Diagnostic methods and apparatus

Patent metadata

Field	Value
Publication number	US-11813196-B2
Application number	US-201916540617-A
Country	US
Kind code	B2
Filing date	Aug 14, 2019
Priority date	Jun 28, 2011
Publication date	Nov 14, 2023
Grant date	Nov 14, 2023

Abstract

An apparatus to treat a patient comprises a container to receive fluid of a device implanted in the eye. The fluid of the device can be analyzed to determine a component of the vitreous humor of the eye.

First claim

What is claimed is:

1. An apparatus for collecting a sample of fluid from a reservoir chamber of a therapeutic device having a porous structure and configured to be implanted in an eye of a patient, the apparatus comprising:
a cartridge comprising:
a connector for coupling the cartridge to a syringe, the cartridge being arranged to contain therapeutic agent;
at least one needle extending along a longitudinal axis and being operable to penetrate the implanted therapeutic device, wherein the at least one needle comprises a first lumen and a second lumen, the first lumen arranged to allow an amount of the therapeutic agent to be injected from the syringe through the first lumen into the reservoir chamber of the implanted therapeutic device;
a visual indicator coupled to a depth stop to guide depth of penetration of the at least one needle within the reservoir chamber, wherein the visual indicator is coaxial with the longitudinal axis of the at least one needle; and
a container coupled to the cartridge and in fluid communication with the second lumen extending through the at least one needle, the container configured to be at atmospheric pressure during use, wherein the second lumen is arranged to allow the sample of fluid to be displaced from the reservoir chamber through the second lumen into the container at the same time as the amount of therapeutic agent is injected from the syringe through the first lumen into the reservoir chamber, the container arranged to collect the displaced sample of fluid for use in one or more analyses, the container comprising a window for viewing a level of the displaced sample of fluid in the container.

2. The apparatus of claim 1 , wherein the porous structure releases the therapeutic agent via diffusion out from the reservoir chamber.

3. The apparatus of claim 2 , wherein the sample of fluid displaced from the reservoir chamber comprises:
liquid from the eye comprising one or more markers of the eye accumulated in the reservoir chamber through the porous structure over a period of time; and
a therapeutic agent formulation remaining in the reservoir chamber after the period of time, the therapeutic agent formulation comprising one or more non-pharmacologic components and an amount of the therapeutic agent.

4. The apparatus of claim 3 , wherein the liquid from the eye comprises an aqueous humor or a vitreous humor fluid from the eye.

5. The apparatus of claim 4 , wherein the one or more non-pharmacologic components comprises one or more of a marker to measure device function, a salt, a surfactant, a stabilizer, or a particle.

6. The apparatus of claim 3 , wherein the therapeutic agent comprises one or more compounds of 2-Methoxyestradiol analogs, 3-aminothalidomide, 13-cis retinoic acid, A0003, A5b1 integrin inhibitor, Abarelix, Abatacept, Abciximab, ABT-578, Acetonide, Adalimumab, Aldesleukin, Alefacept, Alemtuzumab, Alpha-1-proteinase inhibitor, Alteplase, AMG-1470, Anakinra, Anecortave acetate, Angiostatin, Anistreplase, Anti-angiogenesis peptides, Anti-angiogenesis antibodies, TRC093, TRC 105, Anti-angiogeric bifunctional protein, Anti-endothelial growth factor, Antihemophilic Factor, Antithymocyte globulin, Anti-hypertensive MC1101, Anti-platelet derived growth factor, Anti-VEGF, AP23841, ARC1905 (Complement Cascade Inhibitor Factor C5), Aprotinin, Arcitumomab, Asparaginase, Axitinib, Basiliximab, Becaplermin, Bevacizumab, Bivalirudin, Bortezomib, Bosutinib, Botulinum Toxin Type A, Botulinum Toxin Type B, C5 inhibitor, Cal 101 (PI3K Delta Inhibitor), Canstatin, Capromab, Captopril, CCI-779, Cediranib, Celecoxib, Cetrorelix, Cetuximab, Choriogonadotropin alfa, Cilary neurotrophic factor, Coagulation Factor IX, Coagulation factor VIIa, Colchicines, Collagenase, Complement factor H recombinant, Compstatin derivative peptide, POT-4, Corticotropin, Cosyntropin, Cyclophilins, Cyclosporine, Daclizumab, Darbepoetin alfa, Dasatinib, Defibrotide, Denileukin diftitox, Desmopressin, Dexamethasone, Diclofenac, Dithiocarbamate, Dornase Alfa, Drotrecogin alfa, Eculizumab, Efalizumab, Endostatin, Enfuvirtide, Epoetin alfa, Eptifibatide, Erlotinib, Etanercept, Everolimus, Exenatide, FCFD4514S (Complement Cascade Inhibitor Factor D), Felypressin, Fenretinide, Filgrastim, FK605-binding proteins, FKBPs, Fluocinolone Acetonide, Follitropin beta, Fumagillin, Galsulfase, Gefitinib, Gemtuzumab ozogamicin, Glatiramer Acetate, Glucagon recombinant, Goserelin, Human Serum Albumin, Hyaluronidase, Ibritumomab, Idursulfase, Imatinib, Immune globulin, Infliximab, Insulin Glargine recombinant, Insulin Lyspro recombinant, Insulin, Interferon, Interferon Alfa-2a, Interferon Alfa-2b, Interferon alfacon-1, Interferon alfa-n1, Interferon alfa-n3, Interferon beta-1b, Interferon gamma-1b, Lapatinib, Lepirudin, Lestaurtinib, Leuprolide, Lutropin alfa, Mecasermin, Menotropins, Methotrexate, mTOR inhibitors, Muromonab, Natalizumab, Nepafenac, Nesiritide, Nilotinib, NS398, Octreotide, Omalizumab, Oprelvekin, OspA lipoprotein, OT-551, Oxytocin, Palifermin, Palivizumab, Panitumumab, PDGF inhibitor, PEDF (pigment epithelium derived factor), Pegademase bovine, Pegaptanib, Pegaspargase, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pegvisomant, Pentoxifylline, Perindozril, Pimecrolimus, PKC (protein kinase C) inhibitors, Pramlintide, Proteosome inhibitors, Pyrrolidine, Quinopril, Ranibizumab, Rapamycin (siroliums), Rasburicase, Reteplase, Retinal stimulant, Retinoid(s), Rituximab, RNAI (RNA interference of angiogenic factors), Rofecoxib, Rosiglitazone, Ruboxistaurin, Salmon Calcitonin, Sargramostim, SDZ-RAD, Secretin, Selective inhibitor of the factor 3 complement cascade, Selective inhibitor of the factor 5 complement cascade, Semaxanib, Sermorelin, Serum albumin iodinated, Sirolimus reformulation (rapamycin), siRNAi molecule synthetic FTP-801i-14, Somatropin recombinant, Squalamine, Streptokinase, Sunitinib, Complement Cascade Inhibitor (Factor B), Tacrolimus, Tenecteplase, Teriparatide, Tetrathiomolybdate, Thalidomide, Thyrotropin Alfa, Tie-1 and Tie-2 kinase inhibitors, Toceranib, Tositumomab, TPN 470 analogue, Trastuzumab, Triamcinolone acetonide, Troglitazone, Tumistatin, Urofollitropin, Urokinase, Vandetanib, Vasopressin, Vatalanib, VEGF receptor kinase inhibitor, VEGF Trap, Visual Cycle Modulator ACU-4229, Vitamin(s), Vitronectin receptor antagonists, or Volociximab.

7. The apparatus of claim 3 , wherein the component comprises one or more markers of the eye to determine effectiveness treatment of a disease with a therapeutic agent, wherein the one or more markers is selected from the group consisting of one or more of a genetic marker, genomic expression of a marker, a protein marker, a protein biomarker of ocular disease, a biomarker having a linkage to an ocular disease, a biomarker having a linkage to AMD, a biomarker associated with AMD, a biomarker corresponding to a conversion from dry AMD to wet AMD, a biomarker comprising an early predictor of conversion of wet AMD to dry AMD, a complement cascade member, complement H factor (CFH), complement factor B (CFB), complement component 2 (C2), complement component 3 (C3), complement component 5 (C5) complement component 5a (C5a), C5b-9, a marker of expression of pro-inflammatory cytokines, TNF, tissue necrosis factor alpha, a marker of angiogenesis and vascular leakage, VEGF, CEP, IL-6, G-CSF, Serum Amyloid A, I CAM-1, Leptin, Glucose, lactose, C-reactive protein, PEDF, PDGF, IFG, interferon gamma, interleukin 1-beta, and IL-8.

8. The apparatus of claim 1 , wherein the displaced sample of fluid comprises aqueous humor or vitreous humor fluid accumulated within the reservoir chamber from the eye through the porous structure.

9. The apparatus of claim 1 , wherein the displaced sample of fluid

Assignees

• Forsight Vision4 Inc

Inventors

• Erickson Signe
• Doud Darren
• De Juan Jr Eugene
• Alster Yair
• Reich Cary J
• Farinas Kathleen Cogan

Classifications

• A61F9/0017 Primary

  implantable in, or in contact with, the eye, e.g. ocular inserts · CPC title

• A61B10/0045

  Devices for taking samples of body liquids · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• A61P27/02

  Ophthalmic agents · CPC title