U.S. patent application number 12/984246 was filed with the patent office on 2011-05-12 for accommodating intraocular lens measurement implant.
This patent application is currently assigned to NuLens Ltd.. Invention is credited to Yehoshua BEN NUN.
Application Number | 20110112635 12/984246 |
Document ID | / |
Family ID | 34074043 |
Filed Date | 2011-05-12 |
United States Patent
Application |
20110112635 |
Kind Code |
A1 |
BEN NUN; Yehoshua |
May 12, 2011 |
ACCOMMODATING INTRAOCULAR LENS MEASUREMENT IMPLANT
Abstract
An accommodation measurement implant for measuring accommodation
in an experimental set-up including an animal eye having a visual
axis and including a sclera of tough connective tissue, an annular
ciliary sulcus, and a sphincter-like ciliary body having a relaxed
state for tensioning a capsular diaphragm in an anterior direction
along the visual axis. The implant includes a rigid base member
with a haptics system for penetrating the tough connective tissue
of the animal eye's sclera for self-anchoring said base member in
the animal eye's annular ciliary sulcus at least two spaced apart
stationary anchor points, and having a central aperture. The
implant also includes a convex shaped member for placing on the
animal eye's capsular diaphragm from an anterior direction and
biased away from said base member in a posterior direction for
urging the capsular diaphragm in a posterior direction, and having
an upright pin passing through said aperture whereupon relaxation
of the animal eye's ciliary body urges the animal eye's capsular
diaphragm in an anterior direction for urging said pin through said
aperture.
Inventors: |
BEN NUN; Yehoshua; (D.N.
Vitkin, IL) |
Assignee: |
NuLens Ltd.
|
Family ID: |
34074043 |
Appl. No.: |
12/984246 |
Filed: |
January 4, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12906598 |
Oct 18, 2010 |
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12984246 |
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11568416 |
Oct 27, 2006 |
7842087 |
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PCT/IL05/00456 |
May 1, 2005 |
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12906598 |
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60589567 |
Jul 21, 2004 |
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Current U.S.
Class: |
623/6.37 |
Current CPC
Class: |
A61F 2/1616 20130101;
A61F 2/1613 20130101; A61F 2220/0016 20130101; A61F 2/1635
20130101; A61F 2002/1683 20130101; A61F 2002/1699 20150401; A61F
2/1648 20130101; A61F 2002/16902 20150401 |
Class at
Publication: |
623/6.37 |
International
Class: |
A61F 2/16 20060101
A61F002/16 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 29, 2004 |
IL |
161706 IL |
Claims
1-23. (canceled)
24. An accommodation measurement implant for measuring
accommodation in an experimental set-up including an animal eye
having a visual axis and including a sclera of tough connective
tissue, an annular ciliary sulcus, and a sphincter-like ciliary
body having a relaxed state for tensioning a capsular diaphragm in
an anterior direction along the visual axis, the implant
comprising: (a) a rigid base member with a haptics system for
penetrating the tough connective tissue of the animal eye's sclera
for self-anchoring said base member in the animal eye's annular
ciliary sulcus at least two spaced apart stationary anchor points,
and having a central aperture; and (b) a convex shaped member for
placing on the animal eye's capsular diaphragm from an anterior
direction and biased away from said base member in a posterior
direction for urging the capsular diaphragm in a posterior
direction, and having an upright pin passing through said aperture
whereupon relaxation of the animal eye's ciliary body urges the
animal eye's capsular diaphragm in an anterior direction for urging
said pin through said aperture.
25. The implant according to claim 24 wherein said pin has
graduations along at least a portion of its length.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a national stage application of
PCT/IL2005/000456 filed May 1, 2005 claiming priority to IL 161706
filed Apr. 29, 2004 and to US 60/589,567 filed Jul. 21, 2004.
TECHNICAL FIELD
[0002] The invention pertains to accommodating intraocular lens
assemblies and apparatus for measuring accommodation in an
experimental set-up including an animal eye.
BACKGROUND OF THE INVENTION
[0003] Commonly owned PCT International Application No.
PCT/IL02/00693 entitled Accommodating Lens Assembly and published
under PCT International Publication No. WO 03/015669 illustrates
and describes accommodating intraocular lens (hereinafter AIOL)
assemblies, the contents of which are incorporated herein by
reference. The AIOL assemblies include a haptics system adapted to
be securely fixed in a human eye's annular ciliary sulcus at at
least two spaced apart stationary anchor points so that it may act
as a reference plane for an AIOL of continuously variable Diopter
strength affected by a human eye's capsular diaphragm acting
thereagainst from a posterior direction and under control of its
sphincter-like ciliary body. The haptics system includes a rigid
planar haptics plate with a telescoping haptics member for sliding
extension. The haptics plate and the haptics member are preferably
self-anchoring as illustrated and described in commonly owned PCT
International Application No. PCT/IL02/00128 entitled Intraocular
Lens and published under PCT International Publication No. WO
02/065951, the contents of which are incorporated herein by
reference. However, the haptics systems are not readily foldable
thereby requiring a relatively large incision for insertion of an
AIOL assembly into a human eye. Still further, anterior movements
of a human eye's capsular diaphragm may lead to bulging of an AIOL
assembly in an anterior direction instead of affecting an AIOL's
Diopter strength. Moreover, the AIOL assemblies do not afford in
situ re-adjustment along a human eye's visual axis which may be
required due to capsular contraction thereby requiring that a
subject resort to wearing spectacles or undergoing a surgical
procedure for correcting his eyesight.
[0004] U.S. Pat. No. 6,739,722 to Laguette et al. illustrates and
describes apparatus for measuring accommodation of a human eye
including a target, a Badal lens, and a viewing aperture where the
Badal lens and the viewing aperture are positioned so that when the
target moves towards or away from the lens, the apparent size of
the target remains constant to a subject looking in the viewing
aperture regardless of the distance the target moves.
BRIEF SUMMARY OF THE INVENTION
[0005] Generally speaking, the present invention pertains to AIOL
assemblies for self-anchoring implantation in a human eye's annular
ciliary sulcus at least two and preferably more spaced apart
stationary anchor points and having an AIOL of variable Diopter
strength capable of in situ selective displacement along the human
eye's visual axis for enabling accurate eyesight correction in
general, and for compensating for capsular contraction in
particular. The AIOLs include at least one shape memory optical
element resiliently elastically deformable between a natural shape
with a first Diopter strength and a deformed shape with a second
Diopter strength different than the first Diopter strength whereby
the AIOL has a continuously variable Diopter strength between a
minimum Diopter strength for distance vision purposes and a maximum
Diopter strength for near vision purposes. The first Diopter
strength can be greater than the second Diopter strength or vice
versa.
[0006] The AIOL assemblies can be implemented in either a two
component construction including a discrete haptics system for
selectively retaining a discrete AIOL or a unitary construction
including a haptics system integrally formed with an AIOL. Axial
re-positioning of a two component AIOL assembly involves
displacement of its AIOL relative to its haptics system which
remains stationary relative to its stationary anchor points.
Against that, axial re-positioning of a unitary AIOL assembly
involves adjusting the position of the portion of its haptics
system holding its AIOL relative to its stationary anchor points.
In the latter case, this is achieved by the haptics system
including haptics plastically deformable on heating to a so-called
glass transmission temperature higher than a human eye's normal
36.degree. C. temperature but sufficiently low not to damage a
human eye's internal structures by irradiation with selective
electromagnetic radiation.
[0007] The present invention also pertains to an accommodation
measurement implant (AMI) for determining accommodation and the
accommodation forces in an experimental set-up including an animal
eye.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In order to understand the invention and to see how it can
be carried out in practice, preferred embodiments will now be
described, by way of non-limiting examples only, with reference to
the accompanying drawings in which similar parts are likewise
numbered, and in which:
[0009] FIG. 1 is a cross section view of an anterior part of a
human eye in its natural near vision condition in an axial plane of
the human body;
[0010] FIG. 2 is a cross section view of an anterior part of a
human eye in its natural distance vision condition in an axial
plane of the human body;
[0011] FIG. 3 is an exploded perspective view of a two component
AIOL assembly including a discrete haptics system and a discrete
natural low Diopter strength AIOL in accordance with the present
invention;
[0012] FIG. 4 is an assembled front view of FIG. 3's AIOL
assembly;
[0013] FIG. 5 is an assembled side view of FIG. 3's AIOL
assembly;
[0014] FIG. 6 is a longitudinal cross section view of FIG. 3's AIOL
in its natural extended position along line B-B in FIG. 5;
[0015] FIG. 7 is a longitudinal cross section view of FIG. 3's AIOL
in a compressed position along line B-B in FIG. 5;
[0016] FIG. 8 is a longitudinal cross sectional view of another
discrete natural low Diopter strength AIOL in its natural state in
accordance with the present invention;
[0017] FIG. 9 is a longitudinal cross sectional view of a natural
discrete high Diopter strength AIOL in its natural state in
accordance with the present invention;
[0018] FIG. 10 is a cross section view of an anterior part of a
human eye showing an initial position of FIG. 3's AIOL assembly
along the human eye's visual axis in an axial plane of the human
body;
[0019] FIG. 11 is a cross section view of an anterior part of a
human eye showing a subsequent position of FIG. 3's AIOL assembly
along the human eye's visual axis for compensating for capsular
contraction in an axial plane of the human body;
[0020] FIG. 12 is a perspective view of a unitary AIOL assembly in
accordance with the present invention;
[0021] FIG. 13 is a front view of FIG. 12's AIOL assembly;
[0022] FIG. 14 is a side view of FIG. 12's AIOL assembly;
[0023] FIG. 15 is a cross section view of an anterior part of a
human eye showing an initial position of FIG. 12's AIOL assembly
along the human eye's visual axis in an axial plane of the human
body;
[0024] FIG. 16 is a cross section view of an anterior part of a
human eye showing a subsequent position of FIG. 12's AIOL assembly
along the human eye's visual axis for compensating for capsular
contraction in an axial plane of the human body;
[0025] FIG. 17 is a perspective view of an accommodation
measurement implant for measuring accommodation and accommodation
forces in an experimental set-up including an animal eye; and
[0026] FIG. 18 is a cross section view showing deployment of the
accommodation measurement implant of FIG. 17.
DETAILED DESCRIPTION OF THE INVENTION
[0027] FIGS. 1 and 2 are cross section views of an anterior part of
a human eye 10 having a visual axis VA in its natural near and
distance vision conditions, respectively, in an axial plane of the
human body. The human eye 10 has a cornea 11 peripherally connected
to a spherical exterior body made of tough connective tissue known
as the sclera 12 at an annular sclero-corneal juncture 13. An iris
14 inwardly extends into the human eye 10 from its root 16 at the
sclero-corneal juncture 13 to divide the human eye's anterior part
into an anterior chamber 17 and a posterior chamber 18. A
sphincter-like peripheral structure known as the ciliary body 19
includes ciliary processes housing ciliary muscles 21 fired by
parasympathetic nerves. The ciliary muscles 21 are connected to
zonular fibers 22 which in turn are peripherally connected to the
equatorial edge of a membrane known as the capsular bag 23 with an
anterior capsule 24 and a posterior capsule 26 enrobing a natural
crystalline lens 27. The iris's root 16 and the ciliary body 19
delimit a portion of the interior surface of the sclera 12 at the
sclero-corneal juncture 13 known as the ciliary sulcus 28. Remnants
of the anterior capsule 24 which may remain after extraction of the
natural crystalline lens 27 and the intact posterior capsule 26 are
referred to hereinafter as the capsular diaphragm 29. Contraction
of the ciliary body 19 allows the lens 27 to thicken to its natural
thickness T1 along the visual axis VA for greater positive optical
power for near vision (see FIG. 1). Relaxation of the ciliary body
19 tensions the zonular fibers 22 which draws the capsular bag 23
radially outward as shown by arrows A for compressing the lens 27
to shorten its thickness along the visual axis VA to T2<T1 for
lower positive optical power for distance vision (see FIG. 2).
[0028] FIGS. 3-5 show a two part AIOL assembly 31 made from
suitable bio-compatible material such as PMMA, and including a
haptics system 32 for self-anchoring implantation in a human eye's
ciliary sulcus 28 for retaining an AIOL 33 therein for enabling
spectacle free vision over the nominal range of human vision. The
haptics system 32 includes a tubular main body 34 with an axial
length L1 along a longitudinal axis 36 (see FIG. 6), and a pair of
diametrically opposite haptics 37 tangentially extending therefrom
in opposite directions in a front view of the haptics system 32.
The haptics 37 have a pair of parallel and opposite attachment
plates 38 with pointed penetrating members 39 of sufficient
strength for forced penetration into the tough connective tissue of
a human eye's sclera 12. The penetrating members 39 are preferably
dimensioned so as to penetrate slightly more than half of a
sclera's thickness of about 1 mm.
[0029] The main body 34 is in the form of a flexible split ring 41
with a male end 42 for releasable interference fit into a
complementary female end 43 such that the main body 34 is capable
of assuming a clamping state for tightly clamping the AIOL 33
therein. The male end 42 and the female end 43 are each provided
with an axially directed bore 44 such that the split ring 41 can be
prized apart by a suitable ophthalmic surgical tool (not shown) to
an unclamping state for enabling axial displacement of the AIOL 33
for positioning purposes for compensating for capsular contraction,
its entire replacement if necessary, and the like.
[0030] The haptics 37 have a thin profile in a plane perpendicular
to the longitudinal axis 36 such that they are sufficiently
flexible for encircling around the main body 34 in a direction
shown by arrow C for facilitating insertion of the haptics system
32 through a relatively small incision into a human eye. FIG. 4
includes a haptics 37 in dotted lines for showing its encircling
around the main body 34. The haptics 37 have a wide profile along
the longitudinal axis 36 such that they are rigid against a
compressive force therealong. The wide profile preferably tapers
from a haptics' proximal end 37A adjacent the main body 34 towards
its distal end 37B remote therefrom.
[0031] The AIOL 33 includes a tubular casing 47 with an axial
length L2 along a longitudinal axis 48, a leading optically clear
aperture lens 49 with an anterior surface 51, and a trailing flange
52. The casing's axial length L2 is longer than the main body's
axial length L1 such that the main body 34 is capable of fully
contacting the casing 47 along an adjustment stroke longer than the
main body's axial length L1. The casing 47 slidingly supports a
tubular piston-like member 53 with a leading flange 54 and a
trailing flange 56 acting as a posterior surface against which a
human eye's capsular diaphragm 29 bears. The AIOL 33 houses a shape
memory optical element 57 made from soft gel or a fluid or gas
filled membrane. The soft gel or fluid may be silicone based or
water based, for example, Balanced Salt Solution (BSS), or any
other biocompatible transparent liquid having a refractive index
similar to that of the natural crystalline lens 27 or greater. The
AIOL 33 includes a flange 58 for abutting against the main body 34
to stop displacement of the AIOL 33 in a posterior direction.
[0032] The optical element 57 has a natural disc shape with a
natural low Diopter strength for distance vision purposes and which
urges the piston-like member 53 to a natural extended position (see
FIG. 6). The optical element 57 is capable of being resiliently
elastically deformed to a deformed shape by a force imparted by a
human eye's capsular diaphragm on relaxation of its ciliary body
acting against the piston-like member 53 in an anterior direction
such that the piston-like member 53 assumes a compressed position
with some of the optical element 57 bulging thereinto for rendering
a high Diopter strength for near vision purposes (see FIG. 7). The
piston-like member 53 is urged from its compressed position
outwards to its natural extended position by the optical element 57
reverting to its natural shape on constriction of a human eye's
ciliary body. Thus, the AIOL has a continuous variable Diopter
strength between a minimum Diopter strength suitable for distance
vision purposes and a maximum Diopter strength suitable for near
vision purposes depending on the degree of compression of the
piston-like member 53 in the casing 47.
[0033] FIG. 8 shows an AIOL 61 also suitable for deployment in the
haptics system 32 for correcting human eyesight. The AIOL 61
includes a tubular casing 62 with a longitudinal axis 63, and a
flat aperture lens 64 constituting an anterior surface and having a
central aperture 66. The casing 62 houses a shape memory optical
element 67 of a natural disc shape, and a semi-spherical
transparent piston-like member 68 having a flat surface 69
juxtaposed against the optical element 67 and a convex shaped
posterior surface 71 against which a human eye's capsular diaphragm
29 directly bears for affecting the AIOL's Diopter strength. The
optical element 67 has a natural low Diopter strength and is
capable of being resiliently elastically deformed to a deformed
shape with some of it bulging through the central aperture 66 on
relaxation of a human eye's ciliary body for increasing the AIOL's
Diopter strength.
[0034] FIG. 9 shows an AIOL 81 also suitable for deployment in the
haptics system 32 for correcting eyesight. The AIOL 81 includes a
tubular casing 82 with a longitudinal axis 83, and a plano-convex
aperture lens 84 constituting an anterior surface. The casing 82
houses a shape memory optical element 86 with a natural spherical
shape and a posterior surface 87 against which a human eye's
capsular diaphragm 29 directly bears for affecting the AIOL's
Diopter strength. The optical element 86 has a natural high Diopter
strength and is capable of being resiliently elastically deformed
to a compressed shape on relaxation of a human eye's ciliary body
urging its capsular diaphragm 29 against the posterior surface 87
in an anterior direction for decreasing the AIOL's Diopter strength
in a similar fashion as the natural crystalline lens 27.
[0035] The implantation of an AIOL assembly of a variable Diopter
strength in a human eye 10 after removal of its natural crystalline
lens 27 is now described in connection with the AIOL assembly 31
with reference to FIGS. 10 and 11. The AIOL assembly 31 is set up
such that the AIOL's longitudinal axis 48 coincides with the
haptics system's longitudinal axis 36 and the annular flange 58
abuts against the main body 34 as shown in FIG. 6. The AIOL
assembly 31 is typically implanted into a human eye 10 after
administration of a suitable muscle relaxant for relaxing both its
ciliary muscles and its iris muscles thereby dilating its pupil.
The capsular diaphragm 29 has some slack by virtue of the removal
of the natural crystalline lens 27. FIG. 10 shows that the haptics
system's puncturing members 39 are forcibly inserted into the
sclera 12 at stationary anchor points AP for retaining the AIOL
assembly 31 in the annular ciliary sulcus 28. FIG. 10 also shows
that the AIOL assembly 31 is deployed such that its longitudinal
axes 36 and 48 are co-directional and preferably co-axial with the
visual axis VA and the trailing flange 56 is urged in a posterior
direction against the capsular diaphragm 29 tensioning same to
become sufficiently taut to urge the AIOL 33 to its extreme
compressed position as shown in FIG. 7 with maximum Diopter
strength suitable for near vision purposes. Constriction of the
ciliary body 19 enables the AIOL 33 to assume its extreme extended
position as shown in FIG. 6 with minimum Diopter strength suitable
for distance vision purposes. In the case of capsular contraction,
the AIOL 33 is unable to assume its extreme extended position but
rather it remains at least partially compressed depending on the
degree of the capsular contraction thereby diminishing its
accommodation ability. The accommodation ability of the AIOL 33 is
restored by prizing open the split ring 41 and moving the AIOL 33
in an anterior direction as evidenced by the gap between the AIOL's
flange 58 and the split ring 41 as seen in FIG. 11.
[0036] FIGS. 12-16 show an AIOL assembly 91 which is similar to the
AIOL assembly 31 but differs therefrom in two respects: First, the
AIOL assembly 91 is unitary insofar that it includes a haptics
system 92 for self-anchoring implantation in a human eye's ciliary
sulcus 28 at least two stationary anchor points AP integrally
formed with an AIOL 93 of variable Diopter strength. And second,
the haptics system 92 has a longitudinal axis 94 and includes a
pair of haptics 96 which are capable of being plastically deformed
from an initial acute angle .theta..sub.1 (see FIG. 15) subtended
with respect to a plane 97 perpendicular to the longitudinal axis
94 to a less acute angle .theta..sub.2<.theta..sub.1 (see FIG.
16) such that the haptics system 92 is capable of in situ selective
displacement of the AIOL 93 from an initial position to a desired
position along a human eye's visual axis VA. This is achieved by
the haptics 96 having regions 98 adjacent the AIOL 93 impregnated
with radiation sensitive bio-compatible chemicals, for example,
Infra Red (IR) sensitive indocyanine green (ICG), and the like,
such that the haptics 96 are plastically deformable on heating to a
so-called glass transmission temperature higher than a human eye's
normal 36.degree. C. temperature but sufficiently low so as to not
damage a human eye's delicate internal structures.
[0037] FIGS. 17 and 18 show an accommodation measurement implant
(AMI) 101 for determining accommodation and accommodation forces in
an experimental set-up including an animal eye similar to a human
eye and therefore likewise numbered. The AMI 101 includes a
generally rectangular rigid planar base member 102, and a central
aperture 103. The base member 102 includes a haptics system 104 in
the form of oppositely directed pointed puncturing members 106 for
self-anchoring at anchor points AP. A convex shaped member 107
suitably shaped and dimensioned for placing on an animal eye's
capsular diaphragm 29 from the anterior direction is provided with
an upright pin 108 having a pinhead 109 and passing through the
aperture 103. The pin 108 includes a series of graduations 111
therealong at a pitch of less than 500 .mu.m, and preferably at 250
.mu.m. A helical compression spring 112 is placed between the base
member 102 and the convex shaped member 207 for urging them apart
to be stopped by the pinhead 109 abutting against the base member
102. The base member 102, the convex shaped member 107, and the pin
108 are preferably formed of a suitable biocompatible material, for
example, stainless steel, PMMA, and the like. Accommodation is
determined as a function of a pin's displacement relative to the
base member 102 as a result of relaxation of the ciliary body 19.
Pin displacements may be detected by external devices or
alternatively the graduations 111 may be inspected by a direct eye
inspection. The actual forces developed by the relaxation of a
ciliary body can be determined as a function of the compression
spring's spring constant k and pin displacement.
[0038] While the invention has been described with respect to a
limited number of embodiments, it will be appreciated that many
variations, modifications, and other applications of the invention
can be made within the scope of the appended claims.
* * * * *