U.S. patent application number 12/783144 was filed with the patent office on 2010-12-02 for intraocular lens delivery system with a disposable plunger segment and method of use therefor.
Invention is credited to David A. DOWNER, Sushant MUCHHALA.
Application Number | 20100305577 12/783144 |
Document ID | / |
Family ID | 42481052 |
Filed Date | 2010-12-02 |
United States Patent
Application |
20100305577 |
Kind Code |
A1 |
MUCHHALA; Sushant ; et
al. |
December 2, 2010 |
INTRAOCULAR LENS DELIVERY SYSTEM WITH A DISPOSABLE PLUNGER SEGMENT
AND METHOD OF USE THEREFOR
Abstract
The present invention is directed to an intraocular lens
delivery system with a multi-segment plunger. More particularly,
the present invention relates to an intraocular lens delivery
device that includes a disposable plunger tip segment that can be
attached and removed from a reusable plunger base segment.
Inventors: |
MUCHHALA; Sushant;
(Kennedale, TX) ; DOWNER; David A.; (Fort Worth,
TX) |
Correspondence
Address: |
ALCON
IP LEGAL, TB4-8, 6201 SOUTH FREEWAY
FORT WORTH
TX
76134
US
|
Family ID: |
42481052 |
Appl. No.: |
12/783144 |
Filed: |
May 19, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61182270 |
May 29, 2009 |
|
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|
Current U.S.
Class: |
606/107 |
Current CPC
Class: |
A61F 2/167 20130101;
A61F 2/1678 20130101 |
Class at
Publication: |
606/107 |
International
Class: |
A61F 9/007 20060101
A61F009/007 |
Claims
1. A disposable plunger tip segment for an intraocular lens
delivery system, the disposable segment comprising: an elongated
body having a proximate end and a distal end; a fastening
mechanism, which is a projection, a cavity or both, at the
proximate end of the elongated body; and a pushing surface at the
distal end of the elongated body; wherein: i. the elongated body
and fastening projection or cavity are integrally molded of single
polymeric material; ii. the fastening mechanism is configured to
releasably, but securely and rigidly, attach the disposable segment
to a reusable plunger segment of the intraocular lens delivery
system; and iii. the single polymeric material has a flexural
modulus of at least 3500 MPa.
2. A disposable segment as in claim 1 wherein the fastening
mechanism is a cavity that lockably receives a projection extending
from the reusable segment.
3. A disposable segment as in claim 2 wherein the pushing surface
is provided by a soft push tip that is overmolded onto the
elongated body at the distal end thereof.
4. A disposable segment as in claim 3 wherein the soft push tip is
formed of a material having an elongation at break of at least
200%.
5. A disposable segment as in claim 1 wherein the single polymeric
material is a thermoplastic material and has a flexural modulus of
at least 30,000 MPa.
6. A disposable segment as in claim 1 wherein the disposable
segment forms a kit in conjunction with a disposable tool that is
used to attach and detach the disposable segment from the reusable
segment and/or a cartridge that is attachable and detachable from
the handpiece.
7. An intraocular delivery system, the system comprising: an
elongated housing having a length; a plunger having a disposable
tip segment and a reusable base segment wherein: i. the reusable
segment of the plunger is disposed within the housing and movable
along the length of the housing; ii. the reusable segment includes
a fastening mechanism at a distal end thereof; iii. the fastening
mechanism of the reusable segment is a projection or a cavity; iv.
the disposable segment includes an elongated body, a fastening
mechanism at a proximate end of the elongated body and a pushing
surface at a distal end of the elongated body; v. the fastening
mechanism of the disposable segment is a projection or cavity; vi.
the projection or cavity of the fastening mechanism of the reusable
segment mates with the projection or cavity of the disposable
segment of the fastening mechanism of the disposable segment to
releasably, but securely and rigidly, fasten the disposable segment
to the reusable segment; vii. the elongated body and fastening
projection or cavity of the disposable segment are integrally
molded of a single polymeric material; and viii. the single
polymeric material has a flexural modulus of at least 3500 MPa.
8. A system as in claim 7 further comprising a cartridge fastened
to the housing wherein the cartridge includes an opening at a
distal end of the cartridge and the opening has a maximum internal
diameter that is less than 4 millimeters.
9. A system as in claim 7 wherein the fastening mechanism is a
cavity that lockably receives a projection extending from the
reusable segment.
10. A system as in claim 7 wherein the pushing surface is provided
by a soft push tip that is overmolded onto the elongated body at
the distal end thereof.
11. A system as in claim 10 wherein the soft push tip is formed of
a material having an elongation at break of at least 200%.
12. A system as in claim 7 wherein the single polymeric material is
a thermoplastic material and has a flexural modulus of at least
30,000 MPa.
13. A system as in claim 7 wherein the disposable segment forms a
kit in conjunction with a disposable tool that is used to attach
and detach the disposable segment from the reusable segment and/or
a cartridge that is attachable and detachable from the
handpiece.
14. A method of using the system of claim 7, the method including:
advancing the plunger to move an intraocular lens into any eye of a
mammal; releasing the disposable segment from the reusable segment
after location of the intraocular lens within the eye of the
mammal; disposing of the disposable segment.
15. A method as in claim 14 wherein the disposable segment is an
original segment and further comprising: attaching second
disposable segment to the reusable segment.
16. A method as in claim 15 wherein second disposable segment is
sized and/or shape to correspond to a different cartridge than the
original disposable segment.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority under 35 U.S.C. .sctn.119
to U.S. Provisional Patent Application Ser. No. 61/182,270, filed
May 29, 2009, the entire contents of which are incorporated herein
by reference.
TECHNICAL FIELD OF THE INVENTION
[0002] The present invention relates to an intraocular lens
delivery system with a multi-segment plunger. More particularly,
the present invention relates to an is intraocular lens delivery
system that includes a plunger comprised of a disposable plunger
tip segment that can be attached and removed from a reusable
plunger base segment.
BACKGROUND OF THE INVENTION
[0003] The human eye functions to provide vision by transmitting
and refracting light through a clear outer portion called the
cornea, and further focusing the image by way of a lens onto the
retina at the back of the eye. The quality of the focused image
depends on many factors including the size, shape and length of the
eye, and the shape and transparency of the cornea and lens.
[0004] When trauma, age, disease or other malady cause an
individual's natural crystalline lens to become less transparent,
vision deteriorates because of the diminished light which can be
transmitted to the retina. This deficiency in the lens of the eye
is often referred to as a cataract. The treatment for this
condition is surgical removal of the natural crystalline lens and
implantation of an intraocular lens (IOL).
[0005] While early IOLs were made from hard plastic, such as
polymethylmethacrylate (PMMA), soft, foldable IOLs made from
silicone, soft acrylics and hydrogels have become increasingly
popular because of the ability to fold or roll these soft lenses
and insert them through a smaller incision. Several methods of
rolling or folding the lenses are used. One popular method is an
injector cartridge that folds the lenses and provides a relatively
small diameter lumen through which the lens may be pushed into the
eye, usually by a plunger.
[0006] One commonly used injector cartridge design is illustrated
in U.S. Pat. No. 4,681,102 (Bartell), and includes a split,
longitudinally hinged cartridge. Other designs are illustrated in
U.S. Pat. Nos. 5,494,484 and 5,499,987 (Feingold) and U.S. Pat.
Nos. 5,616,148 and 5,620,450 (Eagles, et al.), the entire contents
of which are incorporated herein by reference for all purposes.
Still other cartridges are described in U.S. Pat. No. 5,275,604
(Rheinish, et al.), U.S. Pat. No. 5,653,715 (Reich, et al.) and
U.S. Pat. No. 5,947,876 (Van Noy, et al.), the entire contents of
which are incorporated herein by reference for all purposes.
[0007] The cartridge is typically preloaded with an IOL and then
used as part of a delivery system to deliver the IOL to an eye of a
mammal (e.g., a human). The delivery system will typically include
a hand-piece that includes a plunger within a housing. The delivery
cartridge is attached to the hand-piece (e.g., to the housing of
the hand-piece) and then the tip of the cartridge can be inserted
into an eye of a mammal. The plunger can then advance the IOL along
the lumen of the cartridge and into the eye. After IOL delivery,
the cartridge is typically removed from the hand-piece so that the
hand-piece can be reused with a different cartridge. This system,
while generally desirable, has some drawbacks.
[0008] As one exemplary drawback, the plunger of the hand-piece or
the entire hand-piece must typically be sterilized (e.g., by
autoclaving) after delivery of an IOL. Such sterilization is
typically required because the tip of the plunger often enters the
eye during insertion of the IOL and it can retain biological matter
after removal from the eye. The sterilization process can require
significant amounts of time and can limit the number of IOL
deliveries that can be accomplished in a given time span.
[0009] As another exemplary drawback, the plunger of the hand-piece
is typically sized to accommodate the size of a lumen of a
particular cartridge. If it becomes desirable to use a new
cartridge having a different size lumen, an entirely new plunger or
entirely new hand-piece must typically be employed to accommodate
that cartridge.
[0010] As yet another exemplary drawback, recent trends in IOL
delivery systems have made the use of soft tip plungers quite
desirable, however, the reusable plungers associated with these
types of delivery system are often formed of metal or some other
autoclavable material and providing such materials with a soft tip
can be problematic.
[0011] It would be quite desirable to provide a plunger for an
intraocular lens delivery system where that plunger overcomes one
or more of the aforementioned drawbacks and/or additional drawbacks
associated with conventional IOL delivery systems.
SUMMARY OF THE INVENTION
[0012] Accordingly, the present invention is directed to an
improved plunger for is use in IOL delivery and an IOL delivery
system having such a plunger. The delivery system will typically
include an elongated housing having a length and a plunger having a
disposable tip segment and a reusable base segment. The reusable
segment of the plunger is typically disposed within the housing and
movable along the length of the housing. The reusable segment
typically includes a fastening mechanism at a distal end thereof.
When included, the fastening mechanism of the reusable segment is
typically a projection or a cavity. The disposable segment
typically includes an elongated body, a fastening mechanism at a
proximate end of the elongated body and a pushing surface at a
distal end of the elongated body. The fastening mechanism of the
disposable segment, that that of the reusable segment is typically
a projection or cavity. The projection or cavity of the fastening
mechanism of the reusable segment mates with the projection or
cavity of the disposable segment of the fastening mechanism of the
disposable segment to releasably, but securely and rigidly, fasten
the disposable segment to the reusable segment. The elongated body
and fastening projection or cavity of the disposable segment are
integrally molded of a single polymeric material. The single
polymeric material preferably has a flexural modulus of at least
3500 MPa.
[0013] In preferred embodiment of the invention the system can
include either or both of the following characteristics: an opening
at a distal end of the cartridge having a maximum internal diameter
that is less than 4 millimeters; and/or a soft push tip that is
overmolded onto the elongated body at the distal end thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view of an exemplary hand-piece and
plunger of an exemplary IOL delivery system according to an aspect
of the present invention.
[0015] FIG. 2 is a magnified perspective view of an exemplary
proximate end of an exemplary disposable plunger segment of the IOL
delivery system of FIG. 1.
[0016] FIG. 3 is a perspective view of an exemplary pre-loaded IOL
cartridge of an IOL delivery system in accordance with an aspect of
the present invention.
[0017] FIG. 4 is a perspective view of an exemplary tool for
manipulating a disposable plunger segment in accordance with an
aspect of the present invention.
[0018] FIG. 5 is an illustration of the exemplary tool of FIG. 4
being used to manipulate the disposable plunger segment of FIGS. 1
and 2.
[0019] FIG. 6 is a perspective view of the hand-pieced of FIG. 1
wherein the plunger has been provided with an exemplary soft tip in
accordance with an aspect of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0020] The present invention is predicated upon the provision of a
disposable segment for a plunger of an intraocular lens (IOL)
delivery system. Advantageously, the disposable segment of the
plunger can enter the eye of a mammal during insertion of an IOL
and can then be disposed of after such insertion rather than
requiring sterilization. The disposable segment of the plunger is
particularly desirable for use with an IOL delivery system that
employs a single handpiece in conjunction with multiple cartridges.
The cartridges can also be disposable such that all portions of the
IOL delivery system that potentially contact the eye can be
disposed of subsequent to delivery of an IOL. In such an
embodiment, multiple disposable segments can, if needed or desired,
be shaped or sized to correspond to the multiple different
cartridges.
[0021] FIGS. 1-2 illustrate an exemplary hand-piece 10 of an
exemplary IOL delivery system in accordance with the present
invention. The hand-piece 10 includes a housing 14 and a plunger 16
disposed within the housing 14. The plunger 16 includes a
disposable plunger tip segment 20 and a reusable plunger base
segment 22.
[0022] The disposable segment 20 has an elongated body 26 with a
proximate end 28 opposite a distal end 30. A fastening mechanism 34
is located at the proximate end 28 of the elongated body 26 and a
pushing surface 40 is located at the distal end 30 of the elongated
body 26.
[0023] The reusable segment 22 has an elongated body 44 with a
fastening mechanism 46 located at a distal end 48 of the elongated
body 44. In the embodiment shown, the fastening mechanism 46 of the
reusable segment 22 is a projection that mates with or is received
by the fastening mechanism 34 of the disposable segment 20, which
is a cavity. However, it is contemplated that this system may be
reversed such that the fastening mechanism of the disposable
segment, which would be a projection, would mate with or be
received by the fastening mechanism of the reusable segment, which
would be a cavity. 34. As still another alternative, each of the
fastening mechanisms could include a projection and a cavity such
that the projection of each fastening mechanism mates with or is
received in the cavity the other fastening mechanism.
[0024] In the embodiment illustrated, the fastening mechanisms 34,
46 cooperatively form a twist lock connector. It will be understood
that various different fastening systems may be employed as long as
the system releasably, but securely and rigidly, attaches the
disposable segment 20 to the reusable segment 22.
[0025] The housing 14 and the reusable segment 22 of the handpiece
10 can be formed of a variety of materials and the materials for
each component may be the same or different. The materials of the
housing 14 and the reusable segment 22 should be durable and rigid.
Such materials can include, without limitation, metals, ceramics
and high strength plastics. It is generally preferable that the
material[s] of the housing 14 and reusable segment 22 be easy to
clean, autoclavable (i.e., have a melting temperature greater than
100.degree. C.) or both. In a preferred embodiment, the housing 14
and the reusable segment 22 are formed of the same material and
that material is a metal, most preferably stainless steel or
titanium.
[0026] The disposable segment 20, including the elongated body 26
and the fastening mechanism 34 are formed of one or more molded
polymeric materials, but preferably a singular integrated molded
polymeric material. The pushing surface may also be formed of the
molded polymeric material, however, the pushing surface may
alternatively be provided by a soft tip material, which is further
described herein. The molded polymeric material[s] of the
disposable segment may be filled or unfilled and may include
various additives such as plasticizers, tougheners, etc. The molded
polymeric material is preferably injection molded or compression
molded to its desired shape. In a preferred embodiment, the
moldable material is a rigid plastic material, which may be a
thermoset material, but is preferably a thermoplastic material. The
rigid plastic material preferably exhibits one or more desirable
mechanical properties. In particular, the rigid plastic material
preferably has a flexural modulus of at least 3500 megapascal
(MPa), more typically at least 10,000 MPa, even more typically at
least 30,000 MPa and even possibly at least 50,000 MPa. Flexural
modulus of these materials can be determined in accordance with
ASTM D790. It is also preferable that the rigid plastic material be
formed of a biologically compatible material.
[0027] Examplary preferred rigid plastic materials for the
disposable segment include, without limitation, polystyrene,
acrylonitrile butadiene styrene, polycarbonate, polyamide,
polyimide, polyetherimide, polyarylamide, polyetheretherketone,
polybutylene terephthalate, polypropylene, polysulphone, liquid
crystal polymer, combinations thereof or the like.
[0028] Advantageously, multiple disposable segments according to
the present invention can be rapidly and inexpensively molded
(e.g., injection molded). In turn, it becomes much more reasonable
in terms of cost and other efficiencies to use a new disposable
segment for each IOL insertion procedure.
[0029] As an additional advantage, these disposable segments can be
more easily provided with soft tips. In particular, a relatively
soft material may be overmolded or otherwise located at the distal
end of the disposable segment. Preferably, the soft tip material is
adhered or otherwise non-detachably attached to the material of the
rest of the disposable segment. Such adhesion can be a natural
adhesion between the materials (e.g., natural adhesion occurring
during overmolding) or an adhesive can located between the
materials. FIG. 7 illustrates such a soft tip 60, which also
provides a pushing surface 62 for pushing an IOL. The soft tip
material will typically exhibit an elongation at break of at least
100%, more typically at least 200% and even possibly at least 400%.
The elongation at break of the soft tip material is typically no
greater than 1500% and even more typically no greater than 780%.
Such elongation at break can be measure in accordance with ASTM
D-638. The soft tip materials will also typically have an elastic
modulus of from about 100 psi to about 300 psi at an elongation of
100% and/or an elastic modulus of from about 210 psi to about 540
psi at an elongation of 300%. Such soft tips and soft tip materials
are particularly desirable for pushing an IOL through a narrow
lumen since the tip can deform to accommodate the lumen.
[0030] The soft tip can be formed of a variety of materials such as
silicone, elastomer, combinations thereof or the like. In a
preferred embodiment, the soft tip material is an elastomeric
material, which may be thermoset or thermoplastic. The soft tip
material should also be biologically compatible. Exemplary
potential materials include, without limitation, styrenic block
copolymers, polyolefin blends (TPOs), elastomeric alloys,
thermoplastic polyurethanes (TPUs), thermoplastic copolyesters and
thermoplastic polyamides.
[0031] With reference to FIG. 3, there is illustrated an exemplary
cartridge 70 in accordance with the present invention. The
cartridge 70 has a lumen 72 extending down its length (L) and the
lumen 72 is pre-loaded with an IOL 73. The cartridge 70 and lumen
72 extend from a proximate end 74 of the cartridge 70 to a distal
end 76 of the cartridge 70. The cartridge 70 includes a tip 80 at
its distal end 76 and the lumen 72 extends along the tip 80. The
tip 80 is defined herein to include any portion of the cartridge 70
that is inserted within an eye during insertion of an IOL within
that eye. Preferably, the maximum diameter of lumen 72, taken
perpendicular to the length (L), within the tip 80 is no greater
than 7 millimeters (mm), more typically no greater than 5 mm and
even possibly no greater than 4 mm.
[0032] The cartridge 70 may be formed of multiple different
materials. In a preferred embodiment, the cartridge 70 is formed of
a polymeric material and more preferably, a polypropylene material.
The cartridge 70 may also be disposable. Examples of cartridges
that could be used in conjunction with the present invention are
described in U.S. Pat. Nos. 6,398,789, 6,143,001, 6,083,231, and
5,947,976 all of which are incorporated herein by reference for all
purposes.
[0033] The plunger of the present invention is used to assist in
the delivery of an IOL into an eye. The disposable segment of the
plunger is releasably, but securely and rigidly, attached to the
reusable segment of the plunger. Then, the plunger is advanced
along the length of the housing, the cartridge or both for moving
the IOL into the eye. Thereafter, the disposable segment of the
plunger is removed from the reusable segment and is then preferably
properly disposed of.
[0034] In the particular embodiment illustrated in FIGS. 1-5, the
fastening mechanisms 34, 46 of the disposable segment 20 and the
reusable segment 22 are mated or, more particularly, twist locked.
The cartridge 70 is then attached to the housing 14 to align the
IOL 73 with the plunger 16. The tip 80 of the cartridge 70 is then
inserted into an incision in the eye. The plunger 16 is advanced
along the length of the housing 14 and the length of the cartridge
70 to push the IOL 73 along the lumen 72 until it is released out
of the tip 80 into the eye. The cartridge tip 80 is then removed
from the incision followed by removal of the cartridge 70 from the
housing 14 and removal of the disposable segment 20 from the
reusable segment 22. The disposable segment 20 can then be properly
disposed of.
[0035] A tool may be provided, for example as part of a kit with
any combination of the handpiece, the disposable segment and the
cartridge, to assist in attaching and detaching the disposable
segment from the reusable segment. Preferably, such tool is formed
of the same or a similar material as the disposable segment and is
itself disposable. In such an embodiment, the tool can be used to
assist in attaching and detaching the disposable segment from the
reusable segment and can then be properly disposed of in the same
fashion as the disposable segment.
[0036] With reference to FIGS. 4 and 5, an exemplary tool 90 is
illustrated. As can be seen, the tool 90 includes a shaped cavity
92 (e.g., a hex shape cavity) corresponding to a hex shaped portion
94 (e.g., shown as the proximate end) of the disposable segment 20.
The hex shaped portion is received in the cavity 92 and the tool 90
can then twist the disposable segment 20 to attach or detach that
segment 20 from the reusable segment 22.
[0037] The plunger 16 can be advanced during IOL delivery through
manual pushing of the plunger 16 or through the used of twistable
threaded mechanisms. Plungers have been advanced using these
techniques in products such as the MONARCH.RTM. system, which is
commercially available from Alcon Laboratories, Inc., Fort Worth,
Tex.
[0038] Through use of the system of the present invention, a first
disposable plunger segment and, in particular embodiments, a first
tool and/or a first cartridge can be used in conjunction with a
hand-piece as described above for delivery of a first IOL. Then,
the first disposable plunger segment, the first tool and/or the
first cartridge can be replaced with a second disposable plunger, a
second tool and/or a second disposable cartridge, which can be used
with the same hand-piece that was used in conjunction with the
first segment, tool and/or cartridge to deliver a second IOL.
[0039] Advantageously, the disposable segment of the plunger does
not have to be sterilized after implantation of an IOL. Moreover,
soft tips can be more effectively attached to the disposable
segments for those embodiments where soft tips are desirable (e.g.,
in circumstances where the diameter of the cartridge opening is
small). It is also contemplated that multiple different sized
disposable segments may be used with a single hand-piece to deliver
IOLs using cartridges having differently sized lumens.
Advantageously, the segments can be specifically sized to
correspond to the differently sized lumens.
[0040] The entire contents of all cited references in this
disclosure are specifically incorporated herein by reference.
Further, when an amount, concentration, or other value or parameter
is given as either a range, preferred range, or a list of upper
preferable values and lower preferable values, this is to be
understood as specifically disclosing all ranges formed from any
pair of any upper range limit or preferred value and any lower
range limit or preferred value, regardless of whether ranges are
separately disclosed. Where a range of numerical values is recited
herein, unless otherwise stated, the range is intended to include
the endpoints thereof, and all integers and fractions within the
range. It is not intended that the scope of the invention be
limited to the specific values recited when defining a range.
[0041] Other embodiments of the present invention will be apparent
to those skilled in the art from consideration of the present
specification and practice of the present invention disclosed
herein. It is intended that the present specification and examples
be considered as exemplary only with a true scope and spirit of the
invention being indicated by the following claims and equivalents
thereof.
* * * * *