U.S. patent application number 12/767740 was filed with the patent office on 2010-09-09 for disposable intraocular lens insertion system.
This patent application is currently assigned to STAAR SURGICAL COMPANY. Invention is credited to Daniel C. Eagles, Vladimir Feingold.
Application Number | 20100228261 12/767740 |
Document ID | / |
Family ID | 23354735 |
Filed Date | 2010-09-09 |
United States Patent
Application |
20100228261 |
Kind Code |
A1 |
Feingold; Vladimir ; et
al. |
September 9, 2010 |
DISPOSABLE INTRAOCULAR LENS INSERTION SYSTEM
Abstract
An intraocular lens injection system comprising an injecting
device and cartridge. The cartridge comprises a lens holding
portion and an outer sleeve portion. The invention includes a
method of pre-loading the injecting system, particularly the
cartridge, to reduce the amount of packaging, prevent damage to the
intraocular lens during packaging and shipping, allow the
pre-loaded injecting cartridge to be autoclaved as a unit, and
eliminate the step of loading the cartridge with the intraocular
lens by the end user to prevent potential damage during this
step.
Inventors: |
Feingold; Vladimir; (Laguna
Niguel, CA) ; Eagles; Daniel C.; (Capistrano Beach,
CA) |
Correspondence
Address: |
FULWIDER PATTON LLP
HOWARD HUGHES CENTER, 6060 CENTER DRIVE, TENTH FLOOR
LOS ANGELES
CA
90045
US
|
Assignee: |
STAAR SURGICAL COMPANY
Monrovia
CA
|
Family ID: |
23354735 |
Appl. No.: |
12/767740 |
Filed: |
April 26, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11190311 |
Jul 26, 2005 |
7704258 |
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12767740 |
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10171776 |
Jun 17, 2002 |
6921405 |
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11190311 |
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09038053 |
Mar 11, 1998 |
6406481 |
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10171776 |
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08747308 |
Nov 12, 1996 |
5728102 |
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09038053 |
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08345360 |
Nov 18, 1994 |
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08747308 |
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08240520 |
Jul 19, 1994 |
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08345360 |
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08221013 |
Apr 1, 1994 |
5494484 |
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08240520 |
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08220999 |
Apr 1, 1994 |
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08221013 |
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08197604 |
Feb 17, 1994 |
5499987 |
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08220999 |
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08196855 |
Feb 15, 1994 |
5941886 |
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08197604 |
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08195717 |
Feb 14, 1994 |
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08196855 |
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07953251 |
Sep 30, 1992 |
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08195717 |
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Current U.S.
Class: |
606/107 |
Current CPC
Class: |
A61F 2/167 20130101;
A61F 2/1664 20130101; A61F 2/1667 20130101; A61F 2/1678
20130101 |
Class at
Publication: |
606/107 |
International
Class: |
A61F 9/007 20060101
A61F009/007 |
Claims
1-21. (canceled)
22. An injector system for replacing a cataractuous lens with an
intraocular lens, comprising: a lens receiving portion for
receiving and storing a foldable intraocular lens; a nozzle portion
connected to and extending from the lens receiving portion and
having an outer wall and a free end, the lens receiving portion and
the nozzle portion having a continuous passageway extending
therethrough, the passageway shaped to reduce an outer dimension of
the foldable intraocular lens as it transits through the
passageway; and a transition portion located between the lens
receiving portion and the nozzle portion, the transition portion
having a pair of longitudinal grooves through which the deformable
intraocular lens is guided, the grooves remaining in the same
horizontal plane.
23. The system of claim 22, wherein the receiving portion is
disposed within a removable cartridge configured to be mounted to a
barrel.
24. The system of claim 23, wherein a movable plunger is movably
disposed within the barrel.
25. The system of claim 22, further comprising a cartridge receiver
mounted at one end of the barrel for receiving the removable
cartridge.
26. The system of claim 23, wherein at least one of the injecting
device and cartridge are made of readily disposable material.
27. The system of claim 23, wherein at least one of the injecting
device and cartridge are made of autoclavable material.
28. The system of claim 22, wherein said injecting device is made
of one or more materials selected from the group consisting of
polysulfone, polycarbonate, nylon-66, TEFLON, and KYNAR.
29. The system of claim 22, further comprising: a deformable
intraocular lens loaded within the lens receiving portion for
storage.
29. A system for replacing a cataractuous lens with an intraocular
lens, comprising: an injector having: a lens receiving portion for
receiving and storing a foldable intraocular lens, a nozzle portion
connected to and extending from the lens receiving portion and
having an outer wall and a free end, the lens receiving portion and
the nozzle portion having a continuous passageway extending
therethrough, the passageway shaped to reduce an outer dimension of
the foldable intraocular lens as it transits through the
passageway, and a transition portion located between the lens
receiving portion and the nozzle portion, the transition portion
having a pair of longitudinal grooves through which the deformable
intraocular lens is guided, the grooves remaining in the same
horizontal plane; and a deformable intraocular lens loaded within
the lens receiving portion for storage and shipment.
Description
RELATED APPLICATIONS
[0001] This is a continuation-in-part of U.S. patent application
entitled "INTRAOCULAR LENS INSERTION SYSTEM", Ser. No. 07/953,251
filed on Sep. 30, 1992, now abandoned; U.S. patent application
entitled "METHODS OF IMPLANTATION OF INTRAOCULAR LENS", Ser. No.
08/195,717 filed on Feb. 14, 1994, now pending; U.S. patent
application entitled "HINGELESS INTRAOCULAR LENS MICROCARTRIDGES,
Ser. No. 08/196,855 filed on Feb. 15, 1994, now pending; U.S.
patent application entitled "INTRAOCULAR LENS MICROCARTRIDGE, Ser.
No. 08/197,604 filed on Feb. 17, 1994, now pending, U.S. patent
application entitled "METHOD FOR THE SURGICAL IMPLANTATION OF A
DEFORMABLE INTRAOCULAR LENS IN THE EYE", Ser. No. 08/220,999 filed
on Apr. 1, 1994, now pending, and U.S. patent application entitled
"INTRAOCULAR LENS INJECTION SYSTEM" filed on May 10, 1994, now
pending, and all fully incorporated by reference herein.
FIELD OF THE INVENTION
[0002] This invention relates to an intraocular lens insertion
system having one or more disposable components, in particular an
intraocular injection system comprising two separate main
components including a disposable injecting device and a disposable
cartridge.
BACKGROUND
[0003] The intraocular lens injection system currently being sold
and marketed by STAAR Surgical Company of California has gain
widespread acceptance in the field of intraocular lens replacement.
The current system utilizes an injector made of titanium so that
the unit can be autoclaved and reused numerous times. The
components of the titanium injector are machined from bar stock to
a high degree of accuracy according to current specifications, and
then the components are assembled into the final injector unit. The
cost of the materials, and labor costs involve with machining and
assembly are substantial providing an incentive to seek less
expensive alternatives. Further, the steps of cleaning and
autoclaving the injector unit between operations is a time burden
and nuisance to busy surgeon practitioners having back-to-back
operation schedules. In addition, the injector must be properly
autoclaved to ensure complete cleaning and sterilization to prevent
spread of diseases causing eye infections or other infectious
diseases, prevent transmission of body fluid and prevent resulting
liability problems to surgeon practitioners. These any other
considerations have led to the development of the present
invention.
SUMMARY OF THE INVENTION
[0004] An object of the present invention is to provide a
disposable intraocular lens insertion system.
[0005] A second object of the present invention is to provide one
or more disposable components of an intraocular lens insertion
system.
[0006] A third object of the present invention is to provide a
disposable intraocular lens insertion system comprising two main
separate components including a disposable injecting device and
disposable cartridge.
[0007] A fourth object of the present invention is to provide a
disposable injecting device for an intraocular lens injection
system.
[0008] A fifth object of the present invention is to provide a
disposable cartridge for an intraocular lens injection system.
[0009] A sixth object of the present invention is to provide a
disposable cartridge having a downwardly tapering passageway for
further folding the intraocular lens as it moves through the
cartridge.
[0010] A seventh object of the present invention is to provide a
disposable cartridge unit including a disposable cartridge
containing a preloaded foldable intraocular lens.
[0011] A eighth object of the present invention is to provide a
two-piece disposable cartridge system comprising a lens holding
portion and a sleeve portion.
[0012] A ninth object of the present invention is to provide an
intraocular lens injecting system comprising a cartridge, which
front loads and locks to a injecting device.
[0013] A tenth object of the present invention is to provide an
intraocular lens injecting system having a pre-loaded intraocular
lens for storage and shipment.
[0014] An eleventh object of the present invention is to provide an
intraocular lens injecting system comprising an injecting device
and cartridge with an intraocular lens pre-loaded in the cartridge
for storage and shipment.
[0015] These and other objects can be achieved by various
embodiments of the present invention. Specifically, one or more
components of the intraocular lens insertion system according to
the present invention are disposable. Preferably, the entire system
excluding the intraocular lens itself is disposable to provide the
full advantages according to the present invention.
[0016] The components of the intraocular lens insertion system
according to the present invention must withstand sterilization
methods, in particular autoclaving, in order to be practically
utilized. Preferably, the components of the intraocular lens
insertion system according to the present invention are made from
plastic, most preferably autoclavable plastic (i.e. plastic having
a melting point above approximately 121 degree Celsius) such as
polysulfone, polycarbonate, nylon-66, TEFLON and KYNAR that can
withstand the conditions of high temperature and pressure inside
conventional autoclaving units. Further, the use of plastic allows
the components of the intraocular injection system to be injection
molded and quickly assembled significantly reducing cost in the
construction thereof verses a stainless steel injector.
[0017] An embodiment of the disposable injection system comprises
two separate main components including an injecting device having a
barrel with a cartridge receiver for accommodating a cartridge, and
a cartridge for accommodating a foldable intraocular lens. The
injecting device preferably includes a cylindrical barrel having
one end open, and an opposite end fitted with a movable plunger.
Specifically, the end fitted with the movable plunger is provided
with a guide for defining a passageway for accommodating the
movable plunger. The guide is preferably molded as part of the
inside of the cylindrical barrel, however, alternatively can be
made as a separate piece and then assembled in some suitable manner
inside the cylindrical barrel.
[0018] The guide preferably is configured to allow sliding movement
of the movable plunger in a longitudinal direction with relation to
the cylindrical barrel, however, not allowing rotational movement
of the movable plunger with respect to the cylindrical barrel. For
example, the guide is provided with a keyway preventing relative
rotation. In one preferred embodiment, the passageway through the
guide has a passageway with a cross-sectional shape matching a
movable plunger preventing relative rotation.
[0019] The open end of the cylindrical barrel provides a
cylindrical shaped receiver for accommodating the cartridge
containing the intraocular lens. Further, the open end of the
cylindrical barrel is provided with means for connecting and
securely retaining the cartridge inside the front open end of the
cylindrical barrel. For example, a snap fit connection is provided
between the cylindrical barrel and cartridge so that when the
cartridge is inserted in the end of the cylindrical barrel these
components snap fit together forming a secure connection.
Alternatively or in addition, an interference type connection can
be provided between the open front end of the cylindrical barrel
and the cartridge so that these components are securely connected
together when inserting the cartridge into the open end of the
cylindrical barrel. The interference connection can be provided by
sizing the outer dimensions of the cartridge slightly greater than
the inner dimension of the open end of the barrel. Further, one or
both components can have tapering outer surfaces or taps that
interfere with each other to provide the interference type
connection.
[0020] One end of the plunger is provided with a manipulating tip
for making contact with the intraocular lens, forcing the
intraocular lens from the cartridge, and manipulating the
intraocular lens inside the eye, and an opposite end provided with
means for actuating the plunger. The opposite end can be provided
with a freely rotating finger tip gripping device to allow a user
to exert sufficient pressure on the end of the plunger to
controllably force the intraocular lens from the cartridge. For
example, the finger tip gripping device is provided with a fluted
exterior surface to facilitate gripping thereof, and a through hole
having a predetermined size. The end of the plunger component is
provided with an extension having a hooked end that can be forced
into and through the through hole in the finger tip gripping device
providing a snap connection between these components, and also
allowing free rotation between these components.
[0021] The manipulating end is faceted in a particular manner to
prevent damage to the intraocular lens, particularly the trailing
haptic, during the step of forcibly pushing the intraocular lens
through the nozzle of the cartridge and into the eye.
[0022] The disposable cartridge can have a variety of
configurations. A preferred embodiment according to the present
invention involves a two-piece cartridge system. A lens holding
portion of the disposable cartridge is defined by an outer
cylindrical surface having a wall portion partially removed along
the upper length of a body portion thereof defining a longitudinal
access opening into the lens holder portion. The lower side of the
body portion is provided with a groove and two ramp type catches
provided to define a snap fit connection with a cantilever spring
as part of the outer cylindrical sleeve portion to be described in
detail below.
[0023] The lens holder portion is provided with an inner surface
having a C-shaped cross-sectional shape. Further, at the end of the
lens holder portion opposite to the nozzle portion, a groove is
provided in the inner surface to accommodate a trailing haptic when
the intraocular lens is loaded inside the cartridge. In addition,
the inside surface of the lens holder portion is provided with a
pair of longitudinal protrusions running along the inside edges of
the longitudinal access opening in the lens holder portion serving
to secure the edges of the loaded foldable intraocular lens to
prevent inadvertent movement or dislodging of the intraocular lens
from the cartridge and used as guides to slide the lens and fold it
during the advancement of the plunger forward.
[0024] The lens holder portion includes a nozzle portion, having a
oral-shaped cross-sectional inner wall, disposed at one end of the
body portion forming a one-piece plastic molded construction.
Importantly, the passageway through the body portion is continuous
and transitions with the passageway through the nozzle portion.
Specifically, the inner wall defining the passageway through the
body portion is continuous and smoothly transitions with the inner
wall defining the passageway through the nozzle portion. At the
transition between the body portion and nozzle portion is a
tapering transition portion having downwardly tapering wall
surfaces, since the inner width dimension of the C-shaped
cross-sectional passageway through the body portion is wider than
the inner width dimension of the oval-shaped cross-sectional
passageway through the nozzle portion.
[0025] An intraocular lens is loaded into the cartridge by resting
the lens on top of the body portion so that it bridges the sides of
the longitudinal opening in the open passageway of the body
portion. Tweezers or some other suitable manipulating instrument is
used to press against the center of the intraocular lens in a
downward direction so that the intraocular lens bends in the center
along the longitudinal opening with the sides of the opening acting
as guides for supporting outer edges of the intraocular lens. The
intraocular lens is forced downwardly until it is fully loaded into
the body portion in a folded configuration, specifically, a
C-shaped folded configuration matching the C-shaped cross-section
inner walls of the body portion. In the embodiment of the cartridge
having foldable portions, the intraocular lens can be loaded flat
into the cartridge and folded into a C-shaped configuration as it
is being loaded into the injecting device.
[0026] The two-piece cartridge system includes a sleeve portion,
preferably a cylindrical or oval shaped sleeve portion, that
surrounds the body portion of the lens holding portion. The
cylindrical sleeve portion has an outer cylindrical surface to be
received within the open end receiver of the cylindrical barrel of
the injector. The cylindrical sleeve portion can be provided with a
longitudinal protrusion or key to be received within a longitudinal
groove or keyway inside the open end receiver of the cylindrical
barrel of the injector. This arrangement prevents rotation of the
lens holder portion within the cylindrical sleeve portion.
[0027] The wall of the cylindrical sleeve portion is provided with
a pair of set apart slits extending in the longitudinal direction
of the cylindrical sleeve portion defining a cantilever spring
provided with a hooked end or catch that cooperates with the pair
of ramp type catches provided in the groove in the lower side of
the lens holder portion of the cartridge defining the snap fit
connection therebetween. Specifically, the catch of the cantilever
spring of the cylindrical sleeve portion cooperates with one catch
in the groove in the lens holder portion to prevent the cylindrical
sleeve portion to be removed from the lens holder portion. In this
position, the cartridge is in a configuration for loading the
intraocular lens into the cartridge. When the cartridge is closed
after loading the intraocular lens into the lens holding portion,
the catch of the cantilever spring of the cylindrical sleeve
portion cooperates with the other catch in the groove in the lens
holder portion to lock the cylindrical sleeve portion in the closed
position on the lens holder portion.
[0028] The present invention includes the concept of pre-loading
the intraocular lens in the injection system. Specifically, a
potentially preferred method of making and selling intraocular lens
is to pre-load the intraocular lens in the injection device for
purposes of storage and shipping. For example, the intraocular lens
can be manufactured, and then placed inside the injecting device or
cartridge (i.e. inside injecting system) prior to being packaged
and shipped to a customer. This method reduces the amount of
packaging by not requiring separate packages for the intraocular
lens and the cartridge and/or injecting device. Further, the
cartridge and/or injecting device protects the intraocular lens
during the process of packaging, shipping and other handling, and
eliminates the step of loading the intraocular lens into the
cartridge and/or injecting device that could potentially cause
damage thereto.
[0029] This method would allow the cartridge and/or injecting
device and pre-loaded intraocular lens to be autoclaved together
prior to injection of the intraocular lens.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] FIG. 1 is a perspective view of a preferred embodiment of
the intraocular lens injection system according to the present
invention.
[0031] FIG. 2 is a side longitudinal cross-sectional view of the
intraocular lens injection system shown in FIG. 1.
[0032] FIG. 3 is a longitudinal side cross-sectional view of the
cylindrical barrel of the intraocular lens injection system shown
in FIG. 2.
[0033] FIG. 4 is a transverse cross-sectional view through the
movable plunger, guide, and cylindrical barrel, as indicated in
FIG. 2, to illustrating the movable plunger guiding
arrangement.
[0034] FIG. 5 is a longitudinal side elevational view of the
plunger portion having the manipulating tip.
[0035] FIG. 6 is a transverse cross-sectional view of the plunger
portion, as indicated in FIG. 5.
[0036] FIG. 7 is a transverse cross-sectional view of the plunger
portion, as indicated in FIG. 5.
[0037] FIG. 8 is a transverse cross-sectional view of the plunger
portion, as indicated in FIG. 5.
[0038] FIG. 9 is an end elevation view of the manipulating tip of
the plunger portion shown in FIG. 5.
[0039] FIG. 10 is a longitudinal side elevational view of the
plunger portion that connects to the plunger portion shown in FIG.
5.
[0040] FIG. 11 is an end elevational view of the plunger portion
shown in FIG. 10.
[0041] FIG. 12 is a transverse cross-sectional view of the plunger
portion, as indicated in FIG. 10.
[0042] FIG. 13 is a transverse cross-sectional view of the plunger
portion, as indicated in FIG. 11.
[0043] FIG. 14 is a cross-sectional view of the gripping device to
be connected to the plunger, as shown in FIG. 2.
[0044] FIG. 15 is a side elevational view of the gripping device
shown in FIG. 14.
[0045] FIG. 16 is an end elevational view of the gripping device
shown in FIG. 14.
[0046] FIG. 17 is a perspective view of a preferred cartridge
according to the present invention.
[0047] FIG. 18 is a perspective view of the lens holding portion of
the preferred cartridge shown in FIG. 17.
[0048] FIG. 19 is a is a longitudinal side elevational view of the
lens holding portion shown in FIG. 18.
[0049] FIG. 20 is a top planar view of the lens holding portion
shown in FIG. 18.
[0050] FIG. 21 is a transverse cross-sectional view of the of the
lens holding portion, as indicated in FIG. 19.
[0051] FIG. 22 is a transverse cross-sectional view of the lens
holding portion, as indicated in FIG. 19.
[0052] FIG. 23 is an end elevational view of the end of the lens
holding portion as indicated in FIG. 19.
[0053] FIG. 24 is a perspective view of the sleeve portion of the
preferred cartridge shown in FIG. 17.
[0054] FIG. 25 is another perspective view of the sleeve portion of
the preferred cartridge shown in FIG. 17.
[0055] FIG. 26 is a longitudinal cross-sectional view of the sleeve
portion shown in FIG. 24.
[0056] FIG. 27 is longitudinal side elevational view of the sleeve
portion shown in FIG. 24 with ghost images of the guiding surfaces
of the protrusion located inside the sleeve portion.
[0057] FIG. 28 is an end elevational view of the of the sleeve
portion, as indicated in FIG. 27.
[0058] FIG. 29 is an exploded partial end elevational view of the
sleeve portion shown in FIG. 27.
[0059] FIG. 30 is another perspective view of the lens holding
portion showing the longitudinal groove in the wall of the lens
holding portion with a pair of ramp catches.
[0060] FIG. 31 is an end elevational view of the preferred
cartridge shown in FIG. 17 revealing the detailed configuration of
the lens guiding surfaces inside the cartridge.
[0061] FIG. 32 is a longitudinal cross-sectional view of another
embodiment of an injecting device according to the present
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0062] The term intraocular lens injection system according to the
present invention is used to define two separate main components
including an injecting device and a cartridge. The injecting device
includes a cartridge receiver for accommodating a cartridge, and
the cartridge is configured to accommodate a foldable intraocular
lens. The foldable intraocular lens is first loaded into the
cartridge, and then the cartridge is loaded into the injecting
device providing an intraocular lens injection system readied for
conducting the implantation operation.
[0063] The term disposable in the context of the present invention
is to indicate that the one or more components of the intraocular
lens injection system according to the present invention can be
readily discarded after use due to the inexpensive nature of the
design, construction, and materials of the components. The use of
disposable components provides a variety of convenience factors
such as preloading disposable cartridges with foldable intraocular
lens, improved handling characteristics, reducing weight, and most
importantly ensuring a high level of sterility protecting the
patient from disease.
[0064] A preferred embodiment of the intraocular lens injection
system 10 according to the present invention is shown in FIG. 1.
The intraocular lens injection system comprises two main components
including an injecting device 12 and a cartridge 14.
[0065] The injecting device 12 comprises a cylindrical barrel 16
having a cartridge receiver 18 located at one end thereof, as shown
in FIG. 2. The barrel 16 can have other suitable cross-sectional
shapes, however, a cylindrical-shaped barrel is particular suitable
for making, assembling, and utilizing the injecting device 12. The
cartridge receiver 18 accommodates the cartridge 14, which is
securely connected to the injecting device 12 when inserted into
the cartridge receiver 18. For example, an interference type
connection can be provided between the injecting device 12 and
cartridge 14 by making one or more outer dimensions of the
cartridge 14 slightly larger than one or more inner dimensions of
the cartridge receiver 18. Alternatively or in addition, a snap
type connection can be provided between the injecting device 12 and
cartridge 14. Further, either or both type of connections can be
made so that the cartridge is either removable or non-removable
after insertion into the cartridge receiver 18. Preferably, the
injecting device 12 and cartridge 14 are designed so that the
cartridge 14 can not be rotated within the cartridge receiver 18 to
prevent any relative movement therebetween which can detract from
the manipulating characteristics of the intraocular lens injection
system.
[0066] The design of the cylindrical barrel 12 itself is shown in
FIG. 3. The barrel comprises a portion 12a having thicker walls to
provide structural strength against bending in the longitudinal
direction, and a portion 12b having thinner walls defining the
cartridge receiver 18. An inner edge 18a at the transition between
the portions 12a and 12b defines a stop for the cartridge 14 when
inserted into the cartridge receiver 18.
[0067] The injecting device 12 further includes a movable plunger
20 disposed within the cylindrical barrel 16. Specifically, the
movable plunger 20 is movable disposed within the cylindrical
barrel for movement forward or backwards with respect to the
longitudinal direction of the cylindrical barrel 12. The movable
plunger 20 includes a manipulating tip 22 for engaging with the
intraocular lens for forcing the intraocular lens from the loaded
cartridge 14. In the intraocular lens injection system 10, the
plunger 20 comprises two plunger portions 20a and 20b, as shown in
FIGS. 2, 5 and 6. The two portions 20a and 20b can have a one-piece
construction, or can be made as two separate pieces connected
together is some suitable manner.
[0068] The detailed design of the plunger portion 20a of the
movable plunger 20 is shown in FIGS. 5 to 9, and the detailed
design of the plunger portion 20b of the movable plunger 20 is
shown in FIGS. 10 to 13.
[0069] The plunger portion 20a includes a connector portion 21a
(FIG. 5) for connecting with a connector portion 21b (FIG. 10) of
the plunger portion 20b. Preferably, an interference type
connection and/or snap fit type connection is provided by the
connector portions 21a and 21b to facilitate assembly. In the
embodiment shown, a keyway type connection is provided by the flat
surfaces 21a' of the connector portion 21a (FIG. 6) cooperating
with the flat key surface 21b' of the connector portion 21b (FIG.
13). The keyway type connection prevents relative rotation between
the plunger components 20a and 20b after the plunger 20 is
assembled.
[0070] The detail design of the manipulating tip 22 is shown in
FIG. 9. The manipulating tip 22 is defined by a plurality of facets
for manipulating the intraocular lens from the cartridge and in the
eye. Specifically, the manipulating tip comprises a curved surface
facet 22a, curved surface facet 22b, concave surface facet 22c,
upper protrusion facet 22d, and lower protrusion facet 22e.
[0071] In the preferred embodiment of the intraocular lens
injection system 10, the movable plunger 20 is slidably disposed
within the cylindrical barrel 12. Specifically, a guide 24 is
disposed within the cylindrical barrel 12, which guide 24 is
provided with a passageway 26 for slidably supporting the movable
plunger 20. In the embodiment shown, the inner dimensions of the
passageway 26 of the guide 24 are slightly greater than the outer
dimensions of the movable plunger 20 to provide the guide
arrangement. Further, the cross-section shape of the passageway 26
is preferably made the same as the cross-sectional shape of the
movable plunger 20 (i.e. matching shapes) to enhance a close
tolerance fit therebetween to improve sliding accuracy. More
preferably, the cross-sectional shapes of the passageway 26 of the
guide 24 and the movable plunger 20 are interlocking to prevent
relative rotation between the cylindrical barrel 12 fixed to the
guide 24 and the movable plunger 12, again to enhance the
manipulating characteristics of the intraocular lens injection
system 10. For example, the cross-sectional shapes of the
passageway 26 of the guide 24 and the movable plunger 20 can be
cross-shaped to provide an interlocking arrangement, as shown in
FIG. 4.
[0072] In the embodiment shown in FIG. 2, the guide 24 is part of
the cylindrical barrel 12. For example, the cylindrical barrel 12
can be injection molded from plastic to include the guide 24 as a
one-piece unit. Alternatively, the guide 24 can be made as a
separate piece, and then assembled inside the cylindrical barrel
12. Further, in the embodiment shown, the guide 24 is provided at
one end of the cylindrical barrel 12, however, the guide 24 can be
located at a position inside the cylindrical barrel 12 away from
the end of the cylindrical barrel 12.
[0073] The movable plunger 20 is provided with a finger tip
gripping device 28 located at an end opposite to the manipulating
tip 22. The gripping device 28 is preferably connected in a freely
rotating manner with the end of the plunger 20, however, a
non-rotating type connection can also be utilized.
[0074] In the preferred embodiment of the intraocular injection
system 10, the gripping device is essentially cylindrical-shaped,
and having an inner diameter slightly greater than the outer
diameter of the cylindrical barrel 12 to allow an end portion of
the cylindrical barrel 12 to be accommodated inside the gripping
device 28 when the movable plunger 20 is moved towards the right in
FIG. 1. The outer surface of the gripping device can be fitted to
increasing the gripping ability by a user's finger tips.
[0075] The gripping device 28 is provided with an end portion 30
having a passageway 32 for accommodating a protrusion 34 having a
hooked end portion 35 of the movable plunger 20. Specifically, the
hooked end portion 34 is provided with a conical tapering surface
35a having a lip 35b (FIG. 11) with a slightly greater diameter
than the passageway 32 in the end portion 30 to provide a snap fit
connection therebetween. Thus, the gripping device 28 can be easily
assembled onto the movable plunger 20 by forcing the hooked end
portion through the passageway 32.
[0076] The detailed design of the gripping device 28 is shown in
FIGS. 14 to 16.
[0077] In FIG. 14, the passageway 32 in the end portion 32 of the
gripping device 28 is provided with a conical tapering surface 32'
to facilitate entry of the hooked end 35 of the plunger 20 into and
through the passageway 32 during assembly. The outside of the
gripping device 28 can be provided with a plurality of longitudinal
ribs 36 equally spaced around the perimeter of the gripping device
28, as shown in FIGS. 15 and 16.
[0078] A preferred embodiment of the cartridge 14 is shown in FIGS.
17 to 28.
[0079] The cartridge 14 comprises two main separate components
including a lens holding portion 38 and a sleeve portion 38. The
lens holding portion 38 is defined by a body portion 42 having a
passageway 45, and a nozzle portion 46 having a passageway 48, as
shown in FIGS. 18 to 22.
[0080] The body portion 42 is defined by a lens receiving portion
50 and a lens transition portion 52, as shown in FIG. 20. The lens
receiving portion 50 has a fixed cross-sectional size and shaped
passageway 45a (FIGS. 20 and 21). Specifically, the lens receiving
portion 50 has a C-shaped cross section defining the open
passageway 44a that does not vary in shape or size along the length
of the lens receiving portion 50. Further, the lens transition
portion 52 has a variable or downwardly tapering cross-sectional
size and shape closed passageway 45b (FIGS. 20 and 22).
Specifically, the transition portion 52 initially has a C-shaped
cross section defining the beginning of closed passageway 45b and
matching passageway 45a, however, the shape changes from C-shaped
(i.e. open passageway design), to D-shaped (i.e. closed passageway
design), to oval (i.e. closed passageway design) along the length
of the lens transition portion 52.
[0081] The lens receiving portion 50 and an initial portion of the
lens transition portion having a C-shaped cross section passageway
include a pair of gripping edge protrusions 54 positioned on either
side of opening 56 into passageway 45a. The gripping edge
protrusions 54 grip the outer edges of the folded intraocular lens
once inserted into the lens receiving portion 50.
[0082] The nozzle portion 44 is located at one end of the body
portion 42. Preferably, the lens holding portion 38 including the
body portion 42 and nozzle portion 44 are a molded one-piece
construction.
[0083] The nozzle portion 44 having passageway 48 has an
oval-shaped cross-sectional shape. However, the cross-sectional
size tapers downwardly from the body portion 42 to the end of the
nozzle portion 44 (See tapering passageway 48 in FIG. 22).
[0084] The detailed design of the sleeve portion 40 is shown in
FIGS. 24 to 29.
[0085] The sleeve portion 40 is essentially cylinder-shaped.
Specifically, the inner diameter is approximately equal to the
outer diameter of the cylindrical body portion 42 of the lens
holding portion 38. The cartridge 14 is assembled by inserting the
body portion 42 of the lens holding portion into the sleeve portion
40 until the end of the sleeve portion contacts with the edge 58
(FIG. 19) of the lens holding portion 38.
[0086] The sleeve portion 40 includes a cantilever spring 60 having
a catch 61 provided at the end thereof. The cantilever spring 60 is
formed by providing a pair of parallel slits 62 in the wall of the
sleeve portion 40. Further, the cantilever spring 60 is thicker
than the wall of the sleeve portion 40 and extends along a portion
of the outside thereof defining a protrusion 64 forming a keyway
with the cartridge receiver 18 of the cylindrical barrel 12 of the
injecting device.
[0087] The sleeve portion 40 is provided with a lens guiding
protrusion 66 extending from the inner surface thereof into an
upper portion of the passageway 44 in the body portion 42. The lens
guiding protrusion 66 is defined by a pair of downwardly tapering
grooves 68, 68 (FIGS. 28 and 29) positioned side-by-side defining a
center protrusion 70. Both the downwardly tapering grooves 68
having tapering lens guiding surfaces 66a and center protrusion 70
having tapering lens guiding surface 66b taper in such a manner as
to close down the cross-sectional size of the open passageway 45a
through the body portion 38.
[0088] An outer portion of the lens holding portion 38 is provided
with a longitudinal groove 72 having a pair of engaging ramp type
catches 74 and 76 located in the groove 72, as shown in FIG. 28.
The ramp type catches 74 and 76 cooperated with the catch 61 of the
cantilever spring 60 to lock the sleeve portion 40 onto the lens
holding portion at two different locations.
[0089] The detailed configuration of the lens guiding surfaces
inside the cartridge 14 is shown in FIG. 31.
[0090] Another embodiment of the injecting device 110 is shown in
FIG. 32. This embodiment is provided with an a fingertip gripping
device and a thumb gripping device 128, as shown to enhance
manipulating and using the device.
[0091] The present invention includes the concept of pre-loading
the intraocular lens in the injection system. Specifically, a
potentially preferred method of making and selling intraocular lens
is to pre-load the intraocular lens in the injection device for
purposes of storage and shipping. For example, the intraocular lens
can be manufactured and then placed inside the injecting device or
cartridge (i.e. inside injecting system) prior to being packaged
and shipped to a customer. This method reduces the amount of
packaging by not requiring separate packages for the intraocular
lens and the cartridge and/or injecting device. Further, the
cartridge and/or injecting device protects the intraocular lens
during the process of packaging, shipping and other handling, and
eliminates the step of loading the intraocular lens into the
cartridge and/or injecting device that could potentially cause
damage thereto.
[0092] This method would allow the cartridge and/or injecting
device and pre-load intraocular lens to be autoclaved together
prior to injection of the intraocular lens.
* * * * *