that the covering conforms at
least partially to an ablated stroma when positioned on the cornea
and inhibits irregularities. The covering comprising the can
inhibit the irregularities in many ways, for example by providing a
guide to epithelial growth such that the epithelium grows smoothly,
for example by sealing the cornea to decrease swelling such as
central islands, and for example, smoothing of the
irregularities.
[0027] In many embodiments, the covering comprises a modulus within
a range from about 4 to 20 MPa such that the covering conforms at
least partially to an ablated stroma when positioned on the cornea
and smoothes irregularities.
[0028] In many embodiments, the covering comprises an inner portion
having an amount of rigidity within a range from about 1.times.10-4
to about 5.times.10-3 (Pa*m 3) such that the covering conforms at
least partially to an ablated stroma and smoothes epithelium when
positioned on the cornea and inhibits irregularities. The range can
be from about 2.times.10-4 to about 4.times.10-3 (Pa*m 3).
[0029] In many embodiments, the covering comprises an inner portion
having a thickness and a modulus such that a first area the
covering about 3 mm across deflects about 5 um in response a first
pressure when the first pressure is within a first range from about
200 Pa to about 920 Pa, and a second area of the inner portion of
the covering deflects about 5 um in response to a second pressure
when the second pressure is within a second range from about 25 Pa
to about 120 Pa. The second area may comprise the first area. The
first range can be from about 365 Pa to about 740 Pa the second
range can be from about 45 Pa to about 95 Pa.
[0030] In another aspect, embodiments of the present invention
provide a method of treating an eye of a patient, the eye having an
epithelium with a defect and an ablated stroma, the method
comprising:
providing a covering, wherein the covering contacts the ablated
stroma and the epithelium around the defect to define an enclosure
to promote growth of the epithelium over the ablated stroma.
[0031] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium with a defect and an ablated stroma, the covering
comprising:
an inner portion comprising an inner rigidity to contact the
stroma; an outer portion comprising an outer rigidity to define a
guide with the inner portion and the ablated stroma to promote
growth of the epithelium along the guide when the outer portion is
adhered to the stroma.
[0032] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium with a defect and an ablated stroma, the covering
comprising:
an inner portion comprising an inner rigidity to contact the stroma
to correct vision; an outer portion comprising an outer rigidity to
define an enclosure with the inner portion and the ablated stroma
to promote growth of the epithelium.
[0033] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium with a defect, the covering comprising:
an inner portion which covers the defect; an outer portion
comprising a perimeter and a modulus to form an indentation in the
epithelium when the epithelium regenerates to cover the defect.
[0034] In another aspect, embodiments of the present invention
provide a method of treating an eye of a patient, the eye having an
epithelium with a defect, the method comprising:
positioning a covering on the cornea to cover the defect, the
covering comprising an outer portion comprising a perimeter and a
modulus, wherein the covering forms an indentation in the
epithelium when the epithelium regenerates to cover the defect.
[0035] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium with an irregularity on a ablated stroma, the covering
comprises a conformable inner portion to cover the irregularity,
and the inner portion comprises an upper surface. The irregularity
comprising an irregularity profile, and an outer portion is
configured to adhere to the epithelium. The upper surface profile
corresponds to a profile of the ablated stroma to correct vision
and smooth the irregularity when the outer portion adheres to the
epithelium.
[0036] In many embodiments, the irregularities profile comprises
spatial frequencies and the upper surface profile comprises spatial
frequencies, and wherein the inner portion comprises a low pass
filter such that the upper surface profile spatial frequencies are
lower than the spatial frequencies of the irregularity profile to
correct vision.
[0037] In many embodiments, the inner portion comprises a
stretchable material to stretch across the irregularities of the
epithelium and smooth irregularities transferred from the
irregularity profile in contact with the lower surface to the upper
surface profile when the outer portion is adhered to the
epithelium. The inner portion may comprise a stretchable material
having a thickness profile that smoothes irregularities of the
epithelium when the covering is positioned on the cornea. The inner
portion may comprises a compressible material to conform to the
irregularities of the epithelium with a lower surface and smooth
irregularities transferred from the irregularity profile in contact
with the lower surface to the upper surface profile when the outer
portion is adhered to the epithelium.
[0038] In another aspect, embodiments of the present invention
provide a method treating an eye of a patient, the eye having an
epithelium with an irregularity on a ablated stroma. A covering is
provided that comprises a conformable inner portion to cover the
irregularity and an outer portion to adhere to the epithelium. The
inner portion comprises an upper surface, and the irregularity
comprising an irregularity profile. The inner portion is placed
over the ablated stroma, and the outer portion adheres to the
epithelium and the inner portion conforms to a profile of the
ablated stroma to correct vision and smooth the irregularity when
the outer portion adheres to the epithelium.
[0039] In many embodiments, the irregularities profile comprises
spatial frequencies and the upper surface profile comprises spatial
frequencies. The inner portion comprises a low pass filter such
that the upper surface profile spatial frequencies are lower than
the spatial frequencies of the irregularity profile to correct
vision.
[0040] In many embodiments, the inner portion comprises a
compressible material to conform to the irregularities of the
epithelium with a lower surface and smooth irregularities
transferred from the irregularity profile in contact with the lower
surface to the upper surface profile when the outer portion is
adhered to the epithelium.
[0041] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium with a defect. The covering comprises an inner portion
to cover the defect, and an outer portion comprising an outer
rigidity. The outer portion comprises a superior portion to contact
the epithelium superiorly with a superior rigidity and an inferior
portion to contact the epithelium inferiorly with an inferior
rigidity on the patient, in which the inferior rigidity is less
than the superior rigidity.
[0042] In many embodiments, the superior portion comprises a
superior thickness and the inferior portion comprises an inferior
thickness less than the superior thickness. The covering may
comprise a single piece of material formed with a mold.
[0043] In many embodiments, the superior portion comprises a
superior hardness and the inferior portion comprises an inferior
hardness less than the superior hardness. The covering may comprise
a superior material having a superior hardness and an inferior
material having the inferior hardness.
[0044] In many embodiments, the covering comprises a marking to
align the superior portion superiorly on the patient and the
inferior portion inferiorly on the patient.
[0045] In many embodiments, the covering is adhered to an
applicator and the applicator comprises a marking to align the
superior portion superiorly on the patient and the inferior portion
inferiorly on the patient.
[0046] In another aspect, embodiments of the present invention
provide a method of treating an eye of a patient, the eye having an
epithelium with a defect. A covering is provided with an outer
portion comprising an outer rigidity, the outer portion comprising
a superior portion to contact the epithelium superiorly with a
first rigidity and an inferior portion to contact the epithelium
inferiorly with an second rigidity on the patient, and the first
rigidity greater than the second rigidity.
[0047] In many embodiments, the inferior portion is aligned with an
inferior portion of the eye and the superior portion is aligned
with a superior portion of the eye when the covering is positioned
on the eye.
[0048] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium and a stroma, the covering comprises a conformable inner
portion comprising a first rigidity to conform to the stroma and
guide regeneration of the epithelium, and a conformable outer
portion comprising a second rigidity to conform to the
epithelium.
[0049] In many embodiments, the inner portion comprises a first
configuration prior to placement on the cornea and a second
configuration when placed on the eye, the second configuration
different from the first configuration and conforming substantially
to an ablated stromal surface of the cornea.
[0050] In many embodiments, the second rigidity is less than the
first rigidity.
[0051] In many embodiments, the second rigidity is greater than the
first rigidity. The outer portion may comprises an annular rim
disposed around the inner portion.
[0052] In many embodiments, the first rigidity of the inner portion
is greater than a rigidity of the epithelium and less than a
rigidity of a corneal stroma such that the inner portion smoothes
the epithelium when said inner portion conforms to the stroma.
[0053] In many embodiments, the epithelium comprises an epithelial
rigidity, and the eye comprises a stroma comprising a stromal
rigidity greater than the epithelial rigidity. The inner portion
comprises a rigidity greater than the epithelial rigidity and less
than the stromal rigidity such that the inner portion smoothes the
epithelium when the inner portion conforms to the stroma.
[0054] In many embodiments, the epithelium comprises an epithelial
hardness, and the eye comprises a stroma comprising a stromal
hardness greater than the epithelial hardness and wherein the inner
portion comprises a hardness greater than the epithelial hardness
and less than the stromal hardness such that the inner portion
smoothes the epithelium and conforms to the stroma.
[0055] In many embodiments, the epithelium comprises an epithelial
hardness, and the eye comprises a Bowman's membrane comprising a
Bowman's membrane hardness greater than the epithelial hardness.
The inner portion comprises a hardness greater than the epithelial
hardness and less than the Bowman's membrane hardness such that the
inner portion smoothes the epithelium and conforms to the Bowman's
membrane.
[0056] In many embodiments, the epithelium comprises an epithelial
hardness and wherein the eye comprises a stroma comprising a
stromal hardness greater than the epithelial hardness and wherein
the outer portion comprises a hardness less than the epithelial
hardness and less than the stromal hardness such that the outer
portion conforms to the epithelium.
[0057] In many embodiments, the inner portion comprises silicone
and the outer portion comprises silicone. The inner portion may
comprise at least one of a silica or resin filler. For example, the
inner portion may comprise the resin. The at least the inner
portion may comprise an optically clear material comprising
silicone and resin.
[0058] In many embodiments, at least the inner portion comprises an
optically clear material comprising silicone having an index of
refraction within a range from about 1.4 to about 1.5.
[0059] In many embodiments, the outer portion comprises at least
one of silica or resin filler. For example, the outer portion
comprises silicone and resin
[0060] In many embodiments, the inner portion comprises a thickness
within a range from about 50 um to about 250 um.
[0061] In many embodiments, outer portion comprises a thickness
within a range from about 10 um to about 60 um.
[0062] In many embodiments, a wettable coating is disposed over at
least one of an upper surface or a lower surface of the covering.
The wettable coating may comprise a lubricious coating. The
wettable coating may comprise a contact angle of no more than about
80 degrees. The wettable coating may comprise a contact angle of no
more than about 60 degrees.
[0063] In many embodiments, the lower surface may comprise a
hydrophobic material, and the lower surface may comprise the inner
portion and the outer portion.
[0064] In many embodiments, the at least the outer portion
comprises a lower surface composed of a sticky, tacky, hydrophobic
material.
[0065] In many embodiments, the inner portion comprises the lower
surface composed of the sticky, tacky, hydrophobic material.
[0066] In many embodiments, an upper surface comprises wettable
coating extending over at least the inner portion. The wettable
coating comprises polyethylene glycol (PEG). The PEG coating can be
disposed on a Parylene.TM. coating.
[0067] In many embodiments, the wettable coating comprises a plasma
coating. The plasma coating may comprise a luminous chemical vapor
deposition (LCVD) film. The plasma coating may comprise at least
one of a hydrocarbon, for example CH4, O2 or fluorine containing
hydrocarbon, for example CF4
[0068] In many embodiments, plasma coating comprises a polyethylene
glycol (PEG) coating.
[0069] In many embodiments, wettable coating comprises
2-hydroxyethylmethacrylate (HEMA). The HEMA can be disposed on a
Parylene.TM. coating.
[0070] In many embodiments, the wettable coating comprises
N-vinylpyrrolidone (NVP). The NVP can be disposed on a Parylene.TM.
coating.
[0071] In many embodiments, inner portion is affixed to outer
portion. The inner portion may comprise a first silicone and the
outer portion may comprise a second silicone, and the first
silicone of the inner portion can be affixed to the second silicone
of the outer portion.
[0072] In many embodiments, the covering comprises a single
piece.
[0073] In many embodiments, the covering comprises a single piece
of material formed in a mold.
[0074] In many embodiments, an intermediate portion is disposed
between the inner portion and the outer portion, the intermediate
portion comprising a taper extending from inner portion to outer
portion. The taper may comprise a radial width within a range from
about 0.5 mm to about 2.0 mm
[0075] In many embodiments, the outer portion comprises an annular
flange extending circumferentially around the inner portion and
wherein the outer portion extends radially comprises a radial width
within a range from about 0.05 mm to about 1.2 mm
[0076] In many embodiments, the inner portion comprises a distance
across within a range from about 3 to about 8 mm.
[0077] In many embodiments, the outer portion comprises a distance
across within a range from about 6 to about 12 mm.
[0078] In many embodiments, the covering comprises a lower surface
disposed on a lower side to contact the eye extending along the
inner portion and the outer portion and wherein the lower surface
comprises at least one of a spherical surface, a bi-curve surface
or an aspheric surface.
[0079] In many embodiments, the inner portion of the covering
comprises an optical power of no more than about +/-1 D to correct
vision of the patient when the inner portion conforms to the
ablated surface and smoothes the epithelium.
[0080] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium. The covering comprises an inner portion comprising an
inner first rigidity to smooth the epithelium. An outer portion
comprises an outer second rigidity. A conformable intermediate
portion is disposed between the inner portion and the outer
portion. The conformable intermediate portion comprises a third
rigidity to conform to the epithelium, and the third rigidity is
less than the first rigidity and the second rigidity.
[0081] In many embodiments, the outer second rigidity is greater
than the inner first rigidity.
[0082] In many embodiments, the outer second rigidity is no more
than the inner first rigidity.
[0083] In many embodiments, the inner portion comprises a first
material to smooth the epithelium and the intermediate portion
comprises a soft material to conform to the epithelium. The outer
portion may comprise the soft material. The outer portion may
comprise the first material. The first material may comprise a
rigid material having a Shore A durometer hardness parameter of at
least about 60, and the second material may comprise a soft
material having Shore A durometer hardness parameter of no more
than about 70.
[0084] In many embodiments, the first material comprises a first
silicone comprising a first hardness and the soft material
comprises a second silicone having a second hardness less than the
first hardness.
[0085] In many embodiments, the inner portion comprises an inner
first thickness, the outer portion comprising an outer second
thickness, the middle portion comprising a third thickness, and the
third thickness is less than the inner first thickness and the
outer second thickness.
[0086] In many embodiments, the inner portion comprises a first
material to smooth the epithelium and the intermediate portion
comprises the first material to conform to the epithelium.
[0087] In many embodiments, the covering comprises a single piece
of material formed from a mold.
[0088] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient, the eye having an
epithelium. The covering comprises an inner portion comprising an
optical surface. An outer portion comprises an outer perimeter, and
the outer perimeter comprises a chamfer to contact the epithelium
to seal the cornea.
[0089] In another aspect, embodiments of the present invention
provide a method of treating an eye of a patient, the eye having an
epithelium and a stroma. A covering is placed over the eye. The
covering comprises a conformable inner portion comprising a first
rigidity and a conformable outer portion comprising a second
rigidity, and the conformable inner portion conforms to the stroma
and smoothes the epithelium and the outer portion conforms to the
epithelium.
[0090] In another aspect, embodiments of the present invention
provide a method of treating an eye of a patient, the eye having an
epithelium and an ablated stromal surface. A covering is placed
over the eye, and the covering comprise a conformable inner portion
comprising a first rigidity and a conformable outer portion
comprising a second rigidity. The conformable inner portion
conforms to the ablated surface and smoothes the epithelium, and
the outer portion comprising the second rigidity conforms to the
epithelium.
[0091] In many embodiments, the inner portion of the covering
comprises an optical power of no more than about +/-1 D to correct
vision of the patient when the inner portion conforms to the
ablated surface and smooth the epithelium.
[0092] In many embodiments, the inner portion of the covering
comprises a substantially uniform thickness to correct vision of
the patient when the inner portion conforms to the ablated surface
and smooth the epithelium.
[0093] In many embodiments, the inner portion comprises a first
configuration prior to placement on the cornea and a second
configuration when placed on the eye, the second configuration
different from the first configuration.
[0094] In another aspect, embodiments of the present invention
provide a method of manufacturing a therapeutic covering. An inner
component is positioned in a mold. A flowable material is injected
into the mold to contact the inner component along at least a
periphery of the inner component. The flowable material is cured to
form the covering. The covering is removed from the mold.
[0095] In many embodiments, the first component comprises an
optically transparent material.
[0096] In many embodiments, the first component comprises an
optically transparent material comprising silicone and resin.
[0097] In many embodiments, the flowable material comprises
silicone.
[0098] In many embodiments, the flowable material comprises
resin.
[0099] In many embodiments, at least an upper side of the covering
is coated with a wettable material.
[0100] In many embodiments, the covering is placed in a container.
The covering can be dried prior to placement in the container. The
covering can be sealed in the container in a substantially dry
configuration.
[0101] In many embodiments, the covering is connected to an
applicator and placed in the container in a substantially dry
configuration.
[0102] In many embodiments, a solvent is evaporated to adhere the
covering to the applicator. The solvent may comprises an alcohol,
for example.
[0103] In another aspect, embodiments of the present invention
provide a method of placing a covering on a cornea of an eye having
an epithelium with a defect. A dry covering is provided, the
covering having a configuration for placement on the eye. The
cornea is dried to remove at least some liquid from the cornea. The
dry covering is advanced in the configuration toward the eye to
contact the epithelium and cover the defect with the dry
covering.
[0104] In many embodiments, the dry covering is advanced with an
applicator adhered to the covering in an expanded
configuration.
[0105] In many embodiments, covering comprises an outer portion
having a lower surface that sticks to the epithelium of the dry
eye.
[0106] In many embodiments, the lower surface of the outer portion
comprises a hydrophobic sticky tacky surface.
[0107] In many embodiments, the eye is exposed to a gas to dry the
eye.
[0108] In many embodiments, the epithelial defect comprises a
debridement.
[0109] In many embodiments, the epithelial defect comprises a
debridement and wherein the eye comprises an ablated stroma within
the debridement. The covering can contact the ablated stroma and
the epithelium without a liquid disposed between the covering and
the epithelium.
[0110] In many embodiments, a liquid is not disposed between the
covering and epithelium when the covering contacts the
epithelium.
[0111] In many embodiments, the covering is positioned
substantially uniformly on the dried eye.
[0112] In many embodiments, the covering is positioned
substantially uniformly on the dried eye with an applicator.
[0113] In another aspect, embodiments of the present invention
provide an applicator to position a covering on an eye. The
applicator comprises a support having a surface to contact at least
a peripheral portion of the covering to stick to the covering.
[0114] In many embodiments, the surface comprises a curved surface.
The curved surface may stick to the covering when the curved
surface and the at least the peripheral portion each comprise a dry
surface without a liquid disposed therebetween. The curved surface
may comprise a sticky tacky surface when dry to hold the covering
and a slippery surface when wet to release the covering. The curved
surface can be configured to adhere to the covering with block
adhesion and release the covering in response to peeling of the
covering from the curved surface.
[0115] In many embodiments, the curved surface comprises
silicone.
[0116] In many embodiments, the curved surface comprises a wettable
coating.
[0117] In many embodiments, the support comprises an annular ring
having the curved lower surface disposed on a lower side of the
ring and inclined to contact the peripheral portion of the
covering.
[0118] In many embodiments, the support defines an opening sized
for a surgeon to view at least a pupil of the eye when the covering
is positioned on the eye.
[0119] In many embodiments, a handle is affixed to the support for
placement on the covering when the handle is grasped by a
surgeon.
[0120] In many embodiments, the support comprises foam coupled to
the covering to position the covering on the eye and to release the
covering when the covering is positioned on the eye.
[0121] In another aspect, embodiments of the present invention
provide an applicator to position a covering on an eye. The
applicator comprises a support having a curved surface to contact
at least a peripheral portion of the covering. The curved surfaces
adheres to the covering when dry and releases the covering when
wet.
[0122] In another aspect, embodiments of the present invention
provide an applicator to position a covering on an eye of a
patient. The applicator comprises a support comprising a rigid
first component and a second component movable relative to the
rigid first component to position the covering on the eye, and the
movable component comprises at least a portion viewable
therethrough.
[0123] In many embodiments, the at least the portion is viewable
therethrough from the eye on a first side of the support to an
object on a second side of the support opposite the first side when
the support and the covering are positioned in front of the eye to
place the covering on the eye.
[0124] In many embodiments, the at least the portion is viewable
therethrough from an operating microscope positioned on the second
side of the support to a tissue structure of the eye disposed on
the first side when the support and the covering are positioned in
front of the eye to place the covering on the eye.
[0125] In many embodiments, the rigid component comprises a window.
The window of the rigid component may comprise an opening defined
with the rigid component and sized to receive the movable
component. The at least the portion comprises a window disposed
within the window of the support.
[0126] In many embodiments, the at least the portion comprises a
window composed of a transparent material.
[0127] In many embodiments, the at least the portion comprises an
inner opening defined with an outer portion of the movable second
component.
[0128] In many embodiments, the support comprises a first
configuration to carry the covering and a second configuration to
release the covering. The movable component can urge the covering
toward the eye when the support transitions from the first
configuration to the second configuration. The movable component
peels the covering from the support when the support transitions
from the first configuration to the second configuration.
[0129] In many embodiments, the movable component comprises a thin
transparent flexible sheet coupled to the rigid component to urge
the covering toward the eye.
[0130] In many embodiments, the rigid component and the movable
component define a chamber to urge the covering onto the eye when
fluid is passed into the chamber.
[0131] In many embodiments, the movable component comprises a
popper.
[0132] In many embodiments, the movable component comprises an
optically transparent material sized to fit within the rigid
component to urge the covering toward the eye. The rigid first
component may comprise an annulus having an inner diameter, and the
movable second component may comprise a disc having a diameter
sized to fit within the inner diameter. The movable component can
be coupled to the shield to urge the shield toward the eye.
[0133] In many embodiments, support comprises a single piece of
material formed from a mold, the rigid component comprising the
material and the movable component comprising the material wherein
the rigid component comprises a thickness greater than the movable
component such that a shape of the rigid component is retained
substantially when the movable component flexes.
[0134] In another aspect, embodiments of the present invention
provide a applicator to position a covering on an eye of a patient.
The applicator comprises a rigid first component to carry the
covering with an outer portion of the covering and position the
covering on the eye. A second component is movable relative to the
rigid first component to contact an inner portion of the covering
and separate the covering from the first rigid component when the
covering is positioned on the eye. The movable component may
comprise at least a portion viewable therethrough.
[0135] In many embodiments, the rigid first component comprises an
opening sized to receive second component.
[0136] In many embodiments, the rigid first component comprises an
opening sized to receive second component.
[0137] In many embodiments, the rigid first component comprises a
lower inclined surface to stick to the covering at the outer
portion, and the second component comprises a lower surface to
contact the inner portion of the covering and peel the covering
from the lower inclined surface when the second component moves
toward the eye.
[0138] In many embodiments, a handle is connected to the rigid
first component and a structure extending between the handle and
the movable component to urge the movable component toward the eye
when the handle is grasped by a user.
[0139] In another aspect, embodiments of the present invention
provide an applicator to position a covering on a cornea of an eye
of a patient. The applicator comprises a handle, and a first
component to carry the covering and position the covering on the
cornea of the eye. A rigid second component is rigidly coupled to
the handle and the first component to fix the eye when the covering
is positioned on the eye with the first component.
[0140] In many embodiments, the first component comprises a first
annular portion to couple to the covering and position the covering
on the eye, and the second component comprises a fixation ring to
fix the eye.
[0141] In another aspect, embodiments of the present invention
provide an applicator to position a covering on a cornea of an eye
of a patient. The applicator comprises a handle, and a first
component to carry the covering and position the covering on the
cornea of the eye. The applicator comprises a second component to
de-enervate the eye with at least one of a substance or cooling
when the covering positioned on the cornea with the handle.
[0142] In another aspect, embodiments of the present invention
provide an applicator to position a covering on a cornea of on an
eye of a patient. The apparatus comprises a handle to position the
covering on the eye. At least two contact pads to contact the
covering are coupled to the handle, in which each pad comprises a
lower surface to couple to the covering, and the at least two pads
are separated by a distance. The apparatus comprises at least two
extensions, in which each extension is coupled to one of the pads
and extends between said pad and the handle, and the at least two
extensions are inclined relative to the pads and separated such
that the patient can view an object when the covering is placed on
the eye with the pads separated by the distance.
[0143] In many embodiments, the lower surface of each pad comprises
an inclined surface, and the extensions are configured to separate
to release the covering when the covering is positioned on the
cornea.
[0144] In many embodiments, the inclined lower surface of each pad
is configured to adhere to the covering with block adhesion to
carry the covering prior to placement and wherein the extensions
are configured to separate the pads along a path to peel the
covering away from the covering away from the pads when the pads
separate to release the covering.
[0145] In many embodiments, each contact pad comprises a roller
configured to roll outward along the covering when the pad is
pressed toward the eye with the handle.
[0146] In many embodiments, each contact pad comprises a concave
roller rotationally coupled to said extension to roll outward along
the covering when the pad is pressed toward the eye with the handle
and the extension.
[0147] In another aspect, embodiments of the present invention
provide an apparatus to cover an eye. The apparatus comprises a dry
covering having an upper surface. A support having a lower surface
is coupled to the upper surface to position the covering on the eye
and release the covering when the covering is positioned on the
eye.
[0148] In many embodiments, the lower surface is coupled to an
outer portion of the covering to release the covering.
[0149] In many embodiments, the lower surface is coupled to an
outer portion of the covering with block adhesion to release the
covering in response to peeling of the covering from the
support.
[0150] In many embodiments, the lower surface comprises a
non-wettable surface in contact with the dry covering.
[0151] In many embodiments, the lower surface comprises a wettable
surface coating in contact with the dry covering.
[0152] In many embodiments, the dry covering comprises a
non-wettable surface in contact with the lower surface.
[0153] In many embodiments, the dry covering comprises a wettable
surface in contact with the lower surface.
[0154] In many embodiments, the lower surface comprises a wettable
coating.
[0155] In many embodiments, the lower surface extends along a curve
to define an opening, and the lower surface comprises an inclined
angle along the curve hold the covering for placement on the eye.
The dry covering can be adhered to the lower surface and wherein
the lower surface releases the covering when wet. The support
comprises silicone and the covering comprises silicone. The
silicone of the support can contact the silicone of the covering to
adhere the covering to the support.
[0156] In many embodiments, the covering comprises an upper surface
comprising a wettable coating disposed thereon, and the wettable
coating of the covering sticks to the lower surface of the support.
The wettable coating on the upper surface of the covering can
separates from the lower curved surface when wet. The lower surface
may comprise a hydrophobic material in contact with the wettable
coating on the upper surface of the covering to release the lower
curved surface when wet.
[0157] In many embodiments, the lower surface comprises a wettable
material in contact with the wettable coating on the upper surface
of the covering to adhere the lower curved surface to the upper
surface when dry and to release the upper surface when wet.
[0158] In many embodiments, the dry covering comprises an optically
transparent surface having an optical power of no more than about
+/-1 D.
[0159] In another aspect, embodiments of the present invention
provide an method of placing a covering on a cornea of an eye
having an epithelium with a defect. A fixation light is provided to
a patient to view with the eye. The covering is positioned over the
eye of the patient and separated from the cornea of the eye, and
the patient views the fixation light when the covering is
positioned over the eye and separated from the cornea. The covering
is advanced toward the eye to contact and cover the defect when the
patient views the fixation light.
[0160] In many embodiments, the patient fixates on the fixation
light to stabilize the eye when the covering is advanced toward the
eye. A surgeon can view the eye through an operating microscope to
align the covering with the eye when the covering is advanced
toward the eye.
[0161] In many embodiments, the covering comprises at least a
portion viewable therethrough and wherein the patient fixates on
the fixation light with light from the fixation light transmitted
through the at least the portion when the covering is advanced
toward the eye. The covering may comprise a dry optically
transparent covering having an optical power of no more than about
+/-1 D when positioned in front of the eye. The at least the
portion may comprise a dry anterior surface without a liquid
disposed thereon and a dry posterior surface without a liquid
disposed thereon and wherein the patient views the fixation target
through the dry anterior surface and the dry posterior surface.
[0162] In many embodiments, the surgeon views a structure of the
eye through the at least the portion to align the covering with the
eye when the covering is advanced toward the eye. The structure of
the eye may comprise at least one of the epithelial defect, an iris
of the eye, a pupil or a limbus of the eye.
[0163] In many embodiments, the covering is advanced toward the eye
with an applicator coupled to the covering. The applicator may
comprise a window, and the patient can views the fixation light
through the window when the applicator is advanced toward the eye.
The covering can be released from the applicator when the covering
is positioned in contact with the cornea.
[0164] In many embodiments, the applicator holds the covering in a
substantially expanded configuration for placement on the cornea
when the covering is advanced toward the eye.
[0165] In another aspect, embodiments of the present invention
provide a method of removing a covering from an eye. A covering is
provided positioned over a regenerated epithelium of the eye. An
elongate structure is positioned having a lumen disposed therein,
and the lumen extends to an opening on the distal end and the
opening is positioned under the covering. A liquid is injected
through the opening positioned under the covering so as to separate
the covering from the regenerated epithelium along a lower surface
of the covering.
[0166] In many embodiments, the opening comprises a cross sectional
size having a maximum distance across extending a first direction
and wherein the first direction is aligned substantially with a
lower surface of the covering to inject the liquid along the lower
surface of the covering to separate the covering from the
regenerated epithelium.
[0167] In another aspect, embodiments of the present invention
provide a method of removing a covering from an eye having an
epithelium and ablated stroma. the covering is provided positioned
over a regenerated epithelium substantially covering the ablated
stroma. An elongate structure is positioned having a lumen disposed
therein. The lumen extends to an opening on the distal end. A
liquid is injected to deliver the liquid to a distal end through
the opening and under the covering to separate the covering from
the regenerated epithelium along a lower surface of the
covering.
[0168] In another aspect, embodiments of the present invention
provide an apparatus to remove covering from an eye. The apparatus
comprises an elongate structure having a proximate portion and a
distal portion. The elongate structure has a lumen disposed therein
to deliver a liquid to a distal end of the distal portion. The
lumen extends to an opening on the distal end, and the opening has
a sectional size with a first longer dimension across extending in
a first direction and a second smaller distance across extending in
a second direction. An elongate support extends in an elongate
direction, and the elongate support is attached to the proximal
portion of the elongate structure and graspable by a user to
position the distal end under the covering to align the maximum
distance across a lower surface of the covering when the handle is
positioned near a temple of the patient.
[0169] In another aspect, embodiments of the present invention
provide an apparatus to remove a covering from an eye. The
apparatus comprises an elongate structure having a lumen disposed
therein to deliver a liquid to a distal end, wherein the lumen
extends to an opening on the distal end. The opening has a cross
sectional size with a first longer dimension across extending in a
first direction and a smaller dimension across extending in a
second direction. An elongate support extends in an elongate
direction, the elongate support graspable by a user to position the
distal end under a temporally disposed portion of a perimeter of
the covering when the handle is positioned near a temple of the
patient. The elongate structure comprises a bend between the
support and the distal end and wherein the maximum distance across
is aligned with the temporally disposed portion of the perimeter of
the covering when the handle is positioned near the temple.
[0170] In another aspect, embodiments of the present invention
provide a method of treating an eye of a patient following PRK
surgery, the eye having an epithelium with a defect and an ablated
stroma. A covering is placed over the ablated stroma to cover the
epithelial defect and couple to the cornea so as to improve to at
least about 20/40 between 24 hours to 72 hours post-op and wherein
the patient without the placed covering would have vision of less
than about 20/40 between 24 to 72 hours post-op.
[0171] In many embodiments, the vision is improved to at least
about 20/30 between 24 hours to 72 hours post-op and wherein the
patient without the placed covering would have vision of less than
about 20/30 between 24 to 72 hours post-op.
[0172] In many embodiments, the vision is improved to at least
about 20/25 between 24 to 72 hours post-op and wherein the patient
without the placed covering would have vision of less than about
20/25 between 24 to 72 hours post-op.
[0173] In many embodiments, the vision is improved to at least
about 20/20 between 24 hours to 72 hours post-op and wherein the
patient without the placed covering would have vision of less than
about 20/30 between 24 to 72 hours post-op.
[0174] In another aspect, embodiments of the present invention
provide a method of treating an eye of any of a population of
patients following PRK surgery, the population of PRK patients
having at least about 40% of patients seeing 20/40 or better
between 24 to 72 hours post-op. The eye has an epithelium with a
defect and a successfully ablated stroma. A covering is placed over
the ablated stroma to cover the epithelial defect and improve
vision such that the patient is a member of the population.
[0175] In many embodiments, the population of patients has at least
about 60% of patients seeing 20/40 or better between 24 to 72 hours
post-op.
[0176] In many embodiments, the population of patients has at least
about 80% of patients seeing 20/40 or better between 24 to 72 hours
post-op.
[0177] In many embodiments, the population of patients has at least
about 90% of patients seeing 20/40 or better between 24 to 72 hours
post-op.
[0178] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient following PRK
surgery, the eye having an epithelium with a defect and an ablated
stroma. The covering comprises a curved body to couple to the
cornea and cover the ablated stroma and the epithelial defect so as
to improve vision to at least about 20/40 between 24 to 72 hours
post-op, and the eye without the covering would have vision of less
than 20/40 between 24 to 72 hours post-op.
[0179] In many embodiments, the vision is improved to at least
about 20/30 between 24 hours to 72 hours post-op and wherein the
patient without the placed covering would have vision of less than
about 20/30 between 24 to 72 hours post-op.
[0180] In many embodiments, the vision is improved to at least
about 20/25 between 24 to 72 hours post-op and wherein the patient
without the placed covering would have vision of less than about
20/25 between 24 to 72 hours post-op.
[0181] In many embodiments, the vision is improved to at least
about 20/20 between 24 hours to 72 hours post-op and wherein the
patient without the placed covering would have vision of less than
about 20/30 between 24 to 72 hours post-op.
[0182] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient following PRK
surgery, the PRK surgery comprising epithelial removal from a
region of the cornea of the eye and ablation of stroma of the
cornea underlying the region such that the eye, with an appropriate
standard contact lens disposed on the cornea and without the
treatment, would have visual acuity of worse than 20/40 throughout
the period between 24 to 72 hours after the PRK surgery. The
covering comprises a curved body with a concave surface receiving
the cornea so as to cover the ablated stroma and a convex surface
over which an eyelid passes without dislodging the curved body from
the cornea during blinking of the eye. The curved body is
transparent and engagement of the curved body against the cornea
mitigating the epithelial removal so as to improve the visual
acuity of the eye therethrough to at least about 20/40 between 24
to 72 hours after the PRK surgery.
[0183] In many embodiments, the vision is improved to at least
about 20/30 between 24 hours to 72 hours post-op and wherein the
patient without the placed covering would have vision of less than
about 20/30 between 24 to 72 hours post-op.
[0184] In many embodiments, the vision is improved to at least
about 20/25 between 24 to 72 hours post-op and wherein the patient
without the placed covering would have vision of less than about
20/25 between 24 to 72 hours post-op.
[0185] In many embodiments, the vision is improved to at least
about 20/20 between 24 hours to 72 hours post-op and wherein the
patient without the placed covering would have vision of less than
about 20/30 between 24 to 72 hours post-op.
[0186] In another aspect, embodiments of the present invention
provide a covering to treat an eye of any of a population of
patients following PRK surgery, the population having at least
about 40% of patients seeing 20/40 or better between 24 to 72 hours
post-op, the eye having an epithelium with a defect and a
successfully ablated stroma. The covering comprises a curved body
to couple to the cornea and cover the ablated stroma and epithelial
defect such that the patient is a member of the population.
[0187] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient following PRK
surgery, the patient included within a population of PRK patients
receiving PRK surgery, each PRK surgery comprising epithelial
removal from a region of the cornea of the associated eye and
ablation of stroma of the cornea underlying the region, the
epithelial removal degrading short-term visual acuities of the eyes
after the PRK. The covering comprises a curved body with a concave
surface receiving the cornea so as to cover the ablated stroma and
a convex surface over which an eyelid passes without dislodging the
curved body from the cornea during blinking of the eye, the curved
body being transparent and mitigating the short-term visual acuity
degradation when disposed on the eye. The mitigation is sufficient
that 40% of the eyes of the patients of the population would have
visual acuities of at least about 20/40 between 24 to 72 hours
after the PRK surgery.
[0188] In many embodiments, the population of patients has at least
about 60% of patients seeing 20/40 or better between 24 to 72 hours
post-op.
[0189] In many embodiments, the population of patients has at least
about 80% of patients seeing 20/40 or better between 24 to 72 hours
post-op.
[0190] In many embodiments, the population of patients has at least
about 90% of patients seeing 20/40 or better between 24 to 72 hours
post-op.
[0191] In another aspect, embodiments of the present invention
provide a covering to treat an eye of a patient. The covering
comprises a curved body to fit they eye. The body has a modulus
within a range from about 4 MPa (Mega Pascal's) to about 20
MPa.
[0192] In many embodiments, the body comprises an elastomer. The
elastomer may comprise silicone polymer formed with one or more of
vinyl polymerization, peroxide polymerization or hydrosilation.
[0193] In many embodiments, the body comprises contact lens having
a central lens portion having a center stiffness of at least about
2 psi*mm2 coupled to an outer lenticular junction portion having a
lenticular junction stiffness of at least about 5 psi*mm2.
[0194] In many embodiments, the body comprises an amount of water
within a range from about 0 to 35% and wherein the body comprises a
Dk of 100 or more. The body may comprise silicone comprising one or
more of silicone elastomer or silicone hydrogel. The range of water
can be from about 0 to 10% and the Dk is 100 or more. The body may
comprise the silicone elastomer and the range of water is from
about 0 to 5% and the Dk is 100 or more.
[0195] In many embodiments, the body comprises the silicone
hydrogel and the silicone hydrogel comprises a low ion permeability
and the range of water is from about 5% to about 35% and the Dk is
100 or more. The low ion permeability may comprise an Ionoton Ion
Permeability Coefficient of no more than about 0.25.times.10-3
cm2/sec. The low ion permeability may comprise an Ionoton Ion
Permeability Coefficient of no more than about 0.08.times.10-3
cm2/sec. The low ion permeability may comprise an Ionoton Ion
Permeability Coefficient of no more than about 2.6.times.10-6
mm2/min. The low ion permeability may comprise an Ionoton Ion
Permeability Coefficient of no more than about 1.5.times.10-6
mm2/min.
[0196] In many embodiments, the body comprises a wettable surface
having a tear break up time of no less than about five seconds when
placed on the eye. The wettable surface may comprise a coating of
one or more of luminous chemical vapor deposition (LCVD), hydrogel,
2-hydroxyethylmethacrylate (HEMA), methacrylic acid (MA), methyl
methacrylate (MMA), N,N-dimethylacrylamide (DMA); N-vinyl
pyrrolidone (NVP), phosphorylcholine (PC), poly vinyl alcohol (PVA)
or polyvinyl pyrrolidone (PVP), tris-(trimethylsiloxysilyl)
propylvinyl carbamate (TPVC); N-carboxyvinyl ester (NCVE); silicone
hydrogel, poly[dimethylsiloxyl]di [silylbutanol]bis[vinyl
carbamate] (PBVC); silicate, plasma treated silicone hydrogel,
plasma coating producing glassy islands, 25 nm plasma coating with
high refractive index.
[0197] In many embodiments, wettable surface comprises the material
of the body. The material of the body and surface may comprise
hydrogel. The material of the body comprises an optically clear
silicone elastomer comprising silicate, and the silicone elastomer
may comprise silicate treated with plasma to generate the wettable
surface.
[0198] In many embodiments, the wettable surface comprises hydrogel
and the body comprises silicone elastomer and wherein the hydrogel
is disposed silicone elastomer.
[0199] In many embodiments, the body comprises an inner portion and
an outer portion, wherein the inner portion comprises a lower
surface having a first radius of curvature to fit an ablated region
of a cornea of the eye and the outer portion comprises a lower
surface having a second radius of curvature to fit an unablated
region of the cornea of the eye.
[0200] In many embodiments, the body comprises a lower surface
having an oblate shape to fit an ablated region of a cornea of the
eye and to fit an unablated region of the cornea.
[0201] In many embodiments, the body comprises a first curved
portion, a second curved portion, and a third curved portion,
wherein the first curved comprises a first lower surface having a
first radius of curvature to fit an ablated region of a cornea the
eye, the second curved portion comprising a second lower surface
having a second radius of curvature to fit an unablated region of
the cornea of the eye, the third curved portion comprising a third
lower surface having a third radius of curvature to fit a sclera of
the eye.
[0202] In many embodiments, the second radius of curvature to fit
the unablated cornea is less than the third radius of curvature to
fit the sclera.
[0203] In many embodiments, the curved body comprises an inner
portion to seal the cornea and an outer portion having
fenestrations extending through a thickness of the body to pass a
medicament to treat pain when the lens is adhered to the
cornea.
[0204] In another aspect, embodiments provide a method of treating
an eye an eye of a patient.
[0205] A covering comprising a curved body is placed on the cornea
of the eye. The body has a modulus within a range from about 4 MPa
(Mega Pascal's) to about 20 MPa.
[0206] In many embodiments, the eye comprises an epithelium and an
ablated stroma and wherein covering adheres to the epithelium and
conforms at least partially to the ablated stroma to improve the
vision of the patient. The covering may inhibit irregularities of
one or more of the epithelium or the ablated stroma when the
covering conforms at least partially to the ablated stroma. For
example, the covering may smooth irregularities of the cornea.
[0207] In another aspect, embodiments provide a covering to treat
an eye of a patient. The covering comprises a curved body to fit
the eye. The body comprises an inner portion and an outer portion.
The inner portion has an amount of rigidity within a range from
about 1.times.10E-4 to about 5.times.10E-4 Pa*m 3 (Pascal*meters
cubed), the outer portion has an amount of rigidity less than the
inner portion. The range can be from about 2.times.10E-4 to about
4.times.10E-4 Pa*m 3 (Pascal*meters cubed).
[0208] In many embodiments, the inner portion comprises a first
layer of a first material and a second layer of a second material,
the first material comprising a soft material having a modulus
within a range from about 0.1 to about 5 MPa, the second material
having a modulus within a range from about 5 to about 1900 MPa.
[0209] In many embodiments, the inner portion comprises a third
layer of a third material having a third modulus within a range
from about 0.1 to about 5 MPa.
[0210] In many embodiments, the first material comprises a first
silicone and the second material and the third material comprise a
second silicone, the first silicone comprising a first modulus
within a first range from about 5 to 35 MPa, the second silicone
comprising a modulus from about 0.1 to 5 MPa.
[0211] In many embodiments, the inner portion comprises an RGP
material and the outer portion and the third portion comprise a
hydrogel.
[0212] In many embodiments, the inner portion comprises a first
curved portion and the outer portion comprises a second curved
portion and a third curved portion. The first curved portion
comprises a first lower surface having a first radius of curvature
to fit an ablated region of a cornea the eye. The second curved
portion comprises a second lower surface having a second radius of
curvature to fit an unablated region of the cornea of the eye. The
third curved portion comprises a third lower surface having a third
radius of curvature to fit a sclera of the eye.
[0213] In many embodiments, the first radius of curvature comprises
an apical radius of curvature and the second radius of curvature
corresponds to a conic constant.
[0214] In many embodiments, the third radius of curvature comprises
no more than about 10 mm and a modulus of no more than about 5 MPa
and a thickness of no more than about 200 um so as to stretch
substantially and resist movement of the inner portion when placed
on the sclera.
[0215] In many embodiments, the third radius of curvature comprises
no more than about 9 mm and an amount of rigidity of no more than
about 4E-5 Pa*m 3 so as to stretch substantially for comfort and
resist movement of the inner portion when placed on the sclera.
[0216] In many embodiments, the third curved portion comprises a
maximum dimension across within a range from about 12 to 16 mm to
contact the conjunctiva and couple to the sclera of the eye.
[0217] In many embodiments, the range is from about 14 to 16 mm to
resist movement of the inner portion when the third curved portion
is placed on the conjunctiva and coupled to the sclera.
BRIEF DESCRIPTION OF THE DRAWINGS
[0218] FIG. 1 shows an eye suitable for incorporation of the
covering as described herein, in accordance with embodiments of the
present invention;
[0219] FIG. 1-1A shows an ablated eye immediately following
refractive surgery resulting in an epithelial defect, suitable for
incorporation in accordance with embodiments of the present
invention:
[0220] FIG. 1-1B shows an ablated eye about 1 day following
refractive surgery resulting in an epithelial defect, suitable for
incorporation in accordance with embodiments of the present
invention:
[0221] FIG. 1-1C shows an ablated eye when the epithelium has
regenerated following refractive surgery resulting in an increased
epithelial thickness centrally at about 3 days, suitable for
incorporation in accordance with embodiments of the present
invention:
[0222] FIG. 1-2A shows a covering positioned on an eye having an
epithelial defect, in which the covering abuts the cornea to seal
the cornea, in accordance with embodiments of the present
invention:
[0223] FIG. 1-2B shows a smooth layer of regenerated epithelium
substantially cover an ablated profile, in accordance with
embodiments of the present invention;
[0224] FIG. 1A shows a covering positioned on an eye having an
epithelial defect, in which an outer portion of the covering abuts
and conforms at least partially to the cornea to seal the cornea,
in accordance with embodiments of the present invention:
[0225] FIG. 1A1 shows a covering positioned on an eye and blinking
of the eye, in accordance with embodiments of the present
invention:
[0226] FIG. 1B1 shows a covering sized to seal a cornea, in
accordance with embodiments of the present invention:
[0227] FIG. 1B2 shows the covering conforming to ablated stromal
tissue and guiding regeneration of the epithelium over the ablated
stroma, so as to promote vision, in accordance with embodiments of
the present invention;
[0228] FIG. 1B2A shows a covering forming an indentation in the
epithelium such that the epithelium extends over at least a portion
of the perimeter of the covering, in accordance with embodiments of
the present invention;
[0229] FIG. 1B2B shows a covering forming an indentation in the
epithelium, in accordance with embodiments of the present
invention:
[0230] FIG. 1B2C shows a covering abutting the cornea to seal the
cornea without forming a substantial indentation in the epithelium,
in accordance with embodiments of the present invention:
[0231] FIG. 1C shows a covering comprising a single piece of
material having an inner thickness greater than an outer thickness,
in accordance with embodiments of the present invention;
[0232] FIG. 1C1 shows a covering as in FIGS. 1-2A to 1B2 having an
inner portion comprising an inner thickness and an inner material
and an outer portion comprising an outer thickness and an outer
material, in which the inner thickness is greater than the outer
thickness, in accordance with embodiments of the present
invention;
[0233] FIG. 1C1A shows a covering as in FIG. 1C1 adhered to the
cornea with a smooth upper surface and a lower surface conforming
to irregularity of the cornea comprising a central island of the
stroma, in accordance with embodiments of the present
invention;
[0234] FIG. 1C2 shows a covering as in FIGS. 1-2A to 1B2 having an
inner portion comprising an inner thickness and an inner material
and an outer portion comprising an outer thickness and an outer
material, in which the inner thickness is greater than the outer
thickness and the outer material extends around the inner material,
in accordance with embodiments of the present invention;
[0235] FIG. 1C2A shows a covering as in FIG. 1C1 adhered to the
cornea with a smooth upper surface and a lower surface conforming
to irregularity of the cornea near the edge of the ablation, in
accordance with embodiments of the present invention;
[0236] FIG. 1D shows a covering as in FIGS. 1-2A to 1B2 having an
inner portion comprising an inner thickness and an inner material
and an outer portion comprising an outer thickness and an outer
material, in which the inner thickness is substantially similar to
the outer thickness, in accordance with embodiments of the present
invention;
[0237] FIGS. 1E and 1F show top and side views, respectively, of a
covering comprising an inner portion and an outer portion, as in
FIGS. 1A to 1B2 and a peripheral rim portion disposed around the
outer portion, in accordance with embodiments of the present
invention;
[0238] FIG. 1G shows a covering comprising an inner portion and an
outer portion comprising a taper, in accordance with embodiments of
the present invention;
[0239] FIG. 1G1 shows a covering comprising an inner portion and an
outer portion comprising a taper and an outer rim of substantially
uniform thickness peripheral to the taper, in accordance with
embodiments of the present invention;
[0240] FIGS. 1G1A to 1G1G show a covering as in FIG. 1G1 and
dimensions suitable for use with experiments, clinical studies and
patient treatment in accordance with embodiments;
[0241] FIG. 1H1 shows spatial frequency and elevation smoothing of
an epithelial irregularity transferred to a front surface of a
covering as in FIG. 1-2A, in accordance with embodiments.
[0242] FIG. 1H2 shows spatial frequency and elevation smoothing of
the epithelial irregularity with a plot of height relative to a
reference sphere for the upper surface of the covering and the
upper surface of the irregularity;
[0243] FIG. 1I1 shows inhibition of transfer of an epithelial
irregularity to a front surface of a covering, in accordance with
embodiments.
[0244] FIG. 1I2 shows elevation smoothing of the epithelial
irregularity with a plot of height relative to a reference sphere
for the upper surface of the covering and the upper surface of the
irregularity;
[0245] FIG. 1I3 shows a thickness profile of the covering as in
FIG. 1I2 so as to smooth the front surface of the covering, in
accordance with embodiments of the present invention;
[0246] FIG. 1J1 shows a covering having a bicurve profile to fit an
ablated cornea, in accordance with embodiments of the present
invention;
[0247] FIG. 1J2 shows a covering having an oblate profile to fit an
ablated cornea, in accordance with embodiments of the present
invention;
[0248] FIG. 1J3 shows a covering having a tricurve profile to fit
sclera and an ablated cornea, in accordance with embodiments of the
present invention;
[0249] FIG. 1J4 shows a covering having a curved profile to fit
sclera and an oblate profile to fit ablated cornea, in accordance
with embodiments of the present invention;
[0250] FIG. 1J5 shows a covering having a tricurve profile to fit
sclera and an ablated cornea similar to FIG. 1J3, in accordance
with embodiments of the present invention;
[0251] FIG. 1J6 shows a tapered edge of the covering having a
tricurve profile to fit sclera and an ablated cornea as in FIG.
1J5;
[0252] FIG. 1K shows a covering having fenestrations on an outer
portion to pass a medicament when the cornea is sealed, in
accordance with embodiments of the present invention;
[0253] FIG. 1L shows fitting of a covering to a cornea in
accordance with embodiments as described herein;
[0254] FIG. 1M shows deflection of a portion of a covering in
response to an epithelial irregularity so as to smooth the
irregularity, in accordance with embodiments as described
herein;
[0255] FIG. 1N shows a test apparatus to measure deflection of a
portion of a lens in response to a load, in accordance with
embodiments as described herein;
[0256] FIG. 2A shows surgical placement of a covering on an eye
having an epithelial defect with an applicator, in accordance with
embodiments of the present invention:
[0257] FIG. 2A1 shows a surgeon's view of the eye through the
applicator as in FIG. 2A;
[0258] FIG. 2A2 shows a patient's view of a fixation light through
the applicator as in FIG. 2A;
[0259] FIG. 2B shows a covering coupled to an applicator for
placement on a cornea as in FIG. 2A, in accordance with embodiments
of the present invention;
[0260] FIG. 2C shows an applicator coupled to a covering with block
adhesion and peeling of the covering from the applicator with a
movable component, in accordance with embodiments of the present
invention;
[0261] FIG. 2C1 shows an applicator coupled to a covering with foam
to adhere the covering to the applicator when dry and application
of a liquid to release the covering from the applicator when wet,
in accordance with embodiments of the present invention;
[0262] FIG. 2D shows an applicator as in FIG. 2A coupled to a
covering;
[0263] FIG. 2D 1 shows a covering coupled to an applicator with
adhesion, in accordance with embodiments of the present
invention;
[0264] FIG. 2E shows an applicator comprising a rigid component and
a flexible component, in accordance with embodiments of the present
invention;
[0265] FIG. 2E1 shows coupling of a covering to an applicator as in
FIG. 2E, in accordance with embodiments of the present
invention;
[0266] FIG. 2F shows an applicator and a covering as in FIG. 2E
with the applicator in an expanded configuration to position the
covering on the cornea, in accordance with embodiments of the
present invention;
[0267] FIG. 2G shows an applicator and a covering with the covering
held in a channel of the applicator, in accordance with embodiments
of the present invention;
[0268] FIG. 2H shows an applicator and a covering with the
applicator comprising an extension to deliver the covering, in
accordance with embodiments of the present invention;
[0269] FIG. 2I shows an applicator and a covering with the
applicator comprising a slider to release the covering, in
accordance with embodiments of the present invention;
[0270] FIG. 2J shows an applicator and a covering with the
applicator comprising a hinge to release the covering, in
accordance with embodiments of the present invention;
[0271] FIG. 2K1 and 2K2 show side and top views, respectively, of
an applicator and a covering with the applicator comprising a
compressed structure that is released so as to deliver the covering
to the cornea, in accordance with embodiments of the present
invention;
[0272] FIG. 2K3 shows the applicator as in FIGS. 2K1 and 2K2 in a
released configuration to deliver the covering to the cornea, in
accordance with embodiments of the present invention;
[0273] FIG. 3A shows an applicator comprising extensions coupled to
pads to deliver the covering, in accordance with embodiments of the
present invention;
[0274] FIG. 3B shows an applicator comprising roller pads to
deliver the covering, in accordance with embodiments of the present
invention;
[0275] FIG. 3C shows concave roller pads for use with an applicator
as in FIG. 3B, in accordance with embodiments of the present
invention;
[0276] FIG. 3D shows delivery of a covering to the cornea with an
applicator comprising rollers as in FIG. 3B, in accordance with
embodiments of the present invention;
[0277] FIG. 4A shows an applicator comprising a fixation ring
coupled to a covering, in accordance with embodiments of the
present invention;
[0278] FIG. 4B shows a side view of the applicator as in FIG.
4A;
[0279] FIG. 5A shows an apparatus comprising a covering and
applicator stored in a substantially dry, sterile compartment of a
container, in accordance with embodiments of the present
invention;
[0280] FIG. 5B shows an apparatus comprising a covering and
applicator stored in a substantially moist, sterile compartment of
a container, in accordance with embodiments of the present
invention;
[0281] FIGS. 5B1 and 5B2 shows an apparatus 530 comprising covering
100 and an applicator 200 stored in a sterile compartment of a
container, in which the container comprises a support surface 534
with the covering 100 disposed thereon in a channel 532 sized to
receive the applicator 200. The channel 532 can guide the
applicator onto the covering when the covering is advanced in the
channel to couple to the applicator. The covering can be positioned
on the cornea with the applicator.
[0282] FIG. 5B3 shows an applicator with a support coupled to a
handle with a joint disposed between the support and the handle to
move the handle when the support is coupled to the eye, in
accordance with embodiments of the present invention;
[0283] FIG. 5C1 shows an apparatus comprising a removal tool, in
accordance with embodiments of the present invention;
[0284] FIG. 5C2 shows the distal portion comprising the tip of the
removal tool as in FIG. 5C1.
[0285] FIG. 5C3 shows the apparatus of FIG. 5C1 aligned with the
patient;
[0286] FIG. 5C4 shows the long dimension 568L of the cross section
of the opening of tip 568 aligned substantially with a plane of the
pupil and a peripheral temporal portion of the covering when the
handle is positioned near the temple of the patient;
[0287] FIG. 5D shows a cannula of the apparatus as in FIG. 5C1
inserted under the covering;
[0288] FIG. 6 shows a mold to form a covering and comprising a
solid an inner component placed therein prior to injection of a
flowable material, in accordance with embodiments of the present
invention;
[0289] FIG. 6A shows a mold to form a covering and having a solid
inner component comprising a rigid material placed therein prior to
injection of a flowable material, in accordance with embodiments of
the present invention;
[0290] FIG. 7 shows a method of manufacturing a covering with a
mold as in FIG. 6, in accordance with embodiments of the present
invention;
[0291] FIG. 8 shows a method of placing a covering on a cornea of
an eye, in accordance with embodiments of the present
invention;
[0292] FIG. 9 shows a method of removing a covering from a cornea
of an eye, in accordance with embodiments of the present
invention;
[0293] FIG. 10A shows corneal topography and smoothing of
epithelial irregularities with the covering, in accordance with
embodiments of the present invention;
[0294] FIGS. 10B, 10C and 10D show, horizontal, vertical and
central OCT images, respectively, of the covering on the eye of
FIG. 10A without a gap disposed between the covering and the cornea
such that the covering directly contacts the ablated stroma and
regenerating epithelium;
[0295] FIGS. 11A1A to 11A1D show OCT images of portions of the soft
covering from, respectively, the superior portion of the covering,
the nasal portion of the covering, the temporal portion of the
covering and the inferior portion of the covering at 48 hours
post-op on the right eye (OD);
[0296] FIGS. 11A2A to 11A2D show OCT images of portions of the soft
covering from, respectively, the superior portion of the covering,
the nasal portion of the covering, the temporal portion of the
covering and the inferior portion of the covering at 48 hours
post-op on the left eye (OS);
[0297] FIGS. 11A3A to 11A3D show OCT images of portions of the soft
covering from, respectively, the superior portion of the covering,
the nasal portion of the covering, the temporal portion of the
covering and the inferior portion of the covering at 72 hours
post-op on the right eye (OD);
[0298] FIGS. 12A1A to 12A1C show OCT images of portions of the
rigid covering from, respectively, the temporal portion of the
covering, the nasal portion of the covering and the inferior
portion of the covering at 24 hours post-op on the right eye
(OD);
[0299] FIGS. 12A2A to 12A2D show OCT images of portions of the
rigid covering from, respectively, the superior portion of the
covering, the temporal portion of the covering, the nasal portion
of the covering and the inferior portion of the covering at 48
hours post-op for on the left eye (OS); and
[0300] FIGS. 12A3A to 12A3D show OCT images of portions of the
rigid covering from, respectively, the superior portion of the
covering, the temporal portion of the covering, the nasal portion
of the covering and the inferior portion of the covering at 72
hours post-op on the left eye (OS).
DETAILED DESCRIPTION OF THE INVENTION
[0301] Embodiments of the present invention as described herein can
be combined with the therapeutic covering device for pain
management and vision as described in U.S. patent application Ser.
No. 12/384,659, filed Apr. 6, 2009, entitled "Therapeutic Device
for Pain Management and Vision", the full disclosure of which is
incorporated herein by reference and suitable for combination in
accordance with some embodiments of the present invention as
described herein.
[0302] The embodiments described herein can be used to treat eyes
in many ways with a covering. Although specific reference is made
to treating epithelial defects of the eye, the covering described
herein can be used for long term vision correction with extended
wear contact lenses that inhibit swelling of the cornea when the
covering is positioned on the eye for an extended period.
[0303] The coverings as described herein can seal the cornea, so as
to restore deturgescence of the cornea to decrease pain and improve
vision. The covering can be configured in many ways to seal the
cornea, and the covering comprises a substantially oxygen
permeability to promote growth of the epithelium and to guide the
growth of the epithelium such that the epithelium regenerates
smoothly for patient vision. The restoration of the deturgescence
of the cornea can decrease irregularities of the cornea such as
ablated stromal irregularities, for example central islands. The
sealing of the cornea with the environment to promote epithelial
regeneration can result in improved epithelial smoothness and an
improved profile of the ablated stromal surface under the
regenerating epithelium.
[0304] In many embodiments, the covering comprises an at least
partially conformable portion, such that the at least partially
conformable portion can one or more of match or grossly approximate
the corrected corneal curvature to as to provide vision of at least
about 20/30, and such that the at least partially conformable
portion substantially does not conform to the corneal
irregularities caused by epithelial healing and edema, such as
irregularities of the epithelium and central islands that may
appear post-ablation in ablated eye.
[0305] In many embodiments, the at least partially conformable
portion of the covering can be configured so as to conform at least
partially to the epithelium when the covering is positioned on the
epithelium so as to deflect the epithelium.
[0306] The epithelium can conform to the covering so as to seal the
covering, for example with deformation of the epithelium such as
with one or more of indentation or overgrowth of the epithelium
around a perimeter of the covering.
[0307] In many embodiments, the curvature of the covering can match
substantially the profile of the ablated region, so as to provide
visions of at least about 20/30 when positioned on the cornea.
[0308] As used herein, mathematical equations and scientific
notation can be used to values in many ways understood by a person
of ordinary skill in the art, for example so as to express data in
accordance with notations used in many commercially available
spreadsheets such as Excel.TM. commercially available from
Microsoft. As used herein the symbol "E" can be used to express an
exponent in base 10, such that 1E1 equals about 10, 2E1 equals
about 20, and 4E2 equals about 400. As used herein the symbol " "
can be used to express an exponent, such that A B equals A.sup.B.
Units can be expressed in many ways and as would be understood by a
person of ordinary skill in the art, for example "m" as meters,
"Pa" as the Pascal unit for pressure, "MPa" as Mega Pascal.
[0309] FIG. 1 shows an eye 2 suitable for incorporation of the
covering 100 as described herein. The eye has a cornea 10 and a
lens 4 configured to form an image on the retina 5, and the image
can form on a fovea 5F corresponding to high visual acuity. The
cornea can extend to a limbus 6 of the eye, and the limbus can
connect to a sclera S of the eye. The eye 2 has a pars plana PP
located near limbus 6. A conjunctiva C of the eye can be disposed
over the sclera. The lens can accommodate to focus on an object
seen by the patient. The eye has an iris 8 that defines a pupil 9
that may expand and contract in response to light. The eye also
comprises a choroid CH disposed the between the sclera 7 and the
retina 5. The eye has a vitreous humor VH extending between the
lens and the retina. The retina 5 senses light of the image and
converts the light image to neural pulses that are processed and
transmitted along an optic nerve ON to the brain of the
patient.
[0310] FIG. 1-1A shows an ablated eye immediately following
refractive surgery, for example PRK surgery resulting in an
epithelial defect. The eye 2 comprises an iris 8 that defines a
pupil 9, through which light passes such that the patient can see.
Cornea 10 includes an epithelium 12 disposed over a stroma 16. The
epithelium 12 comprises a thickness 12T that can be about 50 um. A
tear liquid covers the anterior surface of epithelium 12. In at
least humans, primates and some birds, a Bowman's membrane 14 is
disposed between epithelium 12 and stroma 16. Bowman's membrane 14
comprises an acellular substantially collagenous tissue with a
thickness of about 5 to 10 microns. Stroma 16 comprises a
substantially collagenous tissue with keratocytes disposed therein.
In some animals, Bowman's membrane may be absent and the epithelium
may be disposed adjacent to the stromal layer. An endothelium 18 is
disposed under stroma 16. Endothelium 18 comprises a layer of cells
that pump water from cornea 10 toward iris 8. Tear liquid also
covers surfaces of the cornea that are exposed by the epithelial
defect, such as an exposed surface of Bowman's membrane and an
exposed stromal surface.
[0311] In a normal healthy eye, epithelium 12 is disposed across
cornea 10 and is a protective layer. Epithelium 12 covers nerves of
the cornea and minimizes the flow of water from the tear film of
the eye to into the stroma. Epithelium 12 in most human patients
can be about 40 to 60 microns thick, for example about 50 microns.
When epithelium 12 is intact, endothelium 18 can pump water from
stroma 16 and maintain hydration in the cornea at a proper level.
The mechanism by which the stroma of the cornea remains properly
hydrated can be referred to as deturgescence. Deturgescence of the
cornea can be important because excess hydration of the cornea can
result in swelling of the cornea and light scattering, or haze,
that can degrade vision. The total thickness of normal cornea 10
from endothelium 18 to tear liquid in most human patients can be
from about 400 to 600 microns. A healthy cornea with normal
hydration comprises about 80 to 85% water. Edema of the cornea due
to swelling of the cornea, for example with additional water, can
increase the thickness of the cornea.
[0312] With refractive surgery, for example PRK, the epithelium can
be removed to ablate a refractive correction into Bowman's membrane
14 and/or stroma 16. An initial profile of the anterior surface of
stroma and/or Bowman's membrane is ablated to an ablated profile 20
to correct the patient's vision. The profile of tissue removed to
correct vision is described in U.S. Pat. No. 5,163,934, entitled
"Photorefractive keratectomy", the disclosure of which may be
suitable for combination in accordance with some embodiments of the
present invention described herein. Ablated profile 20 generally
comprises an optical zone that extends across the cornea to correct
refractive error of the eye and may correct aberrations of the eye,
for example wavefront aberrations. Ablated profile 20 is bounded by
boundary 20B that may circumscribe the ablated profile. The
ablation profile 20 comprises a maximum dimension across, for
example a diameter 20D.
[0313] The epithelium may comprise an inner boundary that moves
centripetally inward as indicated by arrows 30
[0314] FIG. 1-1B shows an ablated eye about 1 to 2 days following
refractive surgery resulting in an epithelial defect. The
epithelium has at least partially covered the ablation. The
epithelium may comprise irregularities and an inner boundary that
moves centripetally inward as indicated by arrows 30. The thickness
profile 12RP of the regenerating epithelium 12R can be irregular
and degrade vision. The inner portion of the epithelium near the
boundary may comprise a height greater than an outer portion of the
epithelium away from the boundary of the epithelium. The portion of
the ablation not covered with the epithelium and the inner portion
of the epithelium near the boundary can result in aberrations, for
example aberrations corresponding to a meniscus of the tear and a
far sighted portion of the cornea. As variation in epithelial
healing among individuals can be observed, the epithelial defect of
at least some individuals can be present at 2 and 3 days post-op,
with corresponding aberrations.
[0315] FIG. 1-1C shows an ablated eye when the epithelium has
regenerated following refractive surgery resulting in an increased
epithelial thickness centrally when the epithelium has regenerated,
for example at about 3 days post-op. The regenerating epithelium
may have an irregularity 12I, for example corresponding to an
increased elevation of an inner portion of the epithelium near the
center of the ablation, for example. Work in relation to
embodiments as described herein suggests that the natural
regeneration of the epithelium can provide an inner portion having
an increased central elevation with optical power that may
correspond to about 1 to 3 Diopters of additional optical power.
The regenerating epithelium comprises a thickness profile 12RP
extending along the surface of Bowman's membrane 14 and the
ablation 20. With PRK the thickness profile 12RP of the epithelium
can regenerate for at least one week, for example one month, such
that vision can be degraded when the thickness profile 12RP of the
epithelium regenerates, and PRK surgery of the cornea can be
combined in accordance with embodiments described herein so as to
improve vision.
[0316] In many embodiments as described herein, irregularities of
the cornea are decreased when the epithelium regenerates so as to
provide one or more of improved vision or comfort. The coverings as
described herein can be configured so as to decrease an effect on
vision of corneal irregularity 12I, decrease the height profile of
irregularity 12I, decrease transfer of irregularity 12I to an
anterior surface of the covering, smooth irregularity 12I with the
covering, regenerate epithelium 12 such that irregularity 12I is
decreased, or combinations thereof. In many embodiments, the
covering 100 as described herein can be placed on the eye such that
a smooth layer 12S of regenerated epithelium 12R substantially
covers the ablated profile so as to provide improved vision sooner
than would occur without covering, for example at about 3 to 4 days
post-op with PRK. In many embodiments, the covering can provide an
environment 100E as described herein so as to guide epithelial
regeneration and smooth the regenerated epithelium.
[0317] In many embodiments, the cornea 10 of an eye 2 has an
epithelial defect 11 following refractive surgery such as PRK, and
a covering 100 positioned over the epithelial defect 11.
[0318] FIG. 1-2A shows a covering 100 positioned on cornea 10 an
eye 2 having an epithelial defect 11, in which the covering abuts
the cornea to seal the cornea. The covering may comprise a curved
body, for example a curved contact lens body shaped to fit the
cornea.
[0319] The covering 100 can be sized to cover the ablated profile
and epithelial defect. The inner portion 110 comprises a dimension
across 102 that can be sized to extend across a majority of the
ablation, and the outer portion 120 comprises a dimension across
104 sized to extend across at least the epithelial defect and
contact the epithelium on opposite sides of the defect.
[0320] The dimension 102 extending across a majority of the
ablation may extend about 6 to 8 mm, for example, and may be sized
larger than the ablation. The dimension 104 may comprise about 12
to 14 mm across, for example so as to extend to the limbus and can
be sized to the limbus of the patient for example. Work in relation
to embodiments suggests that the covering sized to extend to the
limbus and circumferentially around the limbus can be centered on
the cornea. The covering may extend such that the outer rim of the
covering contacts the conjunctiva disposed above the sclera
peripheral to the limbus, for example, and that such configurations
may center the lens on the cornea, for example.
[0321] The thickness of the covering can be sized and shaped in
many ways. The inner portion 110 of the covering comprises a
thickness 106 and the outer portion 120 of the covering comprises a
thickness 108. The thickness 106 of the inner portion may comprise
a substantially uniform thickness such that the inner portion
comprises an optical power of no more than about +/-1D prior to
placement on the eye, for example when held in front of the eye and
separated from the cornea by a distance. Alternatively, the
thickness of the inner portion may vary so as comprise optical
power, for example optical power to correct vision of the
patient.
[0322] FIG. 1-2B shows a smooth layer 12S of regenerated epithelium
12R substantially covering an ablated profile. The environment 100E
is configured to guide epithelial regeneration and smooth the
regenerated epithelium. The regenerating epithelium comprises a
thickness profile 12RP.
[0323] The epithelium grows centripetally from circumscribing
boundary 12E toward the center of ablated profile 20 to cover the
exposed stroma, as indicated by arrows 30.
[0324] The covering 100 may comprise an inner portion 110 and an
outer portion 120. The outer portion 110 can be configured to form
a seal 100S with the cornea near the edge of the ablation and the
epithelial defect, for example with a soft conformable material
such as silicone or silicone hydrogel. The inner portion 120 is
positioned over the pupil and configured for the patient to see,
and may comprise a rigidity greater than the outer portion, so as
to smooth irregularities of the epithelium when the cornea heals.
Alternatively, the inner portion may comprise a rigidity equal to
or less than the rigidity of the outer portion as well. For
example, the inner portion may comprise silicone and the outer
portion may comprise silicone, and the inner portion may comprise
one or more of a more rigid silicone or a greater thickness such
that the inner portion can be more rigid than the outer portion so
as to smooth the epithelium. Although the inner portion can be more
rigid than the outer portion, the inner portion is sufficiently
soft, flexible and conformable so as to conform at least partially
to the ablated profile 20 in the stroma, such that the patient
receives the benefit of the vision correction with the ablation
profile 20 when the patient looks through the inner portion and the
inner portion smoothes the epithelium. Work in relation to
embodiments of the present invention suggests that the regenerating
epithelium is softer than the underlying stroma of ablation profile
20, such that the inner portion can be configured to conform to the
shape of the ablation profile 20 when the inner portion smoothes
the epithelium disposed under the inner portion.
[0325] The covering 100 may comprise one or more of many optically
clear materials, for example synthetic materials or natural
material such collagen based materials, and combinations thereof,
such as described in U.S. patent application Ser. No. 12/384,659,
filed Apr. 6, 2009, entitled "Therapeutic Device for Pain
Management and Vision", U.S. Pub. No. US 2010-0036488 A1, published
on 11 Feb. 2010. For example, the lens material may comprise a
naturally occurring material, such as collagen based material.
Alternatively or in combination, the lens material may comprise a
known synthetic material, for example hydroxyethyl methacrylate
(HEMA) hydrogel, hydrogel, silicone, for example hydrated silicone
and derivatives thereof. For example the optically clear material
may comprise one or more of silicone, silicone hydrogel, silicone
comprising resin, silicone comprising silicate, acrylate, collagen.
The cured silicone may comprise silicone that is two-part heat
cured and RTV (room temperature vulcanized). For example,
polydimethyl siloxane such as NuSil, or poly(dimethyl) (diphenyl)
siloxane may be used to mold the covering, for example with less
than 10% water content so as to increase oxygen diffusion through
the covering. The covering 100 may comprise perfluoropolyethers or
fluorofocal. The lens material can be elastic, for example a
stretchable elastic material such as silicone, such that the lens
can seal the cornea. The lens material can be cured with a hardness
and size and shape such that the covering comprises a modulus
within a range from about 4 to about 20 MPa. The material may
comprise, for example, silicone elastomer having optically clear
silicate disposed therein and a water content of no more than about
10%, for example no more than about 5%, such that the lens covering
has a very high Dk exceeding 150, and the silicone lens comprising
silicate can be treated to provide a wettable surface. The lens may
comprise hydrogel, for example silicone hydrogel, and can be formed
with a water content within a range from about 5% to about 35% and
a modulus within a range from about 4 to about 20 MPa, such that
the covering conforms at least partially to the ablated stroma.
[0326] The covering may comprise silicone or silicone hydrogel
having a low ionoporosity such that covering seals to the cornea.
For example, covering may comprise silicone hydrogel comprising a
low ion permeability, and the range of water can be from about 5%
to about 35%, such that the Dk is 100 or more. The low ion
permeability may comprise an Ionoton Ion Permeability Coefficient
of no more than about 0.25.times.10-3 cm2/sec so as to seal the
cornea, for example no more than about 0.08.times.10-3 cm2/sec. The
low ion permeability comprises an Ionoton Ion Permeability
Coefficient of no more than about 2.6.times.10-6 mm2/min to seal
the cornea, for example no more than about 1.5.times.10-6
mm2/min.
[0327] The covering 100 may comprise a wettable surface coating 130
disposed on at least the upper side of the covering, such that the
tear film of the patient is smooth over the covering and the
patient can see. The wettable surface coating may comprise a
lubricious coating for patient comfort, for example to lubricate
the eye when the patient blinks. The wettable coating may comprise
a contact angle no more than about 80 degrees. For example the
coating may comprise a contact angle no more than about 70 degrees,
and the contact angle can be within a range from about 55 to 65
degrees to provide a surface with a smooth tear layer for vision.
For example, the wettable coating can be disposed both an upper
surface and a lower surface of the covering. Alternatively, the
lower surface may comprise a hydrophobic surface material and the
lower hydrophobic surface may comprise the inner portion 110 and
the outer portion 120. At least the outer portion 120 may comprises
a lower surface composed of a sticky, tacky, material, for example
a hydrophobic material. The inner portion may also comprise the
lower surface comprised of the sticky, tacky, hydrophobic material.
The upper surface may comprise the wettable coating extending over
at least the inner portion 110.
[0328] The wettable coating may comprise one or more of many
materials. For example, the wettable coating may comprise
polyethylene glycol (PEG), and the PEG coating can be disposed on
Parylene.TM.. Alternatively, the wettable coating may comprise a
plasma coating, and the plasma coating comprise a luminous chemical
vapor deposition (LCVD) film. For example, the plasma coating
comprises at least one of a hydrocarbon, for example CH4, O2 or
fluorine containing hydrocarbon, for example CF4 coating.
Alternatively or in combination, the wettable coating may comprise
a polyethylene glycol (PEG) coating or 2-hydroxyethylmethacrylate
(HEMA). For example, the wettable coating may comprise HEMA
disposed on a Parylene.TM. coating, or the wettable coating may
comprise N-vinylpyrrolidone (NVP) disposed on a Parylene.TM.
coating.
[0329] The covering 100 may comprise a lower surface corresponding
to one or more of many suitable shapes to fit the covering to the
cornea. For example, the lower surface of the covering may
correspond to base radius of curvature. With post ablation corneas,
the covering can conform substantially to the cornea. The covering
may comprise a second curve in combination with a first curve, such
that the lower surface comprises a bicurve surface. Alternatively,
the lower surface may correspond to an aspheric surface. For
example an aspheric surface may comprise an oblate shape and conic
constant to fit a post PRK eye. Also, it may be helpful to fit the
covering to the cornea, for example with selection of one covering
from a plurality of sizes.
[0330] FIG. 1A shows the covering 100 having the thickness 108 of
the outer portion sized such that the outer portion can conform to
the epithelium. The thickness of the outer portion can be
substantially constant, or may vary as described herein below.
[0331] FIG. 1A1 shows covering 100 positioned on an eye and
blinking of the eye. An upper lid and a lower lid can blink over
the eye. Work in relation to embodiments suggests that the upper
lid can exert a downward movement 20 and that the lower lid can
exert an upper movement 22 on the eye. The downward movement 20 can
be greater than the upper movement 22. The wettable coating
material as described herein can decrease force and movement
transferred from the lids to the covering so as to inhibit motion
of the covering. The downward movement 20 greater than the upward
movement 22 can effect epithelial growth near the perimeter of
covering 100.
[0332] FIG. 1B1 shows covering 100 as in FIG. 1-2A prior to
placement on the cornea. The covering 100 may comprise a base
radius R1 of curvature, and the base radius of curvature may be
slightly shorter than the ablated cornea such that the covering can
be steeper than the cornea prior to placement on the cornea. The
covering 100 comprises a first configuration 100C1 prior to
placement on the cornea.
[0333] The base radius R1 can be sized to the cornea in many ways.
For example base radius R1 may have a radius corresponding to the
outer unablated portion of the cornea. Alternatively or in
combination, the base radius R1 may have a radius corresponding to
the post ablated eye.
[0334] The covering 100 may comprise a modulus within a range from
about 4 MPa to about 20 MPa, such that central portion can conform
at least partially to the ablated stroma and so that the covering
can smooth corneal irregularities and stromal irregularities of the
ablated cornea. The covering may comprise an elastomeric
stretchable material such that the covering can stretch to fit the
cornea, for example. The covering having the modulus within a range
from about 4 MPa to about 20 MPa can be formed in many ways as
described herein. For example, the covering may comprise a single
piece of material having a substantially uniform thickness
extending across the ablated cornea and at least a portion of the
unablated cornea, and the single piece of material may comprise an
elastic material such as a silicone elastomer or a hydrogel.
Alternatively, the covering may comprise a single piece of material
having a non-uniform thickness extending across the ablated cornea
and at least a portion of the unablated cornea. The covering can be
shaped in many ways and may comprise a single piece of one
material, or may comprise a single piece composed to two similar
materials, or may comprise a plurality of materials joined
together.
[0335] The covering 100 may comprise one or more outer portions
extending outside the inner central, and these outer portions may
seal the cornea when the inner portion conforms at least partially
to the ablated stroma. For example, the covering 100 may comprise
outer portion additional shapes disposed outward from a central
portion as described herein. For example, the covering may comprise
a bicurve having a second radius of curvature disposed peripheral
to the inner radius R1 of curvature to fit the unablated portion of
the cornea. For example, the second and outer radius of curvature
may comprise a shorter radius of curvature when the central portion
is treated for myopia. The covering may comprise a third radius of
curvature longer than the second radius of curvature so as to fit
the sclera under the conjunctiva. The covering may comprise an
oblate shape to fit the ablated and non-ablated portions of the
cornea, and the covering may extend over the sclera with an outer
portion, for example.
[0336] FIG. 1B2 shows the covering as in FIG. 1B1 conforming to
ablated stromal tissue and smoothing the epithelium over the
ablated stroma. The cornea comprises an ablated surface 20 to
correct vision that may have a corresponding radius of curvature,
for example radius R2. The ablated profile 20 may comprise
additional, alternative, or combinational shapes with those
corresponding to radius R2, such as aberrations ablated into the
cornea to correct aberrations of the eye and astigmatism ablated
into the cornea, and the inner portion 110 of covering 100 can
conform to these ablated profiles of the cornea such that the
patient can receive the benefit of the ablative vision correction
when the covering is positioned on the cornea. For example, the
cornea ablation profile 20 may correspond to radius of curvature
R2, and the inner portion 110 can flatten from configuration 100C1
corresponding to radius of curvature R1 prior to placement to a
second configuration 100C2 corresponding substantially to the
ablated profile 20, such the patient can see with the benefit of
ablation profile 20. For example, the second configuration 100C2
can comprise a conforming radius of curvature R12 that corresponds
substantially to radius of curvature R2. The profile corresponding
to the first configuration 100C1 of the covering 100 is shown
positioned over cornea 10 to illustrate the change in profile of
the covering from configuration 100C1 prior to placement to
conforming configuration 100C2 of the covering 100 when positioned
on the cornea.
[0337] The conformable covering 100 comprises sufficient rigidity
so as to smooth the epithelium when covering 100 is positioned on
the cornea over the ablation profile 20. The epithelium comprises a
peripheral thickness 12T that may correspond substantially to a
thickness of the epithelium prior to debridement of the epithelium
to ablate the cornea. The epithelium also comprises regenerating
epithelium 12R disposed over the ablation profile 20. The covering
100 can smooth the epithelium 12R when conforming to the cornea in
the second configuration 12C2. For example, irregularities 12I of
the regenerating epithelium 12R disposed over the ablation can be
smoothed when the epithelium regenerates along the inner portion of
covering 100, such that the irregularities 12I of the regenerating
epithelium 12R are thinner than the thickness 12T of the peripheral
epithelium.
[0338] Work in relation to the embodiments as described herein
indicates that an at least partially conformable covering having a
modulus within a range from about 4 MPa to about 20 MPa can conform
at least partially to the ablated stroma and smooth irregularities
of the epithelium and stroma so as to improve vision as described
herein. The covering having the modulus within the range from about
4 MPa to about 20 MPa can be formed in many ways as described
herein.
[0339] The conformable covering 100 may comprise a perimeter 120P
with a rigidity sufficient to indent the epithelium along at least
a portion of the perimeter so as to seal the cornea with seal 100S.
The portion 12C of the epithelium 12 can extend over the perimeter
of the covering 120P.
[0340] FIG. 1B2A shows a covering as in FIG. 1B2 forming an
indentation 12I in the epithelium such that the epithelium 12
extends over at least a portion of the perimeter 120P of the
covering. The covering forms indentation 12I in the epithelium such
that the epithelium comprises an indentation thickness 12IT that is
less than an outer thickness of the epithelium 12T. The indentation
of the epithelium with the covering can help to seal the cornea
with the perimeter.
[0341] FIG. 1B2B shows a covering as in FIG. 1B2 forming
indentation 12 in the epithelium. The covering forms indentation
12I in the epithelium such that the epithelium comprises an
indentation thickness 12IT that is less than an outer thickness of
the epithelium 12T. The indentation of the epithelium with the
covering can help to seal the cornea with the perimeter.
[0342] Work in relation to embodiments described herein suggests
the indentation of the covering can vary radially around the eye of
the patient, in accordance with orientation of the covering on the
eye when the covering comprises a substantially constant rigidity
of the outer portion, for example a substantially constant rigidity
around the perimeter. The inferior portion of the covering may
comprise a greater amount of epithelial covering over the perimeter
than the superior portion of the covering. For example, FIG. 1B2A
may correspond to a first portion of covering 100 at an inferior
location of the cornea and FIG. 1B2B may correspond to a second
portion of the covering at a superior location of the cornea. Work
in relation to embodiments also suggests that there may be
variability in covering of the perimeter with the epithelium
between the nasal portion of the perimeter, and the temporal
portion of the perimeter, although both the nasal and temporal
locations can comprise covering intermediate and between the more
extensive covering of the inferior portion and the less extensive
covering of the superior portion of the perimeter.
[0343] FIG. 1B2C shows a covering abutting the cornea to seal the
cornea without forming a substantial indentation in the epithelium.
The covering may comprise a chamfer to contact and seal the cornea.
The rigidity of the outer portion can be determined based on the
thickness of the outer portion of the covering, hardness of the
material, and chamfer angle so as to contact the epithelium to seal
the cornea without substantial deformation of the epithelium.
[0344] The covering may comprise a non-uniform rigidity around the
outer portion of the covering comprising the perimeter. For
example, the covering may comprise a superior portion corresponding
to a superior location on the cornea and an inferior portion
corresponding to an inferior location on the cornea. The superior
portion may comprise a rigidity less than the inferior portion. For
example, the superior portion may comprise the rigidity less than
the inferior portion, such that deformation of the epithelium is
inhibited when the perimeter abuts the cornea is sealed.
Alternatively, the superior portion may comprise the rigidity less
than the inferior portion such the deformation of the epithelium
with the covering comprises a substantially constant amount around
the perimeter, for example a deformation of no more than about 10
um, for example 5 um.
[0345] FIG. 1C shows a therapeutic covering as in FIG. 1-2A
comprising a covering molded with a homogeneous material, in which
the outer portion comprises a thickness configured to conform with
the cornea and in which the inner portion 110 comprises thickness
configured to smooth the epithelium and conform to the ablated
profile 20. The outer portion 120 may comprise a thickness of no
more than about 100 microns. For example the outer portion 120 may
comprise a thickness of about 50 microns at the boundary with the
inner portion 110, and linearly taper from 50 microns at the
boundary with the inner portion to about 20 microns at the
periphery of the outer portion 120. The inner portion 110 may
comprise a thickness of no more than about 250 microns, for example
no more than about 200 microns. For example, the inner portion may
comprise a thickness of about 100 microns. For example, the
thickness of each of the inner portion and the outer portion may
comprise no more than about 50 microns so as to provide substantial
oxygen transport and epithelial regeneration. Many materials can be
used as described herein, and the covering may comprise one or more
materials. For example, the covering may comprise a single piece of
material such as silicone having a water content within a range
from about 0.1% to about 10%, for example no more than about 1%,
and a hardness Shore A durometer parameter within a range from
about 5 to about 90, for example within a range from about 40 to
about 85.
[0346] FIG. 1C1 shows a covering 100 having an inner portion 110
comprising an inner thickness and an inner material 110M and an
outer portion 120 comprising an outer thickness and an outer
material 120M, in which the inner thickness is greater than the
outer thickness. The inner material 110M may comprise many
materials and may comprise an optically clear silicone, for example
silicone with resin. The inner material may comprise silicone
positioned in a mold with the outer portion 120 formed around the
inner portion. The inner portion may comprise a hardness similar to
the outer portion. The outer material 120M of the outer portion 120
may comprise a material similar to the inner portion. For example
the outer material 120M may comprise silicone and the inner
material 110M may comprise silicone. This use of similar materials
on the inner and outer portion can improve adhesion of the inner
portion to the outer portion. The outer material 120M may extend
along the inner portion 110, for example along the underside of the
inner portion 110, such that the inner material 110M is held in a
pocket of the outer material 120M. Alternatively, the inner
material 110M may extend substantially across the thickness of the
inner portion 110, such that the outer material 120M comprises a
substantially annular shape with the inner material 110M comprising
a disc shaped portion disposed within the annulus and extending
substantially from the upper surface coating to the lower surface
coating when present.
[0347] FIG. 1C1A shows a covering as in FIG. 1C1 adhered to the
cornea with a smooth upper surface, and a lower surface conforming
to irregularity of the cornea, for example an irregularity
comprising a central island CI of the ablated stroma. The central
island CI may comprise an outward protrusion in the ablated profile
of the stroma at least about 1 micron outward and about 2.5 mm
across, for example. The upper surface may comprise a substantially
rigid material for vision correction, and the lower surface may
comprise a soft material so as to deflect to irregularities of the
cornea when the upper surface provides optical correction. For
example the lower surface may comprise an indentation 110I when
positioned on the irregularity of the cornea. Although the lower
surface comprising the soft material can deflect to correspond to
the ablation profile 20, the upper surface comprising the rigid
material may comprise a predetermined curvature selected by a
health care provider so as to fit the ablation profile and
correspond to the refractive correction of the patient so as to
provide vision correction.
[0348] FIG. 1C2 shows a covering as in FIGS. 1-2A to 1B2 having
inner portion 110 comprising an inner thickness and inner material
110M and outer portion 120 comprising an outer thickness and outer
material 120M, in which the inner thickness can be greater than the
outer thickness and the outer material 120M extends around the
inner material 110M. The covering 100 may comprise at least a
bicurve covering having at least a second radius RIB. The inner
portion 110M may comprise three layers of material, a first layer
110L1 of a first material 110M1, a second layer 110L2 of a second
material 110M2 and a third layer 110L3 of a third material 110M3.
The second material 110M2 may comprise a rigid material, for
example one or more of a rigid gas permeable material, a rigid
silicone, or a rigid silicon acrylate. The first material 110M1 and
the third material 110M3 may comprise a soft material, for example
a soft elastomer or soft hydrogel such as one or more of a soft
optically clear silicone or a soft silicone hydrogel. The first
material, the third material, and the outer material 120M may
comprise similar materials, such that the second layer of rigid
material 110M2 is encapsulated with the first soft material 110M1,
the third soft material 110M3 and on the perimeter with the soft
outer material 120M. In many embodiments, the second rigid material
110M2 comprises a material similar to each of the first material
110M1, the third material 110M3 and the outer material 120M, for
example each may comprise silicone, such that the corresponding
portions of the covering 100 can be bonded together with the
silicone similar silicone elastomer material, for example. In many
embodiments, the covering 100 can be formed in a mold with rigid
second material 110M2 placed in the mold and encapsulated within a
single piece of material comprising first material 110M1, third
material 110M3 and outer material 120M, such that first material
110M1, third material 110M3 and outer material 120M comprise
substantially the same material, for example silicone elastomer.
The rigid second material 110M2 may comprise silicone bonded to
each of first material 110M1, third material 110M3 and the outer
material 120M, for example with curing such that first material
110M1, third material 110M3 and outer material 120M comprise the
same soft silicone material bonded to the second material 110M2
comprising rigid silicone.
[0349] The soft material comprising soft outer portion 120 composed
of soft material 120M, first layer 110L1 composed of soft material
110M1 and third layer 110L3 composed of soft material 120M3 can
provide improved comfort and healing for the patient. The soft
material can deflect, bend or indent so as to conform at least
partially to the tissue of the eye when the rigid portion
comprising rigid material 110M2 corrects vision of the patient. The
dimension 102 across inner portion 110 can be sized to
substantially cover the ablation zone and slightly smaller than the
ablation dimensions, such as ablation diameter 20D, so that the
epithelium can grow inward and contact the layer 110L1 of soft
first material 110M1 without substantial disruption from the rigid
material 120M2 when the inner portion 110M corrects vision with the
layer of rigid material 110M2. The eyelid can also move over the
third layer 110M3 for improved comfort. The soft first material
110M1 and soft third material 110M3 may comprise soft elastomer or
soft hydrogel, for example, and may each comprise the same material
so as to encapsulate the second layer 110L2 of rigid second
material 110M2.
[0350] The soft material comprising soft outer portion 120 composed
of soft material 120M, first layer 110L1 composed of soft material
110M1 and third layer 110L3 composed of soft material 120M3 can
have a modulus within a range from about 1 to 20 MPa, for example
within a range from about 1 to 5 MPa.
[0351] The material inner material 120M and 120M2 of second layer
120L2 can have a modulus within a range from about 5 to about 35 or
more, for example as set forth in Table A below. For example, when
material 120M comprises silicone elastomer or layer 110L2 of
material 120M2 comprises silicone elastomer, the modulus can be
within a range from about 5 to about 35 MPa, for example within a
range from about 20 to about 35 MPa.
[0352] The layers of covering 100 can comprise dimensions so as to
provide therapeutic benefit when placed on eye 2. The thickness of
layer 110L1 can be from about 5 um to about 50 um, for example,
within a range from about 10-30 um, such that the layer 110L1 can
provide a soft at least partially conformable material to receive
the lens. The middle layer 110L2 can be from about 20 um to about
150 um, for example, and material M2 can have a modulus greater
than first material 110M1 of first layer 110L1, so as to deflect
the epithelium of the eye when the middle layer is deflected. The
third layer 110L3 can be within a range from about 5 um to 50 um,
for example within a range from about 10 um to about 30 um, and can
cover second layer 110L2 so as to retain the second layer in the
inner portion 110 of the covering 100.
[0353] FIG. 1C2A shows a covering as in FIG. 1C1 placed on the
cornea with a smooth upper surface and a lower surface conforming
to irregularity of the cornea near the edge of the ablation. As the
epithelium can be about 50 um thick, in many embodiments the
dimension 102 is sized so as to cover substantially the ablated
cornea for vision correction and smaller than the ablation zone,
such that the outer portion 120 can conform at least partially to
the epithelium. The outer portion 120 may extend to the sclera, and
comprise a tri-curve covering 100 as described herein, with the
inner portion 110 having first layer 110L1 of first material 110M1,
second layer 110L2 of second material 110M2, and third layer 110L3
of third material 110M3.
[0354] FIG. 1D shows a therapeutic covering 100 comprising a first
inner material 110M and a second outer material 120M, in which the
outer portion 120 comprises a hardness configured to conform with
epithelium of the cornea and in which the inner portion 110
comprises second hardness configured to smooth the epithelium and
conform to the ablated profile 20. The outer material 120M may
comprise many materials as herein. The Shore A hardness of each of
the inner portion and the outer portion can be within a range from
about 5 to about 90. For example, the outer material 120M may
comprise silicone having a hardness Shore A durometer parameter
from about 20 to about 50, for example from about 20 to about 40,
and the inner material 110M may comprise silicone having a hardness
durometer parameter from about 40 to about 90, for example from
about 50 to about 90. The outer portion comprises a perimeter 120P,
and the perimeter may comprise a peripheral and circumferential
edge structure to abut the epithelium to form the seal with the
epithelium, for example when the base radius of the covering is
less than the cornea. The peripheral and circumferential edge
structure can be shaped in many ways to define an edge extending
around the perimeter to abut the epithelium, for example with one
or more of a taper of the edge portion extending to the perimeter,
a bevel of the edge portion extending to the perimeter or a chamfer
of the edge portion extending to the perimeter. The inner portion
110 may comprise inner thickness and inner material 110M and the
outer portion 120 may comprise an outer thickness and outer
material 120M, in which the inner thickness is substantially
similar to the outer thickness.
[0355] The peripheral edge structure to abut the epithelium can be
used with many configurations of the inner portion as described
herein. For example, the inner portion may comprise an RGP lens
material having a lower rigid surface to contact and smooth the
cornea and an upper rigid optical surface. Alternatively, the inner
portion may conform to the cornea as described herein. The outer
portion may comprise a skirt, and the skirt may comprise the
peripheral edge structure to abut and seal the cornea, such as the
chamfer. The rigidity of the outer portion comprising the edge
structure can be determined to seal the cornea with one or more of
hardness and thickness, as described herein.
[0356] FIGS. 1E and 1F show top and side views, respectively, of
covering 100 comprising inner portion 110, outer portion 120, and a
peripheral rim portion 140 disposed around outer portion 120. The
peripheral portion 140 can be more rigid than outer portion 120.
Work in relation to embodiments suggests that in some instances the
lower sticky tacky surface of outer portion 120 can stick to itself
during deployment onto the eye, and the peripheral portion 140 can
improve handling when the covering is placed on the eye. The
covering may comprise a single piece of material or may comprise
multiple pieces adhered together, for example molded together. For
example, the covering may comprise an inner thickness of inner
portion 110 and an outer thickness of outer portion 120, in which
the inner thickness is greater than the outer thickness. The
peripheral portion 140 may comprise a thickness, and the thickness
of the peripheral portion 140 can be greater than the thickness of
outer portion 120 such that the peripheral portion 140 is more
rigid than the outer portion 120. The thickness of the inner
portion 110 and the thickness of the peripheral portion 140 can be
substantially similar, and these portions may comprise
substantially the same thickness and rigidity.
[0357] FIG. 1G shows covering 100 comprising inner portion 110 and
outer portion 120, such that outer portion 120 comprises a taper
120T of thickness 108 extending between the perimeter of the inner
portion 110 and the perimeter of the outer portion 120. The taper
may comprise a substantially linear change in thickness 108
extending between the perimeter of the inner portion and the
perimeter of the outer portion.
[0358] FIG. 1G1 shows a covering 100 comprising inner portion 110
and an outer portion 120 comprising the taper as in FIG. 1G, and an
outer rim or flange 120F of substantially uniform thickness
peripheral to the taper 120T. The outer taper may extend from the
dimension across 102 of the inner portion 110 to the dimension
across 154A that is less than the dimension across 104 of the outer
portion. The rim of substantially uniform thickness may comprise an
annular shape having a thickness within a range from about 10 um
thick to about 40 um thick, and may comprise a width 154B within a
range from about 0.05 to about 0.8 mm, for example about 0.5 mm.
The rim, for example flange 120F, may comprise a thickness of no
more than about 50 um, such that the flange comprises a thickness
no more than the epithelium.
[0359] The covering 100 can be dimensioned in many ways. The total
diameter across can be from about 6 mm to about 12 mm, for example
about 10 mm. The inner portion may comprise a diameter within a
range from about 4 mm to 8 mm, for example about 6 mm. The annular
rim comprising flange 120F can extend around the perimeter of the
covering with a thickness of about within a range from about 5 um
to about 50 um, for example about 35 um. The annular rim comprising
flange 120F may comprise an inner diameter of within a range from
about 5 mm to about 11 mm, for example about 9 mm and an outer
diameter within a range from about 6 mm to about 12 mm, for example
about 10 mm and corresponding to the perimeter of the covering. The
annular rim may comprise a width of within a range from about 0.1
mm to about 1 mm, for example 0.5 mm, extending circumferentially
around the covering. The outer portion 120 may comprise the rim
with flange 120F and a taper 120T that extended from inner portion
110 to the rim comprising perimeter 120P. The taper in thickness
can be substantially uniform between the outer diameter of the
inner portion and the inner diameter of the rim, and the boundaries
of the taper can be rounded and smoothed near the inner portion and
the rim. The central portion may comprise a substantially uniform
thickness within a range from about 50 um to about 150 um, for
example 50 um. The base radius of curvature of the lower surface of
the covering can be within a range from about was about 7 mm to
about 8 mm. The lower surface may comprise an aspheric surface or a
bicurve surface and combinations thereof. The upper surface of the
covering can comprise a radius of curvature along the inner portion
within about 0.1 mm curvature of the lower surface, such that the
covering is substantially uniform with no substantial refractive
power, for example refractive power within about +/-1D.
[0360] FIGS. 1G1A to 1G1H show a covering as in FIG. 1G1 and
dimensions suitable for use in accordance with embodiments as
described herein such as with experiments, clinical studies and
patient treatment. FIG. 1G1A shows an isometric view of covering
100 having the inner portion 110, the outer portion 120, the taper
120T and rim comprising flange 120F. FIG. 1G1B shows a bottom view
of covering 100. FIG. 1G1C shows a side view of the covering 100.
FIG. 1G1D shows a top view of the covering 100. FIG. 1G1E shows a
side cross sectional view of covering 100 along section D. FIG.
1G1F shows detail C of cross-section D-D, including the radius of
curvature R1 of the lower surface of the inner portion 110, and the
upper radius of curvature Rupper of the inner portion 110. The
upper radius of curvature Rupper may correspond substantially to
the lower radius of curvature R1 prior to placement on the eye, for
example to within about +/-1 D of optical power, such that the
inner portion 110 prior to placement may comprise no substantial
optical power. Detail C shows a side cross sectional view of
covering 100 of the inner portion. FIG. 1G1G shows detail B of
cross-section D-D. Detail B shows a side cross sectional view of
the rim comprising flange 120F. The flange 102F has a thickness
109. Flange 120F may comprise a taper extending along a width
102FW, for example from a first thickness 109A of about 35 um to
second thickness 109B of about 25 um extending along width 120FW
near the chamfer. Flange 120F comprises a chamfered edge 120FE to
contact the cornea or conjunctiva along perimeter 120P of the
covering.
[0361] FIG. 1H1 shows spatial frequency and elevation smoothing of
an epithelial irregularity 12I transferred to a front surface 110U
of covering 100 as in FIG. 1-2A. The regenerating epithelium 12R
comprises an irregularity 12I. The covering 100 conforms
substantially to the shape ablated in the stroma when positioned on
the eye as noted above. The covering 100 comprises a rigidity so as
to conform substantially to the ablation profile 20 over about at
least about 3 to 4 mm of the ablated stroma such that the patient
can see and receive optical correction with the ablated surface.
The regenerating epithelium comprises a thickness profile 12RP that
includes irregularity 12I. The conformable covering comprises a
thickness profile of thickness 106 that encompasses a deformation
thickness over the irregularity 106D. The thickness of the covering
can vary over the epithelium to smooth the irregularity transmitted
to the front surface of the covering so as to improve patient
vision consistent with the ablation profile 20 when the covering
conforms to the ablation profile 20. For example thickness 106D
over the irregularity can be less than thickness 106 away from the
irregularity. The irregularity may comprise an indentation and the
covering may be thinner over the indentation. The silicone
elastomer and hydrogel materials as described can be at least
somewhat compressible so as to conform at least partially to the
cornea and form an indentation so as to receive a portion of the
cornea comprising one or more of epithelium or ablated stroma and
decrease aberrations.
[0362] Experimental studies of OCT images and Pentacam.TM. images
and topography images, noted below, indicate that the thickness of
the inner portion of the covering 100 can vary so as to decrease
optical aberrations along the upper surface when the covering is
adhered to the cornea. This variation in thickness can be related
to one or more of stretching of the covering over the irregularity
or compression of the covering over the irregularity.
[0363] The irregularities of the epithelium generally comprise
spatial frequencies that are greater than the spatial frequencies
of the vision correcting portion of the ablation. The covering can
provide spatial filtering of the frequencies of the underlying
surface so as to inhibit relatively higher spatial frequencies of
epithelial irregularities and pass relatively lower spatial
frequencies corresponding to vision correction, such as lower
spatial frequencies corresponding to sphere and cylinder. The
spatial frequencies ablation profile 20 that are useful to
correction vision can be lower than the spatial frequencies of the
irregularities, and the spatial dimensions of the vision correction
greater than the dimensions of the irregularities. For example, the
spatial frequencies of the vision correction can correspond to
periods of oscillation less than the periods of oscillation of the
irregularities.
[0364] FIG. 1H2 shows spatial frequency and elevation smoothing of
the epithelial irregularity with a plot of relative height relative
for the upper surface of the covering and the upper surface of the
irregularity. The irregularity of the regenerating epithelium 12R
may comprise a profile height 12RPH and profile width 12RPW. The
upper surface of the covering may comprise a profile 110UP. The
irregularity of the upper surface corresponding comprises a width
110UPW and a height 110UPH. Height 110UPH is less than height 12RPH
so as to correspond to smoothing of the irregularity. Width 110UPW
is greater than width 12RPW so as to correspond to smoothing of the
irregularity. Profile 110UP of the upper surface of the covering
corresponds to lower frequencies than profile 12RP, such that the
covering comprise a low pass spatial frequency filter. This can be
seen with the Pentacam.TM. and topography data shown below in
conjunction with OCT images showing that the covering and cornea
conform without a substantially gap disposed therebetween.
Alternatively or in combination, the covering can smooth the cornea
when a gap is present, for example when a portion of the cornea is
smoothed with contact to the covering and the gap provides an
environment for the epithelium to grow smoothly over the
ablation.
[0365] Based on the teachings described herein, a person of
ordinary skill in the art can conduct studies to determine
empirically the rigidity of the inner portion so as to pass
substantially vision correction spatial frequencies of the ablation
to the upper surface of the covering and inhibit spatial
frequencies of the irregularities of the ablated stroma and
epithelium, for example with Pentacam.TM. and topography studies as
described in the experimental section.
[0366] Work in relation to the embodiments as described herein
indicates that a covering comprising a modulus within a range from
about 4 MPa to about 20 MPa can provide smoothing with low pass
spatial frequency filtering as described with reference to FIGS.
1H1 and 1H2. The covering may comprise an elastically stretchable
material, for example an elastomer or a hydrogel, such that the
lens can conform at least partially to the ablated stroma and exert
at least some pressure on the ablated stroma and epithelium when at
least partially conformed so as to smooth irregularities of the
epithelium and irregularities of the stroma. The covering can
comprise a thickness and a hardness so as to provide the spatial
frequency filtering to improve vision in post-PRK patients with the
modulus within the range from about 4 MPa to about 20 MPa. For
example the lens thickness can be increased to increase the
modulus, decreased to decrease the modulus. The hardness of the
material can be increased to increase the modulus and decreased to
decrease the modulus. The modulus within the range from about 4 MPa
to about 20 MPa can attenuate substantially higher spatial
frequencies corresponding to irregularities of the epithelium and
stroma so as to smooth the high spatial frequencies corresponding
to the irregularities that can degrade vision, and can conform
substantially to lower spatial frequencies that correspond to the
vision correction so as to pass the lower spatial frequencies
corresponding to vision correction so that the patient can
experience an improvement in vision when the epithelium regenerates
under the covering. For example, the high spatial frequencies may
correspond to frequencies greater than about 1/6 (0.17) cycles per
mm, and the low spatial frequencies may correspond to frequencies
less than about 1/6 (0.17) cycles per mm. A person of ordinary
skill in the art can determine the modulus and corresponding
spatial frequencies to attenuate and pass, in accordance with the
teachings as described herein. For example, the modulus of the
covering can be measured with known methods and apparatus to
measure the modulus of a contact lens, and measurements with
Pentacam.TM. images as described herein can be used to determine
the relationship of the modulus of the measured lens coverings to
smooth of irregularities, conformation of the lens coverings to the
ablation, and vision.
[0367] FIG. 1I1 shows an inhibition of transfer of a corneal
irregularity to a front surface of a covering, for example one or
more of a stromal irregularity or an epithelial irregularity. The
front surface of the covering comprises an optical surface for
vision without substantially transfer of the irregularity to the
front surface of the covering.
[0368] FIG. 1I2 shows elevation smoothing of the epithelial
irregularity with a plot of height relative to a reference sphere
for the upper surface of the covering and the upper surface of the
irregularity. The plot shows a substantially spherical front
surface of the covering, such that the transfer of the irregularity
to the front surface is inhibited.
[0369] FIG. 1I3 shows a thickness profile of the covering as in
FIG. 1I2 so as to smooth irregularities transferred to the front
surface of the covering. The thickness profile can vary in response
to the underlying surface, for example with a decrease in thickness
corresponding to an elevation in the surface profile of the
cornea.
[0370] FIG. 1J1 shows covering 100 having a bicurve profile to fit
an ablated cornea. The bicurve profile may comprise an inner
portion having a lower surface comprising a radius of curvature R1
and an outer portion having an radius of curvature RIB. The inner
portion may comprise a radius selected to fit approximately the
post-ablated cornea, for example to within about +/-2D. The outer
portion may comprise the radius of curvature R1B sized to
correspond to the outer unablated cornea, for example to within
about +/-2D. The covering may comprise an elastic material with a
modulus within a range from about 4 MPa to about 20 MPa, such that
the covering can conform at least partially to the cornea and
smooth irregularities of the cornea as described herein. R1 can be
longer than RIB, for example with PRK ablation to treat myopia. R1
can be shorter than R2, for example with PRK ablation to threat
hyperopia.
[0371] FIG. 1J2 shows covering 100 having an oblate profile to fit
an ablated cornea, for example a cornea ablated for myopia. The
covering may comprise an apical radius of curvature corresponding
to R1 near a center of the covering, and a peripheral radius of
curvature, based on the conic constant of the oblate profile of the
lower surface of covering 100. Alternatively, the lower covering
100 may comprise a prolate ellipsoid shape to fit a PRK ablation to
treat hyperopia.
[0372] FIG. 1J3 shows covering 100 having a tricurve profile to fit
sclera and an ablated cornea. The tricurve covering may comprise an
inner portion with an inner lower surface having radius of
curvature R1 and an outer portion comprising an outer lower surface
having radius of curvature RIB, as described above. The covering
may comprise a third portion 132 disposed outside the outer portion
and having a third radius of curvature R1C sized to fit the sclera
and contact the conjunctiva disposed over the sclera. Work in
relation to embodiments suggests that coupling to the sclera may
improve alignment of the lens on the cornea.
[0373] The covering 100 having the tricurve profile may comprise
dimensions sized to fit the cornea and sclera of the eye 2. The
covering 100 having the tricurve profile may comprise an inner
portion 110 and an outer portion 120 as described herein. The outer
portion 120 may comprise the third scleral portion 132S having
curvature R1C shaped to fit the sclera of the eye, for example
shaped so as to contact the conjunctiva of the eye such that the
conjunctiva is located between the sclera and the scleral portion
132S. The inner portion 110 may comprise a dimension 102 and the
outer portion 120 may comprise a dimension 104 as described herein.
The covering 100 may comprise a sag height 105 extending between an
upper location of the inner portion 110 and the outer boundary of
outer portion 120 shaped to fit the cornea. The third portion 132
may comprise a dimension across 103.
[0374] The dimension 102, the dimension 104 and the dimension 103
can be sized to the eye based on measurements of the eye. The
dimension 103 may correspond to an annular region of the sclera
extending from the limbus to the outer boundary of the third
portion across a distance within a range from about 1 to 4 mm, for
example within a range from about 1.5 to 2 mm. The size of the
limbus of the eye can be measured so as to correspond to dimension
104, for example, and can be within a range from about 11 to 13 mm.
The ablation zone can corresponds to dimension 102, and dimension
102 corresponding to the rigid inner portion can be sized about 0.5
to about 2 min less than the dimension across the ablation zone,
such that the soft outer portion 120 contacts the eye near the edge
of the ablation and the epithelial debridement.
[0375] The radius of curvature R1C of portion 132 can be determined
so as to fit the eye, and can be within a range from about 12
mm+/-3 mm. The outer portion can be fit to within about +/-0.5 mm,
for example to within about +/-0.25 mm.
[0376] The dimensions of the covering 100 can be determined in many
ways, for example with topography measurements of the cornea and
sclera. The corneal and scleral topography can be measured with
many instruments, such as with the Orbscan.TM. topography system
commercially available from Bausch and Lomb, and the Pentacam.TM.
Scheimpflug camera system commercially available from Oculus. The
ablation profile can be combined with the topography to determine
the shape of the eye.
[0377] The dimensions of covering 100 can be sized to one or more
of the cornea and sclera based on tolerances that may be determined
clinically.
[0378] The outer portion 120 and the third portion 132 may comprise
openings such as fenestrations as described herein, for example
when the material comprises silicone.
[0379] The outer portion 120 and third portion 132 may comprise a
hydrogel material, for example a silicone hydrogel material, and
the inner portion 110 may comprise the rigid material 110M, for
example second layer 110L2 and second material 110M2 between first
layer 110L1 of first material 110M1 and third layer 110L3 of third
material 110M3 as described herein.
[0380] As the tricurve covering may couple to the sclera so as to
provide environment 100E to promote epithelial regeneration without
substantially sealing the cornea, the outer portion 120 of the
covering and the third portion 132 of the covering may comprise
substantially water permeable material, for example when the inner
portion 120 comprises the rigid material as described herein.
[0381] FIG. 1J4 shows covering 100 having a curved profile to fit
sclera and an oblate profile to fit ablated cornea. The covering
comprises the inner portion having the lower surface with the
oblate profile having radius of curvature R1 comprising an apical
radius of curvature and radius of curvature RO, and an outer
portion comprising a lower surface having radius R1C to couple to
the sclera as described herein. The apical radius of curvature may
comprise a first radius of curvature and the radius of curvature RO
may comprise a second radius of curvature corresponding to a conic
constant of the oblate profile.
[0382] The portions of the coverings as described herein, for
example the inner portion and the outer portion, may comprise a
junction wherein a first portion connects with a second portion,
and the junction may have the modulus as described herein. The
covering may comprise a contact lens having a central lens portion
having a center stiffness of at least about 2 psi*mm2 coupled to an
outer lenticular junction portion having a lenticular junction
stiffness of at least about 5 psi*mm2.
[0383] FIG. 1J5 shows a covering 100 having the tricurve profile to
fit sclera and the ablated cornea similar to FIG. 1J3. The modulus
and thickness of the sclera contacting portion can be configured in
many ways to fit may eyes with comfort and so as to resist movement
of the inner portion 120. The modulus of sclera coupling portion
132 may be no more than about 5 MPa and the thickness no more than
about 200 um so as to stretch substantially for comfort and resist
movement of the inner portion when the placed on the sclera.
[0384] The dimension 103 of sclera contacting portion 132 may
correspond to an annular region of the sclera extending from the
limbus to the outer boundary of the third portion across a distance
within a range from about 1 to 4 mm, such that the dimension 103
can be from about 12 mm to about 16 mm, for example from about 14
mm to about 16 mm.
[0385] The radius of curvature R1C, thickness and modulus of the
portion 132 can be configured so as to fit the eye to resist
movement of inner portion 120 and with comfort. The radius of
curvature R1C can be sized less than the radius of curvature of the
sclera and conjunctiva. For example, the radius of curvature R1C
can be no more than about 10 mm, for example no more than about 9
mm when the curvature of the scleral portion of the eye is at least
about 12 mm for example. The third relative rigidity may comprise
no more than about 4E-5 Pa*m 3 so as to stretch substantially for
comfort and resist movement of the inner portion when the outer
portion is placed on the sclera.
[0386] The thickness of the third portion having radius of
curvature R1C can vary, for example from a thickness of about 200
um to a tapered edge. The outer portion
[0387] FIG. 1J6 shows a tapered edge of the covering having a
tricurve profile to fit sclera and an ablated cornea as in FIG.
1J5. The third portion 132 may comprise a flange 120F having a
narrowing taper extending a distance 120FW to a chamfer 120FE. The
chamfer 120FE can be defined along an outer rim where a first
convexly curved lower surface joins a second convexly curved upper
surface. The convex surfaces along the outer rim allow the covering
to slide along the conjunctiva and the narrowing taper permits the
third portion of the covering to stretch substantially and couple
to the sclera and conjunctiva with decreased resistance for
comfort.
[0388] The dimensions of the covering 100 can be determined in many
ways, for example with topography measurements of the cornea and
sclera. The corneal and scleral topography can be measured with
many instruments, such as with the Orbscan.TM. topography system
commercially available from Bausch and Lomb, and the Pentacam.TM.
Scheimpflug camera system commercially available from Oculus. The
ablation profile can be combined with the topography to determine
the shape of the eye.
[0389] FIG. 1K shows covering 100 having inner portion 110 and
outer portion 120, and fenestrations 100F extending through the
thickness of the covering on the outer portion so as to pass a
medicament when the cornea is sealed. The medicament may comprise
an anesthetic, an analgesic, or other medication, for example. The
covering sealed to the cornea can inhibit the egress of the
medicament toward the epithelial defect so that reepithelialization
is not delayed. For example, an anesthetic such as proparacaine,
lidocaine can be used to inhibit pain when the epithelium
regenerates.
[0390] FIG. 1L shows fitting of a covering 100 to a cornea. The
covering may comprise a base curvature, for example first radius of
curvature R1 of inner portion 110 that may correspond to a radius
of curvature when the covering comprises first configuration C1
prior to placement on the cornea. The covering may comprise a
second radius of curvature R1B. The ablated cornea may comprise a
second radius of curvature R2. The outer unablated portion of the
curvature may comprise a corneal radius of curvature RC. The second
radius of R2 of the outer portion 120 can be sized to fit the outer
unablated portion of the cornea having radius of curvature RC, for
example to within about +/-1D corresponding to within about +/-0.2
mm for RC of about 8 mm.
[0391] The first radius of curvature R1 can be greater than the
ablated radius curvature R2 such that the curvature of the inner
portion of the covering is less than the curvature of the cornea.
As the curvature is inversely related to the radius of curvature,
the inner portion 110 has a curvature less than the curvature of
the ablation profile 20 of the cornea when the base radius of
curvature R1 of the inner portion is greater than the radius of
curvature R2 of the ablated cornea. The covering having
substantially uniform thickness as described herein with the
curvature less than the ablated cornea can correct visual
aberrations that may be related to epithelial irregularity 12I, for
example so as to correct temporary myopia related to irregularity
12I.
[0392] Work in relation to embodiments indicates that environment
100E to promote epithelial regeneration can be enhanced when the
curvature of the inner portion 110 is less than the curvature of
the ablated cornea corresponding to radius R2. The base radius of
curvature R1 sized greater than the radius of curvature R2 of the
ablated profile 20 can define environment 100E with a concave
meniscus profile such that pressure near the boundary of inner
portion 110 is decreased to encourage epithelial migration inward
as indicated by arrows 30 and pressure near a center of inner
portion 110 is increased so as to inhibit formation of irregularity
12I and provide smooth regeneration of the epithelium. For example,
the inner portion of the covering can have a curvature
corresponding to about 1 to about 2.5 D less optical power than the
ablated profile 20. This amount of lesser curvature of the covering
can correct temporary myopia related to epithelial irregularity 12I
and may also smooth the irregularity based on the deflection
pressure as described herein, for example.
[0393] While the outer portion 120 can be fit in many ways, the
outer portion 120 may comprise radius of curvature R1B
corresponding to about 0 to 2D less optical power than the
corresponding optical power of the unablated cornea having
curvature RC. For example, the unablated portion of the cornea may
have an optical power of about 43D, and the outer portion 120 may
have a curvature R1B corresponding to about 41 to 43D, such that
the covering is fit on the cornea with a fit ranging from matched
to loose. Such fitting can be used with tri-curved coverings as
described herein.
[0394] The tri-curve and oblate covering profiles as described
herein can be sized similarly to the bicurve surface so as to
provide inner portion 110 with a decreased curvature and increased
radius of curvature relative to ablation profile 20 so as to
promote epithelial regeneration. For example inner portion 110 may
comprise an increased apical radius of curvature relative to the
radius of curvature of the ablation profile 20 of the cornea.
[0395] The amount of decreased curvature of inner portion 110 can
be characterized in many ways, for example with Diopters of the
cornea and Diopters of the front or back surface of the inner
portion of the covering. In many embodiments the covering may
comprise an inner portion having radius of curvature R1 that can be
about 2 D less than the optical power of the ablated cornea. For
example, when the cornea is ablated from about 43D to about 40D,
the base radius of curvature R1 of covering 100 correspond about
38D, two Diopters flatter than the ablated cornea so as to provide
environment 100E.
[0396] The deflectable coverings having the amount of relative
rigidity within the ranges as described herein can be fit to the
ablated cornea in many ways. As the covering deflects, the patient
can be fit with a covering that can be flatter or steeper than the
ablation prior to placement on the eye, and when the covering is
placed on the eye the covering can deflect substantially in
response to the shape of the ablation so that the patient can see
and receive the visual benefit of the ablation profile.
[0397] In many preferred embodiments, the amount of the difference
in curvature between the front surface of the ablation profile and
the covering prior to placement on the eye can be within a range
from about 0 D to about 3 D so as to promote vision and epithelial
regeneration. For example, the covering prior to placement with
configuration Cl can be flatter than the cornea by an amount within
a range from about 1 D to about 3 D, and when placed on the eye the
covering deflects so as to conform at least partially to the
ablated cornea. The epithelium may comprise a thickness of about 50
um. The covering prior to placement with configuration Cl having a
curvature flatter than the cornea can decrease pressure to the
epithelium near the edge of the covering as the covering with the
flatter curvature may be deflected less when the inner portion
conforms to the ablation. The covering prior to placement with
configuration Cl having a curvature flatter than the cornea can
increase pressure to the epithelium along the inner portion of the
ablation as the covering may be deflected less when the inner
portion conforms to the ablation.
[0398] In many embodiments the inner portion 110 has a
substantially uniform thickness and no substantial optical power
such that the optical power of the covering corresponding to the
index of refraction of the covering, the upper surface of the
covering, and the lower surface of the covering, comprises no more
than about +/-1.5D, for example no more than +/-1D. When the
covering having the substantially uniform thickness is placed on
the eye and deflected so as to conform at least partially to the
ablation and smooth the inner 2-3 mm of the cornea, the covering
corresponds substantially to the ablation profile such that the
patient can see.
[0399] FIG. 1M shows deflection of a portion of a covering in
response to an epithelial irregularity so as to smooth the
irregularity. The regenerating epithelium comprises a smoothed
regeneration profile 12RPS and a smoothed irregularity 12S. For
reference, the regeneration profile 12RP without the covering and
irregularity 12I without the covering are shown. The covering can
smooth the epithelium with pressure corresponding to deflection of
the covering as described when the covering 100 comprises a second
configuration 100C2 as herein.
[0400] FIG. 1N shows a test apparatus 190 to measure deflection of
a portion of a lens in response to a load. The test apparatus 190
may comprise a rigid support having an aperture 192, such that
deflection of the covering 100 through the aperture 192 can be
measured. The aperture 192 has a dimension across 194 that can be
sized smaller than the dimension across inner portion 110, so as to
measure a deflection 110D of the inner portion 110 in response to a
load 196. The deflection 110D may comprise a peak deflection, for
example a distance. The load 196 may comprise a point load or a
load distributed over an area corresponding to diameter 104, for
example a pressure from a gas or liquid on the lower side of the
covering. The covering may comprise a first configuration Cl
corresponding to the shape of the covering prior to placement on
the eye, and the covering may comprise a second configuration C2
when placed on the eye, and the amounts of force and/or pressure to
deflect covering 100 can be determined such that covering 100 can
be deflected without substantially degrading vision and so as to
smooth the epithelium. For example, the covering may deflect
slightly so as to decrease vision no more than about 1 or 2 lines
of visual acuity and such that the covering can smooth the
epithelium and provide environment 100E as described herein.
[0401] The modulus and thickness of the covering can be used to
determine an amount of relative rigidity of the covering 100, the
corresponding amount of force to deflect the covering 100 across a
distance, and the corresponding amount pressure to smooth the
epithelium with the deflected covering as described herein.
[0402] The amount of relative rigidity can be determined based on
the modulus multiplied with cube of the thickness. The amount of
deflection corresponds to the 6.sup.th power of the deflected span
across the covering, the modulus, and the cube of the thickness.
The approximately fourth order relationship of the span to the
deflection can allow the coverings as described herein to conform
at least partially to the ablation profile within a range from
about 4 to 6 mm, and inhibit substantially irregularities having
diameters of about 3 mm or less, for example.
[0403] The deflection can be approximated with the following
equation:
Deflection.apprxeq.(constant)*(Load*Span 4)/(Modulus*thickness
3)
[0404] The above approximation can be useful to understand the
properties of covering 100, for example with a substantially
uniform thickness of the inner portion. The substantially uniform
thickness may comprise a thickness that is uniform to within about
+/-25%, for example to within about +/-10%, such that the covering
can conform substantially to at least a majority of the surface
area of an ablation zone and inhibit irregularities over a smaller
portion of the ablation zone corresponding to no more than a
minority of the surface area of the ablation. In many embodiments,
the covering conforms over an area having diameter of at least
about 4 mm and inhibits irregularities over an area having a
diameter of no more than about 4 mm, for example less inhibits
irregularities over an area of no more than about 3 mm. For
example, based on the above equations, the deflection is related to
the fourth power of the span, such that for a comparable load, a 2
mm span will have about 1/16.sup.th the deflection of a 4 mm span.
Similarly, a 3 mm span will have a deflection that is about
1/16.sup.th the deflection of a 6 mm span. As the deflection is
related to the cube of the thickness, doubling the thickness can
decrease the deflection by about a factor of 8. The above
approximations can be combined with clinical testing to determine
thicknesses and moduli suitable for incorporation in accordance
with embodiments as described herein.
[0405] The equations for deflection of an unsupported circular span
of a material having a substantially uniform thickness are:
E c = E 1 ( t 1 t 1 + t 2 ) + E 2 ( t 2 t 1 + t 2 ) ##EQU00001##
Relative '' `` Rigidity = E C ( t 1 + t 2 ) 3 ##EQU00001.2## y = 3
wR 4 16 Et 3 ( 5 + v ) ( 1 - v ) ##EQU00001.3## w = y 16 Et 3 ( 5 +
v ) ( 1 - v ) 3 R 4 ##EQU00001.4##
where: W=evenly distributed load over the surface, Pressure (Pa)
R=span of unsupported material (m)
E=Young's Modulus (Pa)
[0406] t=Thickness (m) v=Poisson's Ratio (unit-less, assumed to be
constant among materials) y=Deflection (m)
[0407] Equations for deflection is described in Theory and analysis
of elastic plates, Junuthula Narasimha Reddy, p. 201 equation
5.3.43(1999).
[0408] Although the above equations describe relative rigidity for
a substantially flat surface, the equations can approximate a
curved surface and a person of ordinary skill in the art can
determine the deflection load and relative rigidity empirically
based on the teachings described herein, for example with finite
element modeling.
TABLE-US-00001 TABLE A1 Material, modulus, thickness, relative
rigidity Dk/and deflection load of inner portions of coverings as
described herein. Uniform Button Button Flexural Flexural Relative
Button Thickness Thickness Modulus Modulus Rigidity Material
Material (um) (m) (MPa) (Pa) (Pa*m{circumflex over ( )}3) Dk Dk/t
Rigid 250 2.50.E-04 35 35000000 5.47E-04 600 240 Silicone Rigid 200
2.00.E-04 35 35000000 2.80E-04 600 300 Silicone Rigid 150 1.50.E-04
35 35000000 1.18E-04 600 400 Silicone Rigid 100 1.00.E-04 35
35000000 3.50E-05 600 600 Silicone Rigid 50 5.00.E-05 35 35000000
4.38E-06 600 1200 Silicone Exemplary 293 2.93.E-04 20 20000000
5.03E-04 600 205 Silicone Exemplary 272 2.72.E-04 20 20000000
4.02E-04 600 221 Silicone Exemplary 250 2.50.E-04 20 20000000
3.13E-04 600 240 Silicone Exemplary 215 2.15.E-04 20 20000000
1.99E-04 600 279 Silicone Exemplary 200 2.00.E-04 20 20000000
1.60E-04 600 300 Silicone Exemplary 175 1.75.E-04 20 20000000
1.07E-04 600 343 Silicone Exemplary 150 1.50.E-04 20 20000000
6.75E-05 600 400 Silicone Exemplary 100 1.00.E-04 20 20000000
2.00E-05 600 600 Silicone Exemplary 50 5.00.E-05 20 20000000
2.50E-06 600 1200 Material enflufocon 25 2.50.E-05 1900 1900000000
2.97E-05 18 72 A (Boston ES) enflufocon 50 5.00.E-05 1900
1900000000 2.38E-04 18 36 A enflufocon 150 1.50.E-04 1900
1900000000 6.41E-03 18 12 A hexafocon 25 2.50.E-05 1160 1160000000
1.81E-05 141 564 B (Boston XO2) hexafocon 50 5.00.E-05 1160
1160000000 1.45E-04 141 282 B hexafocon 150 1.50.E-04 1160
1160000000 3.92E-03 141 94 B
[0409] As shown in Table A1, an RGP material such as an enflufocon
or hexafocon having a thickness of about 50 um can have a relative
rigidity suitable for epithelial smoothing and so as to conform at
least partially to the ablated stroma. The rigid silicone having a
modulus of about 20 MPa and a thickness of about 250 um will
provide a relative rigidity 3E-4 and deflection under load similar
to the RGP material having a thickness of about 50 um and modulus
of about 1900 MPa so as to provide a relative rigidity of about
2.4E-4. Commercially available RGP lens materials as shown in Table
A1 can be combined in accordance with embodiments as described
herein so as to provide covering 100. Based on the teachings
described herein, a person of ordinary skill in the art can
determine the thickness of the covering based on the modulus and
the intended relative rigidity.
[0410] Work in relation to embodiments in accordance with clinical
studies as described herein has shown that the inner portion 110 of
the covering 100 having the relative rigidity of about 3E-4
(3.times.10.sup.-4 Pa*m 3) can be effective so to improve vision
and conform at least partially of the eye so as to provide at least
some comfort and improve fitting. Many eyes have been measured with
many coverings and work in relation to embodiments indicates that
an inner portion 110 having a relative rigidity within a range from
about 1E-4 to about 5E-4 (Pa*m 3) can allow the covering to conform
to the ablation and smooth the epithelium as described herein. For
example, inner portion 110 may a relative rigidity within a range
from about 2E-4 to about 4E-4, and the eye can be fit accordingly
based on the deflection of the covering 100.
[0411] The relative rigidity can be related to the amount of
deflection of the covering 100 on the eye. Work in relation to
embodiments indicates that a relative rigidity of inner portion 110
about 3E-4 can deflect about +/-2D when placed on the eye so as to
conform to an ablation to within about +/-2D across the
approximately 5 or 6 mm ablation diameter when an inner diameter of
about 2 or 3 mm is smoothed. A covering 100 having a relative
rigidity of about 1.5 E-4 can deflect about +/-4D when placed on
the eye so as to conform to an ablation to within about +/-4D
across an approximately 5 or 6 mm diameter when an inner diameter
of about 2 or 3 mm is smoothed.
[0412] The outer portion of the covering may comprise a relatively
rigidity less than the inner portion to fit an outer portion of the
eye such as an outer portion of the cornea or to fit the sclera
when placed on the conjunctiva.
[0413] The coverings as described herein may comprise a relative
rigidity corresponding to a range within two or more values of many
of the coverings of Table A1, for example a relative rigidity
within a range from about 2.50E-06 to about 6.41E-03 (Pa*m 3), and
two or more intermediate values for example within a range from
about 6.75E-05 to about 5.47E-04 (Pa*m 3). Based on the teachings
described herein the covering can have a relative rigidity within
one or more of many ranges such as within a range from about 0.5
E-3 to about 10 E-3 (Pa*m 3), for example a range from about 1 E-3
to about 6 E-3, for example. Based on the teachings described
herein, a person of ordinary skill in the art can conduct clinical
studies to determine empirically the thickness and modulus
corresponding to a relative rigidity of the inner portion 110 for
the covering 100 so as to smooth irregularities and conform
substantially to the ablation zone.
TABLE-US-00002 TABLE A2 Pressure for 5 um deflection at diameters
of 3, 4, 5 and 6 mm for coverings of Table A1. Pressure Required to
obtain 5 um Button Relative deflection (Pa) Button Thickness
Rigidity 3 mm 4 mm 5 mm 6 mm Material (um) (Pa*m{circumflex over (
)}3) span span span span Rigid 250 5.47E-04 1002.2 317.1 129.9 62.6
Silicone Rigid 200 2.80E-04 513.1 162.4 66.5 32.1 Silicone Rigid
150 1.18E-04 216.5 68.5 28.1 13.5 Silicone Rigid 100 3.50E-05 64.1
20.3 8.3 4.0 Silicone Rigid 50 4.38E-06 8.0 2.5 1.0 0.5 Silicone
Exemplary 293 5.03E-04 921.9 291.7 119.5 57.6 Silicone Exemplary
272 4.02E-04 737.6 233.4 95.6 46.1 Silicone Exemplary 250 3.13E-04
572.7 181.2 74.2 35.8 Silicone Exemplary 215 1.99E-04 364.3 115.3
47.2 22.8 Silicone Exemplary 200 1.60E-04 293.2 92.8 38.0 18.3
Silicone Exemplary 175 1.07E-04 196.4 62.2 25.5 12.3 Silicone
Exemplary 150 6.75E-05 123.7 39.1 16.0 7.7 Silicone Exemplary 100
2.00E-05 36.7 11.6 4.8 2.3 Silicone Exemplary 50 2.50E-06 4.6 1.4
0.6 0.3 Silicone enflufocon 25 2.97E-05 54.4 17.2 7.1 3.4 A (Boston
ES) enflufocon 50 2.38E-04 435.2 137.7 56.4 27.2 A enflufocon 150
6.41E-03 11751.3 3718.2 1523.0 734.5 A hexafocon 25 1.81E-05 33.2
10.5 4.3 2.1 B (Boston XO2) hexafocon 50 1.45E-04 265.7 84.1 34.4
16.6 B hexafocon 150 3.92E-03 7174.5 2270.1 929.8 448.4 B
[0414] The data of Table A1 and A2 show that the pressure to
deflect a 3 mm zone a distance of 5 um can be about three times the
pressure to deflect a 4 mm zone the distance of 5 um, and about 15
times the pressure to deflect the 6 mm zone the 5 um distance. For
example, for the relative rigidity of about 3.13E-4 (Pa*m 3), the 5
um deflection pressures are 572.7, 181.2, 74.2, 35.8 (Pa) for
diameters of 3, 4, 5 and 6 mm, respectively, such that the central
3 mm of inner portion 110 can provide a compressive force to
irregularities of about 570 Pa when the inner portion 110 conforms
to the ablation across a 6 mm span with a pressure of about 35 Pa,
for example.
[0415] The relative rigidity and deflection pressures can be
determined for many coverings based on the teachings described
herein, for example for coverings having a plurality of layers
having a plurality of materials.
TABLE-US-00003 TABLE A3 Relative Rigidity of Layered Coverings
Material 2 (Soft) Composite Material 1 (Rigid) Flexural Composite
Relative Total Layered Thickness Modulus Thickness Modulus
Thickness Modulus Rigidity Thickness Material (m) (Pa) (m) (Pa) (m)
(Pa) (Pa*m{circumflex over ( )}3) 270 um Exemplary 2.40E-04
2.00E+07 3.00E-05 2.00E+06 2.70E-04 1.80E+07 3.54E-04 thick
Silicons Shield Soft and 1.35E-04 2.00E+07 1.25E-04 2.00E+06
2.70E-04 1.13E+07 1.99E-04 Hard are Equal 150 um Exemplary 1.20E-04
2.00E+07 3.00E-05 2.00E+06 1.50E-04 1.64E+07 5.54E-05 thick
Silicone Shield Soft and 7.50E-05 2.00E+07 7.50E-05 2.00E+06
1.50E-04 1.10E+07 3.71E-05 Hard w/ Equal thickness
[0416] When two or more materials are combined so as to provide two
or more layers, the relative rigidity of each layer can be combined
so as to determine a total composite rigidity. For example, the
combined rigidity can be determined for a covering having first
layer 110L1 of first material, a second layer 110L2 of second
material M2 and third layer 110L3 of third material 110L3, in which
the first and third materials can be the same material.
[0417] A weighted average system can be used to treat the two
layers as one material. The relative amounts of each material and
the moduli of the two materials can be combined to determine a
composite modulus based on the weight average of the thickness of
each layer. For example, with 90 um of 20 Mpa material layer and a
10 um of 5 MPa material layer can be combined so as to determine
the composite modulus as 20 MPa*0.9+5 MPa*0.1=18.5 MPa
[0418] The equations described herein accommodate many layers of
different materials and thicknesses.
[0419] Based on the composite modulus, one can multiply the
composite modulus by the overall thickness cubed, in the present
example 18.5 MPa*100 3. Although these calculations can be based on
approximations, a person of ordinary skill in the art can conduct
simulations, for example finite element modeling simulations, so as
to determine the amount of relative rigidity, pressures and
deflection forces and pressures as described herein.
[0420] The index of refraction of one or more layers of covering
100 may correspond substantially to the index of refraction of the
cornea.
[0421] One or more of the materials 110M1, 110M2 or 110M3 may
comprise an index of refraction within a range from about 1.38 to
about 1.43 so as to match the index of refraction of the cornea to
within about +/-0.05. For example the materials 110M1 and 110M3 may
comprise an optically transparent soft silicone elastomer having an
index of refraction of about 1.41 and the material M2 may comprise
an optically transparent rigid silicone elastomer having an index
of refraction of about 1.43, for example available from NuSul.
Alternatively, material 110M1 and material 110M3 may comprise
silicone hydrogel and material 110M2 may silicone, for example.
[0422] While the covering may comprise similar materials such as a
more rigid silicone combined with a softer silicone, the covering
may comprise dissimilar materials. For example, and RGP material
can be combined with a hydrogel, such as the bicurve or tricurve
embodiments as described herein. The covering can extend at least
to the limbus for stability. The RGP material may comprise the
second layer 110L2 of the second material 110M2, for example in
accordance with Table A, and the hydrogel may comprise the first
layer 110L1 of the first material 110M1 and the third layer 110L3
of the third material 110M3. The hydrogel may have an index of
refraction from about 1.38 to about 1.42 so as to match the index
of refraction of the cornea of about 1.377 to within about 0.05 and
may comprise one or more of HEMA, NVP, GMA, MMA, SiH, TRS,
HEMA/NVP, MMA/NVP, HEMA/GMA, or SiH/TRS, commercially available
from Vista Optics, UK, for example. The hydrogel comprising
HEMA/NVP, MMA/NVP, or HEMA/GMA may have water content within a
range from about 40% to about 70% so as to comprise the index of
refraction within the range from about 1.38 to about 1.43. A water
content of about 40% corresponds to an index of refraction of about
1.43 and a water content of about 70% corresponds to an index of
refraction of about 1.38. The hydrogel comprising SiH/TRS may
comprise water content within a range from about 20% to about 70%
so as to comprise the index of refraction within the range from
about 1.38 to about 1.43. With these SiH hydrogels a water content
of about 20% corresponds to an index of refraction of about 1.43
and a water content of about 70% corresponds to an index of
refraction of about 1.38.
[0423] Surgical Placement of the Covering
[0424] FIG. 2A shows surgical placement of covering 100 on an eye
having an epithelial defect with an applicator 200. The applicator
200 comprises a support 210 to carry the covering 100 and a movable
component 230 to advance the covering onto the cornea with motion
240. The support 210 comprises an opening 212 sized to receive the
movable component 230. The support 210 may comprise a lower portion
220 to couple to the covering, for example to adhere to the
covering, and a handle 214. Coupling 220 of the support to the
covering can be used to carry the covering for alignment and
placement on the cornea. The support may comprise a rigid
structure, for example a rigid annular structure 216, to couple the
handle to the lower portion of the support. The handle 214 may
comprise a neck 214N that extends to the rigid annular structure
216.
[0425] The movable component 230 can be sized and shaped in many
ways to advance the covering 100 onto the eye with the support 210.
For example, the movable component 230 may comprise a disc shape
portion of a window 232 sized to pass within opening 212. The disc
shaped portion of rod comprising window 232 may comprise a window
composed of an optically transparent material, for example an
optically transparent material such as one or more of a rigid
material, glass, glass fibers, plastic, polyacrylate, polyimide,
silicone. Alternatively the movable component may comprise an
annulus sized to pass within opening to contact the covering.
[0426] The support 210 and the movable component 230 each comprise
at least a portion viewable therethrough such that the patient can
see a fixation light and the physician can see at least one
structure of the eye to align the covering with the eye when the
covering is positioned on the eye. The covering can be positioned
with an operating microscope 202, for example an operating
microscope of a commercially laser refractive surgery system. The
operating microscope 202 may comprise an objective lens 204 and an
eyepiece 206 for an operator 207 such as a surgeon to view the eye.
A fixation light 208 such as an LED may be positioned on the
operating microscope such that the patient can view the fixation
light and fixate on the light 208 so as to steady the eye.
[0427] The handle 214 can be pivoted with a hinge, bearing, or
pivot mechanism disposed between the handle and the support 210
such that the handle 214 can pivot away from the operating
microscope.
[0428] The covering 100 may comprise a marking 100MK to align the
covering with the cornea. Alternatively or in combination, the
applicator 200 may comprise a marking 200MK to align the covering
with the cornea. The marking can be helpful, for example when the
covering comprises an inferior rigidity less than a superior
rigidity.
[0429] FIG. 2A1 shows a surgeon's view of the eye through the
applicator as in FIG. 2A. The surgeon can view through opening 212
and window 232 so as to visualize a tissue structure of the eye
such as the iris 8 or pupil 9. The surgeon may visualize the limbus
of the eye, for example with low magnification of the microscope.
The surgeon can align the structure of the eye with a structure of
the applicator 200. For example, circular aperture 212 can be
aligned with pupil 9.
[0430] FIG. 2A2 shows a patient's view of a fixation light through
the applicator as in FIG. 2A. The patient can see the fixation
light 208 through the covering and the applicator, such that the
patient can fixate when the covering is placed on the cornea. Prior
to placement of the covering over the ablation and epithelial
defect, the patient may observe haze 208H around the fixation
light, for example when the covering is positioned on cornea
without liquid disposed on the surface. Although haze 208H may be
present, the patient can fixate sufficiently for the surgeon to
position the covering over the ablation and pupil.
[0431] FIG. 2B shows applicator 200 coupled to covering 100 for
placement on a cornea as in FIG. 2A. The applicator 200 comprises a
lower portion 220 to couple the applicator to covering 100. The
coupling 222 of the applicator 200 to the covering 100 can be
achieved in many ways, for example with one or more of adhesion,
block adhesion, sticking, interlocking structures, or surface
tension.
[0432] The coupling 222 of the lower port may comprise block
adhesion. For example, the lower portion 220 may comprise silicone
and the covering may comprise silicone. The covering can be placed
in contact with the lower portion 220 in the presence of a solvent
such as alcohol, and the solvent evaporated such that the covering
100 is adhered to the lower portion 220. Similar adhesion can be
achieved with a wettable coating disposed over the covering 100, as
described above. The lower portion 220 may comprise a wettable
coating to contact the covering.
[0433] Work in relation to embodiments suggests that in some
instances the lower sticky tacky surface of outer portion 120 can
stick to itself during deployment onto the eye, and the applicator
200 can improve handling when the covering 100 is placed on the
eye.
[0434] The covering used with the applicator may comprise many
coverings, for example a covering as described above, a covering as
described in U.S. patent application Ser. No. 12/384,659, filed
Apr. 6, 2009, entitled "Therapeutic Device for Pain Management and
Vision", previously incorporated herein by reference, or a
commercially available covering, such as a commercially available
therapeutic contact lens or a commercially available hybrid lens
comprising an RGP inner portion and a hydrogel skirt.
[0435] FIG. 2C shows applicator 200 coupled to covering 200 with
coupling 222 comprising block adhesion and peeling 242 of the
covering from the applicator with movable component 230. The lower
portion 220 may contact the covering 100 with an angle such that
the covering peels from the support when the movable component is
advanced. Such peel can be effective to remove the covering when
the covering is adhered to the support.
[0436] FIG. 2C1 shows applicator 200 coupled to covering 100 with
foam 222F to adhere to the covering to the applicator when dry and
application of a liquid 222L to release the covering from the
applicator when wet. Alternatively, the foam 222F can couple the
applicator 200 covering 100 such that the covering can be removed
with the movable component 230.
[0437] FIG. 2D shows applicator 200 coupled to covering 100 with
silicone to silicone adhesion. The covering lower portion 220 of
the support 210 may comprise silicone and a silicone surface. In
particular, lower portion 220 may comprise a very smooth
3/8''.times.1/4'' silicone tube stretched over a 0.344'' ring or
tube. The covering 100 may comprise silicone on the upper surface
in contact with the silicone of the lower portion 220, such that
covering 100 is adhered to the support with a silicone to silicone
interface. The silicone to silicone interface can be formed with
evaporation of a solvent when the lower portion 222 contacts the
covering, as described above. Handle 214 may comprise machined
Acrylonitrile Butadiene Styrene (ABS). Neck 214N may comprise 14
Gage TW 204 tube crimped and spot welded so as to attach handle 214
to annular structure 216. Annular structure 216 may comprise a
0.344'' ring or a 0.344''.times.0.324'' 304 tube.
[0438] FIG. 2D1 shows covering 100 coupled to applicator 200 with
silicone to silicone adhesion and the lower surface of the lower
portion 220 inclined at an angle.
[0439] FIG. 2E shows applicator 200 comprising a rigid component
250 and a flexible component 254. The flexible component 254 may
comprise a concave first configuration to carry the covering 100
and a second configuration to release the covering. The rigid
component 250 may comprise a window 252 of a transparent material.
The flexible component 254 may comprise a thin transparent sheet of
material, for example a flexible diaphragm. The flexible component
can be urged downward so as to advance covering 100 downward on to
the eye with movement 240.
[0440] The rigid component 252 and flexible component 254 may
define a chamber 253. The chamber 253 can be filled with a fluid
such as a gas or a liquid. The handle 214 may comprise a button 256
so as to deliver gas to chamber 253 with movement 258 of the button
256. The fluid may comprise a cooled fluid such as a cooled gas or
a cooled liquid so as to cool the cornea and denervate the cornea,
for example as described in U.S. Provisional Pat. App. Ser. No.
61/279,612, filed on 23 Oct. 2009, entitled "Corneal Denervation
for Treatment of Ocular Pain" (attorney docket no.
26322A-000300US), the entire disclosure of which is incorporated
herein by reference and suitable for combination in accordance with
at least some embodiments of the present invention as described
herein.
[0441] The chamber 253 can be configured to displace a
predetermined quantity of air, for example with a syringe to
displace the movable component a predetermined amount toward the
cornea. Alternatively or in combination, the handle may comprise a
bulb to displace the movable component with movement of the
fluid.
[0442] FIG. 2E1 shows coupling of a covering to an applicator as in
FIG. 2E. The thin flexible component 254 can extend substantially
along covering 100. The thin flexible component 254 may comprise a
coating to inhibit adherence of the covering to the thin flexible
component. The covering may be adhered to lower portion 220 with
adhesion as described above.
[0443] FIG. 2F shows an applicator and a covering as in FIG. 2E
with the applicator in an expanded configuration to position the
covering on the cornea. The thin flexible component 254 can expand,
for example to a convex configuration with expansion of chamber
252. The covering 100 can peel from the lower portion as described
above.
[0444] FIG. 2G shows an applicator 200 and covering 100 with the
covering held in a channel 260 of the applicator. The channel 260
can be sized to receive the covering 100, for example with a
diameter slightly larger than the covering.
[0445] FIG. 2H shows applicator 200 and covering 100 with the
applicator comprising an extension 270 to deliver the covering. The
extension 270 can extend between handle 214 and movable component
230 comprising window 232 as described above. Extension 270 may
comprise a flexible component 272 coupled to the window 232, such
that the extension 270 can be pushed toward the eye so as to move
the covering toward the eye with movement 270.
[0446] FIG. 2I shows applicator 200 and covering 100 with the
applicator comprising a slider 270 to release the covering The
slider 270 can be slid toward the eye with movement 284 coupled to
window 232 such that the covering is moved toward the eye with
movement 240.
[0447] FIG. 2J shows applicator 200 and covering 100 with the
applicator comprising a hinge 290 to release the covering. The
hinge 290 can comprise an extension 294 movable about a pivot 292.
Motion of extension 294 about pivot 292 can advance the movable
component 230 comprising window 232 toward the eye with movement
240.
[0448] FIG. 2K1 and 2K2 show side and top views, respectively, of
applicator 200 and covering 100 with the applicator comprising a
compressed structure 296 that is released so as to deliver the
covering to the cornea. The compressed structure 296 may comprise
many materials, for example a shape memory material such as
nitinol, a spring, a metal, plastic, or a combination thereof. The
compressed structure can be connected to the rigid portion of the
support with a trigger structure 298 such as a latch, notch,
L-connector, keeper or loop, such that the compressed structure can
be released with movement 297 the trigger structure. The compressed
structure comprises a first configuration of the movable structure
of the applicator 100. The structure 296 can be sized such that the
patient view of the fixation light for alignment is not occluded
substantially and such that the physician view of the structure of
the eye for placement of the covering on the eye is not occluded
substantially.
[0449] FIG. 2K3 shows the applicator as in FIGS. 2K1 and 2K2 with
the structure 296 in a released second configuration so as to
deliver the covering 100 to the cornea.
[0450] FIG. 3A shows applicator 100 comprising a sliding mechanism
300 and extensions 302 coupled to pads 316 to deliver the covering
100. The pads 316 can be connected to covering 100 with coupling
222. The pads 316 can be spaced apart by a distance such that the
patient can view the fixation light between the pads. The
extensions 302 extend from pads 316 to handle 214 at an oblique
angle such that the handle does not occlude the view of the
fixation light and surgical view of the alignment structures of the
eye. The extension 302 may comprise one or more of a flexible
material, an elastic material, or a shape memory material such that
the pads can urge apart when the covering is positioned on the
cornea with motion 240. For example, a slider 310 can be retracted
with a movement 312 such that pads 316 are urged apart with
movement 314 when the covering is positioned on the cornea. The
pads may comprise an inclined lower surface such that the pads can
peel away from the covering when urged apart.
[0451] FIG. 3B shows applicator 100 a spring mechanism 320
comprising extensions 322 coupled to roller pads 326 to as to
deliver the covering 100 to the cornea. The roller pads can be
coupled to the covering 100 with coupling 222 as described above.
Alternatively, rollers 326 can be used to smooth the covering on
the eye, for example when the covering is substantially dry. The
extensions 322 extend from the handle 214 to the rollers 326 and
may comprise one or more of a flexible, elastic, resilient or shape
memory material such that the rollers can move apart with
separation 240 when positioned on the eye and urged toward the
cornea with movement 240. The extensions 222 can extend from the
rollers to the handle for a sufficient distance at an oblique angle
such that the handle does not interfere with patient fixation. The
rollers can be spaced apart by a distance such that the rollers do
not interfere substantially with patient fixation and the surgeon's
view of the structures of the eye.
[0452] FIG. 3C shows a concave roller pad 326C for use with an
applicator 100 as in FIG. 3B. Each of the roller plurality of
roller pads may comprise concave roller pad 326C. The concave
roller pad can fit the covering on the cornea, so as to smooth the
covering onto the cornea as described above.
[0453] FIG. 3D shows delivery of a covering to the cornea with the
applicator comprising rollers as in FIGS. 3B and 3C. The applicator
can be coupled to the covering with coupling 222. The movement 240
toward the eye can separate the rollers 326 with movement 324. The
rollers can undergo rotational movement 328 when separated with
movement 324 so as to smooth the covering.
[0454] FIG. 4A shows an applicator 400 comprising a fixation ring
410, and FIG. 4B shows a side view of the applicator 400. The
applicator 400 may comprise many of the components of applicator
200, as described above, coupled to fixation structure such as
fixation ring 410. The fixation ring 410 can be affixed to the
rigid portion 216 with extensions 416 extending from the rigid
portion to the fixation ring. The fixation ring may comprise teeth
412. The teeth 412 can be sized such that the teeth engage the
sclera, or the limbus, for example. The covering can be carried
with coupling 222. The fixation ring 410 can be sized such that
covering 100 fits within fixation ring 410. The movable component,
for example window 232, can be moved toward the cornea to deliver
the covering when the fixation ring engages the eye with the rigid
portion and coupling 222 positioning the covering on the cornea.
The applicator 400 can be used with an opaque movable component,
for example a compressible foam to contact the covering.
[0455] FIG. 5A shows an apparatus 500 comprising covering 100 and
applicator 200 stored in a substantially dry, sterile compartment
510 of a container. The apparatus 500 may comprise a kit. The
components and packaging can be sterilized in many known ways such
as e-beam, ethylene oxide gas, and gamma-ray. The apparatus 500 can
be provided to the physician and opened with the applicator 200
coupled to covering 100, for example adhered to covering 100 and
ready for placement on the cornea. The covering may comprise at
least an optically transparent portion when dry, and the applicator
and covering can be viewable therethrough when positioned on the
cornea as described above.
[0456] FIG. 5B shows an apparatus 520 comprising covering 100 and
applicator 200 stored in a substantially moist, sterile compartment
of a container. The apparatus 520 may comprise a kit. The
components and packaging can be sterilized in many known ways such
as e-beam, gamma-ray, ethylene oxide and autoclave. The apparatus
520 can be provided to the physician and opened with the applicator
200 coupled to covering 100, for example adhered to coupled to 100
with support 524 to hold the covering against the applicator during
shipping, such that the covering an applicator are ready for use to
place the covering on the cornea. The covering may comprise at
least an optically transparent portion when dry, and the applicator
and covering can be viewable therethrough when positioned on the
cornea as described above.
[0457] FIGS. 5B1 and 5B2 shows an apparatus comprising a covering
and an applicator stored in a sterile compartment of a container,
in which the container comprises a support surface with the
covering disposed thereon in a channel sized to receive the
applicator, in accordance with embodiments of the present
invention;
[0458] FIG. 5B3 shows an applicator with a support coupled to a
handle with a joint 540 disposed between the support and the handle
to move the handle when the support is coupled to the eye. The
joint may comprise a pivot, u-joint and additional articulating
structures.
[0459] FIG. 5C1 shows an apparatus comprising a removal tool 550.
The removal tool 550 may comprise an elongate structure 552 that is
graspable by a user, for example a syringe or handle. The elongate
structure such as the syringe may comprise a chamber having an
amount of liquid disposed therein. The removal tool comprises a
distal portion 560 having a tip 568. The distal portion 560 may
comprise components of a known hydro dissection tip modified in
accordance with the teachings described herein. The fluid, for
example liquid may 550L, may comprise saline, for example, or a
visco-elastic material. The distal portion 560 may comprise a first
proximal extension 562 and a second distal extension 564 with an
angle 566 disposed therebetween, so as to define an angle and
extend substantially along a plane. The distal portion comprises a
lumen that extends from the syringe to the tip 568. The cross
sectional perimeter of the area of the tip comprises a long
distance dimension 568L and a short distance dimension, for example
major and minor axes of an elliptical cross section. The long
distance dimension 568L of the cross section extends along a third
direction.
[0460] The long distance dimension 568L be oriented with respect to
the handle such that the third long dimension extends along the
lower side of the covering. For example the long distance dimension
568L can extend along the lower surface of the covering, when the
handle is positioned in a superior temporal location relative to
the eye, such that fluid flows inferiorly and nasally when the
covering is separated from the regenerated epithelium with the
liquid.
[0461] FIG. 5C2 shows the distal portion 560 of the removal tool.
The angle 566 can be from about 120 to about 150 degrees, for
example 135 degrees similar to a commercially available
hydro-dissection tip for cataract surgery. The distal portion 560
of the removal tool shown in FIG. 5C2 is angled at 135 degrees with
a 11 mm bend to tip.
[0462] FIG. 5C3 shows the apparatus of FIG. 5C1 aligned with the
patient to position the tip 568 under the covering. The patient
comprises a midline M and the nose is dispose along the midline.
The removal tool 550 can be positioned on either side of the
midline. Alternatively the removal tool may comprise a first
removal tool 550A for positioning on the right side of the patient
and a second removal tool 550B for positioning on the left side of
the patient. The handle of the removal tool can be positioned
oblique to the midline when the tip is positioned under a temporal
location of the covering, such that the physician can rest his or
her hand on a support when the tip is positioned under the
covering. The long dimension 568L can extend substantially along
the plane of the pupil when the tip is positioned under the
perimeter of the covering and aligned with the covering for removal
and the handle is positioned near the temple of the patient. This
alignment of the long dimension with the lower side of the covering
and the plane of the pupil can decrease deformation of the
epithelium when the covering is removed so as to lift the covering
upward and break the seal to lift the covering upward from the
cornea. Although, the long dimension 568L can extend perpendicular
to the plane of the pupil when the tip is positioned under the
perimeter of the covering work in relation to embodiments suggests
that such perpendicular alignment may deflect the epithelium
slightly and may not break the seal of the covering with the
epithelium as effectively.
[0463] FIG. 5C4 shows the long dimension 568L of the cross section
of the opening of tip 568 aligned substantially with a plane of the
pupil and a peripheral temporal portion of the covering when the
handle is positioned near the temple of the patient;
[0464] FIG. 5D shows separation of the covering 100 from the
regenerated epithelium 12R with injection of the liquid 550L. The
regenerated epithelium substantially covers ablated profile 20, and
may comprise at least about 2-3 cell layers thick, for example a
thickness of at least about 20 to 30 um. This substantial covering
can occur 2 days or 3 days post-op, for example. Work in relation
to embodiments suggest that the covering can remain on the cornea
after the initial covering, for example up to one week post
ablation with a high Dk covering providing the environment to
promote reepithelialization as described herein without substantial
swelling of the cornea.
[0465] FIG. 6 shows a mold 600 to form a covering and having a
solid inner component comprising a rigid material placed therein
prior to injection of a flowable material. The mold 600 may
comprise inner material 110M positioned within the mold as a solid
piece of material and outer material 120M comprising a flowable
material injected into mold 600 and cured around the preformed
piece comprising inner material 120M. The flowable material can be
injected around the inner material 100M in many ways. For example,
the inner material 110M may comprise a second layer 110L2 of rigid
material 110M2 of the inner portion 110 as described herein, and
the flowable material can be injected around the upper and lower
surfaces of second material 110M2 so as to form a first layer 110L1
of first material 110M1 and a third layer 110L3 of the third
material 110M3 with the flowable material such that the first
material 110M1, the third material 110M3 and the outer material
120M each comprise substantially the same soft material when cured.
Alternatively or in combination, the mold may have the first layer
110L1 of the first material 110M1 and the second layer 110L2 of the
second material 110M2 placed therein, and the flowable material
injected so as to form outer material 120M and the third layer
110L3 of the third material 110M3. For example, the third layer
110L3 may be formed with a solid spacer of third material 110M3
placed in the mold, and the flowable material comprising material
110M1 injected around the spacer of cured material 110M3 and layer
110M2 so as to form layer.
[0466] FIG. 6A shows a mold 600 to form a covering and comprising a
solid inner component comprising a rigid material placed therein
prior to injection of a flowable material. The mold 600 may
comprise inner material 110M positioned within the mold as a solid
piece of material and outer material 120M comprising a flowable
material injected into mold 600 and cured around the preformed
piece comprising inner material 600. The mold may comprise an upper
portion and a lower portion. In many embodiments, the covering 100
can be formed in a mold with rigid second material 110M2 placed in
the mold and encapsulated within a single piece of material
comprising first material 110M1, third material 110M3 and outer
material 120M, such that first material 110M1, third material 110M3
and outer material 120M comprise the same material, for example
silicone. The rigid second material 110M2 may comprise silicone
bonded to each of first material 110M1, third material 110M3 and
the outer material 120M, for example with curing such that first
material 110M1, third material 110M3 and outer material 120M
comprise the same soft silicone material bonded to the second
material 110M2 comprising rigid silicone.
[0467] FIG. 7 shows a method of manufacturing 700 a covering with a
mold, for example as described above. A step 710 provides the mold.
A step 715 molds the covering to form the covering as described
above.
[0468] The rigidity and hardness of the molded covering can be
determined by one or more of the material hardness, the modulus or
the thickness. The molded covering may comprise a covering with an
inner center more rigid than the outer periphery, for example, and
the center can be thicker than edge. For example, the covering may
comprise a single piece covering with an inner portion thicker than
the outer portion such that the inner portion is more rigid than
the outer portion. Alternatively or in combination, an optically
clear inner portion can be molded; the inner portion placed in the
mold, and the covering molded to form the outer portion around the
inner portion. For example, the molded inner portion comprising
layer 110L2 of material 110M2 as described herein, and one or more
of layers 110L1 or 110L3 molded around layer 110L2. A step 720
removes covering from the mold. A step 725 coats at least the upper
surface of covering with wettable material, and coating of the
lower is optional. A step 730 provides the applicator. A step 735
couples the applicator to the covering. A step 735 evaporates
solvent so as to adhere applicator to covering. A step 740 places
the covering and applicator in packaging. A step 745 sterilizes the
contents of the package. A step 750 provides the sterile package to
physician.
[0469] It should be appreciated that the specific steps illustrated
in FIG. 7 provide a particular method of manufacturing a covering,
according to an embodiment of the present invention. Other
sequences of steps may also be performed according to alternative
embodiments. For example, alternative embodiments of the present
invention may perform the steps outlined above in a different
order. Moreover, the individual steps illustrated in FIG. 7 may
include multiple sub-steps that may be performed in various
sequences as appropriate to the individual step. Furthermore,
additional steps may be added or removed depending on the
particular applications. One of ordinary skill in the art would
recognize many variations, modifications, and alternatives.
[0470] FIG. 8 shows a method 800 of placing a covering on a cornea
of an eye. A step 805 provides the sterile package with covering
and applicator to physician. A step 810 treats the cornea to
inhibit pain. A step 815 debrides the epithelium. A step 820
ablates the cornea. A step 825 allows the cornea to dry at least
slightly, for example with one or more of room air, oxygen or a
sponge. The cornea may also be dried with air flow from a
pressurized source such as oxygen from a canister. A step 830 opens
the packaging. A step 835 fixates the patient visually on the
fixation target with viewing of the fixation target. A step 840
positions the covering above cornea in the optical path of the
fixation light when patient views light. A step 845 advances the
covering toward cornea with the applicator. A step 850 contacts
cornea with the covering. A step 855 releases the covering from the
applicator, for example ejects covering from the applicator. At
step 860, the covering is adhered to the cornea to seal the cornea,
for example with one or more of a radius of the covering less than
the radius of the cornea, a sticky tacky lower surface of the
covering, a substantially conformable outer portion of the covering
to seal the cornea, a rigidity of the perimeter of the covering
sufficient to abut the epithelium and seal the cornea, for example
with deformation of the epithelium, or a conformable portion of the
covering disposed over the boundary of the epithelium and the
debrided region. A step 865 applies one or more of gas, air,
oxygen, or sponge, so as to remove bubbles and/or gaps between the
cornea and the covering positioned thereon. At a step 870 a liquid
comprising water, for example saline, is applied to the covering
and when the covering is sealed on the cornea so as to inhibit
swelling. At a step 875, the epithelium regenerates over at least a
peripheral portion of the covering, for example over a perimeter of
the covering. The epithelium may regenerate toward a center of the
covering over the upper surface of the covering. At step 880 the
epithelium regenerates along a lower side of the covering within
the chamber, for example guided by the lower surface of the
covering and the ablated PRK surface. A step 885 allows the patient
to see with the covering in position. At a step 890, the epithelium
regenerates substantially across the ablated surface, for example
with a cell layer comprising at least about 2-3 cells across the
ablated surface. At a step 895, the covering is removed when the
epithelium is substantially regenerated. The covering can be
removed when no substantial visual interference results from
removal such that vision is not substantially changed with removal,
for example no more than one line of visual acuity.
[0471] Work in relation to embodiments suggests that the covering
can be left on the cornea with high oxygen permeability for more
than a plurality of days, for example at least one week, such as
one month or more, such that the epithelium is substantially
regenerated across the ablation to a thickness of at least about 40
um and at least about 4-5 cell layers and so as the covering has
guided the regeneration of the epithelial and thus provides a
smooth epithelium for vision. For example, the covering may remain
on the cornea for about one month post PRK ablation to smooth and
regenerate the epithelium on the ablation profile with good
adherence of the epithelium to the ablation profile and good
patient vision.
[0472] It should be appreciated that the specific steps illustrated
in FIG. 8 provide a particular method of treating a patient,
according to an embodiment of the present invention. Other
sequences of steps may also be performed according to alternative
embodiments. For example, alternative embodiments of the present
invention may perform the steps outlined above in a different
order. Moreover, the individual steps illustrated in FIG. 8 may
include multiple sub-steps that may be performed in various
sequences as appropriate to the individual step. Furthermore,
additional steps may be added or removed depending on the
particular applications. One of ordinary skill in the art would
recognize many variations, modifications, and alternatives.
[0473] FIG. 9 shows a method 900 of removing a covering adhered to
an epithelium of a patient. A step 905 provides a covering adhered
to the cornea of the patient, for example as described above. A
step 910 anesthetizes the eye with anesthetic, for example numbs
the eye. A step 915 provides a tool to remove the covering. The
tool may comprise an elongate structure having a lumen to extend
under the covering and pass the liquid under the covering, for
example a hydro-dissection tool. A step 920 sprays the covering and
surrounding area of the cornea with liquid. A step 930 identifies,
for example selects, a location of entry under the covering, for
example a point of entry under the covering. A step 940 identifies
and an orientation, for example selects and angel and trajectory,
to advance the removal tool inwardly, for example toward the pupil.
A step 950 gently advances the removal tool. A sub-step 952 limits
the distance the tool is advanced to 1-2 mm. A sub-step 954
responds to tactile feedback so as to limit advancement of the tool
under the covering. A step 960 determines when to inject the liquid
under the covering, for example saline. A step 962 determines a
quantity of liquid to inject. A step 965 injects the liquid to
separate at least partially the covering from the substantially
regenerated epithelium. A step 968 lifts the covering when the
covering is at least partially separated from the epithelium. The
lifting of the covering can identify further separate the covering
from the epithelium so as to identify adherence of the covering to
the epithelium, for example locations of adherence of the covering
to the epithelium.
[0474] A step 970 completes removal of the covering with separation
of the covering from the substantially regenerated epithelium. A
sub-step 972 determines locations of covering attachment to the
cornea, for example when the covering slips. The covering can be
lifted further based on the attachment locations. A sub-step 974
may use forceps to remove the covering.
[0475] A step 980 returns the covering to the supplier for
analysis. A sub-step 982 determines where and what type of material
and/or cells the deposits comprise and whether cells of the
epithelium remain attached to the covering. A sub-step 984
evaluates durability of the covering. A sub-step 986 evaluates the
tear break up time (hereinafter "TBUT") and oxygen (hereinafter
"O2") permeability of the covering.
[0476] It should be appreciated that the specific steps illustrated
in FIG. 9 provide a particular method of removing a covering from a
patient, according to an embodiment of the present invention. Other
sequences of steps may also be performed according to alternative
embodiments. For example, alternative embodiments of the present
invention may perform the steps outlined above in a different
order. Moreover, the individual steps illustrated in FIG. 9 may
include multiple sub-steps that may be performed in various
sequences as appropriate to the individual step. Furthermore,
additional steps may be added or removed depending on the
particular applications. One of ordinary skill in the art would
recognize many variations, modifications, and alternatives.
[0477] The method 700, the method 800 and the method 900 can be
combined. For example a covering can be manufactured in accordance
with method 700 and provided to the physician, the covering placed
in accordance with method 800, and the covering removed in
accordance with the method 900.
[0478] Experimental
[0479] Based on the teachings described herein, a person of
ordinary skill in the art can conduct experiments and clinical
studies to determine sealing of the cornea with the covering to
promote epithelial regeneration and improved vision.
[0480] Clinical studies to determine smoothing of corneal
irregularities with the covering.
[0481] A clinical study was conducted to determine smoothing of
corneal irregularities using the covering with dimensions as
described above with reference to FIGS. 1C1, 1G1A to 1G1H and a
rigid inner portion and softer outer portion as shown with
reference to FIGS. 1C1.
[0482] The clinical study included images from at least 10 patients
that showed consistent smoothing of the front surface of the
covering as compared to the front surface of the cornea.
[0483] FIG. 10A shows corneal topography and smoothing of
epithelial irregularities with the covering at 24 hours post-op.
The Pentacam.TM. image shows the profile of the front surface of
the cornea comprising the epithelium, the epithelial defect and
ablated stroma. The commercially available Pentacam comprises
Scheimpflug camera and prism to profile the front surface of the
cornea when the covering is positioned on the cornea. The central
portion of the ablated stroma profile comprises an irregularity
referred to as a central island having a steep curvature
corresponding to an optical power of about 46D surrounded by
flatter portions of the ablated cornea having a curvature
corresponding to an optical power of about 40D. The EyeSys.TM.
refractive map comprises a front surface refractive map of the
optical power of the covering when the covering is positioned over
the irregularities shown in the Pentacam.TM. image. The refractive
map shows a much smoother surface having a curvature corresponding
to a refractive power of about 43D at 3 mm, 44D at 5 mm and 44D at
7 mm. Based on these images the front surface of the covering is
substantially smoother than the underlying epithelium.
[0484] FIGS. 10B, 10C and 10D show horizontal, vertical and central
OCT images, respectively, of the covering on the eye of FIG. 10A
without a gap disposed between the covering and the cornea such
that the covering directly contacts the ablated stroma and
regenerating epithelium. FIGS. 10B and 10C show an advance edge of
the regenerating epithelium. FIG. 10D shows the thickness of the
central portion of about 93 um and an ablated corneal thickness of
about 427 um and 414 um. Each of these images show direct contact
of the covering to the cornea and no gap appears between the
covering and the cornea.
[0485] Similar images have been obtained at 48 and 72 hours post-op
and show smoothing of the covering, and that the central island of
the cornea decreases with time.
[0486] Images similar to 10A to 10D have been obtained and show
smoothing with a majority of patients, such that the covering with
tear smooth the irregularities of the cornea. The wettable surface
coating of the front surface can provide a tear on the front
surface to smooth irregularities transferred to the covering.
[0487] Clinical Studies to Seal the Covering on the Cornea.
[0488] The clinical studies described herein show sealing of the
cornea and smoothing of the epithelial defects of the study. Based
on the embodiments describe herein, a person of ordinary skill in
the art can conduct additional studies to determine the rigidity of
the outer portion of the covering to facilitate removal and seal
the cornea. Additional studies can be conducted to determine the
conformability of the inner portion to correct vision, for example
with the ablated stroma as described above. Additional studies may
be conducted so as to improve re-epithelialization rates. Such
studies can be conducted separately or in combination, in
accordance with the embodiments studied, as described herein.
[0489] A clinical study was conducted to determine the effect of
covering rigidity on sealing of the covering with the cornea and
epithelial shaping near the perimeter of the covering. Two sets of
coverings were prepared from silicone resin. Each set was coated
with a luminous chemical vapor deposition such that the upper
surface comprised a wettable surface. The coverings had
substantially the same shape in accordance with the dimensions
FIGS. 1G1A to 1G1H. The total diameter across was about 10 mm. The
inner portion comprised a diameter of about 6 mm. An annular rim of
extended around the perimeter of the covering with a thickness of
about 35 um. The annular rim comprised an inner diameter of 9 mm
and an outer diameter of 10 mm corresponding to the perimeter of
the covering. The annular rim comprised a width of 0.5 mm extending
circumferentially around the covering. The outer portion comprised
the rim and a taper that extended from inner portion to the rim.
The taper in thickness was substantially uniform between the outer
diameter of the inner portion at 6 mm diameter and the inner
diameter of the rim at 9 mm. The central portion comprised a
substantially uniform thickness of about 100 um. The outer rim
comprised substantially uniform thickness of about 0.35 um. The
base radius of curvature of the lower surface of the covering was
about 7.5 mm. The upper surface of the covering comprised a radius
of curvature of about 7.529 mm, such that the covering was
substantially uniform with no substantial refractive power.
[0490] The first set of coverings comprised single piece silicone
elastomer coverings having Shore A hardness of about 40
(hereinafter "Group I"), for example about 45, and the second set
comprised single piece silicone elastomer coverings having a Shore
A hardness of about 85 (hereinafter "Group II"). The Shore A
hardness of Group I corresponds to a soft covering, and the Shore A
harness of Group II corresponds to a rigid covering. The covering
comprises a shield that protects the cornea. Both silicone
coverings were coated with an LCVD coating on the upper (anterior)
surface and the lower surface comprised a sticky tacky silicone
surface to adhere to the cornea.
[0491] The OCT images of the eyes show an increased epithelial
covering on the perimeter of the corresponding to an inferior
location on the eye of the patient and a decreased covering the
perimeter of the covering superiorly. The chamfer abuts the
epithelium so as to deflect the epithelium and form an indentation
in the epithelium to seal the cornea. The following images are
substantially representative and show sealing of the epithelial
defect of the cornea following PRK. The hours refers to the hours
post-PRK.
[0492] FIGS. 11A1A to 11A1D show OCT images of portions of the soft
covering from, respectively, the superior portion of the covering,
the nasal portion of the covering, the temporal portion of the
covering and the inferior portion of the covering at 48 hours
post-op on the right eye (OD).
[0493] FIGS. 11A2A to 11A2D show OCT images of portions of the soft
covering from, respectively, the superior portion of the covering,
the nasal portion of the covering, the temporal portion of the
covering and the inferior portion of the covering at 48 hours
post-op on the left eye (OS).
[0494] FIGS. 11A3A to 11A3D show OCT images of portions of the soft
covering from, respectively, the superior portion of the covering,
the nasal portion of the covering, the temporal portion of the
covering and the inferior portion of the covering at 72 hours
post-op on the right eye (OD).
[0495] FIGS. 12A1A to 12A1C show OCT images of portions of the
rigid covering from, respectively, the temporal portion of the
covering, the nasal portion of the covering and the inferior
portion of the covering at 24 hours post-op on the right eye
(OD).
[0496] FIGS. 12A2A to 12A2D show OCT images of portions of the
rigid covering from, respectively, the superior portion of the
covering, the temporal portion of the covering, the nasal portion
of the covering and the inferior portion of the covering at 48
hours post-op for on the left eye (OS).
[0497] FIGS. 12A3A to 12A3D show OCT images of portions of the
rigid covering from, respectively, the superior portion of the
covering, the temporal portion of the covering, the nasal portion
of the covering and the inferior portion of the covering at 72
hours post-op on the left eye (OS).
[0498] The soft shields show less covering of the outer portion
with the epithelium than the rigid coverings. In some of the above
examples with the rigid shield, the chamfer of the rigid portion
extends substantially into the epithelium and may contact Bowman's
membrane in at least some instances. While effective in sealing the
covering, work in relation to embodiments suggests that less
covering of the outer portion can facilitate removal.
[0499] Additional studies are contemplated to determine the
hardness and rigidity to seal the cornea uniformly with hardness
parameter that can be intermediate to those tested as described
above. For example, additional studies are contemplated to
determine the perimeter suitable for substantially uniform covering
of the epithelium around the covering, for example with a variable
rigidity perimeter as described above. Also, studies can be
conducted with the coating disposed over the silicone to determine
the promotion of epithelial growth with the environment provided
high Dk covering and sealing. Work in relation to embodiments
indicates that the epithelium of a majority of patients can
regenerate substantially within two days post-PRK to cover the
ablated stroma, for example with the LCVD coating on silicone and
the shape tested in the embodiments 11A1A to 12A3D. Testing of the
oxygen permeability Dk parameter of these LCVD on silicone
embodiments indicates that the Dk can exceed 400, so as to
substantially promote regeneration of the epithelium.
[0500] Clinical Studies of Patients after PRK.
[0501] Experimental studies have been conducted to determine the
improvement in vision with therapeutic coverings as described
herein. A series of patents was treated with PRK and the patients
received a either commercially available bandage contact lens (BL)
or a therapeutic covering (TC) as described herein. The study
design and protocol was in accordance with the study designs and
protocols described in published U.S. patent application Ser. No.
12/384,659, filed Apr. 6, 2009, entitled "Therapeutic Device for
Pain Management and Vision", the full disclosure of which has been
previously incorporated by reference and suitable for combination
in accordance with some embodiments of the present invention as
described herein. The therapeutic covering as described herein
comprised molded elastomeric silicone lenses formed with a mold
shaped in accordance with FIGS. 1G to 1G1H above. The elastomeric
lens was treated with LCVD as described herein. The molded
elastomeric silicone lenses comprised a modulus within a range from
about 4 to about 20 MPa, a Dk of at least about 150, a water
content of no more than about 10%, and a low ion permeability. The
clinical results are shown in Table I below.
TABLE-US-00004 TABLE I Clinical results with therapeutic covering
following PRK. % 20/40 (6/12) or Better 24 hours 48 hours 72 hours
PRK (BL) 25% (n = 24) 29% (n = 24) 66% (n = 12) PRK (TC) 100% (n =
13) 92% (n = 13) 100% (n = 13)
[0502] The data of Table I show patient visual acuity for the
patients with the commercially available bandage lens (BL) and the
therapeutic covering (TC) as described herein at 24, 48 and 72
hours, respectively. At all time points, at least about 92% of the
TC patients were 20/40 or better. The TC patient population had
100%, 92% and 100% of patients 20/40 or better at 24, 48 and 72
hours post-op, whereas the BL patient population had 25%, 29% and
66% of patients 20/40 or better, at 24, 48 and 72 hours post-op
respectively. These data show that the therapeutic covering as
described herein can improve visual acuity in individual patients
of a population of patients having PRK and that the therapeutic
covering provides better visual acuity for an individual patient
than if the patient had not received the covering. Although the
above data were obtained with a sample size of 24 patients in the
BL ground and 13 patients in the TC group, additional studies can
be undertaken by a person of ordinary skill in the art, in
accordance with the teachings described herein.
[0503] The embodiments as described herein can be combined in many
ways. As used herein like alphanumeric characters describe like
structures and methods and are interchangeable among the figures
and supporting text in accordance with the embodiments described
herein.
[0504] While the exemplary embodiments have been described in some
detail, by way of example and for clarity of understanding, those
of skill in the art will recognize that a variety of modifications,
adaptations, and changes may be employed. Hence, the scope of the
present invention should be limited solely by the appended
claims.
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