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 polytetrafluorethylene (known by the trademark TEFLON), or hydroxyethylmethacrylate (HEMA), hydrophilic polymer, methyl methacrylate, or silicon, or even of stainless steel or other inert metal material.
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.
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.
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.
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.
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.
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.
In the drawings:
Referring now to the drawing,
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.
One of the embodiments illustrated in
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
The hollow implant 10b of
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.
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.
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.
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 by topical 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.
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.
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.
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.
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.
This application is a continuation application of U.S. Ser. No. 13/533,676, Filed 26 Jun. 2012; which is a continuation application of U.S. Ser. No. 12/604,202, filed Oct. 22, 2009; which is a divisional application of U.S. Ser. No. 10/825,047, filed Apr. 15, 2004; the contents of each application are incorporated herein by reference in their entireties.
Number | Name | Date | Kind |
---|---|---|---|
3828777 | Ness | Aug 1974 | A |
3865108 | Hartop | Feb 1975 | A |
3949750 | Freeman | Apr 1976 | A |
4014335 | Arnold | Mar 1977 | A |
4281654 | Shell | Aug 1981 | A |
4660546 | Herrick | Apr 1987 | A |
4886488 | White | Dec 1989 | A |
4915684 | MacKeen | Apr 1990 | A |
4959048 | Seder | Sep 1990 | A |
5041081 | Odrich | Aug 1991 | A |
5049142 | Herrick | Sep 1991 | A |
5053030 | Herrick | Oct 1991 | A |
5098443 | Parel | Mar 1992 | A |
5116371 | Christensen | May 1992 | A |
5128058 | Ishii | Jul 1992 | A |
5133159 | Nelson | Jul 1992 | A |
5163959 | Herrick | Nov 1992 | A |
5171270 | Herrick | Dec 1992 | A |
5283063 | Freeman | Feb 1994 | A |
5300114 | Gwon | Apr 1994 | A |
5318513 | Leib | Jun 1994 | A |
5322691 | Darougar | Jun 1994 | A |
5334137 | Freeman | Aug 1994 | A |
5395618 | Darougar | Mar 1995 | A |
5417651 | Guena | May 1995 | A |
5423777 | Tajiri | Jun 1995 | A |
5443505 | Wong | Aug 1995 | A |
5466233 | Weiner | Nov 1995 | A |
5556633 | Haddad | Sep 1996 | A |
5707643 | Ogura | Jan 1998 | A |
5723005 | Herrick | Mar 1998 | A |
5741292 | Mendius | Apr 1998 | A |
5766243 | Christensen | Jun 1998 | A |
5770589 | Billson | Jun 1998 | A |
5773019 | Ashton | Jun 1998 | A |
5824048 | Tuch | Oct 1998 | A |
5824073 | Peyman | Oct 1998 | A |
5826584 | Schmitt | Oct 1998 | A |
5830171 | Wallace | Nov 1998 | A |
5840054 | Hamano | Nov 1998 | A |
5961370 | Valle | Oct 1999 | A |
5962383 | Doyel | Oct 1999 | A |
5993407 | Moazed | Nov 1999 | A |
6010391 | Lewellen | Jan 2000 | A |
6016806 | Webb | Jan 2000 | A |
6027470 | Mendius | Feb 2000 | A |
6041785 | Webb | Mar 2000 | A |
6082362 | Webb | Jul 2000 | A |
6095901 | Robinson | Aug 2000 | A |
6149684 | Herrick | Nov 2000 | A |
6196993 | Cohan | Mar 2001 | B1 |
6234175 | Zhou | May 2001 | B1 |
6238363 | Kurihashi | May 2001 | B1 |
6254562 | Fouere | Jul 2001 | B1 |
6264971 | Darougar | Jul 2001 | B1 |
6290684 | Herrick | Sep 2001 | B1 |
6306114 | Freeman | Oct 2001 | B1 |
6331313 | Wong | Dec 2001 | B1 |
6371122 | Mandelkorn | Apr 2002 | B1 |
6375972 | Guo | Apr 2002 | B1 |
6383192 | Kurihashi | May 2002 | B1 |
6428502 | Lang | Aug 2002 | B1 |
6441047 | DeSantis | Aug 2002 | B2 |
6455062 | Olejnik | Sep 2002 | B1 |
6605108 | Mendius | Aug 2003 | B2 |
6629533 | Webb | Oct 2003 | B1 |
6706275 | Camp | Mar 2004 | B1 |
6729939 | Wrue | May 2004 | B2 |
6756049 | Brubaker | Jun 2004 | B2 |
6780164 | Bergheim | Aug 2004 | B2 |
6840931 | Peterson | Jan 2005 | B2 |
6846318 | Camp | Jan 2005 | B2 |
6866563 | Green | Mar 2005 | B2 |
6964781 | Brubaker | Nov 2005 | B2 |
6982090 | Gillespie | Jan 2006 | B2 |
6991808 | Brubaker | Jan 2006 | B2 |
6994684 | Murray | Feb 2006 | B2 |
7001615 | Singh | Feb 2006 | B1 |
7017580 | Prescott | Mar 2006 | B2 |
7117870 | Prescott | Oct 2006 | B2 |
7135009 | Tu | Nov 2006 | B2 |
7204253 | Mendius | Apr 2007 | B2 |
7204995 | El-Sherif | Apr 2007 | B2 |
20020032400 | Moazed | Mar 2002 | A1 |
20020055701 | Fischell | May 2002 | A1 |
20020103255 | Hellberg | Aug 2002 | A1 |
20020151960 | Mendius | Oct 2002 | A1 |
20020193441 | Robertson | Dec 2002 | A1 |
20020198453 | Herrick | Dec 2002 | A1 |
20030130612 | Moazed | Jul 2003 | A1 |
20040102729 | Haffner | May 2004 | A1 |
20040121014 | Guo | Jun 2004 | A1 |
20040127843 | Tu | Jul 2004 | A1 |
20040137068 | Bhushan | Jul 2004 | A1 |
20040141151 | Gillespie | Jul 2004 | A1 |
20040147870 | Burns | Jul 2004 | A1 |
20040170685 | Carpenter | Sep 2004 | A1 |
20040175410 | Ashton | Sep 2004 | A1 |
20040210182 | Fouere | Oct 2004 | A1 |
20040249333 | Bergheim | Dec 2004 | A1 |
20040265356 | Mosack | Dec 2004 | A1 |
20050048121 | East | Mar 2005 | A1 |
20050095269 | Ainpour | May 2005 | A1 |
20050129731 | Horres | Jun 2005 | A1 |
20050197614 | Pritchard | Sep 2005 | A1 |
20050220882 | Pritchard | Oct 2005 | A1 |
20050232972 | Odrich | Oct 2005 | A1 |
20050244469 | Whitcup | Nov 2005 | A1 |
20050266047 | Tu | Dec 2005 | A1 |
20050271704 | Tu | Dec 2005 | A1 |
20050283109 | Peyman | Dec 2005 | A1 |
20060013835 | Anderson | Jan 2006 | A1 |
20060020248 | Prescott | Jan 2006 | A1 |
20060020253 | Prescott | Jan 2006 | A1 |
20060074370 | Zhou | Apr 2006 | A1 |
20060100700 | Bernard | May 2006 | A1 |
20060106352 | Kurihashi | May 2006 | A1 |
20060122553 | Hanna | Jun 2006 | A1 |
20070083146 | Murray | Apr 2007 | A1 |
20070123924 | Becker | May 2007 | A1 |
20070132125 | Rastogi | Jun 2007 | A1 |
20070135914 | Herrick | Jun 2007 | A1 |
20070243230 | de Juan | Oct 2007 | A1 |
20070269487 | de Juan | Nov 2007 | A1 |
20070298075 | Borgia | Dec 2007 | A1 |
20070299515 | Herrick | Dec 2007 | A1 |
20070299516 | Cui | Dec 2007 | A1 |
20080038317 | Chang | Feb 2008 | A1 |
20080045878 | Bergheim | Feb 2008 | A1 |
20080045911 | Borgia | Feb 2008 | A1 |
20090092654 | de Juan | Apr 2009 | A1 |
20090104243 | Utkhede | Apr 2009 | A1 |
20090104248 | Rapacki | Apr 2009 | A1 |
20090105749 | de Juan | Apr 2009 | A1 |
20090118702 | Lazar | May 2009 | A1 |
20100040670 | Odrich | Feb 2010 | A1 |
Number | Date | Country |
---|---|---|
20023644336 | Jul 2003 | AU |
0442745 | Aug 1991 | EP |
0621022 | Oct 1994 | EP |
10033584 | Feb 1998 | JP |
2004202276 | Jul 2004 | JP |
2005000628 | Jan 2005 | JP |
2005058622 | Mar 2005 | JP |
2005110765 | Apr 2005 | JP |
2005110930 | Apr 2005 | JP |
2005312835 | Nov 2005 | JP |
2005319190 | Nov 2005 | JP |
2005328922 | Dec 2005 | JP |
2007195819 | Aug 2007 | JP |
WO-9833461 | Aug 1998 | WO |
WO-9842282 | Oct 1998 | WO |
WO-9937260 | Jul 1999 | WO |
WO-9944553 | Sep 1999 | WO |
WO-9964089 | Dec 1999 | WO |
WO-9965544 | Dec 1999 | WO |
WO-0003705 | Jan 2000 | WO |
WO-0027321 | May 2000 | WO |
WO-0062760 | Oct 2000 | WO |
WO-0211783 | Feb 2002 | WO |
WO-02058667 | Aug 2002 | WO |
WO-02083198 | Oct 2002 | WO |
WO-03017897 | Mar 2003 | WO |
WO-03022242 | Mar 2003 | WO |
WO-03057101 | Jul 2003 | WO |
WO-2004004614 | Jan 2004 | WO |
WO-2004024043 | Mar 2004 | WO |
WO-2004105658 | Dec 2004 | WO |
WO-2004112639 | Dec 2004 | WO |
WO-2005000154 | Jan 2005 | WO |
WO-2005086694 | Sep 2005 | WO |
WO-2006014434 | Feb 2006 | WO |
WO-2006031658 | Mar 2006 | WO |
WO-2006044669 | Apr 2006 | WO |
WO-2006057859 | Jun 2006 | WO |
WO-2006096586 | Sep 2006 | WO |
WO-2007008262 | Jan 2007 | WO |
WO-2007115259 | Oct 2007 | WO |
WO-2007115261 | Oct 2007 | WO |
WO-2007149771 | Dec 2007 | WO |
WO-2007149832 | Dec 2007 | WO |
WO-2008056060 | May 2008 | WO |
WO-2008094989 | Aug 2008 | WO |
WO-2009035562 | Mar 2009 | WO |
Entry |
---|
Rathbone and Gurny, Ed. Controlled Release Veterinary Drug Delivery, 2000, p. 118. |
Carter et al. Ophthalmic Plastic and Reconstructive Surgery 4(4), p. 231-233, 1988. |
“U.S. Appl. No. 10/825,047, Response filed Apr. 22, 2009 to Non Final Office Action mailed Oct. 22, 2008”, 17 pgs. |
“U.S. Appl. No. 10/825,047,Final Office Action mailed Jun. 9, 2009”, 14 pgs. |
“U.S. Appl. No. 10/825,047,Non-Final Office Action mailed Oct. 22, 2008”, 13 pgs. |
“U.S. Appl. No. 10/825,047,Response filed Aug. 18, 2008 to Restriction Requirement mailed Jul. 17, 2008”, 10 pgs. |
“U.S. Appl. No. 10/825,047,Response filed Oct. 22, 2009 to Final Office Action mailed Jun. 9, 2009”, 20 pgs. |
“U.S. Appl. No. 10/825,047,Restriction Requirement mailed Jul. 17, 2008”, 6 pgs. |
“U.S. Appl. No. 11/571,147,Restriction Requirement mailed Jun. 26, 2009”, 5 pgs. |
“U.S. Appl. No. 11/695,537, Notice mailed Nov. 28, 2008 Regarding a Noncompliant or Nonresponsive Amendment filed on Nov. 3, 2008”, 3 pgs. |
“U.S. Appl. No. 11/695,537, Response filed Nov. 3, 2008 to Restriction Requirement mailed Oct. 3, 2008”, 15 pgs. |
“U.S. Appl. No. 11/695,537, Response filed Dec. 17, 2008 to Office Communication mailed Nov. 28, 2008”, 8 pgs. |
“U.S. Appl. No. 11/695,537, Restriction Requirement mailed Oct. 3, 2008”, 10 pgs. |
“U.S. Appl. No. 11/695,545, Preliminary Amendment and Response filed Nov. 6, 2008 to Restriction Requirement mailed Oct. 6, 2008”, 14 pgs. |
“U.S. Appl. No. 11/695,545, Restriction Requirement mailed Oct. 6, 2008”, 10 pgs. |
“U.S. Appl. No. 12/604,202, Preliminary Amendment filed Nov. 30, 2009”, 6 pgs. |
Dejuan, Jr E, “Expandable Nasolacrimal Drainage System Implants”, U.S. Appl. No. 60/970,696, filed Sep. 7, 2007, 82 pgs. |
Dejuan, Jr E, “Manufacture of Expandable Nasolacrimal Drainage System Implants”, U.S. Appl. No. 60/970,720, filed Sep. 7, 2007, 57 pgs. |
Dejuan, Jr E, “Multiple Drug Delivery Systems and Combinations of Drugs With Punctal Implants”, U.S. Appl. No. 60/970,820, filed Sep. 7, 2007, 67 pgs. |
“European Application Serial No. 05768122.3, Supplementary European Search Report mailed Mar. 31, 2009”, 3 pgs. |
“European Application Serial No. 05768122.3,Office Action mailed Apr. 17, 2009”, 6 pgs. |
Fukano, Y., et al., “Influence of Benzalkonium Chloride on the Penetration of Latanoprost into Rabbit Aqueous Humor After Ocular Instillations”, AAPS Journal, vol. 8(S2), (2006),1pg. |
Goskonda, V. R., et al., “Permeability of Chemical Delivery Systems Across Rabbit Corneal (SIRC) Cell Line and Isolated Corneas: A Comparative Study”, Pharmaceutical Development and Technology, 5(3), (Abstract Only), (Jul. 2000), 1 pg. |
“Impregnate—Definition by Dictionary.com”, Accessed Apr. 6, 2011. |
“International Application Serial No. PCT/US07/65792, International Search Report mailed Nov. 20, 2008”, 2 pgs. |
“International Application Serial No. PCT/US07/65792, International Written Opinion mailed Nov. 20, 2008”, 5 pgs. |
“International Application Serial No. PCT/US2007/065789, International Search Report mailed Aug. 13, 2008”, 3 pgs. |
“International Application Serial No. PCT/US2007/065789, Written Opinion mailed Aug. 13, 2008”, 5 pgs. |
“International Application Serial No. PCT/US2008/010479, International Search Report mailed Dec. 15, 2008”, 6 pgs. |
“International Application Serial No. PCT/US2008/010479, Written Opinion mailed Dec. 15, 2008”, 7 pgs. |
“International Application Serial No. PCT/US2008/010487, International Search Report mailed May 25, 2009”, 5 pgs. |
“International Application Serial No. PCT/US2008/010487, Written Opinion mailed May 25, 2009”, 8 pgs. |
Kaur, I. P., et al., “Chapter 25—Ocular Penetration Enhancers”, In: Enhancement in Drug Delivery, (2007), 527-548. |
Lazar, E, “Treatment Medium Delivery Device and Methods for Delivery of Such Treatment Mediums to the Eye Using Such a Delivery Device”, U.S. Appl. No. 11/571,147, filed Dec. 21, 2006, 32 pgs. |
Nakajima, M. et al., “Assessment of Drug Concentrations in Tears in Therapeutic Drug Monitoring: I. Determination of Valproic Acid in Tears by Gas Chromatography/Mass Spectrometry With EC/NCI Mode”, Therapeutic Drug Monitoring, 22, (2000), 716-722. |
“Oasis Product Catalog”, (Apr. 2009), 7 pgs. |
“Production Information for EaglePlug(r) TearFlow tm”, (c) 2009 EagleVision, Inc., Memphis, TN, (2009), 1 pg. |
“Production Information for the Micro Flow™ Punctal Occluder”, Odyssey Medical, 1 pg. |
Reich, C, et al., “Manufacture of Drug Cores for Sustained Release of Therapeutic Agents”, U.S. Appl. No. 60/970,699, filed Sep. 7, 2007, 66 pgs. |
Reich, Jr, Carl J.,et al “Nasolacriminal Drainage System Implants for Drug Delivery”, U.S. Appl. No. 60/970,709, filed Sep. 7, 2007, 103 pgs. |
Number | Date | Country | |
---|---|---|---|
20150132358 A1 | May 2015 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 10825047 | Apr 2004 | US |
Child | 12604202 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 13533676 | Jun 2012 | US |
Child | 14472844 | US | |
Parent | 12604202 | Oct 2009 | US |
Child | 13533676 | US |