U.S. patent application number 12/604202 was filed with the patent office on 2010-02-18 for drug delivery via ocular implant.
This patent application is currently assigned to QLT Plug Delivery, Inc.. Invention is credited to Liane C. Glazer, Steven A. Odrich.
Application Number | 20100040670 12/604202 |
Document ID | / |
Family ID | 35096541 |
Filed Date | 2010-02-18 |
United States Patent
Application |
20100040670 |
Kind Code |
A1 |
Odrich; Steven A. ; et
al. |
February 18, 2010 |
DRUG DELIVERY VIA OCULAR IMPLANT
Abstract
A method and apparatus for administering an active agent such as
a medicine to a subject, uses an ocular implant such as a punctal
plug, to which the active agent has been applied. The implant is
installed at the eye of the subject for administering the active
agent via tissues of the eye.
Inventors: |
Odrich; Steven A.; (Bronx,
NY) ; Glazer; Liane C.; (US) |
Correspondence
Address: |
SCHWEGMAN, LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS
MN
55402
US
|
Assignee: |
QLT Plug Delivery, Inc.
Menlo Park
CA
|
Family ID: |
35096541 |
Appl. No.: |
12/604202 |
Filed: |
October 22, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10825047 |
Apr 15, 2004 |
|
|
|
12604202 |
|
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Current U.S.
Class: |
424/427 |
Current CPC
Class: |
A61K 38/13 20130101;
A61F 9/007 20130101; A61K 9/0051 20130101; A61F 9/00772 20130101;
A61K 31/5575 20130101; A61F 9/0017 20130101 |
Class at
Publication: |
424/427 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. An ocular implant comprising: an implant body partially defined
by a first end portion and a second end portion, the implant body
including a hollow portion extending the length of the implant
body, the hollow portion configured to allow for the passage of
tear fluid therethrough; and an active agent.
2. The ocular implant of claim 1, wherein the hollow portion
includes a straw-like configuration.
3. (canceled)
4. The ocular implant of claim 1, wherein the active agent includes
at least one of a topical prostaglandin, latanoprost, travaprost,
bimataprost, a medication for the treatment of corneal infections,
ciprofloxacin, moxifloxacin, gatifloxacin, a systemic medication, a
medication for treating hypertension, atenolol, nifedipine,
hydrochlorothiazide, cyclosporine, or olopatadine.
5. The ocular implant of claim 1, wherein the active agent includes
at least one of an antihistamine, an anti-allergy medication,
olopatadine, or cromalyn sodium.
6. The ocular implant of claim 1, wherein the active agent includes
a chronic medication.
7. The ocular implant of claim 1, wherein the implant body extends
from the first end portion, configured to seat at or near a
lacrimal punctum when implanted, to the second end portion,
configured for insertion through the lacrimal punctum into a
lacrimal canaliculus when implanted, the first end portion
including an opening configured to direct tear fluid into the
hollow portion.
8. The ocular implant of claim 1, wherein the hollow portion is
substantially parallel or concentric with an axis of the implant
body.
9. The ocular implant of claim 1, wherein the hollow portion is at
least partially filled with a second material.
10. The ocular implant of claim 9, wherein the second material
includes the active agent.
11. The ocular implant of claim 1, wherein the implant body is
formed of a porous or absorbent material.
12. The ocular implant of claim 11, wherein the porous or absorbent
material of the implant body is saturated with the active
agent.
13. The ocular implant of claim 1, wherein the active agent is made
available at an interior of the hollow portion.
14. An ocular implant comprising: an implant body extending from a
proximal end, configured to seat against a punctal aperture, to a
distal end, configured to insert into the punctal aperture, and
including a hollow portion, the hollow portion extending from the
proximal end to the distal end and configured for a passage of tear
fluid therethrough; and an active agent disposed in or on one or
more portions of the implant body or the hollow portion, the active
agent deliverable on a sustained release basis to tissue at or near
at least one of an eye or a nasolacrimal system of a subject.
15. The ocular implant of claim 14, wherein the active agent is
made available at an interior of the hollow portion and is
configured to leave the implant body with the passage of tear
fluid, when implanted.
16. The ocular implant of claim 15, wherein the sustained release
of the active agent to tissue at or near the nasolacrimal system of
the subject is via the interior of the hollow portion.
17. The ocular implant of claim 14, wherein the implant body is
configured to provide the sustained release of active agent to
tissue for a time period between 3-6 months, after implant.
18. The ocular implant of claim 14, wherein the entire implant body
is saturated with the active agent.
19. The ocular implant of claim 14, wherein the active agent is
configured to deliver medication, at least in part, to the
nasolacrimal system.
20. The ocular implant of claim 14, wherein the active agent is
configured to treat glaucoma of the eye.
21. A method comprising: placing an ocular implant, including a
hollow portion extending therethrough, adjacent an eye of a
subject; and administering an active agent, applied to the ocular
implant, to tissue of one or both of the eye or a nasolacrimal
system.
22. The method of claim 21, comprising allowing tear fluid to flow
through the hollow portion of the ocular implant.
23. The method of claim 21, comprising treating at least one of
glaucoma, a corneal infection, allergic conjunctivitis or
rhinitis.
24. The method of claim 21, wherein administering the active agent
includes transdermal or surface absorption of the active agent into
the tissue of the eye.
25. The method of claim 21, wherein administering the active agent
includes administering the active agent to tissue at one or more
walls of a lacrimal canaliculus.
26. The method of claim 25, wherein administering the active agent
to the one or more walls of the lacrimal canaliculus includes
systemically delivering the active agent to the subject.
27. The method of claim 21, wherein administering the active agent
includes using tear fluid as a carrier for the active agent from
the ocular implant to tissue of the eye or the nasolacrimal
system.
28. The method of claim 21, wherein administering the active agent
includes providing a sustained agent release for a time period
between 3-6 months after implant.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 10/825,047, entitled "DRUG DELIVERY VIA OCULAR IMPLANT,"
filed on Apr. 15, 2004, the specification of which is incorporated
herein in its entirety by reference.
TECHNICAL FIELD
[0002] The present invention relates generally to the field of
medicine, and in particular to a new and useful method and
apparatus for administering an active agent, i.e. a medicine or
medication, to a subject by transdermal or other surface absorption
of the agent into the tissues in and around one or both eyes of the
subject.
BACKGROUND
[0003] Punctal plugs are known which are made in suitable
dimensions and of suitable materials to be removably inserted into
the upper and/or lower punctal apertures or punctum of the eye, to
block the opening and the canaliculus communicating therewith, to
prevent drainage of lacrimal fluid (tears). Such plugs are known to
be made of suitable materials, such as polymers, for example
polytetrafluoroethylene (known by the trademark TEFLON), or
hydroxyethylmethacrylate (HEMA), hydrophilic polymer, methyl
methacrylate, or silicon, or even of stainless steel or other inert
metal material.
[0004] It is also known to apply an active agent such as nicotine
or a birth control drug, to the inner surface of a patch which can
be worn against the skin of a subject for transdermally
administering the active agent to the subject.
SUMMARY
[0005] It is an object of the present invention to provide a method
and an apparatus for administering an active agent to a subject by
applying the active agent to at least one surface of an ocular
implant such as a punctal plug, and installing the implant, e.g.,
inserting the punctal plug into a punctal aperture of the
subject.
[0006] If the active agent or drug is meant for treating the
tissues at the walls of the canaliculus, for example, the drug is
applied only to inner surfaces of the plug that are adapted to be
in contact with or near the tissues of the canaliculus. The
presence of tears is highly advantageous as a natural vehicle or
carrier for the agent.
[0007] If the active agent or drug is meant for treating the eye
itself, the drug is applied only to outer surfaces of the implant
or plug that are adapted to be outside the canaliculus. Here the
presence of previously secreted tears or a tear pool is again
advantageous as a natural vehicle or carrier for the agent.
[0008] Any or all surfaces of the implant may carry the active
agent there the desire is simply to have the agent enter the
subjects blood stream via the tissues in and around the eye.
[0009] The various features of novelty which characterize the
invention are pointed out with particularity in the claims annexed
to and forming a part of this disclosure. For a better
understanding of the invention, its operating advantages and
specific objects attained by its uses, reference is made to the
accompanying drawings and descriptive matter in which preferred
embodiments of the invention are illustrated.
[0010] These and other examples, aspects, advantages, and features
of the implants described herein will be set forth in part in the
Detailed Description, which follows, and in part will become
apparent to those skilled in the art by reference to the following
description of the present leads and methods, and drawings or by
practice of the same.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] In the drawings, which are not necessarily drawn to scale,
like numerals describe similar components throughout the several
views. The drawings illustrate generally, by way of example, but
not by way of limitation, various embodiments discussed in this
patent document.
[0012] FIG. 1 is a schematic perspective view of an ocular implant
in the form of a punctal plug, as constructed in accordance with at
least one embodiment of the invention.
[0013] FIG. 2 is a perspective view of the area around the eye with
other embodiments of the invention.
DETAILED DESCRIPTION
[0014] Referring now to the drawing, FIG. 1 shows a punctal plug
generally designated 10, having a stem 12 for insertion into the
punctal aperture 20 of an eye 24, and along the canaliculus 22
communicating with the aperture.
[0015] Plug 10 has a large stopper structure 14 connected to the
outer end of stem 12 for seating against the aperture 20 and
sealing the canaliculus 22 against the flow of tears onto the
surface of the eye or eyeball 24.
[0016] FIG. 2, where the same of similar numerals are used to
designate functionally similar parts, illustrates an eye 24
communicating with upper and lower canaliculi 22a and 22b, each
with their our implant 10a and 10b. Implant 10a is a substantially
cylindrical and solid collagen plug that has been inserted into the
upper punctum or tear duct 20a, to block the flow of tears while
lower implant 10b is hollow like a straw for the passage of tears.
Implant 10b includes a tapered shaft or stem 12a with a flared open
end 12b immobilized at the lower punctum 20b. A mushroom shaped
inner stopper 14a is formed at the opposite end of shaft 12a for
further setting the location of the implant in the tear duct.
[0017] One of the embodiments illustrated in FIG. 2, e.g., the
upper implant, may include a hollow core of the plug and another,
e.g., the lower one, may include a hollow core filled with
medication.
[0018] The active agent, e.g., a medicine or medication is applied,
e.g., in one or more bands of polymer material 16 at the inner end
of the stem, or at 18 on the outer end of the stopper 14 in the
embodiment of FIG. 1, or over some or all of the surfaces of the
implants of FIG. 2, or otherwise. Polymer that is absorbent to the
agent is preferable so that sufficient agent is present and
available for discharge into the surrounding tissues. A porous or
absorbent material can alternatively be used to make up the entire
plug or implant which can be saturated with the active agent.
[0019] The hollow implant 10b of FIG. 2 is also particularly useful
in that the active agent can be applied to, or is otherwise
available at the inner surface or interior of the implant, and is
uniquely structured to pass tears and thus administer the active
agent to the tear stream in a fashion that is controlled by the
flow of tears which thus act as the carrier for the agent. Unlike
the usual tear stopping punctal plug, the hollow implant of the
present invention provides a very different drug administering
method, scheme and structure.
[0020] Non-limiting examples of the active agents or medications
which are appropriate for use with the invention include, for
example only: topical prostaglandin derivatives such as
latanoprost, travaprost and bimataprost used for the topical
treatment of glaucoma. Also a treatment for corneal infections is
appropriate using ciprofloxacin, moxifloxacin or gatifloxacin.
Systemic medications useful for this invention are those used for
hypertension such as atenolol, nifedipine or hydrochlorothiazide.
Any other chronic disease requiring chronic medication could be
used.
[0021] The treatment of allergic conjunctivitis and rhinitis are
also good applications for the invention, e.g., using antihistamine
and anti-allergy medication such as olopatadine and cromalyn sodium
in or on the implant.
[0022] The advantage is that there would be no need for chronic
pill-taking or drop taking. A once-per 3-6 month visit to the eye
doctor would be all that is needed. Also the issue of
non-compliance, a major impediment to successful treatment, would
by avoided by the invention.
[0023] This list of active agents is not comprehensive in that many
other agents can be used with the present invention. For example, a
treatment for dry eye bytopical cyclosporin is particularly
interesting for administration by the present invention, but many
other active agents can also be administered using the method and
apparatus of the invention.
[0024] The invention is meant to embody all implants or devices
which are implanted into the eye-lid canalicular puncta of the
naso-lacrimal system with the goal of delivering drug to the eye or
to the body.
[0025] The implant is inserted into either the inferior (lower) or
superior (upper) punctum or possibly both. The apparatus is
constructed so as to have a drug attached to one or both sides of
the implant and an occlusive plug of some inert biocompatible
material.
[0026] Depending on the desired therapy, the implant could be
oriented in the punctal canal to deliver the drug either to the
tear lake and thus the eye, or to the nasolacrimal system and thus
the body's systemic circulation. The drawings illustrate only three
embodiments of the punctal plug or implant delivery system of the
invention.
[0027] While a specific embodiment of the invention has been shown
and described in detail to illustrate the application of the
principles of the invention, it will be understood that the
invention may be embodied otherwise without departing from such
principles.
[0028] In the appended claims, the terms "including" and "in which"
are used as the plain-English equivalents of the respective terms
"comprising" and "wherein." Also, in the following claims, the
terms "including" and "comprising" are open-ended, that is, a
system, device, apparatus, article, or process that includes
elements in addition to those listed after such a term in a claim
are still deemed to fall within the scope of that claim. Moreover,
in the following claims, the terms "first," "second," and "third,"
etc. are used merely as labels, and are not intended to impose
numerical requirements on their objects.
[0029] The Abstract is provided to comply with 37 C.F.R.
.sctn.1.72(b), to allow the reader to quickly ascertain the nature
of the technical disclosure. It is submitted with the understanding
that it will not be used to interpret or limit the scope or meaning
of the claims. Also, in the above Detailed Description, various
features may be grouped together to streamline the disclosure. This
should not be interpreted as intending that an unclaimed disclosed
feature is essential to any claim. Rather, inventive subject matter
may lie in less than all features of a particular disclosed
embodiment. Thus, the following claims are hereby incorporated into
the Detailed Description, with each claim standing on its own as a
separate embodiment. The scope of the invention should be
determined with reference to the appended claims, along with the
full scope of equivalents to which such claims are entitled.
* * * * *