ureteral catheter and system to induce negative pressure in a portion of a patient's urinary tra

专利摘要:
a ureteral catheter for placement in a kidney, renal pelvis and / or a ureter adjacent to a patient's renal pelvis including: an elongated tube with a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube that defines at least one drainage lumen that extends through the tube; and an expandable retention portion configured to transition from a retracted to an implanted position and which, in the implanted position, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through at least the distal end of the tube.
公开号:BR112019022400A2
申请号:R112019022400
申请日:2018-01-25
公开日:2020-05-19
发明作者:E Orr David；L Upperco Jacob；R Erbey Ii John
申请人:Strataca Systems Ltd；
IPC主号:

专利说明:

URETERAL CATHETER, METHOD FOR FACILITATING URINARY DEBIT FROM A PATIENT'S KIDNEY AND SYSTEM FOR INDUCING NEGATIVE PRESSURE IN A PORTION OF A HISTORICAL PATIENT'S URINARY TRACT Technical Domain
[0001] The present disclosure relates to methods and devices to treat impaired renal function in various disease states and, specifically, devices, sets and methods of catheters for collecting urine and / or inducing negative pressure in the kidneys, in the renal pelvis of the kidneys, ureters and / or bladder.
Historic
[0002] The renal or urinary system includes a pair of kidneys, each kidney being connected by a ureter to the bladder, and an urethra to drain the urine produced by the kidneys from the bladder. The kidneys perform several vital functions for the human body, including, for example, filtering the blood to eliminate waste in the form of urine. The kidneys also regulate electrolytes (eg, sodium, potassium and calcium) and metabolites, blood volume, blood pressure, blood pH, fluid volume, red blood cell production and bone metabolism. A proper understanding of the anatomy and physiology of the kidneys is useful to understand the impact that altered hemodynamics and other conditions of excessive fluid flow have on its functioning.
[0003] In normal anatomy, both kidneys are located retroperitoneally in the abdominal cavity. The kidneys are encapsulated organs shaped like beans. Urine is formed by nephrons, the functional unit of the kidney, and then flows through a system of converging tubules called ducts
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2/103 collectors. The collecting ducts come together to form smaller chalices, and then larger chalices, which finally join near the concave portion of the kidney (renal pelvis). An important function of the renal pelvis is to direct the flow of urine into the ureter. Urine flows from the renal pelvis to the ureter, a tubular structure that carries urine from the kidneys to the bladder. The outer layer of the kidney is called the cortex and is a rigid fibrous encapsulation. The inner part of the kidney is called the medulla. The marrow structures are organized in pyramids.
[0004] Each kidney consists of approximately one million nephrons. Each nephron includes the glomerulus, Bowman's capsule and tubules. The tubules include the proximal contorted tubule, the Henle loop, the distal contorted tubule and the collecting duct. The nephrons contained in the cortex layer of the kidney are distinct in terms of anatomy from those contained in the medulla. The main difference is the length of the Henle handle. Medullary nephrons contain a longer Henle loop, which, under normal circumstances, allows for greater regulation of water and sodium reabsorption than in the cortex nephrons.
[0005] The glomerulus is the beginning of the nephron and is responsible for the initial blood filtration. Afferent arterioles pass blood to the glomerular capillaries, where hydrostatic pressure pushes water and solutes to the Bowman's capsule. The net filtration pressure is expressed as the hydrostatic pressure in the afferent arteriole minus the hydrostatic pressure in Bowman's space minus the osmotic pressure in the efferent arteriole.
Net Filtration Pressure = Hydrostatic Pressure
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3/103 (Afferent Arterioles) - Hydrostatic Pressure (Bowman Space) - Osmotic Pressure (Efferent Arterioles) (Equation 1) [0006] The magnitude of this net filtration pressure defined by Equation 1 determines how much ultrafiltrate is formed in the Bowman and taken to the tubules. The remaining blood leaves the glomerulus through the efferent arteriole. Normal glomerular filtration, or transport of ultrafiltrate to the tubules, occurs at about 90 ml / min / 1.73m ² .
[0007] The glomerulus has a three-layer filtration structure, which includes the vascular endothelium, a glomerular basement membrane and podocytes. Usually, large proteins, such as albumin and red blood cells, are not filtered in Bowman's space. However, high glomerular pressures and mesangial expansion create changes in the surface area of the basement membrane and greater fenestrations between podocytes, allowing larger proteins to pass into Bowman's space.
[0008] The ultrafiltrate collected in Bowman's space is taken first to the contorted proximal tubule. The reabsorption and secretion of water and solutes in the tubules are carried out by a mixture of active transport channels and passive pressure gradients. Proximal contorted tubules normally reabsorb most of the sodium chloride and water, and almost all of the glucose and amino acids filtered by the glomerulus. The Henle handle has two components that are designed to concentrate waste in the urine. The descending member is highly permeable to water and reabsorbes most of the remaining water. The rising limb reabsorbs 25% of the remaining sodium chloride, creating a concentrated urine, for example, in terms of urea and creatinine. The distal contorted tubule
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4/103 normally absorbs a small proportion of sodium chloride, and the osmotic gradient creates conditions for the water to flow.
[0009] Under normal conditions, there is a liquid filtration of approximately 14 mmHg. The impact of venous congestion can be a significant reduction in liquid filtration, reaching approximately 4 mmHg. See Jessup M., The cardiorenal syndrome: Do we need a change of strategy or a change of tactics , JACC 53 (7): 597-600, 2009 (hereinafter referred to as Jessup). The second stage of filtration occurs in the proximal tubules. Most of the urine secretion and absorption occurs in tubules in the medullary nephrons. The active transport of sodium from the tubule to the interstitial space initiates this process. However, hydrostatic forces dominate the net exchange of solutes and water. Under normal circumstances, 75% of sodium is believed to be reabsorbed back into the lymphatic or venous circulation. However, as the kidney is encapsulated, it is sensitive to changes in hydrostatic pressures caused by venous and lymphatic congestion. During venous congestion, sodium and water retention can exceed 85%, further perpetuating renal congestion. See Verbrugge et al., The kidney in congestive heart failure: Are natriuresis, sodium, and diruetucs really the good, the bad and the ugly European Journal of Heart Failure 2014: 16.13342 (hereinafter referred to as Verbrugge).
[0010] Venous congestion can lead to a pre-renal form of acute kidney injury (AKI). Pre-renal AKI is due to a loss of perfusion (or loss of blood flow) through the kidney. Many doctors focus on the lack of flow to the kidney due to shocks. However, there is also evidence that
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5/103 the lack of blood flow out of the organ due to venous congestion can be a prolonged and clinically relevant injury. See Damman K, Importance of venous congestion for worsening renal function in advanced decompensated heart failure, JACC 17: 589-96, 2009 (hereinafter referred to as Damman).
[0011] Prerenal AKI occurs in a wide variety of diagnoses that require hospitalization for intensive treatment. The most prominent hospitalizations are for sepsis and decompensated acute heart failure (ICAD). Additional hospitalizations are performed in cases of cardiovascular surgery, general surgery, cirrhosis, trauma, burns and pancreatitis. Although there is great clinical variability in the presentation of these disease states, a common denominator is high central venous pressure. In the case of ICAD, the elevated central venous pressure caused by heart failure leads to pulmonary edema and, subsequently, dyspnea, in turn, precipitating hospitalization. In the case of sepsis, elevated central venous pressure results largely from aggressive fluid resuscitation. Whether the primary insult was low perfusion due to hypovolemia or sodium and fluid retention, the injury suffered is venous congestion, resulting in inadequate perfusion.
[0012] Hypertension is another widely recognized condition that creates disorders in the active and passive transport systems of the kidneys. Hypertension directly affects the pressure of the afferent arterioles and results in a proportional increase in the net filtration pressure within the glomerulus. The increase in the filtration fraction also increases the peritubular capillary pressure, which stimulates the reabsorption of sodium and water.
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6/103
See Verbrugge.
[0013] As the kidney is an encapsulated organ, it is sensitive to changes in pressure in the medullary pyramids. High renal venous pressure creates congestion, which leads to increased interstitial pressures. The high interstitial pressures exert forces on the glomerulus and tubules. See Verbrugge. In the glomerulus, the high interstitial pressures are directly opposed to filtration. The high pressures increase the interstitial fluid, thus increasing the hydrostatic pressures in the interstitial fluid and in the peritubular capillaries in the kidney medulla. In both cases, hypoxia can occur, which leads to cell damage and additional loss of perfusion. The net result is an additional exacerbation of the reabsorption of sodium and water, creating negative feedback. See Verbrugge, 133-42. Fluid overload, particularly in the abdominal cavity, is associated with many diseases and health conditions, including high intra-abdominal pressure, abdominal compartment syndrome and acute renal failure. Fluid overload can be treated through renal replacement therapy. See Peters, CD, Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartanon Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study), PLoS ONE (2015) 10 (6) : e0126882. doi: 10.1371 / journal.pone .0126882 (hereinafter referred to as Peters). However, such a clinical strategy does not allow any improvement in renal function for patients with cardiorenal syndrome. See Bart B, Ultrafiltration in decompensated heart failure with cardiorenal syndrome, NEJM 2012; 367: 2296-2304 (hereinafter
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7/103 referred to as Bart).
[0014] In view of such problematic effects of fluid retention, devices and methods are needed to improve the removal of urine from the urinary tract and, specifically, to increase the quantity and quality of urine output from the kidneys.
SUMMARY
[0015] In some embodiments, a ureteral catheter for placement in a kidney, renal pelvis and / or a ureter adjacent to a patient's renal pelvis is provided and comprises: an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retention portion configured to transition from a retracted to an implanted position and which, in the implanted position, defines a three-dimensional shape positioned to maintain fluid flow from the kidney at least through the distal end of the tube.
[0016] In some embodiments, a method is provided to facilitate urinary output from a patient's kidney, comprising: (a) inserting a ureteral catheter in at least one of the kidneys, renal pelvis or in the adjacent ureter to the renal pelvis, where the catheter comprises: an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion
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8/103 configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through at least the distal end of the tube; (b) implanting the expandable retention portion in the patient's kidney, renal pelvis or ureter adjacent to the renal pelvis to maintain the distal end of the tube in the desired position in the kidney, renal pelvis or ureter adjacent to the patient's renal pelvis; and (c) applying negative pressure to the drainage lumen of the tube through a proximal part of the tube for a period of time to facilitate the production of urine from the kidney.
[0017] In some embodiments, a ureteral catheter is placed on a kidney, renal pelvis and / or a ureter adjacent to a patient's renal pelvis, comprising: an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retention portion configured to transition from a retracted to an implanted position and which, in the implanted position, is configured to maintain the distal end of the tube in the kidney, renal pelvis and / or ureter adjacent to the renal pelvis of the patient and to maintain fluid flow from the kidney through at least the distal end of the tube, the expandable retaining portion comprising at least one flexible member comprising: a first end positioned within a cylindrical space defined by a surface outer side of the elongated tube and extending distally from the distal end of the tube along
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9/103 of a central axis of the expandable retaining portion; and a more distal part in relation to the distal end of the elongated tube, which extends radially outwardly from the cylindrical space.
[0018] In some embodiments, a system is provided to induce negative pressure in a portion of a patient's urinary tract, with the system comprising: at least one ureteral catheter comprising: an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through at least the distal end of the tube; and a pump in fluid communication with the drainage lumen, with the pump being configured to induce negative pressure in a portion of the patient's urinary tract to aspirate liquids through the drainage lumen of the ureteral catheter.
[0019] Some non-limiting embodiments of the present invention will now be described in the following numbered clauses:
[0020] Clause 1: Ureteral catheter for placement in a kidney, renal pelvis and / or a ureter adjacent to a patient's renal pelvis, comprising: an elongated tube comprising a proximal end, a distal end and an extending side wall between the proximal end and the distal end of the tube that defines at least one lumen of
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10/103 drainage that extends through the pipe; and an expandable retaining portion configured to transition from a retracted to an implanted position and which, in the implanted position, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through at least the distal end of the tube.
[0021] Clause 2: The ureteral catheter of clause 1, in which, when implanted, the three-dimensional shape is positioned to maintain the permeability of the liquid flow between the kidney and the proximal end of the tube, so that at least part of the liquid flow flows through the expandable retaining portion.
[0022] Clause 3: The ureteral catheter of clauses 1 or 2, in which, when implanted, the expandable retention portion is configured to prevent the mucous or uroendothelium tissue of the ureter or renal pelvis from occluding at least a section of the portion expandable retainer or distal end of the tube.
[0023] Clause 4: The ureteral catheter of any one of clauses 1-3, in which, when implanted, the expandable part maintains the permeability of the distal end of the tube in at least one of the kidneys, renal pelvis or in a ureter adjacent to the renal pelvis of a patient.
[0024] Clause 5: The ureteral catheter of any one of clauses 1-4, in which an area of two-dimensional sections of the three-dimensional shape defined by the expandable retention portion implanted in a plane transverse to the central axis of the expandable retention portion increases in direction to a distal end of the expandable retaining portion.
[0025] Clause 6: The ureteral catheter of clause 5, in
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11/103 that an area of a two-dimensional section more distal from the three-dimensional shape is larger than a cross-sectional area of the distal end of the tube.
[0026] Clause 7: The ureteral catheter of any one of clauses 1-6, in which the elongated tube has an external diameter between about 0.33 mm and about 3.0 mm.
[0027] Clause 8: The ureteral catheter of any one of clauses 1-7, in which the elongated tube has an internal diameter between about 0.16 mm and about 2.40 mm.
[0028] Clause 9: The ureteral catheter of any one of clauses 1-8, in which a maximum transverse area of the three-dimensional shape defined by the expandable retention portion implanted in a plane transverse to a central axis of the expandable retention portion has about 350 mm ² .
[0029] Clause 10: The ureteral catheter of any one of clauses 1-9, in which the maximum transverse area of the three-dimensional shape defined by the expandable retention portion implanted in a plane transversal to the central axis of the expandable retention portion has between about 10 mm ² and about 350 mm ² .
[0030] Clause 11: The ureteral catheter of any one of clauses 1-10, wherein an axial length of the expandable part of an end proximal to a distal end is about 5 mm to about 100 mm.
[0031] Clause 12: The ureteral catheter of any one of clauses 1-11, in which the central axis of the expandable retention portion is collinear with a central axis of the tube.
[0032] Clause 13: The ureteral catheter of any one of clauses 1-12, in which the distal end of the tube is at least partially closed by the defined three-dimensional shape
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12/103 by the expandable retaining portion.
[0033] Clause 14: The ureteral catheter of any one of clauses 1-13, wherein the expandable retaining portion comprises at least two elongated members extending from the distal end of the tube.
[0034] Clause 15: The ureteral catheter of clause 14, in which at least one of the elongated members is deflected to form a structure sufficient to maintain a position and volume of the three-dimensional shape defined by the implantable expandable part.
[0035] Clause 16: The ureteral catheter of clause 14, in which at least one elongated member is deflected to form a sufficient structure to maintain the position and volume of the three-dimensional shape defined by the implantable expandable part when negative pressure is exposed to the ureter and / or kidney.
[0036] Clause 17: The ureteral catheter of any one of clauses 1-16, wherein the expandable retaining portion comprises a flexible material deviated to an implanted position.
[0037] Clause 18: The ureteral catheter of clause 17, in which the flexible material comprises a material with shape memory.
[0038] Clause 19: The ureteral catheter of clauses 17 or 18, in which the flexible material comprises one or more between nitinol, titanium, chromium, silicone, polyethylene, polyethylene terephthalate, polyurethane and polyvinyl chloride.
[0039] Clause 20: The ureteral catheter of any one of clauses 1-19, in which the expandable retaining portion is attached to a portion of an internal surface and / or a
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13/103 outer surface of the tube.
[0040] Clause 21: The ureteral catheter of any one of clauses 1-20, wherein the expandable retaining portion comprises at least two elongated members connected to a central portion, which extends through at least a portion of at least one drain lumen defined by the tube.
[0041] Clause 22: The ureteral catheter of any one of clauses 1-21, wherein the expandable retaining portion comprises at least one elongated member comprising a first end and a second end, each of which is at least partially enclosed within the drainage lumen defined by the tube and a middle protruding part of the distal end of the tube.
[0042] Clause 23: The ureteral catheter of any one of clauses 1-22, wherein the expandable retaining portion comprises at least one elongated member comprising at least a first curve in a first direction and a second curve in a second direction, where the second direction is not coplanar with the first direction.
[0043] Clause 24: The ureteral catheter of any of clauses 1-13 and 17-20, in which the expandable retaining portion comprises an elongated central member that extends from the distal end of the tube and at least one flexible expandable disk with a central portion connected to the central member and a peripheral portion that extends around the central member.
[0044] Clause 25: The ureteral catheter of clause 24, in which the disc has a diameter between about 1.5 mm and about 25 mm.
[0045] Clause 26: The ureteral catheter of clauses 24 or
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25, the disc comprises at least two rods and a circumferential ring, and each of the two rods comprises a first end connected to the central member and a second end connected to the circumferential ring.
[0046] Clause 27: The ureteral catheter of any one of clauses 24-26, in which at least one disc of the expandable part comprises at least one first disc connected to the central member and a second disc connected to the central member in a position distal to the first member.
[0047] Clause 28: The ureteral catheter of clause 27, in which the diameter of the second disc is greater than or equal to the diameter of the first disc.
[0048] Clause 29: The ureteral catheter of any one of clauses 1-13 and 17-20, in which the three-dimensional space defined by the expandable retention portion encloses at least a portion of the distal end of the elongated tube.
[0049] Clause 30: The ureteral catheter of clause 29, wherein the expandable retaining portion comprises at least one annular member that extends around the tube and at least one support that connects the annular member to a portion of the tube.
[0050] Clause 31: The ureteral catheter of clause 30, in which at least one annular member comprises straight portions and curved portions arranged to form a circuit pattern.
[0051] Clause 32: The ureteral catheter of clause 31, in which the circuit pattern comprises one or more of a zigzag pattern, a sinusoidal pattern, a square wave pattern and any combination thereof.
[0052] Clause 33: The ureteral catheter of clause 29, in which the expandable retaining portion comprises: at least two annular members that extend around the tube, with
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15/103 the at least two annular members arranged so that portions of one of the annular members cross parts of the other annular member; and at least two rods connecting the annular members to the tube.
[0053] Clause 34: A method to facilitate urine output from a patient's kidney, comprising: (a) inserting a ureteral catheter into at least one of the patient's kidneys, renal pelvis or into the ureter adjacent to the renal pelvis, in that the catheter comprises: an elongated tube comprising a proximal end, a distal end and a side wall extending between the proximal end and the distal end of the tube defining at least one drainage lumen extending through the tube; and an expandable retaining portion configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through at least the distal end of the tube; (b) implanting the expandable retention portion in the kidney, renal pelvis or ureter adjacent to the renal pelvis to maintain the distal end of the tube in a desired position in the kidney, renal pelvis or ureter adjacent to the patient's renal pelvis; and (c) applying negative pressure to the drainage lumen of the tube through a proximal portion of the tube for a period of time to facilitate urine output from the kidney.
[0054] Clause 35: The method of clause 34, in which the expandable retention portion is configured to prevent mucosal or uroendothelium tissue from the ureter and / or renal pelvis from obstructing at least the distal end of the tube.
[0055] Clause 36: The method of clauses 34 or 35, wherein the expandable retaining portion comprises at least
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16/103 two elongated members extending from the distal end of the bent tube to form a structure sufficient to maintain the position and volume of the three-dimensional shape defined by the implantable expandable part.
[0056] Clause 37: The method of any of clauses 34-36, wherein the expandable retaining portion comprises a flexible material deviated to the expanded position of the expandable retaining portion.
[0057] Clause 38: The clause 37 method, in which the flexible material comprises a material with shape memory.
[0058] Clause 39: The method of any of clauses 34-38, in which at least a part of the expandable retaining portion is mounted on an internal surface and / or on an external surface of the tube.
[0059] Clause 40: The method of any of clauses 34-39, wherein the expandable retaining portion comprises a central member, which extends over at least a portion of at least one drainage lumen, with at least two members elongated having a first end connected to a central member and a second end extending from the distal end of the tube.
[0060] Clause 41: The method of any one of clauses 34-40, in which a maximum transverse area of the three-dimensional shape defined by the expandable retaining portion implanted in a plane transverse to the central axis of the expandable retaining portion is about 10 mm ² to 350 mm ² .
[0061] Clause 42: A ureteral catheter for placement in a kidney, renal pelvis and / or in a ureter adjacent to a patient's renal pelvis, comprising: an elongated tube comprising
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17/103 a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retention portion configured to transition from a retracted to an implanted position and which, in the implanted position, is configured to maintain the distal end of the tube in the kidney, renal pelvis and / or ureter adjacent to the renal pelvis of the patient and to maintain fluid flow from the kidney through at least the distal end of the tube, wherein the expandable retaining portion includes at least one flexible member comprising: a first end positioned within a cylindrical space defined by a surface external of the side wall of the elongated tube and extending distally from the distal end of the tube along a central axis of the expandable retaining portion; and a more distal portion in relation to the distal end of the elongated tube, which extends radially outwardly from the cylindrical space.
[0062] Clause 43: The ureteral catheter of clause 40, in which the expandable retaining portion comprises at least two elongated flexible members and in which an area of a two-dimensional section defined by at least two flexible members in a plane transverse to the central axis of the expandable retaining portion is greater than a cross-sectional area of the distal end of the elongated tube.
[0063] Clause 44: The ureteral catheter of clauses 42 or 43, in which the expandable retaining portion comprises a flexible material deviated to the implanted position of the expandable retaining portion.
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[0064] Clause 45: The ureteral catheter of clause 44, in which the flexible material comprises a material with shape memory.
[0065] Clause 46: The ureteral catheter of any of clauses 42-45, in which a cross-sectional area of the most distal portion of the expandable retention portion is about 10 mm ² to 350 mm ² .
[0066] Clause 47: The ureteral catheter of any of clauses 42-46, wherein an axial length of the expandable part of an end proximal to a distal end thereof is about 5 mm to 100 mm.
[0067] Clause 48: The ureteral catheter of any of clauses 42-47, in which the elongated tube has an outside diameter of about 0.33 mm to 3.0 mm.
[0068] Clause 49: A system to induce negative pressure in a portion of a patient's urinary tract, with the system comprising: at least one ureteral catheter comprising: an elongated tube comprising a proximal end, a distal end and a side wall extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through at least the distal end of the tube; and a pump in fluid communication with the drainage lumen, with the pump being configured to induce negative pressure in a portion of the patient's urinary tract to aspirate liquids through the drainage lumen of the ureteral catheter.
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[0069] Clause 50: The clause 49 system, in which the expandable retention portion of the ureteral catheter is configured to prevent mucosal tissue or uroendothelium from the ureter and / or renal pelvis from obstructing at least the distal end of the tube.
[0070] Clause 51: The system of clauses 49 or 50, in which, when implanted, the expandable part maintains the permeability of the distal end of the tube in the kidney, renal pelvis and / or in a ureter adjacent to a patient's renal pelvis.
[0071] Clause 52: The system of any of clauses 49-51, in which the expandable retention portion of the ureteral catheter comprises at least two elongated flexible members and in which an area of a two-dimensional section defined by the two flexible members in one plane transverse to a central axis of the expandable retaining portion is greater than a cross-sectional area of the distal end of the elongated tube.
[0072] Clause 53: The system of any of clauses 49-52, in which the expandable retaining portion comprises a flexible material deviated to the implanted position.
[0073] Clause 54: The clause 53 system, in which the flexible material comprises a material with shape memory.
[0074] Clause 55: The system of any of clauses 49-54, in which the pump is configured to generate the position and / or negative pressure at a proximal end of the drainage lumen.
[0075] Clause 56: The system of any of the
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20/103 clauses 49-55, in which the pump applies a negative pressure of about 100 mmHg or less to a proximal end of the drainage lumen.
[0076] Clause 57: The system of any of clauses 49-56, in which the pump is configured to operate at one of the three pressure levels selected by a user, with the pressure levels generating a negative pressure of 2 to
125 mmHg. [0077] Clause 58: The system of any of the clauses 49-57, where the pump is configured to switch between generating negative pressure and generating pressure positive. [0078] Clause 59: The system of any of the clauses 49-58, where the pump has a sensitivity of about 10 mmHg or less. [0079] Clause 60: The system of any of the clauses 49-59, further comprising a bladder catheter placed in the bladder to maintain the flow of liquid from the bladder through the bladder catheter. [0080] Clause 61: A catheter to be placed in the bladder of
a patient, comprising: an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to transition from a retracted to an implanted position and which, in the implanted position, defines a three-dimensional shape positioned to maintain the flow of fluid from the bladder through at least a portion of an interior dimensional shape
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21/103 and at least through the distal end of the tube.
[0081] Clause 62: The catheter of clause 61, in which, when implanted, the three-dimensional shape is positioned to maintain the permeability of the fluid flow between the bladder and the proximal end of the tube, so that at least a portion of the flow fluid flow through the expandable retaining portion.
[0082] Clause 63: The catheter of clauses 61 or 62, in which, when implanted, the expandable part maintains the permeability of the distal end of the tube in a patient's bladder.
[0083] Clause 64: The catheter of any one of clauses 61-63, in which an area of two-dimensional sections of the three-dimensional shape defined by the expandable retention portion implanted in a plane transversal to the central axis of the expandable retention portion increases in the direction of a distal end of the expandable retaining portion.
[0084] Clause 65: The catheter of clause 64, in which an area of a two-dimensional section more distal from the three-dimensional shape is larger than an area of cross-section of the distal end of the tube.
[0085] Clause 66: The catheter of any of clauses 61-65, in which a maximum transverse area of the three-dimensional shape defined by the expandable retaining portion implanted in a plane transverse to a central axis of the expandable retaining portion is up to 1000 mm ² .
[0086] Clause 67: The catheter of any of clauses 61-66, in which a maximum cross-sectional area of the three-dimensional shape defined by the expandable retaining portion implanted in a plane transverse to the central axis
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22/103 of the expandable retaining portion is about 100 mm ² to about 1000 mm ² .
[0087] Clause 68: The catheter of any of clauses 61-67, wherein the axial length of the expandable part of an end proximal to a distal end is about 5 mm to about 100 mm.
[0088] Clause 69: The catheter of any of clauses 61-68, in which the central axis of the expandable retaining portion is collinear with a central axis of the tube.
[0089] Clause 70: The catheter of any of clauses 61-69, in which the distal end of the tube is at least partially closed by the three-dimensional shape defined by the expandable retaining portion.
[0090] Clause 71: The catheter of any one of clauses 61-70, wherein the expandable retaining portion comprises at least two elongated members extending from the distal end of the tube.
[0091] Clause 72: The catheter of clause 71, in which at least one of the elongated members is deflected to form a sufficient structure to maintain the position and volume of the three-dimensional shape defined by the implanted expandable part.
[0092] Clause 73: The catheter of clause 71, in which at least one of the elongated members is deflected to form a sufficient structure to maintain the position and volume of the three-dimensional shape defined by the expandable part implanted when the negative pressure is exposed to the bladder .
[0093] Clause 74: The catheter of any of clauses 61-73, wherein the expandable retaining portion comprises a flexible material deflected into position
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23/103 implanted.
[0094] Clause 75: 0 catheter gives clause 7 4 in what The material flexible comprises a material with memory in form.[0095] Clause 76: 0 catheter of clauses 7 4 or 75, in
that the flexible material comprises one or more of nitinol, titanium, chromium, silicone, polyethylene, polyethylene terephthalate, polyurethane and polyvinyl chloride.
[0096] Clause 77: The catheter of any of clauses 61-76, in which the expandable retaining portion is attached to a portion of an inner surface and / or an outer surface of the tube.
[0097] Clause 78: The catheter of any of clauses 61-77, wherein the expandable retaining portion comprises at least two elongated members connected to a central portion, which extends over a portion of at least one defined drainage lumen through the tube.
[0098] Clause 79: The catheter of any of clauses 61-78, wherein the expandable retaining portion comprises at least one elongated member comprising a first end and a second end, each of which is at least partially enclosed within the drainage lumen defined by the tube, and with a middle part protruding from the distal end of the tube.
[0099] Clause 80: The catheter of any of clauses 61-79, wherein the expandable retaining portion comprises at least one elongated member comprising at least a first curve in a first direction and a second curve in a second direction, in that the second direction is not coplanar with the first direction.
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[0100] Clause 81: The catheter of any of clauses 61-70 and 74-77, wherein the expandable retaining portion comprises an elongated central member extending from the distal end of the tube and at least one flexible expandable disk having a central portion connected to the central member and a peripheral portion extending around the central member.
[0101] Clause 82: The catheter of clause 80, in which at least one disc has a diameter between about 1.5 mm and about 25 mm.
[0102] Clause 83: The catheter of clauses 81 or 82, whose disc comprises at least two rods and a circumferential ring, and each of the at least two rods comprises a first end connected to the central member and a second end connected to the circumferential ring.
[0103] Clause 84: The catheter of any one of clauses 81-84, in which at least one disk of the expandable part comprises at least one first disk connected to the central member and a second disk connected to the central member in a distal position in relation to to the first member.
[0104] Clause 85: The catheter of clause 84, in which the diameter of the second disc is greater than or equal to the diameter of the first disc.
[0105] Clause 86: The catheter of any of clauses 61-70 and 74-77, in which the three-dimensional space defined by the expandable retention portion encloses at least a part of the distal end of the elongated tube.
[0106] Clause 87: The catheter of clause 86, in which the expandable retaining portion comprises at least one member
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25/103 annular that extends around the tube and at least one support that connects the annular member to a portion of the tube.
[0107] Clause 88: The catheter of clause 87, in which at least one annular member comprises straight portions and curved portions arranged to form a circuit pattern.
[0108] Clause 89: The catheter of clause 88, in which the circuit pattern comprises one or more of a zigzag pattern, a sine pattern, a square wave pattern and any combination thereof.
[0109] Clause 90: The catheter of clause 86, wherein the expandable retaining portion comprises: at least two annular members extending around the tube, with at least two annular members arranged so that the portions of one of the members annulars cross parts of the other annular member; and at least two rods connecting the annular members to the tube.
[0110] Clause 91: Method to facilitate the urinary output of a patient's bladder, characterized by the fact that it comprises: (a) inserting a catheter into the patient's bladder, in which the catheter comprises: an elongated tube comprising a proximal end, a distal end, a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube and at least one opening for urine to pass through the distal end and / or lateral wall of the drainage lumen; and an expandable retaining portion configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain the flow of fluid from the bladder through the distal end of the tube; (B)
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26/103 implant the expandable retention portion in the patient's bladder to maintain the distal end of the tube in a desired position in the patient's bladder; and (c) applying negative pressure to the drainage lumen of the tube through a proximal portion of it for a period of time to facilitate urine output from the bladder.
[0111] Clause 92: The clause 91 method, in which, when implanted, the three-dimensional shape is positioned to maintain the permeability of the fluid flow between the bladder and the proximal end of the tube, so that at least a portion of the flow fluid flow through the expandable retaining portion.
[0112] Clause 93: The method of clauses 91 or 92, in which the expandable retaining portion comprises at least two elongated members extending from the distal end of the folded tube to form a structure sufficient to maintain position and volume the three-dimensional shape defined by the expandable retaining portion.
[0113] Clause 94: The method of any of clauses 91-93, wherein the expandable retaining portion comprises a flexible material deviated to the expanded position of the expandable retaining portion.
[0114] Clause 95: The clause 94 method, in which the flexible material comprises a material with shape memory.
[0115] Clause 96: The method of any of clauses 91-95, in which at least part of the expandable retaining portion is mounted on an internal surface and / or an external surface of the tube.
[0116] Clause 97: The method of any of the clauses
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91-96, wherein the expandable retaining portion comprises a central member, which extends over at least a portion of at least one drainage lumen, and at least two elongated members with a first end connected to a central member and a second end extending from the distal end of the tube.
[0117] Clause 98: The method of any of clauses 91-97, in which a maximum transverse area of the three-dimensional shape defined by the expandable retaining portion implanted in a plane transverse to a transverse axis of the expandable retaining portion is about 100 mm ² to about 10 0 0 mm ² .
[0118] Clause 99: A catheter to be placed in a patient's bladder, comprising: an elongated tube comprising a proximal end, a distal end and a side wall extending between the proximal end and the distal end of the tube, defining at least least one drainage lumen that extends through the tube; and an expandable retention portion configured to transition from a retracted to an implanted position and, in the implanted position, configured to maintain the distal end of the tube in the patient's bladder and to maintain the flow of fluid from the bladder through at least one distal end of the tube, wherein the expandable retaining portion comprises at least one flexible member comprising: a first end positioned in a cylindrical space defined by an external surface of the elongated tube side wall, extending from distal way from the distal end of the tube along the central axis of the expandable retaining portion; and a more distal part relative to the end
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28/103 distal from the elongated tube, which extends radially outwardly from the cylindrical space.
[0119] Clause 100: The catheter of clause 99, in which the expandable retaining portion comprises at least two elongated flexible members and in which an area of a two-dimensional section defined by the two flexible members in a plane transverse to the central axis of the expandable retention is greater than the area of a cross section of the distal end of the elongated tube.
[0120] Clause 101: The catheter of clauses 99 or 100, in which the expandable retaining portion comprises a flexible material deviated to the implanted position of the expandable retaining portion.
[0121] Clause 102: The catheter of clause 101, in which the flexible material comprises a material with shape memory.
[0122] Clause 103: The catheter of any of clauses 99-102, in which a cross-sectional area of the most distal portion of the expandable retaining portion is about 100 mm2 to 1000 mm2.
[0123] Clause 104: The catheter of any of clauses 99-103, wherein an axial length of the expandable retaining portion between a proximal end and a distal end is about 5 mm to 100 mm.
[0124] Clause 105: System to induce negative pressure in a portion of a patient's urinary tract, with the system comprising: at least one catheter comprising: an elongated tube comprising a proximal end, a distal end and an extending side wall between the proximal end and the distal end of the tube that
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29/103 defines at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain the flow of fluid from the bladder through the distal end of the tube; and a pump in fluid communication with the drainage lumen, with the pump being configured to induce negative pressure in a portion of the patient's urinary tract to draw fluid through the drainage lumen of the catheter.
[0125] Clause 106: The clause 105 system, where, when implanted, the three-dimensional shape is positioned to maintain the permeability of the fluid flow between the bladder and the proximal end of the tube, so that at least a portion of the flow fluid flow through the expandable retaining portion.
[0126] Clause 107: The system of clauses 105 or 106, in which, when implanted, the expandable part maintains the permeability of the distal end of the tube in a patient's bladder.
[0127] Clause 108: The system of any of clauses 105-107, in which the expandable retention portion of the catheter comprises at least two elongated flexible members and in which an area of a two-dimensional section defined by at least two flexible members in a plane transverse to a central axis of the expandable retaining portion is greater than a cross-sectional area of the distal end of the elongated tube.
[0128] Clause 109: The system of any of clauses 104-107, in which the expandable retaining portion
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30/103 comprises a flexible material deviated to the implanted position.
[0129] Clause 110: The clause 109 system, in which the flexible material comprises a material with shape memory.
[0130] Clause 111: The system of any of the clauses 105-110, in which the pump is configured to generate the position and / or negative pressure at a proximal end of the drainage lumen
[0131] Clause 112: 0 system in any one of clauses 105-111, in which pump applies a pressure negative of fencelumen of 100 mmHg or drainage. less to one proximal end of the [0132] Clause 113: 0 system in any one of clauses 105-112, in what the bomb is configured for
operate at one of the three pressure levels selected by a user, with the pressure levels generating a negative pressure from 2 to 125 mmHg.
[0133] Clause 114: The system of any of the clauses 105-113, in which the pump is configured to alternate between generating negative pressure and generating positive pressure.
[0134] Clause 115: The system of any of the clauses 105-114, in which the pump has a sensitivity of about 10 mmHg or less.
[0135] Clause 116: The system of any one of clauses 105-115, further comprising a ureteral catheter for placement in at least one of the kidneys, renal pelvis or in the ureter adjacent to the renal pelvis, where the ureteral catheter ends in the bladder.
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[0136] Clause 117: The clause 116 system, in which the ureteral catheter comprises: an elongated tube comprising a proximal end, a distal end and a side wall extending between the proximal end and the distal end of the tube, defining at least least one drainage lumen that extends through the tube; and an expandable retaining portion configured to transition from a retracted to an implanted position and which, in the implanted position, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through the distal end of the tube.
[0137] Clause 118: The system of any of clauses 105-117, further comprising a ureteral stent for placement in at least one of the kidneys, renal pelvis or in the ureter adjacent to the renal pelvis, where the ureteral stent ends in the bladder.
[0138] Clause 119: Method for removing fluid from a patient's urinary tract, with the method comprising: implanting a ureteral stent or ureteral catheter into a patient's ureter to maintain the permeability of fluid flow between a kidney and the patient's bladder ; implanting a bladder catheter in the patient's bladder, wherein the bladder catheter comprises a distal end configured to be positioned in a patient's bladder, with a portion of drainage lumen having a proximal end and a side wall extending between them; and applying negative pressure to the proximal end of the bladder catheter to induce negative pressure in a portion of the patient's urinary tract to remove fluid from the patient's urinary tract, wherein the ureteral catheter and bladder catheter comprise a
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32/103 elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to transition from a retracted to an implanted position and which, in the implanted position, defines a three-dimensional shape positioned to maintain the flow of fluid from the bladder through at least a portion of an interior of the shape dimensional and at least the distal end of the tube.
BRIEF DESCRIPTION OF THE DRAWINGS
[0139] These and other features and characteristics of this disclosure, as well as the methods of operation and functions of the related elements of the structures and the combination of parts and manufacturing economies, will become more evident when considering the following description and the attached clauses with reference to the attached drawings, all of which are part of this specification, in which similar reference numbers designate corresponding parts in the various figures. It should be expressly understood, however, that the drawings are for purposes of illustration and description only and are not intended to be a limiting definition of the invention.
[0140] Other resources and other examples and advantages will be evident from the following detailed description made with reference to the drawings, in which:
[0141] FIG. 1 is a schematic drawing of an internal portion of a urine collection set implanted in a patient's urinary tract, according to an example of the present invention;
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[0142] FIG. 2A is a front view of a ureteral catheter with an implanted retention portion according to an example of the present invention;
[0143] FIG. 2B is a front view of the ureteral catheter shown in FIG. 2A, but with a retracted retaining portion according to an example of the present invention;
[0144] FIG. 3A is a front cross-sectional view of a ureteral catheter with an implanted retention portion according to an example of the present invention;
[0145] FIG. 3B is a front cross-sectional view of the ureteral catheter shown in FIG. 3A, with a retracted retaining portion according to an example of the present invention;
[0146] FIG. 4 is an exploded perspective view of a distal end of an elongated tube of a ureteral catheter with an implanted retaining portion according to an example of the present invention;
[0147] FIG. 5 is a top view of the ureteral catheter shown in FIG. 2A according to an example of the present invention;
[0148] FIG. 6 is a perspective view of a ureteral catheter with an implanted retention portion in accordance with another example of the present invention;
[0149] FIG. 7 is a front view of the ureteral catheter shown in FIG. 6;
[0150] FIG. 8A is a front view of a ureteral catheter with an implanted retention portion in accordance with yet another example of the present invention;
[0151] FIG. 8B is a front view of the ureteral catheter shown in FIG. 8A, but with a collapsed retaining portion
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34/103 according to an example of the present invention;
[0152] FIG. 9 is a schematic drawing of another example of an internal portion of a urine collection set implanted in a patient's urinary tract, according to an example of the present invention;
[0153] FIG. 10 is a perspective view of a tubing and y-connector assembly for connecting a ureteral catheter to a fluid pump according to an example of the disclosure;
[0154] FIG. 11 is a perspective view of ureteral catheters being connected to the y-connector of FIG. 10 according to an example of the present disclosure;
[0155] FIG. 12A is a flow chart illustrating a process for inserting and implanting a ureteral catheter or urine collection set according to an example of the present invention;
[0156] FIG. 12B is a flow chart illustrating a process for applying negative pressure using a ureteral catheter or urine collection set according to an example of the present invention;
[0157] FIG. 13 is a schematic drawing of a system for inducing negative pressure in a patient's urinary tract according to an example of the present invention;
[0158] FIG. 14A is a plan view of a pump to be used with the system of FIG. 13 according to an example of the present invention;
[0159] FIG. 14B is a side elevation view of the pump of FIG. 14A;
[0160] FIG. 15 is a flow chart illustrating a process for reducing a patient's creatinine and / or protein levels according to an example of the disclosure;
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[0161] FIG. 16 is a flow chart illustrating a process for treating a patient undergoing fluid resuscitation according to an example of the disclosure;
[0162] FIG. 17 is a schematic drawing of an experimental configuration for evaluating negative pressure therapy in a swine model;
[0163] FIG. 18 is a graph of the creatinine clearance rates in tests performed using the experimental setup shown in FIG. 17;
[0164] FIG. 19A is a low magnification photomicrograph of renal tissue from a congested kidney treated with negative pressure therapy;
[0165] FIG. 19B is a high magnification photomicrograph of the renal tissue shown in FIG. 19A;
[0166] FIG. 19C is a low magnification photomicrograph of renal tissue from a congested and untreated kidney (for example, a control kidney);
[0167] FIG. 19D is a high magnification photomicrograph of renal tissue shown in FIG. 19C;
[0168] FIG. 20 is a graph of serum albumin in relation to the baseline for testing pigs using the experimental method described here;
[0169] FIG. 21 is a schematic drawing of an internal part of a urine collection set implanted in a patient's urinary tract that includes ureteral stents and a bladder catheter, according to an example of the present invention;
[0170] FIG. 22 is a dimetric view of an example of a prior art transformable ureteral stent, according to FIG. 1 of the publication of the PCT WO patent application
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2017/019974, where the image on the left represents the uncompressed state of the stent and the image on the right represents the compressed state of the stent;
[0171] FIG. 23 is a perspective view of an example of a prior art ureteral stent, according to FIG. 4 of the publication of US patent application No. 2002/0183853 A1;
[0172] FIG. 24 is a perspective view of an example of a prior art ureteral stent, according to FIG. 5 of the publication of US patent application No. 2002/0183853 A1; and
[0173] FIG. 25 is a perspective view of an example of a prior art ureteral stent, according to FIG. 7 of the publication of US patent application No. 2002/0183853 Al.
DETAILED DESCRIPTION OF THE INVENTION
[0174] As used herein, the singular form of defined and undefined articles one, one, o and a includes plural referents, unless the context clearly determines otherwise.
[0175] As used in this document, the terms right, left, top and their derivatives will be related to the invention as outlined in the figures drawn. The term proximal refers to the portion of the catheter that is handled or touched by a user and / or an internal portion of a catheter, closest to the urinary tract access site. The term distal refers to the opposite end of the catheter, configured to be inserted into a patient and / or the part of the device that is inserted more deeply into the patient's urinary tract. However,
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37/103 it should be understood that the invention can take several alternative orientations and, therefore, these terms should not be considered limiting. In addition, it should be understood that the invention may assume several alternative variations and sequences of stages, unless expressly specified otherwise. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are examples only. Therefore, specific dimensions and other physical characteristics related to the modalities disclosed in this document should not be considered as limiting.
[0176] For the purposes of this specification, unless otherwise specified, all numbers that express quantities of ingredients, reaction conditions, dimensions, physical characteristics and so on used in the specification and the claims must be understood as modified in all instances by the expression about. Unless otherwise indicated, the numerical parameters set out in the following specification and the appended claims are approximations that may vary depending on the desired properties to be obtained by the present invention.
[0177] Notwithstanding the fact that the ranges and numerical parameters that establish the broadest scope of the invention are approximations, the numerical values established in the specific examples will be reported as accurately as possible. Any numerical value, however, will inherently contain certain errors necessarily resulting from the standard deviation found in their respective test measurements.
[0178] Furthermore, it must be understood that any interval
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38/103 numeric mentioned here intends to include all the subintervals included therein. For example, a range from 1 to 10 is intended to include any sub-intervals between and including the minimum mentioned value of 1 and the maximum mentioned value of 10, that is, all sub-intervals starting with a minimum value equal to or greater than 1 and ending with a maximum value equal to or less than 10 and all subintervals between, for example, 1 and 6.3, or 5.5 and 10 or 2.7 and 6.1.
[0179] As used in this document, the terms communication and communicate refer to the receipt or transfer of one or more signals, messages, commands or other data. When a unit or component is in communication with another unit or component, it means that a unit or component is capable of receiving data directly and indirectly from and / or transmitting data to the other unit or component. This can refer to a direct or indirect connection that can be wired and / or wireless. In addition, two units or components can be in communication with each other, even if the transmitted data can be modified, processed, routed and the like, between the first and the second unit or component. For example, a first unit can be in communication with a second unit, even if the first unit receives data passively and does not actively transmit data to the second unit. As another example, a first unit can be in communication with a second unit if an intermediate unit processes data from one unit and transmits processed data to the second unit. It must be understood that several other arrangements are possible.
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[0180] As used in this instrument, the expression maintaining the fluid flow permeability between the patient's kidney and bladder means establishing, increasing or maintaining the flow of a liquid, such as urine, from the kidneys and through the ureters , ureteral stents and / or ureteral catheters to the bladder. As used herein, the term fluid or liquid means urine and any other fluid in the urinary tract.
[0181] Fluid retention and venous congestion are central problems in the progression to advanced renal dysfunction. Excessive sodium intake, associated with relative reductions in excretion, leads to expansion of the isotonic volume and involvement of the secondary compartment. In some examples, the present invention is generally directed to devices and methods to facilitate the drainage of urine or waste from the bladder, ureter and / or kidney or kidneys of a patient. In some examples, the present invention is generally directed to devices and methods for inducing negative pressure on a patient's bladder, ureter and / or kidney or kidneys. Although this document is not intended to be linked to a specific theory, it is believed that the application of negative pressure to the bladder, ureter and / or kidneys can compensate for the reabsorption of sodium and water by the medullary tubule of the nephron in some situations. Compensating for sodium and water reabsorption can increase urine production, decrease total body sodium and improve erythrocyte production. As intramedullary pressures are triggered by sodium and, therefore, by volume overload, the intended removal of excess sodium allows the maintenance of volume loss. Removing the volume restores medullary hemostasis. Normal production of
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40/103 urine is 1.48-1.96 L / day (or 1-1.4 ml / min).
[0182] Fluid retention and venous congestion are also central problems in the progression of acute prerenal kidney injury (AKI). Specifically, AKI may be related to loss of perfusion or blood flow through the kidneys. Therefore, in some examples, the present invention facilitates the improvement of renal hemodynamics and increases urine production in order to relieve or reduce venous congestion. In addition, the treatment and / or inhibition of AKI is expected to positively impact and / or reduce the occurrence of other conditions, for example, reduction or inhibition of worsening renal function in patients with class III and / or class heart failure NYHA IV. The classification of the different levels of heart failure is described in The Criteria Committee of the New York Heart Association, (1994), Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels, (9th ed.), Boston: Little, Brown & Co. pp. 253-256, the disclosure of which is incorporated herein in full for reference purposes. The reduction or inhibition of AKI episodes and / or chronically reduced perfusion can also be a treatment for Stage 4 or Stage 5 chronic kidney dysfunction. Progression of chronic kidney dysfunction is described in the National Kidney Foundation, K / DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification. Am. J. Kidney Dis. 39: S1-S266, 2002 (Suppl. 1), the disclosure of which is incorporated herein in its entirety for reference purposes.
[0183] Referring to FIG. 1, the urinary tract comprises the patient's right kidney 2 and left kidney 4.
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As discussed above, the kidneys 2, 4 are responsible for blood filtration and the release of residual compounds from the body through urine. The urine produced by the right kidney 2 and the left kidney 4 is drained into the patient's bladder 10 through tubules, that is, a right ureter 6 and a left ureter 8. For example, urine can be conducted through the ureters 6, 8 by peristalsis of the walls of the ureter, as well as by gravity. Ureters 6, 8 enter the bladder 10 through an orifice or ureteral opening 16. Bladder 10 is a flexible and substantially hollow structure, adapted to collect urine until urine is excreted from the body. Bladder 10 can move from an empty position (represented by reference line E) to a full position (represented by reference line F). Normally, when bladder 10 reaches a substantially full state, urine is allowed to drain from the bladder 10 to an urethra 12 through a sphincter or urethral opening 18 located in a lower portion of the bladder 10. Contraction of the bladder 10 can react to tensions and pressures exerted on a trigonal region 14 of the bladder 10, which is the triangular region that extends between the ureteral openings 16 and 18. The trigonal region 14 is sensitive to tensioning and pressure, so that, as the bladder 10 begins to fill, the pressure in the trigonal region 14 increases. When a pressure threshold in the trigonal region 14 is exceeded, the bladder 10 begins to contract to expel the urine collected through the urethra 12.
[0184] In some examples, a method is available to facilitate urine output from the kidney, comprising: (a) insertion of a catheter of the present invention as
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42/103 disclosed in this document in at least one of the kidneys, in the renal pelvis or in the ureter adjacent to the patient's renal pelvis; and (b) applying negative pressure to the proximal portion of the tube, defining a catheter drainage lumen for a period of time to facilitate urine output from the kidney. Specific features of examples of ureteral catheters of the present invention will be described in detail in this document.
[0185] Applying negative pressure to a patient's renal area has several anatomical challenges for at least three reasons. First, the urinary system is made up of highly flexible tissues that are easily deformed. Medical books often describe the bladder as a thick muscle structure that can remain in a fixed form, regardless of the volume of urine contained in the bladder. However, in reality, the bladder is a smooth deformable structure. The bladder shrinks to adapt to the volume of urine contained in the bladder. An empty bladder looks more like an empty latex balloon than a ball. In addition, the mucous lining inside the bladder is soft and susceptible to irritation and damage. It is desirable to avoid dragging tissue from the urinary system into the catheter orifices to maintain an adequate flow of fluid through the catheter and to avoid injury to the surrounding tissue.
[0186] Second, the ureters are small tubular structures that can expand and contract to carry urine from the renal pelvis to the bladder. This transport occurs in two ways: by peristaltic activity and by a pressure gradient in an open system. In peristaltic activity, a portion of urine is
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43/103 pushed in front of a contractile wave, which almost completely obliterates the lumen. The wave pattern begins in the area of the renal pelvis, spreads along the ureter and ends in the bladder. This complete occlusion interrupts the flow of fluid and can prevent the negative pressure released in the bladder from reaching the renal pelvis without assistance. The second type of transport, by pressure gradient through an open ureter, may be present during a large flow of urine. The pressure head in the renal pelvis is not caused by the contraction of the smooth muscles of the upper urinary tract, but is generated by the flow of urine and therefore reflects blood pressure. Kiil F., Urinary Flow and Ureteral Peristalsis in: Lutzeyer W., Melchior H. (eds) Urodynamics. Springer, Berlin, Heidelberg (pp. 57-70) (1973).
[0187] Third, the renal pelvis is at least as flexible as the bladder. The thin wall of the renal pelvis can expand to accommodate normal volume several times, for example, as in patients with hydronephrosis.
[0188] Although this document is not intended to be linked to a specific theory, it is believed that the tissues of the renal pelvis and bladder may be flexible enough to be pulled in during the release of negative pressure to suit a little shape and volume of the tool used to provide negative pressure. As such, it is believed that a three-dimensional shape that maintains a three-dimensional void volume that can transmit negative pressure to at least one cup would be useful for providing negative pressure to the nephrons. In addition, given the flexibility of the fabrics, it is desirable to protect these fabrics against the openings leading to the tool lumen. The catheters
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44/103 discussed here can be useful to provide negative pressure, positive pressure or can be used at ambient pressure, or in any combination thereof.
Examples of ureteral catheters:
[0189] Referring to FIG. 1, a urine collection set 5000 includes an exemplary ureteral catheter 1000 comprising: an elongated tube 1002 to drain fluid, such as urine, from at least one of the kidneys 2, 4 renal pelvis 20, 21 or the ureter 6, 8 adjacent to the patient's renal pelvis 20, 21. Elongated tube 1002 comprises: a distal end 1004 configured to be positioned in one of the kidneys 2, 4 renal pelvis 20, 21 or ureter 6, 8 adjacent to the patient's renal pelvis 20, 21; a proximal end 1006 through which fluid 1008 is drained into the bladder 10 or outside the patient's body (for example, a portion of tube 1002 extending from urethra 12 to an external fluid collection vessel and / or a pump ); and a side wall 1010 extending between the proximal end 1006 and the distal end 1004 of the tube 1002 defining at least one drainage lumen (see reference L of FIG. 5) formed from the tube 1002 and extending through the tube 1002.
[0190] Tube 1002 can be any length suitable to accommodate anatomical differences in gender and / or size of the patient. In some examples, tube 1002 is about 30 cm to about 120 cm long. In addition, elongated tube 1002 can have an outside diameter of about 0.33 mm to about 3.0 mm. The elongated tube 1002 can also have an internal diameter of about 0.16 mm to about 2.40 mm. It should be appreciated that the outer and inner diameters of the elongated tube 1002 can include any of the subintervals
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45/103 described earlier.
[0191] Tube 1002 can be formed from any suitable flexible and / or deformable material. Such materials facilitate the advancement and / or positioning of tube 1002 in bladder 10 and ureters 6, 8. Non-limiting examples of such materials include biocompatible polymers, polyvinyl chloride, polytetrafluoroethylene (PTFE), such as Teflon®, silicon coated latex or silicon. At least a portion or all of the catheter device 1000, particularly the tube 1002, can be coated with a hydrophilic coating to facilitate insertion and / or removal and / or to increase comfort. In some instances, the coating is a hydrophobic and / or lubricant coating. For example, suitable coatings may comprise the ComfortCoat® hydrophilic coating that is available from Koninklijke DSM NV or hydrophilic coatings composed of polyelectrolyte (s), such as those disclosed in United States Patent No. 8,512,795, which is incorporated herein by reference. In some instances, tube 1002 is impregnated or formed from a material visible by fluoroscopic imaging. For example, the biocompatible polymer that forms tube 1002 can be impregnated with barium sulfate or a similar radiopaque material. As such, the structure and position of tube 1002 is visible by fluoroscopy.
[0192] The proximal end 100 6 of tube 1002 is essentially free of openings. Although it is not intended to link this document to a specific theory, it is believed that when negative pressure is applied to the proximal end 1006 of tube 1002, openings in the proximal portion of tube 1002 may be undesirable, as these openings
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46/103 can decrease the negative pressure in the distal portion 1014 of the ureteral catheter 1000 and thus decrease the extraction or flow of fluid or urine from kidney 2, 4 and renal pelvis 20, 21 from kidney 2, 4. It is desirable that the flow of fluid from the ureter 6, 8 and / or kidney 2, 4 is not impeded by the occlusion of the ureter 6, 8 and / or kidney 2, 4 through the 1000 catheter. Furthermore, although this document is not intended to be linked to a theory specific, it is believed that when negative pressure is applied to the proximal end 1006, the ureter 6, 8 can be pulled against or into the openings along the proximal end 1006 of tube 1002, which can irritate the tissues. [0193] Referring to FIG. 1, a distal portion 1014 of ureteral catheter 1000 further comprises a retention portion 1015 for holding distal portion 1014 of tube 1002 and the drainage lumen in ureter 6, 8 and / or kidney 2, 4. Retention portion 1015 is expandable to allow positioning of the retention portion 1015 in the ureter 6, 8, renal pelvis 20, 21 and / or kidney 2, 4. For example, the retention portion 1015 is preferably sufficiently expandable to absorb the forces exerted on catheter 1000 and to prevent such forces from being transmitted to the ureters 6, 8. In addition, if the retention portion 1015 is pulled in the proximal direction (reference P in FIG. 1) towards the patient's bladder 10, the portion retention device 1015 is flexible enough to begin to unroll, straighten or collapse so that it can be attracted to the lumen of tube 1002 and, optionally, through the ureter 6, 8.
[0194] As such, referring to FIGS. 2A-3B, for example, the retaining portion 1015 is configured to transition from a retracted position (FIGS. 2B and 3B) to a
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47/103 implanted position (FIGS. 2A and 3A). In the implanted position, the retaining portion 1015 defines a three-dimensional shape positioned to maintain fluid flow from the kidney 2, 4 through at least distal end 1004 of tube 1002.
[0195] In some examples, the retention portion 1015 comprises a three-dimensional shape that is positioned to maintain the permeability of the fluid flow between the kidney 2, 4 and the proximal end 1006 of the tube 1002, so that at least a portion of the fluid flows through the expandable retention portion 1015. For example, when implanted, the expandable retention portion 1015 can be configured to prevent mucosal or uroendothelial tissue from the ureter 6, 8 or renal pelvis 20, 21 from occluding at least a portion expandable retention portion 1015 or distal end 1004 of tube 1002. In addition, in some examples, expandable retention portion 1015 maintains permeability of distal end 1004 of tube 1002 in at least one of the kidneys 2, 4, renal pelvis 20, 21 or in a ureter 6, 8 adjacent to a patient's renal pelvis 20, 21.
[0196] The three-dimensional shape defined by the implantable expandable retention portion 1015 can be configured to occupy a specific area. For example, and as shown in FIGS. 2A and 3A, the area of two-dimensional slices of the three-dimensional shape defined by the implantable expandable retaining portion 1015 in a plane transverse to a central axis of the expandable retaining portion 1015 increases towards a distal end 1020 of the expandable retaining portion 1015. O central axis of the expandable retaining portion 1015 refers to a straight and / or curved axis that extends through the expandable retaining portion 1015 in an axial or
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48/103 longitudinal.
[0197] The area of the two-dimensional slice 1020 of the most distal end of the three-dimensional shape may also be larger than the area of the cross-section of the distal end 1004 of tube 1002. In some instances, the maximum cross-sectional area of the three-dimensional shape defined by the portion expandable retention area 1015 in a plane transverse to a central axis of the expandable retention portion 1015 is up to about 350 mm ² . In certain examples, the maximum cross-sectional area of the three-dimensional shape defined by the implantable expandable retaining portion 1015 in a plane transverse to a central axis of the expandable retaining portion 1015 is about 10 mm ² to about 350 mm ² .
[0198] With respect to the length of the retaining portion 1015, an axial length of the expandable retaining portion 1015 from a proximal end 1022 to a distal end 1020 can be from about 5 mm to about 100 mm. As shown further in FIGS. 2A-8B, the central axis of the expandable retaining portion 1015 can be collinear with a central axis of the pipe 1002. In some examples, the distal end 1004 of the pipe 1002 is at least partially closed by the three-dimensional shape defined by the expandable retaining portion 1015 .
[0199] In some examples, the expandable retaining portion 1015 is attached to a portion of tube 1002. For example, referring to FIG. 3A, the expandable retaining portion 1015 can be attached to a portion of the inner surface 1001 of the tube 1002, to the outer surface 1003 of the tube 1002 or both. [0200] The retention portion 1015 can be formed from a flexible material deflected to an implanted position
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49/103 of the retaining portion 1015. As such, the material of the retaining portion 1015 automatically deploys the retaining portion 1015 when the retaining portion 1015 is extended from tube 1002. In some examples, the flexible material comprises a material with shape memory. As used here, the term material with form memory refers to a material that is able to return to its original form without the use of an external stimulus. Non-limiting examples of flexible materials that can be used to form the retention portion 1015 include nitinol, titanium, chromium, silicone, polyethylene, polyethylene terephthalate, polyurethane, polyvinyl chloride and any combination thereof.
[0201] In some examples, as shown in FIGS. 2A and 3A, the expandable retaining portion 1015 comprises at least two, and possibly three or four, elongated members 1030 extending from distal end 1004 of tube 1002. As shown in FIG. 3A, the elongated members 1030 may extend through at least a portion of the lumen formed through the interior of the tube 1002 and exit the distal end 1004 of the tube 1002. In addition, at least one of the elongated members 1030 is angled to form a structure sufficient to maintain the position and volume of the three-dimensional shape defined by the implanted expandable retaining portion 1015. For example, at least one of the elongated members 1030 can be tilted to form a structure sufficient to maintain the position and volume of the three-dimensional shape defined by expandable retention portion implanted 1015 when negative pressure is exposed to the ureter 6, 8 and / or kidney 2, 4.
[0202] FIG. 4 further illustrates an expanded view of a
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50/103 elongate member 1030 extending from distal end 1004 of tube 1002. As shown in FIG. 4, the elongated member 1030 is deflected to form a structure sufficient to maintain the position and volume of the three-dimensional shape defined by the implantable expandable retaining portion 1015. [0203] In some examples, referring to FIG. 3A, at least two, or at least three or four, of the elongated members 1030 are connected to a central portion 1040, as a central member in some examples, which extends over at least a portion of the drainage lumen defined by tube 1002 and optionally, from distal end 1004 of tube 1002. Elongated members 1030 can be connected to central portion 1040 using various materials and techniques known in the art to connect materials that form elongated members 1030.
[0204] In some examples, referring again to FIG. 3A, the expandable retaining portion 1015 comprises at least one elongated member 1030 having a first end 1050 and a second end 1052 which can be enclosed within the drainage lumen defined by tube 1002. As shown further in FIGS. 2A, 3A and 5, an intermediate portion 1054 protrudes from the distal end 1004 of tube 1002. It should be appreciated that the intermediate portion 1054 is angled to form a structure sufficient to maintain the position and volume of the three-dimensional shape defined by the portion of deployable retention 1015.
[0205] The elongated members described above 1030 can have various shapes configured to maintain the position and volume of the three-dimensional shape defined by the implantable expandable retention portion 1015. For example, and how
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51/103 shown in FIGS. 2A and 3A, at least one elongated member 1030 can comprise at least a first curve 10 60 in a first direction D 1 and a second curve 10 62 in a second direction D 2. In some examples, the second direction D2 is not coplanar with the first direction Dl.
[0206] As previously described, the retaining portion 1015 can be retracted in the lumen of the elongated tube 1002. As such, the elongated members 1030 described above can be retracted in the lumen of the elongated tube 1002. FIGS. 2B and 3B illustrate elongated elements 1030 which are retracted and attracted to the lumen of the elongated tube 1002. In addition, FIG. 5 illustrates the lumen (reference L) formed from tube 1002.
[0207] The retention portion 1015 can also comprise different configurations. In some examples, referring to FIGS. 6 and 7, portion 1015 comprises an elongated central member 1070 extending from distal end 1004 of tube 1002 and at least one flexible expandable disk 1072, with a central portion 1074 connected to central member 1070 and a peripheral portion 107 6 that extends around the central member 1070.
[0208] In some examples, the retaining portion 1015 comprises more than one expandable flexible disk 1072, such as at least two or three expandable flexible disks 1072. For example, the retaining portion 1015 can comprise at least one first flexible expandable disk 1072 connected to the central member 1070 and a second flexible expandable disk 1080 connected to the central member 1070 in a position distal to the first disk 1072. It should be appreciated that the retaining portion 1015 can include flexible expandable disks
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52/103 additional 1072 which are proximal or distal to the first and / or second flexible expandable disk 1072, 1080, such as, for example, a third flexible expandable disk 1082.
[0209] In addition, each disk 1072, such as disks 1072, 1080, 1082 shown in FIGS. 6 and 7, can have a diameter of about 1.5 mm to about 25 mm. In addition, the various disks 1072, 1080, 1082 can have the same diameter or a different diameter. For example, the diameter of the second disc 1080 may be greater than or equal to the diameter of the first disc 1072 and the diameter of the first disc 1080 may be greater than or equal to the diameter of the third disc 1082. In some examples, as shown in FIGS. 6 and 7, the diameter of the disks 1072, 1080 and 1082 increases from the proximal end 1022 to the distal end 1020 of the retaining portion 1015.
[0210] In some examples, referring to FIGS. 6 and 7, flexible expandable disks 1072, 1080, 1082 can comprise at least two rods 1090, such as at least three rods 1090 or at least four rods 1090, and a circumferential ring 1094 formed by the peripheral portion 1076. Each rod 1090 can comprise a first end 1092 connected to the central member 1070 and a second end 1096 connected to the circumferential ring 1094. When the retaining member 1015 comprises several disks 1072, 1080, 1082, the disks 1072, 1080, 1082 can independently comprise at least two stems 1090 and a circumferential ring 1094, as previously described.
[0211] The retaining portion 1015 comprising at least one flexible expandable disk 1072 can be retracted into the lumen of the elongated tube 1002. Thus, the flexible expandable disks 1072, 1080, 1082 described above can be retracted
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53/103 in the lumen of the elongated tube 1002.
[0212] As previously described, distal end 1004 of tube 1002 can be at least partially enclosed by the three-dimensional shape defined by the expandable retaining portion 1015. In some examples, referring to FIGS. 8A and 8B, the retaining portion 1015 comprises at least one annular member 1100 extending around tube 1002 and at least one support 1102 connecting annular member 1100 to a portion of tube 1002 so that annular member 1100 extends around tube 1002 at least partially enclose distal end 1004 of tube 1002. Annular member 1100 may comprise straight portions 1106 and curved portions 1108 arranged to form a circuit pattern. In some examples, the circuit pattern comprises a zigzag pattern, a sine pattern, a square wave pattern or any combination thereof.
[0213] Referring again to FIGS. 8A and 8B, the expandable retaining portion 1015 may comprise at least two annular members 1100 extending around tube 1002. The two annular members 1100 may be arranged so that portions of one annular member 1100 pass through portions of the other member ring 1100. In addition, at least two supports 1102 can connect ring members 1100 to tube 1002.
[0214] The retaining portion 1015 comprising the annular element 1100 can be retracted into the elongated tube 1002. As such, the annular element 1100 described above can be retracted into the lumen of the elongated tube 1002.
[0215] As indicated, the 1000 ureteral catheters described above can be placed on kidneys 2, 4,
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54/103 renal pelvis 20, 21 and / or in the ureter 6, 8 adjacent to a patient's renal pelvis. In some examples, the ureteral catheter 1000 comprising a retaining member 1015 can be implanted in the patient's urinary tract and, more specifically, in the region of the renal pelvis 20, 21 or in the kidney 2, 4 using a conduit through the urethra 12 and in the bladder 10. In addition, if the retention portion 1015 is pulled in the proximal direction P towards the patient's bladder 10, the retention portion 1015 can be flexible enough to begin to collapse so that it can be pulled through the ureter 6 , 8. To implant the 1000 ureteral catheter, the medical professional could insert a cystoscope into the urethra 12 to provide a channel for the tools to enter the bladder 10. The ureteral orifice would be visualized and the guidewire would be inserted through the cystoscope and ureter until the tip of the guide wire to reach the renal pelvis 20, 21. The cystoscope would probably be removed and a pusher tube would be pushed over the guide wire to the renal pelvis 20, 21. The guide wire would be removed while the pusher tube would remain in place to act as the implant sheath. The 1000 ureteral catheter would be inserted through the pusher / sheath tube and the tip of the catheter would be activated once it extended beyond the end of the pusher / sheath tube. Retaining member 1015 would expand radially to assume the implanted position.
Systems for inducing negative pressure
[0216] Referring to FIG. 9, an exemplary system 1200 is illustrated to induce negative pressure in a patient's urinary tract to increase renal perfusion. The 1200 system comprises one or two 1000 ureteral catheters connected to
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55/103 a 2000 fluid pump to generate negative pressure. More specifically, the patient's urinary tract comprises the right kidney 2 and the left kidney 4. The kidneys 2, 4 are responsible for blood filtration and for expelling residual compounds from the body through urine. The urine produced by the right kidney 2 and the left kidney 4 is drained into the patient's bladder 10 through the tubules, that is, a right ureter 6 and a left ureter 8, which are connected
kidneys in renal pelvis 20, 21. Urine can be conducted through ureters 6, 8 for peristalsis from the walls of the ureter as well as by gravity. The ureters 6, 8 enter the bladder 10 through a hole or opening ureteral 16. The
bladder 10 is a flexible and substantially hollow structure adapted to collect urine until urine is excreted from the body.
[0217] Referring to FIG. 1, the bladder 10 can move from an empty position (represented by reference line E) to a full position (represented by reference line F). Normally, when bladder 10 reaches a substantially full state, urine is allowed to drain from the bladder 10 to an urethra 12 through a sphincter or urethral opening 18 located in a lower portion of the bladder 10. Contraction of the bladder 10 may react to tensions and pressures exerted on a trigonal region 14 of the bladder 10, which is the triangular region that extends between the ureteral opening 16 and the urethral opening 18. The trigonal region 14 is sensitive to stress and pressure, so that according to bladder 10 begins to fill, pressure in the region of trigone 14 increases. When a pressure threshold in the trigone 14 region is exceeded, the bladder 10 begins to contract to
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56/103 expel the urine collected through the urethra 12.
[0218] As shown in FIG. 9, distal portions of the ureteral catheter 1000 are implanted in the renal pelvis 20, 21 near the kidneys 2, 4. Proximal portions of one or more catheters 1000 are connected to a single outlet port of a 2000 fluid pump through a 2002 y connector 2010 and 2050 pipe set. An exemplary y connector 2010 and 2050 pipe set connected to it are shown in FIGS. 10 and 11. Referring to FIGS. 10 and 11, the y connector 2010 comprises a tubular body 2012 formed from a rigid plastic material, with the body 2012 comprising two inlet ports 2014, 2016 and a single outlet port comprising a unidirectional check valve 2018 to prevent the return. Inlet ports 2014, 2016 may comprise a 2020 connector, such as a luer-lock connector, screw connector or mechanism similar to that known in the art for receiving the proximal end of the 1000 catheters. The proximal ends of the 1000 catheters have a corresponding structure for y connector assembly 2010. The 2050 tubing assembly comprises a length of flexible medical tubing 2052 that extends between the 2018 unidirectional check valve of connector y 2010 and a funnel-shaped connector 2054 configured to engage the outlet port 2002 of a fluid pump 2000, as shown in FIG. 9. The shape and size of the 2054 funnel connector can be selected based on the type of pump 2000 being used. In some examples, the 2054 funnel-shaped connector can be manufactured in a different configuration so that it can be connected only to a specific type of pump, considered safe to induce
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57/103 negative pressure on a patient's bladder, ureter or kidneys. In other examples, as described in this document, the 2054 connector may have a more general configuration adapted for attachment to a variety of different types of fluid pumps.
[0219] In some instances, the 2000 pump applies a negative pressure of about 100 mmHg or less to a proximal end of the drain lumen. The 2000 pump can also be configured to operate at one of three pressure levels selected by a user, and the pressure levels generate a negative pressure from 2 mmHg to 125 mmHg, for example. In addition, in some instances, pump 2000 is configured to switch between generating negative pressure and generating positive pressure. In some instances, the 2000 pump also has a sensitivity of about 10 mmHg or less.
[0220] System 1200 is just one example of a negative pressure system to induce negative pressure that can be used with the 1000 ureteral catheters disclosed here. Other urine collection systems and sets can be used with 1000 catheters. In addition, 1000 catheters can be connected to separate negative pressure sources. In other examples, one or more 1000 catheters can be connected to a negative pressure source, while other 1000 catheters can be connected to a non-pressurized fluid collection vessel.
Examples of urine collection sets:
[0221] As previously described, and as shown in FIG. 1, a urine collection set 5000 including ureteral catheters 1000 is configured to be positioned within a patient's urinary tract. For example,
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58/103 distal ends 1014 of the ureteral catheters 1000 can be configured to be implanted in the patient's ureters 2, 4 and, in particular, in an area of the renal pelvis 20, 21 of the kidneys 6, 8.
[0222] In some instances, the urine collection set 5000 may comprise two separate ureter catheters 1000, such as a first catheter 1000 disposed on or adjacent to the renal pelvis 20 of the right kidney 2 and a second catheter 1000 disposed on or adjacent to the pelvis renal 21 of the left kidney 4. The catheters 1000 can be separated along their entire length or they can be kept close to each other by a clip, ring, clamp or other type of connection mechanism (for example, connector 150) to facilitate the placement or removal of 1000 catheters. In some instances, 1000 catheters may fuse or be connected together to form a single drainage lumen. In other examples, catheters 1000 may be inserted through or enclosed within another catheter, tube or sheath along portions or segments thereof to facilitate the insertion and retraction of catheters 1000 from the body. For example, a bladder catheter can be inserted over and / or along the same guidewire as ureteral catheters 1000, causing ureteral catheters 1000 to extend from the distal end of the bladder catheter. In some instances, when a separate bladder catheter is used, the ureteral catheter 1000 ends at the bladder 10.
[0223] In some examples, and as previously described, the ureteral catheter 1000 may comprise: an elongated tube 1002 to drain fluid, such as urine, from at least one of the kidneys 2, 4, the renal pelvis 20, 21 or the ureter 6, 8 adjacent
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59/103 to the renal pelvis 20, 21 of the patient. The elongated tube 1002 comprises: a distal end 1004 configured to be positioned in the kidney 2, 4, renal pelvis 20, 21 and / or in the ureter 6, 8 adjacent to the patient's renal pelvis 20, 21; a proximal end 1006 through which fluid 1008 is drained into the bladder 10 or outside the patient's body (e.g., a portion of tube 1002 extending from urethra 12 to an external fluid collection container and / or pump 2000 ); and a side wall 1010 that extends between the proximal end 1006 and the distal end 1004 of tube 1002, defining at least one drainage lumen that extends through tube 1002. In some examples, tube 1002 ends in another internal catheter and / or drainage lumen, as in a drainage lumen of the bladder catheter. In this case, the fluid is drained from the proximal end of the ureteral catheter 1002 and is directed from the body through the additional internal catheter and / or the drainage lumen.
[0224] As indicated, 1000 ureteral catheters can be connected to the bladder catheter to provide a single drainage lumen for urine, or 1000 ureteral catheters can drain through separate tubes from the bladder catheter. The bladder catheter may comprise an implantable seal and / or anchor to anchor, retain and / or provide passive fixation for portions that remain in the 5000 urine collection set and, in some instances, to prevent premature and / or unwanted removal of assembly components during use. The anchor is configured to be located adjacent to the patient's lower bladder wall 10 to prevent the patient's movement and / or forces applied to the internal catheters 1000 from being transferred to the ureters. The catheter
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60/103 of the bladder comprises an internal part from which to define a drainage lumen configured to conduct urine from the bladder 10 to an external urine collection container.
[0225] In some examples, the size of the bladder catheter can vary from about 8 Fr to about 24 Fr. In some examples, the bladder catheter can have an outer diameter ranging from about 2.7 to about 8 mm. In some instances, the bladder catheter may have an internal diameter ranging from about 2.16 to about 6.2 mm. The bladder catheter may be available in different lengths to accommodate anatomical differences in gender and / or size of the patient. For example, the average length of the female urethra is only a few centimeters; therefore, the length of the tube can be quite short. The average length of the urethra for men is longer due to the penis and can be variable. It is possible that women can use bladder catheters with longer tubes, as long as the excess tubes do not increase the difficulty in handling and / or prevent contamination of sterile portions of the catheter. In some instances, a sterile and internal portion of the bladder catheter can range from about 1 inch to 3 inches (for women) to about 20 inches for men. The total length of the bladder catheter, including sterile and non-sterile portions, can vary from one to several feet.
[0226] Examples of bladder catheters and urine collection kits that can be used with the 1000 ureteral catheters of the present invention are described in paragraphs [0394] to [0414] and in the corresponding figures of US publication No. 2017/0348507 , which is incorporated into this document for reference purposes.
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61/103
Bladder Catheter
[0227] In some examples, referring to FIG. 21, the 1000 ureteral catheters described above are used as a bladder catheter. For example, any of the previously described ureteral catheters 1000 comprising any of the retention portions described above 1015 can be placed in the bladder 10 to facilitate the production of urine from the bladder 10. The catheters 1000 can be placed in the bladder 10 so that the distal end 1004 of tube 1002 and the retaining portion 1015 are positioned in the bladder 10 with the elongated tube 1002 extending out of the bladder 10 and into the patient's urethra. Tube 1002 may also include at least one urine opening 1009 to pass through distal end 1004 and / or side wall 1010 of the drain lumen. When placed in bladder 10, catheters 1000 can be used with any of the additional components described above, including, but not limited to, an implantable seal, anchor and / or a 2000 pump to induce negative pressure.
[0228] It should be appreciated that the dimensions of catheters 1000, when used in bladder 10, will be adjusted to suit bladder 10. In some examples, catheter 1000 is adjusted to a size that can vary from about 8 Fr to about 24 Fr, an outside diameter ranging from about 2.7 to about 8 mm and an inside diameter ranging from about 2.16 to about 6.2 mm. Catheters 1000, when used in bladder 10, may be available in different lengths to accommodate anatomical differences in gender and / or size of the patient, as previously described with
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62/103 other bladder catheters 116.
[0229] In addition, the maximum cross-sectional area of the three-dimensional shape defined by the expandable retaining portion implanted in a plane transverse to a central axis of the expandable retaining portion can be up to about 1000 mm ² or about 100 mm ² to about 1000 mm ² . The axial length of the expandable portion from an end proximal to a distal end can also be from about 5 mm to about 100 mm.
[0230] As previously described, bladder 10 can move from an empty position (represented by reference line E) to a full position (represented by reference line F). Referring again to FIG. 21, when the bladder is in the empty position E, the upper wall of the bladder 70 can be positioned adjacent and / or conform to the periphery 1017 of the distal end 1004 and / or the retention portion 1015 of the bladder catheter 1000.
[0231] In some examples, a method is also available to facilitate urine output from the bladder 10 using the 1000 catheters described above. The method comprises: insertion of a catheter 1000 of the present invention, as disclosed in this instrument, in the bladder 10; implanting the expandable retaining portion 1015 into the patient's bladder 10 to hold the distal end 1004 of tube 1002 in a desired position in the patient's bladder 10; and applying negative pressure to the proximal portion of tube 1002 of catheter 1000 for a period of time to facilitate urinary output of the bladder 10. Elongated tube 1002 also includes at least one opening at the distal end 1004 and / or the side wall 1010 to facilitate fluid removal.
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[0232] It should be understood that the 1000 catheters described above can be used in the bladder 10 and in the kidney, renal pelvis and / or in a ureter adjacent to a patient's renal pelvis, as previously described. For example, the present invention may comprise: a ureteral catheter 1000 placed in a kidney, renal pelvis and / or in a ureter adjacent to a patient's renal pelvis, as shown in FIG. 1; and a bladder catheter 1000 placed in the bladder, as shown in FIG. 21. Catheters 1000 can include any of the catheters 1000 and retention portions 1015 described herein. In addition, the 1000 ureteral catheter can be placed in one or both of the kidneys, renal pelvis and / or ureters adjacent to the renal pelvis.
[0233] In some examples, when the 1000 ureteral catheters described above are used as bladder catheters in the bladder 10, different ureteral catheters other than those described above can be placed in the kidney, renal pelvis and / or in a ureter adjacent to the renal pelvis . Such ureteral catheters are described in paragraphs [0018] to [0240] and in the corresponding figures of US Publication No. 2017/0348507, which is incorporated into this document for reference purposes.
[0234] In other examples, when the 1000 ureteral catheters described above are used as a bladder catheter in the bladder 10, a 3000 ureteral stent is placed in the kidney, renal pelvis and / or in a ureter adjacent to the renal pelvis. As shown in FIG. 21, stent 3000 may comprise: a distal end 3004 placed in the kidney, renal pelvis and / or in a ureter adjacent to the renal pelvis; a proximal end 3006 that ends at the bladder 10; and a side wall 3008 that
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64/103 extends between distal end 3004 and proximal end 3006. In addition, ureteral stent 3000 can be placed in one or both of the kidneys, renal pelvis and / or ureters adjacent to the renal pelvis.
[0235] In some examples, a method is provided for removing fluid from a patient's urinary tract, with the method comprising: implanting a 3000 ureteral stent or ureteral catheter into a patient's ureter to maintain the permeability of fluid flow between the patient's kidneys 2, 4 and bladder 10; implanting a bladder catheter 1000 into the patient's bladder, wherein the bladder catheter 1000 comprises the catheters 1000 described herein in which a distal end 1004 of a tube 1002 is configured to be positioned in a patient's bladder 10, a proximal end 1006 the tube 1002 extends outward from the bladder 10 and a side wall 1010 extends between them; and applying negative pressure to the proximal end 1006 of catheter 1000 to induce negative pressure in a portion of the patient's urinary tract to remove fluid from the patient's urinary tract.
Examples of ureteral stents:
[0236] As previously described, and as shown in FIG. 21, the present invention can include the ureteral catheters 1000 described above, used as a bladder catheter in the bladder 10, and a 3000 ureteral stent placed in one or both kidneys, renal pelvis and / or ureters adjacent to the renal pelvis.
[0237] In some examples, the ureteral stent 3000 comprises an elongated body comprising a proximal end 3006, a distal end 3004, an axis
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65/103 longitudinal and at least one drainage channel extending along the longitudinal axis from the proximal end 3006 to the distal end 3004 to maintain the permeability of fluid flow between the kidney and the patient's bladder. In some examples, the ureteral stent 3000 further comprises a coil or loop 3010 or 3012 at at least one of the proximal ends 3006 or distal 3006. In some examples, the body of the ureteral stent 3000 further comprises at least one perforation in its side wall 3008 In other examples, the body of the ureteral stent 3000 is essentially free of perforations in its side wall.
[0238] Some examples of 3000 ureteral stents that may be useful in the present systems and methods include CONTOUR ™ ureteral stents, CONTOUR VL ™ ureteral stents, POLARIS ™ ureteral stents, POLARIS ™ ureteral stents, POLARIS ™ Ultra ureteral stents, PERCUFLEX ™ ureteral stents, PERCUFLEX ™ Plus ureteral stents, STRETCH ™ VL Flexima ureteral stents, each of which is commercially available from Boston Scientific Corporation of Natick, Massachusetts. See Ureteral Stent Portfolio, a publication by Boston Scientific Corp, (July 2010), incorporated in this document for reference purposes. CONTOUR ™ and CONTOUR VL ™ ureteral stents are constructed with soft Percuflex ™ material that becomes soft according to body temperature and is designed for an internal residence time of 365 days. The variable length coils at the distal and proximal ends allow a stent to fit into various sections of the ureter. The fixed length stent can be 6F - 8F with lengths ranging from 20cm to 30cm, and the variable length stent can be
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4.8F - 7F with lengths of 22 - 30cm. Other examples of suitable ureteral stents include INLAY® ureteral stents, INLAY® OPTIMA® ureteral stents, BARDEX® double ureteral stents and the FLUORO-4 ™ silicone ureteral stent, each commercially available from CR Bard, Inc. from Murray Hill, NJ. See Ureteral Stents, management / ureteral-stents / (21 January 2018), incorporated into this document for reference purposes.
[0239] 3000 stents can be implanted in one or both of the patient's kidneys or renal area (renal pelvis or ureters adjacent to the renal pelvis), as desired. Typically, these 3000 stents are implanted by inserting a stent with a nitinol wire through the urethra and bladder to the kidney, removing the nitinol wire from the stent, which allows the stent to assume an implanted configuration. Many of the stents above have a flat loop 3010 at the distal end 3004 (to be implanted in the kidney), and some also have a flat loop 3012 at the proximal end 3006 of the stent 3000, which is implanted in the bladder. When the nitinol wire is removed, the stent 3000 takes the form of a pre-tensioned flat loop 3010 or 3012 at the distal 3004 and / or proximal ends 3006. To remove the 3000 stent, a nitinol wire is inserted to stretch the 3000 stent and the 3000 stent is removed from the ureter and urethra.
[0240] Other examples of suitable 3000 ureteral stents are disclosed in PCT Patent Application Publication WO 2017/019974, which is incorporated herein for reference purposes. In some examples, as shown, for example, in FIGS. 1-7 of WO 2017/019974 and in FIG. 22 in this document
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67/103 (same as FIG. 1 of WO 2017/019974), the ureteral stent 100 may comprise: an elongated body 101 comprising a proximal end 102, a distal end 104, a longitudinal axis 106, an outer surface 108 and an inner surface 110, wherein the inner surface 110 defines a transformable hole 111 that extends along the longitudinal axis 106 from the proximal end 102 to the distal end 104; and at least two fins 112 projecting radially away from the outer surface 108 of the body 101; wherein the transformable hole 111 comprises: (a) a standard orientation 113A (shown at left in FIG. 22) comprising an open hole 114 that defines a longitudinally open channel 116; and (b) a second orientation 113B (shown at right in FIG. 22) comprising at least an essentially closed hole 118 or a closed hole defining a essentially closed longitudinal drainage channel 120 along the longitudinal axis 106 of the elongated body 101, in that the transformable hole 111 can be moved from the standard orientation 113A to the second orientation 113B after the radial compression forces 122 are applied to at least a portion of the outer surface 108 of the body 101.
[0241] In some examples, as shown in FIG. 22, the drainage channel 120 of the ureteral stent 100 has a diameter D which is reduced over the transformable bore 111 which moves from the standard orientation 113A to the second orientation 113B, where the diameter is reducible to the point above where the flow of urine through the transformable bore 111 would be reduced. In some examples, the diameter D is reduced by up to about 40% in the transformable hole 111 that moves from the standard orientation
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113A for the second orientation 113B. In some instances, ο diameter D in the standard 113A orientation can range from about 0.75 to about 5.5 mm, or about 1.3 mm or about 1.4 mm. In some examples, the diameter D in the second orientation
113B can vary from about 0.4 to about in 4 mm, or about in 0.9 mm.[0242] In some examples, one or more fins 112 are composed for one flexible material that is soft or relatively soft based on scale in Shore hardness. In some examples, the body 101 is composed by a material
flexible that is medium to hard, based on the Shore hardness scale. In some examples, one or more fins have a durometer between about 15 A and about 40 A. In some examples, body 101 has a durometer between about 80A and about 90 A. In some examples, one or more fins 112 and body 101 are composed of a flexible material that is relatively soft to relatively hard based on the Shore hardness scale, for example, having a durometer between about 40 A and about 70 A.
[0243] In some examples, one or more fins 112 and the body 101 are composed of a flexible medium to hard material, based on the Shore hardness scale, for example, having a durometer between about 85 A and about 90 THE.
[0244] In some examples, the standard orientation 113A and the second orientation 113B support the flow of fluid or urine around the outer surface 108 of the stent 100, in addition to through the transformable bore 111.
[0245] In some examples, one or more fins 112 extend longitudinally from the proximal end 102 to the distal end 104. In some examples, the stent has two,
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69/103 three or four fins.
[0246] In some examples, the outer surface 108 of the body has an outer diameter in the standard 113A orientation ranging from about 0.8 mm to about 6 mm, or about 3 mm. In some examples, the outer surface 108 of the body has an outer diameter in the second orientation 113B ranging from about 0.5 mm to about 4.5 mm, or about 1 mm. In some examples, one or more fins have a width or tip that varies from about 0.25 mm to about 1.5 mm, or about 1 mm, projecting from the outer surface 108 of the body in one direction usually perpendicular to the longitudinal axis.
[0247] In some examples, the forces of radial compression are provided by one of the following elements: normal physiology of the ureter, abnormal physiology of the ureter or application of any external force. In some examples, the ureteral stent 100 intentionally adapts to a dynamic ureteral environment, comprising: an elongated body 101 comprising a proximal end 102, a distal end 104, a longitudinal axis 106, an outer surface 108 and an inner surface 110, in that the inner surface 110 defines a transformable hole 111 that extends along the longitudinal axis 106 from the proximal end 102 to the distal end 104; wherein the pourable hole 111 comprises: (a) a standard orientation 113A comprising an open hole 114 that defines a longitudinally opened channel 116; and (b) a second orientation 113B comprising an at least essentially closed hole 118 which defines a longitudinally essentially longitudinally closed channel 120, wherein the transformable hole can pass from the orientation
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70/103 standard 113A for the second orientation 113B by applying radial compressive forces 122 to at least a portion of the outer surface 108 of the body 101, wherein the inner surface 110 of the body 101 has a diameter D which is reduced by movement from the transformable bore 111 of the standard orientation 113A to the second orientation 113B, where the diameter is reducible to the point above, where the flow of fluid through the transformable bore 111 would be reduced. In some examples, the diameter D is reduced by up to about 40% in the pourable hole 111 which moves from the standard orientation 113A to the second orientation 113B.
[0248] Further examples of suitable ureteral stents are disclosed in U.S. Patent Application Publication No. 2002/0183853 A1, which is incorporated herein for reference purposes. In some examples, as shown, for example, in FIGS. 4, 5 and 7 of US 2002/0183853 A1 and in FIGS. 23-25 (as well as in Figures 4, 5 and 7 of US 2002/0183853 A1), the ureteral stent comprises an elongated body 10 comprising a proximal end 121, a distal end 141 (not shown), a longitudinal axis 15 and at least one drainage channel (for example, 26, 28, 30 in FIG. 4; 32, 34, 36 and 38 in FIG. 24; and 48 in FIG. 25) that extends along the longitudinal axis 15 from from the proximal end 121 to the distal end 141 to maintain the permeability of fluid flow between a kidney and the patient's bladder. In some examples, the drainage channel is partially open along a longitudinal portion thereof. In some instances, the drainage channel is closed along a longitudinal portion of it. In some instances, the drainage channel is closed along its longitudinal length.
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In some instances, the ureteral stent is radially compressible. In some instances, the ureteral stent is radially compressible to narrow the drainage channel. In some examples, the elongate body 123 comprises at least one outer fin 40 along the longitudinal axis 15 of the elongate body 123. In some examples, the elongate body comprises one to four drainage channels. The diameter of the drainage channel can be the same as described above.
Method of inserting a urine collection set:
[0249] Referring to FIG. 12A, steps for positioning a fluid collection set on a patient's body and, optionally, to induce negative pressure in a patient's ureter and / or kidneys are illustrated. As shown in box 610, a medical or healthcare professional inserts a flexible or rigid cystoscope through the patient's urethra and into the bladder to obtain a view of the ureteral orifices or openings. Once the proper visualization is obtained, as shown in box 612, a guidewire is advanced through the urethra, bladder, ureteral opening, ureter and into a desired fluid collection position, such as the renal pelvis of the kidney. Once the guide wire is brought to the desired fluid collection position, a ureteral catheter of the present invention (examples of which are discussed in detail above) is inserted over the guide wire to the fluid collection position, as shown in box 614. In some examples, the location of the ureteral catheter can be confirmed by fluoroscopy, as shown in box 616. Once the position of the distal end of the catheter is confirmed, as shown in box 618, the retention portion of the ureteral catheter can be deployed. For example, the wire
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72/103 guide can be removed from the catheter, thus allowing the distal end and / or the retention portion to transition to an implanted position. In some instances, the implanted distal end portion of the catheter does not completely obstruct the ureter and / or the renal pelvis, so that urine can pass out of the catheter and through the ureters into the bladder. As the movement of the catheter can exert forces against the tissues of the urinary tract, avoiding complete blockage of the ureters prevents the application of force on the side walls of the ureter, which can cause injuries.
[0250] After the ureteral catheter is positioned and implanted, the same guidewire can be used to position a second ureteral catheter in the other ureter and / or kidney, using the same insertion and positioning methods described here. For example, the cystoscope can be used to view the other ureteral opening in the bladder and the guide wire can be advanced through the visualized ureteral opening to a fluid collection position in the other ureter. A catheter can be designed along the guidewire and implanted in the manner described here. Alternatively, the cystoscope and the guide wire can be removed from the body. The cystoscope can be reinserted into the bladder over the first ureteral catheter. The cystoscope is used, in the manner described above, to visualize the ureteral opening and assist in advancing a second guidewire into the second ureter and / or kidney to position the second ureteral catheter. Once the ureteral catheters are positioned, in some instances, the guidewire and cystoscope are removed. In other examples, the cystoscope and / or guidewire may remain in the bladder to assist in placing the
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73/103 bladder catheter.
[0251] Optionally, a bladder catheter can also be used. Once the ureteral catheters are positioned, as shown in box 620, the medical professional or healthcare professional can insert a distal end of a bladder catheter in a collapsed or contracted state through the patient's urethra and into the bladder. The bladder catheter can be a conventional Foley bladder catheter or a bladder catheter of the present invention, as discussed in detail above. Once inserted into the bladder, as shown in box 622, an anchor connected and / or associated with the bladder catheter is expanded to an implanted position. For example, when an expandable or inflatable catheter is used, the fluid can be directed through an inflation lumen of the bladder catheter to expand a balloon structure located in the patient's bladder. In some instances, the bladder catheter is inserted through the urethra and into the bladder without the use of a guidewire and / or cystoscope. In other examples, the bladder catheter is inserted over the same guidewire used to position the ureteral catheters. Therefore, when inserted in this way, the ureteral catheters can be arranged to extend from the distal end of the bladder catheter and, optionally, the proximal ends of the ureteral catheters can be arranged to end in a bladder catheter drainage lumen. .
[0252] In some instances, urine is allowed to drain by gravity or peristalsis of the urethra. In other examples, negative pressure is induced in the ureteral catheter and / or bladder catheter to facilitate the drainage of urine.
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[0253] With reference to FIG. 12B, the steps for using the urine collection set to induce negative pressure in the ureter and / or kidney are illustrated. As shown in box 624, after the internal parts of the bladder and / or ureteral catheters are positioned correctly and the anchoring / retention structures are implanted, the proximal outer ends of the catheters are connected to the collection or fluid pump assemblies. For example, ureteral catheters can be connected to a pump to induce negative pressure in the patient's renal pelvis and / or kidney. Similarly, the bladder catheter can be connected directly to a urine collection container for gravitational drainage of urine from the bladder or connected to a pump to induce negative pressure in the bladder.
[0254] Once the catheters and pump assembly are connected, negative pressure is applied to the renal pelvis and / or kidney and / or bladder through the drainage lumens of the ureteral catheters and / or bladder catheter, as shown in box 626. Pressure serves to combat congestion-mediated hydrostatic pressures due to elevated intra-abdominal pressure and consequent or elevated renal venous pressure or renal lymphatic pressure. The negative pressure applied is therefore able to increase the flow of filtrate through the medullary tubules and decrease the reabsorption of water and sodium.
[0255] In some instances, mechanical stimulation may be provided to portions of the ureters and / or renal pelvis to complement or modify the therapeutic effects obtained by applying negative pressure. For example, mechanical stimulation devices, such as linear actuators and other
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75/103 devices that provide, for example, vibration waves, arranged in distal portions of the ureteral catheters can be activated. Although this document is not intended to be linked to a single theory, it is believed that this stimulation affects adjacent tissues, for example, stimulating nerves and / or activating peristaltic muscles associated with the ureters and / or renal pelvis. Stimulation of nerves and activation of muscles can produce changes in pressure gradients or pressure levels in the surrounding tissues and organs, which can contribute or, in some cases, increase the therapeutic benefits of negative pressure therapy. In some instances, mechanical stimulation may comprise pulsating stimulation. In other examples, low levels of mechanical stimulation can be provided continuously as negative pressure is delivered through the ureteral catheters. In other examples, inflatable portions of the ureteral catheter can be inflated and deflated in a pulsating manner to stimulate the adjacent nervous and muscular tissue, similar to the performance of the mechanical stimulation devices described herein.
[0256] As a result of the negative pressure applied, as shown in box 628, urine is aspirated into the catheter in the plurality of drainage holes at the distal end of it, through the drainage lumen of the catheter and into a collection container fluid for disposal. As the urine is being attracted to the collection container, in box 630, the sensors arranged in the fluid collection system provide various measurements on the urine that can be used to assess the volume of urine collected, as well as information on the physical condition of the patient and composition
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76/103 of the urine produced. In some examples, the information obtained by the sensors is processed, as shown in box 632, by a processor associated with the pump and / or another patient monitoring device and, in box 634, is displayed to the user through a visual display of an associated feedback device.
Example of fluid collection system:
[0257] Having described an exemplary urine collection set and method of positioning that set on the patient's body, with reference to FIG. 13, a system 700 for inducing negative pressure in the patient's ureters and / or kidneys will now be described. The 700 system can comprise the ureteral catheters, a bladder catheter or the urine collection set described above. As shown in FIG. 13, the 1000 ureteral catheters and / or the bladder catheter are connected to one or more fluid collection vessels 712 to collect the urine removed from the renal pelvis and / or bladder. In some instances, the bladder catheter and ureteral catheters 1000 are connected to different fluid collection containers 712. The fluid collection container 712 connected to ureteral catheters 1000 may be in fluid communication with an external fluid pump 710 to generate negative pressure in the ureters and kidneys through 1000 ureteral catheters. As discussed here, this negative pressure can be supplied to overcome interstitial pressure and form urine in the kidney or nephron. In some instances, a connection between the fluid collection container 712 and the pump 710 may comprise a fluid lock or fluid barrier to prevent air from entering the renal pelvis or kidney in the event of accidental therapeutic or non-therapeutic changes to the
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77/103 pressure. For example, the fluid container inlet and outlet ports can be positioned below a fluid level in the container. As a result, air is prevented from entering the medical tubing or catheter through the inlet or outlet ports of the fluid container 712. As discussed earlier, external portions of the tubing that extend between the fluid collection container 712 and the pump 710 may include one or more filters to prevent urine and / or particles from entering the 710 pump.
[0258] As shown in FIG. 13, system 700 further comprises a controller 714, such as a microprocessor, electronically coupled to pump 710 and having or associated with a computer-readable memory 716. In some instances, memory 716 comprises instructions that, when executed, cause the controller 714 receives information from sensors 174 located in or associated with parts of the array. Information about a patient's condition can be determined based on information from sensors 174. Information from sensors 174 can also be used to determine and implement operational parameters for the 710 pump.
[0259] In some examples, the 714 controller is incorporated in a separate and remote electronic device in communication with the 710 pump, such as a dedicated electronic device, computer, tablet PC or smartphone. Alternatively, controller 714 can be included in pump 710 and, for example, can control a user interface for manual operation of pump 710, as well as system functions, such as receiving and processing information from sensors 174.
[0260] Controller 714 is configured to receive
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78/103 information from one or more sensors 174 and store the information in the associated computer-readable memory 716. For example, controller 714 can be configured to receive information from sensor 174 at a predetermined rate, such as once every second and for determine a conductance based on the information received. In some examples, the algorithm for calculating conductance may also include other sensor measurements, such as urine temperature, to obtain a more robust determination of conductance.
[0261] Controller 714 can also be configured to calculate physical patient statistics or diagnostic indicators that illustrate changes in the patient's condition over time. For example, system 700 can be configured to identify an amount of total sodium excreted. The total sodium excreted can be based, for example, on a combination of flow and conductance over a period of time.
[0262] Still referring to FIG. 13, system 700 may further comprise a feedback device 720, such as a visual display or audio system, to provide information to the user. In some instances, the feedback device 720 can be formed integrally with the pump 710. Alternatively, the feedback device 720 can be a dedicated electronic device or separate multifunctional device, such as a computer, laptop, tablet PC, smartphone or other electronic devices portable. Feedback device 720 is configured to receive calculated or determined measurements from controller 714 and to present information received to a user via feedback device 720. For example, feedback device 720 can
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79/103 be configured to display the negative pressure (in mmHg) being applied to the urinary tract. In other examples, the feedback device 720 is configured to display current urine flow rate, temperature, current conductance in mS / m urine, total urine produced during the session, total sodium excreted during the session, other physical parameters or any combination of these.
[0263] In some examples, the feedback device 720 further comprises a user interface module or component that allows the user to control the operation of the 710 pump. For example, the user can engage or stop the 710 pump via the user interface. . The user can also adjust the pressure applied by the 710 pump to achieve a higher magnitude or rate of sodium excretion and fluid removal.
[0264] Optionally, the feedback device 720 and / or pump 710 further comprises a data transmitter 722 for sending information from device 720 and / or pump 710 to other electronic devices or computer networks. The data transmitter 722 can use a short- or long-range data communication protocol. An example of a short-range data transmission protocol is Bluetooth®. Long-range data transmission networks include, for example, Wi-Fi or cellular data networks. The data transmitter 722 can send information to a patient's doctor or caregiver to inform the doctor or caregiver about the patient's current condition. Alternatively, or in addition, information can be sent from data transmitter 722 to existing databases or information storage locations, in order to,
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80/103 for example, include the information recorded in the patient's electronic medical record.
[0265] Still referring to FIG. 13, in addition to urine sensors 174, in some examples, system 700 further comprises one or more patient monitoring sensors 724. Patient monitoring sensors 724 may include invasive and non-invasive sensors to measure information on urine composition of the patient, as discussed in detail above, blood composition (eg hematocrit ratio, analyte concentration, protein concentration, creatinine concentration) and / or blood flow (eg blood pressure, blood flow rate). Hematocrit is a ratio between the volume of red blood cells and the total volume of blood. The normal hematocrit is about 25% to 40% and preferably about 35% and 40% (for example, 35% to 40% of red blood cells by volume and 60% to 65% of plasma).
[0266] Non-invasive 724 patient monitoring sensors may include pulse oximetry sensors, blood pressure sensors, heart rate sensors and breath sensors (for example, a capnography sensor). Invasive 724 patient monitoring sensors can include invasive blood pressure sensors, glucose sensors, blood speed sensors, hemoglobin sensors, hematocrit sensors, protein sensors, creatinine sensors and others. In yet other examples, the sensors can be associated with an extracorporeal blood system or circuit and configured to measure parameters of the blood that passes through the extracorporeal system tubing. For example,
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81/103 analytes, such as capacitance sensors or optical spectroscopy sensors, can be associated with the extracorporeal blood system tubing to measure patient blood parameter values as it passes through the tubing. The patient monitoring sensors 724 can be in wired or wireless communication with the pump 710 and / or the controller 714.
[0267] In some examples, controller 714 is configured to have pump 710 provide treatment for patient-based information obtained from urine analyte sensor 174 and / or patient monitoring sensors 724, such as blood monitoring. For example, the operating parameters of the 710 pump can be adjusted based on changes in the proportion of hematocrit in the patient's blood, in the concentration of proteins in the blood, in the concentration of creatinine, in the volume of urine production, in the concentration of proteins in the urine. (e.g. albumin) and other parameters. For example, controller 714 can be configured to receive information about a blood hematocrit ratio or patient creatinine concentration from patient monitoring sensors 724 and / or analyte sensors 174. Controller 714 can be configured to adjust parameters pump 710 based on blood and / or urine measurements. In other examples, the hematocrit ratio can be measured from blood samples taken periodically from the patient. The test results can be provided manually or automatically to the 714 controller for processing and analysis.
[0268] As discussed here, the measured values of
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82/103 hematocrit in the patient can be compared with predetermined threshold values or clinically acceptable for the general population. Generally, hematocrit levels for women are lower than values for men. In other examples, the measured hematocrit values can be compared to the patient's baseline values obtained before a surgical procedure. When the measured hematocrit value increases within the acceptable range, the 710 pump can be turned off, ceasing to apply negative pressure to the ureter or kidneys. Similarly, the intensity of the negative pressure can be adjusted based on the measured parameter values. For example, when the patient's measured parameters begin to approach the acceptable range, the intensity of the negative pressure being applied to the ureter and kidneys can be reduced. On the other hand, if an undesirable trend (for example, a decrease in hematocrit value, urine output rate and / or creatinine clearance) is identified, the intensity of the negative pressure can be increased to produce a positive physiological result. For example, pump 710 can be configured to start by providing a low level of negative pressure (for example, between about 0.1 mmHg and 10 mmHg). The negative pressure can be incrementally increased until a positive trend in the patient's creatinine level is observed. However, in general, the negative pressure supplied by the 710 pump will not exceed about 50 mmHg.
[0269] With reference to FIGS. 14A and 14B, an exemplary pump 710 for use with the system is illustrated. In some instances, pump 710 is a micro pump configured to draw fluid from catheters 1000 and with a sensitivity or
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83/103 accuracy of about 10 mmHg or less. Desirably, the 710 pump is capable of providing a urine flow range between 0.05 ml / min and 3 ml / min for long periods of time, for example, for about 8 hours to about 24 hours a day, for example one (1) about 30 days or more. At 0.2 ml / min, it is expected that about 300 ml of urine per day will be collected by the 700 system. The 710 pump can be configured to provide negative pressure to the patient's bladder, with the negative pressure varying between about 0.1 mmHg and 50 mmHg or about 5 mmHg to about 20 mmHg (pressure gauge on pump 710). For example, a micro pump manufactured by Langer Inc. (model BT100-2J) can be used with the currently disclosed 700 system. Pumps with a diaphragm aspirator, as well as other types of commercially available pumps, can also be used for this purpose. Peristaltic pumps can also be used with the 700 system. In other examples, a piston pump, vacuum bottle or manual vacuum source can be used to supply negative pressure. In other examples, the system can be connected to a wall suction source, as made available in a hospital, through a vacuum regulator to reduce negative pressure to therapeutically appropriate levels.
[0270] In some examples, at least a portion of the pump assembly can be positioned inside the patient's urinary tract, for example, inside the bladder. For example, the pump assembly may comprise a pump module and a control module coupled to the pump module, the control module being configured to direct the movement of the pump module. At least one (one or more)
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84/103 between the pump module, control module or power supply can be positioned inside the patient's urinary tract. The pump module can comprise at least one pump element positioned within the fluid flow channel to draw fluid through the channel. Some examples of suitable pump assemblies, systems and methods of use are disclosed in U.S. Patent Application No. 62 / 550,259, entitled Indwelling Pump for Facilitating Removal of Urine from the Urinary Tract, filed concurrently with this application, incorporated herein for reference purposes.
[0271] In some instances, the 710 pump is configured for extended use and is therefore capable of maintaining accurate suction for long periods of time, for example, for about 8 hours to about 24 hours a day, for 1 about 30 days or more. In addition, in some instances, the pump 710 is configured to be operated manually and, in this case, includes a control panel 718 that allows the user to set a desired suction value. The 710 pump may also include a controller or processor, which may be the same controller that operates the system 700 or may be a separate processor dedicated to the operation of the 710 pump. In both cases, the processor is configured to receive manual operating instructions of the pump and to automatically operate the pump 710 according to predetermined operating parameters. Alternatively, or in addition, the operation of pump 710 can be controlled by the processor based on feedback received from the plurality of sensors associated with the catheter.
[0272] In some examples, the processor is configured to make the 710 pump run intermittently. Per
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85/103 example, pump 710 can be configured to emit pulses of negative pressure followed by periods in which no negative pressure is supplied. In other examples, pump 710 can be configured to alternate between supplying negative pressure and positive pressure to produce an alternating discharge and pumping effect. For example, a positive pressure of about 0.1 mmHg to 20 mmHg and, preferably, about 5 mmHg to 20 mmHg can be provided followed by a negative pressure ranging from about 0.1 mmHg to 50 mmHg.
Treatment to remove excessive fluid from a hemodilution patient
[0273] According to another aspect of the disclosure, there is a method for removing excess fluid from a patient with hemodilution. In some instances, hemodilution may refer to an increase in the volume of plasma in relation to red blood cells and / or a reduced concentration of circulating red blood cells, as can occur when a patient receives an excessive amount of fluid. The method may involve measuring and / or monitoring the patient's hematocrit levels to determine when hemodilution has been adequately treated. Low levels of hematocrit are a common post-surgical or post-trauma condition that can lead to undesirable therapeutic results. Thus, the management of hemodilution and the confirmation that the hematocrit levels have returned to normal levels are a desirable therapeutic result for the patient's surgical and post-surgical care.
[0274] The steps to remove excess fluid from a patient using the devices and systems described in this document are illustrated in FIG. 15. As shown in FIG. 15, the treatment method comprises implanting a catheter of the
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86/103 urinary tract, such as a ureteral catheter, in a patient's ureter and / or kidney, to allow urine to flow through the ureter and / or kidney, as shown in box 910. The catheter can be placed to prevent occlusion of the ureter and / or kidney. In some instances, a fluid collection portion of the catheter may be positioned in the renal pelvis of the patient's kidney. In some instances, a ureter catheter can be placed in each of the patient's kidneys. In other examples, a urine collection catheter can be implanted in the bladder or ureter. In some examples, the ureteral catheter comprises one or more of any of the retaining portions described herein.
[0275] As shown in box 912, the method further comprises applying negative pressure to the ureter and / or kidney through the catheter to induce urine production in the kidneys and to draw urine from the patient. Desirably, the negative pressure is applied for a period of time sufficient to reduce the creatinine levels in the patient's blood by a clinically significant amount.
[0276] Negative pressure can continue to be applied for a predetermined period of time. For example, a user may be instructed to operate the pump for the duration of a surgical procedure or for a period of time selected based on the patient's physiological characteristics. In other examples, the patient's condition can be monitored to determine when sufficient treatment has been provided. For example, as shown in box 914, the method may further comprise monitoring the patient to determine when to stop applying negative pressure to the patient's ureter and / or kidneys. In a preferred, non-limiting example, a patient's hematocrit level is measured.
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For example, patient monitoring devices can be used to obtain hematocrit values periodically. In other examples, blood samples may be collected periodically to directly measure hematocrit. In some instances, the concentration and / or volume of urine expelled from the body through the catheter can also be monitored to determine the rate at which urine is being produced by the kidneys. Similarly, the urine output can be monitored to determine the protein concentration and / or the creatinine clearance rate for the patient. The reduced concentration of creatinine and protein in the urine may be indicative of overdilution and / or depressed renal function. The measured values can be compared to the predetermined limit values to assess whether negative pressure therapy is improving the patient's condition and whether it should be modified or discontinued. For example, as discussed here, a desirable range for the patient's hematocrit can be between 25% and 40%. In other preferred and non-limiting examples, as described herein, the patient's body weight can be measured and compared to a dry body weight. Changes in the patient's measured body weight demonstrate that the fluid is being removed from the body. As such, a return to dry body weight represents that hemodilution has been adequately managed and the patient does not have an overdilution condition.
[0277] As shown in box 916, a user can stop the pump from providing negative pressure therapy when a positive result is identified. Similarly, the patient's blood parameters can be monitored to assess the effectiveness of negative pressure
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88/103 applied to the patient's kidneys. For example, a capacitance sensor or analyte can be placed in fluid communication with the tubing of an extracorporeal blood management system. The sensor can be used to measure information representative of blood protein, oxygen, creatinine and / or hematocrit levels. The measured values of blood parameters can be measured continuously or periodically and compared with various limit or clinically acceptable values. Negative pressure can continue to be applied to the patient's kidney or ureter until a measured parameter value falls within a clinically acceptable range. Once the measured values are within the clinically acceptable limit or range, as shown in box 916, the application of negative pressure can be stopped.
Treatment of patients in a fluid resuscitation procedure
[0278] In accordance with another aspect of the disclosure, a method is available to remove excess fluid for a patient undergoing a fluid resuscitation procedure, such as coronary artery bypass surgery, by removing excess fluid from the patient. During fluid resuscitation, solutions such as saline and / or starch solutions are introduced into the patient's bloodstream by an appropriate fluid delivery process, such as an intravenous drip. For example, in some surgical procedures, a patient may receive between 5 and 10 times the normal daily fluid intake. Fluid replacement or resuscitation can be provided to replace body fluids lost through perspiration,
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89/103 bleeding, dehydration and similar processes. In the case of a surgical procedure, such as bypass surgery, fluid resuscitation is provided to help maintain a patient's fluid balance and blood pressure within an appropriate rate. Acute kidney injury (AKI) is a known complication of myocardial revascularization surgery. AKI is associated with prolonged hospital stay and increased morbidity and mortality, even for patients who do not progress to renal failure. See Kim, et al., Relationship between a perioperative intravenous fluid administration strategy and acute kidney injury following off-pump coronary artery bypass surgery: an observational study, Critical Care 19: 350 (1995). The introduction of fluid into the blood also reduces hematocrit levels, which increases mortality and morbidity. Research has also shown that introducing saline into a patient can decrease kidney function and / or inhibit natural fluid management processes. As such, proper monitoring and control of renal function can produce better results and, in particular, reduce cases of AKI in the postoperative context.
[0279] A method of treating a patient undergoing fluid resuscitation is illustrated in FIG. 16. As shown in box 3010, the method comprises implanting a ureteral catheter in a patient's ureter and / or kidney, so that the flow of urine from the ureter and / or kidney is not impeded by occlusion of the ureter and / or kidney. For example, a collection portion of fluid from the catheter can be positioned in the renal pelvis. In other examples, the catheter can be implanted in the bladder or ureter. The catheter may comprise one or more of the
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90/103 ureteral catheters described here.
[0280] As shown in box 3012, optionally, a bladder catheter can also be implanted in the patient's bladder. For example, the bladder catheter can be positioned to seal the opening of the urethra to prevent urine from passing through the body through the urethra. The bladder catheter may include an inflatable anchor (for example, a Foley catheter) to hold the distal end of the catheter in the bladder. The bladder catheter can be configured to collect the urine that entered the patient's bladder before placing the ureteral catheters. The bladder catheter can also collect urine that flows beyond the fluid collection portions of the ureteral catheter and enters the bladder. In some instances, a proximal portion of the ureteral catheter can be positioned in a drainage lumen of the bladder catheter. Similarly, the bladder catheter can be advanced into the bladder using the same guide wire used for positioning the ureteral catheters. In some instances, negative pressure can be supplied to the bladder through the lumen
drainage catheter gives bladder. In others examples, the negative pressure can to be applied catheters only ureters. In that case, The catheter gives bladder drains through
gravity.
[0281] As shown in box 3014, after implantation of the ureteral catheters, negative pressure is applied to the ureter and / or kidney via the ureteral catheters. For example, negative pressure can be applied for a period of time sufficient to draw the urine that comprises a portion of the fluid supplied to the patient during the fluid resuscitation procedure. As described here, the pressure
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91/103 negative can be provided by an external pump connected to a proximal end or port of the catheter. The pump can be operated continuously or periodically, depending on the patient's therapeutic requirements. In some cases, the pump can alternate between applying negative pressure and positive pressure.
[0282] Negative pressure can continue to be applied for a predetermined period of time. For example, a user may be instructed to operate the pump for the duration of a surgical procedure or for a period of time selected based on the patient's physiological characteristics. In other examples, the patient's condition can be monitored to determine when a sufficient amount of fluid has been withdrawn from the patient. For example, as shown in box 3016, fluid expelled from the body can be collected and a total volume of fluid obtained can be monitored. In this case, the pump can continue to operate until a predetermined volume of fluid has been collected from the ureteral catheters and / or the bladder. The predetermined fluid volume can be based, for example, on a fluid volume supplied to the patient before and during the surgical procedure. As shown in box 3018, the application of negative pressure to the ureter and / or kidneys is stopped when the total volume of fluid collected exceeds the predetermined volume of fluid.
[0283] In other examples, the operation of the pump can be determined based on the patient's measured physiological parameters, such as measured creatinine clearance, blood creatinine level or hematocrit ratio. For example, as shown in box 3020, urine collected from the patient
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92/103 can be analyzed by one or more sensors associated with the catheter and / or pump. The sensor can be a capacitance sensor, analyte sensor, optical sensor or similar device configured to measure the concentration of urine analyte. In a similar manner, as shown in box 3022, a patient's blood creatinine or hematocrit level can be analyzed based on information obtained from the patient monitoring sensors discussed above. For example, a capacitance sensor can be placed in an existing extracorporeal blood system. The information obtained by the capacitance sensor can be analyzed to determine a patient's hematocrit ratio. The measured hematocrit ratio can be compared with certain expected or therapeutically acceptable values. The pump can continue to apply negative pressure to the patient's ureter and / or kidney until measured values within the therapeutically acceptable range are obtained. Once a therapeutically acceptable value is obtained, the application of negative pressure can be stopped as shown in box 3018.
[0284] In other examples, the patient's body weight can be measured to assess whether fluid is being removed from the patient by negative pressure therapy. For example, a patient's measured body weight (including fluid introduced during a fluid resuscitation procedure) can be compared to a patient's dry body weight. As used herein, the term dry weight means the normal body weight measured when a patient is not overdiluted. For example, a patient who is not experiencing one or more of the following: blood pressure
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93/103 elevated, dizziness or cramping, swelling of the legs, feet, arms, hands or around the eyes and that you are breathing comfortably, probably does not have excess fluid. A weight measured when the patient does not have such symptoms can be a dry body weight. The patient's weight can be measured periodically until the measured weight approaches dry body weight. When the measured weight approaches the dry weight (for example, it is about 5% and 10% of the dry body weight), as shown in box 3018, the application of negative pressure can be stopped.
Experimental examples:
[0285] Negative pressure induction in the renal pelvis of swine was performed with the aim of evaluating the effects of negative pressure therapy on renal congestion in the kidney. The purpose of these studies was to demonstrate whether negative pressure applied to the renal pelvis significantly increases urine production in a porcine model of renal congestion. In Example 1, a pediatric Fogarty catheter, normally used in embolectomy or bronchoscopy applications, was used in the swine model only for proof of principle for inducing negative pressure in the renal pelvis. It is not intended to suggest that a Fogarty catheter be used in humans in clinical settings to prevent damage to urinary tract tissues. Example 1 Method
[0286] Four 800 pigs were used to assess the effects of negative pressure therapy on renal congestion in the kidney. As shown in FIG. 17, Fogarty 812, 814 pediatric catheters were inserted into the renal pelvis 820, 821 of each kidney 802, 804 of the four pigs 800. The
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94/103 catheters 812, 814 were implanted in the renal pelvis region, inflating an expandable balloon to a size sufficient to seal the renal pelvis and maintain the balloon position within the renal pelvis. Catheters 812, 814 extend from the renal pelvis 802, 804, through the bladder 810 and the urethra 816, and into fluid collection vessels external to the swine.
[0287] The urine production of two animals was collected over a period of 15 minutes to establish a baseline for the volume and rate of urine production. The urine output of the right kidney 802 and that of the left kidney 804 were measured individually and there was considerable variation. The creatinine clearance values were also determined.
[0288] Renal congestion (eg, congestion or reduced blood flow in the kidney veins) was induced in the right kidney 802 and the left kidney 804 of the animal 800, partially occluding the inferior vena cava (IVC) with an inflatable balloon catheter 850 just above the renal vein outlet. Pressure sensors were used to measure VCI pressure. Normal IVC pressures were 1-4 mmHg. When inflating the 850 catheter balloon to approximately three quarters of the IVC diameter, the IVC pressures were raised to between 15-25 mmHg. Balloon inflation to approximately three quarters of the IVC diameter resulted in a 50 to 85% reduction in urine output. Total occlusion generated IVC pressures above 28 mmHg and was associated with a reduction of at least 95% in urine output.
[0289] One kidney from each 800 animal was not treated and served as a control (the 802 control kidney). The 812 ureteral catheter extending from the control kidney was connected to a
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95/103 fluid collection vessel 819 to determine fluid levels. One kidney (treated kidney 804) from each animal was treated with negative pressure from a negative pressure source (for example, an 818 therapy pump in combination with a regulator designed to more accurately control the low magnitude of negative pressures) connected to the 814 ureteral catheter. Pump 818 was an Air Cadet vacuum pump from Cole-Parmer Instrument Company (model No. EW-07530-85). The 818 pump was connected in series to the regulator. The regulator was a miniature precision vacuum regulator of the V-800 series - 1/8 NPT ports (model No. V-800-10-W / K), manufactured by Airtrol Components Inc.
[0290] Pump 818 was activated to induce negative pressure within the renal pelvis 820, 821 of the kidney treated according to the following protocol. First, the effect of negative pressure was investigated in the normal state (for example, without inflating the balloon in the IVC). Four different pressure levels (-2, -10, -15 and -20 mmHg) were applied for 15 minutes each and the rate of urine produced and creatinine clearance were determined. The pressure levels were controlled and determined on the regulator. After therapy with 20 mmHg, the IVC balloon was inflated to increase the pressure by 15-20 mmHg. The same four levels of negative pressure were applied. The urine output rate and the creatinine clearance rate for the congested control kidney 802 and the treated kidney 804 were obtained. The 800 animals were subjected to congestion due to partial IVC occlusion for 90 minutes. The treatment was carried out for 60 minutes of the 90-minute congestion period.
[0291] After collecting urine output data and
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96/103 creatinine clearance, the kidneys of an animal were subjected to a macroscopic examination and then fixed in 10% neutral buffered formalin. After a general examination, the histological sections were obtained, examined and enlarged images of the sections were captured. The sections were examined using an Olympus BX41 vertical optical microscope and the images were captured using an Olympus DP25 digital camera. Specifically, photomicrographic images of the sampled tissues were obtained with low magnification (20x the original magnification) and high magnification (100x the original magnification). The images obtained were submitted to histological evaluation. The objective of the evaluation was to histologically examine the tissue and qualitatively characterize the congestion and tubular degeneration of the samples obtained.
[0292] The surface mapping analysis was also performed on slides obtained from renal tissue. Specifically, the samples were stained and analyzed to assess differences in tubule size for treated and untreated kidneys. The image processing techniques calculated a number and / or relative percentage of pixels with different colors in the dyed images. Calculated measurement data were used to determine volumes of different anatomical structures.
Results
Urine output and creatinine clearance
[0293] Urine output rates were highly variable. Three sources of variation in the urine output rate were observed during the study. Inter-individual and hemodynamic variability were anticipated sources of variability known in the art. A third source of
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97/103 variation in urinary output, with information and beliefs believed to be previously unknown, was identified in the experiments discussed here, namely, contralateral intraindividual variability in urinary output.
[0294] Baseline urine production rates were 0.79 ml / min for one kidney and 1.07 ml / min for the other kidney (a difference of 26%). The urine output rate is an average rate calculated from the urine output rates for each animal.
[0295] When congestion was delivered by inflating the IVC balloon, the urine output of the treated kidney dropped from 0.79 ml / min to 0.12 ml / min (15.2% of the baseline). In comparison, the rate of urine output from the control kidney during congestion dropped from 1.07 ml / min to 0.09 ml / min (8.4% of the baseline). Based on the urine output rates, a relative increase in the urine output of the treated kidney compared to the urine output of the control kidney was calculated according to the following equation:
(Treated in Therapy / Treated in Baseline) / (Control in Therapy / Control in Baseline) = Relative increase (0.12 ml / min / 0.79 ml / min) / (0.09 ml / min / 1.07 ml / min) = 180.6%
[0296] Thus, the relative increase in the urine output rate of the treated kidney was 180.6% compared to the control kidney. This result shows a greater magnitude of decreased urine output caused by congestion on the control side when compared to the treatment side. The presentation of results as a relative percentage difference in urine output allows an adjustment to differences in urine output between the kidneys.
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[0297] Creatinine clearance measurements for the base, congested and treated parts of one of the animals are shown in FIG. 18.
General examination and histological evaluation
[0298] Based on the macroscopic examination of the control kidney (right kidney) and the treated kidney (left kidney), it was determined that the control kidney had a uniform, dark red-brown color, which corresponds to more congestion in the control kidney in compared to the treated kidney. The qualitative evaluation of the enlarged images in the section also observed increased congestion in the control kidney compared to the treated kidney. Specifically, as shown in Table 1, the treated kidney exhibited lower levels of tubular congestion and degeneration compared to the control kidney. The following qualitative scale was used to evaluate the slides obtained.
Congestion
Injury Psatuacao
Nsiinsua: 0
Light: 1
Moderate: 2
Marked: 3
Severe: 4
Taba Degeneration ·
Lesion
None:
Light:.
Moderate:
Checked:
Serious:
Posts 0 1
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99/103
Table 1
TABLE RESILTS
General Number of dsâe Lesses histalògkasTethers debraima tact lares6343 _; -Rim Left, 'Nstisàl R1MÍ3-1 0 6343.Wmwith bleeding R16-513-2 iV 0343 / RhiDirsítaCwssiic R16-313-3 í i á343.®imI will say iaCo & gssiâo R16-3I3-4 71
[0299] As shown in Table 1, the treated kidney (left kidney) exhibited only mild congestion and tubular degeneration. In contrast, the control kidney (right kidney) exhibited moderate congestion and tubular degeneration. These results were obtained by analyzing the slides discussed below. [0300] Figs. 19A and 19B are low and high magnification photomicrographs of the left kidney (treated with negative pressure) of the animal. Based on the histological review, a slight congestion in the blood vessels at the corticomedullary junction was identified, as indicated by the arrows. As shown in FIG. 19B, a single tubule with hyaline cylinders (as identified by the asterisk) was identified.
[0301] Figs. 19C and 19D are low and high resolution photomicrographs of the control kidney (right kidney). Based on the histological review, moderate congestion in the blood vessel at the corticomedullary junction was identified, as shown by the arrows in FIG. 19C. As shown in FIG. 19D, several tubules with hyaline cylinders were present in the tissue sample (as identified by asterisks in the image). THE
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100/103 presence of a substantial number of hyaline cylinders is evidence of hypoxia.
[0302] The surface mapping analysis provided the following results. The treated kidney was determined to have 1.5 times the fluid volume in the Bowman space and 2 times the fluid volume in the lumen of the tubules. The increase in the volume of fluid in the Bowman space and the lumen of the tubule corresponds to the increase in urine production. In addition, it was determined that the treated kidney had 5 times less blood volume in the capillaries compared to the control kidney. The increase in volume in the treated kidney appears to be the result of (1) a decrease in individual capillary size compared to control and (2) an increase in the number of capillaries without visible red blood cells in the treated kidney compared to the control kidney, an indicator less congestion in the treated organ.
resume
[0303] These results indicate that the control kidney had more congestion and more tubules with intraluminal hyaline molds, which represent intraluminal material rich in proteins, compared to the treated kidney. Consequently, the treated kidney exhibits a lesser degree of loss of kidney function. Although this document is not intended to be linked to a single theory, it is believed that, as severe kidney congestion develops, organ hypoxemia follows. Hypoxemia interferes with oxidative phosphorylation within the organ (eg, production of ATP). The loss of ATP and / or a decrease in ATP production inhibits the active transport of proteins, causing the intraluminal protein content to increase, which manifests itself as cylinders of
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101/103 hyaline. The number of renal tubules with intraluminal hyaline cylinders correlates with the degree of loss of renal function. Therefore, the reduced number of tubules in the treated left kidney is believed to be physiologically significant. Although it is not intended to link this document to a single theory, it is believed that these results show that kidney damage can be prevented or inhibited by applying negative pressure to a catheter inserted in the renal pelvis to facilitate urinary output.
Example 2
Method
[0304] The induction of negative pressure in the renal pelvis of swine was carried out with the aim of evaluating the effects of negative pressure therapy on blood hemodilution. The purpose of these studies was to demonstrate whether negative pressure applied to the renal pelvis significantly increases urine production in a swine model of fluid resuscitation.
[0305] Two pigs were sedated and anesthetized with ketamine, midazolam, isoflurane and propofol. One animal (# 6543) was treated with a ureteral catheter and negative pressure therapy as described herein. The other, who received a Foley bladder catheter, served as a control (# 6566). After placing the catheters, the animals were transferred to a sling and monitored for 24 hours.
[0306] Fluid overload was induced in both animals with constant infusion of saline solution (125 mL / hour) during the 24-hour follow-up. The volume of urine output was measured in 15-minute increments for 24 hours. Blood and urine samples were collected from
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102/103 4-hour increments. As shown in FIG. 17, a therapy pump 818 was adjusted to induce negative pressure within the renal pelvis 820, 821 (shown in FIG. 17) of both kidneys using a pressure of -45 mmHg (+/- 2 mmHg). Results
[0307] Both animals received 7 L of saline during the 24-hour period. The treated animal produced 4.22 L of urine while the control produced 2.11 L. At the end of 24 hours, the control retained 4.94 L of the 7 L administered, while the treated animal retained 2.81 L of the 7 L administered. . FIG. 20 illustrates the change in serum albumin. The treated animal had a 6% drop in serum albumin concentration over 24 hours, while the control animal had a 29% drop.
resume
[0308] Although this document is not intended to be limited to a specific theory, it is believed that the data collected supports the hypothesis that fluid overload induces a clinically significant impact on renal function and, consequently, induces hemodilution. In particular, it has been observed that administration of large amounts of intravenous saline cannot be effectively removed by healthy kidneys. The resulting fluid build-up leads to hemodilution. The data also seem to support the hypothesis that the application of negative pressure diuresis therapy in animals with fluid overload can increase urine output, improve liquid fluid balance and decrease the impact of fluid resuscitation on the development of hemodilution.
[0309] Examples and embodiments of the invention
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Previous 103/103 have been described with reference to several examples. Modifications and changes will occur for other embodiments after reading and understanding the previous examples. Therefore, the previous examples should not be construed as limiting disclosure.

权利要求:
Claims (12)
[1]
1. Urethral catheter for placement in a kidney, renal pelvis and / or in a ureter adjacent to a patient's renal pelvis, characterized by the fact that it comprises:
an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to transition from a retracted to an implanted position and which, in the implanted position, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through at least the distal end of the tube.
[2]
2. Ureteral catheter, according to claim 1, characterized by the fact that, when implanted, the three-dimensional shape is positioned to maintain the permeability of the fluid flow between the kidney and the proximal end of the tube, so that at least one portion of the fluid flow flows through the expandable retaining portion.
[3]
3. Ureteral catheter according to claim 1, characterized by the fact that, when implanted, the expandable retention portion is configured to prevent mucosal tissue or uroendothelium from the ureter or renal pelvis to occlude at least part of the expandable retention or distal end of the tube.
[4]
4. Ureteral catheter, according to claim 1, characterized by the fact that, when implanted, the expandable portion maintains the permeability of the distal end of the tube in at least one of the kidneys, renal pelvis or in a ureter
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2/12 adjacent to a patient's renal pelvis.
[5]
5. Ureteral catheter according to claim 1, characterized by the fact that an area of two-dimensional slices of the three-dimensional shape defined by the expandable retention portion implanted in a plane transverse to the central axis of the expandable retention portion increases towards an end distant from the expandable retaining portion.
6. Catheter ureteral, according with the claim 5, featured by the fact that an area of a slice two-dimensional more distant from the way three-dimensional ional is greater what a cross-sectional area of the end distal tube. 7. Catheter ureteral, according with the claim 1, featured by the fact that the tube elongated has one outside diameter of about 0.33 mm to about 3.0 mm. 8. Catheter ureteral, according with the claim 1, featured by the fact that the tube elongated has one internal diameter of about 0.16 mm to about 2.40 mm. 9. Catheter ureteral, according with the claim 1, featured by the fact that the area section maximum
cross-sectional shape defined by the expandable retention portion implanted in a plane transverse to a central axis of the expandable retention portion is up to about 350 mm ² .
10. Ureteral catheter according to claim 1, characterized by the fact that a maximum cross-sectional area of the three-dimensional shape defined by the expandable retention portion implanted in a plane transversal to the central axis of the expandable retention portion is about 10 mm ² to about 350 mm ² .
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12/3
11. Ureteral catheter according to claim 1, characterized in that the axial length of the expandable portion from a proximal to a distal end is from about 5 mm to about 100 mm.
12. Ureteral catheter, according to claim 1, characterized by the fact that the central axis of the expandable retention portion is collinear with a central axis of the tube.
13. Ureteral catheter according to claim 1, characterized by the fact that the distal end of the tube is at least partially enclosed by the three-dimensional shape defined by the expandable retention portion.
14. Ureteral catheter according to claim 1, characterized in that the expandable retaining portion comprises at least two elongated members extending from the distal end of the tube.
15. Ureteral catheter according to claim 14, characterized by the fact that at least one of the elongated members is inclined to form a structure sufficient to maintain the position and volume of the three-dimensional shape defined by the implantable expandable portion.
16. Ureteral catheter according to claim 14, characterized by the fact that at least one of the elongated members is inclined to form a sufficient structure to maintain the position and volume of the three-dimensional shape defined by the expandable portion implanted when the negative pressure is exposed to the ureter and / or kidney.
17. Ureteral catheter according to claim 1, characterized in that the expandable retaining portion comprises a flexible material deflected to an implanted position.
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4/12
18. Catheter ureteral, in according to claim 17, featured by the fact in that material flexible comprises a material with memory in form. 19. Catheter ureteral, in according to claim 17, featured by the fact in that material flexible comprises
one or more among nitinol, titanium, chromium, silicone, polyethylene, polyethylene terephthalate, polyurethane and polyvinyl chloride.
20. Ureteral catheter according to claim 1, characterized in that the expandable retaining portion is attached to a portion of an inner surface and / or an outer surface of the tube.
21. Ureteral catheter according to claim 1, characterized in that the expandable retaining portion comprises at least two elongated members connected to a central portion, which extends through a portion of the drainage lumen defined by the tube.
22. Ureteral catheter according to claim 1, characterized in that the expandable retaining portion comprises at least one elongated member comprising a first end and a second end, each of which is at least partially enclosed within the lumen of drainage defined by the tube and a medium portion that protrudes from the distal end of the tube.
23. Ureteral catheter according to claim 1, characterized in that the expandable retaining portion comprises at least one elongated member comprising at least a first curve in a first direction and a second curve in a second direction, wherein the
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5/12 second direction is not coplanar with the first direction.
24. Ureteral catheter according to claim 1, characterized by the fact that the expandable retaining portion comprises an elongated central member extending from the distal end of the tube and at least one flexible expandable disk with a central portion connected to the central member and a peripheral portion that extends around the central member.
25. Ureteral catheter according to claim 24, characterized in that at least one disc has a diameter of about 1.5 mm to about 25 mm.
26. Ureteral catheter according to claim 24, characterized in that the one disk comprises at least two rods and a circumferential ring and each of the two rods comprises a first end connected to the central member and a second end connected to the circumferential ring.
27. Ureteral catheter according to claim 24, characterized in that the disc of the expandable retaining portion comprises at least one first disc connected to the central member and a second disc connected to the central member in a position distal to the first member.
28. Ureteral catheter according to claim 27, characterized by the fact that the diameter of the second disc is greater than or equal to the diameter of the first disc.
29. Ureteral catheter according to claim 1, characterized in that the three-dimensional space defined by the expandable retention portion encloses at least a portion of the distal end of the elongated tube.
30. Ureteral catheter according to claim 29,
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[6]
6/12 characterized by the fact that the expandable retaining portion comprises at least one annular member that extends around the tube and at least one support that connects the annular member to a portion of the tube.
31. Ureteral catheter according to claim 30, characterized in that the annular member comprises straight portions and curved portions arranged to form a circuit pattern.
32. Ureteral catheter according to claim 31, characterized in that the circuit pattern comprises one or more of a zigzag pattern, a sinusoidal pattern, a square wave pattern and any combination thereof.
33. Ureteral catheter according to claim 29, characterized in that the expandable retention portion comprises:
at least two annular members extending around the tube, with at least two annular members arranged in such a way that portions of one of the annular members cross parts of the other annular member; and at least two stents connecting the annular members to the tube.
34. Method to facilitate urine output from a patient's kidney, characterized by the fact that it comprises:
(a) insert a ureteral catheter into at least one of the kidneys, renal pelvis or ureter adjacent to the renal pelvis, where the catheter comprises:
an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends
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[7]
7/12 through the tube; and an expandable retaining portion configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through the distal end of the tube;
(b) implanting the expandable retention portion in the kidney, renal pelvis or ureter adjacent to the renal pelvis to maintain the distal end of the tube in a desired position in the kidney, renal pelvis or ureter adjacent to the patient's renal pelvis; and (c) applying negative pressure to the drainage lumen of the tube through a proximal portion of the tube for a period of time to facilitate urine output from the kidney.
35. Method according to claim 34, characterized in that the expandable retaining portion is configured to prevent mucosal or uroendothelium tissue from the ureter and / or renal pelvis from obstructing at least the distal end of the tube.
36. Method according to claim 34, characterized in that the expandable retaining portion comprises at least two elongated members extending from the distal end of the bent tube to form a structure sufficient to maintain position and volume three-dimensional shape defined by the implantable expandable portion.
37. Method according to claim 34, characterized in that the expandable retaining portion comprises a flexible material deflected into the expanded position of the expandable retaining portion.
38. Method according to claim 37, characterized
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[8]
8/12 due to the fact that the flexible material comprises a material with shape memory.
39. Method according to claim 34, characterized in that at least part of the expandable retaining portion is mounted on an internal surface and / or on an external surface of the tube.
40. Method according to claim 34, characterized in that the expandable retaining portion comprises a central portion, which extends through a portion of the drainage lumen and at least two elongated members having a first end connected to the portion center and a second end extending from the distal end of the tube.
41. Method according to claim 34, characterized by the fact that a maximum cross-sectional area of the three-dimensional shape defined by the expandable retaining portion implanted in a plane transverse to a central axis of the expandable retaining portion is about 10 mm ² to 350 mm ² .
42. Ureteral catheter for placement in kidney, renal pelvis and / or in a ureter adjacent to a patient's renal pelvis, characterized by the fact that it comprises:
an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to move from a retracted position to an implanted position and which, in the implanted position, is configured to maintain the
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[9]
9/12 distal end of the tube in the kidney, renal pelvis and / or ureter adjacent to the patient's renal pelvis and to maintain fluid flow from the kidney through the distal end of the tube, wherein the expandable retaining portion comprises at least one flexible member comprising:
a first end positioned within a cylindrical space defined by an external surface of the side wall of the elongated tube and extending distally from the distal end of the tube along a central axis of the expandable retaining portion; and a more distal portion in relation to the distal end of the elongated tube, which extends radially outwardly from the cylindrical space.
43. Ureteral catheter according to claim 42, characterized in that the expandable retaining portion comprises at least two elongated flexible members and in which the area of a two-dimensional slice defined by at least two flexible members in a plane transverse to the central axis of the expandable retaining portion is greater than the cross-sectional area of the distal end of the elongated tube.
44. Ureteral catheter according to claim 42, characterized in that the expandable retaining portion comprises a flexible material deviated to the implanted position of the expandable retaining portion.
45. Ureteral catheter according to claim 44, characterized in that the flexible material comprises a material with shape memory.
46. Ureteral catheter, according to claim 42, characterized by the fact that the cross-sectional area of the
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[10]
10/12 most distal part of the expandable retaining portion is about 10 mm ² to 350 mm ² .
47. Ureteral catheter according to claim 42, characterized in that the axial length of the expandable portion from a proximal to a distal end is about 5 mm to 100 mm.
48. Ureteral catheter according to claim 42, characterized in that the elongated tube has an outside diameter of about 0.33 mm to 3.0 mm.
49. System to induce negative pressure in a portion of a patient's urinary tract, with the system being characterized by the fact that it comprises:
at least one ureteral catheter comprising:
an elongated tube comprising a proximal end, a distal end and a side wall that extends between the proximal end and the distal end of the tube, defining at least one drainage lumen that extends through the tube; and an expandable retaining portion configured to be implanted from the distal end of the tube and, when implanted, defines a three-dimensional shape positioned to maintain fluid flow from the kidney through the distal end of the tube; and a pump in fluid communication with the drainage lumen, the pump being configured to induce negative pressure in a portion of the patient's urinary tract to aspirate fluid through the drainage lumen of the ureteral catheter.
50. System according to claim 49, characterized by the fact that the expandable retaining portion of the ureteral catheter is configured to prevent mucosal tissue or
Petition 870190108371, of 10/25/2019, p. 124/155
[11]
11/12 uroendothelium of the ureter and / or renal pelvis to obstruct at least the distal end of the tube.
51. System according to claim 49, characterized by the fact that, when implanted, the expandable portion maintains the permeability of the distal end of the tube in the kidney, renal pelvis and / or in a ureter adjacent to a patient's renal pelvis.
52. System according to claim 49, characterized in that the expandable retaining portion of the ureteral catheter comprises at least two elongated flexible members and in which the area of the two-dimensional slice defined by the at least two flexible members in a transverse plane to the central axis of the expandable retaining portion is greater than the cross-sectional area of the distal end of the elongated tube.
53. System according to claim 49, characterized in that the expandable retaining portion comprises a flexible material deviated to the implanted position.
54. System according to claim 53, characterized by the fact that the flexible material comprises a material with shape memory.
55. System according to claim 49, characterized by the fact that the pump is configured to generate the position and / or negative pressure at a proximal end of the drainage lumen.
56. System according to claim 49, characterized by the fact that the pump applies a negative pressure of about 100 mmHg or less to a proximal end of the drainage lumen.
57. System according to claim 49, characterized
Petition 870190108371, of 10/25/2019, p. 125/155
[12]
12/12 due to the fact that the pump is configured to operate at one of the three pressure levels selected by a user, with the pressure levels generating a negative pressure from 2 to 125 mmHg.
58. System according to claim 49, characterized by the fact that the pump is configured to alternate between generating negative pressure and generating positive pressure.
59. System according to claim 49, characterized by the fact that the pump has a sensitivity of about 10 mmHg or less.

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法律状态:
2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|

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2022-02-01| B25A| Requested transfer of rights approved|Owner name: ROIVIOS LIMITED (BS) |

优先权:

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申请号 | 申请日 | 专利标题

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US201762489789P| true| 2017-04-25|2017-04-25|

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US201762489831P| true| 2017-04-25|2017-04-25|

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US201815745823A| true| 2018-01-18|2018-01-18|

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