Surgery – Controlled release therapeutic device or system
Reexamination Certificate
2011-06-21
2011-06-21
DeSanto, Matthew F (Department: 3763)
Surgery
Controlled release therapeutic device or system
C604S500000, C604S093010, C604S288010
Reexamination Certificate
active
07963956
ABSTRACT:
The present invention is directed to a device for a portable convection enhanced delivery system that allows administering liquids to specific locations within the body, especially tissues and tumors also allowing outsubject treatment. The application system comprises a portable extracorporal pump with a fluid reservoir that is connected via an infusion system to an infusion catheter placeable to any tissue or tumor the fluid should be administered to by high flow microperfusion. The system enables administration of fluids of any kind by convection enhanced delivery also in out-patient treatment. The system can be used for delivering various drugs, proteins, protein toxins, antibodies-for treatment or imaging, proteins in enzyme replacement therapy, growth factors and viruses or oligonucleotides in gene therapy etc. The application methods as well as the surgical method to implant this device are enclosed to this invention.
REFERENCES:
patent: 4500311 (1985-02-01), Redmond et al.
patent: 4578057 (1986-03-01), Sussman
patent: 4699615 (1987-10-01), Fischell et al.
patent: 5711316 (1998-01-01), Elsberry et al.
patent: 5720720 (1998-02-01), Laske et al.
patent: 5735814 (1998-04-01), Elsberry et al.
patent: 5800390 (1998-09-01), Hayakawa et al.
patent: 5843150 (1998-12-01), Dreessen et al.
patent: 5897528 (1999-04-01), Schultz
patent: 5954687 (1999-09-01), Baudino
patent: 5975085 (1999-11-01), Rise
patent: 6013051 (2000-01-01), Nelson
patent: 6094598 (2000-07-01), Elsberry et al.
patent: 6210346 (2001-04-01), Hall et al.
patent: 6221349 (2001-04-01), Couto et al.
patent: 6272370 (2001-08-01), Gillies et al.
patent: 6309634 (2001-10-01), Bankiewicz et al.
patent: 6346098 (2002-02-01), Yock et al.
patent: 6463317 (2002-10-01), Kucharczyk et al.
patent: 6471689 (2002-10-01), Joseph et al.
patent: 6481758 (2002-11-01), Andre et al.
patent: 6503242 (2003-01-01), Elsberry
patent: 6540724 (2003-04-01), Harris
patent: 6546280 (2003-04-01), Osborne
patent: 6620138 (2003-09-01), Marrgi et al.
patent: 6764472 (2004-07-01), Burke et al.
patent: 2002/0114780 (2002-08-01), Bankiewicz et al.
patent: 2002/0141980 (2002-10-01), Bankiewicz et al.
patent: 2003/0171738 (2003-09-01), Konieczynski et al.
patent: 199 12 434 (2000-09-01), None
patent: 0 995 460 (2000-04-01), None
patent: WO 95/05864 (1995-03-01), None
patent: WO 96/33766 (1996-10-01), None
patent: WO 99/61066 (1999-12-01), None
patent: WO 01/62316 (2001-08-01), None
Broaddus et al., “Distribution and stability of antisense phosphorothioate oligonucleotides in rodent brain following direct intraparenchymal controlled-rate infusion”J Neurosurgvol. 88 (Apr. 1998) pp. 734-742.
Chen et al., “Variables affecting convection-enhanced delivery to the striatum: a systematic examination of rate of infusion, cannula size, infusate concentration, and tissue-cannula sealing time”J Neurosurgvol. 90 (Feb. 1999) pp. 315-320.
Debinski, Waldemar, “Local treatment of brain tumors with targeted chimera cytotoxic proteins”Cancer Investigationvol. 20 Issue 5&6 (2002) pp. 801-809.
Engelhard, Herbert H., “Antisense oligodeoxynucleotide technology: Potential use for the treatment of malignant brain tumors”Cancer Control Journal/Journal of the Moffitt Cancer Center(Mar./Apr. 1998) <http://www.moffitt.usf.edu/pubs/ccj/v5n2/article7.html>.
Groothuis et al., “Comparison of cytosine arabinoside delivery to rat brain by intravenous, intrathecal, intraventricular and intraparenchymal routes of administration”Brain Researchvol. 856 (2000) pp. 281-290.
Groothuis et al., “Comparison of14C-sucrose delivery to the brain by intravenous, intraventricular, and convection-enhanced intracerebral infusion”J. Neurosurgvol. 90 (Feb. 1999) pp. 321-331.
Hamilton et al., “Heparin coinfusion during convection-enhanced delivery (CED) increases the distribution of the glial-derived neurotrophic factor (GDNF) ligand family in rat striatum and enhances the pharmacological activity of neurturin”Experimental Neurologyvol. 168 (2001) pp. 155-161.
Heimberger et al., “Temozolomide delivered by intracerebral microinfusion is safe and efficacious against malignant gliomas in rats”Clinical Cancer Researchvol. 6 (Oct. 2000) pp. 4148-4153.
Laske et al., “Tumor regression with regional distribution of the targeted toxin TF-CRM107 in patients with malignant brain tumors”Nature Medicinevol. 3 No. 12 (Dec. 1997) pp. 1362-1368.
Lieberman et al., “Convection-enhanced distribution of large molecules in gray matter during interstitial drug infusion”J Neurosurgvol. 82 (Jun. 1995) pp. 1021-1029.
Lieberman et al., “Reversal of experimantal parkinsonism by using selective chemical ablation of the medial globus pallidus”J. Neurosurgvol. 90 (May 1999) pp. 928-934.
Mardor et al., “Diffusion weighted MRI-based studies of mechanisms and optimization of convection enhanced delivery (CED) of drugs into brain tumors”Proceedings of the American Association for Cancer Research 93rdAnnual MeetingApr. 6-10, 2002, San Francisco, California, vol. 43 (Mar. 2002).
Mardor et al., “Monitoring response to convection-enhanced taxol delivery in brain tumor patients using diffusion-weighted magnetic resonance imaging”Cancer ResearchVo. 61.(Jul. 1, 2001) pp. 4971-4973.
Moehler et al., “Salvage therapy for multiple myeloma with thalidomide and CED chemotherapy”Bloodvol. 98 No. 13 (Dec. 15, 2001) pp. 3846-3848.
Morrison et al., “High-flow microinfusion: tissue penetration and pharmacodynamics”Am. J. Physiol. vol. 266 No. 1 Pt. 2 (Jan. 1994) pp. R292-R305.
Nguyen, et al., “Convection-enhanced delivery of AAV-2 combined with heparin increases TK gene transfer in the rat brain”Neurochemistryvol. 12 No. 9 (Jul. 3, 2001) pp. 1961-1964.
Pfeffer, et al., “Convection-enhanced intra-tumoral delivery of taxol for recurrent glioblastoma. Results of a phase I clinical study”Proceedings of the American Society of Clinical Oncology Thirty-Eighth Annual MeetingMay 18-21, 2002 Orlando, Florida, pp. 316.
Ratcliff et al., “Convection-enhanced delivery in intact and lesioned peripheral nerve”J. Neurosurg. vol. 95 (Dec. 2001) pp. 1001-1011.
Sandberg et al., “Convection-enhanced delivery into the rat brainstem”J Neurosurgvol. 96 (May 2002) pp. 885-891.
Stevenson et al., “Phase I clinical/pharmacokinetic and pharmacodynamic trial of the c-raf-1 antisense oligonucleotide ISIS 5132 (CGP 69846A)”Journal of Clinical Oncologyvol. 17, No. 7 (Jul. 1999) pp. 2227-2236.
Stocker et al. “Klinisches Management des akut hirnverletzten” (English title: Clinical management of acute head injury)Schweiz Med Wochenschrvol. 130 (2000) pp. 1544-1556.
Tolcher et al., “A randomized phase II and pharmacokinetic study of the antisense oligonucleotides ISIS 3521 and ISIS 5132 in patients with hormone-refractory prostate cancer”Clinical Cancer Researchvol. 8 (Aug. 2002) pp. 2530-2535.
Russel Lonser and Edward Oldfield, Beyond the Blood-Nervous System Barrier Convection-Enhanced Delivery Targets of CNS Disorders, AANS Bulletin, vol. 13(4) Winter 2004, p. 36-37.
Raghu Raghavan et al., Convection-Enhanced Delivery of Therapeutics for Brain Disease, and its Optimization, Neurosurgical Focus, vol. 20(4) (22006) E:12 (abstract only).
Cigna Medical Coverage Policy, Convection-Enhanced Delivery of Therapeutics Agents to the Brain, available at www.cigna.com/customer—care/healthcare—professional/coverage—positions/medical/mm—0476—coveragepositioncriteria—convection—enhanced—delivery—therapeutic—agents.pdf.
International Search Report mailed on Sep. 21, 2004 in PCT/EP2004/004211, European Patent Office.
International Preliminary Report on Patentabiliy issued on Oct. 28, 2005 in in PCT/EP2004/004211, International Bureau of WIPO.
A Graph of Interstitial Concentration versus Time for Pressure-Driven Delivery a
Antisense Pharma GmbH
Desanto Matthew F
Mayer Brown LLP
LandOfFree
Portable equipment for administration of fluids into tissues... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Portable equipment for administration of fluids into tissues..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Portable equipment for administration of fluids into tissues... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2644728