Abstract:
A method for stretching at least a portion of an organ to decrease interstitial hydrostatic pressure and improve at least one organ function. The method comprises providing at least one elastically compressible anchor, compressing the at least one anchor, anchoring the at least one anchor to a portion of an organ from the group of organs consisting of: a kidney, a liver, a bladder, and a stomach. The method further comprises releasing the compressing, thereby stretching the portion and decreasing interstitial hydrostatic pressure.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates generally to methods and devices for changing the hydrostatic pressure in an organ from the group of organs consisting of: kidney, bladder, stomach, and liver; thereby improving at least one aspect of organ function. 
       BACKGROUND OF THE INVENTION 
     Chronic Renal Failure 
       [0002]    Chronic renal failure (CRF) is a progressive disease characterized by an increasing inability of the kidney to maintain normal levels of protein metabolism (such as urea), normal blood pressure, hematocrit, sodium, water, potassium, and acid-base balance. Once the process of nephron destruction begins, it appears that there is a compensatory hyperfiltration in other nephrons. This in turn likely leads to sclerosis, and tubular hypertrophy in the compensating nephrons, resulting in increased expenditure of energy, greater consumption of oxygen, and production of reactive oxygen metabolites, and tubulointerstitial damage. (Cecil Essential of Medicine, Andreoli) 
         [0003]    When CRF reduction dips to 90%, and/or serum creatinine in an adult reaches about 3 mg/dL, and no factors in the renal disease are reversible, the renal disease is highly likely to progress to end-stage renal disease (ESRD) over a variable period (from a few years to as many as 20 to 25 years). There are 4.5 million patients with ESRD in the USA, and about 100,000 new cases every year. The number of ESRD patients increases annually at a rate of about 5-8% due to aging and type II DM. ( Lancet  2005; 365: 331-40) 
         [0004]    Major causes of CRF include type II DM and hypertension. Management of CRF may include treatment, primarily through diet, of underlying cause, whether type II DM or hypertension. 
         [0005]    Following kidney failure, the options for treatment include dialysis, and kidney transplantation. (Cecil Essentials of Medicine, Andreoli) 
         [0006]    Dialysis can be performed on acute or chronic renal failure patients. Despite improved technologies, the annual mortality rates in the United States still average around 20% per year (Cecil Textbook of Medicine, 21 st  edition. W.B. Saunders Company, 2000). 
       Obesity 
       [0007]    Obesity is a major cause of morbidity, and mortality. Food intake is a system that is regulated by a variety of nerves providing signals to the central nervous system (CNS). 
         [0008]    Afferent signals provide information to the CNS, which is the centre for the control of satiety or food seeking. A subset of vagal afferents that have been implicated as key to gastrointestinal (GI) regulation, and ingestive behavior consists of the two morphologically distinct classes of mechanoreceptors supplied to the muscle wall of the GI tract. 
         [0009]    One class is comprised of intraganglionic laminar endings (IGLEs) that innervate myenteric ganglia, and are distributed throughout the GI tract. The other consists of intramuscular arrays (IMAs) that have a much more restricted distribution that is limited to the stomach, and adjacent sphincters. 
         [0010]    In particular, IMAs are concentrated in the circular or longitudinal muscle layers of the fore stomach, and lower esophageal, and pyloric sphincters, where they form appositions with muscle fibers, and/or interstitial cells of Cajal. 
         [0011]    These vagal mechanoreceptors are thought to provide the CNS with negative feedback that is activated by accumulation, and movement of food in the stomach and intestines, and may therefore be involved in regulation of feeding, especially in the control of meal size or short-term satiety (Fox E A et al. J Neurosci. 1 Nov. 2001; 21(21):8602-15.). 
       Urinary Incontinence 
       [0012]    Urinary incontinence is a major social, and hygiene problem. Urinary incontinence is generally classified into three types: stress incontinence, urge incontinence, and mixed incontinence. Detrusor instability (urge incontinence) is characterized by spontaneous and uninhibited contraction of the detrusor muscle during bladder filling. The bladder pressure exceeds the urethral pressure resulting in incontinence. Treatment of detrusor instability is based on inhibiting the symptoms of urgency, and increasing the interval between voids. Options include bladder training, biofeedback, hypnosis, and drugs. Surgery may also be considered either to interrupt the nervous pathways or to increase bladder capacity. A common approach is resection of the vesicle plexus approached vaginally. 
       Cirrhosis 
       [0013]    Cirrhosis, loss of liver function, affects the body in many ways. For example, when the liver loses its ability to make the protein albumin, water accumulates in the legs (edema) and abdomen (ascites). Additionally, a damaged liver cannot remove toxins from the bloodstream, causing them to accumulate in the blood and eventually the brain. There, toxins can dull mental functioning and cause personality changes, coma, and even death. Signs of the buildup of toxins in the brain include neglect of personal appearance, unresponsiveness, forgetfulness, trouble concentrating, or changes in sleep habits. 
       PRIOR ART 
       [0014]    Stomach restriction devices and methods are known. 
         [0015]    Gastric anchors are known. For example Imran teaches a variety of anchor designs, and methods of configuration, in multiple patents, including: U.S. patent application Ser. No. 11/992,382, published on 30 Jun. 2005 as U.S. 2005/0143784 A1, which teaches devices and methods to anchor sensors to a gastric portion; and U.S. patent application Ser. No. 10/991,648 published on 20 Jun. 2005 as U.S. 2005/0143760 A1, which teaches devices and methods to interconnect anchors to gastric tissue, and limit gastric expansion. 
         [0016]    The contents of all of the above-noted applications are hereby incorporated by reference as if fully set forth herein. 
       SUMMARY OF THE INVENTION 
       [0017]    Embodiments of the present invention successfully address at least some of the shortcomings of the prior art by providing methods, and devices for reducing hydrostatic pressure in at least one portion of an organ from the group of organs consisting of a kidney, bladder, stomach, and liver, thereby improving at least one aspect of organ function. 
         [0018]    According to the teachings of the present invention, there is provided a method for stretching at least a portion of an organ. The method comprises, providing at least one elastically compressible anchor, compressing the at least one anchor, anchoring the at least one anchor to a portion of an organ from the group of organs consisting of a kidney, a bladder, a liver, and a stomach, and releasing the compressing, thereby stretching the portion of the organ. 
         [0019]    According to the teachings of the present invention, there is provided a method for stretching at least a portion of an organ. The method comprises, stretching a portion of an organ from the group of organs consisting of a kidney, a liver, a bladder, and a stomach, and anchoring at least one anchor to the portion, thereby at least partially maintaining the stretching. 
         [0020]    In some embodiments, at least a portion of at least one anchor is oriented at an angle relative to an external surface of the portion of the organ at an angle of between 0 degrees and 20 degrees from parallel to the surface. 
         [0021]    In some embodiments, at least a portion of at least one anchor is oriented at an angle relative to an external surface of the portion of the organ, at an angle of between 20 degrees, and 70 degrees from parallel to the surface. 
         [0022]    In some embodiments, at least a portion of at least one anchor is oriented at an angle relative to an external surface of the portion of the organ, at an angle of between about 70 degrees and about 90 degrees from parallel to the surface. 
         [0023]    In some embodiments, the at least one anchor comprises at least two magnets, each magnet having a magnetic field, wherein the compressing includes bringing same polarity of the magnetic fields toward each other so as to increase the magnitude of a repulsive magnetic force produced by the magnetic fields of the magnets. 
         [0024]    In some embodiments, the at least one anchor comprises at least two magnets, each magnet having a magnetic field, wherein, the anchoring includes anchoring the at least two magnets at a distance, and an orientation so that respective the magnetic fields apply a force to substantially maintain the stretching. 
         [0025]    In some embodiments, an axis passing through the at least two magnets is oriented at an angle relative to an external surface of the portion at an angle of between about 0 degrees and about 20 degrees from parallel to the surface. 
         [0026]    In some embodiments, an axis passing through the at least two magnets is oriented at an angle relative to an external surface of the portion, at an angle of between about 20 degrees and about 70 degrees from parallel to the surface. 
         [0027]    In some embodiments, an axis passing through the at least two magnets is oriented at an angle relative to an external surface of the portion, at an angle of between about 70 degrees and about 90 degrees from parallel to the surface. 
         [0028]    According to the teachings of the present invention, there is also provided a method for stretching at least a portion of an organ, the method comprises stretching a portion of an organ portion from the group of organs consisting of a kidney, a bladder, a liver, and a stomach, connecting a first end of a connector to the organ, the at least one connector having a body, a first end, and a second end, connecting the at least one connector second end to the substantially external portion at a distance from the first end, releasing the stretching, so that the stretching is at least partially maintained by the at least one connector. 
         [0029]    According to the teachings of the present invention, there is also provided a method for stretching at least a portion of an organ. The method comprises, compressing at least one elastically compressible connector, the connector having a body, a first end, and a second end, connecting the at least one connector first end to an organ from the group of organs consisting of a liver, a kidney, a bladder, and a stomach, connecting the at least one connector second end to the organ portion at a distance from the first end, and releasing the compressing, thereby stretching the portion. 
         [0030]    In some embodiments, the at least one connector is shaped so as to substantially follow a contour of at least part of an external boundary of the external organ portion. 
         [0031]    In some embodiments, the at least one connector is elastically compressible along a longitudinal axis running through the body, the first end, and the second end. Further, the compressing comprises compressing the at least one connector first end toward the second end, along the longitudinal axis. 
         [0032]    In some embodiments, the connector is substantially a longitudinally compressible spring, such as a helical spring. 
         [0033]    In some embodiments, the at least one connector body is elastically deformable, and the compressing comprises bringing the first connector end toward the second connector end, thereby elastically deforming the body while displacing the body a distance from an axis running through the first, and second ends. 
         [0034]    In some embodiments, the connector is substantially a leaf spring. 
         [0035]    In some embodiments, the connecting comprises, providing at least two anchors, each anchor having a first end, a second end, and a body, anchoring the first end of the anchors to the organ portion so that the second end of the anchors protrudes from the organ, coupling the first end of the connector, and the second end of the connector each to the protruding second end of the anchor. 
         [0036]    In some embodiments, the connecting comprises applying an adhesive between the first, and second ends of the at least one connector, and the organ portion. 
         [0037]    In some embodiments, the adhesive comprises carboxymethyl cellulose. 
         [0038]    In some embodiments, the connecting additionally comprises applying the adhesive to the connector body between the connector, and the portion. 
         [0039]    In some embodiments, the connecting comprises applying the adhesive substantially to the entire contact area between the connector body, and the organ portion. 
         [0040]    According to the teachings of the present invention, there is also provided a method for stretching at least a portion of an external boundary of an organ substantially outward. The method comprises, outwardly stretching a portion of a substantially external boundary of an organ, the organ selected from the group of organs consisting of a kidney, a liver, a bladder, and a stomach, and, conjoining the portion to at least one offset so that the stretching is at least partially maintained. 
         [0041]    In some embodiments, the at least one offset location comprises a bone from the group consisting of ribs and vertebrae. 
         [0042]    In some embodiments, the conjoining comprises anchoring the portion of a substantially external boundary of the organ to a first end of at least one anchor having a first end, and a second end, and attaching the anchor second end to the bone. 
         [0043]    In some embodiments, the conjoining comprises suturing the portion of a substantially external boundary of the organ to the bone using at least one suture. 
         [0044]    In some embodiments, the at least one offset comprises a curved body portion of at least one connector having a first end, a second end, and a body wherein the first end, and the second end are connected proximate to the portion of a substantially external boundary of the organ. 
         [0045]    In some embodiments, the connecting comprises applying an adhesive between the connector body portion, and an outer surface of the organ. 
         [0046]    In some embodiments, the adhesive comprises carboxymethyl cellulose. 
         [0047]    In some embodiments, the adhesive is additionally applied to the first and the second ends of the at least one connector. 
         [0048]    In some embodiments, the adhesive is applied on the entire contact area between the connector and the organ. 
         [0049]    In some embodiments, the connecting comprises anchoring the portion of a substantially external boundary of the organ to a first end of at least one anchor having a first end, and a second end, and coupling the second end of the anchor to the connector body. 
         [0050]    In some embodiments, the first end and the second end of the at least one connector are coupled to a first and a second anchor respectively, and the connecting comprises anchoring the first, and second anchors to the organ proximate to the portion of a substantially external boundary of the organ. 
         [0051]    According to the teachings of the present invention, there is also provided a method for stretching at least a portion of an external boundary of an organ substantially outward. The method comprises, stretching at least one elastically stretchable anchor, the at least one anchor comprising a first end, and a second end, anchoring the first end of the at least one anchor to an organ, the organ selected from the group of organs consisting of a kidney, a liver, a bladder, and a stomach, and conjoining the second end of the at least one anchor with at least one offset so that the stretching is at least partially maintained. 
         [0052]    In some embodiments, the at least one offset comprises a bone from the group consisting of ribs and vertebrae. 
         [0053]    In some embodiments, the at least one offset comprises a curved body portion of at least one connector having a first end, a second end, and the body, wherein the first end, and the second end are implanted proximate to the portion of a substantially external boundary of the organ. 
         [0054]    In some embodiments, the at least one offset comprises a body of at least one connector having a first end, a second end, and a body, wherein the first end, and the second end are attached to a first anchor, and a second anchor respectively, and the connecting comprises connecting the first, and second anchors proximate to the portion of a substantially external boundary of the organ. 
         [0055]    In some embodiments, the stretching includes a linear component substantially parallel to an external boundary of the organ. 
         [0056]    In some embodiments, the stretching is at least about 0.5 centimeters. Alternatively, the stretching is at least about 1.0, 1.5, 2.0, or 2.5 centimeters. 
         [0057]    In some embodiments, the stretching is no more than about 5.0 centimeters. Alternatively, the stretching is no more that about 4.5, 4.0, 3.5, or 3.0 centimeters. 
         [0058]    In some embodiments, the stretching includes an outward component, substantially perpendicular to an external boundary of the organ. 
         [0059]    In some embodiments, the stretching is at least 0.5 centimeters Alternatively, the stretching is at least about 1.0, 1.5, 2.0, or 2.5 centimeters. 
         [0060]    In some embodiments, the stretching is no more than about 5.0 centimeters. Alternatively, the stretching is no more that about 4.5, 4.0, 3.5, or 3.0 centimeters. 
         [0061]    In some embodiments, the at least two anchors comprise at least three anchors. 
         [0062]    In some embodiments, the at least one connector comprises at least two connectors. 
         [0063]    In some embodiments, the at least two connectors substantially describe a line. 
         [0064]    In some embodiments, the at least two connectors substantially describe an open polygon. 
         [0065]    In some embodiments, the at least two anchors comprise at least four anchors. 
         [0066]    In some embodiments, the at least one connector comprises at least three connectors. 
         [0067]    In some embodiments, the at least three connectors substantially describe a line. 
         [0068]    In some embodiments, the at least three connectors substantially describe a closed polygon. 
         [0069]    In some embodiments the at least three connectors substantially describe an open polygon. 
         [0070]    In some embodiments, the at least one connector comprises a sheet material. 
         [0071]    In some embodiments, the at least two connectors comprise a substantially continuous single connector, comprising a sheet material. 
         [0072]    In some embodiments, the at least three connectors comprise a substantially continuous single connector, comprising a sheet material. 
         [0073]    In some embodiments the sheet material is selected from the group consisting of meshes, and nets. 
         [0074]    In some embodiments, the material includes openings having an area of at least about 0.5 mm2. Alternatively, the openings have an area of at least about 0.75, 1.0, 1.25, 1.50, or 2.0 mm2. 
         [0075]    In some embodiments, the material includes openings having an area of no more than about 2.0 mm2. Alternatively, the openings have an area of no more that about 0.50, 0.75, 1.0, 1.25, or 1.50 mm2. 
         [0076]    In some embodiments, at least a portion of at least one anchor comprises at least one screw thread. 
         [0077]    In some embodiments, the implanting includes screwing the at least one screw thread into the portion. 
         [0078]    In some embodiments the organ comprises a kidney. 
         [0079]    In some embodiments, the portion comprises a cortex of a kidney. 
         [0080]    In some embodiments, the at least one stretched portion comprises a tissue located substantially in a kidney cortex. 
         [0081]    In some embodiments, the portion comprises a tissue from the group consisting of a kidney cortex, medulla, ureter, and pelvis. 
         [0082]    In some embodiments the stretched portions comprise a tissue from the group consisting of a kidney cortex, medulla, and pelvis. 
         [0083]    In some embodiments, the stretched portions include at least one Bowman&#39;s capsule. 
         [0084]    In some embodiments, the stretched portions include at least one renal corpuscle. 
         [0085]    In some embodiments, the stretched portions include at least one loop of Henle. 
         [0086]    In some embodiments, the stretched portions include at least one collecting duct. 
         [0087]    In some embodiments, the stretching reduces pressure in at least one kidney filtration structure. 
         [0088]    In some embodiments, the reduction of pressure occurs in a renal structure from the group of renal structures comprising a Bowman&#39;s capsule, a renal corpuscle, a loop of Henle, a collecting duct, and a convoluted tube. 
         [0089]    In some embodiments the stretching leads to an increased glomerular filtration rate. 
         [0090]    In some embodiments, the stretching leads to an increased osmotic pressure. 
         [0091]    In some embodiments, the increased osmotic pressure occurs in at tissue from the group consisting of a loop of Henle, a renal corpuscle, a glomerulus, and a Bowman&#39;s capsule. 
         [0092]    In some embodiments, the organ comprises a liver. 
         [0093]    In some embodiments, the implanting causes increased blood flow through at least a portion of the liver. 
         [0094]    In some embodiments, the implanting improves at least one liver homeostatic function with respect to the group of homeostatic compounds consisting of glucose, proteins, fat, cholesterol, hormones, and vitamins. 
         [0095]    In some embodiments, the at least one liver homeostatic function, comprises homeostasis of a vitamin from the group consisting of vitamins A, D, E, and K. 
         [0096]    In some embodiments, the implanting causes improved liver synthesis of at least one compound from the group consisting of proteins, bile acids, and cholesterol. 
         [0097]    In some embodiments, the improved liver synthesis results in improved synthesis of at least one clotting factor. 
         [0098]    In some embodiments, the implanting improves liver storage of at least one compound from the group consisting of vitamins, and cholesterol. 
         [0099]    In some embodiments, the implanting improves liver excretion of at least one compound from the group consisting of cholesterol, bile acids, phospholipids, bilirubin, drugs, and poisons. 
         [0100]    In some embodiments, the implanting improves liver filtration of at least one compound from the group consisting of gut poisons, nutrients, sugar, fat, bilirubin, bile acids, and immunoglobulins. 
         [0101]    In some embodiments, the improved filtration of nutrients includes filtration of at least one amino acid. 
         [0102]    In some embodiments, the improved filtration of immunoglobulins includes filtration of at least IgA. 
         [0103]    In some embodiments, the implanting improves liver antigenic-based defense of the body by performing functions from the group consisting of excretion of at least one complex of IgA, and release of macrophages. 
         [0104]    In some embodiments, the improved excretion of at least one complex of IgA, improves body defense against pathologic gut bacteria. 
         [0105]    In some embodiments, the improved release of macrophages includes release of at least one Kupfer cell. 
         [0106]    In some embodiments, the organ comprises a stomach. 
         [0107]    In some embodiments, at least a portion of the portion of stomach tissue is selected from the group consisting of a fundus a body an antrum, and a pylorus. 
         [0108]    In some embodiments, the stretching affects at least one bariatric receptor. 
         [0109]    In some embodiments, the portion comprises a portion of bladder tissue. 
         [0110]    In some embodiments, the stretching at least partially stabilizes an instable detrusor muscle; and in some embodiments the stabilizing prevents spontaneous and uninhibited contraction of the detrusor muscle during filling of bladder  1200 . 
         [0111]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector comprise a material selected from the group consisting of nitinol, stainless steel shape memory materials, metals, and polymers. 
         [0112]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, comprise a material selected from the group consisting of nitinol, stainless steel shape memory materials, metals, and polymers. 
         [0113]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, include properties from the group consisting of ductile, extendible, extensible, flexible, plastic, resilient, rubbery, springy, tempered, flexile, and pliant. 
         [0114]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, comprise a material from the group of biocompatible materials consisting of a polymeric material, a synthetic biostable polymer, a natural polymer, and an inorganic material. 
         [0115]    In some embodiments, biostable polymer comprises a material from the group consisting of a polyolefin, a polyurethane, a fluorinated polyolefin, a chlorinated polyolefin, a polyamide, an acrylate polymer, an acrylamide polymer, a vinyl polymer, a polyacetal, a polycarbonate, a polyether, aromatic polyester, a polyester ketone, a polysulfone, a silicone rubber, thermoset polymer, and a polyester imide. 
         [0116]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, comprise properties selected from the group consisting of smooth, undulating, and elastic. 
         [0117]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, are selected from the group consisting of wires, ribbons, filaments, and cables. 
         [0118]    In some embodiments, at least a portion of the at least one connector is substantially flat, and has a shape selected from the group consisting of a pear shape, a fusiform shape, a discoid shape, a triangular shape, and an elongate polygon. 
         [0119]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, have a substantially circular cross section having a diameter of at least about 0.1 millimeters. Alternatively, the diameter is at least about 0.2, 0.3, or 0.4 millimeters. 
         [0120]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, have a substantially circular cross section having a diameter of no more than about 0.4 millimeters. Alternatively, the diameter is no more that about 0.1, 0.2, or 0.3 millimeters. 
         [0121]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector have a cross section having greater, and lesser measurements, and the greater measurement is at least about 0.1 millimeters. Alternatively, the measurement is at least about 0.2, 0.3, or 0.4 millimeters. 
         [0122]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector have a cross section having greater and lesser dimensions, and the greater dimension is no more than about 0.4 millimeters. Alternatively, the greater dimension is no more that about 0.1, 0.2, or 0.3 millimeters. 
         [0123]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector have a cross section having greater, and lesser dimensions, and the lesser dimension is at least about 0.1 millimeters. Alternatively, the lesser dimension is at least about 0.2, 0.3, or0.4 millimeters. 
         [0124]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, has a cross section having greater, and lesser cross sectional dimensions, and the lesser dimension is no more than about 0.4 millimeters. Alternatively, the lesser dimension is no more that about 0.1, 0.2, or 0.3 millimeters. 
         [0125]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, have a shape selected from the group consisting of substantially triangular, square, rectangular, round, hexagonal, and logarithmic. 
         [0126]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, have a length a length of at least about 2.5 centimeters. Alternatively, the length is at least about 3.0, 3.5, 4.0, or 4.5 centimeters. 
         [0127]    In some embodiments, at least a portion of the anchor, and/or at least a portion of the connector, have a length of no more than about 6.5 millimeters. Alternatively, the length is no more that about 6.0, 5.5, 5.0, or 4.5 millimeters. 
         [0128]    According to the teachings of the present invention, there is also provided a method for reducing pressure in a portion of kidney tissue. The method consists of, providing a pressure-reducing chamber, sealingly enclosing at least a portion of a kidney in the chamber, and reducing pressure in the chamber, thereby reducing tissue pressure in a portion of kidney tissue of the kidney. 
         [0129]    In some embodiments, implanting further comprises implanting the pressure-reducing chamber in vivo. 
         [0130]    In some embodiments, the at least one kidney portion includes at least one portion selected from the group consisting of a cortex, medulla, ureter, and pelvis. 
         [0131]    In some embodiments, the at least one kidney portion comprises a kidney substantially in its entirety. 
         [0132]    In some embodiments, at least a portion of the pressure-reducing chamber comprises a material from the group consisting of a polymeric material, a synthetic biostable polymer, a natural polymer, and an inorganic material. 
         [0133]    In some embodiments, the biostable polymer comprises a material from the group consisting of a polyolefin, a polyurethane, a fluorinated polyolefin, a chlorinated polyolefin, a polyamide, an acrylate polymer, an acrylamide polymer, a vinyl polymer, a polyacetal, a polycarbonate, a polyether, an aromatic polyester, a polyester ketone, a polysulfone, a silicone rubber, thermoset polymer, and a polyester imide. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0134]    The present invention providing methods, and devices for limiting gastric expansion so as to affect motility, volume, hunger sensation, and/or nutrient absorption are described by way of example with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example, and for purposes of illustrative discussion of the preferred method of the present invention only, and are presented in the cause of providing what is believed to be the most useful, and readily understood description of the principles, and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the methods of the invention may be embodied in practice. 
           [0135]      FIGS. 1-2  show side and aerial views of a helical spring anchor used in expanding a portion of an organ, in accordance with an embodiment of the present invention; 
           [0136]      FIGS. 3-4  show schematic representations of a kidney and a Bowman&#39;s capsule, under the influence of the anchor shown in  FIG. 1 , in accordance with an embodiment of the present invention; 
           [0137]      FIG. 5  shows a tool used for implanting the anchor of  FIG. 1 , in accordance with an embodiment of the present invention; 
           [0138]      FIGS. 6A-6F  show alternative embodiments of spring anchors, in accordance with the teachings of the present invention; 
           [0139]      FIG. 7  shows a kidney in cross section with a spring anchor implanted in the kidney pelvis, and sutures through the capsule and ribs as an offset, in accordance with an embodiment of the present invention; 
           [0140]      FIG. 8  shows embodiments of the spring anchor shown in  FIGS. 1-2  used in conjunction with connectors, in accordance with an embodiment of the present invention; 
           [0141]      FIGS. 9A-9E  show embodiments of connectors, in accordance with the teachings of the present invention; 
           [0142]      FIG. 10  shows a kidney in a vacuum box, in accordance with an embodiment of the present invention; 
           [0143]      FIGS. 11A-11C  show embodiments of tissue stretching devices deployed in stomachs, in cross section, in accordance with embodiments of the present invention; 
           [0144]      FIGS. 12A-12B  show embodiments of tissue stretching devices deployed in bladders, in cross section, in accordance with embodiments of the present invention; 
           [0145]      FIG. 13  shows an embodiment of a tissue-stretching device deployed on a liver, in accordance with an embodiment of the present invention; 
           [0146]      FIG. 14  shows a rat stomach interior having been fitted with gastric springs, in accordance with embodiments of the present invention; 
           [0147]      FIG. 15  shows another view of the stomach interior of  FIG. 14 , in accordance with embodiments of the present invention; 
           [0148]      FIG. 16  shows the bottom portion of a vacuum chamber inserted into a rat abdomen under the left kidney, in accordance with embodiments of the present invention; 
           [0149]      FIG. 17  the vacuum chamber of  FIG. 16  with a cover in place, in accordance with embodiments of the present invention; and 
           [0150]      FIG. 18  shows the apparatus of  FIG. 17  hooked to a gauge demonstrating a reduction in chamber pressure, in accordance with embodiments of the present invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0151]    In broad terms, the present invention relates to methods, and devices for expanding organ tissue so as to reduce interstitial hydrostatic pressure, thereby enhancing organ function. 
         [0152]    The principles, and uses of the teachings of the present invention may be better understood with reference to the accompanying description, Figures, and examples. In the Figures, like reference numerals refer to like parts throughout. 
         [0153]    Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth herein. The invention can be implemented with other embodiments, and can be practiced or carried out in various ways. It is also understood that the phraseology, and terminology employed herein is for descriptive purpose, and should not be regarded as limiting. 
         [0154]    Generally, the nomenclature used herein, and the laboratory procedures utilized in the present invention include techniques from the fields of biology, engineering, material sciences, medicine, and physics. Such techniques are thoroughly explained in the literature. 
         [0155]    Unless otherwise defined, all technical, and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. In addition, the descriptions, materials, methods, and examples are illustrative only, and not intended to be limiting. Methods, and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. 
         [0156]    As used herein, the terms “comprising”, and “including” or grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This term encompasses the terms “consisting of”, and “consisting essentially of”. 
         [0157]    The phrase “consisting essentially of” or grammatical variants thereof when used herein are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof but only if the additional features, integers, steps, components or groups thereof do not materially alter the basic, and novel characteristics of the claimed composition, device or method. 
         [0158]    As used herein, “a” or “an” mean “at least one” or “one or more”. The use of the phrase “one or more” herein does not alter this intended meaning of “a” or an 
         [0159]    The term “method” refers to manners, means, techniques, and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques, and procedures either known to, or readily developed from known manners, means, techniques, and procedures by practitioners of the chemical, pharmacological, biological, biochemical, and medical arts. Implementation of the methods of the present invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof. 
         [0160]      FIGS. 1 and 2  show side and aerial views respectively of a helical spring anchor  100  that is compressible by pressing a spring first end  101  toward a spring second end  102 . 
         [0161]    In  FIG. 3 , spring anchor  100  is shown implanted in a cortex  122  of a kidney. Spring  100  is compressed prior to implantation in cortex  122 . Upon introduction into cortex  122 , spring  100  is released so that ends  101  and  102  move away from each other, for example end  102  moving in a direction  152 , and end  101  moving in an opposite direction. The force applied by spring  100  causes a kidney capsule  132  to expand substantially radially outward in direction  152 . When placed in a portion of an organ, for example kidney tissue  188 , ( FIG. 3 ) stretch of tissue  188  causes a reduction in pressure that enhances function of an organ that will be described below and demonstrated in “Experimental Results”. 
         [0162]    Referring back to  FIGS. 1 and 2 , in embodiments, spring  100  is placed perpendicular, parallel or at any angle therebetween with respect to capsule  132 , thereby stretching a kidney tissue  188  and thereby improving organ function. In embodiments (not shown), multiple springs  100  are expanded in a kidney  120  at multiple locations, causing capsule  132  to expand radially outward, and stretching kidney tissue  188 , for example located in a kidney cortex  122 , a kidney medullar  124 , a kidney pelvis  128  (below) or, a kidney ureter  130 . 
         [0163]      FIG. 4  shows a typical nephron  180  having glomerular capillaries  182 , separated from a renal corpuscle  184  by a Bowman&#39;s space  186 . As spring  100  expands, ends  101  and  102  move away from each other so that a portion of tissue  188  adjacent to nephron  180  stretches. Stretched tissue  188  thereby expands corpuscle  184 , increasing the volume of, and reducing pressure within Bowman&#39;s space  186 . The reduced pressure in Bowman&#39;s space typically causes a higher filtration rate between capillaries  182  and corpuscle  184 . 
         [0164]    Additionally, it is postulated that the stretch in tissue  188  may cause reduction in interstitial pressure in loop of Henle  112 , a distal convoluted tube  194 , a proximal convoluted tube  196 , and/or a collecting duct  192 , thereby enhancing the filtration rate associated with each of these structures. 
         [0165]    The enhancement of Glomerular Filtration Rate (GFR) is governed by the formula as presented in the text  Physiology  by Berne and Levy: 
         [0000]        GFR=K   f [( P   GC   −P   BS )−(Π GC −Π BS )] 
         [0000]    Wherein the following nomenclature is used: 
         [0166]    i) Kf: the Ultra Filtration Constant 
         [0167]    ii) PGC: Hydrostatic Pressure of Glomerular Capillary 
         [0168]    iii) PBS: Hydrostatic Pressure of Bowman&#39;s Space 
         [0169]    iv) ΠGC: osmotic pressure of Glomerular Capillary 
         [0170]    v) ΠBS: osmotic pressure of Bowman&#39;s Space 
         [0000]        GFR=K   f [(44 [mmHg] −(12 [mmHg] ))−(−34 [mmHg] −0)] 
         [0171]    As noted in the equation above, a P BS  reduction by 10 [mmHg] causes a GFR elevation of 11%. 
         [0172]      FIG. 5 , shows a typical instrument  300  used for insertion of spring  100  into kidney  120 . Spring  100  is pushed into a passage  310 . A driver  380  is pushed along an axis  324  leading into passage  310 , and prongs  362  of driver  380  are placed around a spring abutment  104 . Driver  380  is rotated so that spring  100  follows a rifling  312 , and forms a compressed configuration  302  as spring  100  compresses against a portion of kidney  120 . As driver  380  is further rotated, spring  100  is driven into kidney in compressed configuration  302 , and, in the softer tissue of kidney  120  expands into an expanded configuration  304 , thereby stretching a portion of interstitial tissue of kidney  120  ( FIG. 3 ). 
         [0173]    Spring  100  ( FIG. 2 ) is but one of the many devices that can be used in stretching kidney tissue  188 .  FIG. 6A  shows a first magnet  620  and a second magnet  622  in which same polarities  610  and  612  are aligned and facing toward each other. A repulsive force  600  is thereby created, pushing first magnet  620  away from second magnet  622  so that when implanted in a portion of tissue  188 , tissue  188  is stretched. 
         [0174]      FIG. 6B  shows a leaf spring  630  that has been bent to bring an end  632  toward a second end  634 . Bent spring  630  is implanted in tissue  188  and released as seen in  FIG. 6C . As spring  630  straightens, ends  632  and  634  stretch tissue  188 . 
         [0175]    In an alternative embodiment for stretching tissue  188 ,  FIG. 6D  shows a rigid anchor  650  having a first end  652 , and a second end  654 . Initially, tissue  188  is stretched, after which rigid anchor  650  is implanted in tissue  188  to maintain tissue  188  in the stretched state. 
         [0176]      FIG. 6E  shows an offset frame  660  that is substantially rigid, having first end  652 , and second end  654  projecting from either side of an offset bow  680 . A tensioned spring  662  spans from bow  680  to tissue  188 , and pulls capsule  132  in a direction  602 , thereby stretching tissue  188 . Using offset bow  680 , any biocompatible elastomeric band or device is optionally used in place of tensioned spring  662 , as is easily understood by those familiar with the art. 
         [0177]      FIG. 6F  shows a leaf spring  670  bent at right angle with arms  672  and  674  implanted into tissue  188 , just below kidney capsule  132 . As spring  670  is released, arms  672  and  674  stretch capsule  132  in directions  600 , thereby stretching tissue  188 . 
         [0178]    In an alternative embodiment, arms  672 , and  674  are attached to capsule  132  using biological glue, for example carboxymethyl cellulose. 
         [0179]      FIG. 7  shows a coiled spring  702  that has been expanded inside kidney pelvis  128 . It is postulated that such expansion will also favorably affect hydrostatic pressure within corpuscle  184  ( FIG. 4 ). 
         [0180]    In an alternative embodiment, a first suture loop  710 , and a second suture loop  720  have been attached to kidney capsule  132  with proximal loops  712 , and  722  respectively. Distal loops  714  and  724  have been anchored to a rib  704  that acts as an offset. The generated tension pulls kidney  120  in directions  600 , thereby stretching tissue  188 . While rib  704  is depicted as being used as an offset, in embodiments other body organs and/or tissue are used as an offset, for example parts of the vertebral column. 
         [0181]    Additionally, alternatives to anchor loops  710 , and  712  may be contemplated, as will be easily appreciated by those familiar with the art, including, inter alia: Different spring shapes ( FIGS. 6A-6F ), or varying materials to influence resilience. 
         [0182]      FIG. 8  shows spring anchors  100  implanted in kidney  120 , and connected to a series of connectors  810  that have been assembled into a grid  800 . In an exemplary embodiment, grid  800  is contoured to the shape of the adjacent tissue of kidney  120  so that springs  100  pull kidney capsule radially outward in direction  150 ,  152 , and/or  154 , depending upon placement. 
         [0183]    While connector grid  800  is shown as having square spaces  840  between connectors  810 , a variety of configurations are possible. For example, grid  800  may comprise triangle shaped spaces or even comprise a substantially rigid mesh or net. 
         [0184]    While connector grid  800  is shown as a single unit, in embodiments grid  800  comprises multiple separate connectors  810  that are joined to form grid  800 , separate connectors  810  joined, for example, at anchors  100 . Alternatively, separate multiple connectors  810  are fashioned into a variety of configurations, for example two connectors  810  forming linear or non linear patterns; and multiple connectors forming open or closed polygonal shapes. 
         [0185]      FIGS. 9A-9E  demonstrate embodiments of connectors  810  that can be used in forming grid  800  either as a single unit or made up of multiple units. Connector  910  is optionally configured with any one of a variety of shapes, including: an undulate shape connector  910 , a zigzag shaped connector  920 , a small looped connector  930 , and a large looped connector  940 . 
         [0186]      FIG. 10  is a vacuum box  1000 , having a top  1010 , and a bottom  1020  enclosing kidney  120  and allowing kidney ureter  130  to pass out of vacuum box  1000 . In an exemplary embodiment, and as described in “Experimental Results”, below, pressure in box  1000  is reduced below atmospheric pressure by withdrawing air via a vacuum passage  1040 . Reduction of pressure in box  1000  causes expansion of kidney capsule  132 , thereby stretching kidney  120  in directions  150 ,  152 , and/or  154 . Additionally, because box totally surrounds kidney  120 , expansion in directions  1002 ,  1004 , and  1006  occur, so that expansion of kidney  120  is in three dimensions. 
         [0187]    While vacuum box  1000  is shown totally surrounding kidney  120 , there are many configurations in which box  1000  optionally affects a smaller portion of kidney  120  and, for example, seals against kidney capsule  132 , thereby providing reduced pressure to tissue associated with the portion of kidney  120 . 
         [0188]      FIGS. 11A-11B  show stomachs  1100  in cross section with springs  100  that are placed in a gastric wall  1102  in the compressed state. When springs  100  are allowed to expand, in a gastric wall  1102 , as demonstrated in “Experimental Results”, below, gastric wall  1102  stretches thereby affecting intraganglionic laminar endings (IGLEs)  1154  noted above. 
         [0189]    By stretching IGLEs  1154 , it is postulated that the recipient of springs  100  will feel satiated even though a full meal has not been ingested. 
         [0190]    In  FIG. 11A , springs  100  are placed parallel to gastric wall  1102 , and in  FIG. 11B , springs  100  are placed perpendicular to gastric wall  1102 , both configurations and all angles therebetween being postulated to affect IGLEs  1154  in the above-noted manner. 
         [0191]    The present invention contemplates application of springs  100  to a variety of gastric-related tissue  1102 . For example, springs  100  are optionally implanted in tissue having high density IGLEs  1154 , for example in an esophagus  1126 , a fundus  1172 , an antrum  1170 , a gastric body  1174 , and/or a pylorus  1176 . 
         [0192]    Alternatively, springs  100  may be used to stretch tissue intramuscular arrays (IMAs)  1168  that are known to be more numerous in an esophageal sphincter  1128 , and a pyloric sphincter  1178 . 
         [0193]      FIG. 11C  shows a mesh spring  1140  that has been expanded inside stomach  1100  to stretch stomach wall  1102  thereby affecting receptors including IGLEs  1154 , and IMAs  1168 . 
         [0194]    As with springs  100 , the position of mesh  1140  may be throughout all gastric tissue  1102  or placed in individual areas of gastric tissue  1102 , for example in esophagus  1126 , fundus  1172 , antrum  1170 , gastric body  1174 , and/or pylorus  1176 . 
         [0195]    The exact mechanisms of providing satiety and fullness sensations to an obese individual are not fully known to the bariatric community. It is believed that restricting volume of stomach  1100  causes receptors  1154  and  1168  to register satiation, and/or fullness, thereby favorably influencing diet, and aiding in weight loss. Any reference to receptors  1154 , and  1168  a priori refers to any gastric receptors presently identified, and those that will be identified, for example by bariatric researchers, in the future. 
         [0196]    Additionally, the methods, and/or configuration of material applied to stomach  1100 , for example size, and/or placement of springs  100 , and/or connectors  810  ( FIG. 8 ), a priori include any modifications that are discovered to be efficacious or become known in the future. 
         [0197]    As used herein gastric tissue  1102  refers to any portion of gastric-related tissue  1102  that is part of, or near, stomach  1100 , for example, inter alia, esophagus  1126 , fundus  1172 , antrum  1170 , body  1174 , pylorus  1176 , pyloric sphincter  1178 , and/or an intestine  1198 . 
         [0198]      FIG. 12A  shows a bladder  1200  fitted with a grid  1280  that comprises an embodiment of tissue stretching grid  800  shown in  FIG. 8 . Optionally, grid  1280  is attached to bladder  1200  using a suitable pharmaceutically acceptable adhesive, for example carboxymethyl cellulose, thereby aiding in controlling function of bladder  1200 , as explained below. 
         [0199]      FIG. 12B  shows bladder  1200  fitted with a mesh spring  1240  that comprises an embodiment of mesh spring  1140  shown in  FIG. 11C . 
         [0200]    It is postulated that embodiments of grid  1280 , and mesh spring  1240  will have particular use in treating instability of a detrusor muscle  1292  by preventing spontaneous and uninhibited contraction of detrusor muscle  1292  during filling of bladder  1200 . 
         [0201]      FIG. 13  shows a liver  1300  fitted with tissue stretching device  1280  that is optionally attached to liver  1300  using a suitable pharmaceutically acceptable adhesive. It is postulated that by stretching liver  1300  in at least one of directions  150 ,  152 ,  154 ,  1002 ,  1004 , and  1006 , the resultant increased liver volume will result in greater blood flow volume through a hepatic blood vessel  1320 . It is postulated that the increased blood flow will help alleviate ascites, and foster better liver function. 
         [0202]    The better liver function optionally is evident through improvement of at least one liver function, including, inter alia: 
         [0203]    Increasing homeostatic compounds consisting of glucose, proteins, fat, cholesterol, hormones, and vitamins; Increasing homeostasis of a vitamin from the group consisting of: vitamins A, D, E, and K; Improving liver synthesis of at least one compound from the group consisting of: proteins, bile acids, cholesterol and at least one clotting factor; Improving liver storage of at least one compound from the group consisting of: vitamins, and cholesterol; Improving liver excretion of at least one compound from the group consisting of: cholesterol, bile acids, phospholipids, bilirubin, drugs, and poisons; Improving liver filtration of at least one compound from the group consisting of: gut poisons, nutrients, sugar, fat, bilirubin, bile acids, and immunoglobulins; Improving filtration of nutrients includes filtration of at least one compound from the group consisting of: amino acids, immunoglobulins including IgA; Improving antigenic-based defense of the body by improving functions from the group consisting of: excretion of at least one complex of IgA, and release of macrophages. 
       EXPERIMENTAL RESULTS 
     Example 1  
     Effects of Kidney Spring Implantation 
       [0204]    To investigate the effects of implantation of kidney springs such as kidney springs  100  of the present invention ( FIG. 1 ) on various indicators of kidney function, the following implantation and examination procedures were performed. 
       Kidney Spring Implantation Procedure 
       [0205]    A Sprague-Dawley (SD) rat, weighing about 250 grams, was anesthetized. A laparotomy was performed and the left kidney was exposed. 
         [0206]    A length of surgical grade nitinol wire having a diameter of 0.25 millimeter was coiled to make helical springs, each spring having a helical diameter of 3 millimeter, a length of about 4 millimeters and 4 turns. 
         [0207]    Two such helical springs were screwed into the rat left kidney using a specially designed screwdriver and delivery device, as seen in  FIG. 5 , and as described above. The right rat kidney served as a control. The laparotomies were closed and the rat was revived. 
       Kidney Examination Procedure at Ten Days 
       [0208]    Ten days after spring implantation, the rat was subjected to a second laparotomy procedure to allow macroscopic visualization of hepatic integrity and to check for the presence of bleeding that would indicate trauma caused by the springs. 
         [0209]    Additionally, inulin and saline were infused for the purpose of establishing Glomerular Filtration Rate (GFR). Inulin is an inert polysaccharide, polyfructosan, [C 6 H 10 O 5 ] which readily passes through the glomeruli into the urine without being reabsorbed by the renal tubules. Inulin clearance is an excellent indicator of GFR. 
         [0210]    The inulin clearance test was performed by injecting inulin into the bloodstream, waiting for it to be distributed, and then measuring plasma inulin and urine inulin concentrations. 
         [0211]    To collect urine samples from each kidney independently, the left kidney ureter was incised from its attachment to the urinary bladder and urine was collected through a catheter attached through the left ureter. The right kidney ureter remained intact and urine was collected through a catheter attached to the urinary bladder. 
         [0212]    Urine samples were taken at 30-minute intervals following inulin injection, over a period of 2 hours, from the left ureter (U1, U2, U3 and U4) and from the urinary bladder (U1N, U2N, U3N and U4N). Inulin levels (Inulin OD), of each sample were measured. Also measured was the volume of urine (VU) in □1. 
         [0213]    Based on the urine measurements, urine flow rate [ml/min] (Vf); urine inulin concentration in mg/100 ml (UIn); and inulin amount in milligrams (UIn*dil) were calculated. 
         [0214]    Urine analysis results are presented in Tables 1 and 2 below. 
         [0215]    Samples of blood were removed from the Jugular vein at intervals of 30 minutes over a period of 90 minutes (B1, B2, and B3) and tested for sodium (Na) and potassium (K) concentrations, in mEq/L, in order to establish that the rat did not undergo dehydration. Inulin levels (Inulin OD) were measured and the plasma inulin concentration (PIn), in mg/100 ml, and plasma inulin amount in milligrams (PIn*dil) were calculated. 
         [0216]    Blood test results are presented in Table 3 below. 
         [0217]    GFR was calculated according to the formula: 
         [0000]        GFR =[( UIn*dil )× Vf ]/( PIn*dil ). 
       Results 
       [0218]    The kidneys appeared normal macroscopically and all springs were in place. 
         [0219]    There was no evidence of blood during macroscopic examination of the kidneys. The urinary bladder was lucent and without blood. 
         [0220]    As shown in Table 1 and Table 2, the implanted kidney displayed an increase in GFR of approximately 15% over the control kidney. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 Left (implanted) Rat Kidney Function 
               
             
          
           
               
                   
                   
                 Time 
                   
                 Inulin 
                   
                   
                   
               
               
                   
                 VU 
                 min 
                 Vf 
                 OD 
                 UIn 
                 UIn*dil 
                 GFR 
               
               
                   
                   
               
             
          
           
               
                 U1 
                 0.23 
                 30 
                 0.0077 
                 564 
                 263.7609 
                 10550.437 
                 2.7242 
               
               
                 U2 
                 0.236 
                 30 
                 0.0079 
                 574 
                 268.4375 
                 10737.502 
                 2.5337 
               
               
                 U3 
                 0.232 
                 30 
                 0.0077 
                 450 
                 210.4476 
                 8417.902 
                 2.3274 
               
               
                 U4 
                 0.25 
                 30 
                 0.0083 
                 438 
                 204.8356 
                 8193.425 
                 2.3175 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                 Right (control) Rat Kidney Function 
               
             
          
           
               
                   
                   
                 Time 
                   
                 Inulin 
                   
                   
                   
               
               
                   
                 VU 
                 min 
                 Vf 
                 OD 
                 UIn 
                 UIn*dil 
                 GFR 
               
               
                   
                   
               
             
          
           
               
                 U1N 
                 0.28 
                 30 
                 0.0093 
                 613 
                 286.6763 
                 11467.053 
                 2.1964 
               
               
                 U2N 
                 0.293 
                 30 
                 0.0098 
                 548 
                 256.2784 
                 10251.134 
                 2.3389 
               
               
                 U3N 
                 0.286 
                 30 
                 0.0095 
                 444 
                 207.6416 
                 8305.663 
                 2.0156 
               
               
                 U0N 
                 0.318 
                 30 
                 0.0106 
                 458 
                 214.1888 
                 8567.554 
                 2.0493 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                 Blood sample analysis 
               
             
          
           
               
                   
                   
                   
                 Inulin 
                   
                   
               
               
                   
                 Na 
                 K 
                 OD 
                 BIn 
                 BIn*dil 
               
               
                   
                   
               
             
          
           
               
                   
                 B1 
                 144.5 
                 3.21 
                 77 
                 36.01 
                 36.010 
               
               
                   
                 B2 
                 145.7 
                 3.4 
                 84 
                 39.284 
                 39.284 
               
               
                   
                 B3 
                 146.2 
                 3.49 
                 84 
                 39.284 
                 39.284 
               
               
                   
                   
               
             
          
         
       
     
       Example 2  
     Effects of Stomach Springs Implantation 
       [0221]    To study the effects of implantation of kidney springs such as kidney springs  100  of the present invention ( FIG. 1 ), the following Implantation and Examination procedures were performed: 
       Stomach Spring Implantation Procedure 
       [0222]    Four Sprague-Dawley (SD) rats, each weighing about 250 grams, were anesthetized using using ketamin/xylasine. 
         [0223]    A laparotomy was performed on each rat, exposing the stomach. 
         [0224]    Five helical spiral springs of surgical grade nitinol, as described in detail in Example 1, were screwed to the anterior aspect of each stomach body. 
         [0225]    Two rats (rats 3 and 4) had the springs immediately removed and were observed for bleeding. All rats were then surgically closed. 
         [0226]    Two months later one rat (rat 2) was sacrificed and springs were examined macroscopically for corrosion. 
       Results 
       [0227]    No significant bleeding or significant damage occurred in rats 3 and 4 following immediate removal of the springs. 
         [0228]    There was no macroscopic evidence of corrosion present on the springs from rat 2 at two months. Additionally, there was no evidence of bleeding in rat 2. 
         [0229]    It should be noted that since all rats survived throughout the experiment, it is believed no rat experienced significant bleeding. 
         [0230]      FIGS. 14-15  show inside aspects of the stomach of one rat (rat 2), two months after having been fitted with gastric springs, and showing appropriate organ integrity. 
       Example 3  
     Establishing Kidney Vacuum Chamber Efficacy 
       [0231]    To evaluate the feasibility of enclosing a kidney in a chamber and subjecting the kidney to a partial vacuum, the following Implantation and Examination procedures were performed: 
       Vaccum Chamber Procedure 
       [0232]    One SD rat, weighing 453 grams, was anesthetized using ketamin/xylasine. 
         [0233]    A laparotomy was preformed on the rat, exposing the left kidney. 
         [0234]    As seen in  FIG. 16 , a bottom portion of a vacuum chamber was inserted into the rat abdomen under the left kidney. The vacuum chamber was then closed by addition of an upper portion. 
         [0235]      FIG. 17  shows the left kidney inside the closed vacuum chamber of  FIG. 16 , following which the chamber was sealed with silicone. The right kidney served as a control. 
         [0236]    A vacuum pump was attached to the chamber and, as seen in  FIG. 18 , the reduction in pressure within the chamber was measured. 
       Kidney Examination Procedure 
       [0237]    To determine the efficacy of the vacuum in improving kidney function, the vacuum is maintained in the chamber to continue reduced pressure forces on the kidney. 
         [0238]    Following a period of time, for example two hours, the rat is opened to allow macroscopic visualization of hepatic integrity. 
         [0239]    In order to assess kidney function, inulin is injected for the purpose of establishing GFR. Urine samples are collected from each kidney independently, by incising the left kidney ureter from its attachment to the urinary bladder and collecting urine through a catheter attached through the left ureter. The right kidney ureter remains intact and urine is collected through a catheter attached to the urinary bladder. 
         [0240]    Urine samples are taken at 30-minute intervals following inulin injection, over a period of 2 hours, from the left ureter and from the urinary bladder. Inulin levels of each sample and volume of urine are measured. Based on the urine measurements, urine flow rate; urine inulin concentration; and inulin amount in milligrams are calculated. 
         [0241]    Samples of blood are removed from the Jugular vein at intervals of 30 minutes over a period of 90 minutes and tested for sodium and potassium concentrations, in order to establish that the rat does not undergo dehydration. Inulin levels are measured and the plasma inulin concentration and plasma amount are calculated. GFR is calculated as described hereinabove. 
         [0242]    It is expected that during the life of this patent many relevant delivery systems will be developed, and the scope of the various embodiments of the invention, and the various methods of implementation are intended to include all such new technologies a priori. 
         [0243]    It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. 
         [0244]    Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit, and broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are herein incorporated in their entirety by reference to the specification, to the same extent as if each individual publication, patent or patent application was specifically, and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.