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(12) Patent Application Publication (10) Pub. No.: US 2011/0105825 A1 Nayfach-Battilana (43) Pub US 2011 01 05825A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0105825 A1 Nayfach-Battilana (43) Pub. Date: May 5, 2011 (54) NANOPARTICLE-SIZED MAGNETIC (52) U.S. Cl. ............ 600/12: 424/9.3; 424/400; 424/450; ABSORPTION ENHANCERS HAVING 424/9.32; 977/904 THREE-DIMIENSIONAL GEOMETRIES ADAPTED FOR IMPROVED DAGNOSTICS AND HYPERTHERMIC TREATMENT (57) ABSTRACT Nanoparticle-sized magnetic absorption enhancers (MAES) (75) Inventor: Joseph N. Nayfach-Battilana, San that exhibit a controlled response to a magnetic field, includ Rafael, CA (US) ing a controlled mechanical response and inductive thermal response. The MAEs have a magnetic material that exhibits (73) Assignee: Qteris Inc. the inductive thermal response to the magnetic field and is (21) Appl. No.: 12/925,904 embedded in a coating, such that the MAE conforms to a particular shape, e.g., a hemisphere, a dome or a shell, that is (22) Filed: Nov. 1, 2010 chosen to produce the desired controlled mechanical response of the entire MAE to the magnetic field. A targeting Related U.S. Application Data moiety for specifically binding the MAE to a pathogen target is also provided. The MAEs are preferably bound by a flexible (60) Provisional application No. 61/256,986, filed on Oct. linker to promote the desired mechanical response, which 31, 2009. includes interactions between MAEs that are not bound to their pathogen target for the purpose of forming spheres, Publication Classification spherical shells, or generally spherical dimers. Such forms (51) Int. Cl. contain the thermal energy produced by the thermal inductive A6 IN 2/10 (2006.01) response of the magnetic material and thus reduce collateral A6 IK 49/00 (2006.01) healthy tissue damage during hyperthermic treatment. The A6 IK 9/00 (2006.01) inventing extends to appropriate apparatus and methods for A 6LX 9/27 (2006.01) diagnostics and hyperthermic treatments employing the A6IP3/04 (2006.01) MAES. Patent Application Publication May 5, 2011 Sheet 1 of 12 US 2011/O105825 A1 B 100 A. Z. ARIORAR2 Patent Application Publication May 5, 2011 Sheet 2 of 12 US 2011/O105825 A1 126 s Av. 25 ARIOR AR7) Patent Application Publication May 5, 2011 Sheet 3 of 12 US 2011/O105825 A1 Patent Application Publication May 5, 2011 Sheet 4 of 12 US 2011/O105825 A1 222 202D Patent Application Publication May 5, 2011 Sheet 5 of 12 US 2011/O105825 A1 Patent Application Publication May 5, 2011 Sheet 6 of 12 US 2011/O105825 A1 41 OB 41 OE 416D 41 OF 41 OD 410C 412B 422 410G 416G 418B 420 Patent Application Publication May 5, 2011 Sheet 7 of 12 US 2011/O105825 A1 Patent Application Publication May 5, 2011 Sheet 8 of 12 US 2011/0105825 A1 1. MAE Administration 901 2. Magnetic Resonance 902 Imaging of MAE 903 3. MAE Tissue Saturation Threshold CYES) 907 Reached? 4. Magnetic Dipole 7. Wait for Antibody Bio-Conjugation Recomputation and MAE Tissue Clearance 5. Magnetic Dipole 6. Magnetic Resonance 8. Magnetic Resonance Reorientation Imaging of MAE Imaging of MAE 905 906 908 9. Pathogen and MAE Location/Temperature 909 Map Distribution 911 11. Diagnosis Positive Treatment Recommended 910 913 13. Initial Device 10. MAE Tissue Configuration CYES) Saturation Threshold Maintained? 14. Apply Alternating 914 912 Magnetic Field Pulse 12. Diagnosis Negative Sequence (AMF) No Treatment Needed Treatment Halted 15. IR/Fluorescent 20. Device Re Imaging of MAE configuration Using New Parameters 920 16. Pathogen and MAE Location/Temperature Map Recomputation 17. Adapt AFM Pulse Sequence Parameters to Maximize MAE/ 18. Pathogen 19. Destruction Pathogen Thermal Transient, Treatment Without Exceeding Inflammatory Threshold Halted Response Threshold Reached? Patent Application Publication May 5, 2011 Sheet 9 of 12 US 2011/O105825 A1 a are - a a - a a A a Measure Pathogen.------------------------ Death Rate 1001 Get Temperature 1. Treatment Maps System Control 1004 4. NMR Thermometry Set AMF Parameters Get IR Raditiation Get IR Raditiation 5. Ambient Heat 3. MAE Heat 2. Magnetic Field Absorption Dissipation Generator 1005 Apply Magnetic OO Field Pulse 1002 v. ZO Patent Application Publication May 5, 2011 Sheet 10 of 12 US 2011/O105825 A1 700 708 s 7. Z25 Patent Application Publication May 5, 2011 Sheet 11 of 12 US 2011/O105825 A1 1 1i O 6 110 1108 1109 1110 Patent Application Publication May 5, 2011 Sheet 12 of 12 US 2011/O105825 A1 A. Z4 US 2011/O 105825 A1 May 5, 2011 NANOPARTICLE-SIZED MAGNETIC 0007 Examples of resistant organisms include Methicil ABSORPTION ENHANCERS HAVING lin-resistant Staphylococcus aureus (MRSA), Vancomycin THREE-DIMIENSIONAL GEOMETRIES resistant enterococci (VRE), multiple-drug-resistant Gram ADAPTED FOR IMPROVED DAGNOSTICS negative bacilli, penicillin-resistant Streptococcus AND HYPERTHERMIC TREATMENT pneumoniae, penicillin, tetracycline, and quinolone-resistant Neisseria gonorrhoeae, and multi-resistant Shigella, Salmo RELATED APPLICATIONS nella, and Campylobacter species. In fact, Vancomycin-resis tant enterococi (VRE), which emerged in the late 1980s, are 0001. This application claims priority from U.S. provi now endemic in many hospitals with a prevalence of more sional patent application 61/256,986 filed on 31 Oct. 2009 than 25% reported for intensive care units in the USA in 2000 and incorporated herein by reference. (National Nosocomial Infections Surveillance System report, 2001)VRE infections include urinary tract infections, bacter FIELD OF THE INVENTION aemia, edocarditis, and wound infections. 0008 Patients colonized with MRSA more frequently 0002 This invention relates generally to apparatus and develop systemic infections, including bacteremia, postster methods for diagnostics and hyperthermic treatments notomy media-stinitis, and Surgical site infections. Bacter employing nanoparticle-sized magnetic absorption enhanc emia caused by MRSA has been associated with significantly ers that attach to pathogen targets to be diagnosed or treated, higher mortality rates (29%-36%) than MRSSA (12-23%). and more specifically to three-dimensional geometries of The occurrence of MRSA in surgical site infections has a Such magnetic absorption enhancers that improve diagnostics significant impact on clinical and economic outcomes, nota and hyperthermic treatments. bly an increase in post-operative mortality. Mortality during the 90-day postoperative period was significantly higher in BACKGROUND ART patients with surgical site infections due to MRSA as com pared to patients with MSSA. Hospital costs were signifi General Review of Infectious Diseases and Develop cantly higher for patients with Surgical site infections due to ment of Pathogen Resistance to Current Treatments MRSA as compared with MSSA (p<0.001). (Reed, S. D., 0003. The development of new strains of pathogenic Friedman, J.Y., Engemann, J. J., Griffiths, R.I., Anstrom, K. microorganisms resistant to antimicrobial agents has become J., Kaye, K. S.) a serious risk to public health (G. C. Gemmel, “Glycopeptide 0009 Multi-drug resistant MRSA is now reported in a resistance in Staphylococcus aureus. is it a real threat?'. J. variety of settings in the United States, including communi Infec. Chemother., pp. 10:69-75, 2004, I. Chopra, “Staphylo ties and hospitals. In 2000 the National Nosocomial Infec coccus aureus. concerns, causes, and cures. Expert Rev. tions Surveillance system reported that more than 50% of Anti Infect. Ther. pp. 1:45-55, 2003). This increasing inci Staphylococcus aureus isolates collected from intensive care dence of resistant pathogens presents a serious treat to both units were resistant to methicillin (MRSA). 120,000 people military personnel and civilians alike. Patients suffering from were infected with MRSA in 2005, causing 19,000 deaths. resistant infections often experience increased duration and The cost to just treat MRSA infections in the United States severity of infection and rate of morbidity. can be conservatively estimated at 5 billion dollars annually. 0004 Antimicrobial resistance is a biological phenom The annual cost of treating Staphylococcus Aureus, which is enon where bacteria multiply in the presence of an antibiotic resistant to multiple drugs, can be estimated 1.5 billion dol given at a higher than therapeutic dose (WHO Global Strat lars. There have been reports of an association between egy for Containment of Antimicrobial Resistance, 2001). MRSA infections and major hospital care disruptions when Resistance can be described for an entire species of bacteria cohort isolation and unit closure must be undertaken to con or it may emerge in specific strains of Susceptible species. trol infection outbreaks. The threat of antimicrobial resis There are three stages to the development of resistance: pro tance is also related to bioterrorism. action, acquired response, and selection. 0010. Of particular concern is an increasing incidence of 0005. This resistance results from an interplay of genetics Vancomycin resistance, which has direct consequences on and phenotypic expression. Genetic resistance may be patient mortality (MRSA Initiative, Dept. of Veterans Affairs, acquired through genetic mutation and then propagated 2007, Sharon S. Rotun et al. 1999). Vancomycin, has now through a colony of pathogen cells through DNA transfer. become a commonly used therapy for MRSA, but recent Phenotypic expression can result in the inactivation of the studies show development of resistance to Vancomycin (Van drug (penicillin, chloramphenicaol), expulsion of the drug comycin-intermediate Staphylococcus aureus (VISA)). Iso from
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