Abstract:
A method and apparatus for applying decompressive energy to tissue for the selective destruction of cancerous cells is disclose and claimed. The tissue to be treated is enclosed within a vessel subjected to decompressive energy supplied by said decompressive energy source to said vessel. The decompressive energy is applied in a controlled manner to said tissue in at a pre-selected level of decompressive energy. Loading forces generated by applied decompressive energy and the forces generated between the interior of said vessel and said tissue which said vessel encompasses are to be diffused. As disclosed and claimed, a mass of elastic material comprising an inner radius and outer radius with the inner radius forming a seal with said tissue while allowing said tissue to move in relation to said inner radius and a fluid pocket circumferentially positioned within said elastic mass in combination with a collar positioned at the perimeter of the vessel opening is claimed.

Description:
FIELD OF THE INVENTION  
       [0001]     Vacuum based method (decompressive therapy—DT) and apparatus for treatment of peripheral vascular disease (PVD), Lymphatic, Neuromuscular, bacteriological, host rejection, surgical reattachment of amputated soft tissues, reduction of scar tissue and all other healing/growth response disorders that would benefit from decompressive therapy. Decompressive therapy creates an increase in blood volume and diffusion to targeted tissue (and tissue groups). Decompressive therapy also stimulates the natural creation and transport of growth hormones; responsible for the maintenance and anabolic regenerative tissues of multiple systems including stimulation of the immune system. Also claimed and disclosed vacuum based method and apparatus for selecting and destroying cancerous, malignant and tissue having tumors with cell abnormalities with cellular walls that are weaker than that of healthy cells allowing for selective application of mechanical forces alone or in combination with medicaments for the destruction of the cancerous, malignant and or tumors having cell abnormalities.  
         [0002]     As disclosed the present art increases the strength and mass of cell membranes and or cell walls for therapeutic purposes and repair of function. Additionally, flexibility may be increased for all forms of tissues and or skin, blood vessels, neurological tissues, glandular tissue, muscle tissues and any form of cellular life that responds to external and internal stress, as is needed.  
       CROSS REFERENCE TO RELATED APPLICATIONS  
       [0003]     (Not applicable)  
         [0004]     This non-provisional patent application claims priority from and incorporates in its entirety the contents of the provisional patent application previously filed on Jun. 28, 2005 and assigned Ser. No. 60,694,757 by the United States Patent &amp; Trademark Office. This application seeks both United States and International protection for the inventions and inventive methods disclosed herein under both the laws of the United States and the agreed accords of the Paris Convention Treaty (PCT). Patent applications having the following titles and applicant attorney assigned docket numbers are filed concurrently in the United States Patent &amp; Trademark Office and are incorporated by reference herein: 
        1. USPA0200 “Apparatus for Vascular and Nerve Tissue Histogenesis and Enhancement”;     2. USPA0205 “Method for Histogenesis and Enhancement of Tissue”; and,     3. USPA0210 “Decompressive Thermogenic Bandage”.        
 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
       [0008]     No federal funds were used to develop or create the described disclosure.  
       REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISK APPENDIX  
       [0009]     (Not Applicable)  
       BACKGROUND OF INVENTION  
       [0010]     The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art, or relevant to the presently described or claimed inventions, or that any publication or document that is specifically or implicitly referenced is prior art or a reference that may be used in evaluating patentability of the described or claimed inventions.  
         [0011]     There has long been an understanding that tissue can and does regenerate in response to application of mechanical force and stress upon the tissue. Orthopedic medicine has long understood the impact that stress has on an area of weakness, i.e. Wolf&#39;s Law. For example, any bone(s) under stress, over time, will attract calcium salts which will fuse it to the surrounding bones as a protective measure to resolve the stress or weakness. The body also reacts to the application of abnormal stress. During pregnancy, for example, nature provides for the expansion of the skin (and other parts of body) to accommodate internal growth including subcutaneous growth both the fetus and mother, as well as weight loss and/or gain.  
         [0012]     Prior art devices and methods include surgical techniques wherein balloons and external and/or internal fixation pins are inserted into the body for limb lengthening. See U.S. Pat. No. 5,074,866 issued to Sherman et al. for “Translation/Rotation Device for External Bone Fixation System,” incorporated by reference herein, for further discussion of this area of the prior art. The general background for this area is further set forth in U.S. Pat. No. 5,536,233 issued to Khouri for “Method and Apparatus for Soft Tissue Enlargement” as the basis for the improvement described therein. (Hereinafter referred to as “Khouri”.) The generalized method and apparatus described in Khouri is an improvement over the prior art and describes the general basis for the improved invention described herein. As noted in Khouri, the prior art failed to achieve long term soft tissue enlargement without damage to the soft tissue being enlarged, as well as the surrounding tissue. This damage to the surrounding tissue has limited the amount of vacuum which may be applied to the soft tissue for purposes of enhancement or enlargement. Khouri has attempted to avoid this damage to surrounding tissue by the use of a rim around the periphery of the dome to which the vacuum is applied. This rim is described as having sufficient surface area so that the pressure applied by the rim is less than or equal to the negative pressure applied to the soft tissue under the dome. By regulating the pressure within the dome to 1.5 inches of Mercury (Hg), the damage to the soft tissue is avoided by use of the rim. The prior art is limited to a vacuum with a magnitude of less than 1-1.5 inches of Hg which limits the enhancement. The prior art also uses a band of adhesive applied to the seal to allow it to physically stick to the skin of the individual wearing this invention. The daily use of this device has been shown to cause contact dermabrasion which can leave scars as well as break the skin, increasing susceptibility to infection. Other examples of prior art along this line include U.S. Pat. No. 6,500,112; U.S. Pat. No. 6,478,656; U.S. Pat. No. 6,355,037; U.S. Pat. No. 6,309,394; U.S. Pat. No. 5,704,938; U.S. Pat. No. 5,701,917 and U.S. Pat. No. 5,695,445; U.S. Pat. No. 5,676,634; and U.S. Pat. No. 5,662,583, which are all incorporated by reference herein.  
         [0013]     Other important art in this area includes U.S. Pat. No. 6,042,537 (&#39;537) issued to Kaiser for “Apparatus and Method for Tissue Enlargement” incorporated by reference herein and hereinafter simply referred to as “Kaiser,” which teaches a vacuum apparatus having a dynamic load bearing diffusion seal. The seal as taught by Kaiser in &#39;537 allows for and dynamically absorbs, transfers and directs the dynamic static loads placed upon it to a safe and effective equilibrium. Kaiser teaches a force diffusion seal primarily for loads wherein the plane of the tissue treated is substantially perpendicular to the apparatus vessel walls. Kaiser is an improvement over the cited prior art and is adequate to handle dynamic loading of static forces of this nature. New types of dynamic loads are created by the apparatus, method and process disclosed and claimed herein. The present application requires a diffusion seal capable of handling a plurality of dynamic loads that may be delivered from opposite directions.  
         [0014]     The normal animal cell, including that of humans, has in general a predefined shape and size. It has been discovered when sufficiently stressed, the cell will increase in size and its external structure will also deviate to accommodate most any vacuum or negative force that is applied to the cell. Proper application of decompressive energy (such as by vacuum force) to the cellular structure can induce the cell to replicate and/or accommodate the stress that is applied by the decompressive energy. The resiliency of cellular membranes and supporting structures, as noted in the prior art, can be damaged beyond repair by the improper application of an excessive amount of decompressive energy. The amount of decompressive energy applied should be properly controlled and limited both manually and automatically to avoid damage to both adjacent and treated tissues, including their internal mechanisms and membranes.  
         [0015]     As noted above, the prior art devices have failed to achieve long term soft tissue enlargement while preventing damage to the soft tissue being enlarged, as well as any surrounding tissue. These prior art devices have not been successful because the amount of vacuum necessary to provide successful enlargement of the soft tissue has not been able to be achieved without damage to surrounding tissue. The low vacuum pressure described in the prior art does not provide for adequate enhancement or enlargement of the soft tissue because the amount of pressure was limited by the ability of the device to prevent damage to the surrounding tissue.  
         [0016]     This invention has shown that animal cellular structures can accommodate vacuums from 0.0009 inches of Hg to 30 inches of Hg. It has been found that the optimum decompression energy through vacuum force (in inches of Hg) necessary to produce the desired affect of inducing cellular reproduction due to stimulation of and the release of HGH (human growth hormone) and/or cellular strengthening through hyper-enhancement of the soft tissues immune system responses is approx 8-10 inches of Hg. Clearly, tissue enhancement can be achieved at lower or higher decompressive energy levels. It is contemplated that a range of values may be applied that are both less than 8 inches of Hg and greater than 10 inches of Hg to provide a desired response. Improperly applied lower pressures and stresses if not used in accordance with this invention and its method of operation may also cause cellular damage. It is theorized, however, that if the body&#39;s tissues are stimulated properly and the methods are applied in accordance within tissue limits and with this invention that even higher forces and stresses might safely be obtained.  
         [0017]     The body&#39;s immune system can routinely repair most, if not all, damage caused by minimal to medium amounts of vacuum applied to healthy tissues. This is similar to the repair of minor contusions, discoloration and vascular seepage caused by small amounts of vacuum such as that which can be applied to the skin by the vacuum induced by the mouth.  
         [0018]     As disclosed by the prior art, tissue enhancement and histogenesis by means of vacuum does in fact occur. However, the prior art is limited in application to the breasts and the penis. Additionally, the prior art does not teach a method or apparatus capable of applying increased amounts of vacuum or negative pressure to living tissues without damaging surface or upper layers of tissue to increase circulatory response or cellular enhancement.  
         [0019]     Given the weakness and limitations of the prior art, what is needed and desired is a safe, non-invasive method of tissue histogenesis for skin, vascular tissues, neurological tissues, glandular tissues, muscle tissues and any other form of cellular life that responds to applied external and internal stresses for the treatment of many disorders including many peripheral vascular diseases. A safe way to increase the strength and mass of cell membranes and/or cell walls for therapeutic as well as repair of function and flexibility to all forms of tissues and/or skin, blood vessels, neurological tissues, glandular tissue, muscle tissues and any form of cellular life that responds to external and internal stress is also needed. Additionally, a safe apparatus and method are needed to stimulate the natural immune system response along with tissue repair and formation as discussed above. The prior art fails to provide a diffusion seal capable of handling the dynamic loads created by the specific applications and processes for vascular and nerve tissue histogenesis and enhancement disclosed and claimed herein.  
         [0020]     Peripheral Vascular Disease Physiology (Background)  
         [0021]     All tissues of the body require oxygen and nutrients to survive. Transportation for these two necessities rests solely on the vascular network. Arterial disease can affect the body systemically; however, the peripheral network in the extremities is normally first to be symptomatic. Restoration of blood flow is critical or tissue function deteriorates. Failure to restore vascular integrity results in pain (lactic acidosis) and finally tissue apoptosis—quickly moving on to skin ulcerations, infections and eventually gangrene which will require amputation of the diseased extremity. Amputation however, does not address the need to restore blood flow to the remaining tissue. An understanding of peripheral arterial disease requires knowledge of vascular structural elements and their arrangement within vessel walls. Vessels beyond a certain lumen diameter generally consist of three defined layers: the intima, media, and adventitia. See Talbert R L. Peripheral vascular disease.  
         [0022]     In: DiPiro J T, Talbert R L, Hayes P E, Yee G C, Matzke G R, Posey L M. Pharmacotherapy: A Pathophysiologic Approach. Norwalk, Conn.: Appleton &amp; Lange, 1993: 388-400. The intima is a single layer of endothelial cells on the innermost section of the vessel wall. Media refers to the middle section of the vessel wall and consists of smooth muscle cells surrounded by collagen and elastic tissue. Adventitia, the outermost covering of the vessel wall, consists of a mixture of collagen, elastic tissue, smooth muscle, nerve fibers, vaso vasorum, and lymphatic vessels which accommodate lymphatic flow to nourish and remove metabolic waste products from the vessel wall. See Spittell P C, Spittell J A. Managing combined peripheral and coronary artery disease. Contemp Intern Med 1993 (September). The structural elements most common to arterial vessels consist of five separate tissue components: endothelium, basement membrane, elastic tissue, collagen, and smooth muscle. The endothelium comprises a flat layer of endothelial cells lining the entire vascular system. Below the endothelium is the basement membrane, composed of various proteins and polysaccharides which serve as a support structure and transport medium for various materials. Elastic tissue encompasses the endothelium and basement membrane. Collagen, a major protein of the white fibers of connective tissue, cartilage, and bone, resists stretching and thereby prevents over distension of the vasculature. Smooth muscle provides the contracting component of the vascular system that regulates vasoconstriction and dilation. It has been known for some time that the peripheral pressure pulse contains information on arterial stiffness and vascular tone and that increased arterial stiffness correlates with increased risk of a major cardiovascular event. The specific validation of Pulse Trace was done at St Thomas Hospital and has been published. These papers demonstrated a simple linear relationship between the shape of the Digital Volume Pulse and that of the peripheral pressure pulse which remains constant irrespective of the effects of hypertension or effects of vasodilatation produced by NTG, and that the Stiffness Index (SI) parameter correlates with PWV, the gold standard for arterial stiffness.  
         [0023]     When the vascular system has been compromised (not including trauma induced) there is a cascade effect that, if left unchecked, will continue to deteriorate and starve healthy tissue. Several historical methods of blood restoration to tissue have been attempted and of these methods, surgical and pharmacological remain the most widely accepted. Surgical methods and procedures are similar to a coronary bypass, the procedure to correct or “bypass” a damaged vessel involves the surgical attachment of a synthetic tube or sewing on a segment of healthy vein donated from another area of the body. Blockages in diabetics may occur further down the leg and may require a bypass to an artery such as the posterior tibial or dorsalis pedis. Surgery is generally effective for limited correction each time the surgery is performed. However, it requires a patient in fair health to handle the general anesthesia required for this type of procedure and the same systemic problems that impacted the vessel to begin with will, over time, begin to work against the surgically corrected segments.  
         [0024]     Peripheral Vascular Disease Physiology in Relation to Diabetic Neuropathy  
         [0025]     Vascular compromise is one of the key factors for Diabetic Neuropathy. Nerve tissue is reliant on adequate blood flow to provide nutrients to the tissues and remove metabolic waste. Normally, capillaries facilitate the passage of nutrients into the cell and permit the removal of waste products into the bloodstream. Hyperglycemia will create a less permeable wall which, over time, allows for a buildup of toxic metabolites. The buildup will eventually impact cellular metabolism. When adequate blood flow to nerve tissue is not available to perform these functions, vascular damage and dysfunction of the nervous system can occur.  
         [0026]     The risk of lower limb amputation in patients afflicted with diabetes is 15 to 40 times higher than in those without diabetes. Ulceration of the foot is often the initiating lesion leading to amputation. See Pecoraro R E, Reiber G E, Burgess E M. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care. 1990;13:513-521. Diabetes 1996 Vital Statistics. Alexandria, Va.: American Diabetes Association, 1996:1-102. AD—Section of General Medicine, Veterans Affairs Medical Center, Oregon Health Sciences University, Portland. Diabetic patients are particularly vulnerable to foot ulceration due to the coexistence of peripheral neuropathy and peripheral vascular disease. Peripheral sensory neuropathy is the single most common contributory factor leading to the development of ulcers in the feet of people with diabetes, accounting for up to 87% of new ulcers. See Boulton A J M. The Diabetic foot: Neuropathic in Aetiology? Diabet Med. 1990; 7:852-858. The first examined cause is a length-dependent “dying back” axonopathy, primarily involving the distal portions of the longest myelinated and unmyelinated sensory axons, with relative sparing of motor axons. The morphologic characteristics of diabetic polyneuropathy are consistent with either a vascular or a metabolic cause of the problem.  
         [0027]     Patients with intermittent claudication experience pain or cramping even when they are only resting; and especially for those patients with ulcers that are persistent in not healing, little hope remains for improvement unless a new source of blood can be provided to the affected limb.  
         [0028]     The apparatus and methods claimed and disclosed herein are considered a potential means for the reversal of neuropathy and the effects of peripheral vascular disease (PVD). It is believed that the increase in peripheral and deep blood flow to the tissues in the extremities should have a positive impact on the basement membrane of the blood vessels and increase not only blood flow but also transfer of nutrients and waste products from the tissues previously affected. Upon restoration of the vascular network, there is induced a wound healing response wherein blood vessel histogenesis (vascular tissue generation or regeneration) can occur.  
         [0029]     It is also well known that diabetes has a major impact on the nervous system. Statistics and studies suggest that 60 to 70% of persons having diabetes suffer mild to severe symptoms from attendant nervous system damage. Symptoms may include impaired sensation in the feet and/or hands, pain in the feet and/or hands, slowed digestion of food in the stomach, Carpal Tunnel Syndrome and other nerve problems. Studies and statistics suggest diabetic neuropathy is a causative factor in more than 60% of the non-traumatic lower-limb amputations in the United States. It is an objective of the present apparatus and methods to provide restorative effects upon the vascular network and further induce a wound healing response in the impaired nervous system wherein nervous tissue histogenesis (generation or regeneration) can occur.  
         [0030]     Diabetic neuropathies can be classified as peripheral, autonomic, proximal, and focal. Each affects different parts of the body in different ways. Peripheral neuropathy causes either pain or loss of feeling in the toes, feet, legs, hands, and arms. Autonomic neuropathy causes changes in digestion, bowel and bladder function, sexual response, and perspiration. It can also affect the nerves that serve the heart and control blood pressure. Autonomic neuropathy can also cause hypoglycemia (low blood sugar) unawareness, a condition in which people no longer experience the warning signs of hypoglycemia. Proximal neuropathy causes pain in the thighs, hips, or buttocks and leads to weakness in the legs. Focal neuropathy results in the sudden weakness of one nerve, or a group of nerves, causing muscle weakness or pain. Any nerve in the body may be affected. Neuropathy is a very disturbing consequence of low blood flow states. Different widely know generalized diseases result in neuropathy, such as diabetes. By restoring blood flow, neuropathy may decelerate progression of disease.  
       SUMMARY OF THE INVENTION  
       [0031]     A medical apparatus and methods for the treatment of peripheral vascular disease (PVD) and other medical disorders and ailments that would benefit from increased and enhanced tissue response due to increases in blood flow on both a macro and micro vascular level including increased cellular stimulation and response is disclosed and claimed herein.  
         [0032]     Furthermore, the maintenance of a constant or static negative pressure (vacuum) combined with a continuous dynamic vacuum circulation or recirculation of energy within the unit produces a dynamic micro energy gradient. This dynamic micro energy gradient creates an inducing or directing flow. This energy gradient results in a mass transfer gradient. Thus, allowing the circulation of blood flow to be controlled or directed to areas of the tissue with the greatest resistance to blood flow. Selection of decompressive energy source (such as vacuum), vessel shape and alternating decompressive/non-decompressive force regimens may further optimize the dynamic vacuum circulation of energy.  
         [0033]     As disclosed, the present art is a novel technology and method for application within the medical technology as well as the biological technology fields. The disclosed concepts revolve around the application of decompressive energy or vacuum forces to different elements as well as form, function and homeostasis affecting the cellular biology, neurology, immunology and vascular tissues of humans and animals. Some symptomatic ailments this technology may treat or alleviate are symptoms associated with diabetes and arthritis. Included herein are the device designs and methodology for the treatment of PVD&#39;s (peripheral vascular disease) reduction in blood flow and nerve degeneration symptomatic of human diabetes for the hands and feet.  
         [0034]     The technology has many other therapeutic uses including immune system enhancement, cellular development, vascular and neurological system development or regeneration and even possible organ regeneration on some levels. This technology has proven to be effective in controlling the growth of infectious agents and organisms.  
         [0035]     As disclosed, the components of the technology include the design of the vessel, the application of the dynamic seal between the vessel and the tissue and/or sub terrain tissue to be treated and the method of treatment of the tissue.  
         [0036]     This invention produces a permanent enhancement of tissue, especially soft tissue, without surgical or other deleterious effects on the patient. This invention overcomes the restriction of limiting the negative pressure which may be utilized for cell enhancement by diffusing the contact loads and stresses by using a novel seal, which also overcomes the excessive pressures that previously would have been applied to the surrounding tissue causing crushing and/or cellular tissue damage. This invention allows for the controlled development of increased blood flow deep inside the human body. The method and apparatus disclosed and claimed herein allow the delivery of mechanical force in a safe and non-invasive way deep within the body to stimulate the natural healing mechanisms and the body&#39;s ability to maintain a homeostasis state.  
         [0037]     When this method and apparatus is initially used at vacuum of 1-9 inches of Hg, at the beginning of the hyper-enhancement process, small and superficial contusions or bruising may occur. It has been determined that the comfort level of vacuum should be gradually increased over a period of time, starting from approximately 1.0-1.5 inches of Hg and proceeding to higher values of vacuum and decompression. The apparatus upon which tests were conducted would create a vacuum that was the maximum allowable on and inside earth&#39;s biosphere. This maximum amount was reduced for greater safety to the subject.  
         [0038]     A Phase 1 Study has been designed and approved for use with the apparatus and methods disclosed herein. See “A Study to Document the Effect of a Novel Device Employing Negative Pressure to Increase Vascular Flow and Diffusion in the Extremities.” The objective of the study is to demonstrate the ability of decompressive energy to raise the vascular flow and diffusion of blood supply to the extremities. During the study, the effects on the elasticity of blood vessels (endothelial testing) as well as nerve conduction testing will be monitored. As designed and approved, the eight subjects will be treated for up to five (5) minutes with a range of negative pressures on one or both arms (alternating—not simultaneously). Normal values will be established for pre and post treatment as well as neurological impact, and pre/post skin condition. This study upon completion will provide the basis for a Phase 2 Study which will apply the methods and apparatus disclosed herein to subjects with diagnosed levels of peripheral vascular disease symptomatically present in the extremities, with a special emphasis on diabetes.  
         [0039]     One facet of the vessel design is that it has a specialized flexible vacuum seal having properties that allow the seal, by design, to handle or absorb and/or instantaneously transfer, whether directly and/or indirectly, such dynamic forces and dynamic loads and/or dynamic stresses, as applied to the tissue or in other words “diffuse” the dynamic stresses and forces virtually instantaneously. This specialized vacuum seal, by its very design, dynamically reduces the normal crushing restriction of blood flow, and/or dynamically reduces the normal contact pressures and/or stresses and forces that are delivered to the contact points of the vacuum seal&#39;s contact material, and the living tissue contact areas at the point and/or place of contact with living tissue and the tissues surrounding and under laying the tissues directly affected by treatment.  
         [0040]     Another facet of the vessel design is that it can be constructed of any transparent and/or opaque material that is so engineered and/or designed to withstand vacuum or negative pressure and/or decompressive energy within said vessel to a value of up to 30 inches of mercury (Hg).  
         [0041]     The device as designed can be made of many interlocking sealing segments and/or come as a custom molded unit that is patient specific. Some applications will require customization of the vessel and others will not. The design of the vessel will be determined by the needs of the patient and/or the specific treatment area and/or the therapy necessary to stimulate the desired tissue response (i.e. tissue growth), vascular regeneration, neural network regeneration, increased blood flow, pharmaceutical delivery and selective destruction of diseased or malignant cells.  
         [0042]     The system as envisioned and designed includes a dynamic pump that has sufficient volume to create a desired level of vacuum up to inches 30 Hg in a desired specific amount of time which may range from as little as a nanosecond to hours.  
         [0043]     The system as envisioned and designed includes a control system that can be pre-programmed and/or permanently and/or semi-permanently programmed to allow for specific vacuum loads and application times, or any combination therein to be achieved by the system. The control system as envisioned and designed allows for a combination control of the following system variables: 
        1. Time to peak vacuum (mm Hg) flow;     2. Peak vacuum (mmHg) to be maintained for a predefined amount of time;     3. Controlled release of dynamic vacuum inside the device vessel;     4. Controlled rest periods i.e. periods without application of vacuum and/or reduced vacuum;     5. Automatic programmable functions;     6. All necessary control sensors to analyze environmental factors;     7. All necessary control sensors to analyze stimulation variables;     8. Sensors to provide data on interior and/or exterior environments of said vessel while vacuum chamber of said vessel is both under actual vacuum conditions and not. The sensors can also provide data inputs for, but are not limited to, temperature, humidity, sound/sonic, blood pressure, ambient atmospheric pressure, tissue density, measure by ultrasound, sonar, or any form of sounding device, or any frequency of light and/or radio signal or carrier wave, electrical resistance test to measure cellular conductivity of electrical impulses and/or current flow.     9. The control system also allows control functions to be utilized individually and/or in combination with other control functions.     10. The control system also allows control during application for the depth of tissue penetration of the vacuum energy.     11. Finally, the device as described and shown should be comfortable for patient to wear and use, as well as being easy to use, operate, maintain and sanitize.        
 
         [0055]     Finally, another attribute of the technology as described and disclosed herein is the application of the vacuum or vacuum energy to the tissue itself. The normal animal cell, including that of humans, has in general a predefined shape and size. It has been discovered when sufficiently stressed, the cell will increase in size and its external structure will also deviate to accommodate any vacuum or negative force that is applied to the cell. Proper application of vacuum to the cellular structure can induce the cell to replicate and/or accommodate the stress that is applied by the vacuum. The resiliency of cellular membranes and its supporting structure, as noted in the prior art and as discovered in the use of this invention, can be damaged beyond repair by the improper application of an excessive amount of vacuum. Therefore, the amount of vacuum applied must be properly controlled and limited, either manually or automatically, to avoid damage to the tissues, including their internal mechanisms and membranes.  
         [0056]     It has been shown that animal cellular structures can accommodate vacuums from 0.0009 inches of Hg to less than or equal to 30 inches of Hg without massive destruction of tissue, if properly applied. Vacuum at most any level of Hg may cause damage to cells if the proper application and methodology is not applied and cells are not allowed to properly acclimate to the applied stresses caused by the vacuum. It is also known that improperly applied vacuum even at lower negative pressures may also cause tissue and cellular damage as with the prior art. Improperly applied rapid decompression (applied vacuum) can destroy most soft tissue cells. The body&#39;s healthy immune system can routinely repair most, if not all, light damage caused by vacuum&#39;s decompressive energy.  
         [0057]     This invention has indicated that the optimum pressure or the optimum vacuum in inches of Hg necessary to produce the desired affect of inducing cellular reproduction or cellular strengthening through hyper-enhancement of the soft tissues immune system responses will depend on what one wants to do and what type of cellular matter is being worked with. Neurological versus connective tissue will respond in drastically different ways to decompressive/mechanical forces generated by vacuum energy. It is possible, however, that there are generalities that can be applied to tissue groups, organs and individual tissues needed to provide a desired response.  
         [0058]     As a result of experiments utilizing this invention, it has been recorded that each new generation of cellular growth or enhancement improves the elasticity, toughness and health of the cell membranes. Observations of the experiments of applicant indicate that the longer cell structure is stressed by applying 25-75% of the safe maximum vacuum in inches of Hg over an extended period of time, new cellular growth is stronger in structure and more resilient. It has also been shown from the experiments that the greater the decompression of cellular matter, the greater the benefits; if properly applied through time with proper pressure and vacuum chamber design.  
         [0059]     Continuously or semi-continuously applying the vacuum energy to and into the tissues, as controlled by the system programming, stimulates a dynamic response from the biological mechanisms of the living tissue, one such predicable response is the dramatic increase in blood flow. Another such response is the development of micro-vascularization. By operating the system in this manner, function of the vacuum device may be alternated to stimulate many other predictable events of the bio mechanisms of the living tissues. Another function of the system controls and methods of operation is that the system may be optimized for either tissue generation, regeneration or enhancement. The basic formula criteria or variables needed for treatment or stimulation of tissue for enhancement are: 
        1. Type of tissue;     2. Health of tissue;     3. Gradient or depth of tissue;     4. Amount of decompressive energy to be delivered to the tissue to be treated;     5. Surface loads of the decompressive energy needed to penetrate to the desired depth;     6. Requirement for positive pressure augmentation via compression wrap;     7. Speed of cellular hydration (edema);     8. Recovery time for reclamation of excess fluids in treated cellular tissue;     9. Amount of decompressive energy to be applied;     10. Time of decompressive energy application;     11. Need for incremental increase of application time, decompressive energy applied and positive pressure applied via a compression wrap;     12. Patient compliance;     13. Ability to monitor improvements; and,     14. Patient comfort.        
 
         [0074]     This invention overcomes the prior art&#39;s limitation of limited amounts of negative pressure (vacuum) which may be utilized without tissue damage. This invention, though noninvasive, allows for the controlled increase in sub-dermal blood flow as well as the potential for controlled diffusion of energy to depths in excess of three (3) centimeters inside the human body. The method and apparatus disclosed and claimed herein allow the non-invasive, safe delivery of decompressive energy, through mechanical forces or other means, deep within the body to stimulate the natural systems that are responsible for corporeal repair, regeneration and homeostasis.  
         [0075]     The higher levels of decompressive energy (through vacuum forces) can only be applied safely by diffusing the contact loads and stresses generated through application of vacuum to the tissues as disclosed and claimed herein. One benefit of this invention is the controlled development of increased blood flow deep inside the human body, as well as an increase in micro-vascularization throughout the treatment area. Vascularization is the organic process whereby body tissue becomes vascular and develops capillaries  
         [0076]     When this method and apparatus is used within a range of 0.0001-9 inches of Hg, at the beginning of the hyper-enhancement process, small and superficial contusions or bruising may occur. It has been determined that the comfort level of vacuum should be gradually increased over a period of time, starting from approximately 1.0-1.5 inches of Hg (depending on tissue to be treated) and proceeding to higher values of vacuum and decompression. The apparatus previously used for testing created a vacuum that delivered the maximum allowable decompressive energy (vacuum) within the earth&#39;s atmosphere. This maximum amount was significantly reduced to safe levels when applied to the subject.  
         [0077]     This invention has also been utilized with variations in the configuration of the dome, sphere, or shape of a vacuum applicator and/or containment vessel. Varying the shape of the vacuum applicator varies the forces exerted upon and into the material or tissue exposed to vacuum energy. Thus, the tissue may be elongated, lengthened, or widened by enhancement or expansion within and in conjunction with the sphere.  
         [0078]     It has also been discovered in the use of the invention that the more tissue under and in proximity to the dome increases the dynamic forces and the rate of tissue enhancement and hyper-enhancement. Thus, this invention provides for a plurality of vessels or domes with various configurations to control the direction and the rate of cellular enhancement or enlargement. Additionally, this invention provides for a plurality of vessels or domes with various configurations to control the depth that decompressive energy can penetrate into the body of the subject and the amount of decompressive energy delivered to the surface of the skin and/or deep inside the tissue or tissues being treated.  
         [0079]     The decompressive energy (through vacuum force) acts to cause the veins and arteries to enlarge and engorge, facilitating the benefits of increased blood flow, which is a beneficial side effect provided by this invention in conjunction with tissue growth. Although this invention has not been utilized, except to produce new and enhanced or enlarged soft tissue structures, it is believed that other uses of vacuum pressure to induce cellular growth and immune system hyper-enhancement would be useful in other areas and medical applications and treatments that would benefit from this type of predictable dynamic energy.  
         [0080]     The increase in blood flow, due to enlargement and/or enhancement of healthy and normal blood vessels, is of substantial benefit through the increase in malleability, strength and overall health of the vessels themselves. The increase in blood flow would, over time, improve the surrounding cells and provide more nutrients to damaged areas to aid in the repair of wounds and/or unhealthy tissue that lacked proper oxygen levels. Research and experimentation both by the medical community and inventor suggest the method and apparatus disclosed herein may be useful on most any tissue that has morphemic characteristics.  
         [0081]     This invention allows the use of a method used to enclose soft tissue within a transportable containment device, applying specific and substantial controlled vacuum to decompress soft tissue. The development of new vessels or instruments, which could enclose the area or tissues to be repaired and provide appropriate decompressive energy (vacuum force) while not damaging the surrounding tissue, are disclosed and claimed herein.  
         [0082]     As noted above, the prior art devices have failed to achieve long term soft tissue enhancement while preventing damage to the tissue acted on, as well as any surrounding tissue. These prior art devices have not been successful because the amount of vacuum necessary to successfully create or stimulate the tissues has been limited by the potential for damage to surrounding and supporting tissues.  
         [0083]     This invention allows application of larger amounts of decompressive energy (through vacuum force or negative pressure) to be applied to specific tissues, under substantial control, to decompress tissue within a containing device or vessel without damaging surrounding supporting tissues for the enhancement of the tissue within the vessel.  
         [0084]     The downward force created by the vacuum inside the vacuum chamber is absorbed by diffusion of forces applied and generated through the vacuum seal without damage to the surrounding tissue against which the container reacts. Therefore, this invention is able to use a vacuum pressure which delivers sufficient decompressive energy to create distraction force in adequate supply to facilitate the enlargement, enhancement, stimulation of growth hormone production, increase of blood flow, strengthening of cellular membranes, stimulation of new cellular development, increase of immune system response, stimulation of neurological regeneration and many other positive and predictable responses to targeted soft tissues at greater decompressive energies (vacuum pressures) than prior art devices.  
         [0085]     The novel seal and force diffuser between the vacuum chamber and the human cells or tissues surrounding the tissues to be enhanced permits the use of a dynamic vacuum force which will stimulate cell activity without permanent harm to cells and/or user. The force diffusion seal of the apparatus disclosed and claimed herein allows dynamic handling and control of loads delivered to the bottom surface of the force diffuser seal and loads emanating from inside the force diffuser seal (upward and inside out). These new types of dynamic loads are created specifically due to the nature of the application and process for cellular and/or tissue enhancement as generally disclosed and claimed, and specifically for the methods and apparatus for treatment of peripheral vascular disease and tissue histogenesis and enhancement.  
         [0086]     It has also been demonstrated that the total destruction of the healthy cell membrane and the nucleus by stretching or elongating beyond there physical limits through application of mechanical forces will destroy these cells. Unhealthy cells, however, are proven to be less resilient and can be destroyed at different pressures or forces, thus providing a selective advantage with application of greater decompressive pressures. This provides dual health benefits through the potential destruction of unhealthy cells and enhancement of healthy cells. Some unhealthy cells will be destroyed with even small amounts of vacuum (decompression). This effect may have beneficial effects in the controlled targeting of diseased tissues that need to be eliminated for medical reasons to benefit the patient. This difference in mechanical properties between healthy and unhealthy cells provides an opportunity alone or in combination with the delivery of beneficial compositions to exploit these differences to the benefit of the tissue treated.  
       OBJECTS OF THE INVENTION  
       [0087]     It is therefore an object of this invention to disclose and claim the apparatus and methods for the treatment of peripheral vascular disease (PVD) and other medical disorders and ailments that would benefit from increased and enhanced tissue response due to increases in blood flow on macro-vascular, micro-vascular and a collateral level including increased cellular stimulation and response.  
         [0088]     It is therefore an object of the present invention to provide a method and apparatus to stimulate and improve tissues which may be non-invasive.  
         [0089]     It is still another object of this invention to stimulate increased blood flow in vascular systems.  
         [0090]     It is a further object of the invention to provide a system and method that allows for deep penetration of decompressive energy into human or animal tissues.  
         [0091]     It is still another object of this invention to provide a method and technology that stimulates tissue and cellular growth.  
         [0092]     It is therefore an objective of the invention as disclosed and claimed to allow treated tissue to be affected by decompressive energy to be placed inside and/or underneath the vacuum device.  
         [0093]     It is another objective of the invention as disclosed and claimed to allow placement of apparatus on or around a body part to affect treatment.  
         [0094]     It is another objective of the invention as disclosed and claimed to allow insertion of the decompressive energy or vessel into the body or body part for engagement with the tissue to be treated by decompressive energy.  
         [0095]     It is another objective of the invention to use vacuum as a decompressive energy.  
         [0096]     It is another objective of the invention as disclosed and claimed to control the application of decompressive energy by contouring or shaping the vessel in such a way as to modulate the response of the tissue to the vacuum to affect the desired change in therapeutic application and to control stimulation rate, growth rate and/or blood flows.  
         [0097]     It is still another object of this invention to provide a method and technology that stimulates the strength, flexibility, and expandability of tissues and/or cellular membranes and internals.  
         [0098]     It is still another object of this invention to provide a method and technology that stimulates increased blood flow, vascular elasticity and permeability. U.S. Pat. No. 6,503,205 issued to Manor et al. for “Dual Ultrasonic Transducer Probe for Blood Flow Measurement, and Blood Vessel Diameter Determination Method” is incorporated by reference herein for further background in analytical methods and apparatus available to those skilled in the arts.  
         [0099]     It is still another object of this invention to provide a method and technology in controlling loads delivered onto both the bottom and side surfaces of the force diffuser seal through loads emanating from inside the force diffuser seal (upward and inside out).  
         [0100]     It is another object of the invention to provide a control system for the method and apparatus disclosed herein for improvement of cellular tissues that may be controlled manually or be automated for computer control and data collection.  
         [0101]     It is another object of the invention to use the methods and apparatus disclosed herein with pharmacological compositions beneficial to vascular elasticity, vascular permeability, vascular angiogenesis and vasculogenesis. U.S. Pat. No. 6,713,065 issued to Baron et al. for “Methods of Using Hedgehog Proteins to Modulate Hematopoiesis and Vascular Growth” is incorporated by reference herein for pertinent background on the nature of vascular angiogenesis and vasculogenesis. U.S. patent application filed by Coleman having publication #20060057117 and entitled “Vascular Endothelial Growth Factor 2” relates to compositions useful in stimulating wound healing and vascular tissue repair and is incorporated by reference herein.  
         [0102]     It is another object of the invention to use the methods and apparatus disclosed herein with nano devices, such as nano-cells and nano-shells, for improved delivery of pharmacological compositions beneficial to vascular elasticity, vascular permeability, vascular angiogenesis and vasculogenesis. U.S. Pat. No. 6,645,517, U.S. Pat. No. 6,530,944, and U.S. Pat. No. 6,428,811, issued to West et al. for “Temperature-Sensitive Polymer/Nanoshell Composites for Photothermally Modulated Drug Delivery”; “Optically-Active Nanoparticles for Use in Therapeutic and Diagnostic Methods”; and “Temperature-Sensitive Polymer/Nanoshell Composites for Photothermally Modulated Drug Delivery,” respectively, are incorporated by reference herein.  
         [0103]     It is another object of the invention to use the methods and apparatus disclosed herein with nano devices, such as nano-cells and nano-shells, for improved delivery and/or actuation of pharmacological compositions beneficial to the destruction of diseased, malignant and/or cancerous cells. U.S. patent application filed by Sengupta et al. having publication #20050266067 and entitled “Nanocell Drug Delivery System” is incorporated by reference herein for background on beneficial compositions deliverable by nano device technology. U.S. patent application filed by Kurzrock et al. having publication #20060067998 and entitled “Liposomal Curcumin for Treatment of Cancer” is incorporated by reference herein as related to cancerous cells and treatments therefor. U.S. patent application filed by Meininger having publication #20050053590 and entitled “Endothelium-Targeting Nanoparticle for Reversing Endothelial Dysfunction” discloses compositions beneficial in the treatment of endothelial cells damaged by diabetes, smoking, dyslipidemia, hypertension and cardiovascular disease.  
         [0104]     It is another object of the invention to use the methods and apparatus disclosed herein with compressive technologies such as elastic wraps and hyperbaric chambers to protect surface tissue while increasing blood flow and oxygen concentration in treated tissues.  
         [0105]     It is another object of the invention to use the methods and apparatus disclosed herein with compressive technologies such as elastic wraps and hyperbaric chambers to protect surface tissue while increasing blood flow and oxygen concentration in treated tissues.  
         [0106]     It is a further object of the invention to provide a system and method that allows for deep penetration of decompressive energies in the form of vacuum forces into human or animal tissues.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0107]      FIG. 1  provides a detailed cut-away view of the dynamic load diffusion platform and seal of the present invention.  
         [0108]      FIG. 2  provides a view of a portable lower extremity decompression device and chamber assembly.  
         [0109]      FIG. 3  provides a view of a vessel for treating the hand and forearm areas.  
         [0110]      FIG. 4  provides a view of a vessel for treating the hand and palm areas.  
         [0111]      FIG. 5  provides a view of a vessel and apparatus for treating the hand and finger joints areas.  
         [0112]      FIG. 6  provides an end view of the blood vessel response to proper decompressive treatment.  
         [0113]      FIG. 7  provides a side view of the blood vessel response to proper decompressive treatment.  
         [0114]      FIG. 8  provides an isometric view of the smart chip controlled vacuum charging system of the present invention.  
         [0115]      FIG. 9  provides an isometric view of the dynamic load diffusion platform and seal mating assembly of the present invention.  
         [0116]      FIG. 10  provides an isometric view of the interlocking pressurized load diffusion seal for an interlocking collar for easy on and off application.  
         [0117]      FIG. 11  provides an isometric view of the treatment chamber for the entire lower half body necessary for deep artery treatment and enhancement of the present invention.  
         [0118]      FIG. 12  is an illustration of the decompression gradient produced by application of decompression energy to tissue.  
         [0119]      FIG. 13  is an isometric view of the dynamic energy and load action of one embodiment of the present invention.  
         [0120]      FIG. 14  is an isometric view of the implantable decompression chamber embodiment of the present invention.  
         [0121]      FIG. 15  is a graphic chart comparing dynamic load diffusion to static load distribution.  
         [0122]      FIG. 16  is an isometric view of the double chambered decompression device of the present invention.  
         [0123]      FIG. 17  is an isometric view of the dynamic fluid filled load diffusion seal of the present invention.  
         [0124]      FIG. 18  illustrates the envisioned effects of Vascir™ decompression therapy on neurological tissues.  
         [0125]      FIG. 19  presents an isometric view of the multi-valve release assembly.  
         [0126]      FIG. 20  is an illustration of the effect of decompression energy applied to a cell.  
         [0127]      FIG. 21  is an illustration of tissue having cancerous cells in combination with non-cancerous cells.  
         [0128]      FIG. 22  is an illustration of the effect of decompression energy on cancerous cells as shown in  FIG. 21 .  
         [0129]      FIG. 23  is an illustration of a cancerous cell rupturing under decompressive energy.  
         [0130]      FIG. 24  is another embodiment of a decompression energy apparatus using vacuum for lower extremity tissue treatment.  
         [0131]      FIG. 25  is another embodiment of a decompression energy apparatus using vacuum for tissue treatment for the hand and fingers.  
                                         DETAILED DESCRIPTION - ELEMENT LISTING                                DYNAMIC FLUID FILLED LOAD DIFFUSION SEAL   1       VACUUM VESSEL   2       DYNAMIC ENERGY TRANSFER COLLAR   3       LONGITUDINAL ENERGY FLOW   4       DIAGONALLY UPWARD ENERGY FLOW   5       VERTICALLY UPWARD ENERGY FLOW   6       DYNAMIC ENERGY TRANSFER COLLAR DIRECTIONAL ANGLE   7       TRANSPARENT VACUUM VESSEL   8       BI-DIRECTIONAL CHECK VACUUM VALVE   9       PORTABLE LOWER EXTREMITY DECOMPRESSION DEVICE AND CHAMBER   10       ASSEMBLY       FLUID FILLED CHAMBER   11       DYNAMIC ENERGY TRANSFER COLLAR MITTEN STYLE EMBODIMENT   12       PORTABLE UPPER EXTREMITY DECOMPRESSION DEVICE AND CHAMBER   13       ASSEMBLY       DYNAMIC FLUID FILLED LOAD DIFFUSION SEAL MITTEN STYLE   14       EMBODIMENT       THUMB DECOMPRESSION DEVICE AND CHAMBER ASSEMBLY   15       INDEX FINGER DECOMPRESSION DEVICE AND CHAMBER ASSEMBLY   16       MIDDLE FINGER DECOMPRESSION DEVICE AND CHAMBER ASSEMBLY   17       TRANSPARENT VACUUM VESSEL MITTEN STYLE EMBODIMENT   18       RING FINGER DECOMPRESSION DEVICE AND CHAMBER ASSEMBLY   19       PINKY FINGER DECOMPRESSION DEVICE AND CHAMBER ASSEMBLY   20       FINGER DEVICE ASSEMBLY MANIFOLD   21       SECONDARY TRANSPARENT VACUUM MULTIPLIER VESSEL   22       MOUNTING AND DIGIT SERVICING PLATFORM   23       VACUUM DELIVERY LINES   24       USER&#39;S FOOT   25       USER&#39;S LEG   26       OPPOSING SURFACE CONTACT AREA   27       CHAMBER MATING SECTION WITH THE DYNAMIC ENERGY TRANSFER   28       COLLAR       TRANSPARENT VACUUM VESSEL INDIVIDUAL DIGIT STYLE ASSEMBLY   29       DISEASED UNTREATED BLOOD VESSEL OR ARTERIAL WALL THINNESS   30       (ANEURISM)       DISEASED TREATED BLOOD VESSEL OR ARTERIAL WALL THINNESS   31       (ANEURISM) BEING STRENGTHENED       DISEASED TREATED BLOOD VESSEL OR ARTERIAL WALL THINNESS   32       (ANEURISM) BEING PROGRESSIVELY STRENGTHENED       DISEASED UNTREATED BLOOD VESSEL OR ARTERY WITH NARROWING   33       AND BRITTLENESS       DISEASED BLOOD VESSEL OR ARTERY WITH EXPANSIONISM BEING   34       APPLIED AND TREATED       DISEASED BLOOD VESSEL OR ARTERY BECOMING HEALTHY,   35       UNRESTRICTED AND FLEXIBILITY RESTORED       BLOOD VESSEL WITH RESTRICTIVE BUILDUP AND BRITTLENESS ALONG   36       WITH WALL ABNORMALITY       BLOOD VESSEL BREAK DOWN OF WALL BUILD UPS AND INCREASES IN   37       FLEXIBILITY AND STRENGTH       UNRESTRICTED BLOOD FLOW AND INCREASED STRENGTH ALONG WITH   38       FLEXIBILITY       DYNAMIC ACTION IMPLANTABLE DECOMPRESSION CHAMBER   39       NORMAL HEALTHY HUMAN CELL WITHOUT VACUUM DECOMPRESSION   40       APPLIED       NORMAL HEALTHY HUMAN CELL WITH VACUUM DECOMPRESSION   41       BEING APPLIED       NORMAL HEALTHY HUMAN CELL WITH VACUUM DECOMPRESSION   42       FULLY APPLIED WITH THIN MEMBRANE       NORMAL HEALTHY HUMAN CELL AFTER TREATMENT IS OXYGEN   43       ENRICHED AND VIBRANT       NORMAL HEALTHY HUMAN CELL AFTER TREATMENT WITH STRONGER   44       MEMBRANE WITH MORE FLEXIBILITY       DISEASED HUMAN CELL WITHOUT VACUUM DECOMPRESSION APPLIED   45       DISEASED HUMAN CELL WITH VACUUM DECOMPRESSION BEING APPLIED   46       AND SEVERALLY STRESSED       DISEASED HUMAN CELL WITH FULL VACUUM DECOMPRESSION APPLIED   47       RUPTURING MEMBRANE       DISEASED HUMAN CELL WITH FULL VACUUM DECOMPRESSION APPLIED   48       RUPTURING NUCLEUS       PORTABLE MITTEN STYLE DECOMPRESSION DEVICE AND CHAMBER   49       ASSEMBLY       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S VACUUM PORT   50       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM DEVICE   51       ASSEMBLY       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S ON BUTTON   52       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S DISPLAY   53       SCREEN       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S LOCKING   54       SYSTEM       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S ACCESS DOOR   55       TO SMART CHIP COMPARTMENT       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S SMART CHIP   56       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S DC CONTACTS   57       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S DC BATTERY   58       POWER SOURCE       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S EXTERNAL DC   59       SOURCE       SMART CHIP CONTROLLED VACUUM CHARGING SYSTEM&#39;S OFF BUTTON   60       MAIN COMPUTER SYSTEM FOR PROGRAMMING AND READING EXTERNAL   61       SMART CHIPS       MAIN COMPUTER SYSTEM SMART CHIP INTERFACE DOCKING PORT   62       MAIN COMPUTER SYSTEM HUMAN INTERFACE AND INPUT DEVICE   63       DYNAMIC LOAD DIFFUSION PLATFORM AND SEAL MATING ASSEMBLY.   64       BLOOD VESSEL OR ARTERY WITH 0% VASCIR DECOMPRESSION APPLIED   65       BLOOD VESSEL OR ARTERY WITH 33% VASCIR DECOMPRESSION APPLIED   66       BLOOD VESSEL OR ARTERY WITH 100% VASCIR DECOMPRESSION APPLIED   67       BLOOD VESSEL OR ARTERY THAT IS NARROWED AND MOSTLY BLOCKED   68       BLOOD VESSEL OR ARTERY THAT IS WIDENED AND PARTIALLY BLOCKED   69       INTERLOCKING PRESSURIZED DYNAMIC FLUID FILLED LOAD DIFFUSION   70       SEAL RIGHT SIDE       INTERLOCKING PRESSURIZED DYNAMIC FLUID FILLED LOAD DIFFUSION   71       SEAL LEFT SIDE       INTERLOCKING PRESSURIZED DYNAMIC FLUID FILLED LOAD DIFFUSION   72       SEAL MALE MEMBER       INTERLOCKING PRESSURIZED DYNAMIC FLUID FILLED LOAD DIFFUSION   73       SEAL FEMALE RECEIVER       INTERLOCKING PRESSURIZED DYNAMIC FLUID FILLED LOAD DIFFUSION   74       SEAL MATING OF MALE FEMALE LEFT SIDE       INTERLOCKING PRESSURIZED DYNAMIC FLUID FILLED LOAD DIFFUSION   75       SEAL MATING OF MALE FEMALE RIGHT SIDE       INTERLOCKING PRESSURIZED DYNAMIC FLUID FILLED LOAD DIFFUSION   76       SEAL ASSEMBLY       NERVE TISSUE DAMAGED AND WITHOUT VASCIR THERAPY   77       NERVE TISSUE DAMAGED AND WITH VASCIR THERAPY   78       BLOOD VESSEL OR ARTERY THAT IS FULLY EXPANDED AND HAS   79       MINIMUM BLOCKAGE       HALF BODY DECOMPRESSION TREATMENT CHAMBER ASSEMBLY   80       DECOMPRESSION TREATMENT CHAMBER LOWER HALF OF CHAMBER   81       DECOMPRESSION TREATMENT CHAMBER TRANSPARENT UPPER HALF OF   82       CHAMBER       DECOMPRESSION TREATMENT CHAMBER TOP SECTION OF FLEXIBLE   83       SHEET SEAL WITH ZIPPER       DECOMPRESSION TREATMENT CHAMBER LOWER FLEXIBLE SHEET SEAL   84       WITH ZIPPER       DECOMPRESSION TREATMENT CHAMBER LOWER FLEXIBLE SEAL ZIPPER   85       DECOMPRESSION TREATMENT CHAMBER LOWER SECTION OF FLEXIBLE   86       SEAL RUBBER-LIKE MATERIAL       DECOMPRESSION TREATMENT CHAMBER UPPER FLEXIBLE SEAL ZIPPER   87       DECOMPRESSION TREATMENT CHAMBER LEFT LEG COMPARTMENT   88       DECOMPRESSION TREATMENT CHAMBER REMOVABLE LEG   89       COMPARTMENT DIVIDER       DECOMPRESSION TREATMENT CHAMBER COMPRESSIBLE MATING SEAL   90       OF THE TOP AND LOWER CHAMBERS       DECOMPRESSION TREATMENT CHAMBER RIGHT LEG COMPARTMENT   91       DECOMPRESSION TREATMENT CHAMBER PADDED RESTING AREA FOR   92       THE BUTTOCKS       OPPOSING FORCES RIGHT SIDE   93       OPPOSING FORCES LEFT SIDE   94       DYNAMIC VERTICAL ENERGY   95       DYNAMIC EQUALIZATION OF ENERGY INSTANTANEOUSLY THROUGH   96       THE FLUID FILLED SEAL VESSEL CONTACT POINT       DYNAMIC EQUALIZATION OF ENERGY INSTANTANEOUSLY THROUGH   97       THE FLUID FILLED SEAL VESSEL CONTACT POINT       VACUUM TUBING WITH PRESSURE SENSITIVITY FOR SAFETY   98       OPEN   99       OPEN   100       VACUUM PRESSURE SENSOR   101       OXYGEN (O2) SENSOR   102       WATER (H2O) SENSOR   103       THERMAL SENSOR   104       COLLAR&#39;S VESSEL MATING GROVE   105       BLOOD VESSEL OR ARTERY   106       LEAK PROOF SEAM AND JOINT   107       DYNAMIC LIVE LOADS DIAGONALLY   108       DYNAMIC LIVE LOADS VERTICALLY   109       DYNAMIC LIVE LOADS LONGITUDINAL   110       DOWNWARD ENERGY FLOW   111       DIAGONALLY DOWNWARDLY ENERGY FLOW   112       OPEN   113       EXTERNAL TRANSPARENT VACUUM VESSEL   114       INTERNAL TRANSPARENT VACUUM VESSEL   115       BI-DIRECTIONAL CHECK VACUUM VALVE FOR INTERNAL CHAMBER   116       DOUBLE CHAMBERED DECOMPRESSION DEVICE ASSEMBLY   117       MULTI VALVE O-RING   118       MULTI VALVE BUTTON SHEATH WITH CUT OUT   119       MULTI VALVE ACTIVATION BUTTON WITH BLEED   120       MULTI VALVE ACTIVATION BUTTON BLEED OFF CHANNEL   121       MULTI VALVE CHECK VALVE DIAPHRAM   122       MULTI VALVE CHECK VALVE HOUSING   123       MULTI VALVE DUAL PURPOSE INLET EXHAUST PORTS   124       MULTI VALVE RETURN SPRING   125       MULTI VALVE RETURN SPRING RETAINER WITH EVACUATION NUBS   126       MULTI VALVE STOP PLATE   127       MULTI VALVE RETURN SPRING RETAINER EVACUATION PORT   128       MULTI VALVE THREADED END   129       MULTI VALVE ASSEMBLY   130       VACUUM TUBING WITH PRESSURE SENSITIVITY FOR SAFETY   131       ATMOSPHEREIC PRESSURE, DECOMPRESSSIVE ENERGY IS NEUTRAL   132       DECOMPRESSIVE ENERGY UNITS (DEU)   133       (DE) DECOMPRESSIVE ENERGY   134       SOFT AND/OR PERMEABLE TISSUE   135       VESSEL CONTAINING DECOMPRESSIVE ENERGY   136       DECOMPRESSIVE ENERGY GRADIENT   137       OPEN   138       OPEN   139       CANCER CELLS IN OTHERWISE HEALTHY HUMAN WITHOUT VACUUM   140       DECOMPRESSION APPLIED       CANCER CELL IN OTHERWISE HEALTHY HUMAN WITH VACUUM   141       DECOMPRESSION BEING APPLIED       OPEN   142       MEMBRANE RUPTURE OF CANCER CELL IN OTHERWISE HEALTHY HUMAN   143       WITH VACUUM DECOMPRESSION BEING APPLIED                    
     
    
     DETAILED DESCRIPTION  
       [0132]     In present application, the following preceding terms are defined accordingly: A cell is defined as the individual unit that makes up all of the tissues of the body. All living things are made up of one or more cells. Tissue is defined as a group of similar cells from an animal or mammal united to perform a specific function. Soft tissue is defined as tissue that is not bone. As defined herein, tissue or soft tissue may include organs. Vacuum is defined as the condition of rarefaction, or reduction of pressure below that of the atmosphere, in a vessel, tissue or a cell. This action of creating a vacuum creates a state of energy exchange in what is known as decompressive energy. A state of stable vacuum contains potential decompressive energy. That potential is released, generated, delivered and/or manufactured when it acts on or interacts with other matter in its realm of influence and interaction. Cancer is a term for diseases in which abnormal cells divide (mitosis) without control. Cancer cells can invade nearby tissues and spread through the bloodstream and lymphatic system to other parts of the body (metastasis). Cancer cells also avoid natural cell death (apoptosis). The vascular system is defined as the cardiovascular and lymphatic systems collectively, of a mammal or animal; also referred to as the circulatory system. Pharmacological is a therapy regimen that relies on drugs or includes drugs.  
         [0133]     Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views,  FIG. 1  is a schematic view of the dynamic load diffusion platform and seal of the present art.  
         [0134]     As shown by  FIG. 1 , the present invention functions to allow a safe interface with living tissue while allowing application of dynamic energies to living tissues through application of vacuum. The method and apparatus of the present invention as disclosed herein allows energy to be, but not limited to being, absorbed, burned up, utilized, transferred, redirected, divided, equalized, balanced, stabilized, minimized, transformed, disseminated, channeled, combined, limited, misdirected, vectored, controlled as in the directional flow of stress forces. The present invention also allows for changes in individual characteristics of the load energy being developed between the contact areas of the living tissue and the various forms of decompression chambers or vessels as shown in the following  FIGS. 2, 3 ,  4 ,  5 ,  11 ,  13 ,  14  and  16 .  
         [0135]     In the presence of vacuum and decompression, living tissues reacts in an exponential manner to vacuum energy, thus expanding and stressing the very biological structures that hold the cells and cellular matter together, as illustrated by  FIG. 20 . During the decompression process, the normal cell  40  and its membrane are temporarily expanded, stretched and thinned,  41  and  42 , by the process of deep penetrating decompression due to and dependent upon the amount of vacuum in the particular chamber being used as shown in FIGS.  2 ,  3 , 4 ,  5 ,  11 ,  12 ,  14  and  16 . Because the amount of dynamic energy present and delivered by the chambers shown in  FIGS. 2, 3 ,  4 ,  5 ,  11 ,  12 ,  13 ,  14  and  16  is directly related to the shape, design and volume of the vessel&#39;s chambers, the amount of penetrating energy being delivered to the tissue is thus directly related to these same values.  
         [0136]     It is the stress load placed on the tissue that stimulates certain immune system, as well a given biological responses, not only at a cellular level but also at the atomic levels. During and after this process there appears to be a communication of some type, probably electromagnetic, that senses the change and acts in a way to communicate between the biological systems within the body itself, to indicate and/or direct a growth and/or repair response. During this application process the increase in blood flow, its nutrients and oxygen levels have been shown to increase in excess of three-hundred percent (300%). The tissue at the cellular level responds to the increased blood flow, stress and communication processes to determine a proper response, i.e. growth, repair, strengthening, increase in flexibility, regeneration, histogenesis and so on. There is no single response which does not also involve some stimulation of the other responses. Thus, in order for the deep penetration of decompressive energy to properly expand tissue, its force has to be directed, accelerated, controlled and regulated. The dynamic nature of vacuum applied decompressive energy and its consequential outcome of developing stresses and loads associated with this type of dynamic action and interaction thus creates a healthy cellular response  44  in healthy tissues and cells  40 . It is the objective of each element, design and embodiment as set forth in this application to support this combination of responses.  
         [0137]     The design criteria of this invention is to include, but is not be limited to, the dynamic action of decompression on living tissues which is well documented, as is also the fragileness and delicateness of living tissues. It is also well known that the brittleness and harshness of crushing forces, along with elastic and inelastic stress, linear and non-linear stresses, live and dead loads, tear, shear and all things of the physical universe are made up of energy. This energy is given specific names due to their individual characteristics of travel, transfer and exchange. This advanced design takes into consideration the dynamic nature of energy and can virtually and instantly handle and transfer energies action upon and in connection with the dynamic load diffusion seal.  
         [0138]     Computer modeling indicating the significant difference between load distribution and load diffusion has previously been completed as illustrated by the results found at  FIG. 15 . Load diffusion allows for the virtually instantaneous and dynamic response to a plurality of static, dynamic and radial type energy forces at one time.  
         [0139]     In load distribution, stress concentrations arise from any abrupt change in the geometry of a specimen under loading. As a result, the stress distribution is not uniform throughout a cross section. See Astronautic Structures Manual (On-Line), NASA MSFC (Marshall Space Flight Center), 1975. The load diffusion platform and seal of the present invention eliminates stress concentrations by a virtual instantaneous balancing act that combines the actions of fluidic energy transfer and static load transfer with the mechanical action of compressibility, elasticity and static distributions.  
         [0140]     This is accomplished as indicated in  FIG. 1  by the combination of the five elements shown therein including the chamber mating section with dynamic energy transfer collar  3 , the opposing surface contact area  27 , elastic load diffusion seal  1 , fluid filled chamber  11  and the vacuum vessel  2  wall. These elements work together to provide the necessary productivity and synergy required to produce the load diffusion for application to treatment of tissues for various ailments such as cancer, peripheral vascular disease and other circulatory diseases.  
         [0141]     As shown in  FIG. 1 , dynamic live loads diagonally  108 , dynamic live loads vertically  109  and dynamic live loads longitudinal  110  (hereinafter load energy vectors) are applied to dynamic fluid filled load diffusion seal  1  (hereinafter load diffusion seal) which absorbs burns up, utilizes, transfers, redirects, divides, equalizes, balances, stabilizes, minimizes, transforms, disseminates, channels, combines, limits, misdirects, vectorizes, meters, compensates, and changes directional flow of stress forces and even changes individual characteristics of the load energy. Once the load diffusion seal  1  is loaded with stress energy, it then directs the energy instantaneously to the mating area known as the opposing surface contact area  27 . The opposing surface contact area  27  is a critical part of the pathway to load diffusion, as it acts as footed flanges. To be generally optimal, it should be at least one-fourth the diameter of the load diffusion seal  1  and placed at the lateral centerline of said periphery to incoming load energy vectors  108 ,  109  and  110 . Though less or more than one-quarter opposing surface contact area  27  “arcuate configuration” may be used, it is thought that the one-quarter measurement requirement is a good median line for optimal energy transfer.  
         [0142]     The opposing surface contact area  27  must be partially and/or wholly positively bonded to load diffusion seal  1  as to allow for the best possible energy transfer pathway and have an arcuate configuration that matches the arc of the load diffusion seal&#39;s  1  surface.  
         [0143]     To maximize the energy transfer placed upon load diffusion seal  1  by load energy vectors  108 ,  109  and  110  it is critical that they are transmitted in a fluid-like action, thus the load diffusion seal  1  must be fluid filled. This fluid-like action is not unlike water or air, always seeking equilibrium automatically. This auto response or equilibrium seeking attribute reduces the shear, tear, and crushing forces applied to tissues while continuously maintaining an airtight seal with the supporting or surrounding tissues. Therefore, this seal design is synergistic in that the greater the vacuum inside the vacuum vessel  2 , the more positive the sealing capabilities of the load diffusion seal  1 .  
         [0144]     The load forces or load energy vectors represented by  108 ,  109  and  110  are transmitted in a fluid-like action and directed and distributed in such a manner and in somewhat a radial direction.  FIG. 1  illustrates that the load energy vectors  108 ,  109  and  110  are reduced in amount as the load diffusion seal  1  is compressed. This reduction in force or energy is due to the resistance to compression provided by the elasticity of the seal material and its inner fluid filled center. This dual action resists compression, thus utilizing or dissipating or diffusing even more of the energy or force being delivered by load energy vectors  108 ,  109  and  110 .  
         [0145]     This energy, once it has sufficiently loaded the load diffusion seal  1  and directed through to the opposing surface contact area  27 , is now delivered and directed to the fixed and solid materials that make up the rest of the device. This energy is distributed in a radial type lateral action as shown as illustrated in  FIG. 1  at elements  4 ,  5 ,  6 ,  111  and  112 . Due to the nature of the design, the loaded energy then follows the direction of least resistance and follows the pathway to the vacuum vessels  2  wall for distribution of the energy to the rest of the device and away from the supporting tissues of the user. Each time the energy meets resistance, a portion of energy is utilized or dissipated (or diffused), thus reducing the total amount of energy being transmitted. It is important to note that this happens in a fluid and continuous manners and works with a synergy that is unique to this invention.  
         [0146]     The mating for the vacuum vessel  2  wall and the dynamic energy transfer collar  3  is accomplished by the positively affixed chamber mating section with the dynamic energy transfer collar  28 . This mating provides for a continuous and dynamic energy flow through it, as if it were a solid and homogenous material, and also automatically acts like an extension to the surface contact area  27  of the load diffusion seals  1  mating with the dynamic energy transfer collar  3 . The significance of this feature is to increase the contact area while under loads. Element  7  in  FIG. 1  is a reduction in mass of the dynamic energy transfer collar  3  and allows a smooth finished transition on the top side of dynamic energy transfer collar  3 .  
         [0147]      FIG. 2  provides a view of a portable lower extremity decompression device and chamber assembly  10 . This embodiment of the device is a portable lower extremity decompression device and chamber assembly  10  which is made up of a vacuum vessel  2  designed in such a way as to allow the human foot to fit comfortably inside and at the same time to be strong enough to handle a large amount of vacuum pressure without imploding. The visual inspection section of the portable lower extremity decompression device and chamber assembly  10  (also referred to as assembly) is the transparent vacuum vessel  8 , which allows the doctor or user to view the area that is being treated. The transparent vacuum vessel  8  is topped with a bi-directional check vacuum valve  9  used to evacuate the atmosphere inside the vacuum vessel  2  or assembly  10 . On top of the portable lower extremity decompression device and chamber assembly  10  is the human or user interface element called the dynamic energy transfer collar  3 , which contains the load diffusion seal  1 . This unit is designed to provide a non-invasive way to stimulate the vascular and neurological functions and enhance oxygenation of the extremity being treated by the portable lower extremity decompression device and chamber assembly  10 .  
         [0148]      FIG. 3  is a view of vessel for treating the hand and forearm areas. This device embodiment is of a portable upper extremity decompression device and chamber assembly  13  which is made up of a vacuum vessel  2  designed in such a way as to allow the arm and hand to fit comfortably inside and at the same time to be strong enough to handle a large amount of vacuum pressure without imploding.  
         [0149]     The visual inspection section of the portable upper extremity decompression device and chamber assembly  13  is the transparent vacuum vessel  8 , which allows the doctor or user to view the area that is being treated. The transparent vacuum vessel  8  is topped with a bi-directional check vacuum valve  9  used to evacuate the atmosphere inside the vacuum vessel  2  or portable upper extremity decompression device and chamber assembly  13 . On top of the portable upper extremity decompression device and chamber assembly  13  is the human or user interface element called the dynamic energy transfer collar  3 , which contains the load diffusion seal  1 . This unit is designed to provide a non-invasive way to stimulate the vascular and neurological functions and enhance oxygenation of the extremity being treated by the portable upper extremity decompression device and chamber assembly  13 .  
         [0150]      FIG. 4  provides a view of a vessel for treating the hand and palm areas. This device embodiment is of a portable mitten style decompression device and chamber assembly  49  which is made up of a transparent vacuum vessel mitten style embodiment  18  designed in such a way as to allow the palm of the hand and fingers only to fit comfortably inside the vessel and at the same time to be strong enough to handle a large amount of vacuum pressure without imploding. The transparent vacuum vessel mitten style embodiment  18  which allows the doctor or user to view the area that is being treated and is topped with a bidirectional check vacuum valve  9  used to evacuate the atmosphere inside the portable mitten style decompression device and chamber assembly  49 . The human or user interface element of portable mitten style decompression device and chamber assembly  49  is called the dynamic energy transfer collar mitten style embodiment  12 , which contains the load diffusion seal  14 . This unit is designed to provide a non-invasive way to stimulate the vascular and neurological functions and enhance oxygenation of the extremity being treated.  
         [0151]      FIG. 5  is a view of a vessel and apparatus for treating the hand and figure joints areas. This device embodiment is of a transparent vacuum vessel individual digit style assembly  29 , which is made up of many individual interconnected vacuum vessels  2 . Each vacuum vessel  2  is designed for the appropriate digit. The elements include the thumb decompression device and chamber assembly  15 , the index finger decompression device and chamber assembly  16 , middle finger decompression device and chamber assembly  17 , ring finger decompression device and chamber assembly  19  and the pinky finger decompression device and chamber assembly  20 . Each individual assembly together form the total device embodiment known as the transparent vacuum vessel individual digit style assembly  29  and can be configured with or without all the individual devices installed. Each assembly contains the basic units of assembly just like the rest of the embodiments of this invention. The transparent vacuum vessel individual digit style assembly  29  has a resting plate for the palm of the hand called the mounting and digit servicing platform  23  where all the individual digit assemblies are mounted via the finger device assembly manifold  21 , which as a option can have applied to the secondary transparent vacuum multiplier vessel  22  to increase the reactive state of decompression.  
         [0152]      FIGS. 6 and 7  illustrate the intended vascular development under Vascir TM Decompressive Therapy.  FIG. 6  provides a view of the blood vessel response to proper treatment. As illustrated in  FIG. 6 , there are three (3) stages of vascular tissue (blood vessel). Illustration A of  FIG. 6  represents an average diseased untreated blood vessel or artery with narrowing and brittleness  33 . Treatment with decompression energy can and does affect the value of health and effectiveness of said vessel. Illustration B represents the same diseased untreated blood vessel or artery with narrowing and brittleness  33  and depicts how the diseased blood vessel or artery expands under decompression. Note the blood vessel breakdown of wall and buildups and increases in flexibility and strength  37 . This type of expansion is known to cause the vessel to become more flexible, elastic and stronger as shown in illustration B wherein the diseased blood vessel or artery is becoming healthy, unrestricted and flexibility restored (shown at element  37 ). After the proper treatment regime with decompressive forces, the artery becomes unrestricted, blood flow capacity is increased, and strength along with flexibility are also enhanced as illustrated in C at unrestricted blood flow and increased strength along with flexibility  38 . It is well known from the study of blood vessel aneurisms, that the weakness in the vessel wall will repair itself over time if the vessel does not first rupture. The theory presented is that the vessel senses or responds at the thinned or the stressed area and begins to repair itself or auto-generate tissue. It is believed that this invention enhances the body&#39;s natural repairing mechanism. Illustration A shows a diseased untreated blood vessel with arterial wall thinness  30  similar to the condition that may be found with a potential aneurism  30  vessel situation.  
         [0153]     During decompressive therapy, the gentle expansion or stress upon the vessel can stimulate the vessel to heal itself quicker and help to increase the cell wall thickness through auto-generation of tissue. Furthermore, the slow expansion and contraction of the vessel walls is believed to allow the vessel to become more supple and, thus stronger. This results from the combination of both tissue growth stimulation and the breakdown of vessel wall build-up. Plaque or vessel wall build-up is known to be inelastic or brittle, thus it cannot adhere to the vessel wall as the vessel wall expands.  
         [0154]     Illustration B depicts how this might happen, with the diseased treated blood vessel or arterial wall thinness (aneurism) being strengthened  31 ; diseased treated blood vessel or arterial wall thinness (aneurism) being strengthened  31 ; diseased treated blood vessel or arterial wall thinness (aneurism) being progressively strengthened  32 ; diseased untreated blood vessel or artery with narrowing and brittleness  33 ; diseased blood vessel or artery with expansionism being applied and treated  34 ; diseased blood vessel or artery becoming healthy, unrestricted and flexibility restored  35 ; and, blood vessel with restrictive buildup and brittleness along with wall abnormality  36 . Additionally, Illustration B shows blood vessel breakdown of wall build-ups or scale and increases in flexibility and strength  37 . Illustration C shows unrestricted blood flow and increased strength along with flexibility  38 .  
         [0155]      FIG. 7  illustrates a sectional side view of the blood vessel or artery in various stages of treatment. In the illustration found at  FIG. 7 , a sectional side view of the blood vessel or artery with 0% Vascir™ Decompression Therapy applied  65  is shown. As shown in this illustration, the blood vessel or artery is narrowed and mostly blocked  68 . The middle illustration shows that blood vessel or artery with 33% Vascir™ Decompression Therapy applied is expanded or widened and now a blood vessel or artery that is widened and partially blocked  69 . Finally, the bottom illustration shows a blood vessel or artery with 100% Vascir™ Decompression Therapy applied  67  is now a blood vessel or artery fully expanded and has minimum blockage  79 , thereby improving and enhancing the condition of the tissue at both the micro-vascular and macro-vascular levels through improved artery or vessel condition, improved blood flow, and both cellular response and overall improved body health allowed by the preceding results. The apparatus may also be used with a pharmacological composition beneficial to increasing vascular elasticity and permeability by introducing the pharmacological compositions into said tissue in combination with the vacuum forces. This beneficial use of decompressive energy on the tissue to stimulate increased blood flow and cellular response may be further improved upon by introducing a pharmacological composition beneficial for healthy vascular angiogenesis and vasculogenesis into the tissue in combination with said decompressive energy. Examples of such pharmacological compositions include, but not limited to those named, generally including the class of drugs known as peripheral vasodilators, anticoagulants, beta blockers, combined alpha and beta blockers, central alpha agonists, peripheral alpha- 1  blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel blockers and fenoldopam and combinations thereof. Use and delivery of these pharmacological compositions may be further improved if used in combination with nano-devices, including nano-shells and nanocells, for improved delivery and targeting of the pharmacological compositions to the treated tissues.  
         [0156]      FIG. 8  provides an isometric view of the smart chip controlled vacuum charging system of the present invention. The smart chip system disclosed herein allows for automated operation and patient or user diagnosis. The smart chip and system disclosed herein for this device and devices are designed so that the attending physician can monitor the use of the Vascir™ Decompressive Therapy when the device is used both inside and outside the clinical setting. The smart chip controlled vacuum charging system&#39;s smart chip  56  (hereinafter smart chip) will be programmed by the physician&#39;s office via the main computer system for programming and reading external smart chips  61  (hereinafter main computer system), which in turn cannot only be used for medical diagnoses but can also be programmed through the smart ship  56  in combination with main computer system smart chip interface docking port  62  (hereinafter docking port) for downloading the physician&#39;s prescription and/or protocols. Once the smart chip  56  is programmed in docking port  62 , it is then removed by a staff member in the physician&#39;s office and placed into the smart chip controlled vacuum charging system device assembly  51 . This will allow it to operate virtually autonomously as prescribed and programmed by said physician through main computer system human interface and input device  63  and the main computer system  61  for programming and reading of the smart chip  56 .  
         [0157]     The smart chip  56  has the ability to store not only the instructions for operation prescribed by the physician, but also records and controls the treatment device on/off and date, length of running time, amount of pressures used and solid or pulsated application of Vascir™ decompression energy. The smart chip  56  in combination with various sensors found on the device will record the oxygen levels via the oxygen sensor  102 , temperatures or thermal readings via the thermal sensor  104 , atmospheric water vapor content via the water sensor  103  and even monitor the inches and/or millimeters of vacuum pressure (Hg) via the vacuum pressure sensor  101  before, during and after application. This collection information will be stored to the storage area for download to the physician&#39;s main unit in the office or clinic on the users/patients next visit.  
         [0158]     The smart chip controlled vacuum charging system device assembly  51  consists of many different controls for human interfacing and operation. For example, the smart chip controlled vacuum charging system&#39;s vacuum port  50  is the delivery port for the bidirectional check vacuum valve  9 . The smart chip controlled vacuum charging system device assembly  51  has several ways it can communicate with the user. The digital display is for visual communication between device and operator is the smart chip controlled vacuum charging system&#39;s display screen  53 . An audio tone and/or tones and flashing lighted array all are used to communicate with the operator/patient. For security, the smart chip  56  utilizes a smart chip controlled vacuum charging system&#39;s locking system  54 , to protect it from patient interference. The smart chip  56  may only be removed with a proper key used to unlock the chip from the smart chip controlled vacuum charging system device assembly  51  via the smart chip controlled vacuum charging system&#39;s access door to smart chip compartment  55 .  
         [0159]     The smart chip controlled vacuum charging system device assembly  51  is a portable device and can be power from a smart chip controlled vacuum charging system&#39;s external direct current (DC) source  59  or with its own smart chip controlled vacuum charging system&#39;s DC battery power source  58 , which supplies power though the smart chip controlled vacuum charging system&#39;s DC contacts  57 . Mounted on the exterior of said smart chip controlled vacuum charging system device assembly  51  is a patient controlled smart chip controlled vacuum charging systems off button  60  for quick and easy termination of operation any time the patient so deems it for safety and security.  
         [0160]      FIG. 9  provides an isometric view of the dynamic load diffusion platform and seal mating assembly  64  of the present invention. This figure illustrates that to work properly, the dynamic energy transfer collar  3  must be positively affixed to the vacuum vessel  2  wall via the chamber mating section with the dynamic energy transfer collar  28  and that the load diffusion seal  1  with its fluid filled chamber  11  must be positively affixed to the opposing surface contact area  27  of the dynamic energy transfer collar  3 . As shown, the combination of elements work together to create an airtight seal.  
         [0161]      FIG. 10  provides an isometric view of the interlocking pressurized load diffusion seal for an interlocking collar for easy on and off application. Interlocking pressurized dynamic fluid filled load diffusion seal right side  70  and left side  71 , respectively, are designed to allow for multiple segments and/or parts to fit together in such a way as to create an effective vacuum seal at each coupling area or joint while allowing multiple segments to be used together for “size” to the user. Each interlocking pressurized dynamic fluid filled load diffusion seal male member  72  and interlocking pressurized dynamic fluid filled load diffusion seal female receiver  73  will allow for a fitting that creates an air and vacuum tight fit as illustrated with interlocking pressurized dynamic fluid filled load diffusion seal mating of male female left side  74  and right side  75 , respectively. The fitted ends may be made in such a way as to still allow for maximum compressibility and flexibility of the interlocking pressurized dynamic fluid filled load diffusion seal assembly  76 . The fluidity or communication of fluid-like properties is maintained via the interlocking seal to allow the combination of desired functional feature of sizing and the required load diffusion seal properties for inherent dynamic reaction and diffusion of the dynamic energies and forces applied.  
         [0162]      FIG. 11  provides an isometric view of the treatment chamber for the entire lower half body necessary for deep artery treatment and enhancement via the present invention. Half-body decompression treatment chamber assembly  80  is designed to stimulate and enhance the tissue of the lower half of the human body through decompressive energy. This embodiment allows dynamic vacuum energy to penetrate the body and cause the expansion of the tissues to enhance function and application of the body&#39;s natural biological systems. The main components of the half-body decompression treatment chamber assembly  80  are the decompress treatment chamber lower half of chamber  81 , decompression treatment chamber transparent upper half of chamber  82 , decompression treatment top section of flexible sheet seal with zipper  83 , decompression treatment chamber left leg compartment  88 , decompression treatment chamber removable leg compartment divider  89 , decompression treatment chamber right leg compartment  91  and decompression treatment chamber compressible mating seal of the top and lower chambers  90 . These components come together to produce a vacuum tight assembly that has an open end that has attached to it flexible sheets that can wrap around the patient placed in the box and be zipped tight to form a vacuum-tight seal against the user of the device. The decompression treatment chamber top section of flexible sheet seal with zipper  83  is mated to decompression treatment chamber lower flexible sheet seal  84  with zipper, decompression treatment chamber lower flexible seal zipper  85 , decompression treatment chamber lower section of flexible seal rubber-like material  86  and decompression treatment chamber upper flexible seal zipper  87 . Embedded in the decompression treatment chamber lower half of chamber  81  is a decompression treatment chamber padded resting area for the buttocks  92 . Although not shown, the present invention may also be used in combination with hyperbaric oxygen patient treatment, such as taught by U.S. Pat. No. 6,484,716, which is incorporated by reference herein. A patient placed in the embodiment of  FIG. 11  may also separately or concurrently be subjected to hyperbaric oxygen treatment effectively loading the cardiovascular system with increased levels of oxygen via the respiratory system for improved delivery through tissue having reduced vascular capacity.  
         [0163]      FIG. 12  is a graphical view of the decompressive energy gradient  137 . It attempts to represent the pattern of deliverable decompressive energy to the soft and/or permeable tissue  135  being treated. The energy being greatest on the application surface of the soft and/or permeable tissue  135  and diminishing as it deeply penetrates the depths of the soft and/or permeable tissue  135 . The units of measure are referred to herein as DEU  133  (decompressive energy unit). This diagram of DEU  133  and decompressive energy gradient  137  is a generalized visual representation of a snap shot in time. The decompressive energy gradient  137  is a dynamic event and the DEUs  133  will change depending on soft and/or permeable tissue  135  density, the level of decompressive energy in the vessel containing decompressive energy  136 , application time and a plurality of additional factors.  
         [0164]      FIG. 13  is an isometric view of the dynamic energy and load action of the present invention. As shown, the user&#39;s foot  25  has been placed inside the circulatory and neurological enhancement device for decompressive therapy. The user&#39;s foot  25  rests on the bottom of transparent vacuum vessel  8 . At the top of the transparent vacuum vessel  8  has been placed the dynamic energy transfer collar  3 , which is engaged with the load diffusion seal  1 . The load diffusion seal  1  in combination with the dynamic energy transfer collar  3  are designed to “fit” around an upper portion of the user&#39;s leg  26  and provide dynamic equalization of energy instantaneously through the fluid filled seal vessel contact points  96  and  97  upon application of the vacuum. At no time does the “hard” collar or vessel wall contact the user&#39;s leg  26  or the user&#39;s foot  25 . As can be visualized from this figure, as vacuum energy is applied through decompression, the right and left sides of the interior of vessel opposing forces, represented by opposing forces right side  93  and opposing forces left side  94  respectively, dynamically equalize in response to the application of vacuum and decompression of the interior of vessel that results in an upper ward pull of the transparent vacuum vessel  8  as represented by dynamic vertical energy  95 . Repeated treatment of tissues, such as with the lower extremity unit shown at  FIG. 13 , will increase the health of the tissues and the vascular system of the tissue as indicated by vascular elasticity, vascular strength, vascular blood flow rates, tissue genesis, vascular density and/or vascular permeability. Although not shown, the various embodiments of the present invention may also be used in combination with compressive means such as a compressive wrap comprised of elastic material to reduce edema, increase patient comfort, reduce discoloring of tissue and help facilitate achievement of greater vacuum pressures. Other variations such as those taught in U.S. Pat. Nos. 6,893,409; 6,488,643; and 6,135,116, and incorporated by reference herein, and may be used as those skilled in the arts will appreciate.  
         [0165]      FIG. 14  is an isometric view of the dynamic action implantable decompression chamber  39  embodiment of the present invention. The dynamic action implantable decompression chamber  39  is one embodiment that can be used to enhance tissue deep inside the body. This device has the potential to open collapsed blood vessels or arteries  106 , stimulate neurological growth and expand any tissue that it encloses inside the transparent vacuum vessel  8 . The dynamic action implantable decompression chamber  39  is made up of a load diffusion seal  1  in combination with a transparent vacuum vessel  8 . A bidirectional check vacuum valve  9  is inserted into the transparent vacuum vessel  8  for control of vacuum. The load diffusion seal  1  at either end of the transparent vacuum vessel  8  interfaces with the blood vessel or artery  106 . The transparent vacuum vessel  8  is applied via a clamshell methodology along leak proof seam and joint  107 . These combined elements allow the embodiment to be implanted within the body and for the transparent vacuum vessel  8  to be connected via vacuum tubing to the outside of the user or patient&#39;s body. It envisioned that this dynamic action implantable decompression chamber  39  could be made of materials that safely dissolve within the body so that extraction of the dynamic action implantable decompression chamber  39  after strengthening the blood vessel or artery  106  is not required. It is further envisioned that the dynamic action implantable decompression chamber  39  will be made of material that allows both or either X-rays and magnetic resonance imaging (MRI) emissions through it without hiding the blood vessel or artery  106  tissue inside the dynamic action implantable decompression chamber  39  so the treatment regimen and progress can be monitored. U.S. patent applications having publication numbers 20050107870 and 20050079132 filed by Wang et al. for a “Medical Device with Multiple Coating Layers” and “Medical Device with Low Magnetic Susceptibility” provide thorough examinations related to magnetic resonance imaging.  
         [0166]      FIG. 15  is a graphic chart comparing dynamic load diffusion to static load distribution. This computer model simulation clearly establishes that in fact, the dynamic properties of load diffusion significantly reduce the stresses associated upon supporting and surrounding tissues engaged with the load diffusion seal  1  and thus out perform load distribution platforms and other cushioned applications as found in the prior art.  
         [0167]      FIG. 16  is an isometric view of the double-chambered decompression device assembly  117  of the present invention. This embodiment of the present invention presents a double chambered decompression device assembly  117  that uses a double dome or chamber to multiply the amount of decompressive energy that may be applied to the living tissue. This embodiment utilizes a substantially similar load diffusion seal  1  in combination with a dynamic energy transfer collar  3 . Additionally, a bi-directional check vacuum valve  9  has been installed in the external transparent vacuum vessel  114 . In this embodiment, an internal transparent vacuum vessel  115  having a bi-directional check vacuum valve  116  is placed inside of a specialized external transparent vacuum vessel  114 , which are engaged through the double chambered decompression device assembly  117 . The combination of two vacuum vessels, one inside of the other, with individual check valves engaged with tissue through load diffusion seals  1  protects the external supporting and surrounding tissue while allowing for localized and specialized deep tissue penetration through the large amount of vacuum that can be applied via two inter-deposed vacuum vessels.  
         [0168]      FIG. 17  is an isometric view of the load diffusion seal  1  of the present invention. In this isometric view, the dynamic energy transfer collar  3  is shown in combination with the collar&#39;s vessel mating groove  105  to opposing surface contact area  27  and the chamber mating section with the dynamic energy transfer collar  28  all mated positively together to load diffusion seal  1  which encases the fluid filled chamber  11 , thus creating the load diffusion seal assembly.  
         [0169]      FIG. 18  pictorially illustrates the envisioned effects of Vascir™ decompression therapy on damaged neurological tissues. The nerve tissue damaged and without Vascir™ Therapy  77  which is weak and diseased, and nerve tissue damaged and with Vascir™ Therapy  78  which is healthy and stronger.  
         [0170]      FIG. 19  presents an isometric view of a multi valve assembly  130  that may be used in conjunction with the present invention the purpose of which is to provide a combination check and relief valve which maintains vacuum while allowing the user to manually release the vacuum in the chamber for various purposes including comfort and/or emergency relief. The multi valve assembly  130  via multi valve threaded end  129  is engaged and connected with the vacuum vessel and vacuum tubing with pressure sensitivity for safety  131 . Threaded end  129  and multi valve return spring retainer evacuation port  128  in combination with multi valve stop plate  127  cooperate together to provide a flow through pedestal for the multi valve assembly  130 . The multi valve assembly  130  allows evacuation of the transparent vacuum vessel  8  via cooperation of multi valve return ring  125 , multi valve check valve diaphragm  122  and multi valve check valve housing  123  when a pump is connected and provides suitable down decompression pressure (vacuum) to depress multi valve return spring  125 , which allows multi valve return spring retainer with evacuation nubs  126  to engage with multi valve dual purpose inlet exhaust ports evacuation ports  124  and disengage multi valve check valve diaphragm  122  from the multi valve check valve housing  123 . This allows air to be evacuated from the transparent vacuum vessel  8 . Removal of the pump releases the pressure against the multi valve return spring  125  allowing disengagement of multi valve return spring retainer with evacuation nubs  126  and multi valve dual purpose inlet exhaust ports  124 , thereby sealing or closing the valve and holding vacuum in the transparent vacuum vessel  8 . To release the vacuum, application of force upon the multi-valve activation button with bleed  120  depresses multi valve return spring  125  which allows multi valve return spring retainer with evacuation nubs  126  to engage with multi valve dual purpose inlet exhaust ports  124  to disengage multi valve check valve diaphragm  122  from the multi valve check valve housing  123  to allow fluid or air to pass back through the multi valve assembly  130  and out vacuum tubing with pressure sensitivity for safety  131 . Multi-valve o-ring  118  in cooperation with multi valve button sheath with cut out  119  cooperate with multi valve activation button with bleed  120  with multi valve activation button bleed off channel  121  to seal the multi valve assembly  130  during vacuum operation.  
         [0171]      FIG. 20  illustrates how living cellular tissue reacts in the presence of vacuum energy. The expanding and stressing of the very biological structures that hold the cells and cellular matter together. During the decompression process, the normal healthy human cell without vacuum decompression applied  40  and its membrane are temporarily expanded, stretched and thinned, into normal healthy human cell with vacuum decompression applied  41  and normal healthy human cell with vacuum decompression fully applied with thin membrane  42  by the process of deep penetrating decompression, due to and dependent upon the amount of vacuum applied (up to 30 inches of Hg) in the particular chamber being utilized and the result sought. The expected healthy responses are indicated by normal healthy human cell after treatment is oxygen enriched and vibrant  43  and normal healthy human cell after treatment with stronger membrane with more flexibility  44  of this illustration. As illustrated, the normal healthy human cell after treatment with stronger membrane with more flexibility  44  is thicker and more malleable and the normal healthy human cell after treatment is oxygen enriched and vibrant  43  is oxygenated and has an abundance of nutrients and life supporting blood.  
         [0172]      FIG. 21  is an illustration of tissue having cancerous cells in combination with non-cancerous cells. Normal healthy human cells without vacuum decompression applied  40  can and do sometimes surround or have incorporated within and/or around them cancer cells in otherwise healthy human without vacuum decompression applied  140 . These cancer cells in otherwise healthy human without vacuum decompression applied  140  can be cancerous and/or tumorous in nature. This illustration is a general representation of a cluster of cells. The cancer cells in otherwise healthy human without vacuum decompression applied  140  are surrounded by the normal healthy human cells without vacuum decompression applied  40 . In this state, the cells show initial signs of decompressive energy (expanding) being applied.  
         [0173]      FIG. 22  is an illustration of tissues reacting to decompressive energy having cancer cells in otherwise healthy human with vacuum decompression being applied  141  in combination with normal healthy human cell with vacuum decompression being applied  41 . Normal healthy human cell with vacuum decompression being applied  41  with their stronger membranes can accommodate these decompressive forces by enlarging and/or expanding in size. The cell membranes of healthy cells being stronger and more resilient are able to stretch, and become thinner without the cell membranes of the normal healthy human cell with vacuum decompression being applied  41  reaching the point of rupturing or breaking. Cancer cells in otherwise healthy human with vacuum decompression being applied  141 , however, have a membrane that is thinner which results in a more dramatic response to the decompressive forces being applied to the cancer cells in otherwise healthy human with vacuum decompression being applied  141 .  
         [0174]     As illustrated in  FIG. 23 , continuing to apply decompressive energy to the cancer cells in otherwise healthy human with vacuum decompression being applied  143 , which have a membrane that is thinner and more responsive to the decompressive forces applied, results in rupture and destruction of the cancer cells in otherwise healthy human with vacuum decompression being applied  143 , while the stronger and more resilient membrane of the normal healthy human cell with vacuum decompression being applied  41  allows them to stretch and become thinner without reaching the point of breaking or rupturing. The method and apparatus herein may also be used with a pharmacological composition selected for membrane rupture of cancer cell in otherwise healthy human with vacuum decompression being applied  143 .  
         [0175]     One example of beneficial compositions is generally known as “chemotherapy,” which may include a combination of the following drugs cyclophosphamide, hydroxydaunorubicin (also sometimes known as adriamycin or doxorubicin) and vincristine. Other pharmacological compositions beneficial to membrane rupture of cancer cell in otherwise healthy human with vacuum decompression being applied  143  may also be used in combination with decompressive energy. The application of decompressive energy to cancer cells in otherwise healthy human without vacuum decompression applied  140  effectively increases the permeability of the cancer cells in otherwise healthy human without vacuum decompression applied  140  membranes, increasing the efficacy of the cancer pharmacological composition thereby aiding in destruction of the cancer cells in otherwise healthy human without vacuum decompression applied  140 . Use and delivery of these pharmacological compositions may be further improved if used in combination with nano-devices that rupture or are actuated when they come in to contact with or pass through the decompressive energy gradient  137 , thus delivering their pharmacological payload directly to the area needed to be treated. This improved delivery and targeting of the pharmacological compositions to the treated tissues is critical for effective treatment. As those skilled in the arts will appreciate, nano devices containing pharmacological compositions may also be introduced into the treated tissue directly or indirectly in one of the following four (4) ways, or through a combination of them including, intravenous (IV) infusion, by pill, by injection or shot, and/or through intrathecal and intraventricular injection.  
         [0176]      FIG. 24  is another embodiment of  FIG. 2  to surround the patient&#39;s foot. Similar to  FIG. 2 , the dynamic energy transfer collar  3  is attached to the vacuum vessel  2 . This illustration also embodies the incorporation of the smart chip controlled vacuum charging system device assembly  51  for autonomous operation and fulfillment of the medical prescription on usage, and the transparent vacuum vessel  8 , allowing visual examination of the tissue being treated.  
         [0177]      FIG. 25  is another embodiment of  FIG. 3 , a hand and upper extremity unit that encapsulates the patient&#39;s upper extremity soft and/or permeable tissue  135 . The hand and upper extremity unit consists of the dynamic energy transfer collar  3  and the vacuum vessel  2 . This illustration also embodies the incorporation of the smart chip controlled vacuum charging system device assembly  51  for autonomous operation and fulfillment of the medical prescription on usage, and the transparent vacuum vessel  8 , allowing visual examination of the tissue being treated.  
         [0178]     The following references are also cited in support of the present application: 
        1. Hirsch A T, Munnings F. Intermittent claudication. Physician Sports Med 1993; 21(6).     2. Lindgarde F, Jelnes R, B{umlaut over ( )}jorkman H, et al. Conservative drug treatment in patients with moderately severe chronic occlusive peripheral arterial disease. Circulation 1989; 80: 1549-56.     3. AD—Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pa., USA. Greene, D A, Feldman, E L, Stevens, M J, et al. Diabetic neuropathy. In: Diabetes Mellitus, Porte, D, Sherwin, R, Rifkin, H (Eds), Appleton Lange, East Norwalk, Conn., 1995.     4. Pirart, J. Diabetes mellitus and its degenerative complications: A prospective study of 4,400 patients observed between 1947 and 1973. Diabetes Care 1978; 1:168.     5. TI—A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population. AU—Young M J; Boulton A J; MacLeod A F; Williams D R; Sonksen P H. SO—Diabetologia 1993 February;36(2):150-4.     6. TI—Epidemiological correlates of diabetic neuropathy. Report from Pittsburgh Epidemiology of Diabetes Complications Study. AU—Maser R E; Steenkiste A R; Dorman J S; Nielsen V K; Bass E B; Manjoo Q; Drash A L; Becker D J; Kuller L H; Greene D A; et al. SO—Diabetes 1989 November;38(11):1456-61.     7. Report and recommendations of the San Antonio Conference on Diabetic Neuropathy. Diabetes 1988; 37:1000.     8. TI—Incidence of distal symmetric (sensory) neuropathy in NIDDM. The San Luis Valley Diabetes Study. AU—Sands M L; Shetterly S M; Franklin G M; Hamman R F. SO—Diabetes Care 1997 March;20(3):322-9. AD—Department of Preventive Medicine and Biometrics, University of Colorado School of Medicine, Denver 80262, USA.     9. TI—Hypertension as a risk factor for diabetic neuropathy: a prospective study. AU—Forrest K Y; Maser R E; Pambianco G; Becker D J; Orchard T J SO—Diabetes 1997 April;46(4):665-70.     10. TI—The contribution of non-insulin-dependent diabetes to lower-extremity amputation in the community. AU—Humphrey L L; Palumbo P J; Butters M A; Hallett J W Jr; Chu C P; O&#39;Fallon W M; Ballard D J SO—Arch Intern Med 1994 April 25;154(8):885-92.        
 
         [0189]     It should be noted that the present invention is not limited to the specific embodiments pictured and described herein, but is intended to apply to apparati and methods employing decompressive energy to stimulate tissue growth, enhancement, circulation and/or selective destruction of diseased cells, particularly those having malignant tendencies. Modifications and alterations from the described embodiments will occur to those skilled in the art without departure from the spirit and scope of the present invention.  
                             TABLE 1                           U.S. Food and Drug Administration Center for Drug Evaluation and Research       Listing of Approved Oncology Drugs 1              Drug   Drug Trade Name   Approved Use               abarelix   Plenaxis depot   For the palliative treatment of men with               advanced symptomatic prostate cancer, in               whom LHRH agonist therapy is not               appropriate and who refuse surgical castration,               and have one or more of the following: (1) risk               of neurological compromise due to metastases,               (2) ureteral or bladder outlet obstruction due to               local encroachment or metastatic disease, or (3)               severe bone pain from skeletal metastases               persisting on narcotic analgesia       aldesleukin   Prokine   Treatment of adults with metastatic melanoma       Aldesleukin   Proleukin   Treatment of adults with metastatic renal cell               carcinoma       Alemtuzumab   Campath   Accel. Approv. (clinical benefit not established)               Campath is indicated for the treatment of B-               cell chronic lymphocytic leukemia (B-CLL) in               patients who have been treated with alkylating               agents and who have failed fludarabine               therapy.       alitretinoin   Panretin   Topical treatment of cutaneous lesions in               patients with AIDS-related Kaposi&#39;s sarcoma.       allopurinol   Zyloprim   Patients with leukemia, lymphoma and solid               tumor malignancies who are receiving cancer               therapy which causes elevations of serum and               urinary uric acid levels and who cannot               tolerate oral therapy.       altretamine   Hexalen   Single agent palliative treatment of patients               with persistent or recurrent ovarian cancer               following first-line therapy with a cisplatin               and/or alkylating agent based combination.       amifostine   Ethyol   To reduce the cumulative renal toxicity               associated with repeated administration of               cisplatin in patients with advanced ovarian               cancer       amifostine   Ethyol   Accel. Approv. (clinical benefit not established)               Reduction of platinum toxicity in non-small               cell lung cancer       amifostine   Ethyol   To reduce post-radiation xerostomia for head               and neck cancer where the radiation port               includes a substantial portion of the parotid               glands.       anastrozole   Arimidex   Accel. Approv. (clinical benefit not established)               for the adjuvant treatment of postmenopausal               women with hormone receptor positive early               breast cancer       anastrozole   Arimidex   Conversion to regular approval for the               adjuvant treatment of postmenopausal women               with hormone receptor positive early breast               cancer       anastrozole   Arimidex   Treatment of advanced breast cancer in               postmenopausal women with disease               progression following tamoxifen therapy.       anastrozole   Arimidex   For first-line treatment of postmenopausal               women with hormone receptor positive or               hormone receptor unknown locally advanced               or metastatic breast cancer.       arsenic trioxide   Trisenox   Second line treatment of relapsed or refractory               APL following ATRA plus an anthracycline.       asparaginase   Elspar   Therapy of patients with acute lymphocytic               leukemia       Asparaginase   Elspar   ELSPAR is indicated in the therapy of patients               with acute lymphocytic leukemia. This agent is               useful primarily in combination with other               chemotherapeutic agents in the induction of               remissions of the disease in pediatric patients.       azacitidine   Vidaza   For use for the treatment of patients with the               following myelodysplastic syndrome subtypes:               refractory anemia or refractory anemia with               ringed sideroblasts (if accompanied by               neutropenia or thrombocytopenia and               requiring transfusions), refractory anemia with               excess blasts, refractory anemia with excess               blasts in transformation, and chronic               myelomonocytic leukemia       BCG Live   TICE BCG       bevacuzimab   Avastin   First-line treatment of patients with metastatic               carcinoma of the colon and rectum (in               combination with intravenous 5-fluorouracil-               based chemotherapy)       bexarotene capsules   Targretin   For the treatment by oral capsule of cutaneous               manifestations of cutaneous T-cell lymphoma               in patients who are refractory to at least one               prior systemic therapy.       bexarotene gel   Targretin   For the topical treatment of cutaneous               manifestations of cutaneous T-cell lymphoma               in patients who are refractory to at least one               prior systemic therapy.       bleomycin   Blenoxane       bleomycin   Blenoxane   Sclerosing agent for the treatment of malignant               pleural effusion (MPE) and prevention of               recurrent pleural effusions.       bortezomib   Velcade   Accel. Approv. (clinical benefit not established)               for the treatment of multiple myeloma patients               who have received at least two prior therapies               and have demonstrated disease progression on               the last therapy       bortezomib   Velcade   Conversion to regular approval for treatment               of multiple myeloma patients who have               received as least one prior therapy       busulfan intravenous   Busulfex   Use in combination with cyclophoshamide as               conditioning regimen prior to allogeneic               hematopoietic progenitor cell transplantation               for chronic myelogenous leukemia.       busulfan oral   Myleran   Chronic Myelogenous Leukemia-palliative               therapy       calusterone   Methosarb       capecitabine   Xeloda   Accel. Approv. (clinical benefit subsequently               established) Treatment of metastatic breast               cancer resistant to both paclitaxel and an               anthracycline containing chemotherapy               regimen or resistant to paclitaxel and for               whom further anthracycline therapy may be               contraindicated, e.g., patients who have               received cumulative doses of 400 mg/m2 of               doxorubicin or doxorubicin equivalents       capecitabine   Xeloda   Initial therapy of patients with metastatic               colorectal carcinoma when treatment with               fluoropyrimidine therapy alone is preferred.               Combination chemotherapy has shown a               survival benefit compared to 5-FU/LV alone.               A survival benefit over 5_FU/LV has not been               demonstrated with Xeloda monotherapy.       capecitabine   Xeloda   Conversion to regular approval for treatment               in combination with docetaxel of patients with               metastatic breast cancer after failure of prior               anthracycline containing chemotherapy       capecitabine   Xeloda   Adjuvant treatment in patients with Dukes&#39; C               colon cancer who have undergone complete               resection of the primary tumor when treatment               with fluoropyrimidine therapy alone is               preferred       carboplatin   Paraplatin   Palliative treatment of patients with ovarian               carcinoma recurrent after prior chemotherapy,               including patients who have been previously               treated with cisplatin.       carboplatin   Paraplatin   Initial chemotherapy of advanced ovarian               carcinoma in combination with other approved               chemotherapeutic agents.       carmustine   BCNU, BiCNU       carmustine   Gliadel   Treatment of patients with malignant glioma               undergoing primary surgical resection       carmustine with   Gliadel Wafer   For use in addition to surgery to prolong       Polifeprosan 20       survival in patients with recurrent       Implant       glioblastoma multiforme who qualify for               surgery.       celecoxib   Celebrex   Accel. Approv. (clinical benefit not established)               Reduction of polyp number in patients with               the rare genetic disorder of familial               adenomatous polyposis.       cetuximab   Erbitux   Accel. Approv. (clinical benefit not established)               for treatment of EGFR-expressing metastatic               colorectal carcinoma in patients who are               refractory to irinotecan-based chemotherapy               (in combination with irinotecan); as a single               agent, treatment of EGFR-expressing               metastatic colorectal carcinoma in patients who               are intolerant to irinotecan-based               chemotherapy       cetuximab   Erbitux   For use in combination with radiation therapy               (RT) for the treatment of locally or regionally               advanced squamous cell carcinoma of the head               and neck (SCCHN) or as a single agent for the               treatment of patients with recurrent or               metastatic SCCHN for whom prior platinum-               based therapy has failed.       chlorambucil   Leukeran       cisplatin   Platinol   Metastatic testicular-in established               combination therapy with other approved               chemotherapeutic agents in patients with               metastatic testicular tumors whoc have already               received appropriate surgical and/or               radiotherapeutic procedures. An established               combination therapy consists of Platinol,               Blenoxane and Velbam.       cisplatin   Platinol   Metastatic ovarian tumors - in established               combination therapy with other approved               chemotherapeutic agents: Ovarian-in               established combination therapy with other               approved chemotherapeutic agents in patients               with metastatic ovarian tumors who have               already received appropriate surgical and/or               radiotherapeutic procedures. An established               combination consists of Platinol and               Adriamycin. Platinol, as a single agent, is               indicated as secondary therapy in patients               with metastatic ovarian tumors refractory to               standard chemotherapy who have not               previously received Platinol therapy.       cisplatin   Platinol   as a single agent for patients with transitional               cell bladder cancer which is no longer               amenable to local treatments such as surgery               and/or radiotherapy.       cladribine   Leustatin, 2-CdA   Treatment of active hairy cell leukemia.       clofarabine   Clolar   Accel. Approv. (clinical benefit not established)               for the treatment of pediatric patients 1 to 21               years old with relapsed or refractory acute               lymphoblastic leukemia after at least two prior               regimens       cyclophosphamide   Cytoxan, Neosar       cyclophosphamide   Cytoxan Injection       cyclophosphamide   Cytoxan Injection       cyclophosphamide   Cytoxan Tablet       cytarabine   Cytosar-U       cytarabine liposomal   DepoCyt   Accel. Approv. (clinical benefit not established)               Intrathecal therapy of lymphomatous               meningitis       dacarbazine   DTIC-Dome       dactinomycin,   Cosmegen       actinomycin D       dactinomycin,   Cosmegan       actinomycin D       Darbepoetin alfa   Aranesp   Treatment of anemia associated with chronic               renal failure.       Darbepoetin alfa   Aranesp   Aranesp is indicated for the treatment of               anemia in patients with non-myeloid               malignancies where anemia is due to the effect               of concomitantly administered chemotherapy.       daunorubicin   DanuoXome   First line cytotoxic therapy for advanced, HIV       liposomal       related Kaposi&#39;s sarcoma.       daunorubicin,   Daunorubicin   Leukemia/myelogenous/monocytic/erythroid       daunomycin       of adults/remission induction in acute               lymphocytic leukemia of children and adults.       daunorubicin,   Cerubidine   In combination with approved anticancer       daunomycin       drugs for induction of remission in adult ALL.       decitabine   Dacogen   for the treatment of patients with               myelodysplastic syndromes (MDS) including               previously treated and untreated, de novo and               secondary MDS of all French-American-British               subtypes (refractory anemia, refractory anemia               with ringed sideroblasts, refractory anemia               with excess blasts, refractory anemia with               excess blasts in transformation, and chronic               myelomonocytic leukemia) and intermediate-1,               intermediate-2, and high-risk International               Prognostic Scoring System groups.       Denileukin diftitox   Ontak   Accel. Approv. (clinical benefit not established)               treatment of patients with persistent or               recurrent cutaneous T-cell lymphoma whose               malignant cells express the CD25 component               of the IL-2 receptor       dexrazoxane   Zinecard   Accel. Approv. (clinical benefit subsequently               established) Prevention of cardiomyopathy               associated with doxorubicin administration       dexrazoxane   Zinecard   Conversion to regular approval for reducing               the incidence and severity of cardiomyopathy               associated with doxorubicin administration in               women with metastatic breast cancer who               have received a cumulative doxorubicin dose               of 300 mg/m2 and who will continue to               receive doxorubicin therapy to maintain tumor               control. It is not recommended for use with the               initiation of doxorubicin therapy.       docetaxel   Taxotere   Accel. Approv. (clinical benefit subsequently               established) Treatment of patients with locally               advanced or metastatic breast cancer who have               progressed during anthracycline-based               therapy or have relapsed during anthracycline-               based adjuvant therapy.       docetaxel   Taxotere   Conversion to regular approval - treatment of               locally advanced or metastatic breast cancer               which has progressed during anthracycline-               based treatment or relapsed during               anthracycline-based adjuvant therapy.       docetaxel   Taxotere   For locally advanced or metastatic non-small               cell lung cancer after failure of prior platinum-               based chemotherapy.       docetaxel   Taxotere   for use in combination with cisplatin for the               treatment of patients with unresectable, locally               advanced or metastatic non-small cell lung               cancer who have not previously received               chemotherapy for this condition cisplatin for               the treatment of patients with unresectable,               locally advanced or metastatic non-small cell               lung cancer who have not previously received               chemotherapy for this condition.       docetaxel   Taxotere   For use in combination with prednisone as a               treatment for patients with androgen               independent (hormone refractory) metastatic               prostate cancer       docetaxel   Taxotere   For use in combination with doxorubicin and               cyclophosphamide for the adjuvant treatment               of patients with operable nodepositive breast               cancer       doxorubicin   Adriamycin PFS   For use in combination with               cyclophosphamide as a component of adjuvant               therapy in patients with evidence of axillary               node tumor involvement following resection of               primary breast cancer       doxorubicin   Adriamycin, Rubex       doxorubicin   Adriamycin PFS   Antibiotic, antitumor agent.           Injectionintravenous           injection       doxorubicin liposomal   Doxil   Conversion to regular approval for treatment               of patients with ovarian cancer whose disease               has progressed or recurred after platinum-               based chemotherapy       doxorubicin liposomal   Doxil   Accel. Approv. (clinical benefit not established)               Treatment of AIDS-related Kaposi&#39;s sarcoma in               patients with disease that has progressed on               prior combination chemotherapy or in patients               who are intolerant to such therapy.       doxorubicin liposomal   Doxil   Accel. Approv. (clinical benefit not established)               Treatment of metastatic carcinoma of the ovary               in patient with disease that is refractory to both               paclitaxel and platinum based regimens       DROMOSTANOLONE   DROMOSTANOLONE       PROPIONATE       DROMOSTANOLONE   MASTERONE       PROPIONATE   INJECTION       Elliott&#39;s B Solution   Elliott&#39;s B Solution   Diluent for the intrathecal administration of               methotrexate sodium and cytarabine for the               prevention or treatment of meningeal leukemia               or lymphocytic lymphoma.       epirubicin   Ellence   A component of adjuvant therapy in patients               with evidence of axillary node tumor               involvement following resection of primary               breast cancer.       Epoetin alfa   epogen   EPOGENB is indicated for the reatment of               anemia related to therapy with zidovudine in               HIV-infected patients. EPOGENB is indicated               to elevate or maintain the red blood cell level               (as manifested by the hematocrit or               hemoglobin determinations) and to decrease               the need for transfusions in these patients.               EPOGEND is not indicated for the treatment of               anemia in HIV-infected patients due to other               factors such as iron or folate deficiencies,               hemolysis or gastrointestinal bleeding, which               should be managed appropriately.       Epoetin alfa   epogen   EPOGENB is indicated for the treatment of               anemic patients (hemoglobin &gt;10 to_&lt;13 g/dL)               scheduled to undergo elective,               noncardiac, nonvascular surgery to reduce the               need for allogeneic blood transfusions.       Epoetin alfa   epogen   EPOGENB is indicated for the treatment of               anemia in patients with non-myeloid               malignancies where anemia is due to the effect               of concomitantly administered chemotherapy.               EPOGEND is indicated to decrease the need               for transfusions in patients who will be               receiving concomitant chemotherapy for a               minimum of 2 months. EPOGENB is not               indicated for the treatment of anemia in cancer               patients due to other factors such as iron or               folate deficiencies, hemolysis or               gastrointestinal bleeding, which should be               managed appropriately.       Epoetin alfa   epogen   EPOGEN is indicated for the treatment of               anemia associated with CRF, including               patients on dialysis (ESRD) and patients not on               dialysis.       erlotinib   Tarceva   For treatment of locally advanced or metastatic               Non Small-Cell Lung Cancer (NSCLC) after               failure of at least one prior chemotherapy               regimen       erlotinib   Tarceva   For use in combination with gemcitabine for               the first-line treatment of patients with locally               advanced, unresectable or metastatic               pancreatic cancer       estramustine   Emcyt   palliation of prostate cancer       etoposide phosphate   Etopophos   Management of refractory testicular tumors, in               combination with other approved               chemotherapeutic agents.       etoposide phosphate   Etopophos   Management of small cell lung cancer, first-               line, in combination with other approved               chemotherapeutic agents.       etoposide phosphate   Etopophos   Management of refractory testicular tumors               and small cell lung cancer.       etoposide, VP-16   Vepesid   Refractory testicular tumors-in combination               therapy with other approved               chemotherapeutic agents in patients with               refractory testicular tumors who have already               received appropriate surgical,               chemotherapeutic and radiotherapeutic               therapy.       etoposide, VP-16   VePesid   In combination with other approved               chemotherapeutic agents as first line treatment               in patients with small cell lung cancer.       etoposide, VP-16   Vepesid   In combination with other approved               chemotherapeutic agents as first line treatment               in patients with small cell lung cancer.       exemestane   Aromasin   For adjuvant treatment of postmenopausal               women with estrogen-receptor positive early               breast cancer who have received two to three               years of tamoxifen and are switched to               AROMASIN ® for completion of a total of five               consecutive years of adjuvant hormonal               therapy       exemestane   Aromasin   Treatment of advance breast cancer in               postmenopausal women whose disease has               progressed following tamoxifen therapy.       Filgrastim   Neupogen   Decrease incidence of infection in patients with               nonmyeloid malignancies       Filgrastim   Neupogen   NEUPOGEN is indicated to decrease the               incidence of infection, as manifested by febrile               neutropenia, in patients with nonmyeloid               malignancies receiving myelosuppressive               anticancer drugs associated with a significant               incidence of severe neutropenia with fever.       Filgrastim   Neupogen   NEUPOGEN is indicated for reducing the time               to neutrophil recovery and the duration of               fever, following induction or consolidation               hemotherapy treatment of adults with AML.       Filgrastim   Neupogen   NEUPOGEN is indicated to reduce the               duration of neutropenia and neutropenia-               related clinical sequelae, eg, febrile               neutropenia, in patients with nonmyeloid               malignancies undergoing myeloablative               chemotherapy followed by marrow               transplantation.       floxuridine   FUDR       (intraarterial)       fludarabine   Fludara   Palliative treatment of patients with B-cell               lymphocytic leukemia (CLL) who have not               responded or have progressed during               treatment with at least one standard alkylating               agent containing regimen.       fluorouracil, 5-FU   Adrucil   prolong survival in combination with               leucovorin       fulvestrant   Faslodex   the treatment of hormone receptor-positive               metastatic breast cancer in postmenopausal               women with disease progression following               antiestrogen therapy       gefitinib   Iressa   Accel. Approv. (clinical benefit not established)               as monotherapy for the treatment of patients               with locally advanced or metastatic non-small               cell lung cancer after failure of both platinum-               based and docetaxel chemotherapies       gemcitabine   Gemzar   Treatment of patients with locally advanced               (nonresectable stage II or III) or metastatic               (stage IV) adenocarcinoma of the pancreas.               Indicated for first-line treatment and for               patients previously treated with a 5-               fluorouracil-containing regimen.       gemcitabine   Gemzar   For use in combination with cisplatin for the               first-line treatment of patients with inoperable,               locally advanced (Stage IIIA or IIIB) or               metastatic (Stage IV) non-small cell lung               cancer.       gemicitabine   Gemzar   For use in combination with paclitaxel for the               first-line treatment of patients with metastatic               breast cancer after failure of prior               anthracycline-containing adjuvant               chemotherapy, unless anthracyclines were               clinically contraindicated       gemtuzumab   Mylotarg   Accel. Approv. (clinical benefit not established)       ozogamicin       Treatment of CD33 positive acute myeloid               leukemia in patients in first relapse who are 60               years of age or older and who are not               considered candidates for cytotoxic               chemotherapy.       goserelin acetate   Zoladex       goserelin acetate   Zoladex Implant   Palliative treatment of advanced breast cancer               in pre- and perimenopausal women.       histrelin acetate   Histrelin implant   For the palliative treatment of advanced               prostate cancer       hydroxyurea   Hydrea       hydroxyurea   Hydrea   Decrease need for transfusions in sickle cell               anemia       Ibritumomab Tiuxetan   Zevalin   Accel. Approv. (clinical benefit not established)               treatment of patients with relapsed or               refractory low-grade, follicular, or transformed               B-cell non-Hodgkin&#39;s lymphoma, including               patients with Rituximab refractory follicular               non-Hodgkin&#39;s lymphoma.       idarubicin   Idamycin   For use in combination with other approved               antileukemic drugs for the treatment of acute               myeloid leukemia (AML) in adults.       idarubicin   Idamycin   In combination with other approved               antileukemic drugs for the treatment of acute               non-lymphocytic leukemia in adults.       ifosfamide   IFEX   Third line chemotherapy of germ cell testicular               cancer when used in combination with certain               other approved antineoplastic agents.       imatinib mesylate   Gleevec   Accel. Approv. (clinical benefit not established)               Initial therapy of chronic myelogenous               leukemia       imatinib mesylate   Gleevec   Accel. Approv. (clinical benefit not established)               metastatic or unresectable malignant               gastrointestinal stromal tumors       Imatinib mesylate   Gleevec   Accel. Approv. (clinical benefit not established)               Treatment of patients with Kit (CD117)               positive unresectable and/or metastatic               malignant gastrointestinal stromal tumors               (GIST).       imatinib mesylate   Gleevec   Accel. Approv. (clinical benefit not established)               Initial treatment of newly diagnosed Ph+               chronic myelogenous leukemia (CML).       imatinib mesylate   Gleevec   Accel. Approv. (clinical benefit not established)               for treatment of newly diagnosed adult               patients with Philadelphia chromosome               positive chronic myeloid leukemia (CML) in               chronic phase. Follow-up is limited. Gleevec is               also indicated for the treatment of patients               with Philadelphia chromosome positive               chronic myeloid leukemia (CML) in blast crisis,               accelerated phase, or in chronic phase after               failure of interferon-alpha therapy. There are               no controlled trials demonstrating a clinical               benefit, such as improvement in disease-               related symptoms or increased survival in               patients with CML blast crisis, accelerated               phase or chronic phase after failure of alpha               interferon. Gleevec is also indicated for the               treatment of patients with Kit (CD117) positive               unresectable and/or metastatic malignant               gastrointestinal stromal tumors (GIST)       imatinib mesylate   Gleevec   Accel. Approv. (clinical benefit not established)               Treatment of pediatric patients with Ph+               chronic phase CML whose disease has               recurred after stem cell transplant or who are               resistant to interferon alpha therapy.       imatinib mesylate   Gleevec   Conversion to regular approval for treatment               of patients with Philadelphia chromosome               positive chronic myeloid leukemia (CML) in               blast crisis, accelerated phase, or in chronic               phase after failure of interferon-alpha therapy       interferon alfa 2a   Roferon A   Treatment of patients with hairy cell leukemia       interferon alfa 2a   Roferon A   Chronic phase, Philadelphia chromosome               positive chronic myelogenous leukemia (CML)               patients who are minimally pretreated (within               1 year of diagnosis)       Interferon alfa-2a   Roferon-A       Interferon alfa-2b   Intron A   Interferon alfa-2b, recombinant for Injection is               indicated for the treatment of patients 18 years               of age or older with hairy cell leukemia.       Interferon alfa-2b   Intron A   Interferon alfa-2b, recombinant for Injection is               indicated for intralesional treatment of selected               patients 18 years of age or older with               condylomata acuminata involving external               surfaces of the genital and perianal areas.       Interferon alfa-2b   Intron A   Interferon alfa-2b, recombinant for injection is               indicated for the treatment of selected patients               18 years of age or older with AIDS-related               Kaposi&#39;s Sarcoma. The likelihood of response               to INTRON A therapy is greater in patients               who are without systemic symptoms, who               have limited lymphadenopathy and who have               a relatively intact immune system as indicated               by total CD4 count.       Interferon alfa-2b   Intron A   Interferon alfa-2b, recombinant for injection is               indicated as adjuvant to surgical treatment in               patients 18 years of age or older with               malignant melanoma who are free of disease               but at high risk for systemic recurrence within               56 days of surgery.       Interferon alfa-2b   Intron A   Interferon alfa-2b, recombinant for Injection is               indicated for the initial treatment of clinically               aggressive follicular non-Hodgkin&#39;s               Lymphoma in conjunction with anthracycline-               containing combination chemotherapy in               patients 18 years of age or older.       Interferon alfa-2b   Intron A Intron A       irinotecan   Camptosar   Accel. Approv. (clinical benefit subsequently               established) Treatment of patients with               metastatic carcinoma of the colon or rectum               whose disease has recurred or progressed               following 5-FU-based therapy.       irinotecan   Camptosar   Conversion to regular approval - treatment of               metastatic carcinoma of the colon or rectum               whose disease has recurred or progressed               following 5-FU-based therapy.       irinotecan   Camptosar   For first line treatment n combination with 5-               FU/leucovorin of metastatic carcinoma of the               colon or rectum.       lenalidomide   Revlimid   for the treatment of patients with transfusion-               dependent anemia due to Low- or               Intermediate-1-risk myelodysplastic               syndromes associated with a deletion 5q               cytogenetic abnormality with or without               additional cytogenetic abnormalities       letrozole   Femara   Treatment of advanced breast cancer in               postmenopausal women.       letrozole   Femara   First-line treatment of postmenopausal women               with hormone receptor positive or hormone               receptor unknown locally advanced or               metastatic breast cancer.       letrozole   Femara       letrozole   Femara   Accel. Approv. (clinical benefit not established)               for the extended adjuvant treatment of early               breast cancer in postmenopausal women who               have received five years of adjuvant tamoxifen               therapy.       leucovorin   Wellcovorin,   Leucovorin calcium is indicated fro use in           Leucovorin   combination with 5-fluorouracil to prolong               survival in the palliative treatment of patients               with advanced colorectal cancer.       leucovorin   Leucovorin       leucovorin   Leucovorin       leucovorin   Leucovorin       leucovorin   Leucovorin   In combination with fluorouracil to prolong               survival in the palliative treatment of patients               with advanced colorectal cancer.       Leuprolide Acetate   Eligard   palliative treatment of advanced prostate               cancer.       levamisole   Ergamisol   Adjuvant treatment in combination with 5-               fluorouracil after surgical resection in patients               with Dukes&#39; Stage C colon cancer.       lomustine, CCNU   CeeBU       meclorethamine,   Mustargen       nitrogen mustard       megestrol acetate   Megace       melphalan, L-PAM   Alkeran       melphalan, L-PAM   Alkeran   Systemic administration for palliative               treatment of patients with multiple myeloma               for whom oral therapy is not appropriate.       mercaptopurine, 6-MP   Purinethol       mesna   Mesnex   Prevention of ifosfamide-induced hemorrhagic               cystitis       mesna   Mesnex tabs   Reducing the incidence of ifosfamide-induced               hemorrhagic cystitis       methotrexate   Methotrexate       methotrexate   Methotrexate       methotrexate   Methotrexate       methotrexate   Methotrexate       methotrexate   Methotrexate   osteosarcoma       methotrexate   Methotrexate       methoxsalen   Uvadex   For the use of UVADEX with the UVAR               Photopheresis System in the palliative               treatment of the skin manifestations of               cutaneous T-cell lymphoma (CTCL) that is               unresponsive to other forms of treatment.       mitomycin C   Mutamycin       mitomycin C   Mitozytrex   therapy of disseminated adenocarcinoma of               the stomach or pancreas in proven               combinations with other approved               chemotherapeutic agents and as palliative               treatment when other modalities have failed.       mitotane   Lysodren       mitoxantrone   Novantrone   For use in combination with corticosteroids as               initial chemotherapy for the treatment of               patients with pain related to advanced               hormone-refractory prostate cancer.       mitoxantrone   Novantrone   For use with other approved drugs in the               initial therapy for acute nonlymphocytic               leukemia (ANLL) in adults.       nandrolone   Durabolin-50       phenpropionate       nelarabine   Arranon   Accel. Approv. (clinical benefit not established)               for the treatment of patients with T-cell acute               lymphoblastic leukemia and T-cell               lymphoblastic lymphoma whose disease has               not responded to or has relapsed following               treatment with at least two chemotherapy               regimens       Nofetumomab   Verluma       Oprelvekin   Neumega   Prevention of severe thrombocytopenia               following myelosuppressive chemotherapy       Oprelvekin   Neumega   Neumega is indicated for the prevention of               severe thrombocytopenia and the reduction of               the need for platelet transfusions following               myelosuppressive chemotherapy in adult               patients with nonmyeloid malignancies who               are at high risk of severe thrombocytopenia.       Oprelvekin   Neumega       oxaliplatin   Eloxatin   Accel. Approv. (clinical benefit not established)               in combination with infusional 5-FU/LV, is               indicated for the treatment of patients with               metastatic carcinoma of the colon or rectum               whose disease has recurred or progressed               during or within 6 months of completion of               first line therapy with the combination of bolus               5-FU/LV and irinotecan.       oxaliplatin   Eloxatin   Conversion to regular approval for use in               combination with infusional 5-Fluorouracil (5-               FU) and Leucovorin (LV) for the treatment of               patients previously untreated for advanced               colorectal cancer       oxaliplatin   Eloxatin   for use in combination with infusional 5-               FU/LV, for the adjuvant treatment of stage III               colon cancer patients who have undergone               complete resection of the primary tumor       paclitaxel   Paxene   treatment of advanced AIDS-related Kaposi&#39;s               sarcoma after failure of first line or subsequent               systemic chemotherapy       paclitaxel   Taxol   Treatment of patients with metastatic               carcinoma of the ovary after failure of first-line               or subsequent chemotherapy.       paclitaxel   Taxol   Treatment of breast cancer after failure of               combination chemotherapy for metastatic               disease or relapse within 6 months of adjuvant               chemotherapy. Prior therapy should have               included an anthracycline unless clinically               contraindicated.       paclitaxel   Taxol   New dosing regimen for patients who have               failed initial or subsequent chemotherapy for               metastatic carcinoma of the ovary       paclitaxel   Taxol   second line therapy for AIDS related Kaposi&#39;s               sarcoma.       paclitaxel   Taxol   For first-line therapy for the treatment of               advanced carcinoma of the ovary in               combination with cisplatin.       paclitaxel   Taxol   for use in combination with cisplatin, for the               first-line treatment of non-small cell lung               cancer in patients who are not candidates for               potentially curative surgery and/or radiation               therapy.       paclitaxel   Taxol   For the adjuvant treatment of node-positive               breast cancer administered sequentially to               standard doxorubicin-containing combination               therapy.       paclitaxel   Taxol   First line ovarian cancer with 3 hour infusion.       paclitaxel protein-   Abraxane   For the treatment of breast cancer after failure       bound particles       of combination chemotherapy for metastatic               disease or relapse within 6 months of adjuvant               chemotherapy. Prior therapy should have               included an anthracyline unless clinically               contraindicated       palifermin   Kepivance   Decrease the incidence and duration of severe               oral mucositis in patients with hematologic               malignancies receiving myelotoxic therapy               requiring hematopoetic stem cell support       pamidronate   Aredia   Treatment of osteolytic bone metastases of               breast cancer in conjunction with standard               antineoplastic therapy.       pegademase   Adagen (Pegademase   Enzyme replacement therapy for patients with           Bovine)   severe combined immunodeficiency asa result               of adenosine deaminase deficiency.       pegaspargase   Oncaspar   Acute lymphocytic leukemia in L-asparaginase               hypersensitive patients       Pegfilgrastim   Neulasta   Neulasta is indicated to decrease the incidence               of infection, as manifested by febrile               neutropenia, in patients with non-myeloid               malignancies receiving myelosuppressive anti-               cancer drugs associated with a clinically               significant incidence of febrile neutropenia.       pemetrexed disodium   Alimta   For use in the treatment of patients with               malignant pleural mesothelioma whose               disease is either unresectable or who are               otherwise not candidates for curative surgery       pemetrexed disodium   Alimta   Accel. Approv. (clinical benefit not established)               as a single agent for the treatment of patients               with locally advanced or metastatic non-small               lung cancer after prior chemotherapy       pentostatin   Nipent   Single agent treatment for adult patients with               alpha interferon refractory hairy cell leukemia.       pentostatin   Nipent   Single-agent treatment for untreated hairy cell               leukemia patients with active disease as               defined by clinically significant anemia,               neutropenia, thrombocytopenia, or disease-               related symptoms. (Supplement for front-line               therapy.)       pipobroman   Vercyte       plicamycin,   Mithracin       mithramycin       porfimer sodium   Photofrin   For the ablation of high-grade dysplasia in               Barrett&#39;s esophagus patients who do not               undergo esophagectomy       porfimer sodium   Photofrin   For use in photodynamic therapy (PDT) for               palliation of patients with completely               obstructing esophageal cancer, or patients with               partially obstructing esophageal cancer who               cannot be satisfactorily treated with ND-YAG               laser therapy.       porfimer sodium   Photofrin   For use in photodynamic therapy for treatment               of microinvasive endobronchial nonsmall cell               lung cancer in patients for whom surgery and               radiotherapy are not indicated.       porfimer sodium   Photofrin   For use in photodynamic therapy (PDT) for               reduction of obstruction and palliation of               symptoms in patients with completely or               partially obstructing endobroncial nonsmall               cell lung cancer (NSCLC).       procarbazine   Matulane       quinacrine   Atabrine       Rasburicase   Elitek   ELITEK is indicated for the initial management               of plasma uric acid levels in pediatric patients               with leukemia, lymphoma, and solid tumor               malignancies who are receiving anti-cancer               therapy expected to result in tumor lysis and               subsequent elevation of plasma uric acid.       Rituximab   Rituxan   for use in the first-line treatment of patients               with diffuse large B-cell, CD20-positive, non-               Hodgkin&#39;s lymphoma in combination with               CHOP or other anthracycline-based               chemotherapy regimens.       Rituximab   Rituxan   Treatment of patients with relapsed or               refractory low-grade or follicular B-cell non-               Hodgkin&#39;s lymphoma       sargramostim   Leukine   Acceleration of myeloid recovery following               autologous bone marrow transplant in patients               with non-Hodgkin&#39;s lymphoma, acute               lymphocytic leukemia, or Hodgkin&#39;s disease       Sargramostim   Prokine       sorafenib   Nexavar   For the treatment of patients with advanced               renal cell carcinoma       streptozocin   Zanosar   Antineoplastic agent.       sunitinib maleate   Sutent   treatment of gastrointestinal stromal tumor               after disease progression on or intolerance to               imatinib mesylate       sunitinib maleate   Sutent   Accel. Approv. (clinical benefit not established)               for the treatment of advanced renal cell               carcinoma. Approval for advanced renal cell               carcinoma is based on partial response rates               and duration of responses. There are no               randomized trials of SUTENT demonstrating               clinical benefit such as increased survival or               improvement in disease-related symptoms in               renal cell carcinoma.       talc   Sclerosol   For the prevention of the recurrence of               malignant pleural effusion in symptomatic               patients.       tamoxifen   Nolvadex       tamoxifen   Nolvadex   As a single agent to delay breast cancer               recurrence following total mastectomy and               axillary dissection in postmenopausal women               with breast cancer (T1-3, N1, M0)       tamoxifen   Nolvadex   For use in premenopausal women with               metastatic breast cancer as an alternative to               oophorectomy or ovarian irradiation       tamoxifen   Nolvadex   For use in women with axillary node-negative               breast cancer adjuvant therapy.       tamoxifen   Nolvadex   Metastatic breast cancer in men.       tamoxifen   Nolvadex   Equal bioavailability of a 20 mg Nolvadex               tablet taken once a day to a 10 mg Nolvadex               tablet taken twice a day.       tamoxifen   Nolvadex   to reduce the incidence of breast cancer in               women at high risk for breast cancer       tamoxifen   Nolvadex   In women with DCIS, following breast surgery               and radiation, Nolvadex is indicated to reduce               the risk of invasive breast cancer.       temozolomide   Temodar   Accel. Approv. (clinical benefit not established)               Treatment of adult patients with refractory               anaplastic astrocytoma, i.e., patients at first               relapse with disease progression on a               nitrosourea and procarbazine containing               regimen       temozolomide   Temodar   Conversion to regular approval for the               treatment of patients with newly diagnosed               high grade gliomas concomitantly with               radiotherapy and then as adjuvant treatment       teniposide, VM-26   Vumon   In combination with other approved anticancer               agents for induction therapy in patients with               refractory childhood acute lymphoblastic               leukemia (all).       testolactone   Teslac       testolactone   Teslac       thioguanine, 6-TG   Thioguanine       thiotepa   Thioplex       thiotepa   Thioplex       thiotepa   Thioplex       topotecan   Hycamtin   Treatment of patients with metastatic               carcinoma of the ovary after failure of initial or               subsequent chemotherapy.       topotecan   Hycamtin   Treatment of small cell lung cancer sensitive               disease after failure of first-line chemotherapy.               In clinical studies submitted to support               approval, sensitive disease was defined as               disease responding to chemotherapy but               subsequently progressing at least 60 days (in               the phase 3 study) or at least 90 days (in the               phase 2 studies) after chemotherapy       toremifene   Fareston   Treatment of advanced breast cancer in               postmenopausal women.       Tositumomab   Bexxar   Accel. Approv. (clinical benefit not established)               Treatment of patients with CD20 positive,               follicular, non-Hodgkin&#39;s lymphoma, with and               without transformation, whose disease is               refractory to Rituximab and has relapsed               following chemotherapy       Tositumomab/I-131   Bexxar   Expand the indication to include patients with       tositumomab       relapsed or refractory low grade follicular               transformed CD20-positive non-Hodgkin&#39;s               lymphoma who have not received rituximab       Trastuzumab   Herceptin   HERCEPTIN as a single agent is indicated for               the treatment of patients with metastatic breast               cancer whose tumors overexpress the HER2               protein and who have received one or more               chemotherapy regimens for their metastatic               disease.       Trastuzumab   Herceptin   Herceptin in combination with paclitaxel is               indicated for treatment of patients with               metastatic breast cancer whose tumors               overexpress the HER-2 protein and had not               received chemotherapy for their metastatic               disease       Trastuzumab   Herceptin       Trastuzumab   Herceptin       tretinoin, ATRA   Vesanoid   Induction of remission in patients with acute               promyelocytic leukemia (APL) who are               refractory to or unable to tolerate anthracycline               based cytotoxic chemotherapeutic regimens.       Uracil Mustard   Uracil Mustard           Capsules       valrubicin   Valstar   For intravesical therapy of BCG-refractory               carcinoma in situ (CIS) of the urinary bladder               in patients for whom immediate cystectomy               would be associated with unacceptable               morbidity or mortality.       vinblastine   Velban       vincristine   Oncovin       vincristine   Oncovin       vincristine   Oncovin       vincristine   Oncovin       vincristine   Oncovin       vincristine   Oncovin       vincristine   Oncovin       vinorelbine   Navelbine   Single agent or in combination with cisplatin               for the first-line treatment of ambulatory               patients with unresectable, advanced non-               small cell lung cancer (NSCLC).       vinorelbine   Navelbine   Navelbine is indicated as a single agent or in               combination with cisplatin for the first-line               treatment of ambulatory patients with               unreseactable, advanced non-small cell lung               cancer (NSCLC). In patients with Stage IV               NSCLC, Navelbine is indicated as a single               agent or in combination with cisplatin. In Stage               III NSCLC, Navelbine is indicated in               combination with cisplatin.       zoledronate   Zometa   the treatment of patients with multiple               myeloma and patients with documented bone               metastases from solid tumors, in conjunction               with standard antineoplastic therapy. Prostate               cancer should have progressed after treatment               with at least one hormonal therapy.       zoledronic acid   Zometa   Treatment of hypercalcemia of malignancy                   1 http://www.fda.gov/cder/cancer/druglistframe.htm