Blood Vessel Sample

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BLOOD VESSEL SAMPLE - PROJECT PROPOSAL DR. SHOBHANA SUGIRTHAMUTHU DR. PERIASAMY PARIKUMAR THE LIGHT EYE HOSPITAL 39 D BYPASS ROAD DHARMAPURI 636701 TAMILNADU - INDIA CONCEPT Few centuries ago, our ancestors treated patients by feeling the pulse and made amazing diagnoses. This we call it as the first generation of medical diagnostics. The second generation of medical diagnostics evolved with the invention of needles to obtain a blood sample which was used to diagnose a lot of diseases. Now we propose the third generation of medical diagnostics, where a BLOOD VESSEL SAMPLE, a portion of blood vessel is removed [taken] from the body for diagnostic purposes. Presently, the medical world assesses an individual’s health by taking a blood sample from the body. Now, we propose an analysis of a portion of a blood vessel, taken from the bulbar conjunctiva of the eye and correlate with the blood findings to assess a person’s health and disease state. The idea is to check the CONTENT [ blood ] and the CONTAINER [ blood vessel ] ,to give an exact health report, as the present system examines only the CONTENT [ blood ] and not the functional quality of the CONTAINER [blood vessel].For this reason we propose blood vessel sampling and subjecting the blood vessel to a battery of investigations along with concomitant blood sample study which will give an absolutely accurate result about the health of an individual in a comprehensive way especially regarding diabetes and other micro vascular disorders. SCIENCE We have been well acquainted with Virchow’s triad for 150 years. He speaks about three components of vascular pathology. 1. Hypercoagulability - Viscosity of blood [ constituents of blood ] 2. Blood stasis - Velocity of blood [ pulse rate , blood pressure etc ] 3. Vascular endothelial cell damage - IGNORED TILL DATE - NOT DONE AT ALL AROUND THE GLOBE AS A ROUTINE DIAGNOSTIC PROCEDURE The fact is that we have been treating patients with two thirds of health information and IGNORED the other one third of health information. We have developed a Standard Operating Procedure to obtain a blood vessel sample, a 2 mm length of blood vessel, from the body. The bulbar conjunctiva of the eye is the only place in the body which is blessed with more than 400 mm of exposed blood vessels. Without disturbing the adjacent structures, it is possible to get a sample of blood vessel and it is a painless procedure, not even the pricking pain while blood is drawn. Eye gives a lot of clue regarding a person’s health like jaundice, anemia etc. Even death is declared by examining the pupillary light reflex in the eye. The blood vessel sample is taken from the bulbar conjunctiva of the eye, using a special instrument kit called BLOOD VESSEL SAMPLE KIT, which is patent protected. The vascular endothelial cells are then transported, cultured and subjected to a battery of investigations to assess endothelial function. Endothelial Function Assessment: 1. Assess the pathophysiological function of vascular endothelium by a non- invasive method by doing an ex-vivo study of cultured vascular endothelial cells obtained from conjunctival blood vessel. 2. Assessment of the anatomical and structural integrity and morphology of the vascular endothelium including density and endothelial cell count. 3. Biochemical assessment of injury-causing agents- o Reactive oxygen metabolites/species. o Tumor necrosis factor. o Interleukin 1 and 6. o Cytokines. 4. Biochemical assessment of protective agents: ∑ Nitric oxide production capacity. ∑ Cyclic AMP levels. ∑ Coenzyme Q10 (antioxidant). 5. Immunohistochemical characterization of vascular endothelial cells in healthy and diseased states. 6. Functional endothelial colony-forming assays (increased in diseased states). 7. Measurement of luminal diameter: vessel diameter ratio (L/V ratio). This will serve as a guide line to interpret the endothelial function/dysfunction. The ophthalmologists can carry out the sampling of the blood vessel as an outpatient procedure. In the first phase, this clinical study will be carried out as a multi centric study, pan India, by a reliable Contract Research Organization. Then this will become a standard diagnostic procedure, to treat and prognosticate diabetes and other vascular disorders. The literature about this concept and the standard operating procedure is copy right protected. This project will transform the way Diabetes and micro vascular diseases are being treated worldwide. This will open a new world of medical diagnostics as this is the FIRST TIME IN THE WORLD concept. Days are coming when the BLOOD SAMPLE will be considered as INSUFFICIENT AND INCOMPLETE, without the concomitant BLOOD VESSEL SAMPLE. So blood vessel sample analysis along with blood sample analysis will only give the total health information of the person. THE PROPOSAL IN SHORT: In addition to the blood sample, blood vessel sample also is taken out of the patient’s body to make a perfect diagnosis. So far, the diagnoses made around the world are incomplete and comprise only two thirds of the true health information. We have developed a standard operating procedure, and we also have designed a blood vessel sample kit to obtain the sample. This whole concept is patent and copy right protected worldwide. PATENT STATUS PCT has been filed with WIPO [ World Intellectual Property Organisation ] The Standard Operating Procedure is copy right protected in 170 countries. ∑ This is published by the Indian Patent Office ∑ National phase filings have to be done in each country ∑ Clinical Trial is all set to start in Chennai, India, by MN Eye Hospital and scheduled to be completed in a few months. This is one of the special instruments in the Blood Vessel Sample Kit, needed to obtain the Blood Vessel Sample UNIQUE SELLING POINTS 1. Manufacturing and Marketing of the Blood Vessel Sample Kit worldwide 2. Licensing and sub licensing of the patent worldwide 3. Sale of patent worldwide HIGHLIGHTS OF THE PROJECT 1. It is similar to the transition that happened when the first blood sample was taken from a human being for the purpose of investigations. We categorize the era of medical diagnostics into three generations. The first generation was the palpation of the blood vessel, the pulse examination. The second generation was the blood sample. The third generation is the BLOOD VESSEL SAMPLE. 2. The uniqueness of each and every individual is displayed widely which is better understood now more than before with the latest Personal Identity Tools like Rugoscopy – the study of identity with the rugae of the palate and [ of] like Cheiloscopy - the study of identity with lip pattern . Dactylography - Thumb impression was the first. Iris pattern was the second. Followed by palatal rugae and lip pattern. We claim the vascular endothelium also is unique for every individual. Our study is based on this UNIQUENESS of individuals displayed in the Vascular Endothelium and the Response of the Vascular Endothelium to varying concentrations of blood constituents. 3. We are living in the days of automation and a fully automated BLOOD VESSEL SAMPLE ANALYIS MACHINE(like the cell counter or the auto analyzer for blood sample analysis) is not very far off. 4. In that case, a small bit of conjunctiva with a blood vessel if fed in to the automated machine, will give us the health or disease status of endothelium. We can analyze the blood sample and incorporate it with the Blood vessel sample result and give a complete report on the individual’s health status. 5. All specialty consultants will have to depend on Ophthalmologists to procure a blood vessel sample to diagnose, prognosticate and treat their patients appropriately. 6. The Nitric Oxide[ LIFE MOLECULE ] present in the blood is altered after every meal but the nitric oxide production capacity of the Endothelium is almost stable through the day for a particular period of time. 7. The Nitric Oxide concentrations of blood will vary in different organs, but our focus is NOT the blood levels of it. The nitric oxide production capacity of the vascular endothelium is what we are looking at. 8. Number of Vascular Endothelial Cells per unit area and their morphology will give us a definite clue about the endothelial cell health and the general health of the individual – We do not have a normative study data base. 9. Unexplained sudden death in the middle aged and in some young people with normal blood reports is not understood properly. The reason could be unhealthy vascular endothelium and endothelial response to stress that would have gone undetected because we are unable to look for it with the available modalities of diagnosis. 10. In our clinical experience, many times there is no correlation between the duration of the disease and clinical manifestations. Once this concept is implemented, we will begin to have a perfect correlation between the duration of the disease and the values of blood constituents because it is interpreted with the blood vessel sample report. 11. We have an enormous amount of blood vessels in the conjunctiva for diagnostic purposes. It is a thrill to observe the movement of the blood cells through the conjunctival venules. 12. The eye functions as an indicator of the diseases of the internal organs [ eg: Jaundice / Anemia]. In the same way, the blood vessels of the eye could reflect the health scenario of the internal blood vessels. All the internal organs surely leave an impression or scar in the eye. 13.Unexplained – so called spontaneous sub conjunctival hemorrhage – we call it SPONTANEOUS SUB CONJUNCTIVAL HEMORRHAGE ., What does it indicate / Are we missing any clue the nature is trying to give us through the blood leak from conjunctival blood vessels about the person’s general health ? 14. This proposal involves obtaining a blood vessel sample from the most accessible and convenient part of the body with least collateral damage to the surrounding tissue. 15. The blood sample is surely painful, though a small prick. But, the blood vessel sample taking is an absolutely painless procedure as the conjunctiva is anaesthetized with topical anesthetics. 16. Taking a Blood Vessel Sample form the bulbar conjunctiva poses no threat of bleeding or damage to the adjacent tissues as there is complete sealing of the cut end of the blood vessel without any need for suturing because of the elastic recoiling nature of the bulbar conjunctival blood vessel. 17.We are NOT working on new scientific evidence but on the scientific evidences we already have – we are trying to just correlate and club the available evidences, put it in a matrix and make a perfect diagnosis. 18. We prove that the Blood Vessel Sampling is POSSIBLE 19. We recommend this procedure as a MUST and as a ROUTINE for all patients undergoing blood investigations. 20. If we are able to say that your heart and brain blood vessels are going to be like this by analysing the conjunctival blood vessels, it will be the BEST PGROGNOSTICATOR EVER, as the Vascular endothelium is the same throughout the body. 21. There may be a time when the blood investigation alone will be inadequate to make a diagnosis. A blood report will be studied compulsorily in the back drop of the Blood Vessel Sample report. Those companies performing only blood tests will be forced to come to us for licensing to keep abreast of the latest modalities of diagnosis and management. 22. The vascular endothelium weighs about 1500 grams, 5 times the weight of the heart of a 70 kg person and could be spread over 6 tennis courts with so much surface area –It is considered as an ENDOCRINE ORGAN by many researchers. 23. The outcome of this study could be that a person with 300 mg% sugar levels with a healthy vascular endothelium may be diagnosed as a Non Risky Diabetic and a person with 100 mg % sugar levels with unhealthy vascular endothelium may be diagnosed as a Risky Diabetic. 24. The analogy of a milk vessel and water pipe line of a house could help us understand the importance of this concept. 25.The present imaging technologies and other related studies see only the macroscopic view of the blood vessel, but our concept focuses deep in to the cellular level of diagnosis. We propose to CUT OPEN THE BLOOD VESSEL, SEE , DIAGNOSE AND TREAT. PLAN OF IMPLEMENTATION The patent we own on our individual names has to be transferred to the Willing Organization [either newly formed or a special project vehicle or a subsidiary of an existing organization or body], to manufacture, market, License, Sub License and sell this patent. This involves TECHNOLOGY TRANSFER procedures with necessary agreements. After this, the Willing Organization or body will OWN the patent [during the whole life of the patent 20 years] and be responsible for the worldwide business. THIS IS AN EMPTY PAGE ---------------------------------------------------------------------------------------------------------