Intelligent medical device system for personalized medicine applications

• US 8,617,873 B2
• Filed: 08/07/2009
• Issued: 12/31/2013
• Est. Priority Date: 08/08/2008
• Status: Expired due to Fees

• Current Assignee: Neal Solomon
• Original Assignee: Neal Solomon
• Inventors: Solomon, Neal
• Primary Examiner(s): Beisner, William H
• Assistant Examiner(s): HENKEL, DANIELLE B
• Application Number:
  US12/462,781
• Publication Number:
  US 20100069888A1
• Time in Patent Office: 1,607 Days
• Field of Search: 435/287.2, 435/287.1, 706/46, 422/68.1, 702/19, 702/20, 604/890.1
• US Class Current: 435/287.1
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/4227 endocrine glands, i.e. thyroid, adrenals, hypothalamic, pituitary
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

The system presents applications of personalized medicine with intelligent medical devices (iMDs) and customizes therapies to complex problems involving neurological, cardiovascular, cancer, immunological and endocrinological diseases.

Claims

1. A method for operation of a medical device for diagnostics, analysis and therapeutics for treatment of disease, comprising:

a set of layers of medical device components, a set of compartments for storage of chemicals and biologicals, a set of microfluidic components, including tubes, valves and gates, circuitry configured to control and connect device components, a lab-on-a-chip (LOC) component in a diagnostic module, an analytical module, including a database, for pathology modeling and therapeutic solution modeling and a therapeutic module comprised of a set of compartments, the method comprising;

connecting the diagnostic, analytical and therapeutic modules with electrical interconnects;

activating the diagnostics process of obtaining cell, DNA, RNA and/or protein samples from the patient;

analyzing the cell, DNA, RNA and/or protein samples in the LOC of the diagnostic module;

forwarding the LOC analysis data to the analytical module for modeling of the pathology;

generating remedial solution options from the model in the analytical module;

forwarding solution options for therapeutic recommendations;

configuring the therapeutic module to release specific chemicals and/or biologicals from compartments on at least one of a set of layers through the micro fluidic components in specific measured doses according to the model recommendations;

activating the therapeutic module to combine chemicals and/or biologicals; and

configuring the therapeutic module to transmit the combination of chemicals and/or biologicals to a cell site in a patient to treat disorders.

2. The method of claim 1, further comprising:

transmitting in a patient the therapeutic combination of chemicals and/or biologicals to treat cardiovascular disorders, including cerebrovascular disorders, blood clot disorders, arteriosclerosis disorders, hemophilia disorders, anemia disorders and/or thrombocytopenia disorders.

3. The method of claim 1, further comprising:

transmitting in a patient the therapeutic combination of chemicals and/or biologicals to treat abnormal cells, including neoplasties, cancer metastases, blocking angiogenesis in tumors, gene replacement of mutated genes and/or protein replacement of specific combinations of dysfunctional proteins.

4. The method of claim 1, further comprising:

Receiving biological and chemical samples from feedback of the application of a therapy to the pathology in the diagnostic module;

configuring the diagnostic module that includes the LOC to analyze the biological samples and forwards the analyses to the analytical module;

configuring the analytical module to model the sample data, develop refined solution options to solve the pathology and forward the solution model to the therapeutic module;

configuring the therapeutic module to combine chemicals and/or biologicals to update the solution to solve the pathology; and

managing the pathology with a revised therapy.

5. The method of claim 2, further comprising:

collecting biomarkers in the diagnostic module;

analyzing the biomarkers in the analytical module;

developing an evolving model based on new data inputs of biomarkers;

applying the model to track and anticipate disease progression and scenario pathway vectors;

identifying a blood clot in a cerebrovascular pathway;

identifying and selecting a solution option for solving cerebral disequilibrium; and

activating the medical device to apply chemicals to administer the remedy.

6. The method of claim 2, further comprising:

identifying BAD associated protein isoforms in the diagnostic module;

forwarding data to the analytical module;

constructing a model in the analytical module;

employing the model to compare the BAD biomarkers to a database of brain chemistry;

developing remedy solution pathway vectors with the model;

employing the therapeutics module to combine chemicals and/or biologicals to activate the remedy solution option; and

activating the therapeutics module to apply a remedy.

7. The method of claim 2, further comprising:

activating the medical device to collect cell and protein samples;

analyzing the cell and protein samples in the diagnostic module;

forwarding data to the analytical module;

building a model in the analytical module to map at least one region of the brain;

activating the analytical module to produce remedy solution options;

forwarding the data to the therapeutic module;

applying stem cells to affected regions of the brain; and

monitoring the remedy progress and stem cell assimilation by receiving updated cell and protein samples.

8. The method of claim 1, further comprising:

inputting biomarker samples of cardio reactive protein (CRP) and lipoprotein levels into the medical device diagnostics module;

identifying locations of plaque buildup and arterial calcification in the vasculature by analyzing biological samples in the diagnostics module;

forwarding CRP and lipoprotein data to the analytical module;

generating a model to map the vasculature in the analytical module;

identifying specific proteins associated with vasculature zip codes that differentiate locations in the vasculature;

forwarding the model data to the therapeutic module;

activating the therapeutic module to combine proteins to direct therapeutic remedies to specific vascular locations; and

applying the therapy until arterial plaque is in equilibrium.

9. The method of claim 2, further comprising:

collecting biological samples about specific diseased blood vessels from atherosclerosis in the diagnostics module;

forwarding the data to the analytical module;

building a model of patient vasculature to identify locations of diseased blood vessels in the analytical modules;

forwarding the model data to the therapeutic module;

applying VEGF or FGF 1 to cell clusters or modulating the application of PKC-E in the vasculature; and

regulating the vascular protein levels to an equilibrium state.

10. The method of claim 2, further comprising:

collecting and forwarding cell and protein samples to the diagnostics module;

analyzing biological samples to identify a blood disorder in the diagnostics module;

forwarding the data to the analytical module;

developing model solution options in the analytical module; and

activating the therapeutic module to apply protein replacement therapy.

11. The method of claim 3, further comprising:

collecting biomarkers in the diagnostic module to detect the presence of cancer cells;

analyzing data in the LOC in the diagnostic module;

forwarding the data to the analytical module;

activating the analytical module to model the pathology to identify the cell site;

activating the analytical module to build a model to identify genetic mutations in the cancer cells;

developing a model of solution options in the analytical module;

constructing at least one drug in the therapeutic module tailored to the tumor; and

applying the at least one drug to the cell site.

12. The method of claim 3, further comprising:

receiving cell and protein samples of a cancer tumor at the diagnostic module;

analyzing the biological sample data in the LOC of the diagnostic module;

transferring the data to the analytical module;

developing a model of the cancer tumor in the analytical module;

activating the therapeutic module to combine specific genetic material;

inserting the genetic material into a modified AAV or lentivirus coated with proteins and antibodies;

combining the virus with immune cell microRNA;

transferring the genetic material to the affected cell site;

facilitating the modified virus to resist immune response and penetrate cell surface TK receptors; and

stimulating affected cells to produce healthy proteins and stop generating cancer cells.

13. The method of claim 3, further comprising:

collecting cell, gene and/or protein samples at the diagnostic module;

activating the LOC in the diagnostic module to analyze the biological samples;

forwarding the data to the analytical module;

building a model to develop solution options to solve cancer pathology in the analytical module;

transferring the model with solution options to the therapeutic module;

installing dsRNA or siRNA into an engineered virus in the therapeutic module;

coating the virus with proteins and antibodies to target affected cells;

applying the engineered remedy; and

suppressing abnormal cell growth.

14. The method of claim 3, further comprising:

collecting cell, gene and/or protein samples at the diagnostic module;

activating the LOC in the diagnostic module to analyze the biological samples;

forwarding the data to the analytical module;

building a model to develop solution options to solve cancer pathology in the analytical module;

combining Flt3L protein with HSVI-TK protein and antiviral GCV in the therapeutic module;

applying the combination protein therapy to target cells; and

suppressing abnormal cell growth.

15. A method for operation of a medical device for diagnostics and analysis of disease, comprising:

a set of layers of medical device components, a set of compartments for storage of chemicals and biologicals, a set of microfluidic components, including tubes, valves and gates, circuitry configured to control and connect a device components, a lab-on-a-chip (LOC) component in a diagnostic module, an analytical module, including a database, for pathology modeling and therapeutic solution modeling, the method comprising;

connecting the diagnostic and analytical modules with electrical interconnects;

activating the diagnostics process of obtaining cell, DNA, RNA and/or protein samples from the patient;

analyzing the cell, DNA, RNA and/or protein samples in the LOC of the diagnostic module;

forwarding the LOC data to the analytical module;

analyzing a pathology by generating a model in the analytical module and by comparing the data to the database; and

generating solution options for therapeutic recommendations of combining genes, RNA and/or proteins from the model by accessing the database in the analytical module.

16. The method of claim 15, further comprising:

receiving cell, DNA, RNA and/or protein samples from the patient after the application of a therapy;

analyzing the revised samples in the LOC in an iteration of testing a therapeutics solution;

forwarding the LOC data to the analytical module;

generating revised solution options from the model by accessing the database; and

developing updated solution options for therapeutic recommendations of combining gene, RNA and/or proteins.

17. A method for operation of a medical device for diagnostic analysis and therapeutics for treatment of disease, comprising:

a set of layers of medical device components, a set of compartments for storage of chemicals and biologicals, a set of microfluidic components, including tubes, valves and gates, circuitry and connectors configured to control a set of device components, an analytical module, including a database, for pathology modeling and therapeutic solution modeling, and a therapeutic module, the method comprising;

connecting the analytical and therapeutics modules with electrical interconnects;

generating descriptive modules of a pathology from biological data by comparing the data to a database in the analytical module;

configuring the analytical module to generate solution options from the model; and

forwarding the solution options for therapeutic recommendations;

configuring the therapeutic module to release specific chemicals and/or biologicals from compartments on at least one of a set of layers through the micro fluidic components in specific measured doses according to the model recommendations;

activating the therapeutic module to combine chemicals and/or biologicals; and

configuring the therapeutic module to transmit the combination of chemicals and/or biologicals to a cell site in a patient to treat disorders.

18. The method of claim 17, further comprising:

receiving biological and chemical samples from feedback of the application of a therapy to the pathology in the diagnostic module;

configuring the diagnostic module to analyze the biological samples in the LOC and forward the data to the analytical module;

configuring the analytical module to model the sample data;

developing refined solution options to solve the pathology;

forwarding the solution model to the therapeutic module;

configuring the therapeutic module to combine chemicals and/or biologicals to update the solution to solve the pathology; and

managing the pathology with a revised therapy.

19. The method of claim 17, further comprising:

transmitting in a patient the therapeutic combination of chemicals and/or biologicals to treat abnormal cells, including neoplasties, cancer metastases, to blocking angiogenesis in tumors, gene replacement of mutated genes and/or protein replacement of specific combinations of dysfunctional proteins.

20. The method of claim 19, further comprising:

generating a model of dysfunctional genes in cancer cells by activating the analytical module;

sending the model data to the therapeutic module;

loading engineered genes into a AAV or lentivirus;

inserting the virus into stem cells;

targeting the modified stem cells to the affected cells; and

stopping abnormal cell growth.

21. The method of claim 19, further comprising:

generating a model of dysfunctional genes in cancer cells in the analytical module;

sending the model data to the therapeutic module;

installing engineered proteins in antibodies;

injecting the engineered antibodies into stem cells;

targeting the modified stem cells to affected cells; and

stopping abnormal cell growth.